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Perfusion Insider Archives

July 2010 Product News

Perfusion Study shows Medtronic AFFINITY® Arterial Filter with Carmeda® BioActive Surface and Trillium® Biosurface to be most hemocompatible

Research has shown the importance of biocompatible surfaces and their role in mitigating inflammatory response during cardiopulmonary bypass (CPB). With the large surface areas they contribute to the circuit, and with the variety of filter-coating materials used by manufacturers to improve blood-filter biocompatibility, it was useful to determine the efficacy of individual filters. Hussaini, et al “evaluated eight biocompatible coatings used for arterial filters and their effects on blood components during circulation.” 1

The study, recently published in Perfusion, was conducted on eight anesthetized, intubated, and ventilated adult male swine (82.4±8.7 kg). Each animal was heparinized to achieve a target activated clotting time (ACT) of ≥ 250 seconds. Y-connectors were used to attach the arterial cannula to eight Carmeda-bonded tubing loops (1/4”). Each loop passed through a roller pump and was then connected to one of eight randomly assigned arterial filters (AF). Circuits were primed with Ringers Lactate solution, then filled with blood. The circuits were placed in a 37-degree water bath and circulation was started. The chart below shows the filters that were tested.

Manuf.Coating*Heparin
MedtronicCarmedaY
MedtronicTrilliumY
GishGBSY
Maquet (Jostra)BiolineY
TerumoHeparin**Y
Maquet (Jostra)SafelineN
Sorin (COBE)SMARxTN
TerumoXcoatingN

*GBS is a registered trademark of Medos Medizintechnik AG. Bioline and Safeline are trademarks of the Getinge Group. Xcoating is a trademark of the Terumo Corporation. SMARxT is a trademark of the Sorin Group.
**NOTE: available in Japan only.

Blood samples were drawn from each loop prior to systemic heparinization, immediately following achievement of ACT post-heparinization, and after 30 minutes of blood circulation. Red blood cell, platelet and white blood cell (WBC) counts, as well as thrombin/antithrombin complex all decreased after 30 minutes of circulation for all eight AF circuits tested.

The WBC counts were the only study parameter that demonstrated statistically significant differences (p=0.0005) between filters at 30 minutes. “The average WBC count at baseline was 18.84±4.92 x 103/mm3. In comparison to the baseline value, the WBC counts in the Carmeda and Trillium circuits both decreased by 5.5%, 17.84±4.64 x 103/ mm3 and 17.84±4.43 x10/ mm3, respectively.” These results contrasted with the greatest white blood cell count decline, 41%, 11.13±1.6 x 103/ mm3 (Terumo X-coated filter).

Hussaini, et al noted that the activation of WBCs may initiate the release of inflammatory cytokines and that the reduction in WBCs may adversely affect wound healing and resistance to post-operative healing.

The study concluded that “the Carmeda Bioactive and the Trillium Biopassive filters were the most hemocompatible” of the filters tested in this study. For more information on the Medtronic Carmeda and Trillium coated filters, please contact your Medtronic representative.

Reference

  1. Hussaini BE, Treanor PR, Healey NA, et al. Evaluation of blood components exposed to coated arterial filters inextracorporeal circuits. Perfusion. 2009; 24(5)317-323.

The Hybrid OR of the Future: An Integrated Approach

Medtronic Perfusion Systems partnered with Siemens and other technology manufacturers to host a workshop featuring the hybrid OR of the future. Held at the American Association of Thoracic Surgery 90th Annual Meeting, May 1-5, 2010, in Toronto, Canada, the workshop and exhibit were well attended by more than 800 health care professionals, surgeons and perfusionists eager to experience the future of imaging and advanced hybrid OR technologies.

Interdisciplinary Approach Builds Excitement for the Future

Workshop participants were excited to learn how an interdisciplinary approach to supporting patient care could include teams of interventional cardiologists, cardiac and vascular surgeons as well as perfusionists and anaesthesiologists. Procedures such as transcatheter heart valves are fast becoming alternatives to conventional surgery and are best performed in a hybrid OR using highly advanced imaging systems. The workshop emphasized that the hybrid OR is a collaborative environment that encourages clinicians to look for new ways to care for patients who require the complex procedures of the future.

According to John Byrne, MD., chairman, department of cardiac surgery, Vanderbilt Heart and Vascular Institute, Nashville, TN, “the goal [was] to demonstrate the value of incorporating imaging equipment and catheter-based technologies into a traditional cardiac/general thoracic surgery operating room.”

Key technologies on exhibit in this futuristic OR included:

Perfusion

  • Medtronic showcased the Performer® CPB Extracorporeal Circulatory Support System, which has a substantially smaller footprint and can be used with "mini-circuits" such as the Resting Heart® System to innovate cardiac surgery procedures. Future Cardiac Surgery Therapies

Future Cardiac Surgery Therapies

  • With a focus on offering more cardiac patient care options and improved collaboration among cardiac specialties, Medtronic displayed their latest technologies and therapies, including transcatheter valves, ablation and endovascular stent grafts along with enabling technologies such as minimally invasive cannulae and tissue stabilizers.

Imaging Systems

Highly advanced imaging systems are critical to the success of a hybrid OR, particularly with the evolution of transcatheter heart valves and endovascular therapy in the aorta and peripheral vessels. Imaging technologies presented at this workshop included:

  • Siemens Artis Zeego® imaging employs the first-ever interventional C-arm system with robotic technology
  • ACUSON SC2000 ™ volume imaging ultrasound represents the latest evolution in echocardiography
  • AXIOM Sensis hemodynamic monitoring integrated with syngo® Dynamics data exchange and reporting provide seamless data exchange and reporting
  • RAPIDPoint 400/405 Analyzer and Stratus® CS Acute Care™ Diagnostics provide central lab accuracy and reliable cardiac marker results at the point-of-care

Many other technologies, product systems, and presentations were part of this exciting workshop. To assure success and to enhance the quality and efficacy of patient care in the new hybrid ORs, panelists emphasized the importance of involving every discipline affected by these changes in the planning process.

See more at the AATS website:
http://www.aats.org/annualmeeting/Operating-Rooms-of-the-Future.html

New Perfusion Resources

 

Medtronic Perfusion Systems: A bright future lies ahead

In response to input from you, our customers, Medtronic Perfusion Systems revealed its new Perfusion Business Website on April 28th at the 48th International Conference for AmSECT held in Reno, Nevada. The website offers easy access to the latest information about our products, education, clinical and capital equipment services. And, it features all Medtronic adult and pediatric cardiopulmonary, cannulae, blood management and diagnostics products.

Along with product and service information, the site features our engaging “Our Commitment” video, which defines our commitment to perfusion solutions and the strategies we'll use to achieve it.

The website project is still in its infancy and will be continuously updated; improvements will enhance your engagement opportunities on this site over the course of an exciting year ahead, along with providing a resource for perfusionists to review timely information. Visit often and share your thoughts via the site's Contact Us form.

Shape the Future with Medtronic Academia Education and Training

Perfusionists and blood management specialists come together at Medtronic Academia education and training programs to share their experience and unique approaches to improvements in cardiac surgical procedures. Through Medtronic Academia they deepen their expertise, expand their treatment options, and improve the patient care they provide.

While clinical needs change over time, the cutting edge learning experiences offered through Medtronic Academia anticipate them, helping participants keep pace with the constant advancement in perfusion and blood management. Academia education and training gives clinicians the flexibility to build their skills on their own terms with an unmatched breadth of interdisciplinary programs. Medtronic Academia’s innovative instruction ranges from hands-on-training, peer-to-peer and interactive discussions, live cases and labs to virtual reality simulations and remote access learning.

Join our faculty and your colleagues at Medtronic Academia for dynamic learning, vital connections and inspiring results. Discover relationships of immediate value and receive ongoing support. Contact your Medtronic representative for a recommendation on programs that can best serve your practice and your patients.

Mission in Action

 

Medtronic Donations Help on the Ground in Haiti

After the 7.0 magnitude earthquake struck Haiti on January 12, Medtronic put out a call to business units for product donations. Medtronic CardioVascular’s Coronary and Perfusion business group responded to the immediate need to save lives with $150,000 in donated products.

Jeanne Stanislawski, Custom Pack Product Manager for CardioVascular’s Perfusion Marketing group, knows how to get things done. She routinely works one-on-one with perfusionists to handle tough product situations in the operating room, responds to remove obstacles to manufacturing and design, and quickly resolves high-priority perfusion and patient concerns. When she learned that Medtronic needed product donations for the relief effort in Haiti, she realized immediate action was key. "I had only a few days to identify the supplies needed, find available product, review the list with country managers, regulatory and customs agencies, and get final approval to ship out the donations,” Jeanne said. “I’ve handled the coordination of product donations before through the usual channels. That can be time-consuming enough. In this case, we needed to bypass the normal process to make this happen.”

Making It Happen

Jeanne quickly formed an ad hoc cross-functional team. After assessing the needs of the field hospitals scattered across Haiti, Jeanne’s team found that they desperately needed basic disposable surgical supplies. The team decided that Medtronic’s cardiopulmonary bypass packs ... loaded with tubes, connectors and oxygen filters ... could be used in a wide variety of surgical procedures. Within one day, they gathered more than 3,000 packs to donate.

Living the Mission

With the guidance of the Medtronic Foundation, the packs were sent to the Hospital Sisters Mission Outreach. This organization, a nonprofit based in Springfield, Illinois, works with health care organizations to recover and responsibly redistribute medical supplies. This unexpected disaster provided another opportunity for Medtronic to fulfill our mission to alleviate pain, restore health and extend lives.

“I’ve been a part of Medtronic for many years, and I love helping people,” Jeanne said. “However, this experience made me realize how much more we can do for people in need. I think everyone on our team has a newfound motivation to search out unused products within our organization and get them out to the people who need them the most. To me, that’s a perfect example of living the Medtronic Mission.”

Nearly $900,000 in Medtronic Product Donations

In total, Medtronic donated nearly $900,000 worth of medical devices toward the relief efforts in Haiti. More than $150,000 came from CardioVascular and another $730,000 came from Spine.

Florida Agency for Healthcare Administration (AHCA) Allows Perfusionists Restricted Use of the Medtronic HMS Plus

In 2009, the State of Florida Agency for Healthcare Administration (AHCA) made changes to the rule that provides guidance on diagnostic testing at alternative laboratory sites. At the time, the AHCA ruled that the use of the Medtronic HMS Plus to perform heparin assay testing did not meet the requirements in the changed alternative testing site rule. The result of the determination was that perfusionists would no longer be allowed to perform the testing, and In order for the HMS Plus to be used during cardiac surgery, a licensed Medical Technologist would need to be present to perform the testing. This resulted in the laboratory staff at one Florida hospital being trained to use the HMS Plus, and staffing adjustments made at that laboratory in order to have a Medical Technologist present for all cardiac cases.

Since hearing of this rule change, Medtronic has worked with laboratory and perfusion staff from several Florida hospitals to provide appropriate information and educational materials to assist them in educating the AHCA Laboratory Agency staff on the function and use of the HMS Plus.

On May 25, 2010, Marsha Cusulos MT ASCP, Medtronic Perfusion Systems Technical Specialist, attended a public meeting held by AHCA in order to provide the agency with additional information and support for use of the HMS Plus by Florida perfusionists. As a result, the AHCA is now allowing the use of the HMS Plus by perfusionists with the following restrictions:

  • The HMS Plus may be used to perform ACT and Heparin Assay Testing.
  • The HMS Plus Heparin Assay may be performed only if the HMS Plus is set at “CPB Pump Calc” or “Test Only”.
  • The person using the HMS Plus may not access the Protamine Dose Screen of the Heparin Assay test result.

Medtronic will continue to work with the Florida AHCA staff to provide information needed for a successful challenge to the elements of the alternative testing site rule that limit the use of the HMS Plus.

"The HMS Plus is a unique technology that is used to determine patient specific heparin dosing requirements and appropriate protamine titration during cardiac surgery. In an era of great concern over blood conservation, the HMS Plus has gained widespread acceptance in clinical practice and is in fact utilized by 60% of the country's top 50 hospitals".

 

August 2010 Product News

Medtronic Expands the AFFINITY® Family of Perfusion Products with Release of the AFFINITY™ CP Centrifugal Blood

affinitycp-s

In the tradition of blood handling excellence associated with AFFINITY® perfusion products, Medtronic received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on June 22, 2010, to market the AFFINITY™ CP centrifugal blood pump. The AFFINITY CP Centrifugal Blood Pump is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants). The AFFINITY CP Centrifugal Blood Pump is driven by the External Drive Motor or the Emergency Handcrank. The AFFINITY CP is a low prime centrifugal blood pump that gently handles blood, resulting in low hemolysis.

“Medtronic is excited to continue the great tradition of consistent, dependable performance associated with the AFFINITY family of perfusion products. By expanding the AFFINITY family to include centrifugal pumps, we are able to provide clinicians a low prime solution that includes the options they want and need. The AFFINITY CP pump combines the benefits of a smooth cone with low profile fins in a compact size.” said Tamara Bratland, Senior Product Manager, Perfusion Marketing Medtronic CardioVascular.

The AFFINITY™ CP pump, used with the Bio-Console® system, provides the durability that has long been a hallmark of Medtronic centrifugal pump products. The pump's design allows for even blood flow at lower RPMs as well as low shear and no stagnant blood zones, resulting in reduced heat generation and low hemolysis.

The AFFINITY™ CP is the newest addition to Medtronic's expanding AFFINITY family. For more information, contact your Medtronic representative.

Great Ormond Street Hospital First to Clinically Use New Medtronic Pediatric Oxygenator for Heart Surgery

Great Ormond Street Hospital for Children NHS Trust, London, England, one of the most prestigious pediatric medical institutions in the world, successfully used the new Medtronic Affinity PixieTM Oxygenation System for infant and pediatric heart surgery in the device's first clinical cases.

e-pixie

Affinity Pixie Oxygenation System adds oxygen to the blood and removes carbon dioxide during infant and pediatric heart surgery.

Richard Crook, Deputy Chief Perfusionist at Great Ormond Street Hospital, oversaw the first use of the oxygenator in surgery. “We’re very pleased to be able to use this new oxygenator. At Great Ormond Street Hospital, we pride ourselves on being an early implementer of new technology to help give the very best care to our patients. When you’re operating on babies and young children, improvements in medical equipment like this can make a vital difference. This new product provides a strong option for further optimization of our perfusion practice,” Cook commented.

The Affinity Pixie Oxygenation System with BalanceTM Biosurface* is a sophisticated system that adds oxygen to the blood and removes carbon dioxide. The Affinity Pixie System gained CE Mark for clinical use throughout the European Union in April 2010, but is not yet cleared for clinical use in the United States. With a maximum flow rate of 2.0 L/min and a low oxygenator prime volume of just 48 mL, the Affinity Pixie System can be used to support approximately 75% of the neonate, infant and pediatric population undergoing cardiopulmonary bypass. The system features the Affinity OrbitTM Holder System, which provides flexibility in device positioning and port orientation to help reduce circuit tubing length and associated prime volume.

The system also incorporates new design elements, such as a hydrophilic biosurface without heparin (Balance Biosurface), to minimize the interaction of the patient's blood with foreign surfaces inside the device. This helps to preserve platelet function and patient hemostasis.

Mark Rathbone, Medtronic UK & Ireland Cardiovascular Business Director, commented, “At Medtronic we are committed to ongoing innovation in medical technology. Each year we invest nearly 10 percent of global revenues in R&D. Every 2 minutes, the Affinity NT oxygenator [for adult cardiopulmonary bypass], is used somewhere in the world. It is our intention to bring the Affinity Pixie Pediatric Oxygenation System to that same level of use, supporting young patients around the world.”

The Affinity Pixie Oxygenation System is the newest development in Medtronic's overall program to develop a range of innovative perfusion products to support surgery for children and adults.

*Technology licensed under agreement from BioInteractions Limited, United Kingdom.

Medtronic's New Clear Tray for Custom Packs Enhance Content Visibility

custompack-intro-bth

As part of their commitment to customer satisfaction, Medtronic has developed a new clear tray for custom packs that enhances content visibility while maintaining the pack's sterility. While lighter weight than previous packaging, the new clear trays are stronger and more durable. They are made of polyethylene terephthalate glycol (PETG), a plastic that provides greater content protection. The label on top of each clear custom pack tray clearly identifies the contents.

For many years, Medtronic’s standard packaging for custom packs was a simple corrugated box with a blue tray and sterilization wrap. As hospitals become more environmentally conscious, they have urged manufacturers to reduce packaging components. In response, Medtronic’s packaging engineers have developed a clear plastic tray with a Tyvek® lid for their custom packs. This design replaces the current blue plastic packaging system, thus reducing packaging by 10%.

As part of the design process, the Medtronic packaging development team reviewed the concept with many customers to obtain their feedback. Customer comments have been very positive about the pack's transparency and the sleek Tyvek lid, which, the customers agreed, made the pack "much easier to open than the old tray with the sterilization wrap.”

New custom pack orders are currently available in the new clear tray design in six sizes. Existing custom packs will be available in this design by the end of August 2010.

New Perfusion Resources

 

Medtronic Partners with Spectrum Medical to Bring Innovative Solutions to Cardiac Perfusionists and ECMO Providers

In June 2010, Medtronic entered into an agreement with Spectrum Medical, a leading supplier of diagnostic technologies for cardiovascular perfusion and extracorporeal membrane oxygenation (ECMO) clinical specialties, which grants Medtronic exclusive US distribution rights for territories not currently covered by Spectrum Medical and its partners. Spectrum Medical supplies diagnostic products and electronic medical record systems for cardiovascular perfusion and ECMO support. The company has devoted significant capital and creative resources to develop non-invasive patient monitoring and clinical data collection systems that harmonize with the hospital environment.

VIPER, a variable input patient electronic record, and VISION, its associated database and overall system management module, use open architecture and Web-based technology that make them compatible with all products in the OR. These systems are perfusion tools that compliment the hospital program’s compliance strategies. The clinician can generate an electronic chart, set up customized pre-sets and alerts, manually enter data, and automatically collect data downloaded from various devices in the clinical unit. The electronic chart can then be stored in various locations, including the hospital information system. Charts may also be stored in the VISION online database and later queried to generate a range of management and compliance reports. Reports are tailored to meet the needs of each clinical program and can be re-designed at any time.

Medtronic products have been used in over 60,000 ECMO procedures, using the only artificial lung with a US indication for long-term use. With the industry's most extensive portfolio of products for extracorporeal support, Medtronic has led the market in developing and introducing innovative technologies such as oxygenators, centrifugal pumps, coatings, mini-bypass, and hemostasis management systems. Medtronic’s minority investment in Spectrum Medical, which was announced earlier this year, is part of its commitment to supporting perfusionists in their continuous effort to improve the quality of patient care and streamline hospital efficiencies.

Spectrum Medical remains a private, independent company with operations in the US and UK. Spectrum Medical will continue to support the purchase, installation and future development for these and additional platforms. For additional information on Spectrum Medical’s VIPER and VISION systems and the M3 non-invasive monitoring system, go to www.spectrummedical.com. Medtronic also provides comprehensive financial solutions to meet the needs of your individual hospital or institution. For more details or to schedule a product demonstration, visit www.perfusion.medtronic.com or contact your Medtronic sales representative.

Mission in Action

 

Customer-Focused Quality Key to Product Placement in Prominent Australian Hospital

e-aus

AFFINITY NT® Oxygenators delivered to the hospital within 48 hours

AFFINITY NT® Oxygenators delivered to the hospital within 48 hours

For the last two years, a prominent Australian hospital had been using a competitive oxygenator product line exclusively. As the manufacturer of this product line increased their marketing protection strategies, the hospital became increasingly dissatisfied with the competitor's tactics. For example, the manufacturer insisted that the hospital abandon its custom pack design in favor of a more generic design used in Europe; they discontinued supplying certain products as individual components; and they constantly extended delivery lead times. In May 2010, the Australia Medtronic perfusion team received a call from the hospital's chief perfusionist, who told them that he was notifying all oxygenator suppliers that the hospital would be tendering within a week for a two-year contract with a one-year renewal option.

The Medtronic perfusion team scheduled a presentation to update the hospital reviewing committee on the AFFINITY NT® product line and to assure them of the company's commitment to it. “We needed to convince them that Medtronic was here to stay. And we wanted to share our enthusiasm about products in the pipeline,” said Patricia Currie, Senior Product Manager – Structural Heart Business ANZ (Australia, New Zealand).

The next day, the hospital called Currie and asked for an urgent quote for delivery of 30 AFFINITY NT oxygenators. On-site systems had malfunctioned and a quote from an alternative product source was needed within 90 minutes. “This was an excellent opportunity for Medtronic to demonstrate our commitment to responsive customer service,” said Currie. “I made sure that the department head had the quotation on his desk within 25 minutes.”

Two hours later, the hospital issued a purchase order for 30 units. Medtronic delivered the stock within 48 hours. Impressed by the excellent customer service, efficient turn-around, and product reliability, the hospital placed orders for 50, then 100 more AFFINITY oxygenators, a testament to the faith the hospital now has in Medtronic’s products and service.

The hospital tender has been postponed until 2011. In the meantime, Medtronic is committed to continuing to deliver excellent service.

CardioVascular Academia Hosts “Advanced Topics” for Rush University Perfusion Students

On June 21-22, 2010, the CardioVascular Academia program, a cutting edge education and training program designed to help participants keep pace with advances in the field of perfusion, hosted 13 perfusion technology students from Rush University, Chicago, IL.

The program teaches students the science behind the design of perfusion products. “Perfusionists are taught the clinical aspects of perfusion in school. This course expands that learning to include the technology associated with product functionality. By the course’s conclusion, participants have a clearer understanding of how perfusion equipment is designed and how devices function,” said Mark Bearss, Medtronic Perfusion Education and Training Program Manager.

Over the course of this 1½-day program, students gain knowledge about perfusion science, research findings, technology, and testing methodologies. The program includes interactive classroom discussion and a tour of the Medtronic Perfusion manufacturing facility, where students could observe the direct assembly of main perfusion components including the AFFINITY NT® oxygenator. Following the tour, students agreed that it was “an exciting and invaluable experience to see the manufacturing plant and to talk with the operators. They helped us understand the process associated with making the products and the attention and care paid to testing them.”

Robin Sutton, Chief Perfusionist at Rush University Medical Center and Clinical Coordinator of the Rush University Perfusion Technology Program, added, “This is the third student class to attend Medtronic’s Advanced Topics course. Our decision to return each year is based on the feedback of the students, who greatly value it. The different perspectives shared by engineering, product management and manufacturing are very interesting. All of this adds to the interactivity and dynamics of the course.”

The curriculum included presentations and discussions about testing for gaseous micro-emboli (GME), oxygenator performance, and plasma breakthrough resistance of oxygenators. The hands-on portion of the program was conducted on the Orpheus™ Perfusion Simulator1, which allowed students to problem-solve in realistic crisis management scenarios during a simulated cardiopulmonary bypass procedure. “First-year perfusion students spend a lot of time observing clinical cases, and rarely get the opportunity for hands-on learning. The Orpheus Perfusion Simulator is a great way for them to learn to deal with clinical problems in a simulated case,” Bearss said.

According to Sutton, “These students have just finished their classroom course work and are getting ready to start their 11-month rotations. The Orpheus Perfusion Simulator is an important preparation tool for their upcoming rotations. It’s really helpful for them to be able to simulate putting patients on bypass, taking them off bypass, and learning different case management strategies.”

The Advanced Topics for Perfusion Students is another example of Medtronic’s commitment to leadership in medical education. This workshop broadens perfusion students’ exposure to perfusion technology since it covers topics typically not offered in the conventional perfusion school curriculum. “Educating future perfusionists about the science behind the products they'll use helps to ensure the best possible clinical care in the OR,” Bearss commented.

Medtronic Perfusion Systems hosts three Advanced Topics programs per year at its headquarters in Minneapolis. For more information about CardioVascular Academia or to enroll in any perfusion or blood management educational programs, visit www.perfusion.medtronic.com or contact your local Medtronic representative.

1 The Orpheus™ Perfusion Simulator is a registered trademark of Ulco Medical

October 2010 Product News

Medtronic Expands AFFINITY® Venous Air Removal Device Availability

avard

Perfusionists will now have more options for circuit design with the CE Mark and the recent 510(k) clearance from the U.S. Food and Drug Administration (FDA) of Medtronic’s AFFINITY® Venous Air Removal Device (VARD) as a component in perfusion custom packs. Previously, the AFFINITY® VARD was available only as part of the Resting® Heart System, a miniaturized cardiopulmonary bypass circuit.

The AFFINITY® VARD is one of several new products introduced to the perfusion market this year. "Receiving 510(k) clearance for the AFFINITY® VARD is an important milestone for our business," said Scott Baker, Engineering Supervisor. "Perfusionists will have more options for designing their own mini-circuits."

Part of the RBC® (Rethinking Blood Conservation) Initiative, the AFFINITY® VARD offers perfusionists flexibility to customize their circuit system for improved air handling. It also encourages the use of closed circuits, which have clinically demonstrated a reduction of patient complications1. "This achievement demonstrates our commitment to improving patient outcomes and to providing optimal solutions that support evidence-based practice," said Denise Steinbring, Director of Marketing, Cardiopulmonary/Blood Management.

The AFFINITY® VARD senses and automatically removes any air in the deoxygenated blood that has entered the circuit. Partnered with the recently approved AFFINITY CP™ centrifugal blood pump, the AFFINITY® VARD clearly reduces the priming volume, a major goal for perfusionists who support blood conservation initiatives.

Global Customer Need Drives Dedication to Make It Happen

"The need for making the AFFINITY® VARD available in this configuration was driven by global customer feedback. That gave us the opportunity to be responsive to customer needs," said Peter Horwich, Senior Product Manager, Perfusion. A cross-functional Medtronic perfusion team worked to reconfigure the AFFINITY® VARD and complementary accessories for use in custom packs. "This was a non-traditional project requiring logistics and operations coordination with R&D and regulatory among our facilities in the U.S., Mexico and the Netherlands. It brought four separate pieces of technology together, including disposable and hardware components, for use in our custom pack business," he added.

The AFFINITY® VARD’s Advanced Technology Facilitates Automatic Venous Air Removal

Requiring no intervention, the AFFINITY® VARD facilitates the benefits of closed circuits. As the system automatically and quickly removes air in the extracorporeal circuit, a visual and audible alarm alerts the surgical team to the condition. The AFFINITY® VARD features:

  • Ultrasonicair sensors that detect air at the inlet of the system and monitor the liquid level in the filter
  • A 38 micron screen
  • A chamber and port at the top of the device to collect and remove coalesced air
  • Prime volume of 212 mL (not including purge line)

The AFFINITY® VARD provides perfusionists with the flexibility to include or eliminate a venous hardshell reservoir, cardiotomy, or holding bag, depending on individual circuit set-up preference.

For more information on the AFFINITY® VARD, contact your Medtronic representative or click here.

1 Ranucci M, Isgrò G. Minimally invasive cardiopulmonary bypass: does it really change the outcome? Crit Care. 2007;11(2):R45. PubMed PMID: 17433112; PubMed Central PMCID: PMC2206473.

Mission in Action

 

Medtronic Introduces "Every Patient First" Initiative to Address Disparities in Access to Health Care

Medtronic introduced Every Patient First, a health equity initiative that, in partnership with health care providers, professional societies and patient advocacy groups, aims to reduce disparities at the point of care in the United States. The announcement was made in March 2010 at the 59th Annual Scientific Session of the American College of Cardiology (ACC) in Atlanta.

Health care disparities are defined as the differences in health care quality at the point of care; differences not related to access or clinical need, preferences or appropriateness of intervention. "No one has ever gone into med school planning to have a health care disparity. But it happens," commented Jennifer Ellis, MD, Washington Hospital Center for Cardiac Surgery.

Every Patient First addresses barriers that prevent people from receiving therapies that can improve and even save their lives. Research shows that disparities exist beyond clinical and socioeconomic factors, and persist across many clinical settings and conditions, even after adjusting for age, health insurance, socio-economic status and condition severity.1 The challenges are especially acute for women, racial and ethnic minorities, people 65 and older, and those whose primary language is not English.

With Every Patient First, Medtronic plans to provide health care professionals with targeted, actionable strategies and partnership programs that will help them overcome barriers that prevent patients from getting treatment for cardiovascular disease. To support this initiative, Medtronic is collaborating with the Association of Black Cardiologists (ABC) and the American College of Cardiology (ACC).

Gender and Age Disparities

Disparities in the treatment of women with heart disease are well documented. Melloni et al, in a 2010 Circulation article, found that just 30% of patients enrolled in clinical trials used to support the American Heart Association’s cardiovascular disease (CVD) guidelines for women2 were, in fact, women. And while more women than men die of CVD, women receive only 33% of the angioplasties, stents and bypass surgeries, and 35% of the open-heart surgeries performed to treat CVD.3 In another study, Mosca et al found that just 8% of primary care physicians and 17% of cardiologists know that more women than men die from heart disease every year.4

The U.S. senior population also experiences disparities in CVD treatment. While the majority of people who die from CVD are 65 or older, basic health literacy is lowest among people 75 years and older. Older Americans devote 12.5% of their total expenditures on health care, twice the proportion spent by all other consumers in 2008. In addition, older patients are less likely than younger patients to receive certain types of guideline-indicated interventions.

Racial and Ethnic Disparities

African American, Hispanic/Latino, and Asian/Pacific Islander populations within the U.S. are also victims of health care disparities, including:

  • African Americans experience the highest age-adjusted death rate for heart disease of all races and ethnicities.5
  • Only one in four Hispanic Americans knows that diabetes puts them at-risk for heart disease,6 despite the fact that Hispanics are more than twice as likely to have diabetes.7
  • South Asian Americans have the highest worldwide rates of coronary artery disease (CAD),8 and it is more prevalent among South Asian American women.9

In conjunction with Every Patient First initiative, Medtronic is collaborating with the ABC and the ACC to address these disparities by offering physicians and providers process improvement tools and educational programs to help drive equity in health care. Elements of this collaboration include:

  • Association of Black Cardiologists (ABC) Every Patient First Challenge: a quality improvement pilot program where participating cardiology practices will measure and implement quality protocol and pathway programs to improve adherence to guidelines.
  • The ACC’s Coalition to Reduce Racial & Ethnic Disparities in CV Outcomes (CREDO): an initiative targeted at measurably reducing disparities in the management of cardiovascular disease. Medtronic is the founding sponsor of CREDO.

"This strong collaboration of industry and professional associations will lead the way to providing physicians and practices with real solutions for delivering quality care to all Americans," said Hector Ventura, M.D., co-chair of CREDO and section head, Heart Failure and Heart Transplantation, Ochsner Health Systems in New Orleans. "While CREDO will continue with the registry on health disparities in cardiovascular care, Medtronic's Every Patient First initiative will provide tools for physicians and practices to drive change at the point of care."

Health care professionals can reduce disparities in access to health care by adhering to proven guidelines for optimal care without regard to gender, race or ethnicity.1 For example, new data presented from the Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE HF) showed that cardiology practices significantly improved the quality of care for heart failure patients, both men and women, when they monitored care and applied a practice-specific performance improvement system to better meet heart failure guideline recommendations.

More information on Every Patient First is available online at www.EveryPatientFirst.com, or by e-mailing rs.everypatientfirst@medtronic.com.

References

  1. Kaiser Family Foundation/American College of Cardiology Foundation. Racial/Ethnic Differences in Cardiac Care: The Weight of the Evidence.
  2. Melloni C, Berg J, Wang TY, et al. Representation of Women in Randomized Clinical Trials of Cardiovascular Disease Prevention. Circ Cardiovasc Qual Outcomes. Online February 16, 2010;DOI:10.1161/CIRCOUTCOMES.110.868307.
  3. American Heart Association, the Nurse’s Health Study. WISE and Acute Coronary Syndromes without Chest Pain: Insights from GRACE.
  4. Mosca L, Linfante LH, Benjamin EJ, et al. National study of physician awareness and adherence to cardiovascular disease prevention guidelines. Circulation. 2005; 111:499-510.
  5. CDC Office of Minority Health and Health Disparities, Highlights in Minority Health & Health Disparities, February, 2010.
  6. National Diabetes Education Program. Available at: www.ndep.nih.gov.
  7. Agency for Healthcare Research and Quality. National Healthcare Disparities Report. 2003 – 2006.
  8. Reports of the National Commission on Macroeconomics and Health. Ministry of Health and Family Welfare. Published September 2005.
  9. Enas A, Kannan S. How to Beat the Heart Disease Epidemic among South Asians. 2005 – 2006.

New Perfusion Resources

 

Medtronic Perfusion Participates in the Thoracic Surgery Directors Association’s Cardiothoracic Boot Camp for Residents

On July 8 – 11, 2010, the Thoracic Surgery Directors Association (TSDA) held their third annual Boot Camp for cardiothoracic residents. The Boot Camp program, developed by TSDA and funded by an educational grant from the Joint Council on Thoracic Surgery Education, Inc. (JCTSE), gives resident participants training in five cardiothoracic (CT) surgical areas: cardiopulmonary bypass (CPB), anastomosis, open lobectomy, bronchoscopy/mediastinoscopy, and aortic valve surgery.

Thirty-two residents attended this year’s program, which was conducted by more than 30 volunteer faculty members and guests who donated their time and expertise. Among the guest experts was Mark Bearss, Medtronic Education and Training Program Manager. Bearss assisted in the perfusion simulation portion of the course using the Orpheus™ Perfusion Simulator together with a heart-lung machine. In this setting, a perfusionist facilitates a hands-on, problem-solving simulation to teach residents how to manage a perfusion crisis. Over the two-and-a-half day course, residents participate in numerous simulated cardiopulmonary bypass case scenarios. At the end of the Boot Camp, resident participants commented that they “loved the fact that everything was hands on…the simulation was excellent.”

TSDA’s Boot Camp was developed three years ago to better train residents in key aspects of cardiopulmonary bypass. Designed by James I. Fann, MD (Stanford University Medical Center), Richard H. Feins, MD (University of North Carolina), and George L. Hicks, Jr., MD (University of Rochester), this intensive course addresses the needs emerging from CT surgery residency programs.

The program teaches basic CT operating skills so that residents are better prepared when they enter the operating room in their home programs. “Boot Camp is an impressive program that teaches residents the basics of CPB, including trouble-shooting, recognizing and responding to CPB emergencies and practicing aortic and atrial cannulation techniques. Through simulation, residents experience each step in the process of a patient going on and coming off CPB. The program includes approximately six crisis management scenarios designed to hone the residents' problem-solving skills so they are better prepared for the realities of a cardiac OR,” said Bearss.

“Enhancing residents’ proficiency in perfusion technology and CPB helps ensure the best possible clinical care in the OR and is an important part of Medtronic’s commitment to leadership in medical education,” continued Bearss.

Through program sponsorships like the TSDA CT Surgery Boot Camp and Medtronic’s Academia education and training programs, clinicians strengthen their understanding and experience with the goals of expanding treatment options and improving patient care. For more information about Perfusion Academia, go to http://www.perfusion.medtronic.com/perfusion-equipment-education.html .

For more information about the TSDA’s annual Boot Camp for CT surgery residents, visit www.tsda.org.

Formulation Change Leads to Less Potent Heparin

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HMS Plus Hemostasis Management System

The heparin formulation change continues to trigger questions about the expected clinical results associated with anticoagulation using the new formulation heparin, even though reformulated USP heparin has been in circulation since February 2010. HMS Plus Hemostasis Management System In its April 7, 2010, follow-up to the 2009 heparin formulation change the U.S. Food and Drug Administration (FDA) announced that laboratory studies confirmed the new formulation heparin potency to be approximately 10% less than the previous USP preparations. These studies reinforced the FDA’s previous statements regarding the need for clinical judgment when determining the dose for a patient and the need for more frequent monitoring. The FDA's update went on to state that heparin dosing should be individualized to the specific patient and clinical situation, and that some clinical situations (pediatric patients on ECMO, patients on cardiopulmonary by-pass, and treatment of life-threatening thrombosis) may require more frequent monitoring.

Background

A spike in the number of deaths among patients receiving heparin was reported to the FDA in 2008 and found to be associated with heparin lots from Baxter International, a major supplier. Baxter subsequently recalled all of their heparin production lots. Testing found that the lots were contaminated with over-sulfated chondroitin sulfate (OSCS), which was linked to a raw material supplier in China. Investigation of the OSCS contaminant revealed that it caused activation of the contact system and kallikrein pathway, resulting in generation of bradykinin, a potent vasoactive substance. In addition, OSCS activated the complement system with generation of the potent anaphylatoxins C3a and C5a.

In response, the FDA issued a notice requiring heparin manufacturers to perform new quality tests to identify OSCS contamination. In October 2009 the FDA also required heparin manufacturers to use a new assay, the chromogenic anti-Factor IIa, to measure heparin potency. A new reference standard was also mandated to harmonize USP heparin to the international standard used by the World Health Organization. At the time, the FDA indicated that this change “may result in approximately a 10% reduction in the potency of heparin marketed in the US and Canada and require that larger doses of heparin may be required to achieve the desired effect.1

Identification of New Formulation Heparin

Since the FDA did not require removal of the older formulation heparin from circulation, clinical sites may have both the old and new heparin formulations in the pharmacy. It is important that health care providers distinguish between the new and old heparin formulation and communicate to all parties concerned that a change has taken place.

New formulation heparin manufactured by APP, B. Braun and Baxter uses the letter “N” on the vial by the lot number/expiration date. Lot numbers of new formulation heparin manufactured by Hospira begin with the number “82” or higher. It is also important to note that the FDA-approved labeling for the product, including recommended doses, has not changed.

For more information click here: April 2010 update.

Medtronic Perfusion’s Advanced Technology for Accurate Hemostasis Management

Medtronic Perfusion Systems remains the pioneer and leader providing both a heparin dose response test and the only point of care heparin assay for individualized heparin and protamine management. The HMS Plus Hemostasis Management System is a reliable, versatile and effective platform for accurate management. By providing information regarding the individual patient's response to heparin, the HMS Plus System determines the appropriate dose for the patient so that the needed anticoagulant and antithrombotic effect can be achieved.

References

  1. U.S. Food and Drug Administration. FDA Information for Medical Device Manufacturers About a Change in the USP Heparin Monograph. Available from http://www.fda.gov/Medical Devices/Safety/AlertsandNotices/ucm186227.htm. Accessed October 19, 2009.
  2. Blossom DB, Kallen AJ, Patel PR, et al. Outbreak of Adverse Reactions Associated with Contaminated Heparin. NEJM. 2008;359(25):2674-84.
  3. Kishimoto TK, Viswanathan K, Ganguly T, et al. Contaminated Heparin Associated with Adverse Clinical Events and Activation of the Contact System. NEJM. 2008;358(23):2457-67.
  4. Rollins, G. New Heparin Standards, Will the Change Make a Discernable Difference in Coagulation Monitoring? Clin Lab News. 2009;35(12).
  5. Smythe M, Nutescu EA, Wittkowsky AK. Changes in the USP Heparin Monograph and Implications for Clinicians. Pharmacotherapy. 2010;30(5):428-431.
  6. U.S. Food and Drug Administration. FDA Drug Safety Communication: Update: Follow up to the Public Health Alert about Changes to the Heparin Sodium USP Monograph. Available from http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm207506.htm . Accessed April 8, 2010.

CardioVascular Academia Hosts “Advanced Topics” for Rush University Perfusion Students

On June 21-22, 2010, the CardioVascular Academia program, a cutting edge education and training program designed to help participants keep pace with advances in the field of perfusion, hosted 13 perfusion technology students from Rush University, Chicago, IL.

The program teaches students the science behind the design of perfusion products. “Perfusionists are taught the clinical aspects of perfusion in school. This course expands that learning to include the technology associated with product functionality. By the course’s conclusion, participants have a clearer understanding of how perfusion equipment is designed and how devices function,” said Mark Bearss, Medtronic Perfusion Education and Training Program Manager.

Over the course of this 1½-day program, students gain knowledge about perfusion science, research findings, technology, and testing methodologies. The program includes interactive classroom discussion and a tour of the Medtronic Perfusion manufacturing facility, where students could observe the direct assembly of main perfusion components including the AFFINITY NT® oxygenator. Following the tour, students agreed that it was “an exciting and invaluable experience to see the manufacturing plant and to talk with the operators. They helped us understand the process associated with making the products and the attention and care paid to testing them.”

Robin Sutton, Chief Perfusionist at Rush University Medical Center and Clinical Coordinator of the Rush University Perfusion Technology Program, added, “This is the third student class to attend Medtronic’s Advanced Topics course. Our decision to return each year is based on the feedback of the students, who greatly value it. The different perspectives shared by engineering, product management and manufacturing are very interesting. All of this adds to the interactivity and dynamics of the course.”

The curriculum included presentations and discussions about testing for gaseous micro-emboli (GME), oxygenator performance, and plasma breakthrough resistance of oxygenators. The hands-on portion of the program was conducted on the Orpheus™ Perfusion Simulator*, which allowed students to problem-solve in realistic crisis management scenarios during a simulated cardiopulmonary bypass procedure. “First-year perfusion students spend a lot of time observing clinical cases, and rarely get the opportunity for hands-on learning. The Orpheus Perfusion Simulator is a great way for them to learn to deal with clinical problems in a simulated case,” Bearss said.

According to Sutton, “These students have just finished their classroom course work and are getting ready to start their 11-month rotations. The Orpheus Perfusion Simulator is an important preparation tool for their upcoming rotations. It’s really helpful for them to be able to simulate putting patients on bypass, taking them off bypass, and learning different case management strategies.”

The Advanced Topics for Perfusion Students is another example of Medtronic’s commitment to leadership in medical education. This workshop broadens perfusion students’ exposure to perfusion technology since it covers topics typically not offered in the conventional perfusion school curriculum. “Educating future perfusionists about the science behind the products they'll use helps to ensure the best possible clinical care in the OR,” Bearss commented.

Medtronic Perfusion Systems hosts three Advanced Topics programs per year at its headquarters in Minneapolis. For more information about CardioVascular Academia or to enroll in any perfusion or blood management educational programs, visit www.perfusion.medtronic.com or contact your local Medtronic representative.

* The Orpheus™ Perfusion Simulator is a registered trademark of Ulco Medical

December 2010 Product News

Medtronic South Africa Educates Perfusionists about Clinical Benefits of Extracorporeal Membrane Oxygenation

medtronic-africa

Lancelot Sihe Mlambo, Product Specialist / Perfusionist presenting on perfusion topics.

Since June of 2010, Medtronic South Africa has conducted six Extracorporeal Membrane Oxygenation (ECMO) workshops as part of the Medtronic Academia initiative. These workshops are the only local, hands-on education programs currently available in South Africa. Each program focuses on the clinical and technical applications associated with the use of ECMO for patients with severe but potentially reversible pulmonary and/or cardiac failure. Workshops are comprised of didactic lectures and discussions followed by wet labs that simulate practical, hands-on experience for dealing with perfusion cases.

