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Perfusion Insider Archives
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?
The Affinity NT® Oxygenator provides consistent, efficient gas transfer with its patented radial flow design.
Conduct a hands-on experiment showing how different fiber-winding patterns impact flow and pressure drop through the radial flow oxygenator. Medtronic's proprietary graduated fiber-winding technique, which is used in Medtronic's oxygenators, will also be shown.
Medtronic's Affinity NT® Oxygenator sets the standard for oxygenation systems by providing consistent, efficient gas transfer due to its patented radial flow design.
• Do You Dare to Pump Air?
Learn how an open reservoir system compares with a closed circuit system using the Affinity® Venous Air Removal Device (VARD). During this demonstration, participants will see how micro air enters the circuit and how the Affinity® VARD Venous Air Removal System removes it.
The Affinity® VARD Venous Air Removal System senses and automatically purges any air from deoxygenated blood that has entered the circuit.
The Affinity® VARD system senses and automatically purges any air from deoxygenated blood that has entered the circuit. Together with the recently approved Affinity® CP centrifugal blood pump, the Affinity® VARD supports blood conservation initiatives.
• Find Your Ideal Solution
See and experience Medtronic's broad line of cannulae options to find your ideal solution. Medtronic cannulae cover a wide variety of clinical needs, including:
- Extracorporeal cannulae designed for optimal flow rates, flexibility, and ease of use while providing the interface between the patient and extracorporeal circuit
- Cardioplegia cannulae that facilitate adequate myocardial protection during CPB
- Suction and support products for clearing the field of debris and providing adequate venting during CPB
- Accessory products that help to facilitate surgeries
A variety of Medtronic cannulae can meet a wide variety of clinical needs.
Collaboration with our customers shapes the future of Medtronic's perfusion, cannulae, and blood management technology and innovation. With continued passion and insight, Medtronic is focusing even more closely on perfusionists and their patients.
For additional information about the products exhibited at CREF or the product theater presentations, contact your Medtronic representative.
- Despotis GJ, et al. The impact of heparin concentration and activated clotting time monitoring on blood conservation. J Thorac Cardiovasc Surg 1995;110:46-54.
- Hill AG, et al. More precise heparin and protamine management during cardiopulmonary bypass. Proceedings of the American Academy of Cardiovascular Perfusion 1990;12-16.
- Despotis GJ, et al. More effective suppression of hemostasis system activation in patients undergoing cardiac surgery by heparin dosing based on heparin blood concentrations rather than ACT. Thromb Haemost 1996;67:2-8
- Bowie JE, et al. Automated management of heparin anticoagulation in cardiovascular surgery. Proceedings of the American Academy of Cardiovascular Perfusion 1985;6:1-5.
Florida Perfusion Society Presentation Focuses on Autotransfusion and Blood Conservation
At the Sanibel Perfusion Symposium, hosted by the Florida Perfusion Society on February 18, 2012, John Rivera, Medtronic Senior Therapy Development Manager, presented "Rethinking Blood Conservation: the Role of Autotransfusion." Rivera's presentation focused on the importance of autotransfusion in blood conservation.
Clinicians may decide to use autotransfusion during a procedure instead of allogeneic blood for many reasons. "Blood continues to be in short supply. The costs associated with its processing, testing, maintenance, and transfusion continue to grow," Rivera told attendees. Published clinical studies have noted that patients receiving allogeneic transfusions have more adverse outcomes and longer lengths of stay than patients who do not receive donor blood.1
Autotransfusion is a complementary activity that supports blood conservation. Other reasons for autotransfusions may include:
- Reduces risk of infection
- Considers religious requirements
- Offers immediate availability
- Conserves allogeneic blood for emergencies
- Eliminates blood bank clerical errors
- Is cost effective
Costs associated with transfusions range from $500 to $1,200 when the direct costs of collecting, testing, processing, storing, monitoring, and transfusing blood are taken into account.2
"Autotransfusion is one of the primary modalilties recommended for limiting allogeneic transfusions," Rivera told attendees. "It is a relatively inexpensive and flexible procedure that is safe, fast, efficient, and easy to implement. Commercially available autotransfusion devices, like Medtronic's autoLog® Autotransfusion System, are highly automated and can be rapidly implemented and deployed. In addition, insurance companies are examining surgical outcomes and have instituted a mechanism for reimbursement known as Pay for Performance or P4P. P4P mandates that hospitals that cannot reduce or control rates of complications run the risk of lower reimbursement payments."
The Society of Thoracic Surgeons, in conjunction with the Society of Cardiovascular Anesthesia, issued practice guidelines in 2007 for Perioperative Blood Transfusion and Blood Conservation in Cardiac Surgery that were updated in 2011. Multiple modalities were identified both in the pre- and perioperative settings that impact the practice of transfusion during cardiovascular surgery.3 The Guidelines are intended to assist physicians and other healthcare providers in clinical decision-making by describing a range of generally accepted approaches for the diagnosis, prevention, and treatment of specific diseases or conditions.
Rivera believes that in the hands of appropriately trained perfusionists, "autotransfusion generates a safe and high-quality packed red cell product. The process is fast and the patient benefit is immediate. Blood is literally recycled, and valuable allogeneic blood supplies are conserved for use with other patients not eligible for autotransfusion."
The fully automated Medtronic autoLog® Autotransfusion System produces a high quality end product with a hematocrit of 50% or greater. Its unique bowl design packs blood tightly to increase the hematocrit and allows blood to enter at a moderate G-force, thereby minimizing hemolysis. The system's design also promotes effective removal of free-plasma hemoglobin, residual anticoagulant agents, activated platelets, white blood cells, and activated clotting factors of 90% or greater in accordance with American Association of Blood Banks (AABB) guidelines.3
Importance of Autotransfusion Quality Control
Various personnel are involved in operating autotransfusion devices. Perfusionists are the primary operators during cardiovascular surgery, but other medical personnel run them in non-cardiovascular cases. All personnel must complete annual autotransfusion training and certification. The American Society of Extracorporeal Technology has created a standardized autotransfusion testing program that can be completed online in a proctored setting. Passing this test accredits the participant as a Perioperative Blood Management Technologist (PBMT).
Validation of all practices and ongoing quality control measurement of autotransfusion devices are mandated by the appropriate regulatory bodies, including the AABB. "Quality control procedures are critical to safe and effective autotransfusion procedures," Rivera told the audience. "Too many clinicians are unaware of the regulatory requirements that need to be followed as defined by the AABB's 4th Edition of Standards, which explicitly identifies the need for frequent testing of blood collected and processed using autotransfusion devices.4 These standards clearly state that the blood must be tested both before and after washing."
The autoLog® Autotransfusion System facilitates autotransfusion that supports blood conservation efforts.
To comply with the standards, Rivera reinforced some of the key requirements for autotransfusion quality control to bring perfusionists into compliance. These include5:
- A required 95% reduction of potassium or plasma protein for washed blood (5.1.2). The collection reservoir must be sampled before processing and compared to the hold bag contents.
- The removal rate for free plasma hemoglobin or residual anticoagulant should be 90%. A clear effluent line is not an adequate indicator of washout.
- In-vitro validation of new devices prior to placing them into use (3.3)
- Establishment of a quality control program that "is sufficiently comprehensive to ensure that reagents, equipment, and methods function as expected" (5.1.2)
- Performance of periodic quality control to assess instrument function and operator competency (5.1.2)
- Identification of a medical director who is a licensed physician and who is qualified by training and/or experience (1.1.1)
"While the AABB standards dictate that periodic quality control testing must be performed, the testing frequency should be determined by each facility," Rivera added.
For more information about autotransfusion and the autoLog® Autotransfusion System, contact your Medtronic representative.
- Koch CG, Li L, Duncan AI, et al. Morbidity and mortalilty risk associated with red blood cell and blood-component transfusion in isolated coronary artery bypass grafting. Crit Care Med 2006;34:1608-1616.
- Shander A, Hoffman A, Ozawa S, et al. Activity-based cost of blood transfusions in surgical patients at four hospitals. Transfusion 2010;50:753-765.
- Ferraris VA, Brown JR, Despotis GJ, et al. 2011 Update to the Society of Cardiovascular Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines. Annals of Thorac Surg 2011;91;944-82.
- Standards for Perioperative Autologous Blood Collection and Administration, 4th Edition, AABB, 2009.
- Guidance for Standards for Perioperative Autologous Blood Collection and Administration. First Edition. American Association of Blood Banks, Sec. 5.1.2, p. 21.
Medtronic India Hosts PerfUtech: A Perfusion Advancements Education Program
Medtronic India continues to demonstrate its commitment to perfusion education by conducting PerfUtech education programs. PerfUtech gives experienced and novice perfusionists the opportunity to learn, interact, and exchange views on recent perfusion advancements.
Dr Anil Tendolkar, Prince AlyKhan Hospital, Mumbai, India, is Director of the PerfUtech Program. He is a reputed cardiac surgeon and professor in India with more than 30 years of experience. More than 500 perfusionists have benefitted from PerfUtech programs held in Mumbai, Delhi, Bangalore, Chennai, and Hyderabad.
These five programs featured more than 40 eminent speakers who shared their experience and perspective on a variety of topics, including extracorporeal membrane oxygenation (ECMO), perfusion in minimally invasive surgeries, blood conservation, and novel cardioplegia techniques. Each presenter focused on innovative approaches and recent perfusion advances aimed at reducing morbidities.
"PerfUtech is an optimal opportunity for Medtronic to demonstrate its commitment to perfusion education and for perfusionists in India to share and learn about new therapies and products," said Sagar Mahajan, Product Manager, Cardiovascular Surgery, Structural Heart Division, Medtronic India. "Attendees are particularly enthusiastic about the interactive sessions, which include case presentations, debates, and 'Surgical Surprises during CPB.'
"PerfUtech is also an excellent forum for Medtronic to showcase its broad perfusion product offerings. Perfusionists can learn the latest information about the Medtronic Rethinking Blood Conservation® Initiative and how our products clinically support a reduction in the use of blood transfusions for improved patient outcomes," Mahajan added.
John Patrick, Clinical Perfusionist, Shri Satya Said Institute of Medical Sciences, Bangalore, India, presents centrifugal pump information at the Bangalore PerfUtech program.
At a recent PerfUtech program, John Patrick, Clinical Perfusionist, Shri Satya Said Institute of Medical Sciences, Bangalore, India, presented information on the use of roller pumps compared to centrifugal pumps and the impact on a patient's blood. "The AFFINITY™ CP Pump is a low prime centrifugal blood pump that gently handles blood, resulting in minimized hemolysis. With few moving parts, the pump's design allows for even blood flow at lower RPMs as well as low shear, resulting in reduced heat generation and low hemolysis," he told the audience.
PerfUtech was developed in collaboration with preeminent physicians and perfusionists in India. By openly sharing their perfusion experiences, clinicians who attend PerfUtech programs learn innovative, topical information that can help them optimize their clinical skills and improve their patient care. For more information about Medtronic's educational programs, contact your Medtronic representative.
Saudi Pediatric Patients Benefit from Medtronic's Affinity Pixie™ Oxygenation and Performer® CPB Systems
Since the summer of 2010, 30 pediatric patients at the King Faisal Specialist Hospital (KFSH) in Jeddah, Saudi Arabia, benefitted from the center's first-time clinical use of three perfusion technologies that are part of Medtronic's ever-expanding portfolio of cardiopulmonary perfusion solutions. Used together, these products – the new Affinity Pixie™ Oxygenation System, the Performer® CPB System, and the BP-50 Bio-Pump® Centrifugal Blood Pump – were part of the cardiovascular surgery team's strategies for achieving the best patient outcomes possible.
"One of our goals as clinical perfusionists is the optimization of critical cases using the best technology and equipment," remarked Faiz Al Malki, chief perfusionist at KFSH-Jeddah. "The Affinity Pixie™ Oxygenation System has been shown to be a very effective system since it requires low prime volume and has a good gas exchange with fast heat exchange. It is truly an optimal design. We think the Affinity Pixie™ Oxygenator is very reliable for a wide range of patient weights. This helps us reduce the need to add blood in the prime and helps to minimize the patient's transfusion risk," Al Malki said.
The Affinity Pixie™ Oxygenation System with Balance™ Biosurface* earned its CE Mark for clinical use in May 2010. Designed for use with a broad range of patients, the system supports approximately 75% of the neonate, infant, and pediatric populations requiring cardiopulmonary bypass.
NOTE: In the United States, Food and Drug Administration
(FDA) 510(k) market clearance for the Affinity Pixie™ System
is pending and the device is not yet available for clinical use.
The Affinity Pixie™ Oxygenation System has a maximum flow rate of 2.0 L/min and a low prime volume of 48 mL. It includes new design elements such as Balance™ Biosurface*, a hydrophilic biosurface without heparin that helps to mitigate the foreign body response occurring when blood comes in contact with the device's artificial surfaces. The Balance™ Biosurface is designed to reduce platelet and cell adhesion and activation.
The Affinity Orbit™ Holder System provides versatile device positioning and port orientation to help reduce circuit tubing length and associated prime volume.
The BP-50 Pediatric Bio-Pump® Centrifugal Blood Pump promotes laminar blood flow by using the constrained, forced-vortex pumping principle in which a series of smooth-surfaced, rotating cones pull the blood into the vortex created by the rotation. The BP-50 Bio-Pump® is the only coated centrifugal pump currently available for pediatric use. The pump is available with Carmeda® BioActive Surface**, which combines excellence in blood handling and biocompatibility.
* Balance Biosurface technology is licensed under agreement from BioInteractions Limited, United Kingdom.
**Carmeda is a trademark of Carmeda AB. Products are coated with Carmeda® BioActive Surface, which is licensed from Carmeda AB for use only as part of an extracorporeal blood circulation system or circuit that includes an oxygenator or blood pump.
As the market evolves and arrested heart cardiac surgery procedures play an increasingly important role, pumping technology must be flexible enough to accommodate the changing needs of the operating room, including the need for:
- Reduced prime volumes
- Advanced mini circuits
- Minimally invasive portal or femoral access surgery
The new Affinity Pixie™ Oxygenation System, Performer® CPB System, and BP-50 Bio-Pump® help offer the best pediatric patient outcomes possible at King Faisal Specialist Hospital.
The Performer® CPB system is designed to meet these evolving perfusion needs.
With operating room space at a premium, the Performer® CPB System occupies one- third the space (20" x 22" [50 cm x 56 cm]) of traditional heart lung machines in use today. It can be configured for pediatric cases using the BP-50 Pediatric Bio-Pump® and a quarter-inch Bio-Trend® Probe in the venous line for in-line saturation and hematocrit monitoring.
"We are quite pleased with the recent advances in perfusion and our renewed commitment to our perfusion customers," said Moussa Srour, Business Director of Cardiovascular for Medtronic Middle East/Africa Region. "The Affinity Pixie™ Oxygenation System is a great start that reinvigorates our product line, and we expect even bigger steps in the future."
Use of HMS Plus Hemostasis Management System Enhances South African Hospital's Blood Conservation Efforts
Today's perfusionists need to incorporate better heparin management as a tool for blood conservation during cardiopulmonary bypass (CPB) surgery. Noel Gibson, Clinical Perfusionist, Unitas Netcare Hospital in Centurion, Gauteng, South Africa, believes the Medtronic HMS Plus Hemostasis Management System is a vital tool for accomplishing this.
"As a consequence of HIV and other blood-borne diseases, blood has become extremely expensive and difficult to cross-match in South Africa. More and more screening measures must be employed to ensure blood is safe. It's important for us to use tools that help reduce the amount of blood usage and eliminate blood transfusions where possible. If we can do this by managing the patient intraoperatively with the HMS Plus System, then I think we will achieve our goal of lower blood usage," said Gibson.
"We traditionally used heparin as a way of getting the patient's ACT level above a certain value. Now, with the HMS Plus System, we realize that it's not just a heparin management tool but also a heparin and ACT management system. It's a real-time ACT device. You can see exactly how long it takes for the blood to clot. I have also found that it is more accurate than other devices I have used. We can give patients adequate heparin with a good ACT and see exactly what the heparin and ACT levels are," Gibson continued.
Gibson believes that less blood is used during procedures when the HMS Plus device is employed since the patients tend not to bleed as much. "And, if they do bleed, we know that it's not because of residual heparin, but rather it's a coagulation problem. The HMS Plus System is a good tool for blood conservation as it helps us maintain adequate hemostasis," Gibson noted.
HMS Plus Hemostasis Management System Provides Heparin and Protamine Management
The HMS Plus Hemostasis Management System is a reliable, versatile, and effective platform for accurate heparin and protamine management,1 resulting in lower procedural and operational costs.2- 4 By providing information about the individual patient's response to heparin, the HMS Plus System determines the appropriate dose for the patient so that the needed anticoagulant and antithrombotic effect can be achieved.
Clinical studies have documented patient benefits associated with improved hemostasis management, including:
- Fewer complications associated with excessive blood loss1
- Preservation of the coagulation system, resulting in fewer transfusions2
- Fewer surgical reoperations,3 thereby decreasing associated costs
South African Hospital uses HMS Plus Hemostasis Management System in blood conservation efforts.
Medtronic Perfusion Systems remains the pioneer and leader in providing both a heparin dose response test and the only point-of-care heparin assay for individualized heparin and protamine management.
For more information on the HMS Plus Hemostasis Management System, contact your Medtronic representative.
- Despotis GJ, et al. The impact of heparin concentration and activated clotting time monitoring on blood conservation. J Thorac Cardiovasc Surg 1995;110:46-54.
- Hill AG, et al. More precise heparin and protamine management during cardiopulmonary bypass. Proceedings of the American Academy of Cardiovascular Perfusion 1990;12-16.
- Despotis GJ, et al. More effective suppression of hemostasis system activation in patients undergoing cardiac surgery by heparin dosing based on heparin blood concentrations rather than ACT. Thromb Haemost 1996;67:2-8
- Bowie JE, et al. Automated management of heparin anticoagulation in cardiovascular surgery. Proceedings of the American Academy of Cardiovascular Perfusion 1985;6:1-5.
April 2012 Product News
- 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.
- 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.
