Gennaro Giustino1, Jessica Overbey2, Doris Taylor3, Gorav Ailawadi4, Katherine Kirkwood2, Joseph DeRose5, Marc A Gillinov6, François Dagenais7, Mary-Lou Mayer8, Alan Moskowitz2, Emilia Bagiella2, Marissa Miller9, Paul Grayburn10, Peter K Smith11, Annetine Gelijns12, Patrick O'Gara13, Michael Acker8, Anuradha Lala1, Judy Hung14. 1. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York. 2. Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York. 3. Department of Regenerative Medicine Research, Texas Heart Institute, Houston, Texas. 4. Division of Thoracic and Cardiovascular Surgery, University of Virginia, Charlottesville, Virginia. 5. Department of Cardiovascular and Thoracic Surgery, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York. 6. Department of Thoracic and Cardiovascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. 7. Institut Universitaire de Cardiologie et de Pneumologie de Québec/Québec Heart and Lung Institute, Laval University, Quebec City, Quebec, Canada. 8. Department of Surgery, Division of Cardiovascular Surgery, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania. 9. National Heart, Lung, and Blood Institute of the National Institutes of Health, Bethesda, Maryland. 10. Division of Cardiology, Department of Internal Medicine, Baylor University Medical Center, Dallas, Texas. 11. Division of Cardiothoracic Surgery, Department of Surgery, Duke University, Durham, North Carolina. 12. Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: Annetine.gelijns@mssm.edu. 13. Division of Cardiology, Brigham and Women's' Hospital, Boston, Massachusetts. 14. Division of Cardiology, Massachusetts General Hospital, Boston, Massachusetts.
Abstract
OBJECTIVES: This study investigated sex-based differences in outcomes after mitral valve (MV) surgery for severe ischemic mitral regurgitation (SIMR). BACKGROUND: Whether differences in outcomes exist between men and women after surgery for SIMR remains unknown. METHODS: Patients enrolled in a randomized trial comparing MV replacement versus MV repair for SIMR were included and followed for 2 years. Endpoints for this analysis included all-cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE) (defined as the composite of death, stroke, hospitalization for heart failure, worsening New York Heart Association functional class or MV re-operation), quality of life (QOL), functional status, and percentage of change in left ventricular end-systolic volume index (LVESVI) from baseline through 2 years. RESULTS: Of 251 patients enrolled in the trial, 96 (38.2%) were women. Compared with men, women had smaller LV volumes and effective regurgitant orifice areas (EROA) but greater EROA/left ventricular (LV) end-diastolic volume ratios. At 2 years, women had higher rates of all-cause mortality (27.1% vs. 17.4%, respectively; adjusted hazard ratio [adjHR]: 1.85; 95% confidence interval [CI]: 1.05 to 3.26; p = 0.03) and of MACCE (49.0% vs. 38.1%, respectively; adjHR: 1.58; 95% CI: 1.06 to 2.37; p = 0.02). Women also reported worse QOL and functional status at 2 years. There were no significant differences in the percentage of change over 2 years in LVESVI between women and men (adjβ: -10.4; 95% CI: -23.4 to 2.6; p = 0.12). CONCLUSIONS: Women with SIMR displayed different echocardiographic features and experienced higher mortality and worse QOL after MV surgery than men. There were no significant differences in the degree of reverse LV remodeling between sexes. (Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation [Severe Ischemic Mitral Regurgitation]; NCT00807040).
RCT Entities:
OBJECTIVES: This study investigated sex-based differences in outcomes after mitral valve (MV) surgery for severe ischemic mitral regurgitation (SIMR). BACKGROUND: Whether differences in outcomes exist between men and women after surgery for SIMR remains unknown. METHODS:Patients enrolled in a randomized trial comparing MV replacement versus MV repair for SIMR were included and followed for 2 years. Endpoints for this analysis included all-cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE) (defined as the composite of death, stroke, hospitalization for heart failure, worsening New York Heart Association functional class or MV re-operation), quality of life (QOL), functional status, and percentage of change in left ventricular end-systolic volume index (LVESVI) from baseline through 2 years. RESULTS: Of 251 patients enrolled in the trial, 96 (38.2%) were women. Compared with men, women had smaller LV volumes and effective regurgitant orifice areas (EROA) but greater EROA/left ventricular (LV) end-diastolic volume ratios. At 2 years, women had higher rates of all-cause mortality (27.1% vs. 17.4%, respectively; adjusted hazard ratio [adjHR]: 1.85; 95% confidence interval [CI]: 1.05 to 3.26; p = 0.03) and of MACCE (49.0% vs. 38.1%, respectively; adjHR: 1.58; 95% CI: 1.06 to 2.37; p = 0.02). Women also reported worse QOL and functional status at 2 years. There were no significant differences in the percentage of change over 2 years in LVESVI between women and men (adjβ: -10.4; 95% CI: -23.4 to 2.6; p = 0.12). CONCLUSIONS:Women with SIMR displayed different echocardiographic features and experienced higher mortality and worse QOL after MV surgery than men. There were no significant differences in the degree of reverse LV remodeling between sexes. (Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation [Severe Ischemic Mitral Regurgitation]; NCT00807040).
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