"These workshops are very beneficial because they encourage the exchange of ideas between junior and senior perfusionists. Thanks to this interaction, we are able to address the particular needs of each participant. It also encourages the sharing of clinical experience, which is quite valuable," said Colleen Naude, Product Manager Cardiac Surgery, Medtronic Africa. "Medtronic’s ECMO Workshop program has been accredited by the Medical Council of South Africa for six continuing professional development (CPD) points. Each workshop includes two hours of theory, followed by a practical session," Naude added.

Workshops are taught by Lancelot Sihe Mlambo, Product Specialist / Perfusionist, Medtronic South Africa. "Participants are particularly enthusiastic about the interactive nature of these workshops. I strive to address the clinical questions and needs presented by all attendees. As a result, many participants have commented that they find the program relevant to their clinical needs and that they plan on using the information about ECMO in their hospitals," Mlambo noted. "Participants from one particular academic hospital who attended a workshop told me that the survival rate associated with ECMO increased to 78% for both adult and pediatric patients in their institution," Mlambo said.

As part of Medtronic Academia, the ECMO Workshop conducted in South Africa is an example of Medtronic’s commitment to provide perfusionists worldwide with support they can trust, quality they expect, and training they can rely on. Thanks to the success of this workshop program, Medtronic South Africa is planning to expand this educational initiative into Sub-Saharan Africa in the near future.

For information about Medtronic Academia programs in your area contact your local representative.

 

Medtronic Hosts Customer Advisory Meeting and Plant Tours for Japanese Perfusionists

medtronic-mexico

Medtronic Perfusion Systems, Tijuana, Mexico

In November, Medtronic Perfusion hosted a visit by Japanese perfusionists at their manufacturing facilities as part of their focus on customer satisfaction. Eleven perfusionists participated in a customer advisory meeting and tours of the cannula and custom pack plants.

"Face-to-face meetings with customers are important to Medtronic's focus on customer satisfaction," said Jaime LaMontagne, Group Marketing Manager, Medtronic CardioVascular Perfusion/Blood Management. "We are constantly investigating how changes in our product design can improve our customers’ experiences. By combining advisory board meetings with plant tours, we give customers the opportunity to share their clinical needs with Medtronic management while showing them our commitment to product quality."

Following the tour of the facility, where Medtronic manufactures cannulae, including the Bio-Medicus® Femoral Cannulae, Medtronic management and the visiting perfusionists discussed the unique needs of the Japanese market and recent Medtronic cannula product enhancements.

The next day, the visitors traveled to the Tijuana plant where Medtronic manufactures custom packs. "Our customers were very pleased to see the manufacturing line dedicated to Japanese custom tubing packs," said Kotaro Yoshida, Perfusion and Blood Management Product Manager, Medtronic Japan. "The plant tours and discussions are a positive step in developing a strong customer partnership with Japan. They're an important part of establishing a process for continuous customer feedback. Customer feedback was very positive with comments reinforcing the value of observing the manufacturing process and discussing the products used on a daily basis in their clinical setting," Yoshida added.

Continued product design and development are critical for ensuring Medtronic Perfusion's commitment to perfusion excellence. During the advisory board meeting, Medtronic Perfusion management presented plans for delivering products that will consistently meet the high standards of performance, safety, and quality required by perfusionists around the world. The visiting Japanese perfusionists made valuable suggestions for product improvement. One customer noted that "perfusionists are clinicians with a sense of craftsmanship. The advisory meeting focused on us and reinforced Medtronic’s understanding of our needs."

"This meeting was a great way for us to collaborate with key opinion leaders from Japan, LaMontagne said. "As a result of this dialogue, Medtronic Perfusion more clearly understands the specific needs associated with delivering innovative products, service, and education so that perfusionists in Japan can focus on blood conservation and improved patient outcomes."

 

New Perfusion Resources

Medtronic Symposium at 2010 Latin American Congress of Perfusion focuses on Blood Conservation

medtronic-blood

Medtronic held a symposium on Rethinking Blood Conservation® at the 2010 Congreso Latinoamericano de Tecnología Extracorpórea (CLATE). The most recent CLATE, which convenes every three years, was held in October 2010 in Lima, Peru. Nineteen countries were represented, including all of Latin America, Canada, the United States, Brazil, Spain, Italy, Portugal and Puerto Rico.

Many presentations made at the Congress, including one by Ana Girado, CCP, Medtronic Perfusion Consultant, stressed the importance of blood conservation, Girado’s talk, entitled "Adverse Effects of Blood Transfusion," focused on the increased rates of morbidity, infections and hospital lengths of stay associated with blood transfusions. Since Latin American perfusionists generally have low awareness of STS Guidelines associated with blood transfusions, Girado stressed the importance of developing a good coagulation therapy plan. "A good therapy plan reduces the need for blood transfusions and thereby supports a blood conservation plan," she said. "With hospitals stressing the need to reduce costs, blood conservation also makes economic sense."

Following her presentation, Medtronic hosted a lunch symposium on Rethinking Blood Conservation® (RBC). Presenting in Spanish to over 150 participants John Rivera, Medtronic Senior Development Therapy Manager, elaborated on the blood conservation theme. Medtronic’s RBC Initiative, which focuses on the need for blood conservation in cardiac procedures, was introduced to Latin American perfusionists at this Congress. Rivera presented evidence that blood shortages, the cost of blood, and the risks associated with blood transfusions are key reasons for clinicians to be rethinking their approaches to blood conservation.

"The need to rethink blood conservation was a very timely and relevant message to the participants at CLATE," Rivera said. Several of the preceding program speakers discussed a variety of mechanisms and technologies to reduce the need for transfusions, which Rivera cited during his presentation. "Hospitals throughout the region are beginning to experience decreasing blood supplies and rising transfusion costs. In addition, there’s greater awareness of the adverse effects of allogeneic transfusions," he added.

To support the need for rethinking blood conservation, Rivera cited data showing that patients transfused during coronary artery bypass surgery (CABG), have double the five-year mortality of those not transfused. Morbidities associated with transfusions include adult respiratory distress syndrome (ARDS), infections, atrial fibrillation, and kidney and liver function complications.1

According to Rivera, "Blood is a scarce and expensive resource in Latin America. Perfusionists must begin to adopt a multi-modality approach to reduce the need for transfusions." Costs associated with collecting and transfusing blood are increasing worldwide, driven in part by longer patient lengths of stay, longer ICU stays, and increases in complications and infections requiring medical staff attention. The lack of financial resources to pay for preventable events, such as infections, compound these cost increases. 2

During his presentation, Rivera cited a recent article published in Transfusion that presented an activity-based model to accurately determine the cost of blood in a surgical population. Of particular relevance to the attendees was that data in the article included costs from two European hospitals using a socialized medicine payment system. "Clinicians often mistakenly believe that blood transfusions are 'free' because they work in a socialized medicine system," Rivera observed. "This article quantified costs from 'all major process steps, staff, and consumables associated with red blood cell transfusions to surgical patients' and found that ‘direct and indirect overhead costs contributed to per-RBC-unit costs of between $522 and $1,183.'3 This was an eye-opening cost for many of the participants," he concluded.

The Latin American launch of the Rethinking Blood Conservation® Initiative demonstrates once again that Medtronic is committed to providing perfusionists worldwide with support they can trust, quality they expect, and training they can rely on. To learn more about the RBC® Initiative, contact your Medtronic representative.

References

  1. Rawn J. The Silent Risks of Blood Transfusion. Current Opinion. Anaesthesiology. 2008; 21(5): 664-668.
  2. Brown MZ, et al. The Frequency and Cost of Complications Associated with Coronary Artery Bypass Grafting Surgery: Result from the United States Mediczre Program. Ann Thorac Surg. 2008;85:1980-7.
  3. Shander A, et al. Activity-based costs of blood transfusions in surgical patients at four hospitals. Transfusion. 2010;50:753-765.
 

Mission In Action

Medtronic Continues Membership in the Dow Jones Corporate Sustainability Index and is Recognized in Newsweek Magazine’s 2010 Green Rankings for Corporate Sustainability

medtronic-green

Recognizing the company's leadership in meeting the needs of economic, environmental, and social stakeholders, Medtronic has been made a member of the North America Dow Jones Sustainability Index (DJSI) and the FTSE4Good Index Series.

In addition to the Dow Jones recognition, Medtronic ranked No. 3 in the healthcare industry sector of Newsweek Magazine's 2010 Green Rankings. These rankings assess resource use, emissions, green policies and strategies of U.S. companies and their reputation as environmentally conscientious organizations among their peer companies. Included in the ranking are the 500 largest U.S. companies as measured by revenue, market capitalization and number of employees. In 2009, Medtronic was ranked among the top 15 percent of the 500 largest U.S. companies in the magazine's inaugural Green Rankings report.

"We are honored by our continued inclusion in the DJSI and FTSE4Good Indices as well as our impressive ranking in Newsweek’s Green Rankings," said Bill Hawkins, Medtronic Chairman and CEO. "Our mission to contribute to human welfare with products, therapies and services that help millions of people around the world return to a full life continues to serve as the foundation of everything we do. Promoting a sustainable world is vital to our future and I’m pleased with our continued progress as we advance the Medtronic Mission and create long-term sustainable value for all of our stakeholders."

Launched in 1999, the Dow Jones Sustainability Indexes identify best-in-class companies through an integrated assessment of economic, environmental and social criteria with a strong focus on long-term shareholder value. Assessed are such issues as corporate governance, risk management, branding, climate change mitigation, supply chain standards, and labor practices. For more information about the DJSI, visit http://www.sustainability-indexes.com.

The FTSE4Good Index Series measures the performance of companies that meet globally recognized corporate responsibility standards and facilitates investment in those companies. For more information about the FTSE4Good Index Series, visit http://www.ftse.com/ftse4good.

Newsweek’s Green Rankings are a product of a collaboration between CorporateRegistrar.com, Newsweek and environmental research firms KLD Research & Analytics and Trucost. The ranking’s methodology can be found at http://www.newsweek.com/2010/10/18/green-rankings-2010-full-methodology.html.

Medtronic Integrates Environmental Sustainability into Business Practices

Medtronic employees practice progressive environmental stewardship across all businesses and geographies. "Many of our ideas come directly from employees," said Janice Tobin, Medtronic Environmental Health and Safety (EHS) Manager, "They are very engaged and key to the successful integration of new ways to reduce waste.

"Within Medtronic Perfusion, recycling and waste reduction starts with the integration of new product introductions and new processes. This is when we evaluate opportunities for reuse or recycling as well as the impact on the environment for our customers and ultimately the community," she continued.

To help achieve its fiscal year 2013 Environmental Goals, Medtronic sites have set annual goals for energy, waste and water use reduction. Through successful collaboration among businesses and geographies, Medtronic has already surpassed these 2013 goals.

"Environmental sustainability can be used as an innovation driver and leveraged to provide a competitive advantage," noted Doug Fullen, Medtronic Director of Corporate Environmental Management. "Environmental sustainability can be described as the wise use of the earth’s resources today, so future generations will be able to use and enjoy them tomorrow. It makes good business sense to reduce waste and our impact on the environment since they both save money. We can use sustainability to think differently about how we do things, which is the basis for innovation: Thinking differently about how you do something can drive changes in behavior, practices and processes that lead to innovation," Fullen added.

Medtronic Perfusion's Water Reuse Drives Sustainability

On products that are leak-tested, a considerable amount of ultra pure water is required. Local water does not meet the purity level required for direct use in these tests, so city water is processed through reverse osmosis, an extra step in the purification process, to obtain the needed water quality. In the past, this water was disposed of after the leak tests were completed. "We were throwing away water that was purer than the city water we were buying," commented Al Olson, Medtronic Senior EHS Specialist. In response, Medtronic Perfusion’s engineers designed a purification step to polish the used pure water, making it ready once again for direct reuse. "This eliminates the expensive reverse osmosis step and saves approximately 90% of the original reverse osmosis cost. We’ve reduced our water usage by nearly one million gallons annually, which amounts to savings of from $15,000 to $20,000 a year. This project was a good example of how employees can positively impact the broader policy of sustainability," Olson said.

According to Fullen, "This is one example of how Medtronic integrates sustainability into our business practices so that sustainability, rather than being separate from the process, becomes part of the process. By integrating sustainability into how we do business, it becomes a key innovation driver."

Medtronic Corporate Citizenship Report

In 2008, Medtronic published its first Corporate Responsibility Report, with a commitment to report every two years. Medtronic’s 2010 report combines the Corporate Responsibility Report and the Medtronic Foundation Annual Community Report into a web-based Corporate Citizenship Report, which will then be issued annually. This report provides an accurate, balanced account of Medtronic’s economic, social, and environmental performance in the areas most relevant to our business. Medtronic’s 2010 Corporate Citizenship Report, "Innovating for a Better World," can be accessed at http://www.medtronic.com/about-medtronic/corporate-responsibility.

 
 

February 2011 Product News

Medtronic Celebrates Production of the Four-millionth AFFINITY® Oxygenator System

affinitynews

Medtronic reached a milestone in December 2010 with the production of the four-millionth AFFINITY® Oxygenator. At the time of its launch in June 1993, the AFFINITY® Oxygenator set the standard for oxygenators with its product design. It continues to be the market-leading brand today.

As part of this milestone’s celebration, Medtronic invited one of the more than four million patients served by the AFFINITY® Oxygenator, as well as his surgeon, to attend the event. In addition, many Medtronic employees who have worked on this product since its inception shared some of their thoughts via video. They spoke of the satisfaction they derived from knowing that the AFFINITY® Oxygenator has been used to treat over four million patients, giving each of them a second chance in life. "It’s been enormously satisfying to work on a product that’s treated four million patients. It’s what I think about every day that I come to work," said Zer Cha, Medical Assembler, Medtronic Perfusion.

Denise Steinbring, Marketing Director, Medtronic Perfusion, noted that "customers frequently tell me that the AFFINITY® Oxygenator is their go-to product of choice, especially in very difficult cases where the patient’s life is really on the line."

The AFFINITY® System’s consistent performance starts with an oxygenator design that has set the industry standard. The system’s radial flow design and proprietary fiber winding technique provide the reliable results perfusionists require in a constantly changing cardiac surgery environment. The graduated bundle density design of the AFFINITY. The AFFINITY® System’s consistent performance starts with an oxygenator design that has set the industry standard. The system’s radial flow design and proprietary fiber winding technique provide the reliable results perfusionists require in a constantly changing cardiac surgery environment. The graduated bundle density design of the AFFINITY® Oxygenator maximizes gas transfer as it minimizes blood shear, priming volume, and blood side pressure drop.

"The success of the AFFINITY® Oxygenator is a testament to Medtronic’s commitment to customer- and patient-focused innovation," said Jaime LaMontagne, Medtronic Group Marketing Manager, CardioVascular Perfusion/Blood Management. "The AFFINITY® Oxygenator is the first oxygenator system with a radial blood flow design and integrated computational flow dynamics to optimize the blood flow path. And it’s the only oxygenator with graduated fiber winding technique for optimized bundle efficiency and manufacturing consistency."

For more information on the AFFINITY® Oxygenator, contact your Medtronic representative.

* Carmeda is a trademark of Carmeda AB. Products are coated with Carmeda® BioActive Surface, which is licensed from Carmeda AB for use only as part of an extracorporeal blood circulation system or circuit that includes an oxygenator or blood pump.

** Technology licensed under agreement from BioInteractions, Limited, United Kingdom.

 
affinitynews

Florida Agency For Healthcare Administration Removes Previous Restrictions for Perfusionists’ Use Of The Medtronic HMS Plus

Background: In a 2009 ruling by the Florida Agency for Healthcare Administration (AHCA), use of the Medtronic HMS Plus by perfusionists to perform heparin assay testing did not meet the requirements of the alternative testing site rule. This determination meant that perfusionists would no longer be allowed to use the HMS Plus in procedures or in testing.

Since learning of the 2009 rule change, Medtronic has worked with laboratory and perfusion staffs from several Florida hospitals to provide appropriate information and materials to help educate the AHCA Laboratory Agency staff on the function and use of the HMS Plus.

In an open meeting held in May 2010, Medtronic Perfusion Systems provided the Florida Agency for Healthcare Administration (AHCA) with information and support regarding the use of the HMS Plus by Florida perfusionists. As a result of this meeting, Florida perfusionists were permitted to use the HMS Plus with some restrictions.

Update December 2010: This educational outreach resulted in removal of the restrictions associated with use of the HMS Plus. According to the December 31, 2010, posting on the agency’s web site, perfusionists certified by the American Board of Cardiovascular Perfusion may now use the Medtronic HMS Plus to perform Heparin Dose Response and Heparin Assay (or concentration), in addition to Activated Clotting Times. The agency has also lifted the restrictions on accessing the protamine dose, and use of the pump enter setting.

"Medtronic is pleased that the Florida AHCA has removed the previous restrictions pertaining to the use of the HMS Plus in alternate testing sites. The laboratory and perfusion staffs from several hospitals in Florida worked hard to provide the AHCA with the information needed to help them reach this decision. Florida perfusionists will now be able to offer their patients the same quality clinical care in alternate sites," said Jaime LaMontagne, Medtronic Group Marketing Manager, CardioVascular Perfusion/Blood Management.

For more information about the Medtronic HMS Plus, contact your Medtronic representative or visit

 

New Perfusion Resources

Visit Medtronic at the upcoming 2011 CREF Cardiothoracic Surgery Symposium

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During the week of March 9, 2011, perfusionists and cardiothoracic surgeons will gather in Newport Beach, CA for the 31st Annual CREF Cardiothoracic Surgery Symposium. At the symposium, Medtronic will highlight its mini-bypass systems and RBC® (Rethinking Blood Conservation) Initiative.

"The CREF Cardiothoracic Surgery Symposium is an ideal venue for Medtronic to showcase its latest product innovation and educate perfusionists on the important role these products play in providing optimized clinical care in the OR," commented Denise Steinbring, Marketing Director, Medtronic Perfusion.

Electronic medical record presentation
Medtronic, in partnership with Spectrum Medical, offers a market-leading electronic medical record (EMR) solution. To demonstrate and reinforce the value of this EMR solution to perfusionists, please join Medtronic for a luncheon presentation at the CREF Product Theater at the Marriott Newport Beach Hotel, on Thursday, March 10th, 11:45 a.m - 12:45 p.m.

"Live OR – Experience Electronic Perfusion Charting in Real Time" will be an electronic broadcast from an operating room in which a procedure will be taking place. Robin Sutton, Chief Perfusionist, Rush University Medical Center, Chicago, IL, will lead the broadcast and demonstrate the simplicity of electronic perfusion charting using the Spectrum Viper Data System during the procedure. Participants will learn how to utilize these compliance and clinical interface tools in their provision of patient care.

Mini-circuits in CPB to be highlighted
To demonstrate its commitment to continued product innovations Medtronic will also exhibit the new AFFINITY® VARD and AFFINITY® CP Systems on a mini bypass circuit. The AFFINITY® VARD, part of the RBC® Initiative, lets perfusionists customize their circuit system for improved air handling in a miniaturized circuit. The system senses and automatically purges any air in the deoxygenated blood that has entered the circuit. Together with the recently approved AFFINITY® CP centrifugal blood pump, the AFFINITY® VARD reduces priming volume, a major goal for perfusionists who support blood conservation initiatives.

On Saturday, March 12th, 12:15 p.m. – 1:15 pm, Medtronic will host another luncheon presentation at the CREF Product Theater at the Marriott Newport Beach Hotel. Entitled “Mini-bypass – It’s a Straightforward Path Towards Reduced Blood Utilization,” the presentation will be lead by James Ferguson, CCP, Phoenix Perfusion Services LLC, Phoenix, AZ. Based upon supporting evidence of venous air removal and blood conservation, Mr. Ferguson will discuss a variety of miniaturized circuit configurations for use in CPB. Participants will learn how to implement new practice techniques through a step-wise and safe approach. They will also be able to see a hands-on demonstration and view examples of mini-circuit designs. We look forward to seeing you there!

RBC® Initiative and RBC Registry questions to be addressed At the Medtronic exhibit, perfusionists will be able to learn more about the RBC® Initiative and the RBC® Registry. The RBC® Registry is a custom perfusion-based tracking tool that captures perfusion-related technologies and patient data, linking it to specific STS categories. It allows users to track up to three different clinical protocols and sort the data in multiple ways for comprehensive analysis and practice improvement. The Registry is available to accounts during RBC Initiative implementation. To learn more about Medtronic’s Rethinking Blood Conservation® Initiative, go to http://www.medtronic.com/rbci/ or contact your Medtronic representative.

For additional information about the products to be exhibited at CREF or the Product Theater presentations, contact your Medtronic representative.

 
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Benefits of Blood Management and Conservation Sessions Sponsored by Medtronic at the Society of Thoracic Surgeons Annual Meeting

At the Society of Thoracic Surgeons (STS) 47th Annual Meeting, January 31 – February 2, 2011, in San Diego, CA, Medtronic sponsored a series of one-on-one consultation sessions, emphasizing the importance of blood management and conservation. The sessions were conducted by Pierre R. Tibi, MD, FACS, Cardiac Surgeon and Medical Director of the Yavapai Regional Medical Center in Prescott, AZ. With more than 2,200 medical professionals attending the STS Annual Meeting, it was an ideal venue for reinforcing Medtronic Perfusion System’s theme of Committed to Perfusion Solutions through product exhibits and sponsorship of educational events.

During the meeting, cardiac surgeons were given the opportunity to meet with Dr. Tibi for 30-minute, one-on-one interactive educational sessions. Dr. Tibi’s presentation, “Clinical and Economic Benefits of Implementing a Blood Conservation Program,” described the many benefits to surgeons and medical facilities of a coordinated program of blood management and conservation.

“Through the use of blood conservation, I’ve achieved blood transfusion rates of less than 20% for coronary artery bypass graft procedures at Yavapai Regional Medical Center,” Dr. Tibi said. Citing numerous published clinical articles, Dr. Tibi discussed with participants the risks associated with donor blood, including its limited safety and efficacy, its increasing scarcity, and its escalating cost. “Hospitals continue to under utilize strategies for blood conservation, enhanced endogenous production of a patient’s own blood, or both,” he commented.

“The work I’ve been doing at Yavapai has convinced me that a coordinated, multi-disciplinary, protocol-driven approach to blood management is often successful at reducing allogeneic transfusions, improving patient care, and reducing hospital costs. My objective in meeting with clinicians at these Medtronic-sponsored educational sessions is to help them understand how a multi-disciplinary blood conservation approach involving everyone – from the cardiac surgeons, anesthesiologists and perfusionists to nurses, pharmacists and hospital administrators – can benefit patients and the hospital.” Dr. Tibi has been leading blood conservation programs throughout Arizona for the past 12 years. In addition, he aggressively supports the implementation of comprehensive, multi-modality, system-wide conservation programs throughout the U.S. and internationally.

To support the need for rethinking blood conservation, Dr. Tibi cited data showing that patients transfused during coronary artery bypass surgery (CABG), are 5.6 times more likely to die in the first 100 days following surgery than those not transfused.1 The data also demonstrates a range of morbidities associated with transfusions, including adult respiratory distress syndrome (ARDS), infections, atrial fibrillation, and kidney and liver function complications.2

Medtronic instituted their Rethinking Blood Conservation (RBC)® Initiative over three years ago to help hospitals focus on the need for blood conservation in cardiac procedures. With cardiac transfusions using about 20% of the U.S. blood supply,3 blood use and blood conservation are issues that hospital administrators and medical professionals must urgently address. The effects of mismanaged blood cascade into consequences that affect both patient outcomes and hospital costs.

The Medtronic RBC® Initiative, an evidence-based educational program, works with clinicians and hospital administrators to devise strategies and tactics to help improve patient outcomes, reduce the length of ICU and hospital stays, and minimize complications related to blood use. The RBC® Initiative advocates a multi-modality approach to blood conservation designed to improve patient outcomes and reduce the financial burden of blood use-related complications.

To learn more about Medtronic’s Rethinking Blood Conservation Initiative go to http://www.medtronic.com/rbci/ or contact your Medtronic representative.

References

  1. Moskowitz DM, Klein JJ, Shander A, et al. Predictors of Transfusion Requirements for Cardiac Surgical Procedures at a Blood Conservation Center. Ann Thorac Surg. 2004; 77(2): 626-634.
  2. Rawn J. The Silent Risks of Blood Transfusion. Current Opinion. Anaesthesiology. 2008; 21(5): 664-668.
  3. Speiss BD. Transfusion and Outcome in Heart Surgery. Ann Thorac Surg. 2002;74(4):986-7.
 
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Heriberto (Eddie) Ortiz Senior field Service Representative

Mission in Action

Medtronic Senior Field Service Representative Goes the Extra Mile(s)

Bellevue Hospital Center in Manhattan had set up a Bio-Console 550 in the emergency room (ER) to speed the transition of patients requiring perfusion from the ER to the operating room (OR). Upon setting up the system, Chief Perfusionist Susan Vlahakis found that the batteries, essential for the transport to work, were not functional. She called her Medtronic senior field service representative Heriberto (Eddie) Ortiz and asked him to order and install replacement batteries … a simple, straightforward request, or so he thought.

“I ordered the batteries and scheduled delivery using the FedEx Express address I always use,” said Ortiz. The shipment was due to be delivered on December 6th by 9:00 AM.

On the morning of December 6th, Ortiz packed his equipment and headed to the FedEx Express office to pick up the batteries. Here’s where the simple, straightforward request became complicated. The batteries weighed 57 pounds and therefore had to be shipped via FedEx Ground. According to Ortiz, “It turns out that FedEx Express and FedEx Ground do not share the same serialized tracking system. As a result, the batteries had not been dropped off at the FedEx Express office and I had no way of pinpointing where the package might be.”

Ortiz called the FedEx Ground office and explained the situation. The agent there assured him that the driver would drop off the package at their facility in the Bronx by 11:00 AM.

“Since I had a couple of hours before the 11:00 AM delivery, I went to Bellevue to service another product,” Ortiz noted. “I filled Susan Vlahakis in on the battery situation and she told me not to worry about it. But I had a feeling that if I didn’t fix the Bio-Console 550 right away, Murphy’s Law would kick in, Bellevue would get an emergency case and be short one piece of critical equipment.”

Eleven AM came and went and the package still had not been delivered. Ortiz asked for the driver’s name and cell phone number so that he could meet the delivery truck and retrieve the batteries. The agent told Ortiz that, for the safety of delivery personnel, it was against policy to divulge driver information. Luckily she was not immune to Ortiz’s charm. “I switched my charisma on high,” commented Ortiz. “I told her I was a Medtronic field rep and that the box contained unique batteries for a heart/lung machine. If I did not get those batteries ASAP, a life might well be lost. She smiled and gave me the driver’s name, truck number, and cell phone number.”

The driver, no doubt surprised to get a call from a customer, told Ortiz that he hadn’t planned on delivering the package until the following day as he had received permission to cut his delivery schedule short in order to make an appointment. When Ortiz told him the urgency of the situation, the driver gave him his planned route and said that if Ortiz could catch up, he’d get his batteries.

“After 4 hours of driving all over New York City, I finally caught up with the delivery truck,” said Ortiz. “I took delivery of my batteries in the shadow of Yankee Stadium.”

Ortiz returned to Bellevue, replaced the batteries, performed planned maintenance, calibrated the system and did a performance check.

Not your typical senior field rep kind of day, but typical of Medtronic’s focus on customer service.

April 2011

AFFINITY NT® Oxygenator* with Trillium® Biosurface Provides Benefits During Difficult Case in South Africa

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Trillium-coated Affinity® NT Oxygenator

Natasha Joshua, CCP of the Groote Schuur Hospital in Cape Town, South Africa, recently shared her experience in a case that involved a patient presenting with a dissected aortic aneurysm and the role AFFINITY NT® Oxygenator and Trillium®† Biosurface Coating played in the procedure.

The patient, a 60-year-old female, presented with a dissected aortic aneurysm. She was put on full bypass and cooled to 20 degrees Celsius with circulatory arrest, and a Gortex® graft was implanted. During the procedure, it was necessary to warm and cool the patient on three occasions during the procedure due to bleeding and rupture of the suture sites. A cell saver was used and salvaged blood was reinfused into the bypass reservoir. Throughout the case the ACT levels were kept above 480 seconds, and blood gases were assessed every 20 minutes to ensure optimum perfusion.

According to Joshua, “We knew from the start that this would be a difficult case with an extended bypass time. In contrast, the perfusion aspect of the case ran smoothly with no electrolyte or poor perfusion problems resulting from the long bypass time. Despite the fact that blood products were added throughout the case, we experienced no clotting problems or poor oxygenator performance.” Joshua added that “if we had used a standard oxygenator rather than the AFFINITY NT® with the Trillium® Biosurface, it is possible that we would have experienced oxygenator failure requiring a change out or two.”

In Joshua’s opinion, “The Trillium® Biosurface made the perfusion portion of the case run smoothly. The surgeon even commented on how well the perfusion went given the circumstances. We now use Trillium® coated oxygenators and custom packs as standard protocol for all long, difficult cases. This set-up combination provides us with peace of mind so we don’t have to worry about oxygenator failure during any long case.”

The AFFINITY NT® Oxygenator has proven itself to be a reliable solution. Since its introduction, it has been used in more than 4 million procedures worldwide.1 It provides consistent, efficient gas transfer as a result of its patented radial flow design.

Trillium® Biosurface provides endothelial-like benefits for routine use during cardiopulmonary bypass procedures. Non-leaching heparin molecules are covalently bonded onto the surface to provide anticoagulant and additional beneficial effects similar to those provided by heparin sulfate in the natural endothelium.

For additional information about AFFINITY NT® Oxygenator System and Trillium® Biosurface, go to www.perfusion.medtronic.com or contact your local Medtronic representative. Also visit www.medtronic.com/affinity to get a behind the scenes look at the AFFINITY NT® Oxygenator.

Reference

  1. Medtronic sales data.

*Available with Carmeda® BioActive Surface or Trillium® BioSurface.

†Technology licensed under agreement from BioInteractions, Limited, United Kingdom.

Gortex is a registered trademark of W.L. Gore & Assoc., Inc.  

 
Somasundram

Dr. Ghandhiraj Somasundram at Gleneagle Hospital, Kuala Lampur, uses the Bio-Console® 560 during a life-saving procedure on a 15-year-old patient. 

Medtronic Bio-Console® 560 Used to Help Save Young Boy’s Life

A 15-year-old boy in Kuala Lumpur, Malaysia, took his mother’s car for a joy ride, despite not having a driver’s license. He crashed the car and injured himself severely. The impact of the crash caused a large left hemothorax with a questionable small transection of the aorta distal to the left subclavian artery.

Six weeks later, the boy developed an aneurysm in the affected area of his aorta. A CT scan assisted Dr. Ghandhiraj Somasundram at Gleneagle Hospital, Kuala Lumpur, in assessing the aneurysm. He determined that replacing the damaged aorta segment with a polyester graft was the best option. This approach, however, carries the risk of paralysis due to the length of time the aorta must remain clamped and the resulting reduction of blood flow to the spinal cord.

Dr. Ghandhiraj used the hospital's recently purchased Medtronic Bio-Console® 560 to support the patient's circulation via a Left Heart Bypass for three hours while the aorta was cross-clamped. “The Bio-Console® System combines reliability with user-friendly features and patient adaptable functions,” said "Dr. Ghandhiraj Somasundram. “My patient was very fortunate that we were able to use the Bio-Console® 560 while repairing his aorta. His immediate post-op recovery was uneventful and he experienced no paralysis.”

The Bio-Console® System offers a remote tethered drive system for optimum circuit design and the potential for reduced priming volume. A versatile, easy-to-read, LCD operating display with integrated flow control knob provides remote placement for more user flexibility.

For more information about the Bio-Console® 560, contact your Medtronic representative.

 

NEW PERFUSION RESOURCES

Medtronic Makes Fact-finding Visit to China’s Perfusionists

perfusion products needs china

Wendy Svee, Global Product Manager, leads discussion with perfusion leaders on Medtronic's commitment to perfusion and perfusion product needs for China

Among emerging economies, China’s has one of the fastest paces of growth.1 In March of 2011, Medtronic opened its new regional headquarters building in Shanghai to support China’s anticipated growth over the next five years. Medtronic plans to hire and train 1,000 additional skilled staff, who will focus on strengthening service to customers and patients, and to invest significantly in R&D, clinical studies, and manufacturing. Medtronic China currently employs 1,000 people in nine offices throughout China.

Commenting on the importance of Chinese customers and their patients to Medtronic, William A. Hawkins, Medtronic Chairman and CEO, said, “I am very glad that Medtronic now has a permanent home in China. This means we will have a higher-level platform for future development in the region and are in a position to better fulfill the company’s mission of alleviating pain, restoring health, and extending life in China.”

Wendy Svee, Global Product Manager, Medtronic CardioVascular, observed that “Understanding the clinical needs and current perfusion technology used in China is important in order to succeed in this region of the world.” She added, “During my recent trip to China I focused on gaining an understanding of clinical practices and needs in China and learning about their healthcare system and how it treats cardiac disease and defects.”

Part of Svee’s trip was dedicated to meeting with perfusion leaders in Beijing, Shanghai, Guangzhou, and Sanya and presenting Medtronic Perfusion System’s understanding of key issues challenging perfusionists today as well as Medtronic’s growth plans to address these issues. Svee stressed the critical role that Perfusion System’s technologies play in Medtronic’s broad cardiac business and that Medtronic’s commitment to perfusion is validated by the company’s more than 30-year history in the market.

Svee explained to the Chinese perfusionists she met that more than 3,000 Medtronic perfusion employees play an important role, partnering and collaborating with customers to successfully develop and deliver the procedural technologies required to meet individual patient needs. She added that Medtronic estimates that it will serve 1,400,000 patients globally over the next five years as it continues to increase investment in perfusion product development.

To increase awareness of Medtronic’s broad perfusion product portfolio, Svee presented information about the many perfusion products available to meet the demanding needs of perfusionists. The perfusionists then provided input to Svee regarding their product development needs for China. Svee also reviewed issues that Medtronic knows perfusionists face, including:

  • Need to optimize clinical outcomes, measurement and reporting
  • Patient safety
  • Increased demands for electronic record system implementation
  • Blood conservation
  • Specifically designed technologies for treating neonate, infant and pediatric cardiopulmonary bypass (CPB)

During the discussion about the need to optimize clinical outcomes and patient safety, the perfusion leaders noted their desire to enhance perfusion education, certification and continuing education. Jerry Chen, Marketing Manager, Medtronic China commented, “The perfusionists we met with are very interested in the topics of perfusion education and certification. They also are seeking information about the latest perfusion trends as practiced throughout the world.”

As part of the discussion on blood conservation, Svee highlighted the anticipated publication of the 2011 update to the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines. She presented Medtronic’s Rethinking Blood Conservation® (RBC) Initiative, which advocates a multi-modality approach to blood conservation. With the goals of improving patient outcomes and reducing the cost of blood use-related complications, the RBC® Initiative offers customer education, peer-to-peer training and tools for measuring the impact of program implementation.

Based on feedback Chen has received from clinicians about blood conservation, he remarked that “clinicians recognize the importance of blood conservation and are interested in developing an education course to address China’s needs in this area. The RBC® Initiative will be very helpful to them.” Svee added, “Education is of key importance. We are currently evaluating how we can adapt our successful Medtronic Perfusion customer education programs to partner with our customers worldwide.”

Chen added, “The Chinese clinicians we met with are very excited about Medtronic’s commitment to perfusion and the product development that is underway. They strongly believe that companies need to educate themselves about the unique needs of China to ensure that new product technologies address their patient needs.”

For more information about Medtronic perfusion products and the RBC® Initiative, contact your Medtronic representative.

 
 

Cardiac Surgeon and Perfusionist Collaboration Emphasized at Medtronic Dinner Forum

Steven R. Gundry, MD, FACS, FACC, Medical Director, International Heart and Lung Institute, Palm Springs, CA, emphasized the importance of collaboration between cardiac surgeons and perfusionists for successful minimally invasive cardiac surgery (MICS) at a Medtronic-hosted dinner forum held recently in New York City.

Addressing the topic of minimally invasive cardiac surgery, Gundry drew an analogy between airline pilots and copilots on one hand and cardiac surgeons and perfusionists on the other. “The passenger has many options for flying from point A to B, including flying coach or business class and arriving refreshed, sated with fine food and wine versus paying extra for a pillow, bag of peanuts and arriving with a deep venous thrombosis. While the pilot and co-pilot’s roles are different, collaboration between them can make an enormous difference, just as it can between the cardiac surgeon and perfusionist during minimally invasive cardiac surgery. Closer understanding of each other’s objectives makes it possible for the patient to exit the operating room, the intensive care unit and the hospital feeling like they received first class treatment to their brain, lungs and kidneys,” he said.

While presenting an overview of the cardiovascular perfusion system, Gundry emphasized the concerns of perfusionists as well as different perfusion techniques.

He also remarked upon the fact that there seems to be no formal, agreed upon definition for MICS. While some surgeons consider a small thoracotomy or a mini-sternotomy to be MICS, others relate it to the perfusion circuit size, including reduced priming volume or the absence of any perfusion circuit. Gundry believes that while all these definitions are accurate, he, as a pioneer of the Gundry mini-sternotomy, prefers this type of MICS incision because it does not require changes to his cannulation technique.

Definitions aside, Gundry maintains “the smaller the access, the more a team approach is needed. It’s important to remember that smaller access is not the only form of MICS. There are smaller primes and smaller blood/surface interactions. In fact, achieving smaller amounts of inflammation is probably more important than the size of the incision.”

As a key contributor to the field of cardiac surgery, Gundry invented several cardiac surgery cannulae, including the Medtronic Gundry® retrograde cardioplegia cannula, the MC2 and VC2 oval body venous return cannulas, and the Medtronic dilator system for ascending aortic cannulation. Gundry also spoke about the different incision and cannula choices associated with MICS.

During his discussion, Gundry reviewed the use and evolution of retrograde cardioplegia cannula over the past 25 years, and discussed various truths and dispelled several myths associated with retrograde cardioplegia. Finally, Gundry presented the pros and cons of different catheter and balloon designs, including placement tips.

During the Q and A segment of his presentation, Gundry answered a number of questions regarding retrograde cardioplegia flow rates since he prefers flows at much higher rates than do many clinicians.

This dinner forum is another example of Medtronic’s commitment to leadership in medical education. By broadening the cardiac surgeon’s understanding of perfusion technology's role in MICS procedures, better clinical care in the OR may be achieved.

 

Perfusionists Discuss Value of Electronic Charting at American Academy of Cardiovascular Perfusion Meeting

At the 32nd Annual Meeting of the American Academy of Cardiovascular Perfusion, held in Reno, NV, on January 27-30, 2011, perfusionists discussed the value and impact of computer-assisted bypass and automated electronic records. Their insight was particularly relevant in light of the Health Information Technology for Economic and Clinical Health Act (HITECH) recently passed by Congress to incentivize health care providers and hospitals to implement qualified electronic medical record (EMR) systems. The HITECH Act aims to extend the benefits of EMRs to a wider health care network, the ultimate result of which will be more patient-centered care and enhanced quality and safety of care provided. Click here for more information on the HITECH Act.

Of 20 perfusionists attending one of the fireside chat meetings, four were using electronic charting, six were awaiting implementation of electronic charting, and 14 were still using paper charting. During the discussion, participants touched on the possible or actual advantages of electronic charting, which included:

  • Provides tighter, better and easier perfusion parameter management.
  • Provides biostatistician-friendly data that can be easily accessed and analyzed.
  • Enhances quality control.
  • Pinpoints best-in-class performance.
  • Optimizes performance through use of alerts.
  • Facilitates uniform performance among the entire perfusion team.
  • Makes it easy to ascertain disposable lot numbers after the case is closed.
  • Automatically compiles an equipment repair and maintenance history.
  • Can be used as a teaching aid (using live review and post-procedure data review).
  • Schedules and automatically track hours of perfusionist/surgeon pairings.
  • Resolves issues between anesthesia and perfusion records.

Getting started in perfusion
To ensure that a hospital’s EMR system meets the needs of perfusion, perfusionists must get involved early in the EMR system discussions between hospital administrators and IT department managers. Once involved, perfusionists need to ask a number of important questions when evaluating the various perfusion EMR systems, including:

  • Is the system easy to use?
  • Will it be easy to integrate with other OR equipment?
  • Is it compatible with heart/lung machines?
  • Is it HL7 compliant (this is essential to health care information system interoperability)?
  • Does it offer connectivity options?
  • Can it be configured to meet your department’s particular needs? Can it be adapted to changing clinical circumstances?
  • Does the system have data management and editing capabilities?

Why the need for a system specifically designed for perfusion?
More and more hospitals are looking to acquire hospital-wide EMR systems, in part because of the HITECH Act. Too often, input from perfusion is either not sought during the decision-making process, or perfusion gets involved when IT implements the larger EMR system, too late to have any meaningful impact. As a result, perfusionists’ jobs may be made more difficult rather than more efficient. They may also discover the new EMR system does not connect electronically with the heart-lung machines or other critical OR devices.

What should a perfusion charting system look like?
A charting system specifically designed for perfusion applications and integrated into a central EMR system can make your job much easier. One example is Spectrum Medical’s data management system. Designed specifically for perfusion applications, the system interfaces with heart-lung machines and related perfusion OR devices. The technology shows how intuitive and user-friendly a charting system can be. Spectrum Medical’s system offers three EMR components: VIPER, the data acquisition module; VISION, the data management module; and LIVE VUE, a module for real-time viewing and distribution of the clinical data.

viper-vision-intro-bth

Take action now
Registration for the HITECH EMR incentive program began in January 2011. Now is the time to find out if your hospital is planning to implement an EMR system and to make sure that perfusion is part of the discussion. Perfusion electronic charting can be valuable for your department and hospital as well as your patients.

For more information on these products, you can either contact your local Medtronic representative, Spectrum Medical and their respective distributors in certain markets or visit www.spectrummedical.com.

 

Medtronic Presents Real-Time Electronic Perfusion Charting during 2011 CREF Cardiothoracic Surgery Symposium

At the 2011 CREF Cardiothoracic Surgery Symposium, more than 100 clinicians witnessed a broadcast of a simulated OR procedure demonstrating real-time electronic perfusion charting. Hosted by Medtronic, in partnership with Spectrum Medical, the presentation featured a high fidelity case simulation run by Robin Sutton, Chief Perfusionist at Rush University Medical Center, Chicago, IL, and Clinical Coordinator of the Rush University Perfusion Technology Program.

During the broadcast, Sutton demonstrated the ease of electronic perfusion charting using the Spectrum Viper Data System and the seamless way the system integrates with critical OR devices such as the heart-lung machine, Medtronic’s HMS Plus System and Bio-Console® 560, the patient monitor, and the blood monitoring system.

