Surgery News - June 2008 - (Page 12)

12 THORACIC SURGERY NEWS • J U N E 2 0 0 8 Pump Prolongs Heart Transplant Candidates’ Survival BY MITCHEL L. ZOLER Else vier Global Medical Ne ws B O S T O N — The continuous-flow HeartMate II left ventricular assist device was effective and generally safe during 1-year follow-up in expanded clinical experience with 279 patients. Patients who received the HeartMate II had a 75% actuarial survival rate after 12 months, with an “acceptable risk profile,” Dr. Leslie Miller said at the annual meeting of the International Society for Heart and Lung Transplantation. After 18 months, the actuarial survival rate was 74%, a 1% drop in survival with an additional 6 months of follow-up. Previously reported experience with the HeartMate XVE—a first-generation, pulsatile-flow left ventricular (LV) assist device—had a 69% survival rate after 12 months and a 54% rate after 18 months. The change in long-term survival between the two devices is a “dramatic difference,” said Dr. Miller, chief of the integrated divisions of cardiology at Georgetown Uni- versity and Washington Hospital Center. Another notable finding was that the subgroup of patients who received the HeartMate II between May 2006 and March 2007 as part of a continuedaccess protocol had a 10% increased survival rate after 6 months and 4% greater survival after 12 months, compared with the first subgroup of patients, who received the device during March 2005–May 2006. The improved outcomes seemed linked to surgeons’ increased experience with placing the device, Dr. Miller said. Membership in the American College of Surgeons? H E R E ’ S W H Y I T ’ S I M P O R TA N T: AS A BODY REPRESENTING ALL OF SURGERY, THE COLLEGE: • Provides a cohesive voice addressing societal issues related to surgery. • Is working toward having an increasingly proactive and timely voice in setting a national tone and agenda with regard to health care. • Is dedicated to promoting the highest standards of surgical care through education of and advocacy for its Fellows and their patients. • Serves as a national forum through which surgeons can reinforce the values and ethics that traditionally have characterized the surgical profession. HERE ARE SOME OF THE MANY BENEFITS BEING A MEMBER OF THE COLLEGE AFFORDS YOU: • Free registration at the Clinical Congress • Access to the College’s free coding consultation hotline • Subscription to ACS NewsScope, the College’s weekly electronic newsletter • Subscription to the Bulletin of the American College of Surgeons • Subscription to the Journal of the American College of Surgeons • Access to all College-sponsored insurance, credit card, and other helpful programs • Free posting of resume on ACS Career Opportunities • Access to Surgeons Diversiﬁed Investment Fund THERE IS STRENGTH IN NUMBERS. Our members represent every specialty, practice setting, and stage of practice. Their views and concerns are helping to shape the College’s agenda for the future. If you aren’t a member of the American College of Surgeons, apply for Fellowship today. If you are already a member, maintain that status and consider getting involved in the work of the College. Only by banding together and using our collective strength can we bring about positive change for our patients and ourselves—and for surgeons of the future. Information on becoming a member of the College and an application form are available online at w w w.f ac s .org/dept /fellowship/index .html or contact Cynthia Hicks, Credentials Section, Division of Member Services, via phone at 1-800/293-9623, or via e-mail at chicks@facs.org. The HeartMate II, approved by the Food and Drug Administration in April for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from nonreversible LV heart failure, is a “brand new technology. This played a role in the improvement” seen with greater experience in placing the new pump, said Dr. Miller, who has received research grants and honoraria from Thoratec Corp., maker of the device. The average age of patients receiving the axial-flow device was 55 years (range 15-70 years), and their average LV ejection fraction prior to device placement was 16%. The series included women with body surface areas as low as 1.33 m2. At the time of placement, 56% were listed for a heart transplant with the United Network for Organ Sharing with a 1A status, and the other 44% were listed with 1B status. Once they received the device, 87% of patients were discharged from the hospital. During the year following placement, 51% of the patients subsequently reAt 18 months, the ceived a transplant, actuarial survival 28% still had their rate was 74%, device in place, and vs. 54% for an 1% recovered suffiearlier-generation ciently to have the device. device removed. DR. MILLER Taken together, this meant an overall successful support rate of 80%. A total of 19% of patients died, and 1% had their axial-flow device removed and replaced with another LV assist device. The patients who received a device had, on average, a nearly 10-fold increase in their 6-minute walk distance by 6 months after placement, compared with their baseline performance. Also by 6 months, 83% of patients had improved to New York Heart Association class 1 or 2 heart failure. Adverse events included bleeding that required surgical intervention in 26% of patients and infections in 30%. “Infection remains a substantial cause of death” in patients getting the device, Dr. Miller said. But significant bleeding episodes were reduced by about two-thirds, and the rate of strokes and other neurologic events was reduced by more than a third, compared with patients who received pulsatile-flow devices. Device-related infections occurred in 15%, but pump-pocket infections occurred in 1%, also an improvement over the rate seen with pulsatile-flow devices. “At this point, the HeartMate II appears to offer significant advantages over the HeartMate XVE,” said Dr. Fred A. Crawford Jr., an ACS Fellow who commented on the study. Dr. Crawford, chair of the surgery department at the Medical University of South Carolina, Charleston, said that the intermediate term durabilty of the HeartMate II has been excellent, and suggested that “perhaps it will have its greatest impact as a destination therapy device, eventually replacing the HeartMate XVE, which has been limited to larger adults because of its size.” http://www.facs.org/dept/fellowship/index.html http://www.facs.org/dept/fellowship/index.html

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