Goldstein, D., A. J. Moskowitz, A. C. Gelijns, G. Ailawadi, M. K. Parides, L. P. Perrault, J. W. Hung, P. Voisine, F. Dagenais, A. M. Gillinov, V. Thourani, M. Argenziano, J. S. Gammie, M. Mack, P. Demers, P. Atluri, E. A. Rose, K. O’Sullivan, D. L. Williams, E. Bagiella, R. E. Michler, R. D. Weisel, M. A. Miller, N. L. Geller, W. C. Taddei-Peters, P. K. Smith, E. Moquete, J. R. Overbey, I. L. Kron, P. T. O’Gara, M. A. Acker, M. Mack, T. A. Settele, N. Settele, W. Ryan, R. L. Smith and P. Grayburn (2016). “Two-Year Outcomes of Surgical Treatment of Severe Ischemic Mitral Regurgitation.” N Engl J Med 374(4): 344-353.
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BACKGROUND: In a randomized trial comparing mitral-valve repair with mitral-valve replacement in patients with severe ischemic mitral regurgitation, we found no significant difference in the left ventricular end-systolic volume index (LVESVI), survival, or adverse events at 1 year after surgery. However, patients in the repair group had significantly more recurrences of moderate or severe mitral regurgitation. We now report the 2-year outcomes of this trial. METHODS: We randomly assigned 251 patients to mitral-valve repair or replacement. Patients were followed for 2 years, and clinical and echocardiographic outcomes were assessed. RESULTS: Among surviving patients, the mean (+/-SD) 2-year LVESVI was 52.6+/-27.7 ml per square meter of body-surface area with mitral-valve repair and 60.6+/-39.0 ml per square meter with mitral-valve replacement (mean changes from baseline, -9.0 ml per square meter and -6.5 ml per square meter, respectively). Two-year mortality was 19.0% in the repair group and 23.2% in the replacement group (hazard ratio in the repair group, 0.79; 95% confidence interval, 0.46 to 1.35; P=0.39). The rank-based assessment of LVESVI at 2 years (incorporating deaths) showed no significant between-group difference (z score=-1.32, P=0.19). The rate of recurrence of moderate or severe mitral regurgitation over 2 years was higher in the repair group than in the replacement group (58.8% vs. 3.8%, P<0.001). There were no significant between-group differences in rates of serious adverse events and overall readmissions, but patients in the repair group had more serious adverse events related to heart failure (P=0.05) and cardiovascular readmissions (P=0.01). On the Minnesota Living with Heart Failure questionnaire, there was a trend toward greater improvement in the replacement group (P=0.07). CONCLUSIONS: In patients undergoing mitral-valve repair or replacement for severe ischemic mitral regurgitation, we observed no significant between-group difference in left ventricular reverse remodeling or survival at 2 years. Mitral regurgitation recurred more frequently in the repair group, resulting in more heart-failure-related adverse events and cardiovascular admissions. (Funded by the National Institutes of Health and Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00807040.).