After the case presentation, Medtronic sales representative Kim Lewis, CCP, spoke about the importance of high fidelity simulation for perfusion training. “This is an important training tool for perfusionists since it brings together all of a case’s details in a realistic setting,” Lewis said. “Its sophisticated realism helps train clinicians in the real-time use of products like the VIPER system as well as with clinical decision-making.” Her comments were confirmed by members of the audience who commented on how informative the broadcast was and the value of better understanding how the VIPER system works. Others commented that the high fidelity simulation is an excellent remote training tool, especially useful for professionals for whom travel for educational purposes is not always feasible.

Following Lewis’s comments, Steven Turner, CEO, Spectrum Medical, fielded questions about the Viper Data System and how user-friendly it is for managing and integrating data. “Spectrum Medical’s data management system is a good example of how intuitive and user-friendly a charting system can be,” Turner said. “We offer three electronic perfusion charting system components which you saw demonstrated today: VIPER, the data acquisition module; VISION, the data management module; and LIVE VUE, the module for real-time viewing and distribution of the clinical data,” Turner added.

Sutton and Lewis answered questions about integrating the VIPER system with other OR devices and the process for securing hospital administration’s approval to acquire the system. Sutton confirmed that since the VIPER system is a software system, it integrates easily with all OR devices. As to hospital administration approval, Sutton said that “communication is key to getting their approval. Our process went smoothly and was fairly straightforward. The perfusion department did its homework so that we were able to explain and document the system’s value both for the hospital and for patients. As a result, administration was cooperative in approving the purchase.”

Following the federal government’s recent approval of an electronic medical records act (HITECH) it is important that perfusionists get involved early in the process to ensure that the EMR system their institution ultimately acquires meets perfusion’s clinical needs.

For more information on these products, you can either contact your local Medtronic representative, Spectrum Medical and their respective distributors in certain markets or visit www.spectrummedical.com.

Medtronic Perfusion plans to continue the great momentum experienced at the CREF Symposium at the upcoming Mechanisms of Perfusion Annual Conference in Orlando on May 19 – 22nd, 2011. Be sure to stop by the Medtronic booth to learn more about their commitment to perfusion solutions.

 

Medtronic Highlights Mini-circuits in Coronary Bypass Procedures at CREF Product Theater

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Affinity® VARD

At the 2011 CREF Cardiothoracic Surgery Symposium, Medtronic highlighted their mini-circuits in coronary bypass (CPB) procedures during a luncheon presentation in the CREF Product Theater. James Ferguson, CCP, Phoenix Perfusion Services LLC, Phoenix, AZ, addressed 90 clinicians on the subject of “Mini-bypass – It’s a Straightforward Path Toward Reduced Blood Utilization.” His discussion of miniaturized circuit configurations for use in CPB was supported by evidence showing the relationship between venous air removal and blood conservation.

Ferguson presented clinical study evidence of the impact air emboli can have, including data showing them to be a major cause of morbidity and mortality in CPB. “The key is to prevent neurocognitive deficits such as memory depression, comprehension, perception impairment, attention deficit, and/or stroke or death,”1 Ferguson said.

Reviewing the different causes of gaseous microemboli (GME), Ferguson presented published clinical studies that showed the risk of GME to be specific to the product used in different ECC modalities. A study by Groom, et al, concluded that “changes in CPB techniques and circuit components, including filter size and type of pump, resulted in a reduction rate of 75% of cerebral microemboli … Leaving the arterial filter in the circuit is essential.”2

Ferguson cited Medtronic’s AFFINITY® Venous Air Removal Device (VARD) as an example of a de-airing device that can be incorporated into the circuit. The AFFINITY VARD allows customization of circuit systems for improved air handling in a miniaturized circuit. The system senses and automatically purges any air in the deoxygenated blood from the circuit. Together with the AFFINITY® CP centrifugal blood pump, the AFFINITY® VARD reduces priming volume, a major goal for perfusionists who support blood conservation initiatives

With the AFFINITY® VARD as a component of perfusion custom packs, perfusionists have more options for circuit design. According to Ferguson, “The AFFINITY® VARD is one more tool that can be used for blood conservation since it helps with decreased hemodilution and blood usage. It is easy to incorporate into your circuit and provides another level of safety for removing air from the CPB circuit.”

Ferguson defined the attributes that an “ideal” mini extracorporeal circuit should have. They include:

  • No hemodilution
  • Completely endothelialized tubing
  • Totally closed circuit
  • No activation of the complement/cytokine system
  • Platelets/red blood cells maintain their integrity
  • Excellent gas exchange and CO>2 removal
  • Prevention of neurocognitive deficits
  • No adverse sequelae

“Hospitals today use different types of circuits,” said Ferguson. “ … conventional open reservoir, cross-over extracorporeal (COECC), and the mini-circuit, a reservoirless circuit that uses an air removal device. Since no standards have been set, institutions may use some or all of these circuits, depending on their blood conservation improvement goals.”

Ferguson reminded the audience that the 2011 Update to the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines revised mini-circuits from Class IIb to Class I(A), which indicates that the procedure or treatment is useful/effective with sufficient supporting evidence from multiple randomized trials or meta-analyses.3

Ferguson shared the conclusions of several published clinical studies that “mini-circuits reduce post-operative RBC transfusion in patients undergoing CABG’s.”4 He also mentioned that Medtronic’s multi-modality approach to blood conservation, Rethinking Blood Conservation® (RBC) Initiative, “is an excellent tool to help hospitals improve patient outcomes and reduce the cost of blood use-related complications.”

For more information about the AFFINITY® VARD or RBC® Initiative, contact your Medtronic representative.

Medtronic Perfusion plans to continue the great momentum experienced at the CREF Symposium at the upcoming Mechanisms of Perfusion Annual Conference in Orlando on May 19 – 22nd, 2011. Be sure to stop by the Medtronic booth to learn more about their commitment to perfusion solutions.

 

References

  1. Schönburg M, Ziegelhoeffer T, Kraus B, Mühling A, Heidt M, Taborski U, et al. Reduction of Gaseous Microembolism during Aortic Valve Replacement Using a Dynamic Bubble Trap. Gen Physiol Biophys. 2006;25(2):207-14.
  2. Groom RC, Quinn RD, Lennon P, Donegan DJ, Braxton JH, Kramer, RS, et al. Detection and Elimination of Microemboli Related to Cardiopulmonary Bypass. Circ Cardiovasc Qual Outcomes. 2009;2:191-198.
  3. STS Blood Conservation Guideline Task Force: Ferras VA, Brown JR, Despotis GJ, Hammon JW, Reece B, Sha SP, et al; SCA Special Task Force on Blood Transfusion: Shore-Lesserson LJ, Goodnough LT, Mazer, CD, Shander A, Stafford-Smith M, Waters, J.; Intl. Consortium for Evidence Based Perfusion: Baker, RA, Dickinson, TA, FitzGerald DJ, Likosky DS, Shann, KG. 2011 Update to The Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines. Ann Thorac Surg. 2011;91:944-82.

 

June 2011

Perfusion Customers Praise Medtronic Affinity® Oxygenator for Consistent Performance and Reliable Results

affinity-nt-trillum-small

Trillium-coated Affinity® NT Oxygenator

At a recent Medtronic Advisory Board meeting, perfusionists praised the Affinity® NT Oxygenator for its consistent performance and reliable results. The consensus among perfusionists attending this meeting was that they could always count on the Affinity® Oxygenator. According to Ron Learn, CCP, President/CEO, Circulatory Services, Inc., Gainesville, FL, “Not only is it predictable and reliable, but it handles any size adult patient.”

In 2010, Medtronic reached a milestone with the production of the four-millionth Affinity® Oxygenator. Through ongoing manufacturing process optimization, it continues to deliver consistent performance and reliable results. The Affinity® System’s consistency and reliability start with an oxygenator design that has set the industry standard.

According to Walt Carpenter, Medtronic Senior Mechanical Engineer, “The real innovation in the Affinity® Oxygenator is the system’s radial flow design which allows the blood to escape in all directions and flow out radially for a very short path length versus a long linear path length. This design, together with the proprietary fiber winding technique, provides the reliable results perfusionists require in a constantly changing cardiac surgery environment.” The packing fraction design of the Affinity® Oxygenator maximizes gas transfer as it minimizes blood shear, priming volume, and blood side pressure drop.”

Continuing to provide perfusionists with predictable results and reliable performance is an important part of Medtronic Perfusion Operations’ focus. To accomplish this, they continuously look for ways to drive down variability in the manufacturing processes. Joe Feisthamel, Medtronic Manufacturing, pointed out that, “improvements to such areas as software and testing methods used in product manufacturing ensure the Affinity® NT Oxygenator’s quality remains at the highest standard. Quality is one of the most important things that we do.” For example, the manufacturing process has 22 steps, with at least one quality check at every step that ranges from a leak test to a visual inspection.

Herb Eggers, CCP, President, Louisville Perfusion Services, Louisville, KY, explained the practical side of these quality tests. “In our experience, the Affinity® System is the most consistent and dependable oxygenator out there. We use it every day and haven’t had one problem in over nine years of use. It works the same way every day, so our perfusionists know what to expect. It’s a real workhorse. It gets the job done and makes perfusionists feel safe when they are using it.”

Visit www.medtronic.com/affinity to view a behind-the-scenes video tour to discover why the Affinity® Oxygenator is clearly the choice for consistent performance and reliable results.

For more information on the Affinity® Oxygenator, contact your Medtronic representative.

Medtronic Academia’s Education and Training Help St. Joseph’s Cardiac Surgery Team Deliver Quality Patient Care

Medtronic Academia’s program provided educational support and product training to the perfusion team at St. Joseph’s Hospital in St. Paul, Minnesota, facilitating the successful integration of the Medtronic Resting Heart® System into their blood management program. The program’s result: less blood utilization and improved patient care.

SpecialtyCare provides perfusion services to St. Joseph’s Hospital. Tim Weatherhead, a SpecialtyCare perfusionist at St. Joseph’s, noted that “the Medtronic Resting Heart® System is different from conventional circuits and requires more perfusionist interaction as well as frequent communication between the perfusionist and surgeon. Its addition to the other blood conservation techniques adopted by the perfusionists and cardiac team at St. Joseph’s has contributed to a 61.5% decrease in intraoperative red blood cell use since April 2008.†”

 

Average Intraoperative RBC Transfusions per Patient

 

RBC-Transfusions

 

St. Joseph Hospital experienced a 61.5% decrease in the average number of red blood cell units used per patient for transfusion from 2008 – 2011.

“In addition to product-specific training, Medtronic Academia provided clinical support that facilitated the adoption and implementation of the Resting Heart® System. We found this training and support to be critical to the successful integration of the Resting Heart® System,” Weatherhead said.

resting-heart

“The perfusion team at St. Joseph’s has been using the Resting Heart® System for three years. During this time, we have tracked intraoperative allogeneic blood use (RBC and/or plasma components) as part of our daily practice. St. Joseph’s has decreased their total intraoperative blood use by 36% since 2008. I believe that the Resting Heart® System has contributed significantly to this accomplishment,” Weatherhead added.

 

The Medtronic Resting Heart® System is a low prime, reservoirless, closed-to-air circuit designed to address the traditional challenges of cardiac surgery. It features active air removal technology, no air-blood interface, elimination of active foam agents and tip-to-tip Carmeda®* BioActive Surface.

When Transfusion Is Not an Option
The St. Joseph’s cardiac team realized the need and potential benefit of a mini-circuit perfusion system when they were presented with a complex case in which the patient declined the use of blood and blood products due to religious convictions. The combination of preoperative preparation with erythropoietin, use of the Resting Heart® System in addition to retrograde autologous priming, cell salvage, hemoconcentration, and minimization of intraoperative fluids contributed to a successful surgery. In the post-operative period, fluids were managed conservatively and blood samples were minimized. The patient was successfully discharged home with a satisfactory hemoglobin level and no symptoms of anemia.

Medtronic Perfusion Systems is dedicated to offering perfusionists the potential benefits of devices that promote blood conservation. In its development of the Resting Heart® System, Medtronic gave significant consideration to certain clinical studies that evaluated the potential benefits of lower hemodilution,1-4 reduced compliment activation,5 and less blood contact with foreign surfaces when compared to traditional circuits.6 Mini circuits, like the Resting Heart® System, may reduce hemodilution and blood activation, which may result in a lower need for transfusions perioperatively.

In St. Joseph’s experience, an increasing number of patients do not wish to receive blood or blood products perioperatively. There is a growing body of data demonstrating the benefits of blood conservation. Successful implementation of these types of conservation initiatives will require cardiac surgery teams to explore different blood management-related options. Mini-circuits such as the Medtronic Resting Heart® System offer the latest in technique and technology to help cardiac surgery teams attain these conservation goals.

A multi-disciplinary team approach is necessary to implement a successful blood management program in today’s complex cardiac surgery cases. Through appropriate preparation and practices, a patient’s own blood can be preserved in both routine and complex cases. The Medtronic Resting Heart® System is an adjunctive system that can assist cardiac teams in reducing allogeneic blood use.

For more information about the Resting Heart® System or Medtronic Academia, contact your local Medtronic representative.

Reference

  1. Balachandran S, Cross MH, Karthikeyan S, Mulpur A, Hansbro SD, Hobson P. Retrograde autologous priming of the cardiopulmonary bypass circuit reduces blood transfusion after coronary artery surgery. Ann Thorac Surg. 2002; 73(6):1912-8.
  2. Eising GP, Pfauder M, Niemeyer M, Tassani P, Schad H, Bauernschmitt R, Lange R. Retrograde autologous priming: is it useful in elective on-pump coronary artery bypass surgery? Ann Thorac Surg. 2003; 75(1):23-7.
  3. Rosengart TK, DeBois W, O'Hara M, Helm R, Gomez M, Lang SJ, Altorki N, Ko W, Hartman GS, Isom OW, Krieger KH. Retrograde autologous priming for cardiopulmonary bypass: a safe and effective means of decreasing hemodilution and transfusion requirements. J Thorac Cardiovasc Surg. 1998;115(2):426-38.
  4. Shapira OM, Aldea GS, Treanor PR, Chartrand RM, DeAndrade KM, Lazar HL, Shemin RJ. Reduction of allogeneic blood transfusions after open heart operations by lowering cardiopulmonary bypass prime volume. Ann Thorac Surg. 1998;65(3):724-30.
  5. Svenmarker, S, et al. Use of heparin-bonded circuits in cardiopulmonary bypass improves clinical outcome. Scand Cardiovasc J. 2002;35:241-246.
  6. Cormack JE, Forest RJ, Groom RC, Morton J. Size makes a difference: use of a low-prime cardiopulmonary bypass circuit and autologous priming in small adults. Perfusion. 2000;15:129-35.

†These results are not necessarily predictive of other clinical results.

*Manufactured under license from Carmeda AB, Sweden. Carmeda is a registered trademark of Carmeda AB.

 

NEW PERFUSION RESOURCES

Incentive Payments for Meaningful Use of Electronic Medical Records (EMR) Begin May 2011: What Does This Mean for Perfusion?

In 2009, the United States Congress passed the Health Information Technology for Economic and Clinical Health (HITECH) Act as an incentive for health care providers and hospitals to implement qualified EMR systems. The Department of Health and Human Services set aside $27 billion for incentives to ease the financial burden institutions incur when making the transition to electronic medical records (EMR). In their first year of program participation, eligible hospitals could see as much as a $2 million reimbursement (adjusted based on the hospital’s Medicare share).

The HITECH Act aims to extend the benefits of EMRs to a wider health care network to achieve more patient-centered care and to enhance the quality and safety of the care provided.

Only acute care and critical access hospitals that accept Medicare or Medicaid patients are eligible to participate in this program, and they must use certified EMR systems. Complete incentive program information, including detailed eligibility criteria, can be found on The Office of the National Coordinator for Health Information Technology website (http://healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov_regulations_and_guidance).

Defining and demonstrating meaningful use The Centers for Medicare and Medicaid Services (CMS) has instituted a phased approach to implementation of the EMR reimbursement program that “encompasses reasonable criteria for meaningful use based on currently available technology capabilities…”1 As EMR technology evolves and implementation increases, the CMS will revise the program’s rules and regulations.

Currently, the CMS defines meaningful use as:

  • Using certified EMR technology to expedite delivery of care and to substantiate clinical quality measures.
  • Using electronic exchange of patient information among EMR systems to improve and speed health care delivery.
     

For a complete list of program objectives associated with meaningful use and timing for implementation, go to https://www.cms.gov/EHRIncentivePrograms/Downloads/Hosp_CAH_MU-TOC.pdf.

To be a truly useful tool, EMRs must include vital patient data from every department within a hospital … from the pharmacy and lab to radiology and the OR, including perfusion charting, which is a component of the data recorded from the OR.

Getting started in perfusion More and more hospitals are acquiring hospital-wide EMR systems. Too often, purchase decisions are made without input from perfusion, which can have a direct impact on their working environment. Perfusionists may also discover that the EMR system acquired by the hospital may not connect electronically with the heart-lung machines or with many other critical OR devices.

Consequently, it is essential that perfusion be involved early in the EMR system discussions between hospital administrators and IT department managers. Your first step should be to determine the status of the decision-making process at your hospital. Then, ask to join the team or offer to lead the evaluation team for perfusion.

Once on the team, it is important to gather essential information to bolster perfusion’s argument for a preferred EMR system. This information should include:

  • Determining your departmental goals.
  • Evaluating the features, benefits, and drawbacks of available systems.
  • Defining, based on your evaluation, what an electronic charting system must provide in order to accomplish departmental goals and how it will enhance the quality of service perfusion provides.
     

When evaluating the various perfusion EMR systems, important questions to ask may include:

  • Is the system easy to use?
  • Will it be easy to integrate with other OR equipment?
  • Is it compatible with heart/lung machines?
  • Is it HL7 compliant (this is essential to health care information system interoperability)?
  • Does it offer connectivity options?
  • Can it be configured to meet your department’s particular needs? Can it be adapted to changing clinical circumstances?
  • Does the system have data management capabilities? Editing capabilities?
     
viper-vision-intro-bth

Spectrum Viper Data Management System

The time is now
Registration for the EMR incentive program began January 3, 2011. If your institution is planning to implement an EMR system, make sure that perfusion is part of the discussion. Without your input, perfusion could be working at a serious disadvantage with a cumbersome system not specifically designed with perfusion in mind.

Get involved in the EMR decision process. It’s a good move for you, your department, and your hospital. And, it’s a great move for your patients.

To learn more about electronic perfusion charting, contact your local Medtronic representative, Spectrum Medical and their distributors in certain markets, or visit www.spectrummedical.com

 

Reference

  1. Federal Register Vol. 75, No. 144 /Wednesday, July 28, 2010 /Rules and Regulations, page 44321.
 

Medtronic Perfusion Systems is Expanding Our Clinical Specialist Team

As part of Medtronic’s commitment to the perfusion market, we are expanding our Clinical Specialist team and are actively recruiting for qualified candidates. Clinical Specialists are a critical asset to our sales channel through their support of the Medtronic Perfusion System’s business with surgical case coverage as well as general clinical consulting and troubleshooting related to product usage, circuit design or technique. They also play an integral role in clinician and sales representative education and training. With a significant number of products currently in development and getting ready to launch, it’s an exciting time to join the world’s largest medical device company. If you are interested in learning more about this important opportunity, please apply here.

 

Blood Conservation and Management Still Top of Mind for Professional and Clinical Organizations

Nearly 15 million units of packed red blood cells (PRBC) are used every year in the United States during surgical procedures.1 Paradoxically, while interest in blood conservation's role in reducing blood transfusions grows, the number of yearly transfusions continues to increase.2 According to the Society of Thoracic Surgeons Adult Cardiac Surgery Database, approximately 50% of patients undergoing cardiac procedures receive blood transfusion3 despite growing evidence that transfusions during cardiac procedures negatively impact short- and long-term outcomes.4,5

Koch et al, in a study of nearly 12,000 patients who had isolated coronary artery bypass graft procedures, compared mortality and morbidity measures between patients who had received transfusions and those who had not. The study found that “transfusion of red blood cells was associated with a risk-adjusted increased risk for every postoperative morbid event. The authors concluded that “perioperative red blood cell transfusion is the single factor most reliably associated with increased risk of postoperative morbid events after isolated coronary artery bypass grafting.”6

STS Updates Blood Conservation Practice Guidelines

The Society of Thoracic Surgeons (STS) together with the Society of Cardiovascular Anesthesia (SCA) recently published the 2011 Update to their Blood Conservation Clinical Practice Guidelines. First issued in 2007 to address blood conservation concerns, the Guidelines state that “interventions aimed at reducing bleeding and blood transfusion during cardiac procedures are an increasingly important part of quality improvement and are likely to provide benefit to the increasingly complex cohort of patients undergoing these operations. The 2011 revisions contain new evidence that alters or adds to the 61 previous recommendations.”1

With input from perfusionists, the new guidelines encompass a range of recommendations. Those with specific relevance to perfusion interventions (including the Classification and Level of Evidence*) are summarized here:

  • Blood salvage interventions
    • Expanded use of blood salvage using centrifugation to include patients with known malignancy who require cardiac procedures (11b Classification; B Level of Evidence)
    • Pump salvage of residual blood in cardiopulmonary bypass (CPB) circuit (11a Classification; C Level of Evidence)
    • Centrifugation of pump-salvaged blood, instead of direct infusion, is reasonable for minimizing post-CPB allogeneic RBC transfusion (11b Classification; B Level of Evidence)
  • Perfusion interventions
    • Microplegia to minimize volume of crystalloid cardioplegia and reduce hemodilution (11b Classification; B Level of Evidence)
    • Alternate non-heparin anticoagulation in ECMO patients with HIT to reduce platelet consumption (1 Classification; C Level of Evidence)
    • Mini-circuits (reduced priming volume and circuit volume) to reduce hemodilution (1 Classification; A Level of Evidence)
    • Augmented venous drainage (11b Classification; C Level of Evidence)
    • Biocompatible CPB circuits to limit hemostatic activation and limit inflammatory response (11b Classification; A Level of Evidence)
    • Modified ultra-filtration at the end of CPB (1 Classification; A Level of Evidence)
    • Conventional or zero-balance ultra-filtration during CPB (11b Classification; A Level of Evidence)
    • Leukocyte filters used in the CPB circuit (111 Classification; B Level of Evidence)

"The updated guidelines, from a surgeon's point of view, are an essential tool for assuring we provide our patients with responsible blood management. They are the base upon which a blood conservation strategy can be built that assures effective and legitimate utilization of blood resources while also diminishing the use of unnecessary blood and blood product transfusions, all of which can have significantly deleterious effects on our patients," commented Peter Tibi, MD, FACS, Cardiac Surgeon and Medical Director of the Yavapai Regional Medical Center in Prescott, AZ.

 

Joint Commission Develops Patient Blood Management Performance Measures

In addition to the STS 2011 Guideline Update, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has expressed strong interest in blood management as a performance measure. In a 2010 pilot project, JCAHO tested a draft set of Patient Blood Management (PBM) Performance Measures in hospitals across the United States. Final measures will be placed in the Joint Commission Measure Reserve Library by June 2011 and will be available to all healthcare organizations for use with their internal quality improvement initiatives. The measures include:

  • Transfusion Consent
  • RBC Transfusion Indication
  • Plasma Transfusion Indication
  • Platelet Transfusion Indication
  • Blood Administration Indication
  • Preoperative Anemia Screening
  • Preoperative Blood Type Testing and Antibody Screening

“The Joint Commission remains committed to improving patient blood management and will continue to encourage hospitals to begin reviewing their processes related to transfusion.”7 To read more about the Joint Commission’s PBM Measures, visit their website at www.jointcommission.org.

 

Advanced Technology Key to Effective Blood Conservation

Medtronic Perfusion continues to set industry standards in cardiac surgery technologies that also support blood conservation. These technologies include:

  • autoLog™ Autotransfusion System – easy to use and designed to consistently produce a blood product with a hemotocrit of 50% or greater. The system’s variable speed wash process promotes effective wash out of 90% or greater in accordance with AABB guidelines.8
  • AFFINITY CP™ Centrifugal Blood Pump – a low prime centrifugal pump with smooth cone and low-profile fins that gently handles blood, resulting in low hemolysis.
  • AFFINITY Venous Air Removal Device (VARD) – senses and automatically removes any air that may have entered the deoxygenated blood circuit. Combined with the AFFINITY CP™ pump, the AFFINITY® VARD reduces priming volume, a major goal in blood conservation initiatives.
  • Bio-Pump® Plus Centrifugal Blood Pump – recognized worldwide as the market leader in centrifugal blood pumps, the Bio-Pump® Plus provides perfusionists with a high margin of safety and proven reliability.
  • HMS Plus Hemostasis Management System – a reliable, versatile platform used to perform multiple tests for heparin management. By providing information about a patient's response to heparin, the HMS Plus System determines the appropriate patient dosage for the needed anticoagulant and antithrombotic effect.
  • Carmeda® BioActive Surface** – the industry standard in biosurface technology, with extensive published research documenting its benefits for thromboresistance and biocompatibility.

 

RBC_initiative

Medtronic RBC® Initiative Supports Rethinking Blood Conservation

Medtronic instituted their Rethinking Blood Conservation (RBC)® Initiative over three years ago to support the STS Guidelines and help hospitals focus on the need for blood conservation in cardiac procedures. Cardiac transfusions use about 20% of the U.S. blood supply.9 The effects of mismanaged blood cascade into consequences that affect both patient outcomes and hospital costs. Data shows that patients transfused during coronary artery bypass surgery (CABG), are 5.6 times more likely to die in the first 100 days after surgery than those not transfused.10 The data also demonstrates a range of morbidities associated with transfusions, including adult respiratory distress syndrome (ARDS), infections, atrial fibrillation, and kidney and liver function complications.11

The Medtronic RBC® Initiative, an evidence-based educational program, helps clinicians and hospital administrators devise strategies and tactics to help improve patient outcomes, reduce the length of ICU and hospital stays, and minimize complications related to blood use. The RBC® Initiative advocates a multi-modality approach to blood conservation that helps improve patient outcomes and reduce the financial burden of blood use-related complications.

To learn more about Medtronic’s Rethinking Blood Conservation® Initiative go to http://www.medtronic.com/rbci/ or contact your Medtronic representative.

June Chart 2

June Chart

 

Reference

  1. Ferraris VA, Brown JR, Despotis GJ, Hammon JW, et al. 2011 Update to The Society of Thoracic Surgeons and the Society of Cardiovascular Anestesiologists Blood Conservation Clinical Practice Guidelines. Ann Thorac Surg. 2011;91:944-982.
  2. Sullivan MT, Cotten R, Read EJ, Wallace EL. Blood collection and transfusion in the United States in 2001. Transfusion. 2007;47:385–94.
  3. Mehta RH, Sheng S, O’Brien SM, et al. Reoperation for bleeding in patients undergoing coronary artery bypass surgery: incidence, risk factors, time trends and outcomes. Circ Cardiovasc Qual Outcomes. 2009;2:583–90.
  4. Engoren MC, Habib RH, Zacharias A, et al. Effect of blood transfusion on long-term survival after cardiac operation. Ann Thorac Surg. 2002;74:1180–6.
  5. Koch CG, Li L, Sessler DI, et al. Duration of red-cell storage and complications after cardiac surgery. N Engl J Med. 2008;358:1229–39.
  6. Koch CG, Li L, Duncan AI, Mihaljevic T, Cosgrove DM, et al. Morbidity and Mortality Risk Associated with Red Blood Cell and Blood-component Transfusion in Isolated Coronary Artery Bypass Grafting. Crit Care Med. 2006;34:1608-16.
  7. The Joint Commission January 3, 2011. Patient Blood Management Performance Measures. Retrieved from:
    http://www.jointcommission.org/patient_blood_management_performance_measures_project
  8. Guidance for Standards for Perioperative Autologous Blood Collection and Administration.First Edition.American Association of Blood Banks Sec. 5.1.2, p 21.
  9. Speiss BD. Transfusion and Outcome in Heart Surgery. Ann Thorac Surg. 2002;74(4):986-7.
  10. Moskowitz DM, Klein JJ, Shander A, et al. Predictors of Transfusion Requirements for Cardiac Surgical Procedures at a Blood Conservation Center. Ann Thorac Surg. 2004; 77(2): 626-634.
  11. Rawn J. The Silent Risks of Blood Transfusion. Current Opinion. Anaesthesiology. 2008; 21(5): 664-668.

*Classification of Recommendations

 

MISSION IN ACTION

Medtronic Perfusion Project SEARCH Team's Educational Internship Program for Students with Disabilities Earns CEO Inclusion Award

Seeking out and welcoming people with different backgrounds and perspectives, from employees and suppliers to healthcare partners and patients, is a major part of the Medtronic culture. The CEO Inclusion Award recognizes employees and teams that make outstanding contributions to this effort. In 2010, Medtronic Perfusion's Project SEARCH team earned the award for its commitment to creating an inclusive environment built on Medtronic's Traits and Mission.

In 2004 Medtronic CEO Bill Hawkins initiated the CEO Inclusion Award program. At this year’s award ceremony, Hawkins underscored the award's importance, saying that, “Medtronic employees understand that supporting diverse insights and unique perspectives drives our innovation and gives us competitive advantage. This award recognizes the individuals and teams who have made outstanding contributions to diversity and inclusion at Medtronic. Their passion and commitment support our Traits and Mission, and their results demonstrate for all of us the power of inclusiveness.”

Project SEARCH is a one-year, business-led educational internship program, in partnership with school districts and social service agencies, for students with disabilities in their last year of high school eligibility. The students get the opportunity to learn competitive, transferable and marketable job skills, and they gain increased independence, confidence and self-esteem. Medtronic is the first Minnesota employer to implement Project SEARCH, and during the past year, 10 students worked at Medtronic in manufacturing, the digital print center, expense reporting, and document solutions. Through their immersion in the workplace, students receive continuous feedback and are encouraged to apply their newly acquired skills.

Kristina-Hill

Kristina Hill, a Project SEARCH student, unwraps parts in Medtronic Perfusion’s clean room for the CVR line.

Carolyn Oldani, Medtronic Manufacturing Director, SH Midwest Operations commented that “the Project SEARCH team went beyond their job responsibilities to support this unique program by providing the first internships at Medtronic for these young adults. The presence of Project SEARCH interns at Medtronic fosters a positive environment that embraces another element of diversity and inclusion in the workplace. It also gives Medtronic access to a new, diverse talent stream as well as supporting our community. The potential long-term impact is that more people with disabilities will achieve competitive employment, and more businesses will effectively access this under-utilized talent pool.”

Medtronic Perfusion’s manufacturing organization was particularly interested in the Project SEARCH program because it targeted a group often overlooked in diversity programs. Typically, diversity and inclusion programs focus on women and people of color or on those from different backgrounds or countries. According to Oldani, “We had never focused on people with disabilities. The Project SEARCH students brought a fresh mindset that we had not seen in a long time. They were excited to be here and came into the organization with no sense of entitlement. Rather, they thought about what value they could bring to the organization. They were a delight to work with, and our work force’s response to them was very welcoming.

“Diversity and inclusion isn't only about statistics or meeting a certain demographic quota on your staff. It’s about how you think and understand people. Participating in this program emphasized to each of us how rich an organization can become with a diverse employee population. It helped us understand our patients and customers better. As an organization, we feel we’ve grown from this program and we'll continue to participate in it,” Oldani said.

Medtronic Perfusion’s Project SEARCH team was one of three teams who received the 6th Annual CEO Inclusion Award. In addition, two Employee Resource Groups, five individuals selected from Medtronic’s global businesses, one area/country, and one business unit received this prestigious award. Individual and team winners were presented with a crystal trophy and a monetary award to be used in support of an educational organization or charity of their choosing.

 

Quality Commitment Vital to Ensuring Medtronic’s High Product Performance

Successful manufacturing organizations rely on strong quality strategies to ensure high product performance. For medical device manufacturers, such strategies are essential since regulators in most countries require a Quality System that provides the necessary guidance, governance and oversight to ensure that device performance requirements are met, regardless of a manufacturing company's size.

Medtronic’s commitment to delivering high product performance is driven by a robust internal self-auditing program that continuously monitors compliance with both regulatory and self-imposed quality requirements. For example, quality is always the first agenda item when the Medtronic Perfusion Systems business unit begins its weekly leadership staff meeting. In addition to attending annual training sessions on Medtronic’s Quality policy requirements, every employee's ID badge carries the Medtronic Quality Mission statement to remind employees of the role each individual plays in maintaining quality standards in products, processes, services, and customer relationships:

To strive without reserve for the greatest possible reliability and quality in our products; to be the unsurpassed standard of comparison and to be recognized as a company of dedication, honesty, integrity and service.

This statement helps employees better understand the vital role that strong performance in each of these areas plays for improving business results and, more important, improving patient outcomes. “We have a tremendous opportunity to lead performance improvements across our businesses, whether in product quality, regulatory compliance, waste reduction or customer satisfaction,” said Eric Moore, Quality Systems Director, Cardiac and Vascular Group (CVG). “The potential benefits derived from improved quality are immense, and our strategy provides a path to deliver on those opportunities. In the end, it’s our customers and patients who have the most to gain, and that’s what Medtronic’s mission is all about.”

How does a Quality System benefit you? Medtronic established our Quality System both as a regulatory requirement and as a way to benefit our customers and their patients. Our quality focus ensures that:

  • We deliver safe and reliable products to you and your patients.
  • You and your patients have an avenue to provide input on your product experiences.
  • Our products are available for you and your patients.
  • We develop new products in a manner that that is consistent with your needs and expectations.

“Developing and maintaining a robust Quality System is complicated and expensive, but the cost of poor quality is much higher. As Medtronic continues to explore ways to increase efficiency and operate more economically, we cannot sacrifice quality. That would put us at risk for jeopardizing patient safety and customer satisfaction. To do so would be in direct conflict with Medtronic’s mission to ‘Alleviate Pain, Restore Health and Extend Life,’” commented Rick Leonard, Senior Program Manager, Medtronic Structural Heart Post-Market Quality.

If you would like more information about the quality initiatives at Medtronic, please contact your local sales representative.

August 2011 Product News

Medtronic Receives FDA Premarket Clearance for its AFFINITY™ CP Centrifugal Blood Pump with Balance™Biosurface and Carmeda® BioActive Surface Coatings

centrifugal-blood-pump

AFFINITY CP centrifugal blood pump is now available in the U.S. with either Balance™ Biosurface or with Carmeda® BioActive Surface. It is available with Balance™ Biosurface in Europe.

*Technology licensed under agreement from BioInteractions, Limited, United Kingdom

**Carmeda is manufactured under license from Carmeda A.B.

This July, Medtronic received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the AFFINITY™ CP Blood Pump with the Balance™ Biosurface or Carmeda® BioActive Surface coating in the U.S. The CE (Conformité Europeenee) Mark was also received for marketing the AFFINITY™ CP Blood Pump with the Balance™ Biosurface in Europe.

These approvals make the AFFINITY™ CP blood pump the first adult product available in the U.S. and European Union with Balance™ Biosurface. This hydrophilic polymer for cardiopulmonary bypass (CPB) circuit coating contains no heparin, and reduces platelet adhesion and activation while preserving platelet function.

The AFFINITY™ CP pump is also available with Carmeda® BioActive Surface. Carmeda® BioActive Surface is a durable, non-leaching End Point Attached heparin biocompatible surface technology that enhances blood compatibility and provides thromboresistant blood-contacting surfaces for CPB circuit devices. It has the largest body of peer-reviewed clinical and scientific evidence of any biocompatible surface used for CPB devices today.

“The launch of the AFFINITY™ CP with Balance™ Biosurface and Carmeda® BioActive Surface is another example of Medtronic’s commitment to perfusion solutions. With a choice of the Balance™ Biosurface or Carmeda® BioActive Surface, we’ve expanded the comprehensive strategy options available to cardiovascular surgery teams, allowing them to achieve the best possible outcomes for their CPB patients,” said Denise Steinbring, Marketing Director, Medtronic Perfusion.

The AFFINITY™ CP, designed for the extracorporeal circulation of a patient’s total blood volume for up to six hours, is a low prime centrifugal blood pump that gently handles blood, resulting in minimized hemolysis. Combined with the Bio-Console® system, the AFFINITY™ CP pump exemplifies the durability that is a hallmark of Medtronic centrifugal pump products. With few moving parts, the pump's design allows for even blood flow at lower RPMs as well as low shear, resulting in reduced heat generation and low hemolysis.

Customers continue to respond positively to the AFFINITY™ CP pump’s small size and ease of use. Ron Lawson, Vice President/CFO, Clinical Perfusion Systems, Inc., Tulsa, OK, commented that “we have been very satisfied with the AFFINITY™ CP pump heads. The reduce size, prime, heat, and noise have been a substantial improvement over our other system.” Don Hamilton, CCP, also with Clinical Perfusion Systems said, “The AFFINITY™ CP is easy to prime and easy to debubble. With the methods that we use, the lower priming volume definitely gives us an advantage.”

For more information or to trial the AFFINITY CP pump, contact your Medtronic representative or visit our website.

 

Medtronic CardioVascular Academia Hosts Successful Training Programs for Perfusion Students

2Utilizing-Orpheus

Utilizing the Orpheus™ Perfusion Simulator, perfusion students from Barry University problem-solve in realistic crisis management scenarios during a simulated cardiopulmonary bypass procedure.

Medtronic CardioVascular Academia Hosts Successful Training Programs for Perfusion Students For more than three years, Medtronic CardioVascular Academia’s education and training program has played an important role in the education of perfusion students. To date, six Advanced Topics for Perfusion Students have been conducted. Designed as a cutting edge education and training program to help participants keep pace with advances in the field of perfusion, students gain knowledge about perfusion science, research findings, technology, and testing methodologies. The 1-1/2 day program includes interactive classroom discussion and a tour of Medtronic’s perfusion manufacturing facility, where students can observe first-hand the assembly of oxygenators, reservoirs and other key components of the extracorporeal circuit.

On April 19 - 20, 2011, Medtronic’s CardioVascular Academia program hosted six perfusion technology students from the Barry University Cardiovascular Perfusion Program, Miami Shores, FL. Part of the program focuses on the science behind the design of perfusion products. “Perfusionists learn the clinical aspects of perfusion in school. This course expands their knowledge to include the technology associated with product functionality. By the course’s conclusion, participants have a clearer understanding of how perfusion equipment is designed and how devices function,” said Mark Bearss, Medtronic Education and Training Program Manager.

Cynthia P. Cervantes, CCP, Program Director, Barry University Cardiovascular Perfusion Program commented, “This was the first time our students attended Medtronic’s Advanced Topics course. It was a wonderful experience for the students, with so much to see and learn. All of us have a greater appreciation for Medtronic’s manufacturing process and the people who produce the equipment. The different perspectives shared by engineering, product management and manufacturing are very interesting. All of this makes the course dynamic and interesting.”

The curriculum included presentations and discussions about testing for gaseous micro-emboli (GME), oxygenator performance, and plasma breakthrough resistance of oxygenators. The Orpheus™ Perfusion Simulator, which allows students to problem-solve in realistic crisis management scenarios during a simulated cardiopulmonary bypass procedure, was the focus of the hands-on portion of the program. “First-year perfusion students spend a lot of time observing clinical cases, and rarely get the opportunity for hands-on learning. The Orpheus Perfusion Simulator is a great way for them to learn to deal with clinical problems in a simulated case,” Bearss said.

According to Cervantes, “These senior students were just finishing their classroom course work and will soon be starting their clinical rotations. The Orpheus Perfusion Simulator is an important preparation tool for these rotations. It’s really helpful for them to be able to simulate putting patients on bypass, taking them off bypass, and learning different case management strategies.”

Student feedback was positive as well, echoing Cervantes’ comments. Everyone also appreciated Minnesota’s April snow, something never experienced in southern Florida.

The Advanced Topics for Perfusion Students is another example of Medtronic’s commitment to leadership in medical education. This workshop broadens perfusion students’ exposure to perfusion technology since it covers topics typically not offered in the conventional perfusion school curriculum. “Educating future perfusionists about the science behind the products they'll use helps to ensure the best possible clinical care in the OR,” Bearss commented.

Medtronic Perfusion Systems hosts three Advanced Topics programs per year at its headquarters in Minneapolis. For more information about CardioVascular Academia or to enroll in any perfusion or blood management educational programs, visit www.perfusion.medtronic.com or contact your local Medtronic representative.

 

Medtronic HMS Plus Hemostasis Management System Positively Impacts Cardiac Surgeon’s Clinical Practice and Blood Conservation Efforts

G. Phillip Schoettle, Jr., M.D., FACS, Assistant Professor of Surgery, University of Tennessee Health Science Center, Methodist University Hospital, Memphis, TN, has performed off-pump coronary artery bypass graft (CABG) surgery for 15 years. Initially he was surprised that his blood utilization did not decrease as much as expected. But recently, Dr. Schoettle has achieved a significant blood use reduction – a reduction he attributes mainly to the use of Medtronic’s HMS Plus Hemostasis Management System.

Describing why his team made this blood usage change, Dr. Schoettle said, “From the very beginning I felt there should have been a tremendous decrease in bleeding for my off-pump cases. I was surprised when this did not happen. Without good input as to how much heparin to use or not use, I assumed that reducing heparin would reduce bleeding. At about this time, we found ourselves operating on a sicker group of patients with significant comorbidities who were also frequently using drugs that affected clotting. To compound this, we stopped using an anti-thrombolytic drug that we had often used to decrease bleeding.”

Cross-functional Team Takes Action to Reduce Blood Utilization
Over a year ago, Methodist University Hospital noticed that Dr. Schoettle’s team used more blood than the Society for Thoracic Surgery (STS) data base showed as the norm for a similar institution. To address this issue, a quality improvement group comprised of hematologists, perfusionists, anesthesiologists, surgeons, and blood banking was formed to determine what needed to change. During their monthly meetings, alternatives for reducing blood product usage were reviewed. According to Dr.Schoettle, “Buy-in was key, and everyone bought into this.”

Dr. Schoettle began reviewing literature about similar projects and discovered that the use of the Medtronic HMS Plus System could significantly impact blood conservation. He also discovered that it was a system his team had not yet tried.

“Prior to using the HMS System, my response to bleeding in off-pump cases was an assumption that I was using too much heparin, so I would ratchet it down," said Dr. Schoettle. "The reality was that once we began using the HMS System, we started using more heparin and less protamine. The HMS System removes guess work. My confidence in the device was such that if I still had bleeding at the end of the reversal, I looked for another cause because I knew it wasn’t the heparin or the lack of protamine."

Clinical Impact of the HMS Plus System on Blood Utilization
The HMS Plus System has facilitated a reduction in the team's blood use over the past year. Before implementing new blood use procedures, the team's utilization rate was about 25% above the STS data base standard. Today, their usage is below the STS standard. “While the use of the HMS device was not the only thing that we did, it certainly played an important role. We have been very pleased with the impact that accurate dosing of heparin and protamine has had on our results,” Dr. Schoettle noted.

Schoettle’s team now uses the HMS Plus System in all of their procedures. While results for their valve surgery procedures are not as dramatic due to smaller numbers, they are seeing an overall decrease in blood use. Dr. Schoettle plans to publish this data to support the hospital’s successful blood conservation project.

