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
Medtronic	Carmeda	Y
Medtronic	Trillium	Y
Gish	GBS	Y
Maquet (Jostra)	Bioline	Y
Terumo	Heparin**	Y
Maquet (Jostra)	Safeline	N
Sorin (COBE)	SMARxT	N
Terumo	Xcoating	N

*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.

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

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.

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

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

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

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.

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

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.

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

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

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 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.

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

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

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.

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

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.

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.

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

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.

*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.  

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

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.

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

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.

 

June 2011

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

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.†”

 

 

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.

“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.

†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?
   

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

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.

 

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.

 

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 Core Behaviors 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 Core Behaviors 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.

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

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

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.

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.

October 2011

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

“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?

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.

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

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.