The Effect of Cardiac Resynchronization on Morbidity and Mortality in Heart Failure
John G.F. Cleland, M.D., Jean-Claude Daubert, M.D., Erland Erdmann, M.D., Nick Freemantle, Ph.D., Daniel Gras, M.D., Lukas Kappenberger, M.D., Luigi Tavazzi, M.D., for the Cardiac Resynchronization Heart Failure (CARE-HF) Study Investigators
Background Cardiac resynchronization reduces symptoms and improvesleft ventricular function in many patients with heart failuredue to left ventricular systolic dysfunction and cardiac dyssynchrony.We evaluated its effects on morbidity and mortality.
Methods Patients with New York Heart Association class III orIV heart failure due to left ventricular systolic dysfunctionand cardiac dyssynchrony who were receiving standard pharmacologictherapy were randomly assigned to receive medical therapy aloneor with cardiac resynchronization. The primary end point wasthe time to death from any cause or an unplanned hospitalizationfor a major cardiovascular event. The principal secondary endpoint was death from any cause.
Results A total of 813 patients were enrolled and followed fora mean of 29.4 months. The primary end point was reached by159 patients in the cardiac-resynchronization group, as comparedwith 224 patients in the medical-therapy group (39 percent vs.55 percent; hazard ratio, 0.63; 95 percent confidence interval,0.51 to 0.77; P<0.001). There were 82 deaths in the cardiac-resynchronizationgroup, as compared with 120 in the medical-therapy group (20percent vs. 30 percent; hazard ratio 0.64; 95 percent confidenceinterval, 0.48 to 0.85; P<0.002). As compared with medicaltherapy, cardiac resynchronization reduced the interventricularmechanical delay, the end-systolic volume index, and the areaof the mitral regurgitant jet; increased the left ventricularejection fraction; and improved symptoms and the quality oflife (P<0.01 for all comparisons).
Conclusions In patients with heart failure and cardiac dyssynchrony,cardiac resynchronization improves symptoms and the qualityof life and reduces complications and the risk of death. Thesebenefits are in addition to those afforded by standard pharmacologictherapy. The implantation of a cardiac-resynchronization deviceshould routinely be considered in such patients.
Source Information
From the Department of Cardiology, Castle Hill Hospital, Kingston-upon-Hull, United Kingdom (J.G.F.C.); the Department of Cardiology, Hôpital Pontchaillou, Rennes, France (J.-C.D.); Klinik III für Innere Medizin der Universität zu Köln, Cologne, Germany (E.E.); the University of Birmingham, Edgbaston, United Kingdom (N.F.); Nouvelles Cliniques Nantaises, Nantes, France (D.G.); the Division of Cardiology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland (L.K.); and Istituto di Ricovero e Cura a Carattere Scientifico, Policlinico San Matteo, Pavia, Italy (L.T.). This article was published at www.nejm.org on March 7, 2004.
Address reprint requests to Dr. Cleland at the Department of Cardiology, Castle Hill Hospital, University of Hull, Kingston-upon-Hull, United Kingdom, or at j.g.cleland{at}hull.ac.uk.
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