“Any time you look at a blood conservation project, the HMS device needs to be a part of it," said Dr. Schoettle. “I’m confident in it because I’ve seen it work. I don’t know precisely how much money we’ve saved the hospital, but I do know that hospital administration is ecstatic. And, there’s enough published data to suggest that blood conservation is far better for the patient, in addition to its impact on the hospital’s finances. Even though the majority of my coronary practice is off-pump, we are seeing an impact across the board.”

Medtronic Perfusion’s Advanced Technology for Accurate Hemostasis Management
Medtronic Perfusion Systems is both the pioneer and leading provider of a heparin dose response test and the only point-of-care heparin assay for individualized heparin and protamine management. The HMS Plus Hemostasis Management System is a reliable, versatile, and effective system that automatically analyses a patient's heparin response and determines the appropriate dose to achieve the desired anticoagulant and antithrombotic effect.

For more information on the HMS Plus System, contact your Medtronic representative.

 

4-affinity-vard

William Beaumont Hospital, Troy, MI, was the first U.S. hospital to use a Medtronic custom pack with the Affinity ® VARD (Venous Air Removal Device) for coronary artery bypass grafting procedures.

Michigan Hospital First in U.S. to Use the Medtronic Affinity® Venous Air Removal Device in a Custom Pack Circuit

Building on its legacy of mini-circuit development and incorporation, William Beaumont Hospital, Troy, MI, expanded their use with a custom mini-circuit for their coronary artery bypass grafting (CABG) procedures. They are the first U.S. hospital to use a Medtronic custom pack with the Affinity® Venous Air Removal Device (VARD) as a component.

Citing the ease of use and patient advantages that accompany a low prime mini-circuit, Dan Zwada, CCP, Director of Perfusion, William Beaumont Hospital - Troy, observed, “We were pleased with the air handling capability in our first cases.” The Affinity® VARD senses and removes any air that has entered the circuit. With the Affinity ® VARD now available in a Medtronic custom pack, perfusionists have more options for mini or small circuits.

“I have been using a mini-circuit like this for years. Now that we have the Affinity ® VARD in our circuit, air removal becomes automatic rather than manual. In addition, with the Affinity ® VARD, perfusion team members feel more confident when using our mini-circuit design.”

William Beaumont Hospital’s custom pack was first used by Eric Hanson, MD, Chief of Cardiac Surgery, in a CABG procedure requiring three bypass grafts. Subsequently, Dr. Hanson used the custom pack with the Affinity ® VARD during an aortic valve replacement (AVR) concomitant to a CABG procedure requiring three bypass grafts on an 85-year-old male patient weighing 83 kilograms. The initial prime was 700 mL and the RAP prime was 500 mL. Both antegrade and retrograde cardioplegia were used. There was less than 10cc of blood loss during the procedure as the Affinity ® VARD triggered only once to remove venous air at start-up and never again during the procedure. The patient had a hematocrit level of 34 when he first went on-pump. The last hemotacrit reading was 36.

Following these cases, Dr. Hanson commented, “To date we’ve done three cases using this custom pack. All succeeded very well. We were particularly pleased with the results in our second procedure, which was a challenging AVR with CABG case. The concept of the Affinity ® VARD lets us use smaller priming volumes and a smaller overall volume. We find it to be safe without a need for a large volume in the reservoir. And, there’s less need for transfusions.”

Advanced Technology Facilitates Automatic Venous Air Removal with the Affinity ® VARD
Part of the Rethinking Blood Conservation® (RBC) Initiative, the Affinity ® VARD offers perfusionists the flexibility to customize circuit systems for improved air handling. It encourages the use of closed circuits, which have been clinically demonstrated to reduce patient complications. Paired with the Affinity CP™ centrifugal blood pump, the Affinity ® VARD reduces priming volumes, a major goal for perfusionists and surgeons who support blood conservation initiatives.

The Affinity ® VARD facilitates the benefits of closed circuits by automatically and quickly removing air from the extracorporeal circuit. As it does so, it provides a visual and audible alarm to alert the surgical team to the condition, all with no intervention by the perfusionist. The Affinity ® VARD features:

  • Ultrasonic air sensors that detect air at the system inlet and that monitor liquid level in the filter
  • A 38 micron screen
  • A chamber and port at the top of the device to collect and remove coalesced air
  • Prime volume of 212 mL (not including purge line)
     

The Affinity ® VARD gives perfusionists the flexibility to include or eliminate a venous hardshell reservoir, cardiotomy, or holding bag, depending on individual circuit set-up preference.

For more information on mini-circuits with the Affinity ® VARD, contact your Medtronic representative.

Medtronic Academia Education Courses Designed for Mini-Circuit Training
Mini-circuits are among the latest innovations in perfusion systems, opening the door to more effective blood management through blood conservation. They are integral to Medtronic’s RBC® initiative, an effort to change paradigms and expand patient care possibilities for the cardiac surgeon, perfusionist and anesthesiologist. To support the training and education programs associated with the use of mini-circuits during cardiopulmonary bypass, Medtronic Academia offers three comprehensive, practical courses for cardiac surgery, perfusion and anesthesiology teams.

“Developed in collaboration with preeminent physicians and healthcare professionals, Medtronic Structural Heart Academia offers access to innovative, topical educational opportunities that help clinicians optimize patient care. Each of the three courses is designed to enrich their knowledge and understanding, while advancing clinical skills,” said Mark Bearss, Medtronic Cardiopulmonary Education Program Manager.

For more information about Medtronic Academia mini-circuit education and training courses, contact your Medtronic representative.

 

Medtronic Launches Rethinking Blood Conservation® Initiative in Japan

This July, Medtronic launched its Rethinking Blood Conservation® (RBC) Initiative at a Nagoya perfusionists' seminar. Historically, blood transfusions have been seen as a necessary part of cardiovascular surgery procedures. But over the past few decades, factors have come to light that make reassessment of blood use and conservation vitally important. The World Health Organization has “recognized adjustment of blood use as a societal need.”1 In Japan, the issue of blood conservation is particularly important since they rely exclusively on their own donor supply.

Medtronic invited perfusionists from Nagoya hospitals to hear John Rivera, Medtronic Senior Therapy Development Manager, present the new realities associated with blood conservation. Braving a typhoon on the evening of the seminar, more than 50 perfusionists heard Rivera discuss:

  • Blood shortages associated with complex surgeries and low blood donation rates
  • Increased blood costs arising from increased safety measures
  • Patient safety concerns based on clinical evidence of the risks associated with blood transfusions (e.g., increased viral and bacterial infections, longer hospital stays, increased incidence of adverse reactions).
     

“The need to rethink blood conservation was a timely, relevant message to perfusionists at this seminar,” Rivera said. “Hospitals throughout Japan are beginning to experience decreasing blood supplies and rising transfusion costs. And, there’s greater awareness of the adverse effects of allogeneic transfusions.”

According to Rivera, “Blood is scarce and expensive in Japan. Perfusionists must begin to adopt a multi-modality approach to reduce the need for transfusions.” Costs associated with collecting and transfusing blood are increasing worldwide. These costs are driven in part by:

  • Longer lengths of stay
  • Longer ICU stays
  • Increases in complications requiring medical staff attention.
     

Cost increases are compounded by the lack of financial resources to pay for preventable events, such as infections.2

To emphasize the need to rethink blood conservation, Rivera cited data showing that patients transfused during coronary artery bypass surgery (CABG) have double the five-year mortality of those not transfused. And morbidities associated with transfusions include adult respiratory distress syndrome (ARDS), infections, atrial fibrillation, and kidney and liver function complications.3

Rivera reviewed the recently published update by the Society of Thoracic Surgeons (STS) and the Society of Cardiovascular Anesthesiologists (SCA) to the Blood Conservation Clinical Practice Guidelines.4 “The guidelines emphasize the importance of reducing bleeding as well as reducing the need for transfusions,” noted Rivera. “The STS 2011 Update recommends a multi-modality approach to blood conservation, one that incorporates medical, pharmacological and technological techniques.”

Rivera also reviewed a recent article published in Transfusion that concluded that direct and indirect blood costs contributed between US$522 and US$1,183 per RBC unit transfused.5 "This was eye-opening for many of the participants,” Rivera said.

The Importance of Rethinking Blood Conservation®
Medtronic’s RBC® Initiative, an evidence-based educational program advocating a multi-modality approach to blood conservation "…applies strategies that help achieve the goal of improving patient outcomes and reducing the financial burden associated with blood use-related complications,” Rivera told his audience.

Technology to Facilitate Blood Conservation
Rivera ended his presentation with a review of the advanced technology available from Medtronic to help achieve effective blood conservation. He highlighted the advantages of the HMS Plus Hemostasis Management System, which can be used to perform multiple tests for heparin management. This system provides an individual patient’s dose response to heparin so that the needed anticoagulant and antithrombotic effect can be achieved.

Rivera also discussed the advantages of the autoLog™ Autotransfusion System, an easy- to-use system that is designed to consistently produce a blood product with a high hematocrit of 50% or greater. The system’s variable speed wash process promotes an effective wash out of 90% or greater in accordance with AABB guidelines.6

According to Kotaro Yoshida, Product Specialist, Medtronic Japan, “The launch of the RBC® Initiative in Japan demonstrates Medtronic’s commitment to providing perfusionists with the support they need. Our perfusion customers were pleased with the blood conservation information that was presented as well as with the supporting product technologies that Medtronic offers.”

To learn more about the RBC® Initiative or Medtronic product technologies, contact your local Medtronic representative or visit www.medtronic.com.

References

  1. World Health Organization Malta. The clinical use of blood handbook. WHO; 2001.
  2. Brown MZ, et al. The Frequency and Cost of Complications Associated with Coronary Artery Bypass Grafting Surgery: Results from the United States Medicare Program. Ann Thorac Surg. 2008;85:1980-7.
  3. Rawn J. Blood Transfusion in Cardiac Surgery: A Silent Epidemic. Circ. 2007;116(20): 664-668.
  4. Ferraris VA, et al. The Society of Thoracic Surgeons Blood Conservation Guideline Task Force, 2011 Update to The Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines.
  5. Shander A, et al. Activity-based costs of blood transfusions in surgical patients at four hospitals. Transfusion. 2010;50:753-765.
  6. Guidance for Standards for Perioperative Autologous Blood Collection and Administration. First Edition. American Association of Blood Banks Sec. 5.1.2, p. 21.

October 2011

perfusion-autolog

The fully automated Medtronic autoLog® Autotransfusion System

The autoLog® Autotransfusion System: An Important Component in Blood Conservation

Blood Guys International, Inc., Salt Lake City, UT, an advanced clinical service provider, works with hospitals to improve blood management practices in orthopedic procedures. The autoLog® Autotransfusion System, used for blood salvage both intra- and post-operatively, helps them maximize autologous blood return for each patient.

"We have performed more than 60,000 autotransfusion cases, primarily orthopedic, to maximize autogolous blood return," said Les Bricker, President, Blood Guys International. "Our experience helps hospitals reduce their dependency on blood bank transfusions, thereby reducing their infection and complication rates while saving them money."

Pioneering Blood Conservation in Orthopedics

Mr. Bricker was an early supporter of blood conservation in orthopedics beginning in the 1980s. At the time, autotransfusion was used primarily in cardiovascular surgery and trauma cases. He believed that orthopedic patients would also benefit from autotransfusion. "There seemed to be considerable blood loss during orthopedic surgery. For a variety of reasons, no intra- or post-operative blood salvage protocols were practiced. For one thing, blood was very inexpensive and hospitals were not as cost conscious as they are today," said Bricker. "But when issues of blood-borne pathogens arose, AIDS and hepatitis, for example, they triggered a need for hospitals to be more responsive and to ensure blood safety."

To convince orthopedic surgeons and hospitals that intra-operative blood salvage could be beneficial to patients, blood loss during total hip and knee replacement procedures was measured. After more than 60,000 cases, Bricker's team documented that average blood loss in these procedures is about 800 cc's intra- and post-operatively. In typical blood transfusions, patients receive an average of 1.5 units of packed red blood cells when their starting hematocrit is 38–40%. Since hip and knee replacements are performed overwhelmingly on elderly patients, the impact is significant.

Mr. Bricker also concentrated on educating orthopedic teams on the patient advantages of blood salvage, telling them, among other things, how eliminating the use of banked blood can reduce the chance of clerical errors and minimize the possibility of AIDS and/or hepatitis contamination. "Our success came slowly at first, but it spread to other surgical procedures as hospitals and surgeons realized the patient benefits associated with blood conservation and blood management," Bricker added.

Today, Blood Guys International provides clinical services to hospitals in multiple states, focusing primarily on orthopedic specialties. "We've offered this service for over 23 years and we're still, to my knowledge, one of the few contract service providers doing this business model," Bricker said.

"With banked blood running $1,000+ per unit, when all of the direct and indirect costs are figured in, we're returning about 1.5 units of red packed cells to the patient at a much lower cost. Moreover, our product's hematocrit and safety aspects are superior," Bricker continued.

The Role of Medtronic's autoLog® Autotransfusion System

"In orthopedics, we target a hematocrit of 50–55% since this is the gold standard with banked blood," said Bricker. "We count on the autoLog® System to give us a hematocrit in that range."

In Bricker's opinion, Medtronic is the obvious leader in blood management and blood conservation. "We use Medtronic's autoLog® device because it's state-of-the-art. Based on the consistent high-quality end product, the speed at which we can produce it and the footprint, the autoLog® device is ideal for orthopedics."

RBC® Initiative Center of Excellence

Six years ago, Medtronic established Blood Guys International as an Academia Center of Excellence to train perfusionists beyond their blood management expertise in cardiac surgery. As cardiac procedures have declined, this educational opportunity has become increasingly popular with orthopedic procedures on the rise and blood management becoming more significant.

Perfusionists from all over the country attend the annual training sessions. The sessions consist of a two-day seminar that can include a didactic lab, hands-on autoLog® training, and clinical case observations. Perfusionists learn the Blood Guys' approach to orthopedic procedures and, as part of the course, they are instructed on the use of the autoLog® System and can experience for themselves the autotransfusion efficiencies the device provides.

The fully automated Medtronic autoLog® Autotransfusion System produces a high-quality end product with a hematocrit of 50% or greater. Its unique bowl design packs blood tightly to increase the hematocrit and allows blood to enter at a moderate G-force, thereby minimizing hemolysis. The system's design also promotes effective removal of free-plasma hemoglobin, residual anticoagulant agents, activated platelets, white blood cells, and activated clotting factors of 90% or greater in accordance with aaBB guidelines.1

Learn more about Blood Guys International.

To enroll in an Academia program to expand your scope of practice or to learn more about the autoLog® System and how it can provide your OR with the high-quality end product you need, contact your Medtronic representative.

Reference

  1. Guidance for Standards for Perioperative Autologous Blood Collection and Administration. First Edition. American Association of Blood Banks, Sec. 5.1.2, p. 21.
 

Medtronic Perfusion Systems Expands Clinical Specialist Team

Mark Gilpin, MS, CCP, recently joined the Medtronic Perfusion Systems Clinical Specialist team to support surgical case coverage, general clinical consulting, and to troubleshoot product usage, circuit design, and technique issues. Gilpin's strong background in perfusion, together with his personal interest in blood management, make him a strong asset in this critical Perfusion Systems area.

"I've enjoyed my interaction with Medtronic. In my previous role as a perfusionist, I had the opportunity to do some local speaking in support of their Rethinking Blood Conservation® (RBC) Initiative. I enjoy teaching and am enthusiastic about Medtronic's team approach to better blood management. It's a great fit with what I've been doing, so when the Clinical Specialist position became available, I jumped at the opportunity," Gilpin said.

Gilpin graduated from Ohio State University, Columbus, Ohio, with a Certified Clinical Perfusionist (CCP) Certificate in 2001. His most recent position was Director of Clinical Quality at CETECH in Panama City, FL, where he managed quarterly perfusion performance data. "CETECH collects internal data from their accounts. Part of my job was to analyze it and develop statistical performance measures. We were then able to discuss the data with the hospital and demonstrate progress over time in measures such as blood utilization, pump time, and event time. I then tied those measures to what we had done in changing techniques or bringing in new products like coated circuits or better heparin management. By sharing cost figures for blood products and ICU time and comparing them to national benchmark averages, I was able to demonstrate the value of CETECH's services to the hospital," Gilpin explained.

"With a significant number of Medtronic perfusion products now in development or ready to launch, together with the momentum of our RBC Initiative, Medtronic is pleased to have Mark join our team. His perfusion experience and unique passion for blood conservation is demonstrated by his clinical practice and work with colleagues. Mark has already taken a leadership role in his clinical practice and we expect he'll apply his enthusiasm and experience to what Medtronic is doing," said Michael Kolb, Vice President, U.S. Commercial Operations, Medtronic Structural Heart.

As part of its commitment to perfusion, Medtronic Perfusion is continuing to expand its clinical footprint, according to Kolb. The addition of Clinical Specialists is an important part of this effort. In addition to hiring Gilpin, Medtronic Perfusion is looking to add two Clinical Specialists this quarter, with plans to further expand the team as new products become available in the U.S.

"Medtronic's focus is on aligning initiatives with customer needs and the changing marketplace. Everything new that we do must be consistent with those aims and has to help our customers improve outcomes and reduce cost," Kolb noted.

Learn more about Medtronic's RBC Initiative. If you are interested in the Clinical Specialist opportunity, please apply here.

Mini-circuit Training Courses Continue Medtronic's Commitment to Perfusion Education

Mini-circuits play an important part in perfusion system innovation, providing a gateway to more effective blood management through blood conservation. Medtronic Academia offers three comprehensive courses to help cardiac surgery, perfusion, and anesthesiology teams better understand the subtleties of how to adopt mini-circuits in conjunction with cardiopulmonary bypass (CPB) and to learn how to get started using them.

For organizations focused on adopting new techniques and technologies to improve patient outcomes, mini-circuits are an important practice improvement step within the overall quality improvement process. Medtronic Academia Mini-circuit Courses can equip CPB teams with the products and training necessary to make these improvements in cardiac surgery.

These courses provide comprehensive, practical training and education and are integral to Medtronic's Rethinking Blood Conservation® (RBC) Initiative. The RBC® Initiative focuses on changing paradigms and advancing patient care for the cardiac surgeon, perfusionist, and anethesiologist.

"Developed together with preeminent physicians and healthcare professionals, Medtronic Structural Heart Academia mini-circuit courses give clinicians access to innovative, topical educational opportunities that can help optimize their patient care. Each course is designed to enrich their knowledge and understanding, while advancing clinical skills. Teams that attend these courses learn how to incorporate mini-circuits into their practice. They also gain valuable insight during discussions with experts into the steps necessary to ensure success when making the switch to mini-circuits," said Mark Bearss, Medtronic Cardiopulmonary Education Program Manager.

perfusion-bearss

Mark Bearss, Medtronic Cardiopulmonary Education Program Manager, conducting a Mini-circuit Boot Camp course.

Mini-circuit Boot Camp Instructional Course

"The one-day Boot Camp Instructional Course is designed for cardiac surgery teams interested in becoming more comfortable with the use of mini-circuits during cardiopulmonary bypass. Teams who take this course understand that success is about more than just the products. Team dynamics and the procedural side are also critical," noted Peter Horwich, Senior Product Manager, Medtronic CardioVascular Perfusion Systems.

The Boot Camp Instructional Course gives attendees the chance to learn more about the use of mini-circuits through experiential, problem-based learning. A team-based lab session provides hands-on training for closed-loop reservoir-less systems, automatic venous air removal, and reduced-prime circuits. With the Orpheus™* Perfusion Simulator, the cardiac team is able to problem-solve realistic perfusion and patient management scenarios, and then discuss key considerations for custom mini-circuit design.

*Orpheus is a trademark of Ulco Technologies, Marrickville, Australia.

Peer-to-Peer Immersion Course

This by-request, one-day course is offered at a heart hospital to a team of at least two or three practicing cardiac surgeons, perfusionists, and anesthesiologists. "The Peer-to-Peer Immersion Course helps the clinical team better understand the collaborative roles played by each team member in achieving clinical success when conducting perfusion with mini-circuits during CPB," Bearss noted. While watching one or two live clinical cases, the team gains valuable insight into managing perfusion with closed-loop reservoir-less systems, automatic venous air removal, and reduced-prime circuits. Following the procedures, there is a didactic presentation and an informal discussion of the cases.

Clinicians at the peer-to-peer sites are working hard to achieve zero transfusions within their hospitals. Since mini-circuits are a part of this achievement, teams attending this course will have the opportunity to discuss the learnings associated with this quest.

Local Expert Exchange Event

A by-request event, this training is designed to meet a hospital's needs through a small-group, expert-led discussion of the real-world clinical challenges faced by cardiac surgeons and perfusionist teams during CPB using mini-circuit techniques. Discussion topics typically include complex or challenging CPB cases, cannulae management and considerations during the use of mini-circuits, venous air management, reduced-prime circuits, closed-loop reservoir-less circuits, complications management, published studies, and/or current controversies in mini-circuits.

"Medtronic Structural Heart Academia is another example of Medtronic's continuing commitment to perfusion. These Academia mini-circuit courses, along with our RBC® Initiative, offer customers the tools they need to improve patient outcomes and reduce the cost of blood use-related complications," said Denise Steinbring, Director of Perfusion Marketing, Medtronic CardioVascular. The importance of these three mini-circuit courses is reinforced by the recent 2011 Update to the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines, which revised mini-circuits from Class IIb to Class I(A), indicating that the procedure is effective and that the multiple randomized trials or meta-analyses that have been conducted provide sufficient supporting evidence.

To get started with mini-circuits and to learn more about Medtronic Academia mini-circuit education and training courses, contact your Medtronic representative.

 

Medtronic Develops Virtual Cardiac OR to Promote Hands-on Learning

June 1st marked the opening of Medtronic's Virtual Cardiac OR, designed to provide an immediately recognizable and realistic learning environment for cardiac surgeons, perfusionists, and anesthesiologists. With simulation models ranging from task simulators to the high-fidelity Orpheus™* Perfusion Simulator, this room provides hands-on experiential learning methods for training on devices from Medtronic's numerous cardiovascular businesses.

*Orpheus is a trademark of Ulco Technologies, Marrickville, Australia.

"The Virtual Cardiac OR is ideal for training individual customers on the operation of new devices and getting their input on new product innovations," said Mark Bearss, Medtronic Cardiopulmonary Education Program Manager. "We're also finding that it's a valuable tool for team training on crisis management techniques and for training cardiovascular fellows, residents, employees, and perfusion students on cardiopulmonary bypass techniques. In addition, we can integrate distance learning methods through the use of synchronous learning solutions, such as Webinars, or produce recorded media for asynchronous learning opportunities."

Latest OR Technology for Productive Learning

To provide a productive learning environment, the Virtual Cardiac OR is equipped with the latest OR technology, including:

  • Steris LED overhead lighting
  • Spacelabs patient monitoring system with four flat-panel monitors for easy viewing of patient physiologic parameters
  • Spacelabs anesthesia machine

The room also includes traditional cardiopulmonary bypass devices such as a heart-lung machine, BioConsole® 560 system, autoLog® autotransfusion system, HMS Plus hemostasis management system, ACT Plus® automated coagulation timer system, and a full complement of Affinity®-branded disposables. And, to keep the Virtual OR on the cutting technological edge, the devices are networked by cable.

"We wanted to provide all avenues of training for attendees, from hands-on learning, through simulated cases, to more traditional classroom learning," Bearss said.

The Virtual Cardiac OR has been used to train customers and employees on Medtronic products and on OR applications, but Bearss envisions team training around a hypothetical accident or malfunction to prepare the team to react and to reduce an actual patient's exposure to risk. "The Orpheus Simulator is a great way to accomplish this," said Bearss. "We can create a realistic crisis scenario in a safe environment. This helps develop team dynamics and fosters learning in a situation where risk to a patient is not a factor."

In October, the simulator will help facilitate team learning during the AmSect's Perfusion Safety and Best Practices Meeting in San Antonio, TX. Clinical teams will review the Orpheus Simulator's real-time blood gases screen. They will be able to react to the data, discuss it, and decide on a course of action as the data deteriorates. "Each team can then develop a checklist to take back to their hospital for team planning or remote teaching. They'll be able to share their learning experience without needing access to a simulator in their own hospital," said Bearss.

Potential Limited Only by Imagination

The potential of the Virtual Cardiac OR seems limited only by imagination. Bearss believes that its real-time learning potential can be customized to meet the needs of Medtronic representatives as well as customers. For example, should a representative or customer need a refresher course on a specific device, a live-feed videoconference could be sent to the representative's iPad to address a very specific need in real time. "This completely changes the paradigm of how representatives prepare for customer visits," said Bearss. "One-on-one customized training that targets specific clinical topics that the customer needs to have addressed will be a tremendous tool for the representative."

perfusion-virtualOR

Medtronic's Virtual Cardiac OR promotes hands-on learning.

Bearss also believes that cardiac surgery teams could benefit from training sessions that simulate crisis scenarios associated with cardiopulmonary bypass. During these simulations, the team would have the flexibility to develop a consensus as to which course of action to take. These consensus scenarios would be used to develop best practices for improving patient care.

Medtronic's Virtual Cardiac OR is another example of Medtronic's commitment to cutting edge customer education and training. This commitment offers clinicians access to innovative, topical educational opportunities optimized to improve patient care. For more information about Medtronic Academia Medical Education, contact your Medtronic representative.

December 2011

 

Medtronic Hosts European Conference on Technologies and Techniques to Reduce Blood Transfusions

Evidence continues to show that blood transfusions during cardiovascular procedures adversely impact patient outcomes. Published studies document that transfusions lead to increased morbidity, longer recovery times, longer hospital stays, and increased mortality.1,2 To help hospitals address this growing concern, Medtronic hosted the “Options and Outcomes” Conference, October 27 – 29, 2011, together with the prestigious Sant’ Andrea Hospital in Rome, Italy. The conference attracted more than 150 participants from Europe and the Middle East.

Rethinking Blood Conservation® Initiative

To begin the conference, Michael van Driel, Marketing Group Manager, Extracorporeal Technologies, Medtronic Europe, introduced attendees to Medtronic’s Rethinking Blood Conservation® (RBC) Initiative, a multi-modality, evidence-based approach to improving patient outcomes and reducing the cost of blood use-related complications.

Van Driel presented evidence that blood shortages, the cost of blood, and associated risks of blood transfusions are key reasons for clinicians to rethink their approaches to blood conservation. Additionally, key cardiac surgery and anesthesia societies have published blood conservation guidelines. The Society of Thoracic Surgeons (STS)/Society of Cardiovascular Anesthesiologists (SCA) Guideline Recommendations, originally published in 2007 and updated in 2011, state that “a multi-modality approach involving multiple stakeholders…will limit blood transfusion and provide optimal blood conservation for cardiac operations.”1

In support of the need to rethink blood conservation, van Driel cited published data comparing mortality and measures of morbidity between transfused and non-transfused patients. In this study, the authors concluded that red blood cell transfusion was the most important factor reliably associated with an increased risk of morbid events, including renal morbidity, prolonged ventilation time, and serious post-operative infection.2

“Blood is a scarce, expensive resource. Clinicians must begin to adopt a multi-modality approach to reduce the need for transfusions,” van Driel told the conference. “Costs associated with collecting and transfusing blood are increasing worldwide, driven in part by increased lengths of stay, longer ICU stays, and increases in complications and infections requiring medical staff attention. The lack of financial resources to pay for preventable events, such as infections, compound these cost increases.”3

Technologies and Techniques for Reducing Blood Transfusions

Following van Driel’s presentation, an expert faculty presented technologies and techniques that, in their experience, reduced the need for transfusions.

During the session entitled “Hemostasis and Blood Product Use,” Dr. Marco Ranucci, Chief of Anesthesiology, Policlinico, San Donato, Milan, Italy, addressed the issue of “Blood Conservation in Clinical Practice.” Citing numerous published studies, Dr. Ranucci reviewed the adverse impact on adult and pediatric patients when red blood cell storage exceeds 14 days. Among the adverse effects are higher post-operative complications and reduced survival.4,5

In his presentation “Blood Transfusion Effectiveness in Cardiac Surgery,” Professor Antonio Pavan, Chief Transfusion Center, Azienda Ospedaliera Sant’ Andrea, Rome, Italy, identified preoperative and perioperative interventions most likely to reduce bleeding and postoperative blood transfusions. These included:

  • Identifying high-risk patients who should receive all available preoperative and perioperative blood conservation interventions and on whom the use of antithrombotic drugs should be limited.
  • Using antifibrinolytic drugs perioperatively, using off-pump coronary artery bypass graft surgery selectively, using cell-saving devices routinely, and implementing appropriate transfusion indications.

     

Professor Pavan also discussed the blood transfusion triggers used at Sant’ Andrea Hospital, noting that “recent advances in heart surgery indicate that patients undergoing cardiac surgery with CPB are at risk for developing significant post-operative bleeding and blood requirements.”

To conclude the Hemostasis and Blood Product Use session, James Ferguson, CCP, Arizona Perfusion, Banner Health System, Phoenix, Arizona, presented clinical study evidence illustrating the impact of air emboli, including data that showed them to be a major cause of morbidity and mortality in CPB.6

Reviewing the different causes of gaseous microemboli (GME), Ferguson presented published clinical studies showing the risk of GME to be specific to the product used in different extracorporeal circulation modalities. A study by Groom, et al, concluded that “changes in CPB techniques and circuit components, including filter size and type of pump, resulted in a reduction rate of 75% of cerebral microemboli. … Leaving the arterial filter in the circuit is essential.”7

Ferguson cited Medtronic’s AFFINITY® Venous Air Removal Device (VARD) as an example of a de-airing device that can be incorporated into the circuit, one that allows circuit systems to be customized for improved air handling in a miniaturized circuit. The VARD system senses and automatically purges any air from the deoxygenated blood in the circuit. Perfusion custom packs, with the AFFINITY® VARD as a component, give perfusionists more options for circuit design.

According to Ferguson, “The AFFINITY® VARD is one more tool that can be used for blood conservation since it helps with decreased hemodilution and blood usage. It is easy to incorporate into your circuit and provides another level of safety for removing air from the CPB circuit.”

Other clinician presentations during the conference included discussions of:

  • Bio-coated, closed circuits such as Medtronic’s Carmeda® BioActive Surface*, a durable, non-leaching End-Point-Attached heparin biocompatible surface technology that enhances blood compatibility and provides thromboresistant blood-contacting surfaces for cardiopulmonary bypass circuit devices.
  • The importance of a low heparin protocol that can be implemented using the Medtronic HMS Plus Hemostasis Management System. Presenters emphasized that hemostasis management can result in fewer complications associated with excessive blood loss,8 preservation of the coagulation system to reduce the number of transfusions,9 and surgical reoperations,10 thereby decreasing associated costs.
  • Different perfusion techniques, including mini-bypass for pediatric and adult patients, and how they affect transfusion rates.
  • Pathologies that can benefit from mini-bypass.

 

Medtronic Ex Vitro Workshop

At the conclusion of the clinical presentations, Medtronic hosted a hands-on workshop that gave 80 participants the opportunity to work with Medtronic’s advanced technologies. Technologies showcased during four wet labs included existing products and new innovations and technologies, including:

  • HMS Plus Blood Management System – performs multiple tests for heparin management, and provides a patient’s dose response to heparin to achieve the needed anticoagulant and antithrombotic effect.
  • Mini-bypass Custom Pack – allows customers to design their own mini-circuit system. The availability of the Affinity VARD Air Removal Device in a custom pack gives perfusionists additional design options and flexibility for improved air handling.
  • Spectrum Medical’s Patient Monitoring System – includes VIPER, a variable input patient electronic record, and VISION, its associated database and overall system management module. Both systems use open architecture and web-based technology, making them compatible with all products in the OR.

 

Medtronic sponsored the “ ‘Options and Outcomes’ Conference as part of its Academia Education and Training Program,” noted van Driel. “Teaming with Sant’ Andrea Hospital to present this conference helped demonstrate our commitment to partnering with perfusionists and extracorporeal clinicians to deliver innovative perfusion solutions. Attendees appreciated the focus on perfusion technologies and techniques and how they can help their hospitals lower transfusion rates and enhance patient outcomes.”

For more information about Medtronic products, contact your Medtronic representative. To learn more about Medtronic’s Rethinking Blood Conservation® Initiative, go to http://www.medtronic.com/rbci/ or contact your Medtronic representative. Spectrum Medical product information is available at www.spectrummedical.com.

Christiaan_Matheve

Christiaan Matheve, Principal T&E Specialist, Medtronic Extracorporeal Therapies, presents a technology update during a hands-on workshop.

Reference

  1. STS Blood Conservation Guideline Task Force: Ferras VA, Brown JR, Despotis GJ, Hammon JW, Reece B, Sha SP, et al; SCA Special Task Force on Blood Transfusion: Shore-Lesserson LJ, Goodnough LT, Mazer, CD, Shander A, Stafford-Smith M, Waters, J.; Intl. Consortium for Evidence Based Perfusion: Baker, RA, Dickinson, TA, FitzGerald DJ, Likosky DS, Shann, KG. 2011 Update to the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines. Ann Thorac Surg. 2011;91:944-82.
  2. Koch CG, Li L, Duncan AI, et al. Morbidity and mortality risk associated with red blood cell and blood-component transfusion in isolated coronary artery bypass grafting. Crit Care Med. 2006;34:1608-16.
  3. Brown PP, Kugelmass AD, Cohen DJ, et al. The frequency and cost of complications associated with coronary artery bypass grafting surgery: result from the United States Medicare Program. Ann Thorac Surg. 2008;85:1980-7.
  4. Koch CG, Li L, Sessler DI, Figueroa P, et al. Duration of red-dell storage and complications after cardiac surgery. N Engl J Med. 2008;358:1229-1239.
  5. Ranucci M, Carlucci C, l Isgro, Boncilli, et al. Duration of red blood cell storage and outcomes in pediatric cardiac surgery: an association found for pump time blood. Critical Care. 2009; online at http://coforum//content/13/6/R207.
  6. Schönburg M, Ziegelhoeffer T, Kraus B, Mühling A, Heidt M, Taborski U, et al. Reduction of gaseous microembolism during aortic valve replacement using a dynamic bubble trap. Gen Physiol Biophys. 2006;25:207-14.
  7. Groom RC, Quinn RD, Lennon P, Donegan DJ, Braxton JH, Kramer, RS, et al. Detection and elimination of microemboli related to cardiopulmonary bypass. Circ Cardiovasc Qual Outcomes. 2009;2:191-198.
  8. Hill, AG, et al. More precise heparin and protamine management during cardiopulmonary bypass. Proceedings of the American Academy of Cardiovascula Perfusion.1990;12-16.
  9. Despotis, GJ, Joist JH, Hogue CW, et al. More effective suppression of hemostasis system activation in patients undergoing cardiac surgery by heparin dosing based on heparin blood concentrations rather than ACT. Thromb Haemost. 1996;67:2-8.
  10. Despotis, GJ, Joist JH, Hogue CW, et al. The impact of heparin concentration and activated clotting time monitoring on blood conservation. J Thorac Cardiovasc Surg. 1995;110:46-54.
 
 
 

Medtronic Hosts Crisis Management Simulation Lab during Minnesota Perfusion Society’s Fall Meeting

On Friday, September 30, 2011, 16 perfusionists participated in a Medtronic-hosted crisis management simulation lab during the Minnesota Perfusion Society’s Fall Meeting. Mark Bearss, Medtronic Cardiopulmonary Education Program Manager, explained that “we modeled this lab on the Kolb Theory of Experiential Learning. The lab runs perfusion teams through four crisis management scenarios. They then assess what went right and what didn't. Each team then analyzes its process, identifies forgotten or missed actions, and formulates a new protocol based on their new or modified procedure."

The lab's goal was to help participants realize the importance of a team-based procedure for crisis management that includes the surgeon and anesthesiologist. Participants also learned the value of a checklist to define the team’s procedures and responsibilities.

“The point of this lab was not to test the participants themselves in how they respond to a crisis. Rather, simulating a crisis in a safe environment allowed them to analyze the steps they would take and create a checklist for emergency use,” Bearss added. “We wanted them to realize that they need to think about how they’re going to handle an emergency situation and understand the importance of a pre-defined checklist.”

“The lab participants were very enthusiastic about the experience,” said Dirck Rilla, LP, CCP, Minnesota Perfusion Society President and one of the simulation lab moderators. Participants agreed that the lab's realistic set-up made it easy to “get lost in the moment” and believe they were experiencing a crisis in an actual OR. Because of that, participants felt that they reacted more realistically than they would have in a seminar-type setting. “The lab kept everyone fully engaged for four hours, which isn’t an easy accomplishment. I think the realistic simulation was part of it. At the beginning of the lab, everyone thought they knew exactly how they would respond to the crisis. It was rewarding to see friends and colleagues change their minds about how to approach a situation after listening to one another's input.”

The key to the success of this learning model was the debriefing session that followed the actual simulation. During these conversations, participants discussed their rationale for actions, checklists were modified, and protocols were further reorganized. “Each participant benefited from sharing what he or she thought was the most important first step and how subsequent steps followed. Thanks to this diversity of thinking, everyone’s processes were modified and consensus was amazingly easy to reach,” Rilla noted. Then on Sunday, following the plenary sessions of the Minnesota Perfusion Society’s Fall Meeting, attendees who were unable to take part in the simulations listened to lab participants review and summarize their crisis-scenario experiences and positive outcomes.

Medtronic's participation at the Minnesota Perfusion Society’s meeting and its hosting of the perfusion simulation lab is an example of the company's ongoing commitment to collaborating with perfusionists to deliver future innovation.

For more information about educational opportunities associated with Medtronic’s virtual cardiac OR, contact your Medtronic representative. 

 
 
 

Medtronic Presents Perfusion Technologies and Techniques Workshop at 2011 Federation of Asian Perfusion Society Conference

At the 2011 Federation of Asian Perfusion Society Conference (FAPS), held in Singapore, September 16 – 18, 2011, Medtronic presented a workshop on perfusion technologies and techniques to advance adult and pediatric perfusion practices. In keeping with the conference's “New Frontiers in Cardiovascular Perfusion” theme, the workshop highlighted Medtronic’s Rethinking Blood Conservation® (RBC) Initiative. In addition, Hans Seiler, ECCP, Perfusionist, gave a presentation entitled “Clinical Practice Experience with Mini Circuits.”

“The 2011 FAPS Conference was an excellent opportunity for Medtronic to share its plans for innovation through collaboration with the attendees. This meeting made clear that we share a commitment to serving patients through advanced technology and education, said George Poole, Director, Cardiovascular, Medtronic Asia/Pacific. “FAPS perfusionists were excited about exchanging information and ideas not only with their Asia Pacific colleagues but with those from other parts of the world as well. Every three seconds, Medtronic helps improve a patient’s life. Our commitment to perfusion solutions is an important contribution to this. With more than 30 years of perfusion experience, our dedication to developing innovative solutions to the key issues perfusionists face is as strong as ever.”

The Medtronic workshop “focused on the latest technologies and techniques perfusionists around the world are using to achieve the best possible outcomes for their adult and pediatric cardiopulmonary bypass patients,” said Wendy Svee, Global Product Manager, Perfusion Systems, Medtronic.

Among the issues discussed at the workshop were:

  • Optimizing clinical outcomes, measurement and reporting
  • Patient safety
  • Blood conservation
  • Technologies designed for neonate/infant/pediatric cardiopulmonary bypass (CPB)

 

Meeting_Group

Medtronic management congratulates Mr. Goh Si Guim, FAPS Chairman/President of Congress, on a successful meeting. (Left to right: Wendy Svee, Medtronic; Mr. Goh Si Guim, FAPS Chairman/President of Congress; Mary Muecke, Medtronic; George Poole, Medtronic; Lester Wong, Medtronic)

 

Multi-modality Blood Conservation Strategies: The Latest Recommendations and Technologies

During the workshop, Mary Muecke, Senior Marketing Manager, Perfusion Systems, Medtronic, presented the Rethinking Blood Conservation® (RBC) Initiative. Historically, blood transfusions have been seen as a necessary part of cardiovascular surgery procedures. But over the past few decades, factors have come to light that make reassessment of blood use and conservation vitally important.

“Blood is a scarce and expensive commodity worldwide. Complex cardiac surgeries require significant quantities of blood and that, together with low blood donation rates, compounds the blood shortages hospitals experience. Additional safety measures add cost to blood products, and there are documented patient risks associated with transfusions,” Muecke told her audience. These risks include:

  • increased viral and bacterial infections
  • longer length of stay
  • increased incidence of adverse reactions

 

Key cardiac surgery and anesthesia societies have published blood conservation guidelines. The STS/SCA Guideline Recommendations, originally published in 2007 and updated in 2011, state that “a multi-modality approach involving multiple stakeholders…will limit blood transfusion and provide optimal blood conservation for cardiac operations.”1

The RBC® Initiative advocates a multi-modality blood conservation approach to improve patient outcomes and reduce the cost of blood use-related complications through:

  • Education
  • Peer-to-peer training
  • Measurement tools to assess the impact of program implementation

 

“The need to rethink blood conservation was a timely and relevant message to the FAPS perfusionists,” Muecke noted. “Hospitals throughout Asia Pacific are experiencing decreasing blood supplies and rising transfusion costs. There’s also an elevated awareness of the adverse effects of allogeneic transfusions.”

To learn more about Medtronic’s Rethinking Blood Conservation® Initiative, go to http://www.medtronic.com/rbci/ or contact your Medtronic representative.

Clinical Practice Experience with Mini Circuits: A New Way of Looking at Arrested Heart Surgery

To conclude the Medtronic workshop, Hans Seiler, ECCP, Perfusion Training and Education Consultant, presented information on arrested heart surgery. “The clinical goals for perfusion in arrested heart surgery are identical to those for beating heart surgery,” he said. These include:

  • prevent excessive hemodilution
  • limit systemic inflammatory response syndrome
  • prevent neuro-cognitive deficit

 

Seiler’s presentation included ways to improve patient outcomes. He cited published clinical papers that link blood transfusion before or after cardiac surgery to increased mortality risk, increased post-op infection, longer lengths of stay, and increased costs.2-4 “Clinicians concerned with blood conservation have a compelling alternative in mini circuits such as Medtronic’s Resting Heart® System,” Seilor commented.

