Long-Term Use of a Left Ventricular Assist Device for End-Stage Heart Failure

doi:10.1056/NEJMoa012175

Volume 345:1435-1443		November 15, 2001		Number 20

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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by Jessup, M.

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ABSTRACT

Background Implantable left ventricular assist devices havebenefited patients with end-stage heart failure as a bridgeto cardiac transplantation, but their long-term use for thepurpose of enhancing survival and the quality of life has notbeen evaluated.

Methods We randomly assigned 129 patients with end-stage heartfailure who were ineligible for cardiac transplantation to receivea left ventricular assist device (68 patients) or optimal medicalmanagement (61). All patients had symptoms of New York HeartAssociation class IV heart failure.

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

Conclusions The use of a left ventricular assist device in patientswith advanced heart failure resulted in a clinically meaningfulsurvival benefit and an improved quality of life. A left ventricularassist device is an acceptable alternative therapy in selectedpatients 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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