TY - JOUR
T1 - Left ventricular assist devices as destination therapy
T2 - A new look at survival
AU - Park, Soon J.
AU - Tector, Alfred
AU - Piccioni, William
AU - Raines, Edward
AU - Gelijns, Annetine
AU - Moskowitz, Alan
AU - Rose, Eric
AU - Holman, William
AU - Furukawa, Satoshi
AU - Frazier, O. Howard
AU - Dembitsky, Walter
N1 - Funding Information:
The REMATCH trial was supported, in part, by a cooperative agreement (HL-53986) funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health, Bethesda, Md, and Thoratec Corporation, Pleasanton, Calif. Additional funding for the routine costs of clinical care associated with the trial was made available by the Center for Medicare and Medicaid Services and by the participating clinical centers.
PY - 2005/1
Y1 - 2005/1
N2 - The REMATCH trial compared the use of left ventricular assist devices with optimal medical management for patients with end-stage heart failure. When the trial met its primary end point criteria in July 2001, left ventricular assist device therapy was shown to significantly improve survival and quality of life. With extended follow-up, 2 critical questions emerge: (1) Did these benefits persist, and (2) did outcomes improve over the course of the trial, given the evolving nature of the technology? We analyzed survival in this randomized trial by using the product-limit method of Kaplan and Meier. Changes in the benefits of therapy were analyzed by examining the effect of the enrollment period. The survival rates for patients receiving left ventricular assist devices (n = 68) versus patients receiving optimal medical management (n = 61) were 52% versus 28% at 1 year and 29% versus 13% at 2 years (P =. 008, log-rank test). As of July 2003, 11 patients were alive on left ventricular assist device support out of a total 16 survivors (including 3 patients receiving optimal medical management who crossed over to left ventricular assist device therapy). There was a significant improvement in survival for left ventricular assist devicesupported patients who enrolled during the second half of the trial compared with the first half (P =. 03). The Minnesota Living with Heart Failure scores improved significantly over the course of the trial. The extended follow-up confirms the initial observation that left ventricular assist device therapy renders significant survival and quality-of-life benefits compared with optimal medical management for patients with end-stage heart failure. Furthermore, we observed an improvement in the survival of patients receiving left ventricular assist devices over the course of the trial, suggesting the effect of greater clinical experience.
AB - The REMATCH trial compared the use of left ventricular assist devices with optimal medical management for patients with end-stage heart failure. When the trial met its primary end point criteria in July 2001, left ventricular assist device therapy was shown to significantly improve survival and quality of life. With extended follow-up, 2 critical questions emerge: (1) Did these benefits persist, and (2) did outcomes improve over the course of the trial, given the evolving nature of the technology? We analyzed survival in this randomized trial by using the product-limit method of Kaplan and Meier. Changes in the benefits of therapy were analyzed by examining the effect of the enrollment period. The survival rates for patients receiving left ventricular assist devices (n = 68) versus patients receiving optimal medical management (n = 61) were 52% versus 28% at 1 year and 29% versus 13% at 2 years (P =. 008, log-rank test). As of July 2003, 11 patients were alive on left ventricular assist device support out of a total 16 survivors (including 3 patients receiving optimal medical management who crossed over to left ventricular assist device therapy). There was a significant improvement in survival for left ventricular assist devicesupported patients who enrolled during the second half of the trial compared with the first half (P =. 03). The Minnesota Living with Heart Failure scores improved significantly over the course of the trial. The extended follow-up confirms the initial observation that left ventricular assist device therapy renders significant survival and quality-of-life benefits compared with optimal medical management for patients with end-stage heart failure. Furthermore, we observed an improvement in the survival of patients receiving left ventricular assist devices over the course of the trial, suggesting the effect of greater clinical experience.
UR - http://www.scopus.com/inward/record.url?scp=19944393852&partnerID=8YFLogxK
U2 - 10.1016/j.jtcvs.2004.04.044
DO - 10.1016/j.jtcvs.2004.04.044
M3 - Article
C2 - 15632819
AN - SCOPUS:19944393852
SN - 0022-5223
VL - 129
SP - 9
EP - 17
JO - Journal of Thoracic and Cardiovascular Surgery
JF - Journal of Thoracic and Cardiovascular Surgery
IS - 1
ER -