Medtronic Sponsors Autotransfusion Training at the Washington State Assembly of the Association of Surgical Technologists' Spring Conference
John Rivera, Medtronic Senior Therapy Development Manager presented a training program on autotransfusion and its role in blood conservation at the Spring Continuing Education Conference of the Washington State Assembly (WSA) of the Association of Surgical Technologists (AST), held March 10-11, 2012, in Renton, Washington.
Approximately 250 anesthesia technicians and surgical technologists attended the conference, where, for the first time, formal instruction on the practice of autotransfusion and its role in blood conservation was offered. "I believe that with this presentation, Medtronic has spoken at every meeting of eligible personnel responsible for autotransfusion, including perfusionists, anesthesiologists, anesthesia technicians, surgeons, nurses, and blood bank or laboratory personnel worldwide," Rivera said. "This is important because, while perfusionists are the primary providers of autotransfusion services during cardiac surgery, they"re not routinely available to perform autotransfusion procedures in other surgical specialties. Hospitals must rely on qualified health care professionals other than perfusionists for this service."
Prior to this meeting, Rivera conducted a two-day autotransfusion education program for 20 students at the Renton School of Anesthesia Technology at Renton Technical College. This was the first time that extended autotransfusion training was offered to this medical specialty. "Having met John at a previous American Society of Anesthesia Technicians and Technologists Meeting (ASATT), I was excited about the opportunity to include autotransfusion training as part of our curriculum and to share John"s expertise with our students. The feedback following the program was very positive," said Gary West, RODP, Anesthesia Program Director, Renton Technical College.
Autotransfusion Training and Certification
Because autotransfusion devices are shared among surgical specialties, written policies and procedures detailing consistent use practices in all settings are critical. Rivera told the audience that, to accomplish this, it is important for perfusionists to maintain a high level of visibility in all blood management activities, including interfacing with laboratory personnel to ensure autotransfusion quality control testing.
Perfusionists have established uniform autotransfusion credentialing requirements through the Perioperative Blood Management Technologist (PBMT) exam. Anyone who frequently operates an autotransfusion device is eligible to take this exam, which is available for proctored online testing through the American Society for Extracorporeal Technology (AmSECT) and the International Board of Blood Management (IBBM).
"Personnel running autotransfusion devices must have annual training and recertification or they are out of compliance with the AABB's 4th Edition of Standards.1 Medtronic supports this training by offering a self-guided autotransfusion education program," said Rivera. Interested perfusionists and other personnel may contact their Medtronic representative for more information about this training.
Importance of Blood Conservation
Rivera began his autotransfusion training program by reviewing the key factors that drive blood conservation: blood shortages, blood cost, and patient safety. He then outlined and explained the practice guidelines that the Society of Thoracic Surgeons (STS), in conjunction with the Society of Cardiovascular Anesthesia (SCA), issued in 2007 and updated in 2011 for perioperative blood transfusion and blood conservation in cardiac surgery. The 2011 Guidelines also were written with input from several members of the International Consortium of Evidence Based Perfusion (ICEBP). Those Guidelines identify multiple modalities in both pre- and perioperative settings that impact the practice of transfusion during cardiovascular surgery.2 The Guidelines' goal is to establish a consistent practice of transfusion during cardiovascular surgery.
"I believe awareness of the STS Guidelines and their recommendations for blood conservation are important for all surgical specialties," Rivera told attendees. "Autotransfusion is a complementary activity that supports blood conservation but a multi-modality approach is the most comprehensive plan."
Rivera reviewed published clinical studies that document higher levels of adverse outcomes and longer lengths of stay for patients receiving allogeneic transfusions as compared to patients who do not receive donor blood.3
Acknowledging that autotransfusion is an important factor in blood conservation, Rivera reviewed other reasons why it may be considered:
- Reduced risk of infection3
- Religious considerations
- Immediate availability
- Conserves allogeneic blood for emergencies
- Eliminates blood bank clerical errors
- More cost effective4
"Autotransfusion is a key modality for limiting allogeneic transfusions. It is relatively inexpensive, and it is a flexible procedure that's safe, fast, efficient and easy to implement. Commercially available autotransfusion devices, such as Medtronic's autoLog® Autotransfusion System, are highly automated and can be rapidly implemented and deployed," Rivera told attendees.
"Blood recovered with autotransfusion devices does not make the patient bleed. The washed RBC's are literally the best red blood cells that can be transfused to a patient," Rivera noted.
Rivera concluded by summarizing the role of autotransfusion in blood conservation. "Allogeneic blood is in very short supply and its costs continue to increase. In addition, transfused patients experience more adverse consequences," Rivera reiterated. "The STS Guidelines provide clear directives regarding blood conservation, with a new emphasis on perfusion-based practices. They also recommend a multi-modality approach for high-risk patients that includes autotransfusion. For all of these reasons, it is imperative that autotransfusionists be appropriately trained and credentialed. The bottom line is that blood conservation is both a good clinical program and good business practice."
For autotransfusion, Medtronic offers the fully automated Medtronic autoLog® Autotransfusion System, which produces a high quality end product with a hematocrit of 50% or greater.5 The system's design also promotes effective removal of free-plasma hemoglobin, residual anticoagulant agents, activated platelets, white blood cells, and activated clotting factors of 90% or greater in accordance with AABB guidelines.4
For more information about the autoLog® Autotransfusion System and Medtronic's Autotransfusion Education Program, contact your Medtronic representative.
- Standards for Perioperative Autologous Blood Collection and Administration, 4th Edition, AABB, 2009.
- Ferraris VA, Brown JR, Despotis GJ, et al. 2011 Update to the Society of Cardiovascular Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines. Annals of Thorac Surg. 2011;91;944-82.
- Wiefferink A, Weerwind PW, van Heerde W, et al. Autotransfusion management during and after cardiopulmonary bypass alters fibrin degradation and transfusion requirements. J Extracorporeal Technology 2007;39:66-70
- Koch CG, Li L, Duncan Al, et al. Morbidity and mortality risk associated with red blood cell and blood-component transfusion in isolated coronary artery bypass grafting. Critical Care Medicine. 2006;34(6):1608-16
- The above data is from in vitro research using bovine blood. Clinical data may vary significantly.
Medtronic Hosts Dubai Conference on Structural Heart Options and Outcomes
Clinical evidence shows that technologies and surgical techniques for treating structural heart disease, including the use of mini-bypass circuits, continue to positively impact patient outcomes.
A number of factors drive clinicians' need to define post-operative outcomes associated with cardiac surgery:
- The absence of conclusive outcome data comparing off-pump versus on-pump procedures
- The implementation of more aggressive interventional cardiology procedures results in older cardiac surgery patients presenting with more complex pathologies
- The need for improved patient outcomes in on-pump procedures
To help clinicians address these issues, Medtronic hosted the "3rd Structural Heart Options and Outcomes" meeting, February 9-10, 2012, in Dubai, United Arab Emirates (UAE). The conference attracted over 150 participants from 24 countries in the Middle East and Africa.
While much of the conference addressed heart valve technologies and associated outcomes, other factors impacting patient outcomes were also touched upon.
Optimized Bypass
Michael Van Driel, Marketing Group Manager, Extracorporeal Technologies, Medtronic Europe, gave a presentation on "Optimized Bypass and The Future of On-pump Surgery" that included evidence that blood shortages, the cost of blood, and associated risks of blood transfusions are key reasons clinicians need to rethink their approaches to blood conservation. Major cardiac surgery and anesthesia societies, such as The Society of Thoracic Surgeons (STS)/Society of Cardiovascular Anesthesiologists (SCA), have published blood conservation guidelines. The STS/SCA Guideline Recommendations, updated in 2011, state that "a multi-modality approach involving multiple stakeholders…will limit blood transfusion and provide optimal blood conservation for cardiac operations."1
Van Driel reviewed clinical study results comparing blood transfusion rates between a miniaturized bypass circuit and conventional cardiopulmonary bypass (CPB).2 The study's authors found a 27% overall reduction in transfusion rates when a mini-bypass circuit was used versus conventional CPB (63% vs. 36%; p<.001).
To improve patient outcomes, it is important to reduce the impact of the extracorporeal circuit on the patient. One option Medtronic offers perfusionists is the Resting® Heart System – a safe, easy-to-use mini-bypass circuit. Patient benefits3 associated with this extracorporeal circuit include:
- Less postoperative blood loss
- Lower transfusion rate
- Earlier extubation
"Optimized perfusion incorporates a multimodality approach towards improving patient outcomes and reducing patient morbidity," Van Driel told the audience. Select aspects of this approach with varying levels of clinical evidence1 include:
- Use of mini-circuits – reduced priming volume and hemodilution
- Use of vacuum-assisted venous drainage
- Use of biocompatible CPB circuits
- Use of centrifugal pumps because of perfusion safety features
- Retrograde autologous priming of the CPB circuit
- Separation of suction blood from aspirated blood
"The perfusionist can take several steps to significantly reduce priming volume," Van Driel noted. "For example, eliminating the venous/cardiotomy reservoir permits the patient to become the reservoir while the perfusionist uses a soft-shell bag to manage the patient's blood volume. Use of a centrifugal pump for active venous drainage is also important as is the integration of the system into one combined unit."
Mini-circuit Technologies
Mini-circuits are an important practice improvement step within the overall quality improvement process for hospitals adopting new techniques and technologies to improve patient outcomes. Closed circuit use has been clinically demonstrated to reduce patient complications.4 Closed systems are more physiological and biocompatible," Van Driel told the audience. Medtronic's Affinity® Venous Air Removal Device (VARD) is an example of a de-airing device that can be incorporated into a circuit, permitting the use of active venous drainage systems or closed systems in gravity drainage. As an enabling technology, it permits the use of closed systems in an extracorporeal perfusion circuit.
With the Affinity® VARD, circuit systems can be customized for improved air handling in a miniaturized circuit. The Affinity® VARD system senses and automatically purges air from the deoxygenated blood in the circuit. The Resting® Heart System or perfusion custom packs that include the Affinity® VARD give perfusionists more options for circuit design. Together with the Affinity CP™ centrifugal blood pump, the Affinity® VARD reduces priming volume, a major goal for perfusionists who support blood conservation initiatives.
Biocompatible surfaces, such as Carmeda® BioActive Surface and Balance™ BioSurface, are another important choice for the perfusionist to consider when designing a blood conservation program. Carmeda® BioActive Surface is a durable, non-leaching End Point Attached heparin biocompatible surface technology that enhances blood compatibility and provides thromboresistant blood-contacting surfaces for CPB circuit devices. It has the largest body of peer-reviewed clinical and scientific evidence of any biocompatible surface used for CPB devices today.
Balance™ Biosurface is a hydrophilic polymer for cardiopulmonary bypass (CPB) circuit coating that contains no heparin and reduces platelet adhesion and activation and preserves platelet function. "The availability and choice that these two biocompatible surface options offer demonstrates Medtronic's commitment to perfusion solutions. These biocompatible surface options expand the comprehensive strategy possibilities available to cardiovascular surgery teams," Van Driel noted.
The Future of On-pump Surgery
"While a mini-circuit is ideal for CABG, revascularization or aortic valve repair/replacement, complex surgeries that involve heavy bleeding and an increased need for perfusion cannot be handled by a small circuit," Van Driel said. "In these instances, patient benefits must be realized by changing the surgical technique rather than the perfusion technique. To help achieve these benefits, surgeons are adopting minimally invasive techniques that incorporate thoracotomies, mini-sternotomies, port access, robotics and sutureless heart valves."
These procedures are performed through placement of a cannula in the femoral artery of the patient's leg. "Medtronic's Bio-Medicus® Femoral Cannulae, designed for placement in either the femoral vein or artery, offer clinicians the versatility needed to meet the needs of minimally invasive cardiac procedures as well as the changing patient population," Van Driel told the audience. "This cannula's unique, flat, wire-wound, thin-walled construction maximizes flow rates and cannula flexibility."
Medtronic also offers clinicians a Retrograde Coronary Sinus Perfusion (MiRCSP) cannula and introducer system. This technology facilitates trans-atrial placement into the coronary sinus with access through a thoracotomy or mini-sternotomy. This unique cannula provides the maneuverability and visibility required for minimally invasive cardiac surgery (MICS) procedures.
"There was a time when perfusionists could use one perfusion approach for all patients. But patient benefits and improved outcomes associated with mini-circuits and MICS are changing this paradigm. Medtronic's commitment to perfusion solutions ensures that we will continue to advocate for minimally invasive approaches that include mini-circuits, blood conservation, and surgical-based therapies," concluded Shawn Monaghan, Vice President, General Manager, Surgical-based Therapies for the Medtronic Structural Heart business. "This conference demonstrates our commitment to partnering with perfusionists and extracorporeal clinicians to deliver innovative perfusion solutions to help their hospitals lower transfusion rates and enhance patient outcomes."
Medtronic sponsored the "Structural Heart Options and Outcomes" as part of its Academia Education and Training Program. For more information about Medtronic products, contact your Medtronic representative. To learn more about Medtronic's Rethinking Blood Conservation® Initiative, go to http://www.medtronic.com/rbci/ or contact your Medtronic representative.
- STS Blood Conservation Guideline Task Force: Ferras VA, Brown JR, Despotis GJ, Hammon JW, Reece B, Sha SP, et al; SCA Special Task Force on Blood Transfusion: Shore-Lesserson LJ, Goodnough LT, Mazer, CD, Shander A, Stafford-Smith M, Waters, J.; Intl. Consortium for Evidence Based Perfusion: Baker, RA, Dickinson, TA, FitzGerald DJ, Likosky DS, Shann, KG. 2011 Update to The Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines. Ann Thorac Surg. 2011;91:944-82.
- Harostock M 3rd, Filler JJ, Burak DA McDonnell BE, Emilcar J, et al. Comparison of Transfusion Requirements for Conventional and Miniamturized Extracorporeal Circuits. Heart Surg Forum. 2008;11(3): E188-92.
- Sakwa M, Emery R. Coronary artery bypass grafting with a minimized cardiopulmonary bypass circuit: A prospective, randomized trial. The Journal of Thoracic and Cardiovascular Surgery. Feb 2009; Volume 137, Number 2, pp 481- 485.
- 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.
June 2012 Product News
In this edition:
- Memory of Frank Griemsmann Honored by Medtronic Colleagues and New York Perfusion Community
- Simulated Aorta Model Improves Training Fidelity in Medtronic's Virtual Cardiac Operating Room
- Medtronic and the University of Minnesota Hospital and Clinics Conduct Cardiovascular Surgery Crisis Management Simulation Program
- Medtronic Named One of America's Best Corporate Citizens
- Medtronic Among Top 50 Companies for Diversity
Memory of Frank Griemsmann Honored by Medtronic Colleagues and New York Perfusion Community
On June 14, 2012, Frank Griemsmann's Medtronic colleagues and the greater New York City perfusion community joined his family to honor him and share their memories. Frank passed away on April 3, 2012.
Frank represented Medtronic Perfusion Systems' products in the New York area for over 25 years. According to all who knew and worked with him, Frank was the consummate professional. He dedicated himself to making sure his customers received the service they deserved and the products they needed. "Frank never forgot that there was a patient on the receiving end of each product he sold," recalled Jeanne Stanislawski Hutson, Medtronic Product Manager. "He was methodical in selling our products and making sure every customer had a good experience. He always knew exactly the right person to contact within Medtronic to help resolve a customer issue. And everyone was eager to help Frank when he needed help with a customer issue."
"Frank was known for his professionalism, style, class and integrity. His customers trusted him every bit as much as his colleagues did within Medtronic. The sales force really respected him." said Gary Celo, Medtronic Perfusion Sales Representative.
According to Susan Vlahakis, C.C.P., Chief Perfusionist, Bellevue Hospital Center, New York, "Frank was always there when you needed him. I met him in 1990 when I was a young and very junior member of the Mt. Sinai Hospital staff. Despite my junior status, Frank always treated me like a valued customer, even though I had no say on product selection. He was always friendly and everyone who knew Frank, from perfusionists to surgeons, had a great respect for him.
"As time went on, I became a Senior Perfusionist at Mt. Sinai and eventually the Chief at Bellevue Hospital. Frank was there every step of the way. He would do whatever was necessary to get products to me on time if I needed something on short notice. When I went to him with even a minor problem, Frank would be outraged. He was an advocate for me in every way. He was at all times ethical and devoted to Medtronic's products. He never spoke disparagingly about competitors. That wasn't his style. He believed in his products and always gave me accurate information. Frank's legacy to the perfusion community will be how well he treated all his customers. Whether you were a large or small account, he was an incredibly decent person."
Anatole Kanevsky C.C.P., Chief of Perfusion, Westchester Medical Center, NY, met Frank in 2007. "I have been in perfusion for almost 20 years and have dealt with many sales reps during that time," said Kanevsky. "Frank was one of a kind. Very genuine and never the typical salesman. He called or stopped by almost every week – not to sell anything but to see how my team and I were doing. Frank was one in a million, and he will be missed. I do not think anyone can take his place."
Katherine Cousineau, Chief Perfusionist at Englewood Hospital and Medical Center, Englewood, NJ, added, "The perfusion community lost more than a sales representative. They lost a friend and one of their biggest allies when it came to perfusion equipment and technology. Frank was a man with the utmost integrity. Always there for his clients at a moment's notice, he was efficient and thorough in his knowledge, making sure he clearly understood what his customers needed. I am fortunate to have worked with him over the past 22 years and know that he will be missed by all."
Frank's colleagues at Medtronic will miss him as well. Our heartfelt condolences go out to his wife and family.
Simulated Aorta Model Improves Training Fidelity in Medtronic's Virtual Cardiac Operating Room
The synthetic aorta model with arterial cannula and aortic cross-clamp during delivery of antegrade cardioplegia.
Creating simulated cardiac tissue that feels, behaves and sutures like live tissue is an ongoing clinical training challenge. Perfusionists, surgical residents and cardiac surgeons agree that when it comes to simulated training, the greater the fidelity, the more effective the training experience will be. In an ongoing effort to improve simulated training fidelity, Medtronic worked with LifeLike BioTissue to develop an aorta model.
"Medtronic is always looking for ways to enhance the simulated training experience we offer cardiac perfusionists and surgeons," said Mark Bearss, Medtronic Cardiopulmonary Education Program Manager. "I worked with tissue modeling company Lifelike BioTissue to create an aorta that is thin and has a realistic feel for use in our training programs. The modified model connects to our Orpheus™ Perfusion Simulator*, which creates a realistic pulsatile arterial blood pressure in the aorta. There is enough flex in the model's material that it creates the realistic 'feel' of a patient's aorta."
