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Mitral-valve repair versus replacement for severe ischemic mitral regurgitation.
N. Engl. J. Med..Jan 2, 2014;370(1):23-32.
Acker MA, Parides MK, Perrault LP, Moskowitz AJ, Gelijns AC, Voisine P, Smith PK, Hung JW, Blackstone EH, Puskas JD, Argenziano M, Gammie JS, Mack M, Ascheim DD, Bagiella E, Moquete EG, Ferguson TB, Horvath KA, Geller NL, Miller MA, Woo YJ, D'Alessandro DA, Ailawadi G, Dagenais F, Gardner TJ, O'Gara PT, Michler RE, Kron IL, Miller MA.
From the Department of Surgery, Division of Cardiovascular Surgery, University of Pennsylvania School of Medicine, Philadelphia (M.A.A., Y.J.W.); the International Center for Health Outcomes and Innovation Research (InCHOIR), Department of Health Evidence and Policy, Mount Sinai School of Medicine (M.K.P., A.J.M., A.C.G., D.D.A., E.B., E.G.M.), Division of Cardiothoracic Surgery, Department of Surgery, College of Physicians and Surgeons, Columbia University (M.A.), and the Department of Cardiothoracic Surgery, Montefiore Medical Center and Albert Einstein College of Medicine (D.A.D., R.E.M.) - all in New York; Montreal Heart Institute, University of Montreal, Montreal (L.P.P.); Institut Universitaire de Cardiologie de Québec, Hôpital Laval, Quebec, QC, Canada (P.V., F.D.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University Medical Center, Durham (P.K.S.), and the Department of Cardiovascular Sciences, East Carolina Heart Institute at East Carolina University, Greenville (T.B.F.) - both in North Carolina; Echocardiography Core Lab, Massachusetts General Hospital (J.W.H.), and Cardiovascular Division, Brigham and Women's Hospital (P.T.O.) - both in Boston; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic Foundation, Cleveland (E.H.B.); Clinical Research Unit, Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (J.D.P.); Division of Cardiac Surgery, University of Maryland School of Medicine, Baltimore (J.S.G.); Baylor Research Institute, Dallas (M.M.); National Institutes of Health (NIH) Heart Center at Suburban Hospital (K.A.H.), and the Office of Biostatistics Research (N.L.G.) and the Division of Cardiovascular Sciences (M.A.M.), NIH - all in Bethesda, MD; the Division of Thoracic and Cardiovascular Surgery, University of Virginia School of Medicine, Charlottesville (G.A., I.L.K.); and the Center for Heart and Vascular Health, Christiana Care Health System, Newark, DE (T.J
Ischemic mitral regurgitation is associated with a substantial risk of death. Practice guidelines recommend surgery for patients with a severe form of this condition but acknowledge that the supporting evidence for repair or replacement is limited.
We randomly assigned 251 patients with severe ischemic mitral regurgitation to undergo either mitral-valve repair or chordal-sparing replacement in order to evaluate efficacy and safety. The primary end point was the left ventricular end-systolic volume index (LVESVI) at 12 months, as assessed with the use of a Wilcoxon rank-sum test in which deaths were categorized below the lowest LVESVI rank.
At 12 months, the mean LVESVI among surviving patients was 54.6±25.0 ml per square meter of body-surface area in the repair group and 60.7±31.5 ml per square meter in the replacement group (mean change from baseline, -6.6 and -6.8 ml per square meter, respectively). The rate of death was 14.3% in the repair group and 17.6% in the replacement group (hazard ratio with repair, 0.79; 95% confidence interval, 0.42 to 1.47; P=0.45 by the log-rank test). There was no significant between-group difference in LVESVI after adjustment for death (z score, 1.33; P=0.18). The rate of moderate or severe recurrence of mitral regurgitation at 12 months was higher in the repair group than in the replacement group (32.6% vs. 2.3%, P<0.001). There were no significant between-group differences in the rate of a composite of major adverse cardiac or cerebrovascular events, in functional status, or in quality of life at 12 months.
We observed no significant difference in left ventricular reverse remodeling or survival at 12 months between patients who underwent mitral-valve repair and those who underwent mitral-valve replacement. Replacement provided a more durable correction of mitral regurgitation, but there was no significant between-group difference in clinical outcomes. (Funded by the National Institutes of Health and the Canadian Institutes of Health; ClinicalTrials.gov number, NCT00807040.).