CALENDAR OF EVENTS

May/June 2011 • Volume 14 Issue 3

AmSECT

Continued on page

MESSAGE FROM THE PRESIDENT

odayAnything New with Emerging Technology?By Susan J. Englert RN CNOR CPBMT CCPAmSECT President

The short answer is, “Yes and No.” Using a strict definition, emerging technologies are ad-vances and innovations that represent significant progress within a field for competitive advantage. This is incrementally true for new devices in our field. It is truer for changes in surgical techniques. “No,” applies to changes in professional knowl-edge and the abilities of perfusionists to adjust to incremental changes with new device technologies. This is not new.

The practice of perfusion will always involve incremental changes in the emerging devices that are central to the practice of our profession. When, at a future date, there is a cyborg perfusionist as-signed to the operating room, then there will really be a transformative emerging technology for the profession. Safer devices and practices are impor-tant to our medical responsibilities. The emerging technologies coming to market are incremental developments in the devices being used. A differ-ent term of art for this is “me-too” devices. The two

Susan J. Englert RN CNOR CPBMT CCP

emerging changes in the perfusion de-vice marketplace not involving tech-nology-driven com-petitive advantage are product costs and paperless in-tegration into hos-pital patient elec-tronic health records. These two developments are being driven by federal health care reforms that implemented increased taxes on medical device manufacturers and a national database of electronic medical records. Changes in surgical techniques will continue to take place and impact the practice of our profession. Both of these emer-gent components of our professional field are not new, and are incremental in their impact on overall clinical practice.

In considering this topic, my mind wandered through the changes I’ve seen in our profession. The magnitude of clinical changes over my 30 years of practice is most likely unfamiliar to younger per-

May 1-7, 2011 – National Perfu-sionist Appreciation Week

May 1-June 5, 2011 – Call for Abstracts is open for AmSECT’s New Advances in Blood Manage-ment Symposium, Seattle, WA, September 8-10, 2011. Visit http://amsect.societyhq.com/meetings/nabm/2011/abstracts/ for more information.

May 15-July 15, 2011 – Call for Abstracts is open for AmSECT’s Best Practices in Perfusion, San Antonio, October 5-8, 2011. Visit http: / /amsect.societyhq.com/meetings/best_practices/2011/abstracts/ for more information.

J u n e 1 - A u g u s t 1 8 , 2 0 1 1 – Ca l l fo r Abst rac ts is open fo r AmSECT’s Pediatric Perfusion 2011, Philadelphia, November 4-6, 2011. Visit http://amsect.society-hq.com/meetings/pediatric/2011/abstracts/ for more information.

May 13-14, 2011 – Georgia Health Sciences University: 2011 Perfu-sion Meeting, Augusta GA, CEU’s: 16.8. Heal thcare professionals who aid in the treatment of car-diovascular disease wil l benefit from the contents of this event. Visit www.hatravel.com/default.asp?pid=49063&sid=1905 fo r more information.

What’s Inside

D I G I T A L T A B L E O F C O N T E N T S

Classical Pages ........................................

Theme Article #1 .......................................

Theme Article #2 .......................................

Invited Article ............................................

GRC Committee Update ...........................

Pediatric Fellow Article .............................

Committee Spotlight .................................

Self Quiz ..................................................

Welcome New Members ..........................

AmSECT Today Themes ..........................

Student ViewPoint ....................................

Thank You to Our Sponsors .....................

2011 NABM Registration Form ...............

Call for Abstracts ......................................

Self Quiz Answers ...................................

For current AmSECT Today advertising information, contact Beverly Bernard at beverly@societyhq.com.

Page 2 AmSECT Today - May/June 2011

© Copyright 2011 AmSECT. AmSECT Today (ISSN 1087-32326) is published 6 times a year by the American Society of ExtraCorporeal Technology, 2209 Dickens Road, Richmond, VA 23230-2005. All rights reserved. Postage paid at Richmond, VA and additional mailing offices. Postmaster: Direct address changes, manuscripts, photographs and inquiries about editorial matters to Editor, AmSECT National Headquarters, 2209 Dickens Road, Richmond, VA 23230-2005. Advertising rates and related details are available upon request by contacting the above address, emailing beverly@societyhq.com or calling (804) 565-6363. AmSECT reserves the right to accept or reject advertising. Annual membership dues include subscriptions to AmSECT Today and to the quarterly publication, the Journal of ExtraCorporeal Technology. Non-member subscriptions to AmSECT Today are not available. AmSECT members can elect to receive a paper version of AmSECT Today instead of the electronic version by contacting amsect@amsect.org with your request and a valid mailing address. Opinions expressed in AmSECT Today are not necessarily those of the American Society of ExtraCorporeal Technology.

American Society of ExtraCorporeal Technology

AmSECToday

OFFICERSPresident: Susan J. Englert RN CNOR CPBMT CCP

President-Elect: David C. Fitzgerald CCPTreasurer: Robert C. Groom CCPSecretary: William J. DeBois CCP

BOARD OF DIRECTORSZONE 1

George Putnam CCP RRT RCP Tim Reynolds CCP CPBMT

AK, AZ, CA, CO, HI, ID, MT, NV, NM, OR, UT, WA, WY

ZONE 2Jeffrey B. Riley CCP MHPE CCT CCP

Thomas G. Steffens CCPAR, IL, IA, KS, LA, MN, MO, NE, ND, OK, SD, TX, WI

ZONE 3Bryan V. Lich CCP

David P. Webb MS CCP LPAL, FL, GA, IN, KY, MI, MS, OH, TN, PR

ZONE 4Nicholas B. Mellas CCP

James A. Reagor BS CCP LP CT, DE, DC, ME, MD, MA, NH, NJ, NY, NC, PA,

RI, SC, VT, VA, WV

NEWSLETTER CONTRIBUTORSEDITOR-IN-CHIEF

Kirti P. Patel MPS MPH CCP LP MT(ASCP)patelpump@sbcglobal.net

COLUMN AUTHORSNadia Azuero BS CCP LP

William Mathew Medlin RRT RCP BS CCPStephanie Archer Wetendorf CCP LP

STUDENT AUTHORSJessica Crane Zorana Pentek

Natalija Tauginas BS

INVITED AUTHORSteven M. Parnis

Continued on page

By Gary Grist BS RN CCPThe Children’s Mercy HospitalKansas City, Missouri

The perfusionist’s preparation to deal with MH and its variants should begin with the education of other health care professionals. Because the resuscitation of a patient enduring MH can be lengthy, sufficient time is usually available for a perfusionist to set-up an extra-corporeal circuit for cardiopulmonary support of the MH patient. Since most MH cases occur in the perioperative period, anesthesia, operat-ing room, and recovery room personnel can be educated to notify the perfusionist to standby if MH or a variant is diagnosed. However, since NMS and non-anesthesia related rhabdomyolysis patients are often admitted to the ICU, the ICU personnel should also be educated to the perfusionist’s potential role in a failing resuscitation effort. For these reasons, the perfusionist, along with anesthesia personnel, should provide a resource for training in MH and its variants by participating in regularly scheduled updates to the perioperative and ICU personnel.

Since MH and its variants are very rare, few perfusionists will have an opportunity to participate in the resuscitation efforts. The few perfusionists who do participate in the care of such a patient will probably only have a single opportunity to rescue a child or adult who is dying from MH. So, an accurate assessment of the patient’s condition is vital in quickly planning an extracorporeal perfu-sion strategy. For example, is the patient experiencing cardiac or respiratory failure or both? Is the hyperthermia being well controlled by topical cooling and lavaging or will cooling by extracorporeal circulation be necessary? Is there hemolysis from the elevated temperature? Is rhabdomyolysis present with severe potassium and myoglobin levels? Is the patient hyperosmolar? How severe is the base deficit? Is muscle rigidity going to affect the cannulation site? With these facts in mind, the perfusionist can plan a strategy to best support the patient until the hypermetabolic episode dissipates.

First, the appropriate extracorporeal circuit size should be chosen, particularly if the patient is a child. Neck and femoral muscle rigidity may preclude those sites for cannulation and make sternotomy appropriate. If the hyperthermia is uncontrolled, then the perfusionist must have equipment available to cool the blood, as most conventional ECMO and CPS systems do not have cooling capacity.