The Medtronic Resting Heart® System is a low prime, reservoir-less, closed-to-air circuit designed to address the traditional challenges of cardiac surgery. It features active air removal technology, no blood-to-air interface, elimination of anti-foam agents and tip-to-tip Carmeda® BioActive Surface.*

Medtronic Perfusion Technologies

Advanced technology is key to effective blood conservation. Medtronic has pioneered technologies for cardiac surgery that support the STS guidelines1 and recommendations, and that have set the standard for the entire industry. At the FAPS Conference, Medtronic exhibited some of these technologies, including:

  • Bio-Pump® Centrifugal Blood Pump – uses the constrained, forced-vortex pumping principle in which a series of the smooth-surfaced rotating cones pull the blood into the vortex created by the rotation.5 All commercially available pumps provide acceptable blood conservation during CPB (Class IIb, Level B).The Bio-Pump Plus pump is available with Carmeda® BioActive Surface.*
  • Carmeda® BioActive Surface* – is a durable, non-leaching End-Point-Attached heparin biocompatible surface technology that enhances blood compatibility and provides thromboresistant blood-contacting surfaces for cardiopulmonary bypass circuit devices. It is supported by the largest body of peer-reviewed clinical and scientific evidence of any biocompatible surface used for cardiopulmonary bypass devices today.
  • autoLog® Autotransfusion System – easy to use and designed to consistently produce a blood product with a hematocrit of 50% or greater. The system’s variable speed wash process promotes an effective wash-out of 90% or greater in accordance with AABB guidelines.6
  • Affinity™ CP Centrifugal Blood Pump – a low prime centrifugal pump whose smooth cone and low-profile impeller fins gently handle blood, resulting in low hemolysis without vortex formation around the fins. The Affinity™ CP pump is available with Carmeda® BioActive Surface* as well as Balance™ Biosurface, a hydrophilic biocompatible surface option without heparin.
  • HMS Plus Hemostasis Management System – used to perform multiple tests for heparin management. It provides an individual patient’s dose response to heparin to achieve the needed anticoagulant and antithrombotic effect. Hemostasis management can result in fewer complications associated with excessive blood loss,7 preservation of the coagulation system resulting in fewer transfusions8 and surgical reoperations,9 thereby decreasing associated costs.

 

The FAPS conference offered a “fruitful environment for perfusionists to gain critical new insights that can be incorporated in our practices,” said Mr. Goh Si Guim, Chairman/President of the Congress. "These insights will translate into benefits for patients under our care.” The next conference of the Federation of Asian Pacific Society is scheduled for 2015 in Kyoto, Japan.

For more information on Medtronic’s perfusion technologies, contact your Medtronic representative.

2011 STS/SCA Guidelines for Blood Conservation
* Carmeda® is manufactured under license from Carmeda AB for use only as part of an extracorporeal blood circulation system or circuit that includes an oxygenator or blood pump. Carmeda is a registered trademark of Carmeda AB.
 

Reference

  1. Ferraris VA, Brown JR, Despotis GJ, et al. The Society of Thoracic Surgeons Blood Conservation Guideline Task Force, 2011 Update to the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines.
  2. Vamvakas, et al. Allogeneic blood transfusion, hospital charges, and length of hospitalization: a study of 487 consecutive patients undergoing colorectal cancer resection. Arch Pathol Lab Med. 1998;122:145.
  3. Aldea GS, Doursounian M, O’Gara P, Treanor P, et al. Effect of homologous transfusion on length of stay and post-operative complication rates. Ann Thorac Surg. 1996;62:410-417.
  4. Bagger, et al. Preoperative anemia linked with increased risk of death after cardiac bypass. Lancet. 2002;359:1747-1748.
  5. Klein M, Dauben HP, Schulte H D, Gam E. Centrifugal pumping during routine open heart surgery improves clinical outcome. Artificial Organs. 1998;22:326-336.
  6. Guidance for Standards for Perioperative Autologous Blood Collection and Administration. First Edition. American Association of Blood Banks, Sec. 5.1.2, p. 21.
  7. Hill, AG, et al. More precise heparin and protamine management during cardiopulmonary bypass. Proceedings of the American Academy of Cardiovascular Perfusion.1990;12-16.
  8. Despotis, GJ, Joist JH, Hogue CW, et al. More effective suppression of hemostasis system activation in patients undergoing cardiac surgery by heparin dosing based on heparin blood concentrations rather than ACT. Thromb Haemost. 1996;67:2-8.
  9. Despotis, GJ, Joist JH, Hogue CW, et al. The impact of heparin concentration and activated clotting time monitoring on blood conservation. J Thorac Cardiovasc Surg. 1995;110:46-54.
 
 

Medtronic Exhibits Melody®* Transcatheter Pulmonary Valve Therapy at American Society of Extracorporeal Technology’s 2011 Pediatric Perfusion Meeting

Medtronic's Melody® Transcatheter Pulmonary Valve Therapy (TPV) is designed to restore pulmonary valve function in pediatric and adult patients. Exhibited at the American Society of Extracorporeal Technology’s (AmSECT) Pediatric Perfusion Meeting, held November 4 – 6, 2011, in Philadelphia, PA, this therapy offers patients with failing pulmonary valve conduits a treatment option without resorting to open-heart surgery.

Heart defects are the most common birth defect, with about one in 120 babies born with some kind of heart defect, according to the Adult Congenital Heart Association.1 Approximately one million adults and 800,000 children live with congenital heart defects in the United States today.1 Many people born with congenital heart defects are likely to undergo multiple surgical and interventional procedures during their lifetimes. “In keeping with Medtronic’s commitment to provide innovative therapies for the lifetime management of congenital heart disease, Melody® TPV Therapy offers patients the hope of restoring pulmonary valve function without the invasiveness associated with open-heart surgery,” noted Jill Hennesen, Senior Marketing Manager, Transcatheter Pulmonary Valve Therapies, Medtronic.

As advances are made in technology and medical/surgical management designed to treat congenital heart defects, the survival rates of patients born with these conditions continue to improve. Today, thanks to recent medical breakthroughs, 90% of children born with heart defects are expected to live to adulthood and beyond.1

“Perfusionists are part of this success. They play a critical role in the lifetime management of patients with congenital heart defects by providing cardiopulmonary bypass procedures during surgeries performed to save lives and improve quality of life. Medtronic is committed to developing the technologies perfusionists and physicians need to help treat or manage congenital heart defects, including perfusion technologies, cannulae, and surgical and transcatheter heart valves,” said Wendy Svee, Global Product Manager, Medtronic Perfusion Systems.

For more information about Melody® Transcatheter Heart Valve Therapy, visit www.melody-tpv.com.

 Mel_TC_Valve
To view a brief animation about the Melody® valve, click here

*Humanitarian Device. Authorized by Federal law (USA) for use in pediatric and adult patients with a regurgitant or stenotic Right Ventricular Outflow Tract (RVOT) conduit (> 16 mm in diameter when originally implanted). The effectiveness of this device for this use has not been demonstrated.

Reference

1 Adult Congenital Heart Fact Sheet, Adult Congenital Heart Association, 2011. Melody® Transcatheter Valve.
 
 

New England Perfusionists Enthusiastic About Medtronic’s Affinity™ CP Centrifugal Blood Pump’s Small Prime Volume

Perfusionists in the New England region are enthusiastic about the Affinity™ CP Centrifugal Blood Pump, a low prime centrifugal blood pump that gently handles blood, resulting in low hemolysis.

“During wet labs with perfusionists, we demonstrate the pump’s features and benefits and then encourage hospitals to trial the product,” said Giovanni Cecere, Medtronic’s Manufacturer Representative for the region. “Feedback most often focuses on the advantages of the Affinity™ CP pump’s low prime volume of 40 mL and its better hydraulic ratio and ease of priming compared to other pumps on the market." Cecere added that “hospital trials using wet lab demonstrations are very helpful in showing perfusionists how the AffinityTM CP pump works."

“Heat generation is another issue of importance to perfusionists and since the Affinity™ CP pump is a ceramic-based, single bearing pump, heat generation is minimized,” Cecere noted.

The Affinity™ CP pump maintains the tradition of consistent, dependable performance associated with the AFFINITY family of perfusion products. By expanding the Affinity family to include centrifugal pumps, Medtronic can provide clinicians a low prime solution that includes the options they want and need. The Affinity™ CP pump combines the benefits of a smooth cone with low profile fins in a compact size.

Compatible with the Bio-Console® system, the Affinity™ CP pump provides the durability that is a hallmark of Medtronic centrifugal pump products. With few moving parts, the pump's design allows for even blood flow at lower RPMs as well as low shear and no stagnant blood zones, resulting in reduced heat generation and low hemolysis.

For more information and to schedule a web lab trial of the Affinity™ CP pump, contact your Medtronic representative.

Affinity_CP_BloodPump

The Affinity™ CP Centrifugal Blood Pump is a low prime pump designed for extracorporeal circulation of a patient’s total blood volume for up to six hours.

 
 
 

Medtronic’s Virtual Cardiac OR Offers State-of-the-Art Simulation-based Educational Experiences

Medtronic’s commitment to state-of-the-art simulation-based technology brings best-in-class education and training to perfusionists and their cardiac teams. A recently developed video highlights the role this facility plays in Medtronic’s commitment to promoting perfusion excellence. 

Click here to see a video about Medtronic's Virtual Cardiac OR.

“Our virtual cardiac OR offers clinicians a unique, exciting opportunity to combine experiential learning with product education and training. Simulation-based experiential learning removes patients and animals from the education environment, yet provides perfusionists and cardiac teams with a recognizable and realistic environment," said Mark Bearss, Medtronic Cardiopulmonary Education Program Manager. Simulation models range from task simulators to the high-fidelity Orpheus™* Perfusion Simulator. The virtual cardiac OR allows Medtronic to offer training that ranges from simple product education to complex surgical cases, all customized to meet specific team needs.

“The virtual cardiac OR is a valuable tool for team training on crisis management techniques as well as for training cardiovascular fellows, residents, employees and perfusion students on cardiopulmonary bypass techniques. The simulation scenarios help promote team dynamics in a safe environment where the patient is not at risk while providing a unique opportunity to experience and discuss crisis recognition, intervention and prevention,” Bearss added.  

For more information about Medtronic Academia Medical Education, contact your Medtronic representative.

*Orpheus is a trademark of Ulco Technologies, Marrickville, Australia.

 

February 2012

Medtronic to Exhibit at Upcoming 2012 CREF Cardiothoracic
Surgery Symposium

During the week of February 29th, perfusionists and other medical professionals will gather in San Diego, CA, for the 32nd Annual CREF Cardiothoracic Surgery Symposium, where Medtronic will host product theaters and highlight some of the key scientific areas that support the company's commitment to perfusion solutions.

"Perfusionists attending the CREF Cardiothoracic Surgery Symposium can interactively experience the science that supports Medtronic's product innovations. They'll experience our products first-hand and learn about the important role these products can play in providing optimized clinical care in the OR," said Denise Steinbring, Marketing Director, Medtronic Perfusion Systems.

Product Theater Presentation: Gaseous Micro-Emboli (GME)

Every manufacturer of perfusion equipment strives to incorporate optimal air removal technology in their devices. Experience the principals of physics that manufacturers use to devise engineering solutions for optimal air removal. Join Medtronic for a dinner presentation at the CREF Product Theater, in the Hilton San Diego Bayfront Hotel, on Thursday, March 1, 6:30 – 9:00 p.m. The presentation, entitled "GME: Can CPD Device Design Impact Air Embolism?", will be led by Walt Carpenter, Senior Principal Engineer, Medtronic Cardiac Surgery Research and Development. Participants will experience principles of physics used by manufacturers to engineer device-based solutions for optimal air removal.

Product Theater Presentation: Transcatheter Valve Procedures

The discipline of perfusion is constantly evolving. Learn about the perfusionist's role in transcatheter valve procedures at Medtronic's luncheon presentation on Friday, March 2, 12:00 – 1:00 p.m. at the Hilton San Diego Bayfront Hotel. Christian Matheve, Principle Training and Education Specialist, Medtronic CardioVascular Europe, will share tips for successful perfusion in a transcatheter valve procedure, including perfusionist preparations and equipment needs. He will also talk about the importance of and methods for establishing a solid working relationship with the hospital's cath lab and cardiology teams.

Experience the Science of Perfusion

During CREF's exhibit hours, attendees can experience a number of interactive presentations at the Medtronic booth (#111):

• What's Your Heparin Management IQ?

Patient clinical conditions and sample integrity may impact test results used to monitor heparin anticoagulation during cardiac surgery. At this booth station, perfusionists learn about some of these unique clinical situations and how anticoagulation monitoring can be modified.

For accurate anticoagulation monitoring, Medtronic will demonstrate its HMS Plus Hemostasis Management System, a versatile platform for accurate heparin and protamine management1 designed to lower procedural and operational costs.2- 4 By providing information on a patient's response to heparin, the HMS Plus System determines the appropriate dose for the patient so the required anticoagulant and antithrombotic effect can be achieved.

• Are All Coatings Created Equal?

Can you tell the difference between uncoated, non-heparin coated, and heparin coated tubing surfaces? Visit this booth station to participate in a demonstration showing the difference among coatings on a tubing surface and see if you can identify which coating is which.

Medtronic now offers the Balance Biosurface*, a hydrophilic polymer for cardiopulmonary bypass (CPB) circuit coating that contains no heparin and reduces platelet adhesion and activation while preserving platelet function. This is complemented by the Carmeda® BioActive Surface**, a durable, non-leaching End Point Attached heparin biocompatible surface technology that enhances blood compatibility and provides thromboresistant blood-contacting surfaces for CPB circuit devices. Carmeda® has the largest body of peer-reviewed clinical and scientific evidence of any biocompatible surface used for CPB devices today.

* Balance Biosurface technology is licensed under agreement from BioInteractions Limited, United Kingdom.
**Carmeda is a trademark of Carmeda AB. Products are coated with Carmeda® BioActive Surface, which is licensed from Carmeda AB for use only as part of an extracorporeal blood circulation system or circuit that includes an oxygenator or blood pump. 

• Are You All Wound Up About Fiber?

Affinity Oxygenator

The Affinity NT® Oxygenator provides consistent, efficient gas transfer with its patented radial flow design.

Conduct a hands-on experiment showing how different fiber-winding patterns impact flow and pressure drop through the radial flow oxygenator. Medtronic's proprietary graduated fiber-winding technique, which is used in Medtronic's oxygenators, will also be shown.

Medtronic's Affinity NT® Oxygenator sets the standard for oxygenation systems by providing consistent, efficient gas transfer due to its patented radial flow design.

• Do You Dare to Pump Air?

Learn how an open reservoir system compares with a closed circuit system using the Affinity® Venous Air Removal Device (VARD). During this demonstration, participants will see how micro air enters the circuit and how the Affinity® VARD Venous Air Removal System removes it.

VARD System

The Affinity® VARD Venous Air Removal System senses and automatically purges any air from deoxygenated blood that has entered the circuit.

The Affinity® VARD system senses and automatically purges any air from deoxygenated blood that has entered the circuit. Together with the recently approved Affinity® CP centrifugal blood pump, the Affinity® VARD supports blood conservation initiatives.

• Find Your Ideal Solution

See and experience Medtronic's broad line of cannulae options to find your ideal solution. Medtronic cannulae cover a wide variety of clinical needs, including:

  • Extracorporeal cannulae designed for optimal flow rates, flexibility, and ease of use while providing the interface between the patient and extracorporeal circuit
  • Cardioplegia cannulae that facilitate adequate myocardial protection during CPB
  • Suction and support products for clearing the field of debris and providing adequate venting during CPB
  • Accessory products that help to facilitate surgeries
Medtronic cannulae

A variety of Medtronic cannulae can meet a wide variety of clinical needs.

Collaboration with our customers shapes the future of Medtronic's perfusion, cannulae, and blood management technology and innovation. With continued passion and insight, Medtronic is focusing even more closely on perfusionists and their patients.

For additional information about the products exhibited at CREF or the product theater presentations, contact your Medtronic representative.

References

  1. Despotis GJ, et al. The impact of heparin concentration and activated clotting time monitoring on blood conservation. J Thorac Cardiovasc Surg 1995;110:46-54.
  2. Hill AG, et al. More precise heparin and protamine management during cardiopulmonary bypass. Proceedings of the American Academy of Cardiovascular Perfusion 1990;12-16.
  3. Despotis GJ, et al. More effective suppression of hemostasis system activation in patients undergoing cardiac surgery by heparin dosing based on heparin blood concentrations rather than ACT. Thromb Haemost 1996;67:2-8
  4. Bowie JE, et al. Automated management of heparin anticoagulation in cardiovascular surgery. Proceedings of the American Academy of Cardiovascular Perfusion 1985;6:1-5.
 
 
 

Florida Perfusion Society Presentation Focuses on Autotransfusion and Blood Conservation

At the Sanibel Perfusion Symposium, hosted by the Florida Perfusion Society on February 18, 2012, John Rivera, Medtronic Senior Therapy Development Manager, presented "Rethinking Blood Conservation: the Role of Autotransfusion." Rivera's presentation focused on the importance of autotransfusion in blood conservation.

Clinicians may decide to use autotransfusion during a procedure instead of allogeneic blood for many reasons. "Blood continues to be in short supply. The costs associated with its processing, testing, maintenance, and transfusion continue to grow," Rivera told attendees. Published clinical studies have noted that patients receiving allogeneic transfusions have more adverse outcomes and longer lengths of stay than patients who do not receive donor blood.1

Autotransfusion is a complementary activity that supports blood conservation. Other reasons for autotransfusions may include:

  • Reduces risk of infection
  • Considers religious requirements
  • Offers immediate availability
  • Conserves allogeneic blood for emergencies
  • Eliminates blood bank clerical errors
  • Is cost effective

Costs associated with transfusions range from $500 to $1,200 when the direct costs of collecting, testing, processing, storing, monitoring, and transfusing blood are taken into account.2

"Autotransfusion is one of the primary modalilties recommended for limiting allogeneic transfusions," Rivera told attendees. "It is a relatively inexpensive and flexible procedure that is safe, fast, efficient, and easy to implement. Commercially available autotransfusion devices, like Medtronic's autoLog® Autotransfusion System, are highly automated and can be rapidly implemented and deployed. In addition, insurance companies are examining surgical outcomes and have instituted a mechanism for reimbursement known as Pay for Performance or P4P. P4P mandates that hospitals that cannot reduce or control rates of complications run the risk of lower reimbursement payments."

The Society of Thoracic Surgeons, in conjunction with the Society of Cardiovascular Anesthesia, issued practice guidelines in 2007 for Perioperative Blood Transfusion and Blood Conservation in Cardiac Surgery that were updated in 2011. Multiple modalities were identified both in the pre- and perioperative settings that impact the practice of transfusion during cardiovascular surgery.3 The Guidelines are intended to assist physicians and other healthcare providers in clinical decision-making by describing a range of generally accepted approaches for the diagnosis, prevention, and treatment of specific diseases or conditions.

Rivera believes that in the hands of appropriately trained perfusionists, "autotransfusion generates a safe and high-quality packed red cell product. The process is fast and the patient benefit is immediate. Blood is literally recycled, and valuable allogeneic blood supplies are conserved for use with other patients not eligible for autotransfusion."

The fully automated Medtronic autoLog® Autotransfusion System produces a high quality end product with a hematocrit of 50% or greater. Its unique bowl design packs blood tightly to increase the hematocrit and allows blood to enter at a moderate G-force, thereby minimizing hemolysis. The system's design also promotes effective removal of free-plasma hemoglobin, residual anticoagulant agents, activated platelets, white blood cells, and activated clotting factors of 90% or greater in accordance with American Association of Blood Banks (AABB) guidelines.3

Importance of Autotransfusion Quality Control

Various personnel are involved in operating autotransfusion devices. Perfusionists are the primary operators during cardiovascular surgery, but other medical personnel run them in non-cardiovascular cases. All personnel must complete annual autotransfusion training and certification. The American Society of Extracorporeal Technology has created a standardized autotransfusion testing program that can be completed online in a proctored setting. Passing this test accredits the participant as a Perioperative Blood Management Technologist (PBMT).

Validation of all practices and ongoing quality control measurement of autotransfusion devices are mandated by the appropriate regulatory bodies, including the AABB. "Quality control procedures are critical to safe and effective autotransfusion procedures," Rivera told the audience. "Too many clinicians are unaware of the regulatory requirements that need to be followed as defined by the AABB's 4th Edition of Standards, which explicitly identifies the need for frequent testing of blood collected and processed using autotransfusion devices.4 These standards clearly state that the blood must be tested both before and after washing."

The autoLog® Autotransfusion System facilitates autotransfusion that supports blood conservation efforts.

To comply with the standards, Rivera reinforced some of the key requirements for autotransfusion quality control to bring perfusionists into compliance. These include5:

  • A required 95% reduction of potassium or plasma protein for washed blood (5.1.2). The collection reservoir must be sampled before processing and compared to the hold bag contents.
  • The removal rate for free plasma hemoglobin or residual anticoagulant should be 90%. A clear effluent line is not an adequate indicator of washout.
  • In-vitro validation of new devices prior to placing them into use (3.3)
  • Establishment of a quality control program that "is sufficiently comprehensive to ensure that reagents, equipment, and methods function as expected" (5.1.2)
  • Performance of periodic quality control to assess instrument function and operator competency (5.1.2)
  • Identification of a medical director who is a licensed physician and who is qualified by training and/or experience (1.1.1)

"While the AABB standards dictate that periodic quality control testing must be performed, the testing frequency should be determined by each facility," Rivera added.

For more information about autotransfusion and the autoLog® Autotransfusion System, contact your Medtronic representative.

References

  1. Koch CG, Li L, Duncan AI, et al. Morbidity and mortalilty risk associated with red blood cell and blood-component transfusion in isolated coronary artery bypass grafting. Crit Care Med 2006;34:1608-1616.
  2. Shander A, Hoffman A, Ozawa S, et al. Activity-based cost of blood transfusions in surgical patients at four hospitals. Transfusion 2010;50:753-765.
  3. Ferraris VA, Brown JR, Despotis GJ, et al. 2011 Update to the Society of Cardiovascular Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines. Annals of Thorac Surg 2011;91;944-82.
  4. Standards for Perioperative Autologous Blood Collection and Administration, 4th Edition, AABB, 2009.
  5. Guidance for Standards for Perioperative Autologous Blood Collection and Administration. First Edition. American Association of Blood Banks, Sec. 5.1.2, p. 21.
 
 

Medtronic India Hosts PerfUtech: A Perfusion Advancements Education Program

Medtronic India continues to demonstrate its commitment to perfusion education by conducting PerfUtech education programs. PerfUtech gives experienced and novice perfusionists the opportunity to learn, interact, and exchange views on recent perfusion advancements.

Dr Anil Tendolkar, Prince AlyKhan Hospital, Mumbai, India, is Director of the PerfUtech Program. He is a reputed cardiac surgeon and professor in India with more than 30 years of experience. More than 500 perfusionists have benefitted from PerfUtech programs held in Mumbai, Delhi, Bangalore, Chennai, and Hyderabad.

These five programs featured more than 40 eminent speakers who shared their experience and perspective on a variety of topics, including extracorporeal membrane oxygenation (ECMO), perfusion in minimally invasive surgeries, blood conservation, and novel cardioplegia techniques. Each presenter focused on innovative approaches and recent perfusion advances aimed at reducing morbidities.

"PerfUtech is an optimal opportunity for Medtronic to demonstrate its commitment to perfusion education and for perfusionists in India to share and learn about new therapies and products," said Sagar Mahajan, Product Manager, Cardiovascular Surgery, Structural Heart Division, Medtronic India. "Attendees are particularly enthusiastic about the interactive sessions, which include case presentations, debates, and ‘Surgical Surprises during CPB.'

"PerfUtech is also an excellent forum for Medtronic to showcase its broad perfusion product offerings. Perfusionists can learn the latest information about the Medtronic Rethinking Blood Conservation® Initiative and how our products clinically support a reduction in the use of blood transfusions for improved patient outcomes," Mahajan added.

John Patrick

John Patrick, Clinical Perfusionist, Shri Satya Said Institute of Medical Sciences, Bangalore, India, presents centrifugal pump information at the Bangalore PerfUtech program.

At a recent PerfUtech program, John Patrick, Clinical Perfusionist, Shri Satya Said Institute of Medical Sciences, Bangalore, India, presented information on the use of roller pumps compared to centrifugal pumps and the impact on a patient's blood. "The AFFINITY CP Pump is a low prime centrifugal blood pump that gently handles blood, resulting in minimized hemolysis. With few moving parts, the pump's design allows for even blood flow at lower RPMs as well as low shear, resulting in reduced heat generation and low hemolysis," he told the audience.

PerfUtech was developed in collaboration with preeminent physicians and perfusionists in India. By openly sharing their perfusion experiences, clinicians who attend PerfUtech programs learn innovative, topical information that can help them optimize their clinical skills and improve their patient care. For more information about Medtronic's educational programs, contact your Medtronic representative.

 
 

Saudi Pediatric Patients Benefit from Medtronic's Affinity Pixie Oxygenation and Performer® CPB Systems

Since the summer of 2010, 30 pediatric patients at the King Faisal Specialist Hospital (KFSH) in Jeddah, Saudi Arabia, benefitted from the center's first-time clinical use of three perfusion technologies that are part of Medtronic's ever-expanding portfolio of cardiopulmonary perfusion solutions. Used together, these products – the new Affinity Pixie Oxygenation System, the Performer® CPB System, and the BP-50 Bio-Pump® Centrifugal Blood Pump – were part of the cardiovascular surgery team's strategies for achieving the best patient outcomes possible.

"One of our goals as clinical perfusionists is the optimization of critical cases using the best technology and equipment," remarked Faiz Al Malki, chief perfusionist at KFSH-Jeddah. "The Affinity Pixie Oxygenation System has been shown to be a very effective system since it requires low prime volume and has a good gas exchange with fast heat exchange. It is truly an optimal design. We think the Affinity Pixie Oxygenator is very reliable for a wide range of patient weights. This helps us reduce the need to add blood in the prime and helps to minimize the patient's transfusion risk," Al Malki said.

The Affinity Pixie Oxygenation System with Balance Biosurface* earned its CE Mark for clinical use in May 2010. Designed for use with a broad range of patients, the system supports approximately 75% of the neonate, infant, and pediatric populations requiring cardiopulmonary bypass.

NOTE: In the United States, Food and Drug Administration
(FDA) 510(k) market clearance for the Affinity Pixie System
is pending and the device is not yet available for clinical use.

The Affinity Pixie Oxygenation System has a maximum flow rate of 2.0 L/min and a low prime volume of 48 mL. It includes new design elements such as Balance Biosurface*, a hydrophilic biosurface without heparin that helps to mitigate the foreign body response occurring when blood comes in contact with the device's artificial surfaces. The Balance Biosurface is designed to reduce platelet and cell adhesion and activation.

The Affinity Orbit Holder System provides versatile device positioning and port orientation to help reduce circuit tubing length and associated prime volume.

The BP-50 Pediatric Bio-Pump® Centrifugal Blood Pump promotes laminar blood flow by using the constrained, forced-vortex pumping principle in which a series of smooth-surfaced, rotating cones pull the blood into the vortex created by the rotation. The BP-50 Bio-Pump® is the only coated centrifugal pump currently available for pediatric use. The pump is available with Carmeda® BioActive Surface**, which combines excellence in blood handling and biocompatibility.

* Balance Biosurface technology is licensed under agreement from BioInteractions Limited, United Kingdom.

**Carmeda is a trademark of Carmeda AB. Products are coated with Carmeda® BioActive Surface, which is licensed from Carmeda AB for use only as part of an extracorporeal blood circulation system or circuit that includes an oxygenator or blood pump.

As the market evolves and arrested heart cardiac surgery procedures play an increasingly important role, pumping technology must be flexible enough to accommodate the changing needs of the operating room, including the need for:

  • Reduced prime volumes
  • Advanced mini circuits
  • Minimally invasive portal or femoral access surgery
Affinity Pixie

The new Affinity Pixie Oxygenation System, Performer® CPB System, and BP-50 Bio-Pump® help offer the best pediatric patient outcomes possible at King Faisal Specialist Hospital.

The Performer® CPB system is designed to meet these evolving perfusion needs.

With operating room space at a premium, the Performer® CPB System occupies one- third the space (20" x 22" [50 cm x 56 cm]) of traditional heart lung machines in use today. It can be configured for pediatric cases using the BP-50 Pediatric Bio-Pump® and a quarter-inch Bio-Trend® Probe in the venous line for in-line saturation and hematocrit monitoring.

"We are quite pleased with the recent advances in perfusion and our renewed commitment to our perfusion customers," said Moussa Srour, Business Director of Cardiovascular for Medtronic Middle East/Africa Region. "The Affinity Pixie Oxygenation System is a great start that reinvigorates our product line, and we expect even bigger steps in the future."

 
 

Use of HMS Plus Hemostasis Management System Enhances South African Hospital's Blood Conservation Efforts

Today's perfusionists need to incorporate better heparin management as a tool for blood conservation during cardiopulmonary bypass (CPB) surgery. Noel Gibson, Clinical Perfusionist, Unitas Netcare Hospital in Centurion, Gauteng, South Africa, believes the Medtronic HMS Plus Hemostasis Management System is a vital tool for accomplishing this.

"As a consequence of HIV and other blood-borne diseases, blood has become extremely expensive and difficult to cross-match in South Africa. More and more screening measures must be employed to ensure blood is safe. It's important for us to use tools that help reduce the amount of blood usage and eliminate blood transfusions where possible. If we can do this by managing the patient intraoperatively with the HMS Plus System, then I think we will achieve our goal of lower blood usage," said Gibson.

"We traditionally used heparin as a way of getting the patient's ACT level above a certain value. Now, with the HMS Plus System, we realize that it's not just a heparin management tool but also a heparin and ACT management system. It's a real-time ACT device. You can see exactly how long it takes for the blood to clot. I have also found that it is more accurate than other devices I have used. We can give patients adequate heparin with a good ACT and see exactly what the heparin and ACT levels are," Gibson continued.

Gibson believes that less blood is used during procedures when the HMS Plus device is employed since the patients tend not to bleed as much. "And, if they do bleed, we know that it's not because of residual heparin, but rather it's a coagulation problem. The HMS Plus System is a good tool for blood conservation as it helps us maintain adequate hemostasis," Gibson noted.

HMS Plus Hemostasis Management System Provides Heparin and Protamine Management

The HMS Plus Hemostasis Management System is a reliable, versatile, and effective platform for accurate heparin and protamine management,1 resulting in lower procedural and operational costs.2- 4 By providing information about the individual patient's response to heparin, the HMS Plus System determines the appropriate dose for the patient so that the needed anticoagulant and antithrombotic effect can be achieved.

Clinical studies have documented patient benefits associated with improved hemostasis management, including:

  • Fewer complications associated with excessive blood loss1
  • Preservation of the coagulation system, resulting in fewer transfusions2
  • Fewer surgical reoperations,3 thereby decreasing associated costs
HMS

South African Hospital uses HMS Plus Hemostasis Management System in blood conservation efforts.

Medtronic Perfusion Systems remains the pioneer and leader in providing both a heparin dose response test and the only point-of-care heparin assay for individualized heparin and protamine management.

For more information on the HMS Plus Hemostasis Management System, contact your Medtronic representative.

References

  1. Despotis GJ, et al. The impact of heparin concentration and activated clotting time monitoring on blood conservation. J Thorac Cardiovasc Surg 1995;110:46-54.
  2. Hill AG, et al. More precise heparin and protamine management during cardiopulmonary bypass. Proceedings of the American Academy of Cardiovascular Perfusion 1990;12-16.
  3. Despotis GJ, et al. More effective suppression of hemostasis system activation in patients undergoing cardiac surgery by heparin dosing based on heparin blood concentrations rather than ACT. Thromb Haemost 1996;67:2-8
  4. Bowie JE, et al. Automated management of heparin anticoagulation in cardiovascular surgery. Proceedings of the American Academy of Cardiovascular Perfusion 1985;6:1-5.

April 2012 Product News

In this edition:

  • German Hospital's Mini-circuit Blood Conservation Initiative Includes the Medtronic Affinity CP™ Centrifugal Pump and Affinity® Venous Air Removal Device
  • Medtronic Sponsors Autotransfusion Training at the Washington State Assembly of the Association of Surgical Technologists' Spring Conference
  • Medtronic Hosts Dubai Conference on Structural Heart Options and Outcomes

German Hospital's Mini-circuit Blood Conservation Initiative Includes the Medtronic Affinity CP™ Centrifugal Pump and Affinity® Venous Air Removal Device

Stadtisches Klinikum Braunschweig uses a Medtronic Mini-circuit

Stadtisches Klinikum Braunschweig uses a Medtronic Mini-circuit consisting of the Affinity® VARD and Affinity CP™ pump to help achieve more effective blood management.

The Stadtisches Klinikum Braunschweig near Hanover, Germany recently began using an Affinity CP™ Centrifugal Pump and the Affinity® VARD (Venous Air Removal Device) mini-circuit with Trillium®† Biosurface for coronary artery bypass grafting procedures. Mini-circuits play an important role in effective blood management through blood conservation.

Since 2001, the Stadtisches Klinikum Braunschweig has performed 5,000 mini-bypass cases using different types of circuits. They recently adopted the Medtronic mini-circuit because "its ease of use allows us to focus on the patient rather than on the circuit," said Torsten Schlumbohm, Chief Perfusionist, Stadtisches Klinikum. "Initially, we tested the Affinity® VARD pack in a laboratory setting without an arterial filter to confirm its ease of use and safety. It worked so well for us that we felt an arterial filter was unnecessary."

The Stadtisches Klinikum Braunschweig has been working for years to lower their transfusion rates as part of their approach to blood conservation. In 2005, before they implemented steps to better conserve blood, including the use of mini-circuits, their transfusion rate was 45%. Today, their transfusion rate is 15% and they are taking steps to reduce the rate even further.

"An additional step we are taking is adopting the Medtronic mini-circuit with the Affinity CP™ pump and Affinity® VARD device. This combination gives us one of the lowest prime circuits available," Schlumbohn noted. "The Affinity® VARD allows us to customize the mini-circuit for improved air handling. The system senses and automatically purges any air in the deoxygenated blood from the circuit. Together with the Affinity CP™, the Affinity® VARD reduces priming volume, a major goal associated with our blood conservation initiative."

Schlumbohm further observed that "the ease of use and patient advantages that accompany a low prime mini-circuit are important to us. In our first case, we started with a 700 mL prime in the circuit and a 400 mL retrograde prime. The patient's hemocrit was 32% at the start of the case. It remained stable throughout the procedure at 27%. The drop to 27% was the result of pulling off 500 cc's of blood for use in the ICU. The procedure went very smoothly and we were pleased with the air handling of the Affinity® VARD."

Advanced Technology Facilitates Automatic Venous Air Removal with the Affinity® VARD

The Affinity® VARD offers perfusionists the flexibility to customize circuit systems for improved air handling. It encourages the use of closed circuits, which have been clinically demonstrated to reduce patient complications.1 Paired with the Affinity CP™ centrifugal blood pump, the Affinity® VARD reduces priming volumes, a major goal for perfusionists and surgeons who support blood conservation initiatives.

The Affinity® VARD facilitates the benefits of closed circuits by automatically and quickly removing air from the extracorporeal circuit. As it does so, it provides a visual and audible alarm to alert the surgical team to the condition, all with no intervention by the perfusionist. The Affinity® VARD features:

  • Ultrasonic air sensors that detect air at the system inlet and that monitor liquid level in the filter
  • A 38 micron screen
  • A chamber and port at the top of the device to collect and remove coalesced air
  • Prime volume of 212 mL (not including purge line)

The Affinity® VARD gives perfusionists the flexibility to include or eliminate a venous hardshell reservoir, cardiotomy, or holding bag, depending on individual circuit set-up preference.

The Affinity CP™ Offers Choices in Centrifugal Pumps

The Affinity CP™ pump is designed for the extracorporeal circulation of a patient's total blood volume for up to six hours. It is a low prime centrifugal blood pump that gently handles blood, resulting in minimized hemolysis. Combined with the Bio-Console® system, the Affinity CP™ pump exemplifies the durability that is a hallmark of Medtronic centrifugal pump products. With few moving parts, the pump's design allows for even blood flow at lower RPMs as well as low shear, resulting in reduced heat generation and low hemolysis.

The Affinity CP™ pump is now available with a choice of biocompatible surface options – Carmeda® BioActive Surface with non-leaching End Point Attached Heparin or Balance™ Biosurface, a hydrophilic biosurface without heparin.

For more information on mini-circuits with the Affinity® VARD and Affinity CP™ pump, contact your Medtronic representative.

Technology licensed under agreement from BioInteractions, Limited, United Kingdom.

References

  1. Ranucci M, Isgrò G. Minimally invasive cardiopulmonary bypass: does it really change the outcome? Crit Care. 2007;11(2):R45. PubMed PMID: 17433112; PubMed Central PMCID: PMC2206473.

 

 

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Medtronic Sponsors Autotransfusion Training at the Washington State Assembly of the Association of Surgical Technologists' Spring Conference

John Rivera, Medtronic Senior Therapy Development Manager presented a training program on autotransfusion and its role in blood conservation at the Spring Continuing Education Conference of the Washington State Assembly (WSA) of the Association of Surgical Technologists (AST), held March 10-11, 2012, in Renton, Washington.

Approximately 250 anesthesia technicians and surgical technologists attended the conference, where, for the first time, formal instruction on the practice of autotransfusion and its role in blood conservation was offered. "I believe that with this presentation, Medtronic has spoken at every meeting of eligible personnel responsible for autotransfusion, including perfusionists, anesthesiologists, anesthesia technicians, surgeons, nurses, and blood bank or laboratory personnel worldwide," Rivera said. "This is important because, while perfusionists are the primary providers of autotransfusion services during cardiac surgery, they"re not routinely available to perform autotransfusion procedures in other surgical specialties. Hospitals must rely on qualified health care professionals other than perfusionists for this service."

Prior to this meeting, Rivera conducted a two-day autotransfusion education program for 20 students at the Renton School of Anesthesia Technology at Renton Technical College. This was the first time that extended autotransfusion training was offered to this medical specialty. "Having met John at a previous American Society of Anesthesia Technicians and Technologists Meeting (ASATT), I was excited about the opportunity to include autotransfusion training as part of our curriculum and to share John"s expertise with our students. The feedback following the program was very positive," said Gary West, RODP, Anesthesia Program Director, Renton Technical College.

Autotransfusion Training and Certification

Because autotransfusion devices are shared among surgical specialties, written policies and procedures detailing consistent use practices in all settings are critical. Rivera told the audience that, to accomplish this, it is important for perfusionists to maintain a high level of visibility in all blood management activities, including interfacing with laboratory personnel to ensure autotransfusion quality control testing.

Perfusionists have established uniform autotransfusion credentialing requirements through the Perioperative Blood Management Technologist (PBMT) exam. Anyone who frequently operates an autotransfusion device is eligible to take this exam, which is available for proctored online testing through the American Society for Extracorporeal Technology (AmSECT) and the International Board of Blood Management (IBBM).

"Personnel running autotransfusion devices must have annual training and recertification or they are out of compliance with the AABB's 4th Edition of Standards.1 Medtronic supports this training by offering a self-guided autotransfusion education program," said Rivera. Interested perfusionists and other personnel may contact their Medtronic representative for more information about this training.

Importance of Blood Conservation

Rivera began his autotransfusion training program by reviewing the key factors that drive blood conservation: blood shortages, blood cost, and patient safety. He then outlined and explained the practice guidelines that the Society of Thoracic Surgeons (STS), in conjunction with the Society of Cardiovascular Anesthesia (SCA), issued in 2007 and updated in 2011 for perioperative blood transfusion and blood conservation in cardiac surgery. The 2011 Guidelines also were written with input from several members of the International Consortium of Evidence Based Perfusion (ICEBP). Those Guidelines identify multiple modalities in both pre- and perioperative settings that impact the practice of transfusion during cardiovascular surgery.2 The Guidelines' goal is to establish a consistent practice of transfusion during cardiovascular surgery.

"I believe awareness of the STS Guidelines and their recommendations for blood conservation are important for all surgical specialties," Rivera told attendees. "Autotransfusion is a complementary activity that supports blood conservation but a multi-modality approach is the most comprehensive plan."

Rivera reviewed published clinical studies that document higher levels of adverse outcomes and longer lengths of stay for patients receiving allogeneic transfusions as compared to patients who do not receive donor blood.3

Acknowledging that autotransfusion is an important factor in blood conservation, Rivera reviewed other reasons why it may be considered:

  • Reduced risk of infection3
  • Religious considerations
  • Immediate availability
  • Conserves allogeneic blood for emergencies
  • Eliminates blood bank clerical errors
  • More cost effective4

"Autotransfusion is a key modality for limiting allogeneic transfusions. It is relatively inexpensive, and it is a flexible procedure that's safe, fast, efficient and easy to implement. Commercially available autotransfusion devices, such as Medtronic's autoLog® Autotransfusion System, are highly automated and can be rapidly implemented and deployed," Rivera told attendees.

"Blood recovered with autotransfusion devices does not make the patient bleed. The washed RBC's are literally the best red blood cells that can be transfused to a patient," Rivera noted.

Rivera concluded by summarizing the role of autotransfusion in blood conservation. "Allogeneic blood is in very short supply and its costs continue to increase. In addition, transfused patients experience more adverse consequences," Rivera reiterated. "The STS Guidelines provide clear directives regarding blood conservation, with a new emphasis on perfusion-based practices. They also recommend a multi-modality approach for high-risk patients that includes autotransfusion. For all of these reasons, it is imperative that autotransfusionists be appropriately trained and credentialed. The bottom line is that blood conservation is both a good clinical program and good business practice."

For autotransfusion, Medtronic offers the fully automated Medtronic autoLog® Autotransfusion System, which produces a high quality end product with a hematocrit of 50% or greater.5 The system's design also promotes effective removal of free-plasma hemoglobin, residual anticoagulant agents, activated platelets, white blood cells, and activated clotting factors of 90% or greater in accordance with AABB guidelines.4

For more information about the autoLog® Autotransfusion System and Medtronic's Autotransfusion Education Program, contact your Medtronic representative.

References

  1. Standards for Perioperative Autologous Blood Collection and Administration, 4th Edition, AABB, 2009.
  2. Ferraris VA, Brown JR, Despotis GJ, et al. 2011 Update to the Society of Cardiovascular Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines. Annals of Thorac Surg. 2011;91;944-82.
  3. Wiefferink A, Weerwind PW, van Heerde W, et al. Autotransfusion management during and after cardiopulmonary bypass alters fibrin degradation and transfusion requirements. J Extracorporeal Technology 2007;39:66-70
  4. Koch CG, Li L, Duncan Al, et al. Morbidity and mortality risk associated with red blood cell and blood-component transfusion in isolated coronary artery bypass grafting. Critical Care Medicine. 2006;34(6):1608-16
  5. The above data is from in vitro research using bovine blood. Clinical data may vary significantly.

 

 

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Medtronic Hosts Dubai Conference on Structural Heart Options and Outcomes

Clinical evidence shows that technologies and surgical techniques for treating structural heart disease, including the use of mini-bypass circuits, continue to positively impact patient outcomes.

A number of factors drive clinicians' need to define post-operative outcomes associated with cardiac surgery:

  • The absence of conclusive outcome data comparing off-pump versus on-pump procedures
  • The implementation of more aggressive interventional cardiology procedures results in older cardiac surgery patients presenting with more complex pathologies
  • The need for improved patient outcomes in on-pump procedures

To help clinicians address these issues, Medtronic hosted the "3rd Structural Heart Options and Outcomes" meeting, February 9-10, 2012, in Dubai, United Arab Emirates (UAE). The conference attracted over 150 participants from 24 countries in the Middle East and Africa.