LifeLike BioTissue provided a 2.5-3 mm thick by 25-30 mm diameter model. Several surgical fellows who used the model during a training session at Medtronic's Virtual Cardiac OR agreed that it was a great teaching device. "They all thought that it felt authentic and that it held sutures like a real aorta," Bearss noted. "Since it lacks the supporting structures of real anatomy, the model is harder to cannulate, but it still provides the ability to demonstrate and practice procedures rather than just talking about them." Clinicians who have used this aorta model find they can do nearly everything to it that can be done to a native aorta, with the exception of creating an aneurysm or a false lumen.
Medtronic and Lifelike BioTissue are exploring the possibility of developing a model with a pericardial reflection and a right atrium to further advance the hands-on realism for surgical trainees. "Medtronic's Virtual Cardiac OR is a valuable tool for team training on crisis management techniques and for training cardiovascular fellows, residents, employees and perfusion students on cardiopulmonary bypass techniques. Providing a more realistic simulation through the use of the aorta model is one more way to improve the training experience," Bearss added.
To learn more about Medtronic's Virtual Cardiac Operating Room, click here to view the video. For more information about Medtronic Academia Medical Education, contact your Medtronic representative. For information about LifeLike BioTissue, visit www.lifelikebiotissue.com
* Orpheus is a trademark of Ulco Technologies
Medtronic and the University of Minnesota Hospital and Clinics Conduct Cardiovascular Surgery Crisis Management Simulation Program
Kris Nielsen, CCP, Director of Perfusion Services, University of MN Hospital and Clinics, Fairview, MN, debriefs the cardiac surgeon fellows and perfusionists following a simulated crisis management training session.
In April 2012, the University of Minnesota Hospital and Clinics, Fairview, MN, together with Medtronic, conducted a simulated crisis management training program that focused on perfusion and surgeon teamwork. Kris Nielsen, CCP, Director of Perfusion Services at the University of Minnesota Hospital and Clinics, brought a team of ten perfusionists and four cardiovascular surgery fellows together over the course of three days. In order to accommodate everyone's busy schedules, the four-hour crisis scenarios were repeated five times during the three days.
Mark Bearss, Medtronic Cardiopulmonary Education Program Manager, noted that the simulated scenarios focused on perfusionist-surgeon communication as a way to define a procedure for crisis recognition and management. "Both perfusionist and surgeon must understand that a crisis is happening and how to manage it. Team dynamics and training are key elements to solving these kinds of problems. Ideally, the team develops a 'best practice' for handling crises. The beauty of this simulation program was that participants came to the realization that they needed to cooperate to develop a workable crisis scenario plan. They couldn't successfully do it alone," Bearss said.
The simulation training took place in Medtronic's Virtual Cardiac OR, where a synthetic aorta was recently added to allow surgeons to suture, cannulate, and make connections in the chest. Medtronic's ability to replicate a customer's perfusion set-up also makes the simulation as realistic as possible. "The objective of any simulation exercise is to test a clinician's knowledge of perfusion, not their ability to adapt to unfamiliar equipment," Bearss commented. Nielsen agreed, adding, "It was extremely helpful to duplicate our circuit set-up in the simulation lab so we didn't waste time and effort on things that are different than what we use on a daily basis. I highly recommend this approach."
"The idea for this training was sparked by an actual near miss incident," Nielsen said. "In that case, we managed the situation clinically and the patient was fine, but I wanted to find a way to prevent a repetition."
The incident forced Nielsen's team to think about how their methods and procedures could be improved. "When you operate successfully on thousands of patients without incident, it's easy to believe you're doing everything as safely as possible – until something happens," Nielsen observed. "The Medtronic simulation lab allowed us to duplicate the incident exactly as it happened. We went through our entire protocol and determined precisely what occurred. From there, we developed an improved procedure for handling an event like this."
Crisis simulation program incorporates hands-on training and debriefing
During the program, each group was confronted with a crisis scenario. Immediately after managing the "emergency," they debriefed, compiling a list of the procedural aspects they felt needed to be reconsidered. "The debriefings encouraged dialogue between surgeons and perfusionists," Nielsen noted. "Group members suggested methods in which the successful crisis procedure could be effectively recalled should a similar crisis actually occur. They also assessed whether a better, more efficient and effective way to handle each crisis scenario could be implemented since there are many ways to produce the same outcome.
"The surgeons focused on what they should be doing during particular portions of procedures. For example, when the perfusionist is doing retrograde cerebral perfusion, what can the surgeon do to expedite returning the patient to regular bypass? It's important to listen, to get other people's ideas and try to incorporate them into a protocol." The hands-on crisis simulation and subsequent debriefings prompted the team to revise policies and procedures for about 10 scenarios.
Kris Nielsen (left), CCP, Director of Perfusion Services, University of MN Hospital and Clinics, Fairview, MN, works with Dr. David Odell during a simulated acute aortic decannulation.
Simulation mirrors reality
The first crisis scenario closely mirrored reality in that it was unplanned. The arterial cannula flew out of the simulated aorta. "OK team, this can really happen. What do we do?" Nielsen asked. The team listed action steps for a beating heart scenario, then listed how those steps would differ in a non-beating heart scenario. "After taking the needed steps to replace the cannula, the group stopped to analyze their actions, resulting in a defined procedure for each team member. It turned out to be a very good learning situation."
Another scenario the team faced was an oxygenator that stopped working. They were challenged to identify if it was, in fact, a true oxygenator failure or a changing clinical scenario. They then discussed whether to change it out and, if so, when and how. "This is one of the more common scenarios perfusionists and surgeons need to practice since they both need to be involved," said Bearss. "The timing of an oxygenator failure determines the course of action. Is it before cross clamp, before or after cardioplegia? Is the patient warm or cold? Decision trees have to be developed and the entire team needs to be aware of what's happening. The advantage of a simulation lab is that the 'crisis' happens in a safe environment so everyone can practice their technique development and get their crisis checklist down pat."
Following the training program, Nielsen updated his policy and procedures and emailed them to the participating surgeons for review. Nielsen suggested to those surgeons who were just finishing their training that they take the procedures developed during this session to their new hospitals and share them with their new perfusion groups as a way to compare protocols, identify differences, and refine procedures. "Usually, the basic premises are the same from one group to another, but there may be nuances that need to be changed. Simulation training and written protocols are good methods for people to confirm and verify that they're doing the right things in a crisis situation," Nielsen noted.
Michael Bradner, MD, Cardiothoracic Surgery Fellow, University of Minnesota, Fairview, a surgeon participant, found that practicing disaster scenarios with his perfusionists and identifying each person's role was an important part of the session. "I thought it was valuable to have the entire team there to simulate the crisis, particularly from a communications skills standpoint," Bradner said. "The team aspect of the training will help us work better together since we all want to do what is in the best interest of the patient. If we train for a crisis, then hopefully we will be able to alleviate any adverse outcomes associated with it should it ever really happen."
Simulated crisis management training in Medtronic's Virtual Cardiac OR is another example of Medtronic's commitment to cutting-edge customer education and training. For more information about Medtronic Academia Medical Education, contact your Medtronic representative.
Medtronic Named One of America's Best Corporate Citizens
Corporate Responsibility magazine ranked Medtronic 50th among America's best corporate citizens in the publication's recently released top 100 list. On last year's list, Medtronic ranked 66th.
"Good corporate citizenship is an important part of our Mission," said Omar Ishrak, Medtronic Chairman and Chief Executive Officer. "We're proud of our accomplishments in this area, particularly the significant steps we've taken in transparency and citizenship performance in philanthropy, environmental stewardship, inclusion and good corporate governance. We are pleased to see our progress recognized on the list of the top 100 Best Corporate Citizens."
Corporate Responsibility bases its ratings on publicly available information regarding a company's policies and actions relating to the environment, climate change, human rights, employee relations, philanthropy and financial and corporate governance. Within these seven social responsibility categories, the publication considers 318 separate elements to arrive at their final rankings. The list is recognized as one of the nation's top acknowledgments of corporate responsibility.
"The corporate citizenship movement began more than 30 years ago in Europe when companies began focusing on environmental responsibility," said Ginny Cassidy, Medtronic Corporate Citizenship Consultant. "Since then, that focus has broadened to include not only how companies impact the environment but also their impact on, employees, customers, business ethics, and broad social issues, such as human rights and global health."
Medtronic's corporate citizenship approach
Earl Bakken, Medtronic's founder, set the tone for the company's corporate citizenship approach 50 years ago when he stated its Mission was to "alleviate pain, restore health, and extend life" and "to maintain good citizenship as a company." Medtronic's corporate citizenship vision is two-fold:
- To operate responsibly in all facets where our business intersects with society, and
- To leverage our resources, assets, and expertise to catalyze dramatic improvement in the lives of those affected by chronic disease.
In 2008, Medtronic shareholders asked the company to issue a corporate citizenship report using the Global Reporting Initiative™ (GRI) framework as a guide for reporting. Medtronic's Mission Statement and the GRI framework define the focus of its citizenship pillars:
- Global Leadership in Addressing Chronic Disease
- Collaborative Culture of Innovation
- Responsibility in the Marketplace
- Total Employee Engagement
- Progressive Environmental Stewardship
Global leadership in addressing chronic disease initiative
"It's generally expected that companies should strive to be good corporate citizens, but there's a corporate responsibility trend that goes beyond this expectation," Cassidy noted. Companies such as Medtronic are combining their business expertise with government, academic, and nonprofit organizations to affect global society positively. They see that the world faces enormous problems that governments and society cannot handle alone. These corporations are finding ways to help solve social issues by engaging on different levels.
As part of the company's Global Leadership in Addressing Chronic Disease initiative, Medtronic and the Medtronic Foundation established the Medtronic Global Non-communicable Disease (NCD) Initiative. The Global NCD Initiative will enable Medtronic to "leverage its corporate assets – product, people and philanthropy – to maximize the business and social impact of efforts to combat NCDs."1
Each year, more people die from cancer, diabetes, lung and heart disease than from any other cause. Categorized as non-communicable diseases, these conditions account for 75% of global health care spending.1 Medtronic's expertise in treating heart disease and diabetes positions the company to help alleviate the worldwide effects of these conditions.
The Global NCD Initiative's strategy focuses on strengthening health systems, contributing to global policy and advocacy, and continuing innovation in therapy and healthcare delivery. "With these strategies, we can make a real difference," Cassidy observed. "The Global NCD Initiative is a signature program that aligns with Medtronic's Global Leadership in the Addressing Chronic Disease pillar and allows us to engage in a meaningful way around our core competencies as a medical technology company."
Medtronic is also recognized in several other corporate citizenship ratings, including the 2011 Newsweek Green Rankings (ranked 55th) and 2012 Forbes America's Most Reputable Companies (ranked 28th). Recognizing its leadership in meeting the needs of economic, environmental, and social stakeholders, Medtronic, Inc. was also named a member company in the Dow Jones Sustainability World Index (DJSI World) and the FTSE4Good Index Series. The DJSI World lists the top 10 percent of the largest 2,500 companies in the Dow Jones Global Total Stock Market. Medtronic was the largest addition to the 2011 DJSI World index as measured by market capitalization.
To learn more about Medtronic's corporate citizenship programs, visit www.medtronic.com/about-medtronic/corporate-citizenship. For more information about the Medtronic Global Non-communicable Disease Initiative, go to www.medtronic.com/ncd.
- Medtronic creates shared value with strategy for disease battle, The Corporate Citizen. 2011(6): 10-13.
Medtronic Among Top 50 Companies for Diversity
For the first time, Medtronic is ranked in the 2012 DiversityInc Top 50 List. DiversityInc, a leading source of diversity management information in the U.S., brings education and clarity to the business benefits of diversity. At number 38, Medtronic joins a prestigious group of organizations that link diversity management with fostering nimble and innovative cultures. "We are honored to receive this recognition as an inclusive, global workplace that encourages employees to be themselves and to be engaged in their work," said Michele DeSmet, Vice President of Global Inclusion, Diversity and Engagement. As an additional achievement, Medtronic placed fourth on DiversityInc's Top 10 Companies for Asian Americans.
Medtronic's diversity commitment is driven by its Mission "to improve the lives of others." Through inclusion, diversity and engagement, Medtronic innovates for life. "I am personally committed to guiding our continued growth as a diverse and inclusive organization, where employees are engaged and focused on executing the Medtronic Mission," said Chairman and CEO Omar Ishrak.
"We come together from all parts of the world, leveraging our diverse perspectives, backgrounds, cultures and generations to fulfill our Mission," added Caroline Stockdale, Medtronic Senior Vice President and Chief Human Resources Officer. "As a world leader in medical technology, Medtronic is committed to global diversity and inclusion in our workplace."
Medtronic creates a GIDE strategy for diversity
During fiscal 2012, Medtronic applied a new diversity strategy that recognizes the global nature of Medtronic's business and the importance of integrating inclusion, diversity and engagement into its business practices. This strategy, known as GIDE (global inclusion diversity engagement), charges the company's leaders, managers, and employee groups/networks to accelerate the results.
The strategy's implementation begins at the executive level with the formation of a global Inclusion Advisory Group. In addition, business- and geography-led inclusion coalitions were formed to address unique cultural perspectives, demographics, and the needs of customers and markets in all parts of the world. Employee-driven, company-sponsored networks and resource groups enable employees to connect with others who share similar cultures, identities and interests. These groups and networks provide professional development, networking support and opportunities to participate in recruiting, retention, mentoring, and community outreach.
Employee resource groups strengthen relationships
"Building personal and professional relationships is important," said Tonia Shupien, Medtronic Senior Program Manager, Global Inclusion, Diversity and Engagement. "We offer numerous Employee Resource Groups (ERGs) to help employees with common backgrounds or affiliations to connect and network." Recently a global women's network was initiated. "This network will support local women's employee resource groups and allow women across the company to have a global voice, which will ultimately benefit our patients and customers. The global network will focus on improving Medtronic's ability to attract, develop, and retain employees and to accelerate the advancement of women."
Medtronic Perfusion Systems participates in Project SEARCH
Project SEARCH is an example of Medtronic's push to be an inclusive employer. Project SEARCH is a one-year, business-led educational internship program for students with disabilities in their last year of high school eligibility. A team that included Medtronic's Perfusion Systems business was recognized for their support of this unique program, which, in turn, led to the first internships at Medtronic for these young adults.
The program, which partners with school districts and social service agencies, is for students with disabilities whose post-school goal is competitive employment. "Both Medtronic and the Project SEARCH students benefit from this program," said Val Nauth, Medtronic Perfusion Systems Manufacturing Manager. "It gives us access to a new, diverse talent pool and it helps support our community. The potential long-term impact is that more people with disabilities will achieve competitive employment, and more businesses will be prompted to access this under-utilized talent resource."
Medtronic Perfusion Systems celebrates diversity
Medtronic Perfusion employees come from 56 countries and are emblematic of Medtronic's diversity, its customers, and the communities they live in. During May 2010, David Varden, Medtronic Perfusion Systems Production Supervisor, held a Diversity Festival to celebrate this diversity. During the festival, many activities highlighted the varied backgrounds of Perfusion employees. Employees decorated Medtronic's Brooklyn Park, MN, headquarters with the flags of their 56 home countries and translated "good morning" and "good evening" into the 18 languages spoken there. They hosted an International Potluck so everyone could share the universal love of food and created a museum that displayed a wide range of cultural and historical items from employees' native countries.
"The Diversity Festival generated noticeable energy and truly enhanced employee engagement for all involved," Varden said. "I believe all of the Perfusion employees recognized the diversity of personal worth at the festival's conclusion."
Medtronic's business is as diverse as their customers. "We need to have a workplace that reflects the diversity of our customers and our business," CEO Ishrak stated. "This also provides us an opportunity to have multiple varieties of ideas. Diversity breeds differences and differences of opinion breed a better and more innovative business culture."
September 2012 Product News
In this edition:
- Medtronic's Partnership with Italy's Lombardy Region Helps Deliver Quality Healthcare
- Medtronic Teams with University of Washington Regional Heart Center to Sponsor RBC Evaluation Program
- Medtronic Affinity Pixie Oxygenation System Successfully Used at High Altitude in South Africa
- Medtronic Perfusion Participates in the Thoracic Surgery Directors Association's Fifth Annual Cardiothoracic Boot Camp for Residents
- Medtronic in the News
- Medtronic Supports Perfusion Education Around the World
Medtronic's Partnership with Italy's Lombardy Region Helps Deliver Quality Healthcare
In April, a team of Medtronic executives that included Omar Ishrak, Medtronic Chairman and CEO, and Luciano Frattini, Medtronic Italy's Regional Vice President, met with Italy's Lombardy Region and its president to discuss how using Medtronic technologies could help the region deliver higher-quality healthcare.
During the meeting, partnership roles were discussed and clinical areas where Medtronic technologies could help deliver sustainable, quality health care were identified. The talks led to creation of the O.R.M.E. (Outcomes, Research, Medtech, Efficiency) Global Project, which will study seven disease areas:
- Blood management in cardiac surgery
- Resistant hypertension
- Syncope
- Diabetic foot
- Atrial fibrillation
- Degenerative spine disorders
- Sudden cardiac death
Lombardy is one of 20 regions in Italy, with one-sixth of Italy's population. "Among Italy's biggest healthcare concerns is how to maximize the budget return for healthcare," Frattini said. "Italy's current focus is on ensuring that budgeted money is spent appropriately, especially with the austerity measures being implemented here."
"For a project of this scope to benefit the entire region, Lombardy officials are seeking a partner with a broad product offering, since they want to consolidate suppliers," added Michael Van Driel, Medtronic European Group Marketing Manager. "They want to avoid dealing with a different company for each separate need. With Medtronic's broad cardiac surgery product portfolio, hospitals can work with one representative for needs as diverse as blood management, anti-coagulation management, perfusion circuits, and cannulae."
