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Current Newsletter

In this edition:

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

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

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

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

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

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

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

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

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

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

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

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

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

The Affinity CP™ Offers Choices in Centrifugal Pumps

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

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

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

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

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

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

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

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

Autotransfusion Training and Certification

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

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

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

Importance of Blood Conservation

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

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

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

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

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

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

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

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

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

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

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Medtronic Hosts Dubai Conference on Structural Heart Options and Outcomes

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

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

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

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

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

Optimized Bypass

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

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

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

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

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

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

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

Mini-circuit Technologies

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

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

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

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

The Future of On-pump Surgery

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

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

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

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

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

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