If severe hemolysis or rhabdomyolysis is present, then hemodilution of the patient’s blood volume with the circuit prime is appropriate. The choice of oxygenator is critical because the patient will be in a hypermetabolic state with increased oxygen consumption and excessive C02 excretion. If the patient is a child, then a borderline sized oxygenator should not be used. If previous hemodilution has already been performed, then a crystalloid prime might be inappropriate if the hematocrit is already low. A Catch-22 situation may occur wherein hemodilution with normal saline is necessary to reduce the potassium and myoglobin concentration, but in a hypermetabolic state a reduced hematocrit might result in tissue hypoxia and worsening of the acidosis. Since a hypermetabolic state is usually present, pump flow should be based on an increased cardiac index, the sweep gas should be kept high until the carbon dioxide is well controlled and 100% oxygen should be used to maximize tissue oxygenation, even if arterial hemoglobin is 100% saturated.

The type of prime is important and depends upon the presence of elevated potassium, myo-globin or free hemoglobin. It also depends upon the presence of a hyperosmolar state. If serum electrolytes are normal, then a balanced electrolyte, calcium free saline solution can be used. Sodium bicarbonate should be added to this prime in the appropriate amount to prevent the hemodilution of the patient’s remaining inherent bicarbonate level. If there is no hyperosmolar state, then mannitol can be added to stimulate urine output. In the presence of hyperosmolar state, no mannitol should be used. In addition, any saline solution should be diluted with the appropriate amount of water such

CLASSICAL PAGES

Malignant Hyperthermia: How It’s Done Part II

(Reprint with permission from AmSECT Today July 1998)

What Role Might the Perfusionist Play in the Treatment of Malignant Hyperthermia and Its Variants?

Gary Grist BS RN CCP

AmSECT Today - May/June 2011 Page 3

THEME ARTICLE #1

Emerging Technology/Pharmacology

By Stephanie Archer Wetendorf CCP LP Des Plaines, IL

The perfusion profession is one that is constantly changing. There is no status quo. It can be tough to keep up with technology, especially for perfusionists at small community hospitals with minimal exposure to complex cases. A great way to stay on top of current perfusion trends is by attending a perfusion meeting.

Take the time to go to a meeting. Usually meeting time is classified as professional leave and shouldn’t affect vacation time. Although it can be hard to clear personal obligations to take a trip, move this to the front burner. There are some really great local meet-ings if you are unable to get away, not to mention the state or national meetings. For instance, there was a very informative meeting on adult ECMO at Columbia last fall. This one-day course even had a hands-on session, if interested. It was meant for surrounding hospitals, but it was open to anyone.

Get your money’s worth when choosing a meeting. Keep in mind that some meetings offer enough continuing education for two years worth of American Board credits. A national meeting may seem like a huge expense in the beginning, but when divided over 2 years it may not seem as significant. The ABCP posts on its website the meeting points that have been awarded for each program. It is actually an interesting place to look for a meeting to attend. The marketing for local meetings may not always reach you, and this is one place to find them.

Location can be a selling point when selecting a meeting. Some meetings and locations are family friendly, and some aren’t. No matter the available activities at the meeting site, try to stay in the sessions, don’t just sign in and then walk away for the day. Instead, schedule some time before or after the meeting days to explore the city. It’s hard to keep up with perfusion trends if you are sliding down the three-story water slide at the nearby water park.

Don’t shy away from sessions that don’t apply to you at that moment. Pediatrics, ECMO, and VAD talks are likely to be skipped for those that aren’t actively performing those procedures. It may be sooner than you think that your surgeon or hospital will want to start one of those programs. All it usually takes is one person to champion a cause for it to be brought to fruition. It’s best to have an understanding of current technology, and meetings are a great place to learn. Perhaps you find yourself interviewing for a new position at an institution that does these procedures and are able to ask reasonable questions regarding technique based on information that you received at a recent perfusion meeting.

Meetings are a good place to network, and swap case stories and other pertinent information. This is also one way to keep in contact about geographical job openings. Some perfusion meetings now even keep boards of available positions and persons looking for work.

There are other ways to stay on top of emerging technology, such as reading journal articles, participating in research studies, keeping up with email PerfList, or completing online self-study modules, but going to a meeting can offer that as well as networking, travel opportunities, continu-ing education and much more. Technology happens and you can’t get away from it, so embrace it by making your continuing education a priority.

Contact Greg Leasuregreg@amsect.org

Membership Questions?

Stephanie Wetendorf CCP LP

THEME ARTICLE #2

The Emerging Technology of Bone Marrow Stem Cells

By Mat Medlin RRT BS CCP LPSavannah, GA

The body’s response to injury is a very detailed and well-documented series of steps collectively referred to as the “Healing Cascade”. This natural healing process requires a combination of stem cells, growth factors, and tissue repair along with regeneration. The use of these bioactive cells to supplement and quicken the natural healing process is considered by many to be a new frontier of clinical treatment.

Bone marrow is a rich source of autologous adult stem cells, growth fac-tors, and accessory cells. Current technologic advances now provide the ability to highly concentrate these stem cells and growth factors at the point-of-care in less than 15 minutes.

There’s been a lot of interest in developing alternatives to autograft and the associated complications of iliac crest bone harvesting. One emerging alternative is to obtain the rich source of stem cells and proteins found in autograft without surgically harvesting the bone.

The bone marrow cavity in the hip contains a source of stem cells, platelets, growth factors, adhesion molecules, and other proteins respon-sible for tissue repair and regeneration. Through simple aspiration, a physician can obtain all of these cells from the bone marrow.Concentrated bone marrow contains enhanced levels of:

• Bone Marrow-Mesenchemyl Stem (BM-MS) - Cells for bone formation

• Endothelial Stem Cells for supporting vasculature• Hematopoietic Stem Cells for supplying nutrients• Platelets to modulate the regeneration process• Adhesion MoleculesThe gold standard among bone grafting materials remains the use

of the patients’ own healthy bone tissue (autograft). Generally this bone is harvested from the patients’ iliac crest and delivered to the surgical site. Autografts are considered to be osteogenic, osteoinductive, and osteoconductive.

Reference: Harvest Technologies

Mat Medlin RRT BS CCP LP

Page 4 AmSECT Today - May/June 2011

INVITED ARTICLE

By Steven M. ParnisAssistant Director, Technology DevelopmentTexas Heart InstituteHouston, Texas

Over the last 30 years tremendous advances have been made in tech-nology to assist the failing heart. Approximately 2500 heart transplants are performed each year In the U.S; however, on any given day an additional 3000 patients are awaiting a heart transplant. Additionally, not all patients with advanced heart failure are candidates for a heart transplant. Some patients may not be eligible to receive a heart transplant due to various exclusion criteria.

As the field of mechanical circulatory support becomes more mature, we are learning more about how the body reacts to different technologies of pumping blood. Larger volume displacement or “pulsatile” blood pumps have been replaced by smaller rotary blood pumps. Experience gained with the first generation of implantable long-term support pulsatile blood pumps helped pave the way for the first generation of long term support continuous flow rotary blood pumps. These “non-pulsatile” or continuous flow pumps are less complicated, have fewer moving parts, are energy efficient and require less power to operate.

The use of rotary blood pumps to support the failing left ventricle dates back to the 1950’s when Dennis and colleagues used a transseptal technique to cannulate the left atrium and bypass the left ventricle, and blood was returned via the femoral artery with the use of a roller pump. In 1963, Hall and colleagues reported the first clinical implantation of a left ventricular assist device (LVAD). This pulsatile device was implanted within the chest, and connected between the left atrium and descending thoracic aorta. The first successful use of an LVAD was in 1965, when Debakey re-ported utilizing a paracorporeal pulsatile device in cardiogenic shock patient, which connected to the left atrium and right subclavian artery. The device was removed at bedside and the patient was eventually discharged home.

Continuous flow VADs normally uses either centrifugal or axial flow pump technology. Both types have a central rotor containing permanent magnets. Controlled electric currents running through coils contained in the pump housing apply forces to the magnets, causing the rotors to rotate. In the centrifugal pumps, the rotors are shaped to accelerate the blood circumferentially and cause it to move toward the outer rim of the pump, whereas in axial flow pumps the rotors are more or less cylindrical with blades that are more or less helical, causing the blood to be accelerated in the direction of the rotor’s axis.