Blood Management in Cardiac Surgery
"Whole blood and blood components for transfusion are vital, but limited, resources in Italy, particularly in cardiac surgery," noted Laura Maglio, Perfusion Marketing Product Specialist, Medtronic Italy. "In Milan, Lombardy's capital, over 38 percent of the 12,000 units of packed red blood cells transfused annually come from outside of Milan. Countrywide, more than 11,400 daily blood component transfusions (red blood cells, platelets or plasma) were administered in 2010. In 2009, more than four million patients received whole blood transfusion therapies. Because the need for plasma greatly outpaces the supply, Italian healthcare systems must either purchase it from sources outside of Italy or acquire expensive pharmacological substitutes."1
"Another reason Medtronic was selected for this project is our unique Rethinking Blood Conservation (RBC)® Initiative, which helps hospitals focus on the need for blood conservation in cardiac procedures," added Van Driel. "It was an advantage to have an established program like this in place that includes a multi-modality approach to help hospitals conserve blood, improve patient outcomes and reduce the financial burden of blood-use-related complications."
As part of the O.R.M.E. project presentation, Maglio reviewed the need for blood conservation in cardiac surgery, noting three key factors:
- Blood shortages, associated with complex surgeries and low donation rates
- Patient safety risks, associated with blood transfusion
- Increasing blood costs, related to additional required safety measures
The blood management component of the O.R.M.E. project will measure and compare the consumption of donor blood products as well as the postoperative outcomes associated with various blood management techniques and their associated costs. Scheduled to begin in September 2012, the project will study blood management at 12 hospitals throughout Lombardy. Within each hospital, a team that includes a cardiac surgeon, a perfusionist and an anesthesiologist will lead the process. During the initial six-month phase, the teams will review their hospitals' current processes and blood product usage to identify technique and technology gaps that, if addressed, would potentially conserve blood usage and benefit patients. The final six-month phase of the project will occur after implementation of the updated blood conservation measures. At the conclusion of the one-year study, the hospitals will do another assessment to determine if these changes made a difference in their blood product usage, patient outcomes and costs.
"Medtronic has spent the past decade studying alternatives and designing equipment to help cardiac teams avoid transfusions," Maglio concluded. "Everyone involved with the blood management portion of the O.R.M.E. project believes that patients deserve the benefits of better blood utilization, and hospitals value the information that the study's cost/quality metrics will provide."
- Saturni V. All About Blood (Tutto sul sangue). Associazione Volontari Italiani Sangue (AVIS), Regionale Lombardia. 24 March 2011.
Medtronic Teams with University of Washington Regional Heart Center to Sponsor RBC Evaluation Program
Clinical evidence continues to show that blood transfusions during cardiovascular procedures adversely impact patient outcomes. Published studies document that transfusions lead to increased morbidity, longer recovery times, longer hospital stays, and increased mortality.1,2 To help hospitals address this growing concern, Medtronic developed the Rethinking Blood Conservation® (RBC) Evaluation Program in conjunction with the University of Washington Regional Heart Center, Seattle, WA, a center of excellence for blood conservation.
"The RBC Evaluation Program is designed for cardiac teams and introduces practices and perspectives intended to lead to fewer blood transfusions. Medtronic gives visiting cardiac teams a look at the devices and techniques that have helped reduce blood usage. We've arranged for faculty from the University of Washington Regional Heart Center in Seattle, WA, to provide clinical practices instruction and give their perspectives on blood conservation," said Mary Muecke, Senior Program Manager, Medtronic Perfusion Systems.
With monthly programs starting in November, the two-day course will be led by a faculty under the direction of Gabriel S. Aldea, MD, Professor and Chief of Adult Cardiac Surgery, University of Washington Regional Heart Center (UWARHC). The course is designed for cardiac OR teams, including cardiac surgeons, perfusionists, anesthesiologists, post-op ICU nurses, data managers and executive-level administrators.
"The RBC Evaluation Program is structured as a team learning experience. We believe it to be imperative that the cardiac OR team participate in discussions about the practice changes necessary to reduce blood usage," noted Dr. Aldea.
To enhance the productivity of this evaluation program, Dr. Aldea developed a pre-audit form for participants to complete before they arrive. "This information gives me a better understanding of the blood usage protocols participants currently employ. I'm then able to focus the course and discussions on the needs of the attending hospital," Dr. Aldea said.
The RBC Evaluation Program demonstrates Medtronic's ongoing commitment to helping clinicians realize their blood conservation goals. "We foster an ongoing dialogue with our customers so that we can share with them the new blood management trends and techniques in cardiac surgery," said Denise Steinbring, Director of Marketing, Medtronic Perfusion Systems.
"Team involvement and communications are key to the success of blood conservation initiatives. The discussions that take place during this course help the entire team – cardiac surgeon, perfusionist, anesthesiologist, and cardiac nurse – better understand how a coordinated, protocol-driven multidisciplinary approach can help reduce blood transfusions and lead to better patient care," said Craig R. Vocelka, Chief, Perfusion Services, University of Washington.
While participating in the RBC Evaluation Program, cardiac teams view didactic presentations and participate in informal discussions focusing on better blood management. They also observe a cardiac procedure during which key practice techniques and technologies intended to reduce the need for transfusions are demonstrated, including:
- Closed heparin bonded circuits and centrifugal arterial pumps
- Reduced anticoagulation during coronary artery bypass graft (CABG) procedures
- Separation of suction blood
- Precise heparin and protamine dosing
- Collection, concentration and washing of autologous blood
For more information about the RBC Evaluation Program, contact your Medtronic representative.
- Koch CG, Li L, Duncan AI, et al. Morbidity and mortality risk associated with red blood cell and blood-component transfusion in isolated coronary artery bypass grafting. Crit Care Med. 2006;34:1608-16.
- Brown PP, Kugelmass AD, Cohen DJ, et al. The Frequency and Cost of Complications Associated with Coronary Artery Bypass Grafting Surgery: Result from the United States Medicare Program. Ann Thorac Surg. 2008;85:1980-7.
Medtronic Affinity Pixie Oxygenation System Successfully Used at High Altitude in South Africa
Since July 2011, pediatric cardiac surgery using the Medtronic Affinity Pixie® Oxygenation System has been successfully performed at the Unitas Netcare Hospital in Centurion, Gauteng, S. Africa, which is located about 5,000 feet (1,500 m) above sea level. Oxygen gas transfer during cardiopulmonary bypass procedures at high altitude can be particularly challenging.
"We first used the Affinity Pixie Oxygenation System on a straightforward ventricular septal defect (VSD) case. The patient weighed six and a half kilograms and was on bypass for about 35 minutes. The oxygenator performance was fantastic. The oxygen transfer and CO2 off-load were quite efficient and the case went very well," said Noel Gibson, Clinical Perfusionist, Unitas Netcare Hospital.
In the past, Gibson has experienced problems with oxygenators underperforming at high altitude. At higher altitudes, oxygenators, including small oxygenators designed for use with pediatric patients, may transfer gas less efficiently.
"I am concerned about gas exchange when I begin to use a new oxygenator," said Gibson. "Over time I've found that oxygenators may have performance issues. For example, they may not transfer oxygen the way I want, and they don't blow off CO2 as efficiently as I'd like. Consequently, I usually have to make significant adjustments in FiO2 or gas flow to compensate."
Since the Affinity Pixie Oxygenator was new to Gibson, he decided to use it first for a shorter cardiopulmonary bypass procedure in support of a less complex surgical repair to experience its performance. Subsequent cases were longer and involved more complex surgical procedures.
The second case was performed on an infant weighing just over 5 kg, who was undergoing an atrial ventricular canal repair with a cardiopulmonary bypass time of approximately 100 minutes. The third case was a challenging reoperation on a one-year-old child, who weighed 6.8 kg and was diagnosed with an aortic outflow tract obstruction with a severely stenotic root. An aortic root replacement procedure with a homograft was performed. The bypass duration was 197 minutes with an aortic cross clamp time of 130 minutes. "The patient did exceptionally well and had an uncomplicated postoperative period. The Affinity Pixie System performed far beyond my expectations," said Gibson.
"Before using the Affinity Pixie Oxygenator, I thought we might have a problem with efficiently cooling or warming the patient, considering how small the heat exchanger was. But it worked very well," Gibson said.
"In each instance, I found that the Affinity Pixie Oxygenation System performed well, giving me the confidence to use it at high altitude, where it performed incredibly well," Gibson commented.
Delivering Performance and Flexibility for Your Smallest Patients
The Affinity Pixie Oxygenation System with Balance® Biosurface earned its CE Mark in May 2010. In the United States, it received Food and Drug Administration (FDA) 510(k) market clearance in September 2012. It delivers performance and versatility for neonates, infants and small children requiring cardiopulmonary bypass at flow rates up to 2.0 L/min. With a low prime volume of just 48 mL, the Affinity Pixie System can be used to support approximately 75% of the neonate, infant and pediatric population requiring cardiopulmonary bypass.
"It's important that perfusionists have confidence in the cardiopulmonary bypass technologies they use for their youngest and smallest patients. Oxygenator performance is critical, even more so when the device will be used at high altitude," said Wendy Svee, Global Product Manager, Perfusion Systems, Medtronic. "Additionally, it's especially beneficial when pediatric technologies can support a wide range of patient sizes and also are easy to set up and operate."
The Affinity Pixie Oxygenation System in use at Unitas Netcare Hospital, Centurion, Gauteng, South Africa
The Affinity Pixie Oxygenation System features quick setup with custom device positioning and orientation, adapting to any pump setup. Design advancements include the Affinity Orbit® Holder System, which provides flexibility in device positioning and port orientation to help reduce circuit tubing length and associated prime volume. The oxygenator and reservoir are available with two biocompatible surface options:
- Carmeda® BioActive Surface,* a durable, non-leaching End Point Attached heparin coating that provides thromboresistance and enhanced blood compatibility.
- Balance Biosurface,** a hydrophilic biosurface option without heparin that reduces platelet activation and adhesion.
The Affinity Pixie Oxygenation System is the newest development in Medtronic's overall program to develop a range of innovative perfusion products to support surgery for children and adults. For more information about the Affinity Pixie Oxygenation System, contact your Medtronic representative.
* Products are coated with Carmeda BioActive Surface, which is licensed from Carmeda AB for use only as part of an extracorporeal blood circulation system or circuit that includes an oxygenator or blood pump.
** Technology licensed under agreement from BioInteractions, Limited, United Kingdom.
Affinity Pixie, Affinity Orbit and Balance are registered trademarks of Medtronic, Inc. Carmeda is a registered trademark of Carmeda AB.
Medtronic Perfusion Participates in the Thoracic Surgery Directors Association's Fifth Annual Cardiothoracic Boot Camp for Residents
On July 26-29, 2012, the Thoracic Surgery Directors Association (TSDA) held its fifth annual Boot Camp for cardiothoracic residents. Developed by TSDA and funded by an educational grant from the Joint Council on Thoracic Surgery Education, Inc. (JCTSE), the program gives participating residents training in five cardiothoracic surgical areas: cardiopulmonary bypass (CPB), anastomosis, open lobectomy, bronchoscopy/mediastinoscopy, and aortic valve surgery, including a mini-session on aortic root replacement.
Forty residents attended this year's program, which was conducted by more than 30 volunteer faculty members and guests who donated their time and expertise. As with prior Boot Camp programs, one of the guest experts was Mark Bearss, Medtronic Education and Training Program Manager. Together with Ed Darling, MS, CCP, Associate Professor of CHP-Cardiovascular Perfusion, SUNY Upstate Medical University, Syracuse, NY, Bearss assisted in the perfusion simulation portion of the course using the Orpheus™ Perfusion Simulator* together with a heart-lung machine. In this setting, a perfusionist facilitates a hands-on, problem-solving simulation to teach residents how to manage the fundamentals of cardiopulmonary bypass. Over the two-and-a-half day course, residents participated in numerous simulated CPB case scenarios. At the end of the Boot Camp, resident participants found the training to be excellent and "an extremely valuable experience."
TSDA's Boot Camp was developed five years ago to better train residents in key aspects of cardiopulmonary bypass. Designed by James I. Fann, MD (Stanford University Medical Center), Richard H. Feins, MD (University of North Carolina), and George L. Hicks, Jr., MD (University of Rochester), this intensive course addresses the needs emerging in CT surgery residency programs. The simulators used during the cardiac and thoracic sessions give the residents experience and hands-on practice in basic CT operating skills.
By teaching basic CT operating skills, residents are better prepared when they enter the operating room in their home programs. "Boot Camp is an impressive program that teaches residents the basics of CPB, including troubleshooting, recognizing and responding to CPB emergencies and practicing aortic and atrial cannulation techniques," Darling said. "With simulation, residents experience each step in the process of a patient going on and coming off CPB. With the different crisis management scenarios we designed to hone the residents' problem-solving skills, they come away from Boot Camp better prepared for the realities of a cardiac OR."
TSDA Boot Camp participants learn important problem-solving techniques during CPB crisis simulation. (Photo courtesy of Thoracic Surgery Directors Association)
"Enhancing residents' proficiency in perfusion technology and CPB helps ensure the best possible clinical care in the OR and is an important part of Medtronic's continued commitment to leadership in medical education," noted Bearss.
Through program sponsorships like the TSDA CT Surgery Boot Camp and Medtronic's Academia education and training programs, clinicians strengthen their understanding and experience with the goals of expanding treatment options and improving patient care. For more information about Perfusion Academia, go to http://www.perfusion.medtronic.com/perfusion-equipment-education.html.
For more information about the TSDA's annual Boot Camp for CT surgery residents, visit www.tsda.org.
* Orpheus is a trademark of Ulco Technologies.
Medtronic in the News
A global leader in medical technology, Medtronic strives to improve and extend the lives of millions of people around the world through its efforts to alleviate pain and restore health. This commitment is reflected in ongoing activities throughout the corporation, such as helping underserved areas of the world promote sustainable cardiac care and instilling "green and lean" as a corporate culture. Medtronic's initiatives were recently recognized in a number of local and national news stories, which are summarized here.
Medtronic Ranks 28th on Forbes "America's Most Reputable Companies" List
An article published recently in Forbes, entitled "America's Most Reputable Companies," highlights the results of research conducted by Reputation Institute, a private research and consulting firm that evaluated consumer perceptions of the 150 largest companies in the U.S. familiar to consumers. Reputation Institute assigned scores to the companies based on four indicators: trust, esteem, admiration, and good feeling. It then analyzed seven dimensions of corporate reputation, including workplace, governance, citizenship, financial performance, and leadership. They found that a company's image or reputation "trumped product perceptions in driving behaviors."1
Medtronic was ranked 28th on the list, one-tenth of a point behind 3M. General Mills, Kraft, and Johnson & Johnson topped the list.
Medtronic Foundation Awards $230,000 Grant to Children's HeartLink for Pediatric Cardiac Care in India
In July, the Medtronic Foundation awarded a $230,000 grant to Children's HeartLink for growing and improving cardiac programs over the next two years in its partner sites in India. Children's HeartLink is a nonprofit organization that partners with healthcare centers in underserved regions of the world to promote sustainable cardiac care for children with heart disease.
"The world has turned its attention to non-communicable diseases (NCDs) such as cardiovascular disease and diabetes... diseases that collectively kill more people each year than any other cause of death. India is not immune to this ever-growing threat," said Dr. Jacob Gayle, Vice President, Medtronic Community Affairs and Executive Director of the Medtronic Foundation. "By supporting the important work of organizations such as Children's HeartLink, Medtronic hopes to improve access to crucial diagnosis and treatment options in India and elsewhere."
Enterprise Minnesota Features "Leaner and Greener" Medtronic Perfusion Systems
The June issue of Enterprise Minnesota Magazine stated that "instilling green and lean as cultural cornerstones helps manufacturers realize significant savings, attract top talent, and keep one step ahead of the competition."2 The article cites a number of manufacturers, including Medtronic, who have implemented green practices for cost savings and efficiency.
Janice Tobin, Senior Operations Manager, Medtronic Environmental, Health and Safety Department, said Medtronic's lean and green culture is driven by both internal and external forces. "Our employees, customer base and shareholders have asked for it. Most important, it is linked to our mission... to ensure we are good citizens to a wide variety of stakeholders. With more than 38,000 employees and annual sales topping $15 billion, those requests inspired the implementation of a companywide sustainability policy in 2006."
Medtronic Perfusion Systems employees have a sustainability council that oversees initiatives to reduce waste and examine discarded waste to devise ways in which it can be reused or recycled more efficiently. Today, 52 percent of the industrial waste created at Medtronic Perfusion Systems' manufacturing site in Brooklyn Park, MN, is reused or recycled. That's up from 27 percent six years ago.
Read more about leaner and greener initiatives.
- Smith, J. America's Most Reputable Companies. Forbes. April 4, 2012.
- Lahouze A., Enterprise Minnesota Magazine. Leaner and Greener. June 2012.
Medtronic Supports Perfusion Education Around the World
Committed to perfusion, Medtronic supports education programs around the world. Please see the list below of recent and upcoming cardiovascular perfusion, surgery and anesthesia meetings supported by Medtronic. We invite you to visit the Medtronic exhibit at future meetings and look forward to seeing you!
December 2012 Product News
In this edition:
- Medtronic Launches New Affinity Fusion® Oxygenator with Balance® Biosurface at the 2012 European Board of Perfusion and European Association for Cardio-thoracic Surgery Annual Meetings
- Medtronic Gains FDA Clearance for New Infant and Pediatric Cardiopulmonary Bypass Surgery Oxygenation System
- FDA Grants Clearance for New Medtronic Affinity® AF100 Arterial Filter
- Medtronic to Launch eManual Website
- Medtronic Academia to Host Annual 2013 European Options and Outcomes Conference in Rome
- Medtronic Collaborates with Caribbean and Latin American Perfusion Leaders on Education
- Medtronic in the News
- Medtronic's John Rivera Honored with the American Society of Anesthesia Technologists and Technicians' (ASATT) Regional Educational Award
- Meeting Sponsorship
Medtronic Launches New Affinity Fusion® Oxygenator with Balance® Biosurface at the 2012 European Board of Perfusion and European Association for Cardio-thoracic Surgery Annual Meetings
Customers actively engaged in demos and discussions with Medtronic development engineers at the Fusion Experience Center.
