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Original Article
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Volume 357:885-896 August 30, 2007 Number 9
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Use of a Continuous-Flow Device in Patients Awaiting Heart Transplantation
Leslie W. Miller, M.D., Francis D. Pagani, M.D., Ph.D., Stuart D. Russell, M.D., Ranjit John, M.D., Andrew J. Boyle, M.D., Keith D. Aaronson, M.D., John V. Conte, M.D., Yoshifumi Naka, M.D., Donna Mancini, M.D., Reynolds M. Delgado, M.D., Thomas E. MacGillivray, M.D., David J. Farrar, Ph.D., O.H. Frazier, M.D., for the HeartMate II Clinical Investigators

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ABSTRACT

Background The use of left ventricular assist devices is an accepted therapy for patients with refractory heart failure, but current pulsatile volume-displacement devices have limitations (including large pump size and limited long-term mechanical durability) that have reduced widespread adoption of this technology. Continuous-flow pumps are newer types of left ventricular assist devices developed to overcome some of these limitations.

Methods In a prospective, multicenter study without a concurrent control group, 133 patients with end-stage heart failure who were on a waiting list for heart transplantation underwent implantation of a continuous-flow pump. The principal outcomes were the proportions of patients who, at 180 days, had undergone transplantation, had cardiac recovery, or had ongoing mechanical support while remaining eligible for transplantation. We also assessed functional status and quality of life.

Results The principal outcomes occurred in 100 patients (75%). The median duration of support was 126 days (range, 1 to 600). The survival rate during support was 75% at 6 months and 68% at 12 months. At 3 months, therapy was associated with significant improvement in functional status (according to the New York Heart Association class and results of a 6-minute walk test) and in quality of life (according to the Minnesota Living with Heart Failure and Kansas City Cardiomyopathy questionnaires). Major adverse events included postoperative bleeding, stroke, right heart failure, and percutaneous lead infection. Pump thrombosis occurred in two patients.

Conclusions A continuous-flow left ventricular assist device can provide effective hemodynamic support for a period of at least 6 months in patients awaiting heart transplantation, with improved functional status and quality of life. (ClinicalTrials.gov number, NCT00121472 [ClinicalTrials.gov] .)


Source Information

From the University of Minnesota, Minneapolis (L.W.M., R.J., A.J.B.); the University of Michigan, Ann Arbor (F.D.P., K.D.A.); Johns Hopkins Hospital, Baltimore (S.D.R., J.V.C.); Columbia University, New York (Y.N., D.M.); Texas Heart Institute, Houston (R.M.D., O.H.F.); Massachusetts General Hospital, Boston (T.E.M.); and Thoratec, Pleasanton, CA (D.J.F.).

Drs. Miller and Pagani contributed equally to this article.

Address reprint requests to Dr. Miller at Washington Hospital Center, 110 Irving St. NW, Rm. 1F-1208, Washington, DC 20010-2975, or at leslie.w.miller{at}medstar.net.

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Related Letters:

Continuous-Flow Ventricular Assist Device
Weiss G. J., Miller L. W., Pagani F. D.
Extract | Full Text | PDF  
N Engl J Med 2007; 357:2305-2306, Nov 29, 2007. Correspondence

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