An important issue with continuous flow pumps is in the technology utilized to suspend the rotor. Early versions used solid bearings while the newer pumps, some of which are approved for use outside of the US, use either electromagnetic or hydrodynamic suspension. These pumps contain only one moving part. Manufacturers claim that these technological differences in suspension not only virtually eliminate wear but also reduce damage to blood cells.

Current pumps, based on this principle, are much smaller, simpler, and more efficient. They fit a wider size range of patients and are less invasive to implant. Since they have fewer moving parts, they are less susceptible to infection and failure. In addition, these pumps offer much greater patient comfort, allowing a relatively normal lifestyle. Although these devices do not have flexing, moving diaphragms or membranes and do not have valves to ensure unidirectional flow during operation, they generally do require

Use of Long-Term Ventricular Assist Devices with Continuous Flow Pumps in the United States

chronic anticoagulation (i.e. warfarin). Percutaneous drivelines are also smaller than first generation pumps and management techniques have improved over the years to decrease the incidence of infection. Although these improvements have been engineered into all these devices, complica-tions, though reduced from first generation experience, still do exist, such as percutaneous driveline site infections or external pump cable fractures. Many of the lessons learned by pioneering surgeons have enabled the widespread use of these implantable ventricular assist devices. HeartMate II

The HeartMate II is an FDA approved ventricular assist device and has been implanted in more than 6,000 patients worldwide as a bridge to transplant, destination therapy and/or bridge to recovery for durations of up to six years.4 The HeartMate II (Thoratec Corporation, Pleasanton, CA) consists of an implantable axial flow blood pump, controller module, power based unit and external batter-ies. The small (four cm diameter and six cm in length) blood pump weighs 375 g and has one moving part, a high speed impeller which spins on inlet and outlet ball and cup bearings. This impeller is contained within a pump housing which surrounds a brush-less DC motor which creates the magnet to spin the impeller. Rotational speeds range from 6,000 to 15,000 rpm and can provide up to 10 L/min of continuous output. The sintered titanium inflow cannula is inserted into the left ventricle via a sewing ring, and blood is returned via a 12 mm outflow graft anastomosed to the ascending aorta (Figure 1). Power is delivered via a percutaneous lead which exits the left upper abdomen and is con-nected to external controllers and an AC power based unit or wearable portable batteries.

Of the 469 patients who received a HeartMate II, from 35 centers involved in clinical bridge to transplant trials from March 2005 to April 2008, 250 underwent cardiac transplantation, 12 demonstrated ventricular recovery and had the device explanted, 106 had died on pump and 100 were still on LVAD support. Of those 250 transplanted patients, 30-day and one-year survival was 97% and 87% respectively. Device reliability has been reported to be greatly improved over its predecessor first gen-eration HeartMate XVE pulsatile device. No mechanical failures of the device pumping mechanism were reported in the HeartMate II bridge to transplantation clinical trial, unlike the experience in the REMATCH Trial with the HeartMate XVE LVAD in which nearly 50% of the patients required device exchange at 18 months due to mechanical malfunction or infection. This is the first implantable rotary blood pump to have widespread use.

One of the major design concerns with first generation of implantable rotary blood pumps, axial-flow pumps, are the use of mechanical bearings, which could potentially become worn and cause performance and durability issues. Engineers began to develop implantable, magnetically suspended pumps, which have the potential for longer durability. Most of these pumps have magnetically levitated (maglev) impellers that eliminate the need for mechanical bearings and physical contact between moving parts. By generating higher torque at a lower speed, these pumps should minimize

Figure 1: HeartMate II

AmSECT Today - May/June 2011 Page 5

INVITED ARTICLE

wear, heat generation, and hemolysis. Several maglev designs are being developed and should soon see widespread use. HeartWare HVAD

The HeartWare HVAD (HeartWare, Inc. Miami Lakes, FL) is a small (displacement volume of 50 mL, weight 145 g), continuous- flow, centrifu-gal pump that uses a hybrid system, a combination of passive magnetic and hydrodynamic thrust bearings to create contact-free rotation of a wide blade impeller, the only moving part within the pump. The front and rear housings are titanium-ceramic hybrid assemblies. Both housings contain sealed motor stators which rotate the wide blade impeller and allow for power redundancy. Radial and axial support are provided by a magnetic center post in the rear housing and three stacks of magnets in the impeller. When the pump is turned on, the impeller is pushed away from the front housing and it begins to rotate. A very thin cushion of blood maintains the gap between the impeller and the front housing. Once power is applied to the device, there are no points of mechanical contact within the pump. This feature is expected to improve device reliability and reduce the risk of blood trauma as cells pass through the pump.

The pump is implanted within the pericardial sac. The titanium inflow cannula is inserted into the ventricular cavity via a sewing ring which contains a metallic C-clamp to allow for a secure attachment to the base of the pump. Blood is returned via a 10 mm outflow graft which is attached to the ascending aorta (Figure 2). A percutaneous driveline exits the right subcostal margin and is connected to an external microprocessor control-ler which is powered by lithium ion batteries. A tablet computer monitor displays system information and allows for AC power options. The HVAD can generate up to 10 L/min of forward flow and is currently involved in clinical trials in the US. DuraHeart

The DuraHeart (Terumo Heart, Inc. Ann Arbor, MI) is an implantable centrifugal blood pump which uses magnetic levitation to suspend a rotating impeller within a titanium housing. The pump is 72 mm in diameter, with a thickness of 45 mm and weighs 540 g with a displacement volume of 180ml. The DuraHeart can provide up to 8 L/min of blood flow at 120 mmHg head pressure with pump speeds of 1200 rpm to 2600 rpm. The impeller is suspended magnetically by three electromagnets mounted in the up-per housing and on the motor side of the impeller, which is rotated by a magnetic coupling between the impeller and a brushless DC motor. Tilting and axial placement of the impeller are monitored by three position sensors to ensure the impeller is free-floating at the center of the pump housing. This also maintains consistent washout of the blood path within the pump. A titanium inflow conduit connects the pump to the heart and blood is retuned via a 12mm GelweaveTM graft to ascending aorta (Figure 3). The pump is placed in an abdominal pocket and connected to an external controller via a percutane-ous lead which exits in the abdominal wall. The controller can be powered

by wearable external batteries or a console and charger system.The DuraHeart is currently in clinical trials in the US. Reports of

implants in patients in the U.S and Europe with pump durations of over three years show similar results with those of other rotary blood pumps. To date, no incidence of mechanical pump failure or pump thrombosis has been reported. Summary

Today’s small pumps have greatly expanded the options for treating chronic heart failure. Unexpectedly, continuous-flow pumps with bearings have evidenced minimal device wear. The lack of infection, ease of implant-ability, and ease of explantability are additional reasons to consider using these pumps before patients enter the terminal stages of heart failure. Early interruption of the heart failure cascade may lead to a higher incidence of re-mission of heart failure and ultimate device removal. Ongoing technological advances will give rise to even better device-related therapies in the future.

References:1. National Heart Lung and Blood Institute–Diseases and Conditions Index. http://

www.nhlbi.nih.gov/health/dci/Diseases/ht/ht_before.html March 20112. Dennis, C., Carlens, C., Senning, A., et al. (1962) Clinical use of a cannula for

left heart bypass without thoracotomy Ann Surg 156, 623–37.3. DeBakey, ME, Liotta, D, Hall, CW. Left ventricular bypass pump for cardiac

assistance. Clinical experience. Am J Cardiol. 1971;27:3-11.4. Thoratec date on file.

Figure 2: HeartWare HVAD

Figure 3: DuraHeart

that the addition of sodium bicarbonate does not result in a hyperosmolar prime solution. If the potassium is elevated, then a normal saline solution plus bicarbonate should be used to dilute the patient’s inherent potassium level without increasing the base deficit further.

Heparinization is dependent upon several things also. In the trauma patient, particularly head trauma, with rhabdomyolysis, heparinization may be a relative contraindication. If available, heparin-bonded circuits are indicated. Trauma may also be associated with DIC, and depending on the opinions of the individual health care professionals involved, heparinization may be beneficial or detrimental. Heparinization of post-surgery patient may also result in increase blood loss from the surgery site.