Medtronic launched its new Affinity Fusion® Oxygenator with Balance® Biosurface in Europe during the 2012 European Board of Perfusion (EBP) and European Association for Cardio-thoracic Surgery (EACTS) Annual Meetings in Barcelona, Spain, October 28th - 30th. This system, which received the Conformité Européenne (CE) Mark in September, incorporates innovations for increased patient safety and ease of use, including enhancements designed to prevent air bubbles from entering the blood during a procedure.
"These meetings provided a great opportunity for perfusionists to experience the Affinity Fusion Oxygenator first-hand," said Tamara Bratland, Global Product Manager, Medtronic Perfusion Systems. Approximately 250 people took advantage of Medtronic's Fusion Experience Center during the two Barcelona meetings. "We held 12 sessions in eight languages, so we were able to provide customers an experience that was specific to their needs." The Experience Center workshops provided a detailed overview of the Affinity Fusion Oxygenator features, followed by wet labs where customers could simulate using it as:
- an open system with a centrifugal pump
- an open system with a roller pump
- a closed circuit with reservoir bag
- a mini-circuit combined with a Venous Air Removal device (VARD)
"The Affinity Fusion Oxygenator's design is fundamentally different from previous designs," Bratland noted. It provides perfusionists with a true advancement in adult oxygenation technology, including:
- improved flexibility and ease of use
- proactive air handling
- integrated arterial filter
- unique design for hemocompatibility
- expanded heat exchanger and gas transfer
"We are excited about the European launch of the Affinity Fusion Oxygenator," said Denise Steinbring, Director of Perfusion Marketing, Medtronic Structural Heart. "More than 500 perfusionists worldwide provided Medtronic with their input on the design for this system." The result is an adult oxygenator that uniquely fuses clinical insight with engineering expertise to provide perfusionists with 79 design enhancements. "Perfusionists are very excited and have told us that Medtronic has once again raised the bar for perfusion product performance."
The Affinity Fusion Oxygenator is not currently available in the United States. An application for clearance with the US Food and Drug Administration (FDA) has been submitted.
For more information about the Affinity Fusion Oxygenator, go to www.fusionoxygenator.com.
Medtronic Gains FDA Clearance for New Infant and Pediatric Cardiopulmonary Bypass Surgery Oxygenation System
Affinity Pixie® Oxygenation System receives FDA clearance for neonate, infant and pediatric cardiopulmonary bypass surgery.
On October 26, 2012, Medtronic announced US Food and Drug Administration (FDA) 510(k) clearance and the first US clinical use of its new Affinity Pixie® Oxygenation System. "The system's advancements offers a range of children for which it can be used, and make setup and use easier for perfusionists," noted Denise Steinbring, Director of Perfusion Marketing, Medtronic Structural Heart.
The Affinity Pixie® Oxygenation System was first used in the United States at Advocate Christ Medical Center in Oak Lawn, IL. It gained its CE (Conformité Européenne) Mark in May 2010 and is used in over 50 countries worldwide.
With a maximum flow rate of 2.0 L/min and a low oxygenator prime volume of just 48 mL, the Affinity Pixie® System can be used to support a broad range of the neonate, infant and pediatric population undergoing cardiopulmonary bypass. Both the oxygenator and reservoir are coated with either Carmeda® BioActive Surface,* a non-leaching, End Point Attached heparin biosurface, or Balance® Biosurface,** a hydrophilic biocompatible surface option without heparin. The system features the Affinity Orbit® Holder System for flexibility in device positioning and port orientation to help reduce circuit tubing length and associated prime volume.
Approximately 25% of the 36,000 infants born each year in the United States with congenital heart disease require invasive treatment within the first year of life,1 and some require additional procedures as they grow older. Due to advances in medical care, infants born with congenital heart defects are living longer and healthier lives. Today an estimated one million adults in the United States are living with a congenital heart defect.2
"Medtronic is committed to investing its resources to provide successful therapies to underserved populations, including pediatric patients," said John Liddicoat, M.D., Senior Vice President, Medtronic and President of the Structural Heart business. "The Affinity Pixie® Oxygenation System is the latest innovation in Medtronic's expanding portfolio of products for pediatric cardiac patients, which includes transcatheter pulmonic valves, cannula products, arterial filters and temporary pacing leads."
The Affinity Pixie® Oxygenation System is another example of Medtronic's commitment to advancing the treatment of cardiovascular disease through collaboration with leading clinicians, researchers and scientists worldwide. For more information about the system, go to www.affinitypixie.com.
- American Heart Association – 2012 Congenital Cardiovascular Defects Fact Sheet
- http://www.cdc.gov/ncbddd/heartdefects/facts.html
* Carmeda is a trademark of Carmeda AB. Products are coated with Carmeda® BioActive Surface, which is licensed from Carmeda AB for use only as part of an extracorporeal blood circulation system or circuit that includes an oxygenator or blood pump.
** Balance Biosurface technology is licensed under agreement from BioInteractions, Limited.
FDA Grants Clearance for New Medtronic Affinity® AF100 Arterial Filter
The Affinity® AF100 Filter with Balance® Biosurface provides perfusionists with maximum performance and a 100mL prime volume
On December 7, 2012, Medtronic received US Food and Drug Administration (FDA) 510(k) clearance for its new Affinity® AF100 Arterial Filter with Balance® Biosurface*, which provides maximum performance while reducing prime volume by 50%.
"The device's advancements demonstrate Medtronic's continued dedication to providing perfusion products that reduce prime volume while enhancing performance," noted Denise Steinbring, Director of Perfusion Marketing, Medtronic Structural Heart. "The Affinity AF100 filter follows last year's launch of the Affinity® CP centrifugal pump, which also decreases prime volume by 50%."
"The Affinity AF100 gives perfusionists everything they expect from an arterial filter in addition to an instant prime volume savings of 112 mL as compared to the Affinity® Arterial Filter," said Tamara Bratland, Senior Product Manager, Medtronic Perfusion. Along with its low 100 mL prime volume, the Affinity AF100 provides:
- Ease of prime
- Efficient air handling
- Low pressure drop
- Gentle blood handling
The Affinity AF 100 features Balance® Biosurface, which is a hydrophilic biosurface option without heparin. It reduces platelet activation and adhesions while preserving platelet function.1
This system is one more example of Medtronic's commitment to perfusion solutions. For more information, contact your Medtronic representative.
* Balance Biosurface technology is licensed under agreement from BioInteractions, Limited, United Kingdom
Medtronic to Launch eManual Website
Customers can soon access perfusion, diagnostic, and blood management product manuals on a 24/7 basis by going to www.manuals.medtronic.com.
To address the growing demand for 24/7 access to product manuals, Medtronic will launch its redesigned eManual website (www.manuals.medtronic.com) in January. The revamped site will include perfusion, diagnostic, and blood management Instructions for Use (IFU) and User Manuals. Content will be added weekly until the site library is completed later in 2013.
"To ensure a user-friendly site redesign, we conducted usability studies with physicians, nurses, and technologists," said Tim Stanley, Graphic Design Manager, Medtronic CardioVascular Technical Communication. "Customers were asked to click through the site to find the manuals they needed. They then provided us with suggestions about how the site could be made more user-friendly. Based on their input, we redesigned the site so users can find a manual by model number (eg, BBP211, BBP242, CBP211, BBP241), product name (eg, Affinity Pixie, Affinity Orbit), or by manual document number."
Currently, only the United States and Canada have approved electronic labeling, which allows Medtronic to provide electronic manuals in place of printed IFUs shipping with the product. In the US, eLabeling is approved for every product line. In Canada, it is approved only for in vitro diagnostic (IVD) and Class IV devices, which include implantables, their accessories and other devices of substantial medical importance. In March 2013, the European Union (EU) plans to approve eLabeling for implantable devices, their accessories, and fixed capital products (products that cannot be moved from room-to-room). Medtronic CardioVascular will continue to include printed IFUs with most products. These documents will not be removed from any products shipped to countries where printed labeling is required by local regulations.
"Despite varying country documentation requirements, customers have made it clear to us that they need 24/7 access to IFUs. Medtronic's eManual website gives customers ready access to needed manuals," Stanley added.
When customers first access the site, a screen will appear asking for their language preference. US customers are given a choice of English, French, Italian, German, or Spanish. On the following page, customers can enter the product model number, if known, or the product name. After the customer enters the first few letters of the product name, a "type-ahead" drop-down list will appear. From this list, the customer can select the desired product. When the product name is highlighted, a link to the manual appears.
The eManual website is another example of Medtronic's ongoing commitment to perfusionists. For more information about perfusion products, contact your Medtronic representative.
Medtronic Academia to Host Annual 2013 European Options and Outcomes Conference in Rome
As part of Medtronic's ongoing commitment to perfusion, Medtronic Academia will again host the annual European Options and Outcomes Conference at Sant'Andrea Hospital, Rome, Italy, March 7 - 8, 2013. Last year's conference attracted over 150 participants from Europe and the Middle East.
Professor Riccardo Sinatra, MD., Chief of Cardiac Surgery, Sant'Andrea Hospital, will moderate a scientific program lead by 13 leading practitioners in anesthesia, surgery, and perfusion. Topics featured at the 2013 program will include:
- Initial European clinical experience with the Affinity Fusion® Oxygenation System
- Pediatric cardiopulmonary bypass using the Affinity Pixie® Oxygenation System
- Individualized heparin and protamine management using the HMS Plus Hemostasis Management System
- Blood conservation strategies associated with the Affinity™ VARD and Performer™ CPB System
- Non-invasive monitoring and real-time data acquisition with the Spectrum System M*
- Gaseous microemboli minimization during cardiopulmonary bypass procedures
Medtronic sponsors the Options and Outcomes Conference as part of its Academia Education and Training Program. Teaming with Sant'Andrea Hospital to present this conference demonstrates Medtronic's commitment to working with perfusionists and extracorporeal clinicians to deliver innovative perfusion solutions. "During last year's Conference, attendees appreciated the focus given to perfusion technologies and techniques. The 2013 Conference will build on the success we had last year and will incorporate the feedback we received," said Michael van Driel, Marketing Group Manager, Extracorporeal Technologies, Medtronic Europe.
Medtronic invites you to attend the 2013 Options and Outcomes Conference. For additional meeting and registration information, contact your Medtronic representative or send your inquiry to email@example.com.
* System M is a trademark of Spectrum Medical
Medtronic Collaborates with Caribbean and Latin American Perfusion Leaders on Education
Many Caribbean and Latin America countries offer no formal perfusion education programs. Consequently, perfusionists there must travel to the US or Europe for training and continuing education. On a few Caribbean islands, on-the-job training with another perfusionist is the only option available. Despite these challenges, perfusionists in these areas strive to further their education and perfusion expertise. To help meet this demand, Medtronic recently sponsored continuing education courses for perfusionists in Mexico, Puerto Rico, and the Dominican Republic as part of its worldwide commitment to perfusion.
The Medtronic Latin America organization collaborated with local perfusionists to organize and teach these courses. "Perfusionists everywhere want and need education, but it's difficult for some to attend training sessions in the US or Europe," said Susan Guerra, Senior Product Specialist, Surgical-based Therapies, Medtronic Latin America. "We decided to help them strengthen their perfusion skills by providing meaningful education on topics of interest to them. Their feedback reinforced how beneficial these sessions were. For many, the course was the first they had attended."
Each course incorporated instruction led by local perfusion leaders or Medtronic perfusion clinical and education specialists, combining lectures with hands-on experiences with Medtronic perfusion, blood management and diagnostic technologies. To establish course objectives and agendas, the Medtronic Latin America organization polled perfusionists and its local distributors to identify learning needs and topics of interest. Key topics identified were blood conservation strategies during cardiopulmonary bypass, mini-circuit design, and perfusion safety. Based on this feedback, course objectives and agendas were established in concert with the local perfusion leaders.
Tijuana, Mexico Training Course Includes Medtronic Plant Tour
In early September, 2012, 18 perfusionists from Mexico, Nicaragua, Costa Rica, and Panama assembled at the Medtronic manufacturing facility in Tijuana, Mexico, for a week-long perfusion update course. The course was lead by three Mexico City perfusionists: Dr. Cesar Sabalza Lucano, Instituto Nacional de Pediatria, and President, Sociedad Metropolitanan de Perfusion in Mexico; Rolando Ferra Ferrer, Hospital de Especialidades Centro Medico La Raza del IMSS, and Guadalupe Arrieta, Instituto Nacional de Cardiologia Ignacio Chavez.
Oxygenators, mini-circuits, myocardial protection, and blood monitoring were discussed in-depth during the lectures. Perfusionists also received hands-on training with the Medtronic autoLog® Autotransfusion System, a sophisticated device that provides autologous blood during surgical procedures, and the Bio-Console® 560 Speed Controller System, an established centrifugal blood pump platform that is used with newer cardiopulmonary bypass technologies in reduced prime circuits.
Following a discussion on the role of biocompatible surfaces in multi-modality strategies for conserving blood during cardiac surgery, perfusionists toured the coatings manufacturing operations for Carmeda®1 BioActive Surface—a durable, non-leaching End Point Attached heparin coating technology that enhances blood compatibility and provides thromboresistant blood-contacting surfaces for cardiopulmonary bypass circuit devices. Next, they observed the coating process for devices with Trillium®2 Biosurface, a polymer coating with heparin applied to the blood-contacting surfaces of cardiopulmonary bypass devices. The perfusionists also visited oxygenator manufacturing and tubing pack assembly operations.
"The feedback we received was very positive. The perfusionists showed great enthusiasm for the presentations and hands-on learning, and everyone enjoyed the manufacturing operations tour. The tubing pack line proved to be of particular interest since many perfusionists attending the course had never used a pre-assembled tubing pack before and were impressed with its potential design options and ease of use," Guerra noted.
Perfusion Summit, San Juan, Puerto Rico
In November, a "first of its kind" Perfusion Summit drew 17 perfusionists from Puerto Rico, Trinidad, Jamaica, Bahamas, Guyana, Barbados, and Belize. Mark Bearss, Medtronic Perfusion Education and Training Manager; Jim Beavers, Medtronic Clinical Support Specialist; and Anibal Marin, lead perfusionist, Hospital Centro Cardiovascular, San Juan, presented during the day-long course. Bearss led an informational session on mini-circuits, the most requested topic prior to the meeting. Citing a number of clinical studies, he emphasized that there is no single definition or design for a mini-circuit. Instead, perfusionists incorporate several approaches to reduce circuit tubing length and prime volume. Describing examples of different mini-circuit designs, Bearss noted that they have become an important part of multi-modality strategies for blood conservation during cardiopulmonary bypass (CPB). He cited the 2011 Update to the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists Blood Conservation Clinical Practice Guidelines where the level of evidence supporting the use of mini-circuits was raised from Class IIb, in the original 2007 guidelines, to Class I(A).
In a session on perfusion safety, Bearss focused on the need for standardized checklists and procedures to address perfusion emergencies. "I can't stress enough how important it is to practice these scenarios in a non-patient setting," Bearss said. "The entire OR team, (perfusionist, anesthesiologist, cardiac surgeon and OR nurses) needs to participate in crisis simulation scenarios as though a patient was actually involved. This helps everyone understand what is expected of them in a real emergency."
Jim Beavers led a session on blood conservation strategies, including use of the Medtronic HMS Plus Hemostasis Management System, where he stressed the importance of developing multi-modality strategies. This topic generated considerable discussion among the attendees and fostered strategies to put in place for conserving blood.
Perfusion Summit, Santo Domingo, Dominican Republic
All 14 Dominican Republic Island perfusionists attended a daylong meeting in November. Alileny Perez, Medtronic Perfusion Specialist for Latin America, conducted the course. As with the Puerto Rican course, Perez covered information on blood conservation, oxygenators, perfusion emergencies, and tubing packs. "Feedback from the Dominican Republic perfusionists was very rewarding," Perez said. "Not only did they find the session educational but they appreciated the opportunity to network with colleagues. Everyone is already looking forward to the next summit."
"Medtronic will definitely build on the success of these three programs," Guerra observed. "Supporting perfusion education is an important part of our commitment to perfusion. We're in the process of planning additional offerings for 2013, including participation in the Latin American Congress next year." Medtronic will sponsor several sessions and activities at this Congress, including presentations on blood management and autotransfusion. Medtronic will also have on hand the Orpheus™3 Perfusion Simulator, allowing perfusionists to test their knowledge and skills in handling perfusion emergencies. The VIII Latin American Congress on Extracorporeal Technology is scheduled for October 23-25, 2013, Isla de Margarita, Venezuela.
For more information, go to www.clateven.com.
- 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.
- Orpheus is a trademark of Ulco Technologies.
Medtronic in the News:
Through its efforts to alleviate pain and restore health, Medtronic, a global leader in medical technology, strives to improve and extend the lives of millions around the world through its efforts to alleviate pain and restore health. This commitment permeates the entire corporation with ongoing activities such as promoting sustainable cardiac and diabetes care, in the world's under-served areas. Medtronic's initiatives recently recognized in local and national news stories are summarized here.
Medtronic Commits $6 Million to Address Cardiovascular Disease and Diabetes Care for Underserved in India
Adding to the more than $1.2 million health-related grants it has already awarded in India, the Medtronic Foundation announced a five-year, $6 million philanthropic commitment in India to accelerate programs designed to expand access to quality care and management of heart disease and diabetes, two of the world's leading killers.
"By focusing on diabetes and cardiovascular disease, we hope to strengthen overall health systems to expand access to care in underserved communities. Given both the need and opportunity in India, it was clear that our support to help those working to improve care had to be ramped up," said Dr. Jacob Gayle, Executive Director, Medtronic Foundation and Vice President, Medtronic Community Affairs.
Cardiovascular disease (CVD), India's leading cause of death, claims three million people each year. India also has more than 60 million diabetics — more than in any other country. On September 20th, the Medtronic Foundation convened a group of community health experts, as well as representatives of non-profits, academia, and the private sector in New Delhi. Using a "continuum of care" framework to guide the discussion, participants identified barriers and gaps within the current health system in order to formulate solutions to strengthen them.
Since 2010, the Medtronic Foundation has committed more than $7.5 million (US) in non-communicable disease (NCD)-related grants worldwide, including $1.2 million (US) to NCD-related efforts in India. The Foundation will continue to increase global funding to expand access to NCD care for underserved communities, focusing on efforts to recruit, train, and equip frontline health workers, and reinforce patient-centered approaches to health promotion.