While much of the conference addressed heart valve technologies and associated outcomes, other factors impacting patient outcomes were also touched upon.

Optimized Bypass

Michael Van Driel, Marketing Group Manager, Extracorporeal Technologies, Medtronic Europe, gave a presentation on "Optimized Bypass and The Future of On-pump Surgery" that included evidence that blood shortages, the cost of blood, and associated risks of blood transfusions are key reasons clinicians need to rethink their approaches to blood conservation. Major cardiac surgery and anesthesia societies, such as The Society of Thoracic Surgeons (STS)/Society of Cardiovascular Anesthesiologists (SCA), have published blood conservation guidelines. The STS/SCA Guideline Recommendations, updated in 2011, state that "a multi-modality approach involving multiple stakeholders…will limit blood transfusion and provide optimal blood conservation for cardiac operations."1

Van Driel reviewed clinical study results comparing blood transfusion rates between a miniaturized bypass circuit and conventional cardiopulmonary bypass (CPB).2 The study's authors found a 27% overall reduction in transfusion rates when a mini-bypass circuit was used versus conventional CPB (63% vs. 36%; p<.001).

To improve patient outcomes, it is important to reduce the impact of the extracorporeal circuit on the patient. One option Medtronic offers perfusionists is the Resting® Heart System – a safe, easy-to-use mini-bypass circuit. Patient benefits3 associated with this extracorporeal circuit include:

  • Less postoperative blood loss
  • Lower transfusion rate
  • Earlier extubation

"Optimized perfusion incorporates a multimodality approach towards improving patient outcomes and reducing patient morbidity," Van Driel told the audience. Select aspects of this approach with varying levels of clinical evidence1 include:

  • Use of mini-circuits – reduced priming volume and hemodilution
  • Use of vacuum-assisted venous drainage
  • Use of biocompatible CPB circuits
  • Use of centrifugal pumps because of perfusion safety features
  • Retrograde autologous priming of the CPB circuit
  • Separation of suction blood from aspirated blood

"The perfusionist can take several steps to significantly reduce priming volume," Van Driel noted. "For example, eliminating the venous/cardiotomy reservoir permits the patient to become the reservoir while the perfusionist uses a soft-shell bag to manage the patient's blood volume. Use of a centrifugal pump for active venous drainage is also important as is the integration of the system into one combined unit."

Mini-circuit Technologies

Mini-circuits are an important practice improvement step within the overall quality improvement process for hospitals adopting new techniques and technologies to improve patient outcomes. Closed circuit use has been clinically demonstrated to reduce patient complications.4 Closed systems are more physiological and biocompatible," Van Driel told the audience. Medtronic's Affinity® Venous Air Removal Device (VARD) is an example of a de-airing device that can be incorporated into a circuit, permitting the use of active venous drainage systems or closed systems in gravity drainage. As an enabling technology, it permits the use of closed systems in an extracorporeal perfusion circuit.

With the Affinity® VARD, circuit systems can be customized for improved air handling in a miniaturized circuit. The Affinity® VARD system senses and automatically purges air from the deoxygenated blood in the circuit. The Resting® Heart System or perfusion custom packs that include the Affinity® VARD give perfusionists more options for circuit design. Together with the Affinity CP™ centrifugal blood pump, the Affinity® VARD reduces priming volume, a major goal for perfusionists who support blood conservation initiatives.

Biocompatible surfaces, such as Carmeda® BioActive Surface and Balance™ BioSurface, are another important choice for the perfusionist to consider when designing a blood conservation program. Carmeda® BioActive Surface is a durable, non-leaching End Point Attached heparin biocompatible surface technology that enhances blood compatibility and provides thromboresistant blood-contacting surfaces for CPB circuit devices. It has the largest body of peer-reviewed clinical and scientific evidence of any biocompatible surface used for CPB devices today.

Balance™ Biosurface is a hydrophilic polymer for cardiopulmonary bypass (CPB) circuit coating that contains no heparin and reduces platelet adhesion and activation and preserves platelet function. "The availability and choice that these two biocompatible surface options offer demonstrates Medtronic's commitment to perfusion solutions. These biocompatible surface options expand the comprehensive strategy possibilities available to cardiovascular surgery teams," Van Driel noted.

The Future of On-pump Surgery

"While a mini-circuit is ideal for CABG, revascularization or aortic valve repair/replacement, complex surgeries that involve heavy bleeding and an increased need for perfusion cannot be handled by a small circuit," Van Driel said. "In these instances, patient benefits must be realized by changing the surgical technique rather than the perfusion technique. To help achieve these benefits, surgeons are adopting minimally invasive techniques that incorporate thoracotomies, mini-sternotomies, port access, robotics and sutureless heart valves."

These procedures are performed through placement of a cannula in the femoral artery of the patient's leg. "Medtronic's Bio-Medicus® Femoral Cannulae, designed for placement in either the femoral vein or artery, offer clinicians the versatility needed to meet the needs of minimally invasive cardiac procedures as well as the changing patient population," Van Driel told the audience. "This cannula's unique, flat, wire-wound, thin-walled construction maximizes flow rates and cannula flexibility."

Medtronic also offers clinicians a Retrograde Coronary Sinus Perfusion (MiRCSP) cannula and introducer system. This technology facilitates trans-atrial placement into the coronary sinus with access through a thoracotomy or mini-sternotomy. This unique cannula provides the maneuverability and visibility required for minimally invasive cardiac surgery (MICS) procedures.

"There was a time when perfusionists could use one perfusion approach for all patients. But patient benefits and improved outcomes associated with mini-circuits and MICS are changing this paradigm. Medtronic's commitment to perfusion solutions ensures that we will continue to advocate for minimally invasive approaches that include mini-circuits, blood conservation, and surgical-based therapies," concluded Shawn Monaghan, Vice President, General Manager, Surgical-based Therapies for the Medtronic Structural Heart business. "This conference demonstrates our commitment to partnering with perfusionists and extracorporeal clinicians to deliver innovative perfusion solutions to help their hospitals lower transfusion rates and enhance patient outcomes."

Medtronic sponsored the "Structural Heart Options and Outcomes" as part of its Academia Education and Training Program. For more information about Medtronic products, contact your Medtronic representative. To learn more about Medtronic's Rethinking Blood Conservation® Initiative, go to http://www.medtronic.com/rbci/ or contact your Medtronic representative.

References

  1. STS Blood Conservation Guideline Task Force: Ferras VA, Brown JR, Despotis GJ, Hammon JW, Reece B, Sha SP, et al; SCA Special Task Force on Blood Transfusion: Shore-Lesserson LJ, Goodnough LT, Mazer, CD, Shander A, Stafford-Smith M, Waters, J.; Intl. Consortium for Evidence Based Perfusion: Baker, RA, Dickinson, TA, FitzGerald DJ, Likosky DS, Shann, KG. 2011 Update to The Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines. Ann Thorac Surg. 2011;91:944-82.
  2. Harostock M 3rd, Filler JJ, Burak DA McDonnell BE, Emilcar J, et al. Comparison of Transfusion Requirements for Conventional and Miniamturized Extracorporeal Circuits. Heart Surg Forum. 2008;11(3): E188-92.
  3. Sakwa M, Emery R. Coronary artery bypass grafting with a minimized cardiopulmonary bypass circuit: A prospective, randomized trial. The Journal of Thoracic and Cardiovascular Surgery. Feb 2009; Volume 137, Number 2, pp 481- 485.
  4. Ranucci M, Isgrò G. Minimally invasive cardiopulmonary bypass: does it really change the outcome? Crit Care. 2007;11(2):R45. PubMed PMID: 17433112; PubMed Central PMCID: PMC2206473.

 

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June 2012 Product News

In this edition:

  • Memory of Frank Griemsmann Honored by Medtronic Colleagues and New York Perfusion Community
  • Simulated Aorta Model Improves Training Fidelity in Medtronic's Virtual Cardiac Operating Room
  • Medtronic and the University of Minnesota Hospital and Clinics Conduct Cardiovascular Surgery Crisis Management Simulation Program
  • Medtronic Named One of America's Best Corporate Citizens
  • Medtronic Among Top 50 Companies for Diversity

Memory of Frank Griemsmann Honored by Medtronic Colleagues and New York Perfusion Community

Frank Griemsmann Honored

On June 14, 2012, Frank Griemsmann's Medtronic colleagues and the greater New York City perfusion community joined his family to honor him and share their memories. Frank passed away on April 3, 2012.

Frank represented Medtronic Perfusion Systems' products in the New York area for over 25 years. According to all who knew and worked with him, Frank was the consummate professional. He dedicated himself to making sure his customers received the service they deserved and the products they needed. "Frank never forgot that there was a patient on the receiving end of each product he sold," recalled Jeanne Stanislawski Hutson, Medtronic Product Manager. "He was methodical in selling our products and making sure every customer had a good experience. He always knew exactly the right person to contact within Medtronic to help resolve a customer issue. And everyone was eager to help Frank when he needed help with a customer issue."

"Frank was known for his professionalism, style, class and integrity. His customers trusted him every bit as much as his colleagues did within Medtronic. The sales force really respected him." said Gary Celo, Medtronic Perfusion Sales Representative.

According to Susan Vlahakis, C.C.P., Chief Perfusionist, Bellevue Hospital Center, New York, "Frank was always there when you needed him. I met him in 1990 when I was a young and very junior member of the Mt. Sinai Hospital staff. Despite my junior status, Frank always treated me like a valued customer, even though I had no say on product selection. He was always friendly and everyone who knew Frank, from perfusionists to surgeons, had a great respect for him.

"As time went on, I became a Senior Perfusionist at Mt. Sinai and eventually the Chief at Bellevue Hospital. Frank was there every step of the way. He would do whatever was necessary to get products to me on time if I needed something on short notice. When I went to him with even a minor problem, Frank would be outraged. He was an advocate for me in every way. He was at all times ethical and devoted to Medtronic's products. He never spoke disparagingly about competitors. That wasn't his style. He believed in his products and always gave me accurate information. Frank's legacy to the perfusion community will be how well he treated all his customers. Whether you were a large or small account, he was an incredibly decent person."

Anatole Kanevsky C.C.P., Chief of Perfusion, Westchester Medical Center, NY, met Frank in 2007. "I have been in perfusion for almost 20 years and have dealt with many sales reps during that time," said Kanevsky. "Frank was one of a kind. Very genuine and never the typical salesman. He called or stopped by almost every week – not to sell anything but to see how my team and I were doing. Frank was one in a million, and he will be missed. I do not think anyone can take his place."

Katherine Cousineau, Chief Perfusionist at Englewood Hospital and Medical Center, Englewood, NJ, added, "The perfusion community lost more than a sales representative. They lost a friend and one of their biggest allies when it came to perfusion equipment and technology. Frank was a man with the utmost integrity. Always there for his clients at a moment's notice, he was efficient and thorough in his knowledge, making sure he clearly understood what his customers needed. I am fortunate to have worked with him over the past 22 years and know that he will be missed by all."

Frank's colleagues at Medtronic will miss him as well. Our heartfelt condolences go out to his wife and family.

 


 

Simulated Aorta Model Improves Training Fidelity in Medtronic's Virtual Cardiac Operating Room

Simulated Aorta Model in Medtronic's Virtual Cardiac OR

The synthetic aorta model with arterial cannula and aortic cross-clamp during delivery of antegrade cardioplegia.

Creating simulated cardiac tissue that feels, behaves and sutures like live tissue is an ongoing clinical training challenge. Perfusionists, surgical residents and cardiac surgeons agree that when it comes to simulated training, the greater the fidelity, the more effective the training experience will be. In an ongoing effort to improve simulated training fidelity, Medtronic worked with LifeLike BioTissue to develop an aorta model.

"Medtronic is always looking for ways to enhance the simulated training experience we offer cardiac perfusionists and surgeons," said Mark Bearss, Medtronic Cardiopulmonary Education Program Manager. "I worked with tissue modeling company Lifelike BioTissue to create an aorta that is thin and has a realistic feel for use in our training programs. The modified model connects to our Orpheus™ Perfusion Simulator*, which creates a realistic pulsatile arterial blood pressure in the aorta. There is enough flex in the model's material that it creates the realistic 'feel' of a patient's aorta."

LifeLike BioTissue provided a 2.5-3 mm thick by 25-30 mm diameter model. Several surgical fellows who used the model during a training session at Medtronic's Virtual Cardiac OR agreed that it was a great teaching device. "They all thought that it felt authentic and that it held sutures like a real aorta," Bearss noted. "Since it lacks the supporting structures of real anatomy, the model is harder to cannulate, but it still provides the ability to demonstrate and practice procedures rather than just talking about them." Clinicians who have used this aorta model find they can do nearly everything to it that can be done to a native aorta, with the exception of creating an aneurysm or a false lumen.

Medtronic and Lifelike BioTissue are exploring the possibility of developing a model with a pericardial reflection and a right atrium to further advance the hands-on realism for surgical trainees. "Medtronic's Virtual Cardiac OR is a valuable tool for team training on crisis management techniques and for training cardiovascular fellows, residents, employees and perfusion students on cardiopulmonary bypass techniques. Providing a more realistic simulation through the use of the aorta model is one more way to improve the training experience," Bearss added.

To learn more about Medtronic's Virtual Cardiac Operating Room, click here to view the video. For more information about Medtronic Academia Medical Education, contact your Medtronic representative. For information about LifeLike BioTissue, visit www.lifelikebiotissue.com

* Orpheus is a trademark of Ulco Technologies

 


 

Medtronic and the University of Minnesota Hospital and Clinics Conduct Cardiovascular Surgery Crisis Management Simulation Program

Cardiovascular Surgery Crisis Management Simulation Program

Kris Nielsen, CCP, Director of Perfusion Services, University of MN Hospital and Clinics, Fairview, MN, debriefs the cardiac surgeon fellows and perfusionists following a simulated crisis management training session.

In April 2012, the University of Minnesota Hospital and Clinics, Fairview, MN, together with Medtronic, conducted a simulated crisis management training program that focused on perfusion and surgeon teamwork. Kris Nielsen, CCP, Director of Perfusion Services at the University of Minnesota Hospital and Clinics, brought a team of ten perfusionists and four cardiovascular surgery fellows together over the course of three days. In order to accommodate everyone's busy schedules, the four-hour crisis scenarios were repeated five times during the three days.

Mark Bearss, Medtronic Cardiopulmonary Education Program Manager, noted that the simulated scenarios focused on perfusionist-surgeon communication as a way to define a procedure for crisis recognition and management. "Both perfusionist and surgeon must understand that a crisis is happening and how to manage it. Team dynamics and training are key elements to solving these kinds of problems. Ideally, the team develops a 'best practice' for handling crises. The beauty of this simulation program was that participants came to the realization that they needed to cooperate to develop a workable crisis scenario plan. They couldn't successfully do it alone," Bearss said.

The simulation training took place in Medtronic's Virtual Cardiac OR, where a synthetic aorta was recently added to allow surgeons to suture, cannulate, and make connections in the chest. Medtronic's ability to replicate a customer's perfusion set-up also makes the simulation as realistic as possible. "The objective of any simulation exercise is to test a clinician's knowledge of perfusion, not their ability to adapt to unfamiliar equipment," Bearss commented. Nielsen agreed, adding, "It was extremely helpful to duplicate our circuit set-up in the simulation lab so we didn't waste time and effort on things that are different than what we use on a daily basis. I highly recommend this approach."

"The idea for this training was sparked by an actual near miss incident," Nielsen said. "In that case, we managed the situation clinically and the patient was fine, but I wanted to find a way to prevent a repetition."

The incident forced Nielsen's team to think about how their methods and procedures could be improved. "When you operate successfully on thousands of patients without incident, it's easy to believe you're doing everything as safely as possible – until something happens," Nielsen observed. "The Medtronic simulation lab allowed us to duplicate the incident exactly as it happened. We went through our entire protocol and determined precisely what occurred. From there, we developed an improved procedure for handling an event like this."

Crisis simulation program incorporates hands-on training and debriefing

During the program, each group was confronted with a crisis scenario. Immediately after managing the "emergency," they debriefed, compiling a list of the procedural aspects they felt needed to be reconsidered. "The debriefings encouraged dialogue between surgeons and perfusionists," Nielsen noted. "Group members suggested methods in which the successful crisis procedure could be effectively recalled should a similar crisis actually occur. They also assessed whether a better, more efficient and effective way to handle each crisis scenario could be implemented since there are many ways to produce the same outcome.

"The surgeons focused on what they should be doing during particular portions of procedures. For example, when the perfusionist is doing retrograde cerebral perfusion, what can the surgeon do to expedite returning the patient to regular bypass? It's important to listen, to get other people's ideas and try to incorporate them into a protocol." The hands-on crisis simulation and subsequent debriefings prompted the team to revise policies and procedures for about 10 scenarios.

Simulated acute aortic decannulation

Kris Nielsen (left), CCP, Director of Perfusion Services, University of MN Hospital and Clinics, Fairview, MN, works with Dr. David Odell during a simulated acute aortic decannulation.

Simulation mirrors reality

The first crisis scenario closely mirrored reality in that it was unplanned. The arterial cannula flew out of the simulated aorta. "OK team, this can really happen. What do we do?" Nielsen asked. The team listed action steps for a beating heart scenario, then listed how those steps would differ in a non-beating heart scenario. "After taking the needed steps to replace the cannula, the group stopped to analyze their actions, resulting in a defined procedure for each team member. It turned out to be a very good learning situation."

Another scenario the team faced was an oxygenator that stopped working. They were challenged to identify if it was, in fact, a true oxygenator failure or a changing clinical scenario. They then discussed whether to change it out and, if so, when and how. "This is one of the more common scenarios perfusionists and surgeons need to practice since they both need to be involved," said Bearss. "The timing of an oxygenator failure determines the course of action. Is it before cross clamp, before or after cardioplegia? Is the patient warm or cold? Decision trees have to be developed and the entire team needs to be aware of what's happening. The advantage of a simulation lab is that the 'crisis' happens in a safe environment so everyone can practice their technique development and get their crisis checklist down pat."

Following the training program, Nielsen updated his policy and procedures and emailed them to the participating surgeons for review. Nielsen suggested to those surgeons who were just finishing their training that they take the procedures developed during this session to their new hospitals and share them with their new perfusion groups as a way to compare protocols, identify differences, and refine procedures. "Usually, the basic premises are the same from one group to another, but there may be nuances that need to be changed. Simulation training and written protocols are good methods for people to confirm and verify that they're doing the right things in a crisis situation," Nielsen noted.

Michael Bradner, MD, Cardiothoracic Surgery Fellow, University of Minnesota, Fairview, a surgeon participant, found that practicing disaster scenarios with his perfusionists and identifying each person's role was an important part of the session. "I thought it was valuable to have the entire team there to simulate the crisis, particularly from a communications skills standpoint," Bradner said. "The team aspect of the training will help us work better together since we all want to do what is in the best interest of the patient. If we train for a crisis, then hopefully we will be able to alleviate any adverse outcomes associated with it should it ever really happen."

Simulated crisis management training in Medtronic's Virtual Cardiac OR is another example of Medtronic's commitment to cutting-edge customer education and training. For more information about Medtronic Academia Medical Education, contact your Medtronic representative.

 


 

Medtronic Named One of America's Best Corporate Citizens

Corporate Responsibility magazine ranked Medtronic 50th among America's best corporate citizens in the publication's recently released top 100 list. On last year's list, Medtronic ranked 66th.

"Good corporate citizenship is an important part of our Mission," said Omar Ishrak, Medtronic Chairman and Chief Executive Officer. "We're proud of our accomplishments in this area, particularly the significant steps we've taken in transparency and citizenship performance in philanthropy, environmental stewardship, inclusion and good corporate governance. We are pleased to see our progress recognized on the list of the top 100 Best Corporate Citizens."

Corporate Responsibility bases its ratings on publicly available information regarding a company's policies and actions relating to the environment, climate change, human rights, employee relations, philanthropy and financial and corporate governance. Within these seven social responsibility categories, the publication considers 318 separate elements to arrive at their final rankings. The list is recognized as one of the nation's top acknowledgments of corporate responsibility.

"The corporate citizenship movement began more than 30 years ago in Europe when companies began focusing on environmental responsibility," said Ginny Cassidy, Medtronic Corporate Citizenship Consultant. "Since then, that focus has broadened to include not only how companies impact the environment but also their impact on, employees, customers, business ethics, and broad social issues, such as human rights and global health."

Medtronic's corporate citizenship approach

Earl Bakken, Medtronic's founder, set the tone for the company's corporate citizenship approach 50 years ago when he stated its Mission was to "alleviate pain, restore health, and extend life" and "to maintain good citizenship as a company." Medtronic's corporate citizenship vision is two-fold:

  • To operate responsibly in all facets where our business intersects with society, and
  • To leverage our resources, assets, and expertise to catalyze dramatic improvement in the lives of those affected by chronic disease.

In 2008, Medtronic shareholders asked the company to issue a corporate citizenship report using the Global Reporting Initiative™ (GRI) framework as a guide for reporting. Medtronic's Mission Statement and the GRI framework define the focus of its citizenship pillars:

  • Global Leadership in Addressing Chronic Disease
  • Collaborative Culture of Innovation
  • Responsibility in the Marketplace
  • Total Employee Engagement
  • Progressive Environmental Stewardship

Global leadership in addressing chronic disease initiative

"It's generally expected that companies should strive to be good corporate citizens, but there's a corporate responsibility trend that goes beyond this expectation," Cassidy noted. Companies such as Medtronic are combining their business expertise with government, academic, and nonprofit organizations to affect global society positively. They see that the world faces enormous problems that governments and society cannot handle alone. These corporations are finding ways to help solve social issues by engaging on different levels.

As part of the company's Global Leadership in Addressing Chronic Disease initiative, Medtronic and the Medtronic Foundation established the Medtronic Global Non-communicable Disease (NCD) Initiative. The Global NCD Initiative will enable Medtronic to "leverage its corporate assets – product, people and philanthropy – to maximize the business and social impact of efforts to combat NCDs."1

Each year, more people die from cancer, diabetes, lung and heart disease than from any other cause. Categorized as non-communicable diseases, these conditions account for 75% of global health care spending.1 Medtronic's expertise in treating heart disease and diabetes positions the company to help alleviate the worldwide effects of these conditions.

The Global NCD Initiative's strategy focuses on strengthening health systems, contributing to global policy and advocacy, and continuing innovation in therapy and healthcare delivery. "With these strategies, we can make a real difference," Cassidy observed. "The Global NCD Initiative is a signature program that aligns with Medtronic's Global Leadership in the Addressing Chronic Disease pillar and allows us to engage in a meaningful way around our core competencies as a medical technology company."

Medtronic is also recognized in several other corporate citizenship ratings, including the 2011 Newsweek Green Rankings (ranked 55th) and 2012 Forbes America's Most Reputable Companies (ranked 28th). Recognizing its leadership in meeting the needs of economic, environmental, and social stakeholders, Medtronic, Inc. was also named a member company in the Dow Jones Sustainability World Index (DJSI World) and the FTSE4Good Index Series. The DJSI World lists the top 10 percent of the largest 2,500 companies in the Dow Jones Global Total Stock Market. Medtronic was the largest addition to the 2011 DJSI World index as measured by market capitalization.

To learn more about Medtronic's corporate citizenship programs, visit www.medtronic.com/about-medtronic/corporate-citizenship. For more information about the Medtronic Global Non-communicable Disease Initiative, go to www.medtronic.com/ncd.

References

  1. Medtronic creates shared value with strategy for disease battle, The Corporate Citizen. 2011(6): 10-13.

 


 

Medtronic Among Top 50 Companies for Diversity

For the first time, Medtronic is ranked in the 2012 DiversityInc Top 50 List. DiversityInc, a leading source of diversity management information in the U.S., brings education and clarity to the business benefits of diversity. At number 38, Medtronic joins a prestigious group of organizations that link diversity management with fostering nimble and innovative cultures. "We are honored to receive this recognition as an inclusive, global workplace that encourages employees to be themselves and to be engaged in their work," said Michele DeSmet, Vice President of Global Inclusion, Diversity and Engagement. As an additional achievement, Medtronic placed fourth on DiversityInc's Top 10 Companies for Asian Americans.

Medtronic's diversity commitment is driven by its Mission "to improve the lives of others." Through inclusion, diversity and engagement, Medtronic innovates for life. "I am personally committed to guiding our continued growth as a diverse and inclusive organization, where employees are engaged and focused on executing the Medtronic Mission," said Chairman and CEO Omar Ishrak.

"We come together from all parts of the world, leveraging our diverse perspectives, backgrounds, cultures and generations to fulfill our Mission," added Caroline Stockdale, Medtronic Senior Vice President and Chief Human Resources Officer. "As a world leader in medical technology, Medtronic is committed to global diversity and inclusion in our workplace."

Medtronic creates a GIDE strategy for diversity

During fiscal 2012, Medtronic applied a new diversity strategy that recognizes the global nature of Medtronic's business and the importance of integrating inclusion, diversity and engagement into its business practices. This strategy, known as GIDE (global inclusion diversity engagement), charges the company's leaders, managers, and employee groups/networks to accelerate the results.

The strategy's implementation begins at the executive level with the formation of a global Inclusion Advisory Group. In addition, business- and geography-led inclusion coalitions were formed to address unique cultural perspectives, demographics, and the needs of customers and markets in all parts of the world. Employee-driven, company-sponsored networks and resource groups enable employees to connect with others who share similar cultures, identities and interests. These groups and networks provide professional development, networking support and opportunities to participate in recruiting, retention, mentoring, and community outreach.

Employee resource groups strengthen relationships

"Building personal and professional relationships is important," said Tonia Shupien, Medtronic Senior Program Manager, Global Inclusion, Diversity and Engagement. "We offer numerous Employee Resource Groups (ERGs) to help employees with common backgrounds or affiliations to connect and network." Recently a global women's network was initiated. "This network will support local women's employee resource groups and allow women across the company to have a global voice, which will ultimately benefit our patients and customers. The global network will focus on improving Medtronic's ability to attract, develop, and retain employees and to accelerate the advancement of women."

Medtronic Perfusion Systems participates in Project SEARCH

Project SEARCH is an example of Medtronic's push to be an inclusive employer. Project SEARCH is a one-year, business-led educational internship program for students with disabilities in their last year of high school eligibility. A team that included Medtronic's Perfusion Systems business was recognized for their support of this unique program, which, in turn, led to the first internships at Medtronic for these young adults.

The program, which partners with school districts and social service agencies, is for students with disabilities whose post-school goal is competitive employment. "Both Medtronic and the Project SEARCH students benefit from this program," said Val Nauth, Medtronic Perfusion Systems Manufacturing Manager. "It gives us access to a new, diverse talent pool and it helps support our community. The potential long-term impact is that more people with disabilities will achieve competitive employment, and more businesses will be prompted to access this under-utilized talent resource."

Medtronic Perfusion Systems celebrates diversity

Medtronic Perfusion employees come from 56 countries and are emblematic of Medtronic's diversity, its customers, and the communities they live in. During May 2010, David Varden, Medtronic Perfusion Systems Production Supervisor, held a Diversity Festival to celebrate this diversity. During the festival, many activities highlighted the varied backgrounds of Perfusion employees. Employees decorated Medtronic's Brooklyn Park, MN, headquarters with the flags of their 56 home countries and translated "good morning" and "good evening" into the 18 languages spoken there. They hosted an International Potluck so everyone could share the universal love of food and created a museum that displayed a wide range of cultural and historical items from employees' native countries.

"The Diversity Festival generated noticeable energy and truly enhanced employee engagement for all involved," Varden said. "I believe all of the Perfusion employees recognized the diversity of personal worth at the festival's conclusion."

Medtronic's business is as diverse as their customers. "We need to have a workplace that reflects the diversity of our customers and our business," CEO Ishrak stated. "This also provides us an opportunity to have multiple varieties of ideas. Diversity breeds differences and differences of opinion breed a better and more innovative business culture."

September 2012 Product News

In this edition:

  • Medtronic's Partnership with Italy's Lombardy Region Helps Deliver Quality Healthcare
  • Medtronic Teams with University of Washington Regional Heart Center to Sponsor RBC Evaluation Program
  • Medtronic Affinity Pixie Oxygenation System Successfully Used at High Altitude in South Africa
  • Medtronic Perfusion Participates in the Thoracic Surgery Directors Association's Fifth Annual Cardiothoracic Boot Camp for Residents
  • Medtronic in the News
  • Medtronic Supports Perfusion Education Around the World

Medtronic's Partnership with Italy's Lombardy Region Helps Deliver Quality Healthcare

In April, a team of Medtronic executives that included Omar Ishrak, Medtronic Chairman and CEO, and Luciano Frattini, Medtronic Italy's Regional Vice President, met with Italy's Lombardy Region and its president to discuss how using Medtronic technologies could help the region deliver higher-quality healthcare.

During the meeting, partnership roles were discussed and clinical areas where Medtronic technologies could help deliver sustainable, quality health care were identified. The talks led to creation of the O.R.M.E. (Outcomes, Research, Medtech, Efficiency) Global Project, which will study seven disease areas:

  • Blood management in cardiac surgery
  • Resistant hypertension
  • Syncope
  • Diabetic foot
  • Atrial fibrillation
  • Degenerative spine disorders
  • Sudden cardiac death

Lombardy is one of 20 regions in Italy, with one-sixth of Italy's population. "Among Italy's biggest healthcare concerns is how to maximize the budget return for healthcare," Frattini said. "Italy's current focus is on ensuring that budgeted money is spent appropriately, especially with the austerity measures being implemented here."

"For a project of this scope to benefit the entire region, Lombardy officials are seeking a partner with a broad product offering, since they want to consolidate suppliers," added Michael Van Driel, Medtronic European Group Marketing Manager. "They want to avoid dealing with a different company for each separate need. With Medtronic's broad cardiac surgery product portfolio, hospitals can work with one representative for needs as diverse as blood management, anti-coagulation management, perfusion circuits, and cannulae."

Blood Management in Cardiac Surgery

"Whole blood and blood components for transfusion are vital, but limited, resources in Italy, particularly in cardiac surgery," noted Laura Maglio, Perfusion Marketing Product Specialist, Medtronic Italy. "In Milan, Lombardy's capital, over 38 percent of the 12,000 units of packed red blood cells transfused annually come from outside of Milan. Countrywide, more than 11,400 daily blood component transfusions (red blood cells, platelets or plasma) were administered in 2010. In 2009, more than four million patients received whole blood transfusion therapies. Because the need for plasma greatly outpaces the supply, Italian healthcare systems must either purchase it from sources outside of Italy or acquire expensive pharmacological substitutes."1

"Another reason Medtronic was selected for this project is our unique Rethinking Blood Conservation (RBC)® Initiative, which helps hospitals focus on the need for blood conservation in cardiac procedures," added Van Driel. "It was an advantage to have an established program like this in place that includes a multi-modality approach to help hospitals conserve blood, improve patient outcomes and reduce the financial burden of blood-use-related complications."

As part of the O.R.M.E. project presentation, Maglio reviewed the need for blood conservation in cardiac surgery, noting three key factors:

  • Blood shortages, associated with complex surgeries and low donation rates
  • Patient safety risks, associated with blood transfusion
  • Increasing blood costs, related to additional required safety measures

The blood management component of the O.R.M.E. project will measure and compare the consumption of donor blood products as well as the postoperative outcomes associated with various blood management techniques and their associated costs. Scheduled to begin in September 2012, the project will study blood management at 12 hospitals throughout Lombardy. Within each hospital, a team that includes a cardiac surgeon, a perfusionist and an anesthesiologist will lead the process. During the initial six-month phase, the teams will review their hospitals' current processes and blood product usage to identify technique and technology gaps that, if addressed, would potentially conserve blood usage and benefit patients. The final six-month phase of the project will occur after implementation of the updated blood conservation measures. At the conclusion of the one-year study, the hospitals will do another assessment to determine if these changes made a difference in their blood product usage, patient outcomes and costs.

"Medtronic has spent the past decade studying alternatives and designing equipment to help cardiac teams avoid transfusions," Maglio concluded. "Everyone involved with the blood management portion of the O.R.M.E. project believes that patients deserve the benefits of better blood utilization, and hospitals value the information that the study's cost/quality metrics will provide."

Reference

  1. Saturni V. All About Blood (Tutto sul sangue). Associazione Volontari Italiani Sangue (AVIS), Regionale Lombardia. 24 March 2011.

 


 

Medtronic Teams with University of Washington Regional Heart Center to Sponsor RBC Evaluation Program

Clinical evidence continues to show that blood transfusions during cardiovascular procedures adversely impact patient outcomes. Published studies document that transfusions lead to increased morbidity, longer recovery times, longer hospital stays, and increased mortality.1,2  To help hospitals address this growing concern, Medtronic developed the Rethinking Blood Conservation® (RBC) Evaluation Program in conjunction with the University of Washington Regional Heart Center, Seattle, WA, a center of excellence for blood conservation.

"The RBC Evaluation Program is designed for cardiac teams and introduces practices and perspectives intended to lead to fewer blood transfusions. Medtronic gives visiting cardiac teams a look at the devices and techniques that have helped reduce blood usage. We've arranged for faculty from the University of Washington Regional Heart Center in Seattle, WA, to provide clinical practices instruction and give their perspectives on blood conservation," said Mary Muecke, Senior Program Manager, Medtronic Perfusion Systems.

With monthly programs starting in November, the two-day course will be led by a faculty under the direction of Gabriel S. Aldea, MD, Professor and Chief of Adult Cardiac Surgery, University of Washington Regional Heart Center (UWARHC). The course is designed for cardiac OR teams, including cardiac surgeons, perfusionists, anesthesiologists, post-op ICU nurses, data managers and executive-level administrators.

"The RBC Evaluation Program is structured as a team learning experience. We believe it to be imperative that the cardiac OR team participate in discussions about the practice changes necessary to reduce blood usage," noted Dr. Aldea.

To enhance the productivity of this evaluation program, Dr. Aldea developed a pre-audit form for participants to complete before they arrive. "This information gives me a better understanding of the blood usage protocols participants currently employ. I'm then able to focus the course and discussions on the needs of the attending hospital," Dr. Aldea said.

The RBC Evaluation Program demonstrates Medtronic's ongoing commitment to helping clinicians realize their blood conservation goals. "We foster an ongoing dialogue with our customers so that we can share with them the new blood management trends and techniques in cardiac surgery," said Denise Steinbring, Director of Marketing, Medtronic Perfusion Systems.

"Team involvement and communications are key to the success of blood conservation initiatives. The discussions that take place during this course help the entire team – cardiac surgeon, perfusionist, anesthesiologist, and cardiac nurse – better understand how a coordinated, protocol-driven multidisciplinary approach can help reduce blood transfusions and lead to better patient care," said Craig R. Vocelka, Chief, Perfusion Services, University of Washington.

While participating in the RBC Evaluation Program, cardiac teams view didactic presentations and participate in informal discussions focusing on better blood management. They also observe a cardiac procedure during which key practice techniques and technologies intended to reduce the need for transfusions are demonstrated, including:

  • Closed heparin bonded circuits and centrifugal arterial pumps
  • Reduced anticoagulation during coronary artery bypass graft (CABG) procedures
  • Separation of suction blood
  • Precise heparin and protamine dosing
  • Collection, concentration and washing of autologous blood

For more information about the RBC Evaluation Program, contact your Medtronic representative.

References

  1. Koch CG, Li L, Duncan AI, et al. Morbidity and mortality risk associated with red blood cell and blood-component transfusion in isolated coronary artery bypass grafting. Crit Care Med. 2006;34:1608-16.
  2. Brown PP, Kugelmass AD, Cohen DJ, et al. The Frequency and Cost of Complications Associated with Coronary Artery Bypass Grafting Surgery: Result from the United States Medicare Program. Ann Thorac Surg. 2008;85:1980-7.

 


 

Medtronic Affinity Pixie Oxygenation System Successfully Used at High Altitude in South Africa

Since July 2011, pediatric cardiac surgery using the Medtronic Affinity Pixie® Oxygenation System has been successfully performed at the Unitas Netcare Hospital in Centurion, Gauteng, S. Africa, which is located about 5,000 feet (1,500 m) above sea level. Oxygen gas transfer during cardiopulmonary bypass procedures at high altitude can be particularly challenging.

"We first used the Affinity Pixie Oxygenation System on a straightforward ventricular septal defect (VSD) case. The patient weighed six and a half kilograms and was on bypass for about 35 minutes. The oxygenator performance was fantastic. The oxygen transfer and CO2 off-load were quite efficient and the case went very well," said Noel Gibson, Clinical Perfusionist, Unitas Netcare Hospital.

In the past, Gibson has experienced problems with oxygenators underperforming at high altitude. At higher altitudes, oxygenators, including small oxygenators designed for use with pediatric patients, may transfer gas less efficiently.

"I am concerned about gas exchange when I begin to use a new oxygenator," said Gibson. "Over time I've found that oxygenators may have performance issues. For example, they may not transfer oxygen the way I want, and they don't blow off CO2 as efficiently as I'd like. Consequently, I usually have to make significant adjustments in FiO2 or gas flow to compensate."

Since the Affinity Pixie Oxygenator was new to Gibson, he decided to use it first for a shorter cardiopulmonary bypass procedure in support of a less complex surgical repair to experience its performance. Subsequent cases were longer and involved more complex surgical procedures.

The second case was performed on an infant weighing just over 5 kg, who was undergoing an atrial ventricular canal repair with a cardiopulmonary bypass time of approximately 100 minutes. The third case was a challenging reoperation on a one-year-old child, who weighed 6.8 kg and was diagnosed with an aortic outflow tract obstruction with a severely stenotic root. An aortic root replacement procedure with a homograft was performed. The bypass duration was 197 minutes with an aortic cross clamp time of 130 minutes. "The patient did exceptionally well and had an uncomplicated postoperative period. The Affinity Pixie System performed far beyond my expectations," said Gibson.

"Before using the Affinity Pixie Oxygenator, I thought we might have a problem with efficiently cooling or warming the patient, considering how small the heat exchanger was. But it worked very well," Gibson said.

"In each instance, I found that the Affinity Pixie Oxygenation System performed well, giving me the confidence to use it at high altitude, where it performed incredibly well," Gibson commented.

Delivering Performance and Flexibility for Your Smallest Patients

The Affinity Pixie Oxygenation System with Balance® Biosurface earned its CE Mark in May 2010. In the United States, it received Food and Drug Administration (FDA) 510(k) market clearance in September 2012. It delivers performance and versatility for neonates, infants and small children requiring cardiopulmonary bypass at flow rates up to 2.0 L/min. With a low prime volume of just 48 mL, the Affinity Pixie System can be used to support approximately 75% of the neonate, infant and pediatric population requiring cardiopulmonary bypass.

"It's important that perfusionists have confidence in the cardiopulmonary bypass technologies they use for their youngest and smallest patients. Oxygenator performance is critical, even more so when the device will be used at high altitude," said Wendy Svee, Global Product Manager, Perfusion Systems, Medtronic. "Additionally, it's especially beneficial when pediatric technologies can support a wide range of patient sizes and also are easy to set up and operate."

Affinity Pixie in use at Unitas Netcare Hospital, South Africa

The Affinity Pixie Oxygenation System in use at Unitas Netcare Hospital, Centurion, Gauteng, South Africa

The Affinity Pixie Oxygenation System features quick setup with custom device positioning and orientation, adapting to any pump setup. Design advancements include the Affinity Orbit® Holder System, which provides flexibility in device positioning and port orientation to help reduce circuit tubing length and associated prime volume. The oxygenator and reservoir are available with two biocompatible surface options:

  • Carmeda® BioActive Surface,* a durable, non-leaching End Point Attached heparin coating that provides thromboresistance and enhanced blood compatibility.
  • Balance Biosurface,** a hydrophilic biosurface option without heparin that reduces platelet activation and adhesion.

The Affinity Pixie Oxygenation System is the newest development in Medtronic's overall program to develop a range of innovative perfusion products to support surgery for children and adults. For more information about the Affinity Pixie Oxygenation System, contact your Medtronic representative.

* Products are coated with Carmeda BioActive Surface, which is licensed from Carmeda AB for use only as part of an extracorporeal blood circulation system or circuit that includes an oxygenator or blood pump.

** Technology licensed under agreement from BioInteractions, Limited, United Kingdom.

Affinity Pixie, Affinity Orbit and Balance are registered trademarks of Medtronic, Inc. Carmeda is a registered trademark of Carmeda AB.

 


 

Medtronic Perfusion Participates in the Thoracic Surgery Directors Association's Fifth Annual Cardiothoracic Boot Camp for Residents

On July 26-29, 2012, the Thoracic Surgery Directors Association (TSDA) held its fifth annual Boot Camp for cardiothoracic residents. Developed by TSDA and funded by an educational grant from the Joint Council on Thoracic Surgery Education, Inc. (JCTSE), the program gives participating residents training in five cardiothoracic surgical areas: cardiopulmonary bypass (CPB), anastomosis, open lobectomy, bronchoscopy/mediastinoscopy, and aortic valve surgery, including a mini-session on aortic root replacement.

Forty residents attended this year's program, which was conducted by more than 30 volunteer faculty members and guests who donated their time and expertise. As with prior Boot Camp programs, one of the guest experts was Mark Bearss, Medtronic Education and Training Program Manager. Together with Ed Darling, MS, CCP, Associate Professor of CHP-Cardiovascular Perfusion, SUNY Upstate Medical University, Syracuse, NY, Bearss assisted in the perfusion simulation portion of the course using the Orpheus™ Perfusion Simulator* together with a heart-lung machine. In this setting, a perfusionist facilitates a hands-on, problem-solving simulation to teach residents how to manage the fundamentals of cardiopulmonary bypass. Over the two-and-a-half day course, residents participated in numerous simulated CPB case scenarios. At the end of the Boot Camp, resident participants found the training to be excellent and "an extremely valuable experience."

TSDA's Boot Camp was developed five years ago to better train residents in key aspects of cardiopulmonary bypass. Designed by James I. Fann, MD (Stanford University Medical Center), Richard H. Feins, MD (University of North Carolina), and George L. Hicks, Jr., MD (University of Rochester), this intensive course addresses the needs emerging in CT surgery residency programs. The simulators used during the cardiac and thoracic sessions give the residents experience and hands-on practice in basic CT operating skills.

By teaching basic CT operating skills, residents are better prepared when they enter the operating room in their home programs. "Boot Camp is an impressive program that teaches residents the basics of CPB, including troubleshooting, recognizing and responding to CPB emergencies and practicing aortic and atrial cannulation techniques," Darling said. "With simulation, residents experience each step in the process of a patient going on and coming off CPB. With the different crisis management scenarios we designed to hone the residents' problem-solving skills, they come away from Boot Camp better prepared for the realities of a cardiac OR."

TSDA Boot Camp participants during CPB crisis simulation

TSDA Boot Camp participants learn important problem-solving techniques during CPB crisis simulation. (Photo courtesy of Thoracic Surgery Directors Association)

"Enhancing residents' proficiency in perfusion technology and CPB helps ensure the best possible clinical care in the OR and is an important part of Medtronic's continued commitment to leadership in medical education," noted Bearss.