Once on extracorporeal support, ancillary interventions should be considered, depending on the patient’s condition. If the hematocrit is low, the base deficit is extreme, or bleeding excessive, the transfusion of washed, low potassium red blood cells and other blood products may be appropriate. If potassium, myoglobin, or free hemoglobin is high, then high flux, zero-balanced hemofiltration should be attempted. Some myo-globin and free hemoglobin proteins can be forced across a hemofiltration device and success is readily seen by a pink colored ultrafiltrate. While hemodialysis may be capable of removing potassium, the urgency of the situation may preclude its relatively slow correction using hemodialysis. And hemodialysis will not remove myoglobin or free hemoglobin.

The resolution of the hypermetabolic state, the resolution of the elevated potassium, the resolution of calcium metabolism and resolution of the hyperthermia can be accomplished within a few hours of extracor-poreal support. However, cardiac or pulmonary damage may result in the need to prolong extracorporeal cardiopulmonary support. And failure to adequately reduce myoglobin or free hemoglobin levels may result in the need for hemodialysis for many days or weeks before resolution of the acute renal failure.

Malignant HyperthermiaContinued from page 2

Page 6 AmSECT Today - May/June 2011

GOVERNMENT RELATIONS COMMITTEE UPDATE

The Federal Stark Regulations and Perfusion Practice

By Mike Troike LCP CCP, Chairman and Lee Bechtel, Director of Government Relations

Lee BechtelMike Troike LCP CCP

The clinical practice issue of the ap-plication of the federal physician self-referral law, the Stark law, and the regulations issued by the Centers for Medicaid and Medicaid

Services (CMS), on the employment arrangements of perfusionists, particularly those employed by surgical groups, has been around for over fifteen years. Still, questions are received from AmSECT members. The purpose here is to shed light on why and how Stark does not apply to perfusion employment arrangements. This should not be interpreted as an official position statement of the Society. Interested persons can contact either of the authors at Mike Troike at mtroike@bellsouth.net or Lee Bechtel at balobby@verizon.net.

There have been two revisions/clarifications made to the original Stark physician self-referral law, also known as Stark I, Stark II, and Stark III. Medicare physician self-referral of patients is a different federal statutory provision than the Medicare anti-kickback law and its regulations. People have, and do, get these confused. Both are complex in their interpretations and application to surgeon group business models and the contractual arrangements with hospitals for perfusion services. There are state phy-sician self-referral laws that could come into play as well as the federal Stark law and regulations. There is a webpage covering the Stark laws at http://starklaw.org/stark_guidelines.htm.

The core principle of the Stark law is focused on physician self-referral to entities in which a surgeon or surgical group, or another physician subspecialty, has an ownership or investment interest in, but at which a surgeon or surgical group does not personally perform the professional services. The core principle and its application covers physician self referral to an entity for a Medicare Designated Health Service (DHS), such as a medical test, and imaging center, a free-standing ambulatory surgical cen-ter, or a surgical procedure like CPB, and in which an ownership or invest-ment interest is held, and which can directly receive Medicare payment for a billed service. This is passed through the ownership/investment interest entity back to the referring physician/surgeon or surgical group practice. All of these are important components in the self-referring process.

The players involved must be able to directly bill Medicare for the services rendered, and also not be personally involved in the performance of the service. The Stark law has no application to surgeons employed by a hospital, as with university based hospital open-heart programs. This is normally the case because the surgeons don’t separately bill Medicare. Hospital employed perfusionists are not at issue with the Stark regulations for obvious reasons, nor are perfusion service contract companies that bill the hospital directly for the services being provided. The perfusion services contract company is not in the position to refer patients, cannot bill Medicare separately for services, and payments made by the hospital are to a company which employs medical staff that cannot bill or receive payment for services provided to Medicare patients. Private insurance billing and payment for contracted perfusion services is a different matter and not addressed in this article.

For a few years, there was the creation of physician group owned specialty hospitals which were exempt from the Stark regulations. For a number of reasons, too numerous to address here, Congress enacted, and Medicare enforced, a ban on physician owned specialty hospitals. Those

that were previously opened were allowed to continue, but this is no longer permissible under federal Medicare law.

There are three remaining business models for perfusion employment arrangements that involve surgical group practices. These consist of (1) perfusionists directly employed by a surgical group; (2) perfusionists employed by a surgical group with the group billing hospitals for the perfusion services provided by its employees; and (3) a surgical group that has separately incorporated perfusionists into a company, and the company billing the hospital. There is essentially no difference between business models (2) and (3), other than the formation of a subsidiary. There is an important difference between business model (1) and the other two. Perfusionists who are on the staff of a surgical group are generally paid from the revenue the group receives for its physician services under the Medicare Physician Fee Schedule (PFS). The physician fee schedule is composed of three components. The Professional Compo-nent (PC) is paid for a surgeon’s personal work; the Technical Component (TC) covers malpractice insurance costs, office leases, staff support services, and administrative costs. The combination of both of these is the “global fee”. The surgical group ultimately decides how to allocate staff salaries and surgical partner salary/compensation after other fixed costs are subtracted. For the most part, the perfusionist’s salary comes from the TC component of the global fee charged for each procedure. In model (1), the surgical group is not referring patients to its own staff.

Surgical group businesses models (2) and (3) differ from the first in that the group contracts with the hospital for the perfusion services they provide. In these circumstances, the hospital most likely pays for perfusion services that it does not pay to hospital employed staff perfusionists, out of the hospital’s surgical case DRG payment revenues, and the other designated health services provided to Medicare patients at open-heart hospital programs. There is no blanket; all are the same, contractual rela-tionship that can even be speculated on since this is a proprietary financial arrangement. What is known is that in business models (1), (2), and (3) the surgical group and its surgeons are performing surgical designated health services in which the perfusionist is involved - patients are not being referred to a perfusionist employee or a subsidiary company providing perfusion services that is owned by the surgical group, for services for which there is separately recognized Medicare reimbursement that can be billed for. Perfusionists cannot directly bill Medicare for their services.

The Medicare Physician Fee Schedule (PFS) specifically recognizes eligible providers of services that can bill Medicare for their professional services. There are 20 recognized Medicare PFS medical professionals who can bill independently for their services. Perfusionists are not on this list and are therefore prevented from billing. Most importantly, Medicare provided an explanation in its 2008 Stark III clarification regulations that addresses this matter. It says in part and with clarification added:

“In the FY 2009 IPPS final rule, (containing Stark III) we amended the definition of ‘entity’ at 42 CFR §411.351 to clarify that “[a] person or entity (a physician/surgeon or group or a hospital are entities) is consid-ered to be furnishing DHS if it is the person or entity that has performed services that are billed as a DHS or presented as a claim to Medicare for the DHS (73 FR 48751). We declined to provide a specific definition

AmSECT Today - May/June 2011 Page 7

GRC UPDATE

of ‘perform’ in the final rule, but stated that it should have its common meaning.... In addi-tion, we stated: “We do not consider an entity that provides personnel.....for performing the service to be performing a separate DHS (73 FR 48726). ..... We delayed the effective date of the amendment to the definition of “entity” until October 1, 2009, in order to afford parties adequate time to restructure arrangements (73 FR 48721).”

The application of the Stark self-referral law and regulations do not apply to perfusion-ists and their services, regardless of what they are, when provided by a surgical group. Perfusionists and their services are a part of a designated health service, but perfusionists are only personnel involved in the performance of the services that a surgeon or members of a surgical group furnishes as a DHS for Medicare payment policy purposes. Second, perfusionists are not recognized as “eligible providers of services” under the Medicare Physician Fee Schedule and cannot independently bill for services. There is no Medicare payment that can be passed through to the surgical group. In a surgical group employment arrangement perfusionists are employees. A hospital can, and does, use its DRG revenues to pay a perfu-sion contract company or a surgical group that employs perfusionists, but the surgical group is not an owner/investor with the exceptions noted, that directly benefits financially.