For more information about the Medtronic Foundation, go to www.medtronicfoundation.org.
Medtronic Extends Sponsorship of Twin Cities Marathon, TC 10 Mile, and Affiliated Youth Events
Medtronic and Twin Cities In Motion, organizers of the Medtronic Twin Cities Marathon, announced a three-year agreement to keep Medtronic as the title sponsor of four premier Twin Cities In Motion events: TC 1 Mile, TC Family Events, TC 10 Mile, and the Twin Cities Marathon. Medtronic will continue its support of the Medtronic TC Kids Marathon, a nationally recognized youth running program promoting exercise, wellness, and healthy lifestyles.
Medtronic became title sponsor of the four events in 2006, and since then event participation has increased more than 82 percent. A recent Twin Cities survey also showed that 21 percent of the population jogs or runs, a 25 percent increase since 2009. "This partnership lets us help promote health and fitness in Minnesota," said Virginia Brophy Achman, Twin Cities In Motion executive director. "Not only do we see an overall increase in running, we see more kids and their families running for the first time. It's great to see so many people make physical activity a part of their lives."
"Medtronic supports 'Healthy Medtronic Communities' worldwide, and that commitment starts in our hometown," said Dr. Jacob Gayle, Executive Director, Medtronic Foundation and Vice President, Medtronic Community Affairs. "The marathon and related races not only help encourage physical activity, they represent world-class events that the entire community can celebrate, adding to our overall quality of life."
Newsweek Magazine Names Medtronic One of 2012's "Greenest" Healthcare Companies
Newsweek's recent "Green Rankings" of the 500 largest publicly-traded companies in America for 2012 ranked Medtronic 11th (out of 51) in the Health Care Industry and 65th overall (out of 500). Medtronic also ranked in the top 30% of global companies, at 136th (out of 500).
To arrive at the ranking, Newsweek determined the nation's largest public companies based on revenue, market capitalization, and number of employees. The magazine then collaborated with environmental research firms Trucost and Sustainalytics to assess various metrics, including greenhouse gas emissions, water use, solid waste disposal, and emissions that contribute to acid rain and smog. On a scale of 100 points, Medtronic earned an overall "Green Score" of 65.4.
Categories included in the ranking process were further defined as follows:
- Environmental Impact (weighted at 45%): Over 750 metrics including greenhouse emissions, water use, and waste disposal.
- Environmental Management (weighted at 45%): Environmental policies, programs, certifications, initiatives, and controversies.
- Disclosure (weighted at 10%): Environmental reporting and transparency initiatives.
Medtronic's Environmental Sustainability Policy defines responsible environmental management through implementation of the following actions:
- conserve natural resources
- promote energy efficiency
- eliminate waste
- reduce emissions associated with climate change
- develop and implement specific requirements for new facility construction, existing facility modification, and equipment selection that will reduce our environmental impact
For more info on this year's Newsweek rankings, visit http://www.thedailybeast.com/newsweek/features/2012/newsweek-green-rankings.html.
Medtronic Foundation Donates $250,000 to Hurricane Sandy Relief Efforts
On October 29, 2012, the US eastern coastline was struck by a Category 1 superstorm, triggering floods and widespread power outages, prompting officials to declare states of emergency in 13 states. Medtronic's response to relief and recovery efforts was immediate, with the primary focus on the safety and well-being of employees and their families.
The Medtronic Foundation granted $250,000 to the American Red Cross in support of their relief efforts for areas affected by Hurricane Sandy. The company set up an Employee Disaster Relief Fund with an initial donation of $50,000 and committed to match employee giving up to an additional $100,000. Medtronic employees and contractors responded generously, donating over $35,000. In total, $120,749 was raised for individual Medtronic employees impacted by superstorm Sandy.
In addition to financial aid, employees assisted in direct relief efforts and were granted five days of paid leave. Mathew (Max) Tans, Clinical Specialist, Medtronic Neuromodulation, lives in Connecticut, a few miles from some of the areas hardest hit. "Living so close to the disaster area, I really wanted to help," Tans said. As a Navy veteran and volunteer firefighter, Tans knew his skills would be valuable to disaster recovery and rescue efforts. "I took an entire week off and did search and rescue efforts with Team Rubicon, an organization that unites the skills and experiences of military veterans with medical professionals to rapidly deploy emergency response teams into crisis situations. We found an elderly couple trapped because a tree had fallen on their house and was blocking both their front and back doors. We used chain saws to cut the tree out of their house."
"People were so appreciative. It was the greatest experience, and Medtronic made it fantastic. They gave me the time off to help people in the community and then they finished it off with a grant to the organization."
David Bloch, an attorney in Medtronic's Washington, DC office also wanted to help after seeing the news and pictures. "When I realized how many people were hurting, I wanted to do something in addition to contributing money," Bloch said. After receiving the email about granting employees time off to assist with relief efforts, Bloch took action through the Jewish Family Services in Cape May, NJ, which was running a food distribution center. He emailed colleagues and friends to collect food and supply donations. With a full car, he drove to New Jersey and helped sort and stack the food and supplies. While the center opened for only a couple of hours, more than a hundred storm victims lined up for assistance. That afternoon, Bloch joined Samaritan's Purse and helped repair a damaged house. "While it was a long, tiring day, I came home feeling I had done something worthwhile."
Medtronic's John Rivera Honored with the American Society of Anesthesia Technologists and Technicians' (ASATT) Regional Educational Award
John Rivera, Medtronic Senior Development Therapy Manager (right), accepts the Region 7 Education Award from Delbert Macanas, Cer AT, ASATT President
John Rivera, Medtronic Senior Development Therapy Manager, was honored with the Region 7's Education Award at the 2012 American Society of Anesthesia Technologists and Technicians (ASATT) Education Conference. Held in Washington, DC, in October, approximately 300 anesthesia technologists and technicians attended the meeting to learn more about their integral role in the patient care team.
ASATT's Region 7 comprises Alaska, Washington, Oregon, Idaho, Montana, Wyoming, and Hawaii. For the past 15 years, the membership has selected an individual, group, or company to receive their educational award. Nominations are based on contributions made to the education of anesthesia technicians and technologists. The recipient is selected by the Regional Director. Award recipients are often members of ASATT's Board of Directors.
"John has been a pillar of education for ASATT, lecturing for five years at consecutive Region 7 meetings. Region 7 has a minimum of two regional meetings a year, with one in Hawaii and one in either Washington or Oregon. John also lectured at two ASATT Annual Meetings as well as a Region 5 meeting and one in Renton, WA," said Delbert Macanas, Cer AT, ASATT President and former Region 7 Director. "It's been a privilege to have him involved with our meetings. John's ongoing commitment to education comes through strongly in every one of his presentations." Many Region 7 members also expressed their appreciation for John's tireless enthusiasm and hard work on their behalf.
"I am honored to teach these students through presentations at their medical meetings. It is truly one of my favorite things to do," said Rivera. In addition to receiving the award, John presented on the topic of "Rethinking Blood Conservation and the Role of Autotransfusion." His presentation reviewed the need for blood conservation in cardiac surgery. Using clinical data that illustrates the impact of allogeneic blood on cost and patient care, Rivera highlighted some of the following findings:
- Allogeneic blood is in very short supply and its cost continues to increase.
- Patients transfused with allogeneic blood experience more adverse consequences than patients not receiving transfusions.
- The STS Guidelines provide clear directives regarding blood conservation with new emphasis on perfusion-based practices.
- High-risk patients require a multi-modality, evidence-based medicine approach.
Rivera reminded the audience of the important role autotransfusion plays in blood conservation. "I believe blood conservation is both a very good clinical program and a very good business practice. I encourage all of you to become trained and credentialed as autotransfusionists by taking the AmSECT Perioperative Blood Management Technologists (PBMT) exam."
"Medtronic and our customers greatly benefit from John Rivera's extensive expertise and history in autotransfusion and hematology," said Denise Steinbring, Director of Perfusion Marketing, Medtronic Structural Heart. "He embodies Medtronic's commitment to helping customers keep pace with the continuous advances in their fields, and we appreciate the numerous opportunities that are given to John to support local, regional, national and international education programs."
For more information about Medtronic's Rethinking Blood Conservation® Initiative, go to www.medtronic.com/rbci or contact your local Medtronic representative.
Meeting Sponsorship
Medtronic Supports Perfusion Education around the World
Committed to Perfusion, Medtronic supports education programs around the world. Please see the list below of recent and upcoming Cardiovascular Perfusion, Surgery and Anesthesia meetings supported by Medtronic. We invite you to visit the Medtronic exhibit at future meetings and look forward to seeing you!
|4th Annual Medical Education Day: The Role of Patient Blood Management in Education and Practice
|November 2, 2012
|Englewood, NJ
|American Academy of Cardiovascular Perfusion
|January 24-27, 2013
|Los Angeles, CA
|Society of Thoracic Surgeons Annual Meeting
|January 26-30, 2013
|Los Angeles, CA
|CREF (Cardiothoracic Surgery Symposium)
|February 6-9, 2013
|San Diego, CA
|February 10-15, 2013
|Aspen, CO
|Sanibel Symposium
|February 13-16, 2013
|Fort Myers, FL
|Indian Society of Extra Corporeal Technology National Congress (ISECT CON)
|February 15-16, 2013
|Mumbai, India
|World Congress of Pediatric Cardiology and Cardiothoracic Surgery
|February, 17-22, 2013
|Cape Town, South Africa
|AmSECT International Conference
|March 6-9, 2013
|Las Vegas, NV
|Society of Cardiovascular Anesthesiologists
|April 6-10, 2013
|Miami Beach, FL
March 2013 Product News
In this edition:
- Medtronic's Affinity Fusion® Oxygenation System Granted Clearance by U.S Food and Drug Administration (FDA)
- Italian Earthquake Response Earns Medtronic Perfusion Systems the "Partnership in Clinical Support" Award from SpecialtyCare
- Medtronic Highlights Perfusion Product Portfolio at CREF Cardiothoracic Surgery Symposium
- Medtronic Displays the Affinity Fusion® Oxygenation System at the Society of Thoracic Surgeons Annual Meeting Using Fully-Interactive Cardiac Perfusion Simulation
- Clinical Use of the New Affinity Fusion® Oxygenator With Balance® Biosurface Expands Throughout the European Union
- Use of the Medtronic HMS Plus Hemostasis Management System for a Factor XII Deficient Cardiac Surgery Patient
- Factor XII Deficiency Case Study
- 1,000th Trainee Welcomed to Medtronic European Training and Education Center
- Medtronic Supports Perfusion Education around the World
Medtronic's Affinity Fusion Oxygenation System Granted Clearance by U.S Food and Drug Administration (FDA)
Affinity Fusion Oxygenation System gains U.S. FDA 501(k) clearance.
With the FDA's 510(k) clearance, the Affinity Fusion® Oxygenation System will now benefit adult cardiac surgery patients in the United States with its fundamentally different design approach. Incorporating input from more than 500 perfusionists worldwide, the Affinity Fusion Oxygenator's thoughtful design provides ease of use and includes enhancements that reduce air bubbles from entering the blood during a procedure.
"The Affinity Fusion Oxygenator's design is a unique fusion of our customers' clinical insight and Medtronic's engineering expertise," said Tamara Bratland, Global Product Manager, Medtronic Perfusion Systems. With over 79 new design features, this oxygenator significantly advances adult oxygenation technology with features including:
- proactive air handling through an entire oxygenation system designed to handle air up front
- hemocompatibility to reduce blood trauma, lower hemolysis rates, and minimize exposure to foreign surfaces
- perfusion-practical ergonomics to improve flexibility and ease of use with enhanced customization capabilities
- integrated arterial filter
- expanded heat exchanger and gas transfer capabilities
Cleveland Clinic and The Heart Hospital Baylor Plano First to Use Affinity Fusion System in U.S.
Currently, perfusionists in more than 23 countries and 100 medical centers throughout the world use the Affinity Fusion Oxygenator. Its first U.S. use occurred at the Cleveland Clinic, Cleveland, OH, where Patrick Grady, Director of Perfusion Services and a paid member of the Fusion expert advisory board, assisted an open-heart surgery for a mini right thoracotomy and mitral valve repair procedure. Joseph Sabik, M.D., Chair of the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, and a paid member of Medtronic's heart valve scientific advisory board, performed the procedure.
Additionally, The Heart Hospital Baylor Plano (HHBP), Plano, TX, used the system for the first time during a mitral valve repair cases. Will Ryan, M.D., and Robert L. Smith, M.D., cardiothoracic surgeons at The HHPB, performed the procedures with Al Lione, Chief Perfusionist.
Affinity Fusion Oxygenation System Incorporates Design Enhancements from Inlet to Outlet
With a fundamentally different design approach, perfusionists will experience design enhancements that include:
- Progressive fiber filtration – a proprietary fiber winding process with an interlaced pattern that efficiently filters the blood and removes particles and air while oxygenating the blood.
- Uniform flow distribution – smooth tubular blood pathways and a unique curved venous inlet tube, both of which reduce blood turbulence during the surgical procedure.
- Improved flexibility and ease of use – enhanced setup and customization features include a new oxygenation system holder, the Affinity Orbit®, that gives perfusionists more room to shorten lines in various operating rooms, including those with limited space.
As a fully integrated oxygenator and arterial filter, the Affinity Fusion Oxygenator features:
- An electrical shunt that creates equilibrium between the blood and water pathway voltages, reducing the potential for electrostatic discharge that roller pump head rotation may develop.
- A plastic heat exchanger that increases heat exchange performance, decreases prime volume, minimizes blood-contacting surfaces and enables device incineration.
- Radial blood flow design that facilitates short, uniform blood flow to avoid areas of stasis while minimizing blood contact with foreign surfaces
- Pre-membrane bubble trap that purges air before it reaches the fiber membrane by means of a built-in, one-way valve. The tangential flow creates centrifugal force that moves air to the center of the device where it is removed through a purge line.
The Affinity Fusion Oxygenator is available with two biocompatible surface options:
- Balance Biosurface – a hydrophilic biosurface option without heparin that reduces platelet activation and lowers platelet adhesion.1
- Carmeda® BioActive Surface – a durable, non-leaching end point attached heparin that provides thromboresistance and enhanced blood compatibility.2
"With a 260 mL prime volume, enhanced gas transfer and heat exchange performance, the Affinity Fusion Oxygenator is indicated for use as both an oxygenator and arterial filter system," noted Bratland. "Its 25µm filtration capability efficiently handles air and particulates."
The introduction of the Affinity Fusion System is another example of Medtronic's commitment to perfusion solutions. For more information about the Affinity Fusion Oxygenator, go to www.fusionoxygenator.com.
- Technology licensed under agreement from Biointeractions, Ltd., United Kingdom.
- Carmeda is manufactured under license from Carmeda® A.B. for use only as a part of an extracorporeal blood circulation system or circuit that includes an oxygenator or blood bump.
Italian Earthquake Response Earns Medtronic Perfusion Systems the "Partnership in Clinical Support" Award from SpecialtyCare
Michael Kolb (center), Medtronic VP, Commercial Operations, receives the Partnership in Clinical Support Award from Bill Elliott (left), SpecialtyCare Executive VP, COO, and Kathy Irvin (right), RN, SpecialtyCare VP, Supply Chain Services.
On February 8, 2013, Michael Kolb, Medtronic Vice President, U.S. Commercial Operations accepted on behalf of Medtronic Perfusion Systems the "Partnership in Clinical Support" Award from SpecialtyCare, the largest U.S. perfusion services company. "This award recognizes a business partner who is dedicated to and supportive of the exceptional care SpecialtyCare's clinical associates provide our patients and hospital clients," said Kathy Irvin, RN, Vice President of Supply Chain Services, SpecialtyCare, Nashville, TN. "Medtronic and Michael's efforts went 'above and beyond' as they helped us obtain alternative critical cardiac products following the May 2012 earthquake in Italy."
The earthquake devastated the Italian manufacturing facilities of Sorin and Euroset, crippling over 35% of the market's perfusion and autotransfusion products supply. Many customers asked Medtronic for quick support of their case needs, including oxygenators, blood pumps, blood reservoirs, and autotransfusion disposables. "Medtronic provided critical product support, often in the eleventh hour," Irvin noted. "Thanks to their response, SpecialtyCare did not have to cancel a single open heart case during this time. Michael was extremely professional and committed to putting patients first, stepping in to help us with critically needed products."
"We committed ourselves to helping customers impacted by the Sorin and Euroset service disruption as well as our existing customers," Kolb said. "Had Medtronic not been able to respond to everyone's needs, customers would have been unable to serve their patients and surgeries would have been cancelled.
The award was presented at SpecialtyCare's annual meeting in Nashville where about 500 SpecialtyCare executives, associates, and supply partners convened. SpecialtyCare has its roots in cardiac perfusion, participating in one out of every 9 open-heart surgeries performed in the United States and assisting in 44,000 open-heart procedures worldwide each year. The company serves upward of 820 hospitals, including more than 192 cardiac surgery programs at hospitals in 45 states, the District of Columbia and Puerto Rico, and in Germany through their Life Systems subsidiary.
Italian Earthquake's Impact
On May 20 and 29, 2012, two major earthquakes struck the heart of the medical device manufacturing "hub" in northern Italy. The disaster had far-reaching consequences for Medtronic's perfusion and autotransfusion product lines. With increased demand in Italy and from customers around the world, Medtronic ramped up production in their Brooklyn Park, MN, Grand Rapids, MI, and Kerkrade, The Netherlands manufacturing facilities. "We realized that our entire supply chain would be affected by this new demand," Kolb said. "Close coordination was required between sales, marketing, global supply chain and manufacturing."
After the earthquake, as customers approached Medtronic to ascertain their ability to provide incremental perfusion and blood management products, Medtronic was able to assure them that supplies were well stocked. "We assured them that Medtronic could support patient surgeries without interruption," Kolb added. To achieve this, Medtronic implemented 24-hour, seven-day-per week work shifts at manufacturing facilities that produced the needed products.
"As we managed this situation, our foremost concern was for our patients, employees, and their families in the quake zone," said Denise Steinbring, Director of Perfusion Marketing, Medtronic Structural Heart. "Our efforts to provide uninterrupted patient care to support our employees and our customers was consistent with the overall Medtronic mission."
