Daniel Goldstein1, Alan J Moskowitz, Annetine C Gelijns, Gorav Ailawadi, Michael K Parides, Louis P Perrault, Judy W Hung, Pierre Voisine, Francois Dagenais, A Marc Gillinov, Vinod Thourani, Michael Argenziano, James S Gammie, Michael Mack, Philippe Demers, Pavan Atluri, Eric A Rose, Karen O'Sullivan, Deborah L Williams, Emilia Bagiella, Robert E Michler, Richard D Weisel, Marissa A Miller, Nancy L Geller, Wendy C Taddei-Peters, Peter K Smith, Ellen Moquete, Jessica R Overbey, Irving L Kron, Patrick T O'Gara, Michael A Acker. 1. From the Department of Cardiothoracic Surgery, Montefiore Medical Center-Albert Einstein College of Medicine (D.G., R.E.M.), International Center for Health Outcomes and Innovation Research, Department of Population Health Science and Policy (A.J.M., A.C.G., M.K.P., K.O., D.L.W., E.B., E.M., J.R.O.) and Cardiovascular Institute (E.A.R.), Icahn School of Medicine at Mount Sinai, and Division of Cardiothoracic Surgery, Department of Surgery, College of Physicians and Surgeons, Columbia University (M.A.) - all in New York; the Division of Thoracic and Cardiovascular Surgery, University of Virginia School of Medicine, Charlottesville (G.A., I.L.K.); Montreal Heart Institute, University of Montreal, Montreal (L.P.P., P.D.), Institut Universitaire de Cardiologie de Québec, Hôpital Laval, Quebec, QC (P.V., F.D.), and Peter Munk Cardiac Centre and Division of Cardiovascular Surgery, Toronto General Hospital, University Health Network and the Division of Cardiac Surgery, University of Toronto, Toronto (R.D.W.) - all in Canada; the Echocardiography Core Lab, Massachusetts General Hospital (J.W.H.), and the Cardiovascular Division, Brigham and Women's Hospital (P.T.O.) - both in Boston; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic Foundation, Cleveland (A.M.G.); the Clinical Research Unit, Division of Cardiothoracic Surgery, Emory University School of Medicine, Atlanta (V.T.); the University of Maryland, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T-.P.) and Office of Biostatistics Research (N.L.G.), National Heart, Lung, and Blood Institute, Bethesda - both in Maryland; Baylor Research Institute, Dallas (M.M.); the Department of Surgery, Division of Cardiovascular Surgery, University of Pennsylvania School of Medicine, Philadelphia (P.A., M.A.A.); and the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University Medical Center, Durham, NC (P.K.S.).
Abstract
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.).
RCT Entities:
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.).
Authors: Christina M Vassileva; Theresa Boley; Stephen Markwell; Stephen Hazelrigg Journal: Eur J Cardiothorac Surg Date: 2010-08-19 Impact factor: 4.191
Authors: Michele De Bonis; Elisabetta Lapenna; Alessandro Verzini; Giovanni La Canna; Antonio Grimaldi; Lucia Torracca; Francesco Maisano; Ottavio Alfieri Journal: Ann Thorac Surg Date: 2008-03 Impact factor: 4.330
Authors: Louis P Perrault; Alan J Moskowitz; Irving L Kron; Michael A Acker; Marissa A Miller; Keith A Horvath; Vinod H Thourani; Michael Argenziano; David A D'Alessandro; Eugene H Blackstone; Claudia S Moy; Joseph P Mathew; Judy Hung; Timothy J Gardner; Michael K Parides Journal: J Thorac Cardiovasc Surg Date: 2011-11-04 Impact factor: 5.209
Authors: Irving L Kron; Judy Hung; Jessica R Overbey; Denis Bouchard; Annetine C Gelijns; Alan J Moskowitz; Pierre Voisine; Patrick T O'Gara; Michael Argenziano; Robert E Michler; Marc Gillinov; John D Puskas; James S Gammie; Michael J Mack; Peter K Smith; Chittoor Sai-Sudhakar; Timothy J Gardner; Gorav Ailawadi; Xin Zeng; Karen O'Sullivan; Michael K Parides; Roger Swayze; Vinod Thourani; Eric A Rose; Louis P Perrault; Michael A Acker Journal: J Thorac Cardiovasc Surg Date: 2014-11-06 Impact factor: 5.209
Authors: Edwin C McGee; A Marc Gillinov; Eugene H Blackstone; Jeevanantham Rajeswaran; Gideon Cohen; Farzad Najam; Takahiro Shiota; Joseph F Sabik; Bruce W Lytle; Patrick M McCarthy; Delos M Cosgrove Journal: J Thorac Cardiovasc Surg Date: 2004-12 Impact factor: 5.209
Authors: Julien Magne; Nicolas Girerd; Mario Sénéchal; Patrick Mathieu; François Dagenais; Jean G Dumesnil; Eric Charbonneau; Pierre Voisine; Philippe Pibarot Journal: Circulation Date: 2009-09-15 Impact factor: 29.690
Authors: Judy Hung; Lampros Papakostas; Stephen A Tahta; Bruce G Hardy; Bruce A Bollen; Carlos M Duran; Robert A Levine Journal: Circulation Date: 2004-09-14 Impact factor: 29.690
Authors: Michael A Acker; Michael K Parides; Louis P Perrault; Alan J Moskowitz; Annetine C Gelijns; Pierre Voisine; Peter K Smith; Judy W Hung; Eugene H Blackstone; John D Puskas; Michael Argenziano; James S Gammie; Michael Mack; Deborah D Ascheim; Emilia Bagiella; Ellen G Moquete; T Bruce Ferguson; Keith A Horvath; Nancy L Geller; Marissa A Miller; Y Joseph Woo; David A D'Alessandro; Gorav Ailawadi; Francois Dagenais; Timothy J Gardner; Patrick T O'Gara; Robert E Michler; Irving L Kron Journal: N Engl J Med Date: 2013-11-18 Impact factor: 91.245
Authors: Bart S Ferket; Vinod H Thourani; Pierre Voisine; Samuel F Hohmann; Helena L Chang; Peter K Smith; Robert E Michler; Gorav Ailawadi; Louis P Perrault; Marissa A Miller; Karen O'Sullivan; Stephanie L Mick; Emilia Bagiella; Michael A Acker; Ellen Moquete; Judy W Hung; Jessica R Overbey; Anuradha Lala; Margaret Iraola; James S Gammie; Annetine C Gelijns; Patrick T O'Gara; Alan J Moskowitz Journal: J Thorac Cardiovasc Surg Date: 2019-07-02 Impact factor: 5.209