A surgical group, regardless of size, is not self-referring a patient for a Medicare covered surgical procedure when the surgeons are per-sonally involved in the delivery of the service. They cannot self-refer to themselves to receive compensation for procedures they have done with the assistance of a perfusionist. Perfusion services, in and of themselves, are non-eligible and therefore non-reimbursable as a covered service under the Medicare PFS. Surgeons are not self-referring patients to hospitals for com-pensation for services they are not performing in the hospital.

Having presented this educational informa-tion, perfusionists may disagree. The for-sure caveat is that an attorney with Stark experience will disagree, as many have made a livelihood from offering legal opinions. The weight of the evidence strongly suggests that the Stark law and regulations do not apply to hospital employed perfusionists, to contract perfusion services companies, nor to perfusionists em-ployed by surgical groups or groups owning a separate perfusion services company. Individual state physician self-referral laws come into play as do as the federal Stark law and regulations, and need to be taken into consideration.

By Ronald E. Angona, Jr. BS CCP FPP

By definition, a fellow is someone who is an ‘equal’ or a ‘comrade.’ In the academic world, the designation of Fellow can take on one of many meanings. Those of us who work in academic institutions are most familiar with our Cardiothoracic or Cardiovascular Fellows: That is, someone who has completed residency training and is currently in a one- to three-year surgical subspecialty training program. Alter-natively, a person can be entitled Research or Teaching Fellow, common at many institutions of higher education in the U.S. Many universities have Fellows on their Board of Trustees, where they hold administrative positions. Even some large corporations entitle a few of their senior scientists or engineers as Fellow.

With regard to professional societies, a Fellow is typically the highest grade of mem-bership. Lower grades may include the titles member or associate. Internationally, many exclusive societies have Fellow as their only category of membership. While they differ in how this title is acquired, most include many of the following requirements: passing a series of examinations, a certain period of time within a given field, nomination by members within the society, evidence of additional training and/or participation in research, etc. This is in line with the designation of Fellow given by our Ameri-can College of Surgeons (F.A.C.S.). Those letters after a surgeon’s name mean that the surgeon’s education and training, professional qualifications, surgical competence, and ethical conduct have passed a rigorous evaluation, and have been found to be consistent with the high standards established and demanded by the College1.

As AmSECT Pediatric Fellows, peers work together in the pursuit of knowledge, and continuously strive to improve the quality of care for the little patients they serve. The AmSECT Pediatric Fellow was first awarded in 2007, after years of development. Qualifica-tion for the award has multiple requirements, including a minimum pediatric clinical caseload and current membership in our professional

What it Means to Be An AmSECT Fellow of Pediatric Perfusion

society. An interest in pursuing professional excellence in pediatric perfusion (as evidenced by memberships, teaching, research, etc.) and a strong ethical fitness, among other things, are also requirements for the application. Multiple letters of recommendation, from a perfusion colleague, surgeon, and anesthesiologist, are required that describe the applicant’s qualifica-tions as a pediatric perfusionist as well as the applicant’s professional and ethical standing in the community2. Applications are reviewed by AmSECT national headquarters for complete-ness, and then evaluated by the Pediatric Fel-low Review Committee. The committee then decides whether or not to approve the candidate for the Fellow designation. The entire applica-tion process is rigorous for the candidate, and gives an excellent, comprehensive review of the candidates’ commitment to pediatric perfusion.

What does it mean to me to be an AmSECT Pediatric Fellow? I was fortunate enough to receive my award in 2010. An excerpt of the fellowship pledge says it best: I also prom-ise to further my knowledge through research and education, and to share my knowledge and experience with oth-ers in an effort to advance the practice of pediatric perfusion. Those of us lucky enough to have the opportunity in our career to perform bypass on neonatal patients have an obligation to disseminate our knowledge to our colleagues, as well as to use all possible resources to expand our knowledge base. Because of the small numbers of patients and centers who actually do these cases, failure to do this would result in stagnation. Not only is this not fair to our patients, but it doesn’t honor the pioneers in our field who came before us and made our field what it is today. References:

1 http://www.facs.org/about/corppro.html 3/21/20112 http://www.amsect.org/sections/membership/

PediatricFellow/index.html 3/23/2011

FELLOW OF PEDIATRIC PERFUSION

Page 8 AmSECT Today - May/June 2011

Portable extracorporeal cardiopul-monary life support (ECLS) devices are increasingly gaining the attention of main-stream medicine. On the surface such attention could only be expected to benefit patients with occurrences of acute respira-tory failure or acute myocardial infarction. As perfusionists, we know the advantages and disadvantages of these devices, which we operate routinely to rescue patients who may otherwise decompensate and die before the proper treatment can be effected. Device manufacturers realize the untapped markets for these advanced products and pursue bringing mechanical circulatory support

(MCS) devices to the mainstream. There is a great risk that the future operators of these devices may not include perfusionists and will not have the background or experience to safely manage these devices and patients. The recent introduction of percutaneous mechanical circulatory support devices to cardiac cath labs have shown the direction that these newer generation of portable ECLS devices will most likely take.

AmSECT President Susan Englert has already stated (AT, Jan-Feb11), that the merit of using MCS devices such as portable heart-lung machines in broader clinical applications certainly exists. Heart disease remains the leading cause of death in the United States with lung dis-ease the third leading cause. Consider that mortality caused by acute cardiogenic shock is estimated at 50-70% even with current therapeutic paradigms including inotropes and IABPs. While some heart failure and respiratory failure patients are treated with immediate transplants, the limited availability of donor organs often requires MCS devices as a bridge to transplant, bridge to decision or as destination therapy. The use of Extracorporeal membrane oxygenation (ECMO), has developed into a specialized, multidisciplinary effort with steadily improving results for respiratory failure. Perhaps wider availability of cardiopulmonary rescue devices would decrease patient morbidity and mortality. But also, perhaps not; if the device operator is insufficiently prepared to manage acutely ill patients supported on the device or to be able to respond to device emergencies that could be disastrous.

Over the past several years, the MCS Committee has been work-ing to provide resources for MCS knowledge and create standards and guidelines for training and competency in current and emerging circulatory assist technologies. As part of these efforts, the committee has evaluated publicly available information on the newer generation of devices and has determined that a qualified perfusionist should be involved directly, as a

Each 2011 issue of AmSECT Today will highlight one of the many AmSECT committees.For this issue, the spotlight is on the Mechanical Circulatory Support Committee.

Mark Lucas MPS CCP CPBMT

UPDATE: Mechanical Circulatory Support Committee Recommendation on Portable and Percutaneous Extracorporeal

and Mechanical Circulatory Support Devices

Mark Lucas - ChairJames Reagor - Co-chair

Ron MatheisThomas Rusk

Gary Grist

primary consultant or in a supervisory capacity in the operation of all such devices to provide the highest degree of patient safety. Perfusion practice has more than fifty years of knowledge and experience in extracorporeal support and a proven record of safety . The following letter has been approved by the AmSECT Board of Directors for publication in AmSECT Today and for release to all device manufacturers. The purpose of dis-tributing this letter is to open dialogue with device manufacturers on the qualifications of device operators and clearly establish the organization’s position regarding perfusionist involvement.

AmSECT’s Recommendation on Portable and Percutaneous Mechanical

Circulatory Support Devices The American Society of ExtraCorporeal Technology (AmSECT)

is the world’s largest professional society of cardiovascular perfusion-ists. AmSECT seeks to foster improved care, safety and outcomes for patients supported with extracorporeal devices. Perfusionists are the only medical professionals whose scope of practice expressly includes the utilization of extracorporeal devices to support patients in a variety of clinical circumstances. Perfusionists are qualified through CAAHEP-accredited educational programs and certified by the American Board of Cardiovascular Perfusion.

It is AmSECT’s position that optimal patient care and safety must not be compromised. Mechanical Circulatory Support (MCS) devices which are a variation on or are substantially equivalent to current systems operated by perfusionists are beginning to be utilized by other health care providers. AmSECT has charged its Mechanical Circulatory Support Committee with providing knowledge, guidance and insight into MCS devices.

The MCS Committee continues to evaluate the available information regarding the current and pending generation of devices. Upon delibera-tion, the MCS Committee finds that safe and effective operation of these life-sustaining systems requires that a qualified perfusionist directly participate in or supervise their use. The introduction of such life support devices into the clinical setting without the involvement of a properly trained cardiovascular perfusionist will jeopardize safety and subject patients to substantial and unnecessary risk of injury. AmSECT strongly recommends that a perfusionist qualified by formal education and possessing clinical expertise be utilized directly or in a supervisory capacity throughout the implementation, operation and management of all MCS systems.

