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J Thorac Cardiovasc Surg 2005;129:9-17
© 2005 The American Association for Thoracic Surgery
Cardiopulmonary Support and Physiology |
a University of Minnesota, Minneapolis, Minn
b St Luke's Medical Center, Chicago, Ill
c Rush Presbyterian, Chicago, Ill
d Bryan LGH Heart Institute, Lincoln, Neb
e University of Alabama at Birmingham, Birmingham, Ala
f Temple University Hospital, Philadelphia, Pa
g Texas Heart Institute, Houston, Tex
h Sharp Memorial Hospital, San Diego, Calif
Read at the Eighty-third Annual Meeting of The American Association for Thoracic Surgery, Boston, Mass, May 4-7, 2003.
Received for publication May 20, 2003; revisions received April 2, 2004; accepted for publication April 12, 2004. * Address for reprints: Soon J. Park, MD, California Pacific Medical Center, Chairman, Department of Cardiovascular and Thoracic Surgery, 2100 Webster St, Suite 521, San Francisco, CA 94115 (E-mail: ParkS{at}sutterhealth.org).
OBJECTIVE: 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?
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
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