For more information about Medtronic perfusion and blood management products, contact your Medtronic representative. For information about SpecialtyCare, visit www.specialtycare.net.
Medtronic Highlights Perfusion Product Portfolio at CREF Cardiothoracic Surgery Symposium
Product Experience Center guests discussed pack configurations incorporating the Affinity Fusion Oxygenation System with Medtronic tubing pack design experts.
At the February 6-9, 2013 CREF Cardiothoracic Surgery Symposium in San Diego, CA, Medtronic highlighted its perfusion product portfolio, including the new Affinity Fusion® and Affinity Pixie® Oxygenation Systems. "Collaboration between Medtronic and perfusionists is transforming our business," said Tamara Bratland, Global Product Manager, Medtronic Perfusion Systems. "Our new Affinity Fusion Oxygenation System is an excellent example."
Thursday evening Medtronic set up a Product Experience Center, giving perfusionists hands-on experience with the newest products in its perfusion portfolio. Using the Orpheus® Perfusion Simulator, Medtronic demonstrated how the Affinity Fusion Oxygenation System lets perfusionists handle air without an external arterial filter. "Among the Affinity Fusion System's unique aspects is its fully integrated oxygenator and arterial filter," Bratland noted.
Designed for careful blood handling and air management, the Affinity Fusion System's unique design gives perfusionists many features, including:
- Proactive air handling
- Enhanced hemocompatibility
- Improved flexibility and ease of use
- Oxygenator with integrated arterial filter
- Expanded heat exchanger and gas transfer capabilities
In a wet lab set-up at the Product Experience Center perfusionists also got hands-on experience with the Affinity Pixie Oxygenation System. With a maximum flow rate of 2.0 L/min and a low oxygenator prime volume of just 48 mL, the Affinity Pixie® System supports a broad range of neonates and infants undergoing cardiopulmonary bypass.
To finish the demonstrations, perfusionists received updates on other Medtronic perfusion solutions, including cannulae, the HMS Plus Blood Management System and the autoLog® Autotransfusion System. They also heard an update on the Rethinking Blood Conservation program, which has been effective in helping hospitals reduce the financial and clinical complications of blood transfusions. Medtronic engineers answered technical questions, and Medtronic custom pack coordinators helped perfusionists better understand how the new perfusion products could be incorporated in their custom packs.
"Our Product Experience Center provided a 'hands-on' experience for customers as they moved from station to station, talking with engineers, observing and using products, and learning how our perfusion products impact blood conservation techniques," said Bratland. "Thursday evening we arranged for a chef to prepare pasta. Dessert was served on a stick. Another hands-on experience. Everyone enjoyed the evening and left with some key takeaways."
For more information about Medtronic's perfusion portfolio contact your Medtronic representative. Visit www.fusionoxygenator.com for additional information about the Affinity Fusion Oxygenation System and www.affinitypixie.com to learn more about the Affinity Pixie Oxygenation System.
Medtronic Displays the Affinity Fusion Oxygenation System at the Society of Thoracic Surgeons Annual Meeting Using Fully-Interactive Cardiac Perfusion Simulation
Clinicians attending the STS Annual Meeting simulated arrested heart perfusion in the Medtronic exhibit.
Medtronic displayed the Affinity Fusion® Oxygenation System at the Society of Thoracic Surgeons (STS) 48th Annual Meeting, January 26-30, 2013, with clinicians simulating arrested heart perfusion on the Orpheus® Perfusion Simulator.1 Nearly 2,300 medical professionals attended the STS Annual Meeting, where Medtronic reinforced their exhibit theme, "Find Opportunity in Change," with product exhibits and hands-on simulations.
During the meeting, cardiac surgeons performed hands-on aortic cannulation with the fully-interactive cardiac perfusion simulator. "Clinicians visiting our exhibit were very engaged in placing purse string sutures and cannulating our aortic model," said Mark Bearss, Medtronic Cardiopulmonary Education Program Manager. "With simulated training, the greater the fidelity, the more effective the training experience. Medtronic has worked with a tissue modeling company to create a thin aorta that connects to the Orpheus Perfusion Simulator to create realistic, pulsatile arterial blood pressure in the aorta."
Aortic model used during interactive cardiac perfusion in the Medtronic exhibit at STS.
Bearss asked clinicians who used the simulator if they ever experienced air problems during bypass. Many answered that they had and were informed that the Affinity Fusion Oxygenation System has a pre-membrane bubble trap positioned at the top of the oxygenator to purge air before it reaches the fiber membrane. "Cardiac Surgeons enjoyed learning about the perfusion circuit in addition to cannulation during the simulation exercise. This included learning about the new Affinity Fusion Oxygenation System recently cleared for clinical use in the United States," Bearss noted. "The innovative design of the Affinity Fusion System makes it one of the most enhanced products of its kind. The ability to use the system in a simulated arrested heart procedure reinforced their enthusiasm."
For more information about the Affinity Fusion Oxygenation System, visit www.fusionoxygenator.com or contact your Medtronic representative.
- Orpheus is a trademark of Ulco Technologies.
Clinical Use of the New Affinity Fusion Oxygenator With Balance Biosurface Expands Throughout the European Union
Dr. h.c. Erich Gygax, chief perfusionist at Universitäts Klinik in Bern, Switzerland, is one of Affinity Fusion Oxygenator's major users.
Perfusionists in 22 European Union (EU) countries are now using the New Affinity Fusion® Oxygenlator with Balance Biosurface¹. To date, more than 2,100 cases have been performed using the system at more than 100 hospitals/medical centers. Medtronic launched the new Affinity Fusion Oxygenator with Balance Biosurface in Europe in October 2012 after it received the Conformité Européenne (CE) Mark in September.
The Universitäts Klinik in Bern, Switzerland, is one of the Affinity Fusion Oxygenator's major users. "We use primarily in our mini bypass procedures," said Dr. h.c. Erich Gygax, Chief Perfusionist. "The oxygenator's design features a venous air removal device and a premembrane bubble trap, which add a level of safety to the procedure."
Universitätsklinikum Hospital in Essen, Germany, also uses the Affinity Fusion Oxygenator. Together with the Universitäts Klinik in Bern, the two hospitals have used the system in approximately 500 cases. "I appreciate the system's flexible design," said Wolf Ingo Wiese, chief perfusionist at Universitätsklinikum. "It's a big advantage that we can gain prime during set up. I also like the design of the new Affinity Orbit® holder. It's easy to position on the heart-lung machine."
"EU perfusionists are enthusiastic about the Affinity Fusion Oxygenator, which is fundamentally different from previous designs," said Christiaan Matheve, Medtronic Training and Education Manager, Perfusion Technology for Europe and Canada. "Once they begin using it, they realize that it is truly the product of collaboration between perfusionists and Medtronic's engineering experts."
For more information about the Affinity Fusion Oxygenator, go to www.fusionoxygenator.com.
- Balance is a registered trademark of Medtronic Technology licensed under agreement from BioInteractions, Limited, United Kingdom.
Use of the Medtronic HMS Plus Hemostasis Management System for a Factor XII Deficient Cardiac Surgery Patient
For patients with Factor XII Deficiency, the HMS Plus Hemostasis Management System may provide an alternative for anticoagulation monitoring.
Significant challenges are associated with heparin anticoagulation in patients with Factor XII deficiency. Tests such as the activated clotting time (ACT), which demonstrates heparin's effect, do not provide adequate information for patients with Factor XII deficiency.
Medtronic was recently asked to assist in the management of a Factor XII Deficient patient's heparin anticoagulation during aortic valve replacement surgery, since the ACT provided insufficient information to indicate adequate pre- and intra-procedure heparinization. Additionally, the ACT was unable to confirm reversal of the heparin by protamine following bypass. To jump the case study, click here.
Factor XII Deficiency or Hageman Factor was identified in 1955 when a routine pre-operative blood sample taken from a patient, John Hageman, was found to have a prolonged clotting time despite the patient's negative history for abnormal bleeding. Unlike other clotting factor deficiencies, Factor XII Deficient individuals are asymptomatic for abnormal bleeding, even when challenged with major surgery, injury, and dental extraction. Factor XII Deficiency is an autosomal-recessive disorder with an estimated incidence of one in one million.
Congenital Factor XII Deficiency is the most common cause of an isolated prolongation of Activated Partial Thromboplastin Time (APTT) in a non-bleeding child or adult and is usually detected during routine pre-operative coagulation screening. The platelet count, prothrombin time (PT), and thrombin time are normal in patients with isolated Factor XII Deficiency. The APTT is markedly prolonged in patients with homozygous Factor XII Deficiency, but corrects to the normal range when the patient's plasma is mixed 1:1 with normal plasma. A specific assay is required to confirm a diagnosis of Factor XII Deficiency.
In contrast to the lack of bleeding manifested in patients with congenital Factor XII Deficiency, there is an increased incidence of serious thromboembolic events. Different studies report a 1% to 8% incidence of serious thromboembolic disease.1,2,4 Unusually high incidences of stroke, deep vein thrombosis, and myocardial infarction have also been described in patients with Factor XII Deficiency,3,5 which is also the case in two other contact factor deficiency states: Fletcher Factor (Prekallikrein) deficiency and Fitzgerald Factor (High Molecular Weight Kininogen) deficiency.6,7
In all of these situations, the ability to measure and maintain a stable heparin concentration with the Medtronic HMS Plus Hemostasis Management System provides an alternative for anticoagulation monitoring in these types of patients. It is a reliable, versatile, and effective platform for accurate management.
The use of the HMS Plus System in patients with antiphospholipid antibodies and the Lupus Anticoagulant with a prolonged baseline ACT has also been documented in the literature as a good alternative for monitoring heparin during cardiac surgery.8,9,10,11,12
For more information about the HMS Plus Hemostasis Management System, contact your Medtronic representative or visit www.perfusion.medtronic.com.
- Coleman R, Hirsch J, Marder V, et al. Hemostasis and Thrombosis, Basic Principles and Clinical Practice. 4th ed. Philadelphia, PA: Lippincott Williams and Wilkins; 2001, Chapter 6, Robert W. Colman, author, Contact Activation Pathway: Inflammatory, Fibrinlytic, Anticoagulant, Antiadhesive and Antiangiogenic Activities.
- Jespersen J, Munkvad S, Pedersen OD, Gram J, Kluft C. Evidence for a role of Factor XII dependent fibrinolysis in cardiovascular disease. Ann NY Academy of Science 1992.
- Von Kanel R, Wuillemin WA, Frulan M, Lammle B. Factor XII clotting activity and antigen levels in patient with thromboembolic disease. Blood Coagulation and Fibrinolysis 1992.
- Goodnought LT, Saito H, Ratnoff OD. Thrombosis or myocardial infarction in congenital clotting factor abnormalitites and chronic thrombocytopenias: a report of 21 patients and a review of 50 previously reported cases. Medicine (Baltimore) 1983.
- Lammle B, Wuihlemin WA, Huber I, et al. Thromboembolism and bleeding tendency in congenital Factor XII deficiency: a study on 74 subjects from 14 Swiss families. Thrombosis and Haemostasis 1991.
- Bick, R, Disorders of Thrombosis and Hemostasis. Philadelphia, PA: Lippincott Williams and Wilkins; 2002.
- Girolami A, et al. Comparative incidence of thrombosis in reported cases of deficiencies of factors of the contact phase of blood coagulation. J Thromb Thrombolysis 2011 Jan.
- Hogan W, McBane R, Santrach P, Plumhoff E, Oliver W, Schaff H, Rodeheffer R, Eddwards W, Duffy H, Nichols W. " Antiphospholipid Syndrome and Perioperative hemostatic Management of Cardiac Valvular Surgery". Mayo Clinic Proceedings 2000; 75: 971-976
- Jervis K, Senthilnathan V, Lerner A. "Management of a Patient with Lupus Anticoagulant and Antiphospholipid Syndrome fo Off-Pump Coronary Artery Bypass Grafting Using the Hepcon System". Anesthesia and Analgesia 2009;108, No. 4, 1116-1119.
- Brownstein L, Bartholomew D, Silver D, Berry C. "A case report of mitral valve replacement in a patient with lupus antibody syndrome". Perfusion 2003; 18: 373-376.
- Ducart A, Collard E, Osselaer J, Broka S, Eucher P, Joucken K. "Management of Anticoagulation During Cardiopulmonary Bypass in a Patient With a Circulating Lupus Anticoagulant". Journal of Cardiothoracic and Vascular Anesthesia 1997; 11: No 7: 878-879.
- Metzdorff M, Hansen K, Wright G, Fried S. "Interference With Anticoagulation Monitoring by Procainamide-Induced Lupus Anticoagulant". Annals of Thoracic Surgery 1996; 61: 994-995.
Factor XII Deficiency Case Study
Factor XII Deficient Patient - Heparin Concentration
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A 70-year-old male was admitted for aortic valve replacement surgery. His history and physical examination were unremarkable for bleeding problems, and he was taken to the operating room and anesthetized. Blood was collected for the baseline activated clotting time (ACT), which was found to be greater than 800 seconds. A second test conducted to rule out contamination confirmed the original results. The valve replacement procedure was cancelled pending further laboratory investigation.
Laboratory specimens revealed normal Prothrombin Time (PT) with Activated Partial Thromboplastin Time (APTT) of greater than 160 seconds, which corrected to 29 seconds when mixed 1:1 with normal human plasma.
The normal PT and markedly prolonged APTT, which corrected with the addition of normal plasma, are consistent with a deficiency in Factors VIII, IX, XI or XII. Factor VIII and Factor IX Deficiency are associated with Hemophilia A and B. These patients exhibit remarkably abnormal bleeding with or without trauma. Factor XI Deficiency is also associated with abnormal bleeding. The absence of a bleeding history in this patient made a strong case in favor of testing for Factor XII Deficiency.
The specific Factor XII assay result for this patient was <1% activity. Further investigation revealed that other members of the patient's family also have a history of Factor XII Deficiency.
Medtronic HMS Plus Hemostasis Management System Provides an Alternative for Factor XII Deficient Cardiac Surgery Patients
Medtronic was asked to assist with the management of this patient's heparin anticoagulation during the surgery, since the ACT would be unable to provide sufficient information to indicate adequate pre- and intra-procedure heparinization. The ACT would also be unable to confirm reversal of the heparin by protamine following the procedure.
Discussion of how to handle the case cited several papers describing administration of fresh frozen plasma to correct clotting time so that an ACT could be used to monitor anticoagulation. This method was rejected since it would expose the patient to blood products that might otherwise not be required.
The surgical team decided that using the Medtronic HMS Plus Hemostasis Management System to measure heparin concentration during the procedure was a good alternative to ACT testing.
Prior to surgery, an HMS Plus System and the appropriate heparin assay cartridges were delivered to the site and the laboratory validated it for clinical use. Additionally, in-vitro samples of the patient's blood were heparinized and tested with the HMS Plus heparin assay cartridges to demonstrate that the heparin assay would provide the needed monitoring information for this Factor XII deficient patient.
The patient was admitted for surgery and heparinized to 400 units/kg prior to bypass (bolus dose: 40,000 units). The heparin concentration was measured before bypass initiation and every 8 to 10 minutes during bypass. Additional heparin was administered during the case as indicated by the HMS Plus heparin assay to maintain a concentration of 400 units/kg. A total of 15,000 additional units of heparin were given during the course of bypass.
After coming off bypass, the heparin was reversed with protamine sulfate. The HMS Plus System recommended 436 mg of protamine and 440 mg were given. No additional protamine was required.
The patient stayed in the intensive care unit for one day and demonstrated no abnormal bleeding. No blood was administered to the patient, and he was discharged on the fifth day following surgery.
- Coleman R, Hirsch J, Marder V, et al. Hemostasis and Thrombosis, Basic Principles and Clinical Practice. 4th ed. Philadelphia, PA: Lippincott Williams and Wilkins; 2001.
1,000th trainee welcomed to Medtronic European Training and Education Center
Björk Tuija was the 1,000th Trainee at the Medtronic European Training and Education Center.
In January of this year, the Medtronic European Training and Education Center in Kerkrade, The Netherlands, welcomed Björk Tuija from Helsinki University Hospital in Helsinki, Finland, as its 1,000th participant since 2007.
The Medtronic European Training and Education Center was established in the mid-1980s and began offering continuing education and training programs in 2006. Since then, the programs developed by a core of medical and technical professionals have been delivered to clinicians from locations as diverse as Iceland, South Africa and the Far East. Clinicians from more than 56 countries have participated in the Center's programs. "Our goal is to deliver cutting edge education and training programs on our products and therapies," said Christiaan Matheve, Medtronic Training and Education Manager for Perfusion Technology in Europe and Canada. "We have developed more than 10 distinct programs, including scientific education sessions, product training and therapy training." The Center is distinguished by its multilingual character and ability to deal with cultural differences among attendees.
"We were pleased to welcome Björk as our 1,000th trainee, and that we have accomplished this training objective within five years. Participant feedback has been outstanding, particularly as it pertains to the quality and interactivity of our training," Matheve added.
"I appreciated the scientific information Medtronic shared at our training program," said Björk Tuija. "It's very helpful to understand the scientific background that supports the function of their products. The hands-on training was also very informative."
The hands-on training Björk mentioned is an important part of the added value Medtronic brings to education. "Medtronic strives to offer clinicians the best possible tools to improve their skills," Matheve noted.
Besides the Kerkrade-based training programs and in order to stay close to customers, Medtronic provides local education programs to clinicians in their home countries. "These programs facilitate clinician participation and improve the cost effectiveness of our efforts," Matheve said. Many perfusion societies and schools are integrating Medtronic's programs into their training portfolios, including the German Perfusion Society, DGfK, the Dutch Perfusion School in Leiden, The Netherlands, and the Scandinavian School of Perfusionists in Aarhus, Denmark.
Medtronic plans to expand program offerings, to include high-fidelity simulation, to more locations around the world and to adapt them to the future needs of the medical community, helping to ensure the best possible quality of care and service. "It is a privilege to be able to deliver knowledge and share experience with our clinicians so that they can improve patient outcomes during and following a medical intervention," Matheve concluded.
For more information about Medtronic Academia Training and Education programs, contact your Medtronic representative.