We welcome any questions and further discussion of our concerns and position on this matter.

COMMITTEE SPOTLIGHT - MCS COMMITTEE

Board of DirectorsAmerican Society of ExtraCorporeal TechnologyJanuary 13, 2011

James A. Reagor BS CCP

AmSECT Today - May/June 2011 Page 9

Respectfully,

Th e future of innovation? It’s always within our sights.

As perfusion technology evolves, you can count on Medtronic to

lead the way with innovative products, helpful support, and reliable

training. It’s part of our commitment to perfusionists. And it’s part of

our commitment to the lives we help improve every day.

Join the conversation at:

CommittedtoPerfusion.com/AmSECT

UC201006162 EN © Medtronic, Inc. 2010

Committed to perfusion solutions. Committed to life.

201006162_EN.indd 1 4/26/10 10:13 AM

Page 10 AmSECT Today - May/June 2011

AmSECT Today - May/June 2011 Page 11

?How much do you know about...E M E R G I N G T E C H N O L O G Y

By Nadia C. Azuero BS CCP LP Atlanta, GA

AnswerstoQuizonpage

1. Perfluorocarbons are: A. Hydrocarbon molecule products that have the ability to

carry oxygen & carbon dioxide B. A flouride-carbon molecule that expands circulating blood

volume to increase oxygen carrying capacity C. An aromatic carbon ring that carries oxygen and regulates

pH having 2 carbonic acids on its ring D. An unsaturated hydrocarbon molecule that stimulates RBC

production

2. The Quest MPS2 has a maximum flow rate of: A. 500 cc/min B. 750 cc/min C. 1000 cc/min D. 1500 cc/min

3. Which of the following is/are considered to to be advantage(s) of blood product substitutes?

A. Universal compatibility B. Longer shelf life C. Greater availability D. Free from infectious diseases E. All of the above

4. The following is the only manufacturer that offers prescrip-tive oxygenation to cardiac surgery patients:

A. Sorin Biomedical with the ECCO 5 B. Medtronic with the Affinity CP C. Maquet with the Acrobat D. Terumo with the FX Series

5. Which of the following drug(s) is/are intended for patients with hemophilia for short-term use (two-eight days) and is utilized to reduce or prevent hemorrhage?

A. Cyklokapron B. Amicar C. Aggrastat D. Argatroban

6. _______ is the first approved direct thrombin inhibitor, a recombinant derivative of hirudin, and is a naturally occur-ring anticoagulant found in medicinal leech.

A. Hirudo B. Lepirudin C. Bivalirudin D. Warfarin

7. Like lepirudin, argatroban binds reversibly to the catalytic domain of thrombin at a single location.

A. True B. False

8. Heparin is considered to be the most commonly used anticoagulant. Which of the following is considered to be the second most common?

A. Bivalirudin B. Warfarin C. Ximelegatran D. Argatroban

9. When the tricuspid valve is replaced, a bioprosthetic or mechanical valve with only two leaflets can be used, since tri-leaflet valves are not available.

A. True B. False

10. Which of the following anticoagulant(s) was/were withdrawn from the market due to hepatic toxicity?

A. Aprotinin B. Aggrastat C. Ximelegatran D. Transexamic acid

NadiaC.AzueroBSCCPLP

Page 12 AmSECT Today - May/June 2011

AmSECT Today - May/June 2011 Page 13

Welcome to our New ContributorsNatalija Tauginas BSRush University Medical Center

I would like to introduce myself as one of the new members of the “Student Corner” section for AmSECT Today. My name is Natalija Tauginas and I am de-lighted to be part of this new and exciting adventure. I have chosen to be part of AT because I am eager to learn more about special topics in perfusion technology and relate them to my career as a perfusion-ist. Currently, I am a master’s student at Rush University in Perfusion Technology. I graduated with my bachelors in science degree from University of Illinois at Chicago in Movement Sci-ence. I have also completed some work in clinical exercise physiology at Benedictine University. My ultimate goal is to become a certified licensed perfusionist and specialize in pediatric patients. I look forward to working with AmSECT Today and thank you for the opportunity.

Natalija Tauginas BS

Zorana Pentek Rush University Medical Center

My name is Zorana Pentek, and as a first year Master’s perfusion student at Rush University Medical Center in Chicago, IL, one of my main goals is to become involved in various organiza-tions and become more involved in my future career as a perfusionist. I gradu-ated from Lewis University in 2009, with a Bachelor’s in Biology and a minor in Chemistry and Biochemistry. Throughout my time at Lewis, I became very involved in the community and the Biology department. I spent most of my senior year as a teacher assistant for the chemistry class, and as an active member of the Biology Honor Society. I am hoping to continue to be an involved member in the perfusion society throughout my studies and career; this is one of the reasons I feel very fortunate to be able to have this opportunity to be involved with AT. I am hoping to be able to provide some valuable insight in the “Student Corner” of AmSECT Today.

Zorana Pentek

W E L C O M E N E W

StudentAuthors

2011 AmSECT Today ThemesJanuary/February Extended Life SupportMarch/April Emergency Preparedness Adjunctive Perfusion/Ancillary Perfusion Responsibilites AmSECT International Meeting PromotionMay/June Emerging Technologies - PharmacologyJuly/August AmSECT International Meeting Summary & Photos Blood ManagementSeptember/October Perfusion Safety/Best Practices in PerfusionNovember/December Pediatric & Congenital Perfusion

ACTIVETrang N. Bodtke BS CCP ................................................. Little Rock, ARMelanie Marie Canatella RN CCP ................................... Greenwood, LA Keith E. Cook PhD .............................................................. Ann Arbor, MI Angela DeLong CCP .............................................................McAllen, TX Brad C. Field MS CCP ..................................................Reisterstown, MD Benjamin L. Greenfield ...........................................................Lincoln, NE Derek S. Moore CCP ................................................................ Yuma, AZ Jonathan L. Neyman CCP ............................................Cross Lanes, WV Jack R. Reed JD CCP ..............................................................Chico, CA Bruce J. Resell CCP .............................................................St. Paul, MN Joseph Valashinas CCP ........................................Manhattan Beach, CA Scott M. Yaskulka CCP .................................................... Gainesville, GA

ASSOCIATE John H. Higgins MS .............................................................. Norwich, CT

INTERNATIONALMaria Albalushi CCP ..........................................................Muscat, OmanRodrigo Diaz MD ..............................................................Santiago, Chile Seo Jungho ............................................................. Daegu, South Korea Ashley O’Brien MD ............................................ Saint John, NB, Canada

STUDENT Julie L. Bagozzi RN BSN .......................................Midwestern UniversityScott Boulais ..........................................................Midwestern University Jenna Cornibe ........................................University of PA Medical Center Gregory G. Gutowski ...........................Milwaukee School of Engineering Jennifer Roberts .............................Medical University of South Carolina Scott Sandeerson ........................University of Nebraska Medical Center Kelsey Schipull ............................University of Nebraska Medical Center Holly Spinello ..........................................University of PA Medical Center Amanda Starleaf ..............................................................Rush University

WELCOME NEW MEMBERS

Vis i t www.amsect.org for upcoming meet ings!Ú

Page 14 AmSECT Today - May/June 2011

By Jessica CraneTexas Heart Institute School of Perfusion Technology

A 56-year-old male is wheeled into Dr. AmSECT’s operating room for a coronary artery bypass graft (CABG). As the perfu-sionist, you review his history and instantly see “NO HEPARIN” written across the front of the chart in big, bold, red letters. ‘What now?’ you ask yourself.

