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Original Article
Volume 345:1435-1443 November 15, 2001 Number 20
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Long-Term Use of a Left Ventricular Assist Device for End-Stage Heart Failure
Eric A. Rose, M.D., Annetine C. Gelijns, Ph.D., Alan J. Moskowitz, M.D., Daniel F. Heitjan, Ph.D., Lynne W. Stevenson, M.D., Walter Dembitsky, M.D., James W. Long, M.D., Ph.D., Deborah D. Ascheim, M.D., Anita R. Tierney, M.P.H., Ronald G. Levitan, M.Sc., John T. Watson, Ph.D., Nuala S. Ronan, R.N., Peter A. Shapiro, M.D., Ronald M. Lazar, Ph.D., Leslie W. Miller, M.D., Lopa Gupta, R.D., M.P.H., O. Howard Frazier, M.D., Patrice Desvigne-Nickens, M.D., Mehmet C. Oz, M.D., Victor L. Poirier, M.B.A., Paul Meier, Ph.D., for the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group

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ABSTRACT

Background Implantable left ventricular assist devices have benefited patients with end-stage heart failure as a bridge to cardiac transplantation, but their long-term use for the purpose of enhancing survival and the quality of life has not been evaluated.

Methods We randomly assigned 129 patients with end-stage heart failure who were ineligible for cardiac transplantation to receive a left ventricular assist device (68 patients) or optimal medical management (61). All patients had symptoms of New York Heart Association class IV heart failure.

Results Kaplan–Meier survival analysis showed a reduction of 48 percent in the risk of death from any cause in the group that received left ventricular assist devices as compared with the medical-therapy group (relative risk, 0.52; 95 percent confidence interval, 0.34 to 0.78; P=0.001). The rates of survival at one year were 52 percent in the device group and 25 percent in the medical-therapy group (P=0.002), and the rates at two years were 23 percent and 8 percent (P=0.09), respectively. The frequency of serious adverse events in the device group was 2.35 (95 percent confidence interval, 1.86 to 2.95) times that in the medical-therapy group, with a predominance of infection, bleeding, and malfunction of the device. The quality of life was significantly improved at one year in the device group.

Conclusions The use of a left ventricular assist device in patients with advanced heart failure resulted in a clinically meaningful survival benefit and an improved quality of life. A left ventricular assist device is an acceptable alternative therapy in selected patients who are not candidates for cardiac transplantation.


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From the College of Physicians and Surgeons (E.A.R., A.C.G., A.J.M., D.D.A., A.R.T., R.G.L., P.M.), and the Joseph L. Mailman School of Public Health (A.C.G., A.J.M., D.F.H., P.M.), Columbia University, New York; Brigham and Women's Hospital, Boston (L.W.S.); Sharp Memorial Hospital, San Diego, Calif. (W.D.); LDS Hospital, Salt Lake City (J.W.L.); and the National Heart, Lung, and Blood Institute, Bethesda, Md. (J.T.W.).

Other authors were Nuala S. Ronan, R.N., Peter A. Shapiro, M.D., and Ronald M. Lazar, Ph.D. (College of Physicians and Surgeons, Columbia University, New York); Leslie W. Miller, M.D. (University of Minnesota, Minneapolis); Lopa Gupta, R.D., M.P.H. (College of Physicians and Surgeons, Columbia University, New York); O. Howard Frazier, M.D. (Texas Heart Institute, Houston); Patrice Desvigne-Nickens, M.D. (National Heart, Lung, and Blood Institute, Bethesda, Md.); Mehmet C. Oz, M.D. (College of Physicians and Surgeons, Columbia University, New York); and Victor L. Poirier, M.B.A. (Thoratec Corporation, Pleasanton, Calif.).

Address reprint requests to the International Center for Health Outcomes and Innovation Research, Columbia University, 600 W. 168th St., 7th Fl., New York, NY 10032.

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