Through program sponsorships like the TSDA CT Surgery Boot Camp and Medtronic's Academia education and training programs, clinicians strengthen their understanding and experience with the goals of expanding treatment options and improving patient care. For more information about Perfusion Academia, go to http://www.perfusion.medtronic.com/perfusion-equipment-education.html.

For more information about the TSDA's annual Boot Camp for CT surgery residents, visit www.tsda.org.

* Orpheus is a trademark of Ulco Technologies.

 


 

Medtronic in the News

A global leader in medical technology, Medtronic strives to improve and extend the lives of millions of people around the world through its efforts to alleviate pain and restore health. This commitment is reflected in ongoing activities throughout the corporation, such as helping underserved areas of the world promote sustainable cardiac care and instilling "green and lean" as a corporate culture. Medtronic's initiatives were recently recognized in a number of local and national news stories, which are summarized here.

Medtronic Ranks 28th on Forbes "America's Most Reputable Companies" List

An article published recently in Forbes, entitled "America's Most Reputable Companies," highlights the results of research conducted by Reputation Institute, a private research and consulting firm that evaluated consumer perceptions of the 150 largest companies in the U.S. familiar to consumers. Reputation Institute assigned scores to the companies based on four indicators: trust, esteem, admiration, and good feeling. It then analyzed seven dimensions of corporate reputation, including workplace, governance, citizenship, financial performance, and leadership. They found that a company's image or reputation "trumped product perceptions in driving behaviors."1

Medtronic was ranked 28th on the list, one-tenth of a point behind 3M. General Mills, Kraft, and Johnson & Johnson topped the list.

Read the complete story.

Medtronic Foundation Awards $230,000 Grant to Children's HeartLink for Pediatric Cardiac Care in India

In July, the Medtronic Foundation awarded a $230,000 grant to Children's HeartLink for growing and improving cardiac programs over the next two years in its partner sites in India. Children's HeartLink is a nonprofit organization that partners with healthcare centers in underserved regions of the world to promote sustainable cardiac care for children with heart disease.

"The world has turned its attention to non-communicable diseases (NCDs) such as cardiovascular disease and diabetes... diseases that collectively kill more people each year than any other cause of death. India is not immune to this ever-growing threat," said Dr. Jacob Gayle, Vice President, Medtronic Community Affairs and Executive Director of the Medtronic Foundation. "By supporting the important work of organizations such as Children's HeartLink, Medtronic hopes to improve access to crucial diagnosis and treatment options in India and elsewhere."

View the full press release.

Enterprise Minnesota Features "Leaner and Greener" Medtronic Perfusion Systems

The June issue of Enterprise Minnesota Magazine stated that "instilling green and lean as cultural cornerstones helps manufacturers realize significant savings, attract top talent, and keep one step ahead of the competition."2 The article cites a number of manufacturers, including Medtronic, who have implemented green practices for cost savings and efficiency.

Janice Tobin, Senior Operations Manager, Medtronic Environmental, Health and Safety Department, said Medtronic's lean and green culture is driven by both internal and external forces. "Our employees, customer base and shareholders have asked for it. Most important, it is linked to our mission... to ensure we are good citizens to a wide variety of stakeholders. With more than 38,000 employees and annual sales topping $15 billion, those requests inspired the implementation of a companywide sustainability policy in 2006."

Medtronic Perfusion Systems employees have a sustainability council that oversees initiatives to reduce waste and examine discarded waste to devise ways in which it can be reused or recycled more efficiently. Today, 52 percent of the industrial waste created at Medtronic Perfusion Systems' manufacturing site in Brooklyn Park, MN, is reused or recycled. That's up from 27 percent six years ago.

Read more about leaner and greener initiatives.

 

References

  1. Smith, J. America's Most Reputable Companies. Forbes. April 4, 2012.
  2. Lahouze A., Enterprise Minnesota Magazine. Leaner and Greener. June 2012.

 


 

Medtronic Supports Perfusion Education Around the World

Committed to perfusion, Medtronic supports education programs around the world. Please see the list below of recent and upcoming cardiovascular perfusion, surgery and anesthesia meetings supported by Medtronic. We invite you to visit the Medtronic exhibit at future meetings and look forward to seeing you!

Meeting Dates Location
China Heart Congress (CHC) August 9 - 12, 2012 Beijing, China
Joint Scandinavian Conference in Cardiothoracic Surgery August 16 - 18, 2012 Vilnius, Lithuania
AmSECT Annual Symposium on Advances in Blood Management August 23 - 25, 2012 Savannah, GA
AmSECT Pediatric Perfusion in conjunction with ELSO Annual Conference September 14 - 16, 2012 Seattle, WA
Society for the Advancement of Blood Management (SABM) September 20 - 22, 2012 Pittsburgh, PA
Georgia Health Sciences University Annual Cardiac Conference September 21 - 23, 2012 Atlanta, GA
Lake Tahoe Fall Symposium (California Perfusion Society) September 21 - 23, 2012 South Lake Tahoe, NV
TEAM SUNY 2012 September 27 - 30, 2012 Syracuse, NY
Euro-Asian Bridge September 28 - 30, 2012 Pravets, Bulgaria
Belgian Society of Extracorporeal Technology Symposium on Perfusion September 29, 2012 Brussels, Belgium
Congreso Latinoamericano de Cirugía Vascular y Angiología October 3 - 6, 2012 Santa Cruz, Bolivia
American Association of Blood Banks (AABB) October 6 - 9, 2012 Boston, MA
Russian Society for Extracorporeal Technologies October 9 - 14, 2012 Saint-Petersburg, Russian Federation
AmSECT Perfusion Safety & Best Practices October 10 - 12, 2012 San Diego, CA
JaSECT Educational Seminar October 17 - 18, 2012 Fukuoka, Japan
Update on Perfusion Devices October 18 - 20, 2012 Charleston, SC
Society of Clinical Perfusion Scientists of Great Britain and Ireland Congress on Perfusion October 19 - 20, 2012 Reading, United Kingdom
Illinois State Perfusion Society October 19 - 21, 2012 Oak Brook, IL
Minnesota Perfusion Society Fall Educational Meeting October 26 - 28, 2012 Rochester, MN
Canadian Society of Clinical Perfusion October 27 - 30, 2012 Toronto, Canada
European Board of Cardiovascular Perfusion October 27, 2012 Barcelona, Spain
European Association for Cardio-Thoracic Surgery Annual Meeting October 27 - 31, 2012 Barcelona, Spain
The Australian and New Zealand College of Perfusionists November 1 - 3, 2012 Uluru Northern Territory, Australia
Chinese Society for Thoracic and Cardiovascular Surgery (CSTCVS) Meeting November 1 - 3, 2012 Nanjing, China
Scientific Congress Of The Hungarian Society Of Heart Surgeons November 2 - 4, 2012 Budapest, Hungary
JaSECT National Convention November 3 - 4, 2012 Chiba, Japan
Italian Society for Cardiac Surgery Congress (SICCH) November 10 -13, 2012 Rome, Italy
Australian and New Zealand Society of Cardiac and Thoracic Surgeons Annual Scientific Meeting November 11 - 14, 2012 Hobart, Tasmania, Australia
International Congress of Cardiothoracic and Vascular Anesthesia and the New Zealand Anesthesia Annual Scientific Meeting November 14 - 17, 2012 Auckland, New Zealand
Kardio-Technik November 20 - December 2, 2012 Berlin, Germany
All-Russian Congress of Cardiovascular Surgeons November 25 - 28, 2012 Moscow, Russian Federation

December 2012 Product News

In this edition:

  • Medtronic Launches New Affinity Fusion® Oxygenator with Balance® Biosurface at the 2012 European Board of Perfusion and European Association for Cardio-thoracic Surgery Annual Meetings
  • Medtronic Gains FDA Clearance for New Infant and Pediatric Cardiopulmonary Bypass Surgery Oxygenation System
  • FDA Grants Clearance for New Medtronic Affinity® AF100 Arterial Filter
  • Medtronic to Launch eManual Website
  • Medtronic Academia to Host Annual 2013 European Options and Outcomes Conference in Rome
  • Medtronic Collaborates with Caribbean and Latin American Perfusion Leaders on Education
  • Medtronic in the News
  • Medtronic's John Rivera Honored with the American Society of Anesthesia Technologists and Technicians' (ASATT) Regional Educational Award
  • Meeting Sponsorship

Medtronic Launches New Affinity Fusion® Oxygenator with Balance® Biosurface at the 2012 European Board of Perfusion and European Association for Cardio-thoracic Surgery Annual Meetings

perfusion-dec2012-fusion

Customers actively engaged in demos and discussions with Medtronic development engineers at the Fusion Experience Center.

Medtronic launched its new Affinity Fusion® Oxygenator with Balance® Biosurface in Europe during the 2012 European Board of Perfusion (EBP) and European Association for Cardio-thoracic Surgery (EACTS) Annual Meetings in Barcelona, Spain, October 28th - 30th. This system, which received the Conformité Européenne (CE) Mark in September, incorporates innovations for increased patient safety and ease of use, including enhancements designed to prevent air bubbles from entering the blood during a procedure.

"These meetings provided a great opportunity for perfusionists to experience the Affinity Fusion Oxygenator first-hand," said Tamara Bratland, Global Product Manager, Medtronic Perfusion Systems. Approximately 250 people took advantage of Medtronic's Fusion Experience Center during the two Barcelona meetings. "We held 12 sessions in eight languages, so we were able to provide customers an experience that was specific to their needs." The Experience Center workshops provided a detailed overview of the Affinity Fusion Oxygenator features, followed by wet labs where customers could simulate using it as:

  • an open system with a centrifugal pump
  • an open system with a roller pump
  • a closed circuit with reservoir bag
  • a mini-circuit combined with a Venous Air Removal device (VARD)

"The Affinity Fusion Oxygenator's design is fundamentally different from previous designs," Bratland noted. It provides perfusionists with a true advancement in adult oxygenation technology, including:

  • improved flexibility and ease of use
  • proactive air handling
  • integrated arterial filter
  • unique design for hemocompatibility
  • expanded heat exchanger and gas transfer

"We are excited about the European launch of the Affinity Fusion Oxygenator," said Denise Steinbring, Director of Perfusion Marketing, Medtronic Structural Heart. "More than 500 perfusionists worldwide provided Medtronic with their input on the design for this system." The result is an adult oxygenator that uniquely fuses clinical insight with engineering expertise to provide perfusionists with 79 design enhancements. "Perfusionists are very excited and have told us that Medtronic has once again raised the bar for perfusion product performance."

The Affinity Fusion Oxygenator is not currently available in the United States. An application for clearance with the US Food and Drug Administration (FDA) has been submitted.

For more information about the Affinity Fusion Oxygenator, go to www.fusionoxygenator.com.

 


 

Medtronic Gains FDA Clearance for New Infant and Pediatric Cardiopulmonary Bypass Surgery Oxygenation System

perfusion-dec2012-pixie

Affinity Pixie® Oxygenation System receives FDA clearance for neonate, infant and pediatric cardiopulmonary bypass surgery.

On October 26, 2012, Medtronic announced US Food and Drug Administration (FDA) 510(k) clearance and the first US clinical use of its new Affinity Pixie® Oxygenation System. "The system's advancements offers a range of children for which it can be used, and make setup and use easier for perfusionists," noted Denise Steinbring, Director of Perfusion Marketing, Medtronic Structural Heart.

The Affinity Pixie® Oxygenation System was first used in the United States at Advocate Christ Medical Center in Oak Lawn, IL. It gained its CE (Conformité Européenne) Mark in May 2010 and is used in over 50 countries worldwide.

With a maximum flow rate of 2.0 L/min and a low oxygenator prime volume of just 48 mL, the Affinity Pixie® System can be used to support a broad range of the neonate, infant and pediatric population undergoing cardiopulmonary bypass. Both the oxygenator and reservoir are coated with either Carmeda® BioActive Surface,* a non-leaching, End Point Attached heparin biosurface, or Balance® Biosurface,** a hydrophilic biocompatible surface option without heparin. The system features the Affinity Orbit® Holder System for flexibility in device positioning and port orientation to help reduce circuit tubing length and associated prime volume.

Approximately 25% of the 36,000 infants born each year in the United States with congenital heart disease require invasive treatment within the first year of life,1 and some require additional procedures as they grow older. Due to advances in medical care, infants born with congenital heart defects are living longer and healthier lives. Today an estimated one million adults in the United States are living with a congenital heart defect.2

"Medtronic is committed to investing its resources to provide successful therapies to underserved populations, including pediatric patients," said John Liddicoat, M.D., Senior Vice President, Medtronic and President of the Structural Heart business. "The Affinity Pixie® Oxygenation System is the latest innovation in Medtronic's expanding portfolio of products for pediatric cardiac patients, which includes transcatheter pulmonic valves, cannula products, arterial filters and temporary pacing leads."

The Affinity Pixie® Oxygenation System is another example of Medtronic's commitment to advancing the treatment of cardiovascular disease through collaboration with leading clinicians, researchers and scientists worldwide. For more information about the system, go to www.affinitypixie.com.

Reference

  1. American Heart Association – 2012 Congenital Cardiovascular Defects Fact Sheet
  2. http://www.cdc.gov/ncbddd/heartdefects/facts.html

*  Carmeda is a trademark of Carmeda AB. Products are coated with Carmeda® BioActive Surface, which is licensed from Carmeda AB for use only as part of an extracorporeal blood circulation system or circuit that includes an oxygenator or blood pump.

** Balance Biosurface technology is licensed under agreement from BioInteractions, Limited.

 


 

FDA Grants Clearance for New Medtronic Affinity® AF100 Arterial Filter

perfusion-dec2012-af100-01

The Affinity® AF100 Filter with Balance® Biosurface provides perfusionists with maximum performance and a 100mL prime volume

On December 7, 2012, Medtronic received US Food and Drug Administration (FDA) 510(k) clearance for its new Affinity® AF100 Arterial Filter with Balance® Biosurface*, which provides maximum performance while reducing prime volume by 50%.

"The device's advancements demonstrate Medtronic's continued dedication to providing perfusion products that reduce prime volume while enhancing performance," noted Denise Steinbring, Director of Perfusion Marketing, Medtronic Structural Heart. "The Affinity AF100 filter follows last year's launch of the Affinity® CP centrifugal pump, which also decreases prime volume by 50%."

"The Affinity AF100 gives perfusionists everything they expect from an arterial filter in addition to an instant prime volume savings of 112 mL as compared to the Affinity® Arterial Filter," said Tamara Bratland, Senior Product Manager, Medtronic Perfusion. Along with its low 100 mL prime volume, the Affinity AF100 provides:

  • Ease of prime
  • Efficient air handling
  • Low pressure drop
  • Gentle blood handling

The Affinity AF 100 features Balance® Biosurface, which is a hydrophilic biosurface option without heparin. It reduces platelet activation and adhesions while preserving platelet function.1

This system is one more example of Medtronic's commitment to perfusion solutions. For more information, contact your Medtronic representative.

perfusion-dec2012-af100-02

Comparison between Balance-coated and uncoated in vitro bench test circuits of percentage of platelets that are activated with adenosine diphosophate (ADP @20 µm) in circulating heparinized human blood over time. Error bars represent standard deviation. († indicates p<0.025)

* Balance Biosurface technology is licensed under agreement from BioInteractions, Limited, United Kingdom

 


 

Medtronic to Launch eManual Website

perfusion-dec2012-emanuals

Customers can soon access perfusion, diagnostic, and blood management product manuals on a 24/7 basis by going to www.manuals.medtronic.com.

To address the growing demand for 24/7 access to product manuals, Medtronic will launch its redesigned eManual website (www.manuals.medtronic.com) in January. The revamped site will include perfusion, diagnostic, and blood management Instructions for Use (IFU) and User Manuals. Content will be added weekly until the site library is completed later in 2013.

"To ensure a user-friendly site redesign, we conducted usability studies with physicians, nurses, and technologists," said Tim Stanley, Graphic Design Manager, Medtronic CardioVascular Technical Communication. "Customers were asked to click through the site to find the manuals they needed. They then provided us with suggestions about how the site could be made more user-friendly. Based on their input, we redesigned the site so users can find a manual by model number (eg, BBP211, BBP242, CBP211, BBP241), product name (eg, Affinity Pixie, Affinity Orbit), or by manual document number."

Currently, only the United States and Canada have approved electronic labeling, which allows Medtronic to provide electronic manuals in place of printed IFUs shipping with the product. In the US, eLabeling is approved for every product line. In Canada, it is approved only for in vitro diagnostic (IVD) and Class IV devices, which include implantables, their accessories and other devices of substantial medical importance. In March 2013, the European Union (EU) plans to approve eLabeling for implantable devices, their accessories, and fixed capital products (products that cannot be moved from room-to-room). Medtronic CardioVascular will continue to include printed IFUs with most products. These documents will not be removed from any products shipped to countries where printed labeling is required by local regulations.

"Despite varying country documentation requirements, customers have made it clear to us that they need 24/7 access to IFUs. Medtronic’s eManual website gives customers ready access to needed manuals," Stanley added.

When customers first access the site, a screen will appear asking for their language preference. US customers are given a choice of English, French, Italian, German, or Spanish. On the following page, customers can enter the product model number, if known, or the product name. After the customer enters the first few letters of the product name, a "type-ahead" drop-down list will appear. From this list, the customer can select the desired product. When the product name is highlighted, a link to the manual appears.

The eManual website is another example of Medtronic’s ongoing commitment to perfusionists. For more information about perfusion products, contact your Medtronic representative.

 


 

Medtronic Academia to Host Annual 2013 European Options and Outcomes Conference in Rome

As part of Medtronic's ongoing commitment to perfusion, Medtronic Academia will again host the annual European Options and Outcomes Conference at Sant'Andrea Hospital, Rome, Italy, March 7 - 8, 2013. Last year's conference attracted over 150 participants from Europe and the Middle East.

Professor Riccardo Sinatra, MD., Chief of Cardiac Surgery, Sant'Andrea Hospital, will moderate a scientific program lead by 13 leading practitioners in anesthesia, surgery, and perfusion. Topics featured at the 2013 program will include:

  • Initial European clinical experience with the Affinity Fusion® Oxygenation System
  • Pediatric cardiopulmonary bypass using the Affinity Pixie® Oxygenation System
  • Individualized heparin and protamine management using the HMS Plus Hemostasis
  • Management System
  • Blood conservation strategies associated with the Affinity™ VARD and Performer™ CPB System
  • Non-invasive monitoring and real-time data acquisition with the Spectrum System M*
  • Gaseous microemboli minimization during cardiopulmonary bypass procedures

Medtronic sponsors the Options and Outcomes Conference as part of its Academia Education and Training Program. Teaming with Sant'Andrea Hospital to present this conference demonstrates Medtronic's commitment to working with perfusionists and extracorporeal clinicians to deliver innovative perfusion solutions. "During last year's Conference, attendees appreciated the focus given to perfusion technologies and techniques. The 2013 Conference will build on the success we had last year and will incorporate the feedback we received," said Michael van Driel, Marketing Group Manager, Extracorporeal Technologies, Medtronic Europe.

Medtronic invites you to attend the 2013 Options and Outcomes Conference. For additional meeting and registration information, contact your Medtronic representative or send your inquiry to sevada.avaksoumbatian@medtronic.com.

* System M is a trademark of Spectrum Medical

 


 

Medtronic Collaborates with Caribbean and Latin American Perfusion Leaders on Education

Many Caribbean and Latin America countries offer no formal perfusion education programs. Consequently, perfusionists there must travel to the US or Europe for training and continuing education. On a few Caribbean islands, on-the-job training with another perfusionist is the only option available. Despite these challenges, perfusionists in these areas strive to further their education and perfusion expertise. To help meet this demand, Medtronic recently sponsored continuing education courses for perfusionists in Mexico, Puerto Rico, and the Dominican Republic as part of its worldwide commitment to perfusion.

The Medtronic Latin America organization collaborated with local perfusionists to organize and teach these courses. "Perfusionists everywhere want and need education, but it's difficult for some to attend training sessions in the US or Europe," said Susan Guerra, Senior Product Specialist, Surgical-based Therapies, Medtronic Latin America. "We decided to help them strengthen their perfusion skills by providing meaningful education on topics of interest to them. Their feedback reinforced how beneficial these sessions were. For many, the course was the first they had attended."

Each course incorporated instruction led by local perfusion leaders or Medtronic perfusion clinical and education specialists, combining lectures with hands-on experiences with Medtronic perfusion, blood management and diagnostic technologies. To establish course objectives and agendas, the Medtronic Latin America organization polled perfusionists and its local distributors to identify learning needs and topics of interest. Key topics identified were blood conservation strategies during cardiopulmonary bypass, mini-circuit design, and perfusion safety. Based on this feedback, course objectives and agendas were established in concert with the local perfusion leaders.

Tijuana, Mexico Training Course Includes Medtronic Plant Tour

In early September, 2012, 18 perfusionists from Mexico, Nicaragua, Costa Rica, and Panama assembled at the Medtronic manufacturing facility in Tijuana, Mexico, for a week-long perfusion update course. The course was lead by three Mexico City perfusionists: Dr. Cesar Sabalza Lucano, Instituto Nacional de Pediatria, and President, Sociedad Metropolitanan de Perfusion in Mexico; Rolando Ferra Ferrer, Hospital de Especialidades Centro Medico La Raza del IMSS, and Guadalupe Arrieta, Instituto Nacional de Cardiologia Ignacio Chavez.

Oxygenators, mini-circuits, myocardial protection, and blood monitoring were discussed in-depth during the lectures. Perfusionists also received hands-on training with the Medtronic autoLog® Autotransfusion System, a sophisticated device that provides autologous blood during surgical procedures, and the Bio-Console® 560 Speed Controller System, an established centrifugal blood pump platform that is used with newer cardiopulmonary bypass technologies in reduced prime circuits.

Following a discussion on the role of biocompatible surfaces in multi-modality strategies for conserving blood during cardiac surgery, perfusionists toured the coatings manufacturing operations for Carmeda®1 BioActive Surface—a durable, non-leaching End Point Attached heparin coating technology that enhances blood compatibility and provides thromboresistant blood-contacting surfaces for cardiopulmonary bypass circuit devices. Next, they observed the coating process for devices with Trillium®2 Biosurface, a polymer coating with heparin applied to the blood-contacting surfaces of cardiopulmonary bypass devices. The perfusionists also visited oxygenator manufacturing and tubing pack assembly operations.

"The feedback we received was very positive. The perfusionists showed great enthusiasm for the presentations and hands-on learning, and everyone enjoyed the manufacturing operations tour. The tubing pack line proved to be of particular interest since many perfusionists attending the course had never used a pre-assembled tubing pack before and were impressed with its potential design options and ease of use," Guerra noted.

Perfusion Summit, San Juan, Puerto Rico

In November, a "first of its kind" Perfusion Summit drew 17 perfusionists from Puerto Rico, Trinidad, Jamaica, Bahamas, Guyana, Barbados, and Belize. Mark Bearss, Medtronic Perfusion Education and Training Manager; Jim Beavers, Medtronic Clinical Support Specialist; and Anibal Marin, lead perfusionist, Hospital Centro Cardiovascular, San Juan, presented during the day-long course. Bearss led an informational session on mini-circuits, the most requested topic prior to the meeting. Citing a number of clinical studies, he emphasized that there is no single definition or design for a mini-circuit. Instead, perfusionists incorporate several approaches to reduce circuit tubing length and prime volume. Describing examples of different mini-circuit designs, Bearss noted that they have become an important part of multi-modality strategies for blood conservation during cardiopulmonary bypass (CPB). He cited the 2011 Update to the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines where the level of evidence supporting the use of mini-circuits was raised from Class IIb, in the original 2007 guidelines, to Class I(A).

In a session on perfusion safety, Bearss focused on the need for standardized checklists and procedures to address perfusion emergencies. "I can't stress enough how important it is to practice these scenarios in a non-patient setting," Bearss said. "The entire OR team, (perfusionist, anesthesiologist, cardiac surgeon and OR nurses) needs to participate in crisis simulation scenarios as though a patient was actually involved. This helps everyone understand what is expected of them in a real emergency."

Jim Beavers led a session on blood conservation strategies, including use of the Medtronic HMS Plus Hemostasis Management System, where he stressed the importance of developing multi-modality strategies. This topic generated considerable discussion among the attendees and fostered strategies to put in place for conserving blood.

Perfusion Summit, Santo Domingo, Dominican Republic

All 14 Dominican Republic Island perfusionists attended a daylong meeting in November. Alileny Perez, Medtronic Perfusion Specialist for Latin America, conducted the course. As with the Puerto Rican course, Perez covered information on blood conservation, oxygenators, perfusion emergencies, and tubing packs. "Feedback from the Dominican Republic perfusionists was very rewarding," Perez said. "Not only did they find the session educational but they appreciated the opportunity to network with colleagues. Everyone is already looking forward to the next summit."

"Medtronic will definitely build on the success of these three programs," Guerra observed. "Supporting perfusion education is an important part of our commitment to perfusion. We're in the process of planning additional offerings for 2013, including participation in the Latin American Congress next year." Medtronic will sponsor several sessions and activities at this Congress, including presentations on blood management and autotransfusion. Medtronic will also have on hand the Orpheus™3 Perfusion Simulator, allowing perfusionists to test their knowledge and skills in handling perfusion emergencies. The VIII Latin American Congress on Extracorporeal Technology is scheduled for October 23-25, 2013, Isla de Margarita, Venezuela.

For more information, go to www.clateven.com.

Reference

  1. Carmeda is a trademark of Carmeda AB. Products are coated with Carmeda® BioActive Surface, which is licensed from Carmeda AB for use only as part of an extracorporeal blood circulation system or circuit that includes an oxygenator or blood pump.
  2. Technology licensed under agreement from BioInteractions, Limited, United Kingdom.
  3. Orpheus is a trademark of Ulco Technologies.

 


 

Medtronic in the News:

Through its efforts to alleviate pain and restore health, Medtronic, a global leader in medical technology, strives to improve and extend the lives of millions around the world through its efforts to alleviate pain and restore health. This commitment permeates the entire corporation with ongoing activities such as promoting sustainable cardiac and diabetes care, in the world's under-served areas. Medtronic's initiatives recently recognized in local and national news stories are summarized here.

Medtronic Commits $6 Million to Address Cardiovascular Disease and Diabetes Care for Underserved in India

Adding to the more than $1.2 million health-related grants it has already awarded in India, the Medtronic Foundation announced a five-year, $6 million philanthropic commitment in India to accelerate programs designed to expand access to quality care and management of heart disease and diabetes, two of the world's leading killers.

"By focusing on diabetes and cardiovascular disease, we hope to strengthen overall health systems to expand access to care in underserved communities. Given both the need and opportunity in India, it was clear that our support to help those working to improve care had to be ramped up," said Dr. Jacob Gayle, Executive Director, Medtronic Foundation and Vice President, Medtronic Community Affairs.

Cardiovascular disease (CVD), India's leading cause of death, claims three million people each year. India also has more than 60 million diabetics — more than in any other country. On September 20th, the Medtronic Foundation convened a group of community health experts, as well as representatives of non-profits, academia, and the private sector in New Delhi. Using a "continuum of care" framework to guide the discussion, participants identified barriers and gaps within the current health system in order to formulate solutions to strengthen them.

Since 2010, the Medtronic Foundation has committed more than $7.5 million (US) in non-communicable disease (NCD)-related grants worldwide, including $1.2 million (US) to NCD-related efforts in India. The Foundation will continue to increase global funding to expand access to NCD care for underserved communities, focusing on efforts to recruit, train, and equip frontline health workers, and reinforce patient-centered approaches to health promotion.

For more information about the Medtronic Foundation, go to www.medtronicfoundation.org.

Medtronic Extends Sponsorship of Twin Cities Marathon, TC 10 Mile, and Affiliated Youth Events

Medtronic and Twin Cities In Motion, organizers of the Medtronic Twin Cities Marathon, announced a three-year agreement to keep Medtronic as the title sponsor of four premier Twin Cities In Motion events: TC 1 Mile, TC Family Events, TC 10 Mile, and the Twin Cities Marathon. Medtronic will continue its support of the Medtronic TC Kids Marathon, a nationally recognized youth running program promoting exercise, wellness, and healthy lifestyles.

Medtronic became title sponsor of the four events in 2006, and since then event participation has increased more than 82 percent. A recent Twin Cities survey also showed that 21 percent of the population jogs or runs, a 25 percent increase since 2009. "This partnership lets us help promote health and fitness in Minnesota," said Virginia Brophy Achman, Twin Cities In Motion executive director. "Not only do we see an overall increase in running, we see more kids and their families running for the first time. It's great to see so many people make physical activity a part of their lives."

"Medtronic supports 'Healthy Medtronic Communities' worldwide, and that commitment starts in our hometown," said Dr. Jacob Gayle, Executive Director, Medtronic Foundation and Vice President, Medtronic Community Affairs. "The marathon and related races not only help encourage physical activity, they represent world-class events that the entire community can celebrate, adding to our overall quality of life."

Newsweek Magazine Names Medtronic One of 2012's "Greenest" Healthcare Companies

Newsweek's recent "Green Rankings" of the 500 largest publicly-traded companies in America for 2012 ranked Medtronic 11th (out of 51) in the Health Care Industry and 65th overall (out of 500). Medtronic also ranked in the top 30% of global companies, at 136th (out of 500).

To arrive at the ranking, Newsweek determined the nation's largest public companies based on revenue, market capitalization, and number of employees. The magazine then collaborated with environmental research firms Trucost and Sustainalytics to assess various metrics, including greenhouse gas emissions, water use, solid waste disposal, and emissions that contribute to acid rain and smog. On a scale of 100 points, Medtronic earned an overall "Green Score" of 65.4.

Categories included in the ranking process were further defined as follows:

  • Environmental Impact (weighted at 45%): Over 750 metrics including greenhouse emissions, water use, and waste disposal.
  • Environmental Management (weighted at 45%): Environmental policies, programs, certifications, initiatives, and controversies.
  • Disclosure (weighted at 10%): Environmental reporting and transparency initiatives.

Medtronic's Environmental Sustainability Policy defines responsible environmental management through implementation of the following actions:

  • conserve natural resources
  • promote energy efficiency
  • eliminate waste
  • reduce emissions associated with climate change
  • develop and implement specific requirements for new facility construction, existing facility modification, and equipment selection that will reduce our environmental impact

For more info on this year's Newsweek rankings, visit http://www.thedailybeast.com/newsweek/features/2012/newsweek-green-rankings.html.

Medtronic Foundation Donates $250,000 to Hurricane Sandy Relief Efforts

On October 29, 2012, the US eastern coastline was struck by a Category 1 superstorm, triggering floods and widespread power outages, prompting officials to declare states of emergency in 13 states. Medtronic's response to relief and recovery efforts was immediate, with the primary focus on the safety and well-being of employees and their families.

The Medtronic Foundation granted $250,000 to the American Red Cross in support of their relief efforts for areas affected by Hurricane Sandy. The company set up an Employee Disaster Relief Fund with an initial donation of $50,000 and committed to match employee giving up to an additional $100,000. Medtronic employees and contractors responded generously, donating over $35,000. In total, $120,749 was raised for individual Medtronic employees impacted by superstorm Sandy.

In addition to financial aid, employees assisted in direct relief efforts and were granted five days of paid leave. Mathew (Max) Tans, Clinical Specialist, Medtronic Neuromodulation, lives in Connecticut, a few miles from some of the areas hardest hit. "Living so close to the disaster area, I really wanted to help," Tans said. As a Navy veteran and volunteer firefighter, Tans knew his skills would be valuable to disaster recovery and rescue efforts. "I took an entire week off and did search and rescue efforts with Team Rubicon, an organization that unites the skills and experiences of military veterans with medical professionals to rapidly deploy emergency response teams into crisis situations. We found an elderly couple trapped because a tree had fallen on their house and was blocking both their front and back doors. We used chain saws to cut the tree out of their house."

"People were so appreciative. It was the greatest experience, and Medtronic made it fantastic. They gave me the time off to help people in the community and then they finished it off with a grant to the organization."

David Bloch, an attorney in Medtronic's Washington, DC office also wanted to help after seeing the news and pictures. "When I realized how many people were hurting, I wanted to do something in addition to contributing money," Bloch said. After receiving the email about granting employees time off to assist with relief efforts, Bloch took action through the Jewish Family Services in Cape May, NJ, which was running a food distribution center. He emailed colleagues and friends to collect food and supply donations. With a full car, he drove to New Jersey and helped sort and stack the food and supplies. While the center opened for only a couple of hours, more than a hundred storm victims lined up for assistance. That afternoon, Bloch joined Samaritan's Purse and helped repair a damaged house. "While it was a long, tiring day, I came home feeling I had done something worthwhile."

 


 

Medtronic's John Rivera Honored with the American Society of Anesthesia Technologists and Technicians' (ASATT) Regional Educational Award

perfusion-dec2012-asatt

John Rivera, Medtronic Senior Development Therapy Manager (right), accepts the Region 7 Education Award from Delbert Macanas, Cer AT, ASATT President

John Rivera, Medtronic Senior Development Therapy Manager, was honored with the Region 7's Education Award at the 2012 American Society of Anesthesia Technologists and Technicians (ASATT) Education Conference. Held in Washington, DC, in October, approximately 300 anesthesia technologists and technicians attended the meeting to learn more about their integral role in the patient care team.

ASATT's Region 7 comprises Alaska, Washington, Oregon, Idaho, Montana, Wyoming, and Hawaii. For the past 15 years, the membership has selected an individual, group, or company to receive their educational award. Nominations are based on contributions made to the education of anesthesia technicians and technologists. The recipient is selected by the Regional Director. Award recipients are often members of ASATT's Board of Directors.

"John has been a pillar of education for ASATT, lecturing for five years at consecutive Region 7 meetings. Region 7 has a minimum of two regional meetings a year, with one in Hawaii and one in either Washington or Oregon. John also lectured at two ASATT Annual Meetings as well as a Region 5 meeting and one in Renton, WA," said Delbert Macanas, Cer AT, ASATT President and former Region 7 Director. "It's been a privilege to have him involved with our meetings. John's ongoing commitment to education comes through strongly in every one of his presentations." Many Region 7 members also expressed their appreciation for John's tireless enthusiasm and hard work on their behalf.

"I am honored to teach these students through presentations at their medical meetings. It is truly one of my favorite things to do," said Rivera. In addition to receiving the award, John presented on the topic of "Rethinking Blood Conservation and the Role of Autotransfusion." His presentation reviewed the need for blood conservation in cardiac surgery. Using clinical data that illustrates the impact of allogeneic blood on cost and patient care, Rivera highlighted some of the following findings:

  • Allogeneic blood is in very short supply and its cost continues to increase.
  • Patients transfused with allogeneic blood experience more adverse consequences than patients not receiving transfusions.
  • The STS Guidelines provide clear directives regarding blood conservation with new emphasis on perfusion-based practices.
  • High-risk patients require a multi-modality, evidence-based medicine approach.

Rivera reminded the audience of the important role autotransfusion plays in blood conservation. "I believe blood conservation is both a very good clinical program and a very good business practice. I encourage all of you to become trained and credentialed as autotransfusionists by taking the AmSECT Perioperative Blood Management Technologists (PBMT) exam."

"Medtronic and our customers greatly benefit from John Rivera's extensive expertise and history in autotransfusion and hematology," said Denise Steinbring, Director of Perfusion Marketing, Medtronic Structural Heart. "He embodies Medtronic's commitment to helping customers keep pace with the continuous advances in their fields, and we appreciate the numerous opportunities that are given to John to support local, regional, national and international education programs."

For more information about Medtronic's Rethinking Blood Conservation® Initiative, go to www.medtronic.com/rbci or contact your local Medtronic representative.

 


 

Meeting Sponsorship

Medtronic Supports Perfusion Education around the World
Committed to Perfusion, Medtronic supports education programs around the world. Please see the list below of recent and upcoming Cardiovascular Perfusion, Surgery and Anesthesia meetings supported by Medtronic. We invite you to visit the Medtronic exhibit at future meetings and look forward to seeing you!

Meeting Dates Location
4th Annual Medical Education Day: The Role of Patient Blood Management in Education and Practice November 2, 2012 Englewood, NJ
American Academy of Cardiovascular Perfusion January 24-27, 2013 Los Angeles, CA
Society of Thoracic Surgeons Annual Meeting January 26-30, 2013 Los Angeles, CA
CREF (Cardiothoracic Surgery Symposium) February 6-9, 2013 San Diego, CA
SCA CPB February 10-15, 2013 Aspen, CO
Sanibel Symposium February 13-16, 2013 Fort Myers, FL
Indian Society of Extra Corporeal Technology National Congress (ISECT CON) February 15-16, 2013 Mumbai, India
World Congress of Pediatric Cardiology and Cardiothoracic Surgery February, 17-22, 2013 Cape Town, South Africa
AmSECT International Conference March 6-9, 2013 Las Vegas, NV
Society of Cardiovascular Anesthesiologists April 6-10, 2013 Miami Beach, FL

 

March 2013 Product News

In this edition:

  • Medtronic's Affinity Fusion® Oxygenation System Granted Clearance by U.S Food and Drug Administration (FDA)
  • Italian Earthquake Response Earns Medtronic Perfusion Systems the "Partnership in Clinical Support" Award from SpecialtyCare
  • Medtronic Highlights Perfusion Product Portfolio at CREF Cardiothoracic Surgery Symposium
  • Medtronic Displays the Affinity Fusion® Oxygenation System at the Society of Thoracic Surgeons Annual Meeting Using Fully-Interactive Cardiac Perfusion Simulation
  • Clinical Use of the New Affinity Fusion® Oxygenator With Balance® Biosurface Expands Throughout the European Union
  • Use of the Medtronic HMS Plus Hemostasis Management System for a Factor XII Deficient Cardiac Surgery Patient
  • Factor XII Deficiency Case Study
  • 1,000th Trainee Welcomed to Medtronic European Training and Education Center
  • Medtronic Supports Perfusion Education around the World

Medtronic's Affinity Fusion Oxygenation System Granted Clearance by U.S Food and Drug Administration (FDA)

Affinity Fusion

Affinity Fusion Oxygenation System gains U.S. FDA 501(k) clearance.

With the FDA's 510(k) clearance, the Affinity Fusion® Oxygenation System will now benefit adult cardiac surgery patients in the United States with its fundamentally different design approach. Incorporating input from more than 500 perfusionists worldwide, the Affinity Fusion Oxygenator's thoughtful design provides ease of use and includes enhancements that reduce air bubbles from entering the blood during a procedure.

"The Affinity Fusion Oxygenator's design is a unique fusion of our customers' clinical insight and Medtronic's engineering expertise," said Tamara Bratland, Global Product Manager, Medtronic Perfusion Systems. With over 79 new design features, this oxygenator significantly advances adult oxygenation technology with features including:

  • proactive air handling through an entire oxygenation system designed to handle air up front
  • hemocompatibility to reduce blood trauma, lower hemolysis rates, and minimize exposure to foreign surfaces
  • perfusion-practical ergonomics to improve flexibility and ease of use with enhanced customization capabilities
  • integrated arterial filter
  • expanded heat exchanger and gas transfer capabilities

Cleveland Clinic and The Heart Hospital Baylor Plano First to Use Affinity Fusion System in U.S.

Currently, perfusionists in more than 23 countries and 100 medical centers throughout the world use the Affinity Fusion Oxygenator. Its first U.S. use occurred at the Cleveland Clinic, Cleveland, OH, where Patrick Grady, Director of Perfusion Services and a paid member of the Fusion expert advisory board, assisted an open-heart surgery for a mini right thoracotomy and mitral valve repair procedure. Joseph Sabik, M.D., Chair of the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, and a paid member of Medtronic's heart valve scientific advisory board, performed the procedure.

Additionally, The Heart Hospital Baylor Plano (HHBP), Plano, TX, used the system for the first time during a mitral valve repair cases. Will Ryan, M.D., and Robert L. Smith, M.D., cardiothoracic surgeons at The HHPB, performed the procedures with Al Lione, Chief Perfusionist.

Affinity Fusion Oxygenation System Incorporates Design Enhancements from Inlet to Outlet

With a fundamentally different design approach, perfusionists will experience design enhancements that include:

  • Progressive fiber filtration – a proprietary fiber winding process with an interlaced pattern that efficiently filters the blood and removes particles and air while oxygenating the blood.
  • Uniform flow distribution – smooth tubular blood pathways and a unique curved venous inlet tube, both of which reduce blood turbulence during the surgical procedure.
  • Improved flexibility and ease of use – enhanced setup and customization features include a new oxygenation system holder, the Affinity Orbit®, that gives perfusionists more room to shorten lines in various operating rooms, including those with limited space.

As a fully integrated oxygenator and arterial filter, the Affinity Fusion Oxygenator features:

  • An electrical shunt that creates equilibrium between the blood and water pathway voltages, reducing the potential for electrostatic discharge that roller pump head rotation may develop.
  • A plastic heat exchanger that increases heat exchange performance, decreases prime volume, minimizes blood-contacting surfaces and enables device incineration.
  • Radial blood flow design that facilitates short, uniform blood flow to avoid areas of stasis while minimizing blood contact with foreign surfaces
  • Pre-membrane bubble trap that purges air before it reaches the fiber membrane by means of a built-in, one-way valve. The tangential flow creates centrifugal force that moves air to the center of the device where it is removed through a purge line.

The Affinity Fusion Oxygenator is available with two biocompatible surface options:

  • Balance Biosurface – a hydrophilic biosurface option without heparin that reduces platelet activation and lowers platelet adhesion.1
  • Carmeda® BioActive Surface – a durable, non-leaching end point attached heparin that provides thromboresistance and enhanced blood compatibility.2

"With a 260 mL prime volume, enhanced gas transfer and heat exchange performance, the Affinity Fusion Oxygenator is indicated for use as both an oxygenator and arterial filter system," noted Bratland. "Its 25µm filtration capability efficiently handles air and particulates."

The introduction of the Affinity Fusion System is another example of Medtronic's commitment to perfusion solutions. For more information about the Affinity Fusion Oxygenator, go to www.fusionoxygenator.com.

References

  1. Technology licensed under agreement from Biointeractions, Ltd., United Kingdom.
  2. Carmeda is manufactured under license from Carmeda® A.B. for use only as a part of an extracorporeal blood circulation system or circuit that includes an oxygenator or blood bump.

 


 

Italian Earthquake Response Earns Medtronic Perfusion Systems the "Partnership in Clinical Support" Award from SpecialtyCare

Award from SpecialtyCare

Michael Kolb (center), Medtronic VP, Commercial Operations, receives the Partnership in Clinical Support Award from Bill Elliott (left), SpecialtyCare Executive VP, COO, and Kathy Irvin (right), RN, SpecialtyCare VP, Supply Chain Services.