Heparin still remains the gold standard for anticoagulation for cardiopulmonary bypass (CPB); however, a small percentage of the patient population is hypersensitive to heparin and may acquire heparin-induced thrombocytopenia (HIT). This poses a dilemma for the entire surgical team, and if the reaction is severe enough the patient may require alternative anticoagulation methods. Direct thrombin inhibitors are one such group, and one of these agents gaining widespread use is bivalirudin (Angiomax).1

Heparin-induced thrombocytopenia is a disorder which the patient can have severe thromboembolic complications such as limb ischemia, stroke, pulmonary embolism, myocardial infarction (MI), and even death.2 HIT is divided into two subtypes. Type I HIT usually develops within 48 hours of initiating heparin and causes a mild decrease in platelet count, but patients can still receive heparin for CPB. Type II develops after five or more days of heparin administration, is more severe than Type I, and will require an alternative approach to anticoagulation.3

The main question surgeons, anesthesiologists, and perfusionists should ask one another is: Do we use heparin or an alternative antico-agulant during CPB for a patient who has been diagnosed with Type II HIT? Enzyme-linked immunosorbent assay (ELISA) testing is used to detect antibodies against heparin-PF4 complexes. This test detects all antibodies that bind to heparin-PF4, and may falsely identify antibodies that do not cause HIT. Therefore, an additional functional assay should be performed. A patient may still receive heparin for CPB if antibody levels have dropped to undetectable concentrations within the blood stream and they have not received heparin for over 90 days. However, other forms of anticoagulation, such as bivalirudin, should be used for CPB if antibodies reach an undesirable level.3

Bivalirudin is an alternative anticoagulant that directly inhibits thrombin and has no known antidote.4 Post surgical bleeding is the main risk of using bivalirudin, and increases more in those patients with renal dysfunction. Patients with normal renal functions will clear bivalirudin from the plasma by renal filtration and proteolytic cleavage in approximately 24 minutes.5 This short half-life can prove to be a challenge if appropriate steps are not taken to maintain proper anticoagulation before, during, and after CPB.

If the surgical team determines that bivalirudin is to be used for CPB, steps to ensure circuit integrity should be taken by the anesthesiologist and the perfusionist pre-CPB. There is a “zero” tolerance for stagnation in the CPB circuit. With such a short half-life any stagnant blood within the CPB circuit will increase the risk of clot formation in the circuit. Some examples of places in the circuit where blood can become stagnant are the membrane purge line, recirculation line, manifold, bridge, arterial line filter purge, and the hemoconcentrator. If a shunt is opened during bypass, be

Bivalirudin

Jessica Crane

S T U D E N T ViewPointsure to maintain continuous flow to this section throughout the pump run to avoid stagnant blood, and ultimate clotting off the circuit.

A bolus of 50 mg should be added to the CPB circuit prime, while a loading dose of 2.25 mg/kg should be given via IV infusion from anesthesia. Next, a constant infusion should be given through the same IV line at 1.25 mg/kg/hr. Wait five minutes before checking the ACT and do not initiate CPB unless the ACT is 2-3 times greater than the baseline ACT. If the first ACT is less than the target, then re-bolus the patient with 1.125 mg/kg of bivalirudin and repeat the ACT after 5 minutes. Once the ACT has been modified and reconfirmed, then initiation of CPB may begin.3

Upon initiation of CPB, transfer the constant infusion IV line from anesthesia to the CPB circuit. During the pump run ACTs should be taken every 10-15 minutes to help ensure circuit integrity. If an ACT falls below the target of 2-3 times greater than the baseline, then re-bolus the patient with 0.25 mg/kg and increase the constant infusion rate by 0.5 mg/kg/hr. ACTs over 2-3 times the baseline also require attention by lowering the constant infusion rate by 0.5 mg/kg/hr.4 Running a TEG and an aPTT test might also be beneficial in monitoring the anticoagulation status. The results may take longer, but are good for additional documentation.1

When preparing for CPB termination, communication with the surgeon is vital so the perfusionist is aware of the remaining CPB time. Once the estimated time remaining on CPB is addressed, it is important to communicate with anesthesia about the ideal ACT to terminate CPB, and discontinue bivalirudin infusion 30 minutes prior to termination. Pump suckers should be discontinued 15-30 minutes prior to termination, and the remaining suction blood sent to the cell saver for washing.4 Be sure to use an alternative to heparin-based saline for washing, such as ACD-A. Once CPB is terminated and the patient is decannulated, the focus is to maintain the integrity of the circuit in case re-initiation becomes necessary. To achieve this, reconnect the circuit and continue recirculating with an ongoing infusion of bivalirudin.1

In conclusion, communication within the surgical team is the key to successfully using bivalirudin before, during, and after CPB.

References: 1. Nikolaidis, N, Velissaris, T, & Ohri, S.K. (2007). Bivalirudin Anticoagulation for

Cardiopulmonary Bypass. Texas Heart Institute Journal, 34(1), 115-118. 2. Koster, A., Dyke, C., Aldea, G., Smedira, N., McCarthy, H., Aronson, S., et al.

(2007). Bivalirudin during cardiopulmonary bypass in patients with previous or acute heparin-induced thrombocytopenia and heparin antibodies: results of the choose-on trial. The Annals of Thoracic Surgery, 83, 572-577.

3. Bojar, R.M. (2005). Manual of Perioperative Care in Adult Cardiac Surgery. Malden, Massachusetts: Blackwell Publishing Inc.

4. Jenkins, E, & Kazanjian, P.E. (2003). Bivalirudin (Angiomax). Retrieved March 1, 2011, from www.spectrummedicalgroup.com/ps/ar/Docs/bivalirudin.pdf

5. Vasquez, J.C., Vichiendilokkul, A, Mahmood, S, & Baciewicz, F.A. (2002). Anticoagulation with Bivalirudin During Cardiopulmonary Bypass in Cardiac Surgery. The Annals of Thoracic Surgery, 74, 2177-2179.

AmSECT Today - May/June 2011 Page 15

THANK YOU FROM AmSECT

AmSECT Thanks the 2011 Corporate Sponsors & Exhibitors

GOLD LEVELMAQUET Cardiovascular

MedtronicSorin Group

Terumo Cardiovascular Systems

SILVER LEVELThe Wood Insurance Group

BRONZE LEVEL

OPTI Medical Systems, Inc.Quest Medical, Inc.

49th International Conference Exhibitors

Arteriocyte Medical Systems, Inc.

California Medical Laboratories, Inc.

CAS Medical Systems, Inc.

Circulatory Technology

Global Blood Resources, LLC

MAQUET Cardiovascular

Medtronic, Inc.

Micromedics, a Nordson Company

Quest Medical, Inc.

Saint-Gobain Performance Plastics

Sorin Group, Inc.

SpecialtyCare, Inc.

Terumo Cardiovascular Systems

The Wood Insurance Group, Inc.

Stewart A. Hinckley Executive Director Email: stewart@amsect.org

Heather A. Spiess Chief Operating Officer Email: heather@societyhq.com

Donna Pendarvis Association Manager Email: donna@amsect.org

Greg Leasure Membership Manager Email: greg@amsect.org

Matthew Carpenter Manager of Meetings and Conventions Email: mattc@societyhq.com

Kevin F. Johns CMP CAE Director of Meetings and Conventions Email: kevin@societyhq.com

Kimberly Robertson CPA Controller Email: kimberly@societyhq.com

Daniel Gainyard Director of Information Technology Email: daniel@societyhq.com

Matt Van Wie Manager of Corporate and Educational Support Email: mattv@societyhq.com

Beverly Bernard Graphic Design / Publications Email: beverly@societyhq.com

Phone: (804) 565-6363

NATIONAL OFFICE

AmSECT Needs YOU!!Get Involved!

Page 16 AmSECT Today - May/June 2011

REGISTER NOW! ONLINE REGISTRATION

& HOTEL RESERVATIONSARE AVAILABLE AT

www.amsect.org

AmSECT Today - May/June 2011 Page 17

- PLEASE PRINT OR TYPE - Name ________________________________________________________________ Degree ____________________ Last First MI

Mailing Address ___________________________________________________________________________________

________________________________________________________________________________________________

City / State / ZIP ___________________________________ Email Address* _________________________________

Offi ce Phone _______________________ Home Phone _____________________ Fax # _______________________

Accompanying Person(s) Name(s) ____________________________________________________________________

*Please provide an email address for confi rmation of your registration.

