Long-term use of a left ventricular assist device for end-stage heart failure

Background: Implantable left ventricular assist devices have benefited pati ents with end-stage heart failure as a bridge to cardiac transplantation, b ut their long-term use for the purpose of enhancing survival and the qualit y 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 patient s 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 ventricul ar 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 o f survival at one year were 52 percent in the device group and 25 percent i n the medical-therapy group (P=0.002), and the rates at two years were 23 p ercent and 8 percent (P=0.09), respectively. The frequency of serious adver se events in the device group was 2.35 (95 percent confidence interval, 1.8 6 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 a dvanced heart failure resulted in a clinically meaningful survival benefit and an improved quality of life. A left ventricular assist device is an acc eptable alternative therapy in selected patients who are not candidates for cardiac transplantation.