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Ann Thorac Surg 1999;67:723-730
© 1999 The Society of Thoracic Surgeons
a International Center for Health Outcomes and Innovation Research, Columbia University, New York Presbyterian Hospital, New York, New York, USA
b Department of Surgery, College of Physicians and Surgeons, Columbia University, New York Presbyterian Hospital, New York, New York, USA
c Department of Medicine, College of Physicians and Surgeons, Columbia University, New York Presbyterian Hospital, New York, New York, USA
d Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York Presbyterian Hospital, New York, New York, USA
e Department of Neurology, College of Physicians and Surgeons, Columbia University, New York Presbyterian Hospital, New York, New York, USA
f Division of Biostatistics, School of Public Health, Columbia University, New York, New York, USA
g Brigham and Women’s Hospital, Boston, Massachusetts, USA
h National Heart, Lung, and Blood Institute, Bethesda, MD, USA
Accepted for publication November 10, 1998.
Address reprint requests to Dr Gelijns, International Center for Health Outcomes and Innovation Research, Columbia University, Harkness Pavilion, Room 758, 180 Fort Washington Ave, New York, NY 10032
e-mail: acp10{at}columbia.edu
Background. Because left ventricular assist devices have recently been approved by the Food and Drug Administration to support the circulation of patients with end-stage heart failure awaiting cardiac transplantation, these devices are increasingly being considered as a potential alternative to biologic cardiac replacement. The Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial is a multicenter study supported by the National Heart, Lung, and Blood Institute to compare long-term implantation of left ventricular assist devices with optimal medical management for patients with end-stage heart failure who require, but do not qualify to receive cardiac transplantation.
Methods. We discuss the rationale for conducting REMATCH, the obstacles to designing this and other randomized surgical trials, the lessons learned in conducting the multicenter pilot study, and the features of the REMATCH study design (objectives, target population, treatments, end points, analysis, and trial organization).
Conclusions. We consider what will be learned from REMATCH, expectations for expanding the use of left ventricular assist devices, and future directions for assessing clinical procedures.
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E. A. Rose, A. C. Gelijns, A. J. Moskowitz, D. F. Heitjan, L. W. Stevenson, W. Dembitsky, J. W. Long, D. D. Ascheim, A. R. Tierney, R. G. Levitan, et al. Long-Term Use of a Left Ventricular Assist Device for End-Stage Heart Failure N. Engl. J. Med., November 15, 2001; 345(20): 1435 - 1443. [Abstract] [Full Text] [PDF]
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