On February 8, 2013, Michael Kolb, Medtronic Vice President, U.S. Commercial Operations accepted on behalf of Medtronic Perfusion Systems the "Partnership in Clinical Support" Award from SpecialtyCare, the largest U.S. perfusion services company. "This award recognizes a business partner who is dedicated to and supportive of the exceptional care SpecialtyCare's clinical associates provide our patients and hospital clients," said Kathy Irvin, RN, Vice President of Supply Chain Services, SpecialtyCare, Nashville, TN. "Medtronic and Michael's efforts went 'above and beyond' as they helped us obtain alternative critical cardiac products following the May 2012 earthquake in Italy."

The earthquake devastated the Italian manufacturing facilities of Sorin and Euroset, crippling over 35% of the market's perfusion and autotransfusion products supply. Many customers asked Medtronic for quick support of their case needs, including oxygenators, blood pumps, blood reservoirs, and autotransfusion disposables. "Medtronic provided critical product support, often in the eleventh hour," Irvin noted. "Thanks to their response, SpecialtyCare did not have to cancel a single open heart case during this time. Michael was extremely professional and committed to putting patients first, stepping in to help us with critically needed products."

"We committed ourselves to helping customers impacted by the Sorin and Euroset service disruption as well as our existing customers," Kolb said. "Had Medtronic not been able to respond to everyone's needs, customers would have been unable to serve their patients and surgeries would have been cancelled.

The award was presented at SpecialtyCare's annual meeting in Nashville where about 500 SpecialtyCare executives, associates, and supply partners convened. SpecialtyCare has its roots in cardiac perfusion, participating in one out of every 9 open-heart surgeries performed in the United States and assisting in 44,000 open-heart procedures worldwide each year. The company serves upward of 820 hospitals, including more than 192 cardiac surgery programs at hospitals in 45 states, the District of Columbia and Puerto Rico, and in Germany through their Life Systems subsidiary.

Italian Earthquake's Impact

On May 20 and 29, 2012, two major earthquakes struck the heart of the medical device manufacturing "hub" in northern Italy. The disaster had far-reaching consequences for Medtronic's perfusion and autotransfusion product lines. With increased demand in Italy and from customers around the world, Medtronic ramped up production in their Brooklyn Park, MN, Grand Rapids, MI, and Kerkrade, The Netherlands manufacturing facilities. "We realized that our entire supply chain would be affected by this new demand," Kolb said. "Close coordination was required between sales, marketing, global supply chain and manufacturing."

After the earthquake, as customers approached Medtronic to ascertain their ability to provide incremental perfusion and blood management products, Medtronic was able to assure them that supplies were well stocked. "We assured them that Medtronic could support patient surgeries without interruption," Kolb added. To achieve this, Medtronic implemented 24-hour, seven-day-per week work shifts at manufacturing facilities that produced the needed products.

"As we managed this situation, our foremost concern was for our patients, employees, and their families in the quake zone," said Denise Steinbring, Director of Perfusion Marketing, Medtronic Structural Heart. "Our efforts to provide uninterrupted patient care to support our employees and our customers was consistent with the overall Medtronic mission."

For more information about Medtronic perfusion and blood management products, contact your Medtronic representative. For information about SpecialtyCare, visit www.specialtycare.net.

 


 

Medtronic Highlights Perfusion Product Portfolio at CREF Cardiothoracic Surgery Symposium

Product Experience Center guests

Product Experience Center guests discussed pack configurations incorporating the Affinity Fusion Oxygenation System with Medtronic tubing pack design experts.

At the February 6-9, 2013 CREF Cardiothoracic Surgery Symposium in San Diego, CA, Medtronic highlighted its perfusion product portfolio, including the new Affinity Fusion® and Affinity Pixie® Oxygenation Systems. "Collaboration between Medtronic and perfusionists is transforming our business," said Tamara Bratland, Global Product Manager, Medtronic Perfusion Systems. "Our new Affinity Fusion Oxygenation System is an excellent example."

Thursday evening Medtronic set up a Product Experience Center, giving perfusionists hands-on experience with the newest products in its perfusion portfolio. Using the Orpheus® Perfusion Simulator, Medtronic demonstrated how the Affinity Fusion Oxygenation System lets perfusionists handle air without an external arterial filter. "Among the Affinity Fusion System's unique aspects is its fully integrated oxygenator and arterial filter," Bratland noted.

Designed for careful blood handling and air management, the Affinity Fusion System's unique design gives perfusionists many features, including:

  • Proactive air handling
  • Enhanced hemocompatibility
  • Improved flexibility and ease of use
  • Oxygenator with integrated arterial filter
  • Expanded heat exchanger and gas transfer capabilities

In a wet lab set-up at the Product Experience Center perfusionists also got hands-on experience with the Affinity Pixie Oxygenation System. With a maximum flow rate of 2.0 L/min and a low oxygenator prime volume of just 48 mL, the Affinity Pixie® System supports a broad range of neonates and infants undergoing cardiopulmonary bypass.

To finish the demonstrations, perfusionists received updates on other Medtronic perfusion solutions, including cannulae, the HMS Plus Blood Management System and the autoLog® Autotransfusion System. They also heard an update on the Rethinking Blood Conservation program, which has been effective in helping hospitals reduce the financial and clinical complications of blood transfusions. Medtronic engineers answered technical questions, and Medtronic custom pack coordinators helped perfusionists better understand how the new perfusion products could be incorporated in their custom packs.

"Our Product Experience Center provided a 'hands-on' experience for customers as they moved from station to station, talking with engineers, observing and using products, and learning how our perfusion products impact blood conservation techniques," said Bratland. "Thursday evening we arranged for a chef to prepare pasta. Dessert was served on a stick. Another hands-on experience. Everyone enjoyed the evening and left with some key takeaways."

For more information about Medtronic's perfusion portfolio contact your Medtronic representative. Visit www.fusionoxygenator.com for additional information about the Affinity Fusion Oxygenation System and www.affinitypixie.com to learn more about the Affinity Pixie Oxygenation System.

 


 

Medtronic Displays the Affinity Fusion Oxygenation System at the Society of Thoracic Surgeons Annual Meeting Using Fully-Interactive Cardiac Perfusion Simulation

Medtronic exhibit

Clinicians attending the STS Annual Meeting simulated arrested heart perfusion in the Medtronic exhibit.

Medtronic displayed the Affinity Fusion® Oxygenation System at the Society of Thoracic Surgeons (STS) 48th Annual Meeting, January 26-30, 2013, with clinicians simulating arrested heart perfusion on the Orpheus® Perfusion Simulator.1 Nearly 2,300 medical professionals attended the STS Annual Meeting, where Medtronic reinforced their exhibit theme, "Find Opportunity in Change," with product exhibits and hands-on simulations.

 

During the meeting, cardiac surgeons performed hands-on aortic cannulation with the fully-interactive cardiac perfusion simulator. "Clinicians visiting our exhibit were very engaged in placing purse string sutures and cannulating our aortic model," said Mark Bearss, Medtronic Cardiopulmonary Education Program Manager. "With simulated training, the greater the fidelity, the more effective the training experience. Medtronic has worked with a tissue modeling company to create a thin aorta that connects to the Orpheus Perfusion Simulator to create realistic, pulsatile arterial blood pressure in the aorta."

Aortic model at STS

Aortic model used during interactive cardiac perfusion in the Medtronic exhibit at STS.

Bearss asked clinicians who used the simulator if they ever experienced air problems during bypass. Many answered that they had and were informed that the Affinity Fusion Oxygenation System has a pre-membrane bubble trap positioned at the top of the oxygenator to purge air before it reaches the fiber membrane. "Cardiac Surgeons enjoyed learning about the perfusion circuit in addition to cannulation during the simulation exercise. This included learning about the new Affinity Fusion Oxygenation System recently cleared for clinical use in the United States," Bearss noted. "The innovative design of the Affinity Fusion System makes it one of the most enhanced products of its kind. The ability to use the system in a simulated arrested heart procedure reinforced their enthusiasm."

For more information about the Affinity Fusion Oxygenation System, visit www.fusionoxygenator.com or contact your Medtronic representative.

Reference

  1. Orpheus is a trademark of Ulco Technologies.

 


 

Clinical Use of the New Affinity Fusion Oxygenator With Balance Biosurface Expands Throughout the European Union

Dr. h.c. Erich Gygax

Dr. h.c. Erich Gygax, chief perfusionist at Universitäts Klinik in Bern, Switzerland, is one of Affinity Fusion Oxygenator's major users.

Perfusionists in 22 European Union (EU) countries are now using the New Affinity Fusion® Oxygenlator with Balance Biosurface¹. To date, more than 2,100 cases have been performed using the system at more than 100 hospitals/medical centers. Medtronic launched the new Affinity Fusion Oxygenator with Balance Biosurface in Europe in October 2012 after it received the Conformité Européenne (CE) Mark in September.

The Universitäts Klinik in Bern, Switzerland, is one of the Affinity Fusion Oxygenator's major users. "We use primarily in our mini bypass procedures," said Dr. h.c. Erich Gygax, Chief Perfusionist. "The oxygenator's design features a venous air removal device and a premembrane bubble trap, which add a level of safety to the procedure."

Universitätsklinikum Hospital in Essen, Germany, also uses the Affinity Fusion Oxygenator. Together with the Universitäts Klinik in Bern, the two hospitals have used the system in approximately 500 cases. "I appreciate the system's flexible design," said Wolf Ingo Wiese, chief perfusionist at Universitätsklinikum. "It's a big advantage that we can gain prime during set up. I also like the design of the new Affinity Orbit® holder. It's easy to position on the heart-lung machine."

"EU perfusionists are enthusiastic about the Affinity Fusion Oxygenator, which is fundamentally different from previous designs," said Christiaan Matheve, Medtronic Training and Education Manager, Perfusion Technology for Europe and Canada. "Once they begin using it, they realize that it is truly the product of collaboration between perfusionists and Medtronic's engineering experts."

For more information about the Affinity Fusion Oxygenator, go to www.fusionoxygenator.com.

 

Reference

  1. Balance is a registered trademark of Medtronic Technology licensed under agreement from BioInteractions, Limited, United Kingdom.

 


 

Use of the Medtronic HMS Plus Hemostasis Management System for a Factor XII Deficient Cardiac Surgery Patient

HMS Plus Hemostasis Management System

For patients with Factor XII Deficiency, the HMS Plus Hemostasis Management System may provide an alternative for anticoagulation monitoring.

Significant challenges are associated with heparin anticoagulation in patients with Factor XII deficiency. Tests such as the activated clotting time (ACT), which demonstrates heparin's effect, do not provide adequate information for patients with Factor XII deficiency.

Medtronic was recently asked to assist in the management of a Factor XII Deficient patient's heparin anticoagulation during aortic valve replacement surgery, since the ACT provided insufficient information to indicate adequate pre- and intra-procedure heparinization. Additionally, the ACT was unable to confirm reversal of the heparin by protamine following bypass. To jump the case study, click here.

Factor XII Deficiency or Hageman Factor was identified in 1955 when a routine pre-operative blood sample taken from a patient, John Hageman, was found to have a prolonged clotting time despite the patient's negative history for abnormal bleeding. Unlike other clotting factor deficiencies, Factor XII Deficient individuals are asymptomatic for abnormal bleeding, even when challenged with major surgery, injury, and dental extraction. Factor XII Deficiency is an autosomal-recessive disorder with an estimated incidence of one in one million.

Congenital Factor XII Deficiency is the most common cause of an isolated prolongation of Activated Partial Thromboplastin Time (APTT) in a non-bleeding child or adult and is usually detected during routine pre-operative coagulation screening. The platelet count, prothrombin time (PT), and thrombin time are normal in patients with isolated Factor XII Deficiency. The APTT is markedly prolonged in patients with homozygous Factor XII Deficiency, but corrects to the normal range when the patient's plasma is mixed 1:1 with normal plasma. A specific assay is required to confirm a diagnosis of Factor XII Deficiency.

In contrast to the lack of bleeding manifested in patients with congenital Factor XII Deficiency, there is an increased incidence of serious thromboembolic events. Different studies report a 1% to 8% incidence of serious thromboembolic disease.1,2,4 Unusually high incidences of stroke, deep vein thrombosis, and myocardial infarction have also been described in patients with Factor XII Deficiency,3,5 which is also the case in two other contact factor deficiency states: Fletcher Factor (Prekallikrein) deficiency and Fitzgerald Factor (High Molecular Weight Kininogen) deficiency.6,7

In all of these situations, the ability to measure and maintain a stable heparin concentration with the Medtronic HMS Plus Hemostasis Management System provides an alternative for anticoagulation monitoring in these types of patients. It is a reliable, versatile, and effective platform for accurate management.

The use of the HMS Plus System in patients with antiphospholipid antibodies and the Lupus Anticoagulant with a prolonged baseline ACT has also been documented in the literature as a good alternative for monitoring heparin during cardiac surgery.8,9,10,11,12

For more information about the HMS Plus Hemostasis Management System, contact your Medtronic representative or visit www.perfusion.medtronic.com.

 

Reference

  1. Coleman R, Hirsch J, Marder V, et al. Hemostasis and Thrombosis, Basic Principles and Clinical Practice. 4th ed. Philadelphia, PA: Lippincott Williams and Wilkins; 2001, Chapter 6, Robert W. Colman, author, Contact Activation Pathway: Inflammatory, Fibrinlytic, Anticoagulant, Antiadhesive and Antiangiogenic Activities.
  2. Jespersen J, Munkvad S, Pedersen OD, Gram J, Kluft C. Evidence for a role of Factor XII dependent fibrinolysis in cardiovascular disease. Ann NY Academy of Science 1992.
  3. Von Kanel R, Wuillemin WA, Frulan M, Lammle B. Factor XII clotting activity and antigen levels in patient with thromboembolic disease. Blood Coagulation and Fibrinolysis 1992.
  4. Goodnought LT, Saito H, Ratnoff OD. Thrombosis or myocardial infarction in congenital clotting factor abnormalitites and chronic thrombocytopenias: a report of 21 patients and a review of 50 previously reported cases. Medicine (Baltimore) 1983.
  5. Lammle B, Wuihlemin WA, Huber I, et al. Thromboembolism and bleeding tendency in congenital Factor XII deficiency: a study on 74 subjects from 14 Swiss families. Thrombosis and Haemostasis 1991.
  6. Bick, R, Disorders of Thrombosis and Hemostasis. Philadelphia, PA: Lippincott Williams and Wilkins; 2002.
  7. Girolami A, et al. Comparative incidence of thrombosis in reported cases of deficiencies of factors of the contact phase of blood coagulation. J Thromb Thrombolysis 2011 Jan.
  8. Hogan W, McBane R, Santrach P, Plumhoff E, Oliver W, Schaff H, Rodeheffer R, Eddwards W, Duffy H, Nichols W. " Antiphospholipid Syndrome and Perioperative hemostatic Management of Cardiac Valvular Surgery". Mayo Clinic Proceedings 2000; 75: 971-976
  9. Jervis K, Senthilnathan V, Lerner A. "Management of a Patient with Lupus Anticoagulant and Antiphospholipid Syndrome fo Off-Pump Coronary Artery Bypass Grafting Using the Hepcon System". Anesthesia and Analgesia 2009;108, No. 4, 1116-1119.
  10. Brownstein L, Bartholomew D, Silver D, Berry C. "A case report of mitral valve replacement in a patient with lupus antibody syndrome". Perfusion 2003; 18: 373-376.
  11. Ducart A, Collard E, Osselaer J, Broka S, Eucher P, Joucken K. "Management of Anticoagulation During Cardiopulmonary Bypass in a Patient With a Circulating Lupus Anticoagulant". Journal of Cardiothoracic and Vascular Anesthesia 1997; 11: No 7: 878-879.
  12. Metzdorff M, Hansen K, Wright G, Fried S. "Interference With Anticoagulation Monitoring by Procainamide-Induced Lupus Anticoagulant". Annals of Thoracic Surgery 1996; 61: 994-995.

 


 

Factor XII Deficiency Case Study

Factor XII Deficient Patient - Heparin Concentration

Factor XII Deficient Patient - Heparin Concentration
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A 70-year-old male was admitted for aortic valve replacement surgery. His history and physical examination were unremarkable for bleeding problems, and he was taken to the operating room and anesthetized. Blood was collected for the baseline activated clotting time (ACT), which was found to be greater than 800 seconds. A second test conducted to rule out contamination confirmed the original results. The valve replacement procedure was cancelled pending further laboratory investigation.

Laboratory specimens revealed normal Prothrombin Time (PT) with Activated Partial Thromboplastin Time (APTT) of greater than 160 seconds, which corrected to 29 seconds when mixed 1:1 with normal human plasma.

The normal PT and markedly prolonged APTT, which corrected with the addition of normal plasma, are consistent with a deficiency in Factors VIII, IX, XI or XII. Factor VIII and Factor IX Deficiency are associated with Hemophilia A and B. These patients exhibit remarkably abnormal bleeding with or without trauma. Factor XI Deficiency is also associated with abnormal bleeding. The absence of a bleeding history in this patient made a strong case in favor of testing for Factor XII Deficiency.

The specific Factor XII assay result for this patient was <1% activity. Further investigation revealed that other members of the patient's family also have a history of Factor XII Deficiency.

Medtronic HMS Plus Hemostasis Management System Provides an Alternative for Factor XII Deficient Cardiac Surgery Patients

Medtronic was asked to assist with the management of this patient's heparin anticoagulation during the surgery, since the ACT would be unable to provide sufficient information to indicate adequate pre- and intra-procedure heparinization. The ACT would also be unable to confirm reversal of the heparin by protamine following the procedure.

Discussion of how to handle the case cited several papers describing administration of fresh frozen plasma to correct clotting time so that an ACT could be used to monitor anticoagulation. This method was rejected since it would expose the patient to blood products that might otherwise not be required.

The surgical team decided that using the Medtronic HMS Plus Hemostasis Management System to measure heparin concentration during the procedure was a good alternative to ACT testing.

Prior to surgery, an HMS Plus System and the appropriate heparin assay cartridges were delivered to the site and the laboratory validated it for clinical use. Additionally, in-vitro samples of the patient's blood were heparinized and tested with the HMS Plus heparin assay cartridges to demonstrate that the heparin assay would provide the needed monitoring information for this Factor XII deficient patient.

The patient was admitted for surgery and heparinized to 400 units/kg prior to bypass (bolus dose: 40,000 units). The heparin concentration was measured before bypass initiation and every 8 to 10 minutes during bypass. Additional heparin was administered during the case as indicated by the HMS Plus heparin assay to maintain a concentration of 400 units/kg. A total of 15,000 additional units of heparin were given during the course of bypass.

After coming off bypass, the heparin was reversed with protamine sulfate. The HMS Plus System recommended 436 mg of protamine and 440 mg were given. No additional protamine was required.

The patient stayed in the intensive care unit for one day and demonstrated no abnormal bleeding. No blood was administered to the patient, and he was discharged on the fifth day following surgery.

Reference

  1. Coleman R, Hirsch J, Marder V, et al. Hemostasis and Thrombosis, Basic Principles and Clinical Practice. 4th ed. Philadelphia, PA: Lippincott Williams and Wilkins; 2001.

 


 

1,000th trainee welcomed to Medtronic European Training and Education Center

Björk Tuija

Björk Tuija was the 1,000th Trainee at the Medtronic European Training and Education Center.

In January of this year, the Medtronic European Training and Education Center in Kerkrade, The Netherlands, welcomed Björk Tuija from Helsinki University Hospital in Helsinki, Finland, as its 1,000th participant since 2007.

The Medtronic European Training and Education Center was established in the mid-1980s and began offering continuing education and training programs in 2006. Since then, the programs developed by a core of medical and technical professionals have been delivered to clinicians from locations as diverse as Iceland, South Africa and the Far East. Clinicians from more than 56 countries have participated in the Center's programs. "Our goal is to deliver cutting edge education and training programs on our products and therapies," said Christiaan Matheve, Medtronic Training and Education Manager for Perfusion Technology in Europe and Canada. "We have developed more than 10 distinct programs, including scientific education sessions, product training and therapy training." The Center is distinguished by its multilingual character and ability to deal with cultural differences among attendees.

"We were pleased to welcome Björk as our 1,000th trainee, and that we have accomplished this training objective within five years. Participant feedback has been outstanding, particularly as it pertains to the quality and interactivity of our training," Matheve added.

"I appreciated the scientific information Medtronic shared at our training program," said Björk Tuija. "It's very helpful to understand the scientific background that supports the function of their products. The hands-on training was also very informative."

The hands-on training Björk mentioned is an important part of the added value Medtronic brings to education. "Medtronic strives to offer clinicians the best possible tools to improve their skills," Matheve noted.

Besides the Kerkrade-based training programs and in order to stay close to customers, Medtronic provides local education programs to clinicians in their home countries. "These programs facilitate clinician participation and improve the cost effectiveness of our efforts," Matheve said. Many perfusion societies and schools are integrating Medtronic's programs into their training portfolios, including the German Perfusion Society, DGfK, the Dutch Perfusion School in Leiden, The Netherlands, and the Scandinavian School of Perfusionists in Aarhus, Denmark.

Medtronic plans to expand program offerings, to include high-fidelity simulation, to more locations around the world and to adapt them to the future needs of the medical community, helping to ensure the best possible quality of care and service. "It is a privilege to be able to deliver knowledge and share experience with our clinicians so that they can improve patient outcomes during and following a medical intervention," Matheve concluded.

For more information about Medtronic Academia Training and Education programs, contact your Medtronic representative.

 


 

Medtronic Supports Perfusion Education around the World

Committed to Perfusion, Medtronic supports education programs around the world. Please see the list below of recent and upcoming Cardiovascular Perfusion, Surgery and Anesthesia meetings supported by Medtronic. We invite you to visit the Medtronic exhibit at future meetings and look forward to seeing you!

Meeting Dates Location
Transfuse-Transformative Fusion of Innovative Patient Blood Management March 13-16, 2013 Phoenix, AZ
Simposio Internacional de la Sociedad Colombiana de Cardiología y Cirugía Cardiovascular March 14-16, 2013 Cartagena, Columbia
Society for Cardiothoracic Surgery in Great Britain & Ireland March 17-19, 2013 Brighton, UK
Impact Jakarta March 29-30, 2013 Jakarta, Indonesia
Sociedad Mexicana de Cirugía Cardiaca April 3-6, 2013 Puerto Vallarta, Mexico
Society of Cardiovascular Anesthesiologists April 6-10, 2013 Miami Beach, FL
Wisconsin Perfusion Society Annual Spring Meeting April 12-14, 2013 Wisconsin Dells, WI
Network for Advancement of Transfusion Alternatives (NATA) April 18-19, 2013 Vienna, Austria
InterCEPT - International Course on Extracorporeal Perfusion Technologies April 18-20, 2013 Milan, Italy
Five-Continent International Symposium on Cardiovascular Diseases (FISCD) April 19-21, 2013 Beijing, China
Perfusion in the 21st Century (Pennsylvania Perfusion Society) April 27-28, 2013 Pittsburgh, PA
American Association for Thoracic Surgery May 4-8, 2013 Minneapolis, MN
Hungarian Society of Cardiology May 5-11, 2013 Balatonfüred, Hungary
Royal Australasian College of Surgeons Annual Scientific Congress May 6-10, 2013 Auckland, New Zealand
Mechanisms of Perfusion May 16-19, 2013 Orlando, FL
16th Annual Session of the A.N. Bakoulev Scientific Center for Cardiovascular Surgery May 18-21, 2013 Moscow, Russia
Korean Society for Thoracic and Cardiovascular Surgery Spring Meeting May 23, 2013 Seoul, Korea
French Society of Cardiothoracic and Vascular Surgery (SFCTCV) June 12-15, 2013 Marseille, France
International Society for Minimally Invasive Cardiac Surgery (ISMICS) June 12-15, 2013 Prague, Czech Republic
The New Orleans Conference June 12-15, 2013 New Orleans, LA
European Congress on Extracorporeal Circulation Technology (FECECT) June 12-15, 2013 Toledo, Spain
Association of Cardiac Surgeons June 20-22, 2013 Madrid, Spain
Cardiothoracic, Vascular and Perfusion SIG Meeting (ANZCA) June 30-July 5, 2013 Port Douglas, QLD, Australia
Annual Meeting of Japanese Society of Pediatric Cardiology and Cardiac Surgery July 11-13, 2013 Tokyo, Japan
Caribbean Cardiology Conference. July 24-27, 2013 Curacao, Curacao
Biennial Conference of the Society of Cardiothoracic Surgeons (SCTSSA) August 2-4, 2013 KwaZulu Natal, South Africa
Annual Scientific Meeting of the Cardiac Society of Australia and New Zealand (CSANZ) August 8-11, 2013 Gold Coast, QLD, Australia
Australian and New Zealand Society of Cardiac and Thoracic Surgeons Annual Scientific Meeting August 22-25, 2013 Darwin, NT, Australia

October 2013 Product News

In this edition:

  • Medtronic Introduces Affinity Fusion® Oxygenation System to Perfusionists at the 2013 American Society of Extracorporeal Technology (AmSECT) International Conference
  • Now is the Time for Better Blood Conservation
  • Medtronic Gains Insight into Local Needs during Visits with Clinicians in India and Central and Eastern Europe
  • Medtronic Sponsors Session on Oxygenation System Design Considerations at 2013 AmSECT International Conference
  • Japanese Perfusionists Experience the Art and Technology of Medtronic Perfusion Systems
  • Medtronic Hosts Annual European Conference on Extracorporeal Technology (ECT) Options and Outcomes

 

Medtronic Introduces Affinity Fusion® Oxygenation System to Perfusionists at the 2013 American Society of Extracorporeal Technology (AmSECT) International Conference

John Knoll, Product Development Manager, Medtronic Perfusion Systems 

John Knoll, Product Development Manager, Medtronic Perfusion Systems presents air handling information during the 2013 AmSECT conference.

Medtronic displayed its Affinity Fusion Oxygenation System at the 2013 AmSECT conference, March 28-31, 2013, in Las Vegas, NV. Medtronic development engineers were on hand to discuss the system's development and operation with perfusionists.

Designed for careful blood handling and air management, the Affinity Fusion System's unique design provides perfusionists with many advantages, including:

  • Proactive air handling
  • Enhanced hemocompatibility
  • Improved flexibility and ease of use
  • Oxygenator with integrated arterial filter
  • Expanded heat exchanger and gas transfer capabilities

John Knoll, Product Development Manager, Medtronic Perfusion Systems, gave an in-booth presentation entitled "Air Handling in the Affinity Fusion Oxygenation System" to help perfusionists understand the importance of air handling in an oxygenation system.

"Gaseous micro-emboli (GME) are a cause of neurocognitive deficits associated with tissue ischemia, inflammation and complement activation,1" Knoll told his audience. "The clinical consequences are most damaging if this happens in brain or cardiac circulation since damage there is irreversible."

Knoll reviewed the importance of air handling, the different types of air, and options for handling them. He concluded his presentation by explaining how the Affinity Fusion System's cardiotomy/venous reservoir (CVR) and Affinity Fusion Oxygenator handle air and why this design was chosen.

"Our philosophy for designing the Affinity Fusion CVR was centered on proactive air handling," Knoll said. "To accomplish this, we improved flow dynamics to minimize GME generation by incorporating smooth surfaces, gentle transitions, and eliminating falling or dripping liquid." To eliminate air, the CVR uses:

  • buoyancy to keep air bubbles large
  • defoamers
  • filtration

The Affinity Fusion Oxygenator employs a bubble trap for air handling, which "keeps big air big and removes it before it travels through a bundle. It also eliminates reliance on fibers to remove gross air, since fibers are not designed to remove large bubbles and can become coated with protein during bypass," Knoll noted.

Knoll explained the theory and practice of passive and active air handling, concluding with a description of the graduated packing density design used to maintain even blood flow while accomplishing gas exchange and particulate filtration in the Affinity Fusion Oxygenator.

"There are different types of air and many options for handling it. Medtronic chose a design approach based on sound reasoning and data," Knoll concluded. "We believe our results validate the choices we made and invite perfusionists to see the Affinity Fusion Oxygenation System in action."

For more information about the Affinity Fusion Oxygenation System, contact your Medtronic representative or go to www.fusionoxygenator.com.

Reference

  1. De Somer FMJJ, Vetrano MR, Van Beeck JPAJ, Van Nooten, GJ. Extracorporeal bubbles: a word of caution. Interactive CardioVasc and Thorac Surg. 2012; 995-1002.
 

 

Now is the Time for Better Blood Conservation

For years, most hospitals gave little thought to the amount of blood transfused during surgery, unless there was a shortage. Today, clinical evidence suggests an association between blood transfusions during cardiovascular procedures and longer recovery times, longer hospital stays, and increased morbidity.1-3

Blood transfusions have not only shown to be associated with increased exposure to patient risks, they have also been shown to be linked to increased costs. A recent study compared blood usage at New Jersey's Englewood Hospital, which has practiced blood conservation since 2000, with conventional usage practices at 16 other New Jersey hospitals. It showed a transfusion rate of 10.6% at Englewood Hospital compared to a 42.5% transfusion rate at the other 16 hospitals.4

Hospitals with Blood Conservation

To help clinicians rethink blood management at their hospitals, Medtronic Perfusion Systems developed the Rethinking Blood Conservation (RBC®) Initiative. Based on extensive research, evidence-based practices, and a consultative approach, the RBC Initiative can help hospitals develop customized programs tailored to their specific needs. It is designed to help hospitals:

  • Improve patient outcomes
  • Reduce the length of ICU and hospital stays
  • Minimize blood use-related post-operative complications
  • Reduce costs
Medtronic Empowers Hospitals

Medtronic launched the RBC website on August 5th as an educational resource to support this program. The website provides cardiovascular surgeons, perfusionists, nurses and hospital administrators with the tools necessary to better understand the risks that have been associated with blood transfusions and the potential benefits of blood conservation practices.

On the site, customers will find:

  • Links to published clinical articles on blood conservation that detail studies that have evaluated the risks and costs associated with transfusions.
  • Links to international guidelines published by professional societies, country-level organizations, and international organizations.
  • An overview of how conservation works, utilizing a multi-disciplinary, multi-modality approach.
  • A description of the RBC Initiative – what it is, the role of education and training, how Medtronic technology supports it, and the tools needed to support blood conservation efforts.

They will also find success stories from hospitals that have implemented conservation programs, and the site encourages participants to share their stories. The RBC faculty includes clinical champions from across the care continuum—cardiac surgeons, anesthesiologists, perfusionists, pathologists, nurses and hospital administrators.

Medtronic is committed to helping hospitals learn more about blood conservation strategies and how to implement them. Patients deserve it, hospitals need it, and the evidence supports it. Now is the time for better blood conservation.

If you are interested in learning about blood conservation, visit www.medtronic.com/rbc.

References

  1. Koch CG, Li L, Duncan AI, et al. Morbidity and mortality risk associated with red blood cell and blood-component transfusion in isolated coronary artery bypass grafting. Critical Care Medicine. 2006;34(6):1608-16.
  2. Murphy GJ, Reeves BC, Rogers CA, et al. Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation. 2007;116:2544-2552.
  3. Brown PP, Kugelmass AD, Cohen DJ, et al. The frequency and cost of complications associated with coronary artery bypass grafting surgery: Results from the United States Medicare program. Annals of Thoracic Surgery. 2008;85:1980-7.
  4. Moskowitz DM, McCullough JN, Shandler A, et al. The impact of blood conservation on outcomes in cardiac surgery: Is it safe and effective? Annals of Thoracic Surgery. 2010;90:451-9.

 


 

Medtronic Gains Insight into Local Needs during Visits with Clinicians in India and Central and Eastern Europe

Visits with Clinicians

A multi-functional team from Medtronic observes a perfusionist in India adjusting the flow rate to optimize perfusion product performance for the patient.

During the first quarter of 2013, Medtronic personnel traveled to India, Russia, Serbia, and Romania to gain a deeper understanding of evolving customer needs in each location. "Collaboration is key to innovation at Medtronic," said Kelly Jorgensen, Medtronic Development Manager. "Each year millions of patients and providers benefit from the improved clinical outcomes and greater industry efficiencies our products provide. Although Medtronic has provided products to countries worldwide for many years, patient outcomes and product improvements result from our collaboration with local physicians, perfusionists, clinicians, engineers, and others who are as passionate as we are about advancing medical technology."

In late January, a Medtronic team consisting of an engineer, a marketer, and a clinical specialist traveled to four cities in India to work alongside perfusionists, surgeons, and distributors. "Our goal was to better understand how to innovate specifically for economically challenged markets," Jorgensen noted. India is a multi-faceted region with unique challenges in perfusion therapy, such as awareness, use conditions, affordability, infrastructure accessibility, and a shifting trend toward beating heart procedures. India's ever-changing socio-economic environment further complicates their medical system as hospital management plays an increasing role in the purchasing decision. "Changing healthcare dynamics associated with government-sponsored reimbursement plans for below poverty line patients (BPL plans) puts additional pricing pressures on medical devices like the ones Medtronic offers," noted Dr. Sagar Mahajan, Marketing Manager, Structural Heart, Medtronic South Asia. During the team's visit, customers shared information about the effect of pricing on patients and the programs designed to offer economic alternatives, the impact of product support provided by the local government, and the unique financial awareness of hospital employees. "The information gained from this visit enhances our ability to devise specific solutions to meet the growing needs of our customers in India," Jorgensen said.

In March, a four-person Medtronic team made a two-week visit to Russia, Serbia and Romania, where they interviewed and studied the clinical practices of leading surgeons, anesthesiologists, perfusionists, and spoke with their patients as well. The team examined the perfusion circuits used in these countries, observed different surgical techniques, and asked customers about their needs. An important part of the team's visit included a discussion about patient waiting lists, referral networks, and costs associated with providing care to patients located within and beyond city limits. "This intensive two-week visit provided our team with ideas on how to better interact with customers in Central and Eastern Europe," observed Jorgensen.

Visits with Clinicians

A Medtronic team observes a patient coming off bypass in a Russian OR to gain insight into the types of perfusion circuits used.

Medtronic's Perfusion Initiative aligns with its globalization actions. In the 2013 annual report, Omar Ishrak, Medtronic Chairman and Chief Executive Officer shared that future "key strategies are aimed at tailoring our market development activities, customizing our offerings to meet local demands, creating and enhancing our relationships and partnerships with key local and regional stakeholders, and adapting our distribution models to deliver our products more efficiently."

"Our team appreciated the unique opportunity these customer visits provided," Jorgensen said. "The insight we gained will help Medtronic continue to innovate so that medical professionals around the world can achieve the best possible patient outcomes." 

 


 

Medtronic Sponsors Session on Oxygenation System Design Considerations at 2013 AmSECT International Conference

Medtronic exhibit

Mike Hobday, Senior Program Manager, Medtronic Perfusion Systems, presents the role of design considerations in oxygenation system development at the 2013 AmSECT conference.

At the Medtronic-sponsored breakfast session, Mike Hobday, Senior Program Manager, Medtronic Perfusion Systems, used analogies from everyday life to highlight the many considerations involved in designing oxygenation systems. "I wanted to illustrate the design tradeoffs that have to be made to optimize perfusion product performance for patients," Hobday said.

To better clarify design impact, Hobday reviewed some of the new Affinity Fusion® Oxygenation System's reservoir design considerations, drawing parallels to familiar designs. With each parameter, he pointed out the variables that were considered and balanced to achieve optimal performance.

One example he presented was how the goal of integrated filtration in the oxygenator is to create one device that performs both oxygenation and arterial blood filtration, but each function requires its own unique design. While two separate devices could be harnessed together in a "bolt-on method," this would be unlikely to produce size, volume or weight savings. A truly integrated design must perform both functions while providing cost, size, weight, and volume savings. "Smart phones are examples of devices that integrate multiple functions into a single device—computer, camera, MP3 player, and phone. This was the design paradigm we followed while designing the Affinity Fusion Oxygenation System."

An arterial filter functions as an air handler and a particulate filter. An integrated oxygenator must perform both functions. To accomplish this, Hobday reviewed the design benefits and trade-offs associated with the physical geometry and filtration process, among which are an upfront bubble trap design, particulate filtration options, and additional functions added to existing filtration features.

Hobday concluded by reviewing physical design considerations, including port placement, safety considerations, and holder designs. "This lecture generated a lot of discussion on this topic as evidenced by the level of customer engagement we had in our booth following the talk. It was our goal to educate the perfusion community on the intentional thought process used in our product development efforts as we look to optimize design trade-offs."

For more information about the Affinity Fusion Oxygenation System, contact your Medtronic representative or visit www.fusionoxygenator.com.

 


 

Japanese Perfusionists Experience the Art and Technology of Medtronic Perfusion Systems

Japanese Perfusionists

Perfusionists from Japan visit Medtronic headquarters to share their views and learn more about innovative perfusion solutions.

In late May 2013, Medtronic Perfusion hosted perfusionists from seven Japanese hospitals at its Minneapolis, MN, headquarters as part of the company's focus on customer needs and innovative solutions. The event included discussions on product design and simulated perfusion education in the Medtronic Virtual Cardiac Operating Room (VCOR).

"This important meeting allowed Japanese perfusionists to experience the art and technology of Medtronic perfusion systems," said Chikako Konomi, Senior Product Specialist, Structural Heart Marketing, Medtronic Japan. "We named the program 'Takumi Innovation.' 'Takumi' means 'artisan' in Japanese, so the title represents the tie between the artisan's technique and the innovation of the manufacturer."

During the three-day meeting, the Japanese perfusionists met with marketing personnel, engineers, and scientists. The perfusionists presented information about their cardiac surgery programs, and Medtronic's engineers provided feedback on current products and obtained customer inputs for future product concepts. "These dialogues helped Medtronic management better understand the specific interests and needs of perfusionists in Japan," observed Konomi.

The visiting perfusionists also participated in an oxygenator manufacturing plant tour, which gave them a deeper appreciation of the focus on quality in Medtronic's perfusion technologies. The tour was followed by simulated crisis management training in Medtronic's VCOR. By participating in simulated crises in a safe environment, perfusionists gain insight into appropriate responses to incidents that may occur in every-day clinical settings. It also helps participants analyze the steps they would take and to create a safety checklist for emergency use.

"Our guests were impressed with Medtronic's dedication and focus on perfusion, including our new product design efforts and our vision for the future," Konomi noted. "This program is a great asset that helps customers not only learn more about Medtronic but understand the design concepts that support and drive product development."

"Face-to-face meetings with customers are important to the collaboration that drives Medtronic's innovative solutions," said Tamara Bratland, Global Product Manager, Medtronic Perfusion Systems. "Input regarding our customers' technological needs is very valuable as we strive to develop innovative products and value-driven solutions. We are constantly investigating how to improve our product design to enhance clinical outcomes and our customers' experiences. Meetings like this one give customers the opportunity to share their clinical needs with Medtronic's development teams while showing them our commitment to product quality."

 


 

Medtronic Hosts Annual European Conference on Extracorporeal Technology (ECT) Options and Outcomes

Sant' Andrea Hospital, Rome, Italy

Medtronic hosted their 2013 European Conference on ECT Options and Outcomes at Sant' Andrea Hospital, Rome, Italy.

As part of its ongoing commitment to perfusion, Medtronic hosted its annual European Conference on ECT Options and Outcomes at Sant' Andrea Hospital, Rome, Italy, March 7 – 8, 2013. More than 200 physicians and perfusionists from Europe and the Middle East participated in the conference.

The conference, moderated by Professor Riccardo Sinatra, MD., Chief of Cardiac Surgery, Sant' Andrea Hospital, featured 13 leading anesthesiologists, surgeons, and perfusionists who addressed a broad range of extracorporeal technology topics. Their presentations focused primarily on transfusion and patient parameter monitoring during bypass but other technology-specific topics were discussed as well, including mini bypass, pediatric perfusion, heparin management, gaseous emboli and monitoring, and the quality of perfusion and long-term support with extracorporeal membrane oxygenation (ECMO). Based on the curriculum's scientific merit, ECM and the European Board of Clinical Perfusion (EBCP) awarded educational credits to Italian and international participants, respectively.

Attendees found the presentation made by Ingo Wiese, Chief of Perfusion, Universitätsklinikum, Essen Thorax und Kardiovaskularchirurgie, Germany, of particular interest. Entitled "Investigation of the Affinity Fusion® Oxygenator Performance with Fully Integrated Arterial Filter Using Simulated Blood Sucker Embolization," Wiese's presentation analyzed whether the protein deposits associated with the Affinity Fusion Oxygenator's integrated arterial filter impact the device's gas transfer.

In the study on which his presentation was based, Wiese put emulsified fat into a solution. A particle counter then measured the number of fat particles going into and coming out of the filter. "Our premise was to measure whether the protein deposition caused by the filtration action has an impact on the gas transfer of the device," said Wiese. "If there are fat particles or protein floating into the oxygenator and the oxygenator fibers are providing the filtration, does the oxygenator's filtration action impact the ability of the device to transfer gas?"

Based on the resulting data, Wiese concluded that the filtration action does not affect the gas performance of the Affinity Fusion Oxygenator. Michael van Driel, Marketing Group Manager, Extracorporeal Technologies, Medtronic Europe, observed that, "this was one of the conference's best presentations, based on the audience's questions and the discussions it generated. Participants were enthusiastic about the study's design and its convincing results."

Dr. h.c. Erich Gygax's clinical update on mini-bypass clinical results, entitled "Physiology and Microemboli Performance of Different MECC Systems," also drew considerable interest. Dr. Gygax, Head of Perfusion Services, The Universitäts Klinik, Bern, Switzerland, studied patient outcomes in mini bypass procedures, comparing results from different MECC systems, including the Affinity Fusion Oxygenation System.

Of the study's devices, two had arterial filters attached to the outside. The Affinity Fusion Oxygenator, with its integrated filter, is smaller and requires a lower priming volume. Dr. Gygax's study tested the overall size of the priming volume for each circuit. "We found that the Affinity Fusion device required a much smaller circuit prime of about 500 mL, compared with about 650 mL for the other devices. The lower priming volume helps reduce the need for blood transfusions, which is clinically beneficial to our patients."

"We also compared the air quality and quantity performance of the Affinity Fusion Oxygenator to three other centrifugal and rotary pumps," Dr. Gygax noted. "Our study concluded that the Affinity Fusion Oxygenator gave us an excellent balance between prime volume and the elimination of micro bubbles."

"Every year, attendees at this conference tell us how much they appreciate the focus it gives to perfusion technologies and techniques," said Van Driel. "The presentations build on our past successes and on participant feedback." The Medtronic Options and Outcomes Conference is part of the company's Academia Education and Training Program. Teaming with Sant' Andrea Hospital to present this conference underlines Medtronic's commitment to working with perfusionists and extracorporeal clinicians to deliver innovative perfusion solutions.

Medtronic invites you to attend the 2014 Options and Outcomes Conference, scheduled for May 15-16, 2014, in Rome, Italy. For additional meeting information, contact your Medtronic representative or send your inquiry to sevada.avaksoumbatian@medtronic.com.

For more information about Medtronic products, contact your Medtronic representative. 

Last updated: 5 Apr 2011

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