A Comparison of Outcomes in Men 11 Years after Heart-Valve Replacement with a Mechanical Valve or Bioprosthesis
Karl E. Hammermeister, Gulshan K. Sethi, William G. Henderson, Charles Oprian, Tai Kim, Shahbudin Rahimtoola, for The Veterans Affairs Cooperative Study on Valvular Heart Disease
Background Mechanical heart valves are durable but thrombogenic,and their use requires that the patient receive anticoagulants.In contrast, bioprosthetic valves are less thrombogenic, butthey have limited durability because of tissue deterioration.
Methods To compare the outcomes of patients who receive thesetwo types of valves, we randomly assigned 575 men scheduledto undergo aortic-valve or mitral-valve replacement to receiveeither a mechanical or a bioprosthetic valve. The primary endpoints were death from any cause and any valve-related complication.
Results During an average follow-up of 11 years, there was nodifference between the two groups in the probability of deathfrom any cause (11-year probability for mechanical valves, 0.57;for bioprostheses, 0.62; P = 0.57) or in the probability ofany valve-related complication (0.65 and 0.69, respectively;P = 0.39). There was a much higher rate of structural valvefailure among patients who received bioprosthetic valves (11-yearprobability, 0.15 for the aortic valves and 0.36 for the mitralvalves) than among those who received mechanical valves (novalve failures; P<0.001). However, this difference was offsetby a higher rate of bleeding complications among patients withmechanical valves than among those with bioprosthetic valves(11-year probability, 0.42 and 0.26, respectively; P<0.001)and by a greater frequency of periprosthetic valvular regurgitationamong patients with mechanical mitral valves than among thosewith mitral bioprostheses (11-year probability, 0.17 and 0.09,respectively; P = 0.05).
Conclusions After 11 years, the rates of survival and freedomfrom all valve-related complications were similar for patientswho received mechanical heart valves and those who receivedbioprosthetic heart valves. However, structural failure wasobserved only with the bioprosthetic valves, whereas bleedingcomplications were more frequent among patients who receivedmechanical valves.
Source Information
From the Cardiology Section, Veterans Affairs Medical Center, and the Department of Medicine, University of Colorado School of Medicine, Denver (K.E.H.); the Cardiothoracic Surgery Section, Veterans Affairs Medical Center, and the Department of Surgery, University of Arizona Health Sciences Center, Tucson (G.K.S.); the Cooperative Studies Program Coordinating Center, Veterans Affairs Medical Center, Hines, Ill. (W.G.H., C.O., T.K.); and the Department of Medicine, Section of Cardiology, University of Southern California, Los Angeles (S.R.). The participants in this study are listed in the Appendix.
Address reprint requests to Dr. Hammermeister at the Cardiology Section (111B), Veterans Affairs Medical Center, 1055 Clermont, Denver, CO 80220.
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