On or Before After August 15 August 15

AmSECT Member $325 $375 = $ _______ Certifi ed PBMT - AmSECT Member $150 $200 = $ _________

(only non-perfusionists qualify for CPBMT rate) Certifi ed PBMT – Nonmember $250 $300 = $ _______

(only non-perfusionists qualify for CPBMT rate) Non-Member* $550 $600 = $ _______ Student AmSECT Member $100 $150 = $ _______ Institution ___________________________

Graduation Date ______________________ Meeting Total = $ _______

I am registering for continuing education credit as a registered nurseAmSECT, 2209 Dickens Road, Richmond, VA 23230, is an approved provider of continuing nursing education by the Virginia Nurses’ Association, an accredited approver by the American Nurses’ Credentialing Center’s Commission on Accreditation.

*To register at the reduced Member rate, attach a membership application and dues payment to this registration form. AmSECT membership applications can be obtained at www.amsect.org.

How did you hear about the meeting? Broadcast Email PerfList Printed Brochure www.amsect.org CTSnet Other ____________________

Method of Payment Check VISA MasterCard American ExpressCredit Card No. __________________________________________________Exp. Date ________ CVV Security Code* ________

Credit Card Billing Address ______________________________________________________________Zip Code ______________

Signature ___________________________________________ Printed Name on Card ____________________________________

*CVV code is the three digit number on the back of VISA or MC or 4 digit number on the front of AMEX card above the account number.If paying by check, please make checks payable to AmSECT and mail to:

AmSECT • 2209 Dickens Road • Richmond, VA 23230-2005 • Phone (804) 565-6363 • Fax form to: (804) 282-0090Refund Policy: 80% refund through August 15, 2011; no refunds after August 15, 2011. Refunds will be determined by the date a cancel-lation request is received in writing at AmSECT National Headquarters. If you do not receive confi rmation from AmSECT National Head-quarters within 30 days of submitting your registration, please call the offi ce to confi rm that your registration material has been received.

Americans with Disabilities Act: The American Society of ExtraCorporeal Technology has fully complied with the legal requirements of the ADA and the rules and regulations thereof. If any participant in this educational activity is in need of accessible accommodations, please contact AmSECT at (804) 565-6363 for assistance.

CONFERENCE REGISTRATION 19th Annual Symposium on

New Advances in Blood ManagementSeptember 8-10, 2011

P012011

Westin Seattle • Seattle, Washington

Page 18 AmSECT Today - May/June 2011

CALL FOR ABSTRACTS

CALL FOR ABSTRACTSPerfusion Safety & Best

Practices in Perfusion 2011Open May 15 - July 15, 2011

CALL FOR ABSTRACTS1New Advances in

Blood ManagementOpen May 1 - June 5, 2011

CALL FOR ABSTRACTSPediatric Perfusion

Open June 1 - August 14, 2011

AmSECT Today - May/June 2011 Page 19

fusionists. I entered the field just as they were putting away the disk oxygenators, and bubble oxygenators were becoming the new standard. We assembled circuits in a sterile field, filed burrs off our metal tubing connectors, wired our tubing connections, read pressures with manometers, and kept time with stopwatches. We even hand-crafted coronary perfusion can-nulaes. Now it’s membrane oxygenators and pre-assembled and totally disposable circuits. The EKG used to be a green worm squirming across a small scope, but now we have full-color, multi-channel, large screen monitors. These are just the changes for CV surgery. Perioperative autologous blood recovery and platelet gel, or regional and hyperthermic perfu-sion services, have taken us into other surgical specialties.

From my point of view, the profession has changed dramatically in the past 30 years. Any-one not expecting or preparing for change may become a dinosaur perfusionist. I am sure that the younger generation of perfusionists will not face the scale of emerging technology that older perfusionists have experienced, based on my own discussions with AmSECT members in re-cent years. The safety of the newer versions of ‘older’ devices that represent today’s emerging technologies is a more important consideration.

Many perfusionists think that new innova-tive surgical techniques will lead to the end of open-heart surgery as we know it today. CPB cases have declined since their peak years but the need for open-heart surgery and the roles of the perfusionist are far from being things of the past. Perfusionists have been down this road before. The field of perfusion has experienced the introductions of new surgical techniques, that after several years of clinical use, where shown not always to be ‘the greatest thing since sliced bread’ for decreased risk of infection, less bleeding and pain, decreased length of hospital stays and overall cost when compared to open-heart surgery. Examples are off-pump or ‘beating heart bypass surgery; transcatheter aortic valve implantation (TAVI) as an alternative treatment to open‐heart surgery for patients with severe aortic stenosis, robotically-assisted heart surgery, and closed-chest heart surgery for certain types of patients, are all currently in clinical testing. All are minimally invasive surgical techniques. Not everyone needing heart surgery is a candidate for these types of surgical techniques. There is ongoing scientific and econometric debate over the longer-term effectiveness of these techniques for patients. A comparison exists over the use of stents versus

open-heart surgery, with the weight of evidence now swinging back toward open-heart surgery.

To keep abreast of developments with emerging technologies, AmSECT has a long history of involvement dating to before 2003. In 2003, the first exclusively focused seminar on emerging technologies was held in Cancun, Mexico, organized by our previous AmSECT President, Carla Maul. I had the honor of presenting the clinical applications of platelet gel. Platelet gel was just catching on for use in cardiovascular surgeries; I remember this well since my presentation was just before the optional Jungle Tour. Another topic was Emerg-ing Technologies and Lawsuits: How to Protect Yourself, along with updates from manufactur-ers. For several years thereafter, the emerging technologies seminar was the CME meeting to attend for its content and locations. Since online versions of AmSECT Today were posted on the webpage at the end of 2003, there have been 78 monthly and bimonthly editions for down-loading. Many of these have special articles on advancements in emerging technology, focusing on particular devices and comparative device reviews. Included are emerging technology quizzes. Review of the articles and quizzes was insightful. They refreshed my memory about the preceding seven years over which some of the now older devices, when compared to their successor generation, were considered emerging technology.

The underlying base of professional knowledge, clinical practice experience, ability of perfusionists to adjust to incremental changes in CPB devices and devices used outside of the OR have not really changed that dramatically in my opinion. The more sophisticated design and use applications for emerging devices, while perhaps improving the work environment, brings a higher level of concern for patient safety. On this point of emerging technology devices, one needs only to review recent studies on medical devices approved for marketing through the FDA’s 510(K) device approval process. Many perfusion-related emerging devices on the

market or coming to market generally go through this process. The 510(k) approval process only requires a manufacturer to show that a device is substantially equivalent to an already approved device, with no submission of longer-term safety and use data.

Sparked by the recent marketing of an unapproved mitral valve ring by a manufacturer, the FDA’s 510(K) approval process was called into serious question. The studies found that 80 of the 113 class 1 (highest risk) devices were recalled by the FDA between 2005 and 2009. Not all devices were in the field of CV surgery, but a 70% failure rate to perform as advertised in clinical use is a serious red flag to consider. New devices and emerging technology are good, but not if the older generation device is more dependable and equally safe for patients when used by a perfusionist.

Our profession is closely linked to incre-mental developments in existing devices being used in the conduct of perfusion services, i.e. emerging technologies. However, newer is not always better when it comes to day-to-day practice in the operating room. As perfusionists, we test these to see if they fit our needs and the requirements of surgeons and the hospital administrations since it is the administration that is paying the bill. As a profession, we can-not avoid this dependency. We can, however, always rely on education and training, clinical practice experience and abilities as perfusion-ists to adjust to incremental changes. These are intangible assets that do not change with the latest device improvement or developments with new surgical techniques.

Every day you may make progress. Every step may be fruitful. Yet there will stretch out before you an ever-lengthening, ever-ascending, ever-improving path. You know you will never get to the end of the journey. But this, so far from discouraging, only adds to the joy and glory of the climb.

~ Sir Winston ChurchillBritish politician (1874 - 1965)

PRESIDENT’S MESSAGE

Continued from page 1

CE SELF-QUIZ ANSWERS

1. A. Hydrocarbon molecule products that have the ability to carry oxygen & carbon dioxide

2. C. 1000 cc/min3. E. All of the above4. D. Terumo with the FX Series5. A. Cyklokapron

6. B. Lepirudin7. B. False - unlike lepirudin8. B. Warfarin9. A. True10. C. Ximelegatran

Page 20 AmSECT Today - May/June 2011

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