Medtronic Supports Perfusion Education around the World
Committed to Perfusion, Medtronic supports education programs around the world. Please see the list below of recent and upcoming Cardiovascular Perfusion, Surgery and Anesthesia meetings supported by Medtronic. We invite you to visit the Medtronic exhibit at future meetings and look forward to seeing you!
October 2013 Product News
In this edition:
- Medtronic Introduces Affinity Fusion® Oxygenation System to Perfusionists at the 2013 American Society of Extracorporeal Technology (AmSECT) International Conference
- Now is the Time for Better Blood Conservation
- Medtronic Gains Insight into Local Needs during Visits with Clinicians in India and Central and Eastern Europe
- Medtronic Sponsors Session on Oxygenation System Design Considerations at 2013 AmSECT International Conference
- Japanese Perfusionists Experience the Art and Technology of Medtronic Perfusion Systems
- Medtronic Hosts Annual European Conference on Extracorporeal Technology (ECT) Options and Outcomes
Medtronic Introduces Affinity Fusion® Oxygenation System to Perfusionists at the 2013 American Society of Extracorporeal Technology (AmSECT) International Conference
John Knoll, Product Development Manager, Medtronic Perfusion Systems presents air handling information during the 2013 AmSECT conference.
Medtronic displayed its Affinity Fusion Oxygenation System at the 2013 AmSECT conference, March 28-31, 2013, in Las Vegas, NV. Medtronic development engineers were on hand to discuss the system's development and operation with perfusionists.
Designed for careful blood handling and air management, the Affinity Fusion System's unique design provides perfusionists with many advantages, including:
- Proactive air handling
- Enhanced hemocompatibility
- Improved flexibility and ease of use
- Oxygenator with integrated arterial filter
- Expanded heat exchanger and gas transfer capabilities
John Knoll, Product Development Manager, Medtronic Perfusion Systems, gave an in-booth presentation entitled "Air Handling in the Affinity Fusion Oxygenation System" to help perfusionists understand the importance of air handling in an oxygenation system.
"Gaseous micro-emboli (GME) are a cause of neurocognitive deficits associated with tissue ischemia, inflammation and complement activation,1" Knoll told his audience. "The clinical consequences are most damaging if this happens in brain or cardiac circulation since damage there is irreversible."
Knoll reviewed the importance of air handling, the different types of air, and options for handling them. He concluded his presentation by explaining how the Affinity Fusion System's cardiotomy/venous reservoir (CVR) and Affinity Fusion Oxygenator handle air and why this design was chosen.
"Our philosophy for designing the Affinity Fusion CVR was centered on proactive air handling," Knoll said. "To accomplish this, we improved flow dynamics to minimize GME generation by incorporating smooth surfaces, gentle transitions, and eliminating falling or dripping liquid." To eliminate air, the CVR uses:
- buoyancy to keep air bubbles large
- defoamers
- filtration
The Affinity Fusion Oxygenator employs a bubble trap for air handling, which "keeps big air big and removes it before it travels through a bundle. It also eliminates reliance on fibers to remove gross air, since fibers are not designed to remove large bubbles and can become coated with protein during bypass," Knoll noted.
Knoll explained the theory and practice of passive and active air handling, concluding with a description of the graduated packing density design used to maintain even blood flow while accomplishing gas exchange and particulate filtration in the Affinity Fusion Oxygenator.
"There are different types of air and many options for handling it. Medtronic chose a design approach based on sound reasoning and data," Knoll concluded. "We believe our results validate the choices we made and invite perfusionists to see the Affinity Fusion Oxygenation System in action."
For more information about the Affinity Fusion Oxygenation System, contact your Medtronic representative or go to www.fusionoxygenator.com.
- De Somer FMJJ, Vetrano MR, Van Beeck JPAJ, Van Nooten, GJ. Extracorporeal bubbles: a word of caution. Interactive CardioVasc and Thorac Surg. 2012; 995-1002.
Now is the Time for Better Blood Conservation
For years, most hospitals gave little thought to the amount of blood transfused during surgery, unless there was a shortage. Today, clinical evidence suggests an association between blood transfusions during cardiovascular procedures and longer recovery times, longer hospital stays, and increased morbidity.1-3
Blood transfusions have not only shown to be associated with increased exposure to patient risks, they have also been shown to be linked to increased costs. A recent study compared blood usage at New Jersey's Englewood Hospital, which has practiced blood conservation since 2000, with conventional usage practices at 16 other New Jersey hospitals. It showed a transfusion rate of 10.6% at Englewood Hospital compared to a 42.5% transfusion rate at the other 16 hospitals.4
To help clinicians rethink blood management at their hospitals, Medtronic Perfusion Systems developed the Rethinking Blood Conservation (RBC®) Initiative. Based on extensive research, evidence-based practices, and a consultative approach, the RBC Initiative can help hospitals develop customized programs tailored to their specific needs. It is designed to help hospitals:
- Improve patient outcomes
- Reduce the length of ICU and hospital stays
- Minimize blood use-related post-operative complications
- Reduce costs
Medtronic launched the RBC website on August 5th as an educational resource to support this program. The website provides cardiovascular surgeons, perfusionists, nurses and hospital administrators with the tools necessary to better understand the risks that have been associated with blood transfusions and the potential benefits of blood conservation practices.
On the site, customers will find:
- Links to published clinical articles on blood conservation that detail studies that have evaluated the risks and costs associated with transfusions.
- Links to international guidelines published by professional societies, country-level organizations, and international organizations.
- An overview of how conservation works, utilizing a multi-disciplinary, multi-modality approach.
- A description of the RBC Initiative – what it is, the role of education and training, how Medtronic technology supports it, and the tools needed to support blood conservation efforts.
They will also find success stories from hospitals that have implemented conservation programs, and the site encourages participants to share their stories. The RBC faculty includes clinical champions from across the care continuum—cardiac surgeons, anesthesiologists, perfusionists, pathologists, nurses and hospital administrators.
Medtronic is committed to helping hospitals learn more about blood conservation strategies and how to implement them. Patients deserve it, hospitals need it, and the evidence supports it. Now is the time for better blood conservation.
If you are interested in learning about blood conservation, visit www.medtronic.com/rbc.
- Koch CG, Li L, Duncan AI, et al. Morbidity and mortality risk associated with red blood cell and blood-component transfusion in isolated coronary artery bypass grafting. Critical Care Medicine. 2006;34(6):1608-16.
- Murphy GJ, Reeves BC, Rogers CA, et al. Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation. 2007;116:2544-2552.
- Brown PP, Kugelmass AD, Cohen DJ, et al. The frequency and cost of complications associated with coronary artery bypass grafting surgery: Results from the United States Medicare program. Annals of Thoracic Surgery. 2008;85:1980-7.
- Moskowitz DM, McCullough JN, Shandler A, et al. The impact of blood conservation on outcomes in cardiac surgery: Is it safe and effective? Annals of Thoracic Surgery. 2010;90:451-9.
Medtronic Gains Insight into Local Needs during Visits with Clinicians in India and Central and Eastern Europe
A multi-functional team from Medtronic observes a perfusionist in India adjusting the flow rate to optimize perfusion product performance for the patient.
During the first quarter of 2013, Medtronic personnel traveled to India, Russia, Serbia, and Romania to gain a deeper understanding of evolving customer needs in each location. "Collaboration is key to innovation at Medtronic," said Kelly Jorgensen, Medtronic Development Manager. "Each year millions of patients and providers benefit from the improved clinical outcomes and greater industry efficiencies our products provide. Although Medtronic has provided products to countries worldwide for many years, patient outcomes and product improvements result from our collaboration with local physicians, perfusionists, clinicians, engineers, and others who are as passionate as we are about advancing medical technology."
In late January, a Medtronic team consisting of an engineer, a marketer, and a clinical specialist traveled to four cities in India to work alongside perfusionists, surgeons, and distributors. "Our goal was to better understand how to innovate specifically for economically challenged markets," Jorgensen noted. India is a multi-faceted region with unique challenges in perfusion therapy, such as awareness, use conditions, affordability, infrastructure accessibility, and a shifting trend toward beating heart procedures. India's ever-changing socio-economic environment further complicates their medical system as hospital management plays an increasing role in the purchasing decision. "Changing healthcare dynamics associated with government-sponsored reimbursement plans for below poverty line patients (BPL plans) puts additional pricing pressures on medical devices like the ones Medtronic offers," noted Dr. Sagar Mahajan, Marketing Manager, Structural Heart, Medtronic South Asia. During the team's visit, customers shared information about the effect of pricing on patients and the programs designed to offer economic alternatives, the impact of product support provided by the local government, and the unique financial awareness of hospital employees. "The information gained from this visit enhances our ability to devise specific solutions to meet the growing needs of our customers in India," Jorgensen said.
In March, a four-person Medtronic team made a two-week visit to Russia, Serbia and Romania, where they interviewed and studied the clinical practices of leading surgeons, anesthesiologists, perfusionists, and spoke with their patients as well. The team examined the perfusion circuits used in these countries, observed different surgical techniques, and asked customers about their needs. An important part of the team's visit included a discussion about patient waiting lists, referral networks, and costs associated with providing care to patients located within and beyond city limits. "This intensive two-week visit provided our team with ideas on how to better interact with customers in Central and Eastern Europe," observed Jorgensen.
A Medtronic team observes a patient coming off bypass in a Russian OR to gain insight into the types of perfusion circuits used.
Medtronic's Perfusion Initiative aligns with its globalization actions. In the 2013 annual report, Omar Ishrak, Medtronic Chairman and Chief Executive Officer shared that future "key strategies are aimed at tailoring our market development activities, customizing our offerings to meet local demands, creating and enhancing our relationships and partnerships with key local and regional stakeholders, and adapting our distribution models to deliver our products more efficiently."
"Our team appreciated the unique opportunity these customer visits provided," Jorgensen said. "The insight we gained will help Medtronic continue to innovate so that medical professionals around the world can achieve the best possible patient outcomes."
Medtronic Sponsors Session on Oxygenation System Design Considerations at 2013 AmSECT International Conference
Mike Hobday, Senior Program Manager, Medtronic Perfusion Systems, presents the role of design considerations in oxygenation system development at the 2013 AmSECT conference.
At the Medtronic-sponsored breakfast session, Mike Hobday, Senior Program Manager, Medtronic Perfusion Systems, used analogies from everyday life to highlight the many considerations involved in designing oxygenation systems. "I wanted to illustrate the design tradeoffs that have to be made to optimize perfusion product performance for patients," Hobday said.
To better clarify design impact, Hobday reviewed some of the new Affinity Fusion® Oxygenation System's reservoir design considerations, drawing parallels to familiar designs. With each parameter, he pointed out the variables that were considered and balanced to achieve optimal performance.
One example he presented was how the goal of integrated filtration in the oxygenator is to create one device that performs both oxygenation and arterial blood filtration, but each function requires its own unique design. While two separate devices could be harnessed together in a "bolt-on method," this would be unlikely to produce size, volume or weight savings. A truly integrated design must perform both functions while providing cost, size, weight, and volume savings. "Smart phones are examples of devices that integrate multiple functions into a single device—computer, camera, MP3 player, and phone. This was the design paradigm we followed while designing the Affinity Fusion Oxygenation System."
An arterial filter functions as an air handler and a particulate filter. An integrated oxygenator must perform both functions. To accomplish this, Hobday reviewed the design benefits and trade-offs associated with the physical geometry and filtration process, among which are an upfront bubble trap design, particulate filtration options, and additional functions added to existing filtration features.
Hobday concluded by reviewing physical design considerations, including port placement, safety considerations, and holder designs. "This lecture generated a lot of discussion on this topic as evidenced by the level of customer engagement we had in our booth following the talk. It was our goal to educate the perfusion community on the intentional thought process used in our product development efforts as we look to optimize design trade-offs."
For more information about the Affinity Fusion Oxygenation System, contact your Medtronic representative or visit www.fusionoxygenator.com.
Japanese Perfusionists Experience the Art and Technology of Medtronic Perfusion Systems
Perfusionists from Japan visit Medtronic headquarters to share their views and learn more about innovative perfusion solutions.
In late May 2013, Medtronic Perfusion hosted perfusionists from seven Japanese hospitals at its Minneapolis, MN, headquarters as part of the company's focus on customer needs and innovative solutions. The event included discussions on product design and simulated perfusion education in the Medtronic Virtual Cardiac Operating Room (VCOR).
"This important meeting allowed Japanese perfusionists to experience the art and technology of Medtronic perfusion systems," said Chikako Konomi, Senior Product Specialist, Structural Heart Marketing, Medtronic Japan. "We named the program 'Takumi Innovation.' 'Takumi' means 'artisan' in Japanese, so the title represents the tie between the artisan's technique and the innovation of the manufacturer."
During the three-day meeting, the Japanese perfusionists met with marketing personnel, engineers, and scientists. The perfusionists presented information about their cardiac surgery programs, and Medtronic's engineers provided feedback on current products and obtained customer inputs for future product concepts. "These dialogues helped Medtronic management better understand the specific interests and needs of perfusionists in Japan," observed Konomi.
The visiting perfusionists also participated in an oxygenator manufacturing plant tour, which gave them a deeper appreciation of the focus on quality in Medtronic's perfusion technologies. The tour was followed by simulated crisis management training in Medtronic's VCOR. By participating in simulated crises in a safe environment, perfusionists gain insight into appropriate responses to incidents that may occur in every-day clinical settings. It also helps participants analyze the steps they would take and to create a safety checklist for emergency use.
"Our guests were impressed with Medtronic's dedication and focus on perfusion, including our new product design efforts and our vision for the future," Konomi noted. "This program is a great asset that helps customers not only learn more about Medtronic but understand the design concepts that support and drive product development."
"Face-to-face meetings with customers are important to the collaboration that drives Medtronic's innovative solutions," said Tamara Bratland, Global Product Manager, Medtronic Perfusion Systems. "Input regarding our customers' technological needs is very valuable as we strive to develop innovative products and value-driven solutions. We are constantly investigating how to improve our product design to enhance clinical outcomes and our customers' experiences. Meetings like this one give customers the opportunity to share their clinical needs with Medtronic's development teams while showing them our commitment to product quality."
Medtronic Hosts Annual European Conference on Extracorporeal Technology (ECT) Options and Outcomes
Medtronic hosted their 2013 European Conference on ECT Options and Outcomes at Sant' Andrea Hospital, Rome, Italy.
As part of its ongoing commitment to perfusion, Medtronic hosted its annual European Conference on ECT Options and Outcomes at Sant' Andrea Hospital, Rome, Italy, March 7 – 8, 2013. More than 200 physicians and perfusionists from Europe and the Middle East participated in the conference.
The conference, moderated by Professor Riccardo Sinatra, MD., Chief of Cardiac Surgery, Sant' Andrea Hospital, featured 13 leading anesthesiologists, surgeons, and perfusionists who addressed a broad range of extracorporeal technology topics. Their presentations focused primarily on transfusion and patient parameter monitoring during bypass but other technology-specific topics were discussed as well, including mini bypass, pediatric perfusion, heparin management, gaseous emboli and monitoring, and the quality of perfusion and long-term support with extracorporeal membrane oxygenation (ECMO). Based on the curriculum's scientific merit, ECM and the European Board of Clinical Perfusion (EBCP) awarded educational credits to Italian and international participants, respectively.
Attendees found the presentation made by Ingo Wiese, Chief of Perfusion, Universitätsklinikum, Essen Thorax und Kardiovaskularchirurgie, Germany, of particular interest. Entitled "Investigation of the Affinity Fusion® Oxygenator Performance with Fully Integrated Arterial Filter Using Simulated Blood Sucker Embolization," Wiese's presentation analyzed whether the protein deposits associated with the Affinity Fusion Oxygenator's integrated arterial filter impact the device's gas transfer.
In the study on which his presentation was based, Wiese put emulsified fat into a solution. A particle counter then measured the number of fat particles going into and coming out of the filter. "Our premise was to measure whether the protein deposition caused by the filtration action has an impact on the gas transfer of the device," said Wiese. "If there are fat particles or protein floating into the oxygenator and the oxygenator fibers are providing the filtration, does the oxygenator's filtration action impact the ability of the device to transfer gas?"
Based on the resulting data, Wiese concluded that the filtration action does not affect the gas performance of the Affinity Fusion Oxygenator. Michael van Driel, Marketing Group Manager, Extracorporeal Technologies, Medtronic Europe, observed that, "this was one of the conference's best presentations, based on the audience's questions and the discussions it generated. Participants were enthusiastic about the study's design and its convincing results."
Dr. h.c. Erich Gygax's clinical update on mini-bypass clinical results, entitled "Physiology and Microemboli Performance of Different MECC Systems," also drew considerable interest. Dr. Gygax, Head of Perfusion Services, The Universitäts Klinik, Bern, Switzerland, studied patient outcomes in mini bypass procedures, comparing results from different MECC systems, including the Affinity Fusion Oxygenation System.
Of the study's devices, two had arterial filters attached to the outside. The Affinity Fusion Oxygenator, with its integrated filter, is smaller and requires a lower priming volume. Dr. Gygax's study tested the overall size of the priming volume for each circuit. "We found that the Affinity Fusion device required a much smaller circuit prime of about 500 mL, compared with about 650 mL for the other devices. The lower priming volume helps reduce the need for blood transfusions, which is clinically beneficial to our patients."
"We also compared the air quality and quantity performance of the Affinity Fusion Oxygenator to three other centrifugal and rotary pumps," Dr. Gygax noted. "Our study concluded that the Affinity Fusion Oxygenator gave us an excellent balance between prime volume and the elimination of micro bubbles."
"Every year, attendees at this conference tell us how much they appreciate the focus it gives to perfusion technologies and techniques," said Van Driel. "The presentations build on our past successes and on participant feedback." The Medtronic Options and Outcomes Conference is part of the company's Academia Education and Training Program. Teaming with Sant' Andrea Hospital to present this conference underlines Medtronic's commitment to working with perfusionists and extracorporeal clinicians to deliver innovative perfusion solutions.
Medtronic invites you to attend the 2014 Options and Outcomes Conference, scheduled for May 15-16, 2014, in Rome, Italy. For additional meeting information, contact your Medtronic representative or send your inquiry to email@example.com.
For more information about Medtronic products, contact your Medtronic representative.