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Randomized Controlled Trial Multicenter Study
Concomitant Tricuspid Repair in Patients with Degenerative Mitral Regurgitation.
- James S Gammie, ChuMichael W AMWAFrom the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Volkmar Falk, Jessica R Overbey, Alan J Moskowitz, Marc Gillinov, Michael J Mack, Pierre Voisine, Markus Krane, Babatunde Yerokun, Michael E Bowdish, Lenard Conradi, Steven F Bolling, Marissa A Miller, Wendy C Taddei-Peters, Neal O Jeffries, Michael K Parides, Richard Weisel, Mariell Jessup, Eric A Rose, John C Mullen, Samantha Raymond, Ellen G Moquete, Karen O'Sullivan, Mary E Marks, Alexander Iribarne, Friedhelm Beyersdorf, Michael A Borger, Arnar Geirsson, Emilia Bagiella, Judy Hung, Annetine C Gelijns, Patrick T O'Gara, Gorav Ailawadi, and CTSN Investigators.
- From the Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore (J.S.G.), and the Division of Cardiovascular Sciences (M.A.M., W.C.T.-P.), National Heart, Lung, and Blood Institute (N.O.J.), National Institutes of Health, Bethesda - both in Maryland; the Division of Cardiac Surgery, Western University, London Health Sciences Centre, London, ON (M.W.A.C.), and the Division of Cardiovascular Surgery, Toronto General Hospital and University of Toronto, Toronto (R.W.), Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (P.V.), and Cardiovascular and Thoracic Surgery, Department of Surgery, University of Alberta, Edmonton (J.C.M.) - all in Canada; the Department of Cardiothoracic and Vascular Surgery, Deutsche Herzzentrum Berlin, the Department of Cardiovascular Surgery, Charité Universitätsmedizin Berlin, and DZHK (German Center for Cardiovascular Research), Berlin (V.F.), Technical University of Munich, School of Medicine and Health, the Department of Cardiovascular Surgery, Institute Insure (Institute for Translational Cardiac Surgery), German Heart Center Munich, and DZHK, Munich (M.K.), the Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg (L.C.), the Department of Cardiovascular Surgery, University Heart Center Freiburg, and Albert Ludwigs University Freiburg, Freiburg (F.B.), and Leipzig Heart Center, University of Leipzig, Leipzig (M.A.B.) - all in Germany; the Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai (J.R.O., A.J.M., E.A.R., S.R., E.G.M., K.O., M.E.M., E.B., A.C.G.) and the Department of Cardiothoracic and Vascular Surgery, Montefiore Medical Center, Albert Einstein College of Medicine (M.K.P.) - both in New York; the Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland (M.G.); the Department of Cardiac and Thoracic Surgery, Baylor Scott and White Health, Plano (M.J.M.), and American Heart Association, Dallas (M.J.) - both in Texas; the Department of Surgery, Division of Cardiac Surgery, Yale School of Medicine, New Haven, CT (A.G., M.K.); the Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University, Durham, NC (B.Y.); the Departments of Surgery and Population and Public Health Sciences, Keck School of Medicine, University of Southern California, Los Angeles (M.E.B.); the Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor (S.F.B., G.A.); the Section of Cardiac Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (A.I.); and the Division of Cardiology, Massachusetts General Hospital (J.H.) and the Division of Cardiovascular Medicine, Brigham and Women's Hospital (P.T.O.) - both in Boston.
- N. Engl. J. Med. 2022 Jan 27; 386 (4): 327339327-339.
BackgroundTricuspid regurgitation is common in patients with severe degenerative mitral regurgitation. However, the evidence base is insufficient to inform a decision about whether to perform tricuspid-valve repair during mitral-valve surgery in patients who have moderate tricuspid regurgitation or less-than-moderate regurgitation with annular dilatation.MethodsWe randomly assigned 401 patients who were undergoing mitral-valve surgery for degenerative mitral regurgitation to receive a procedure with or without tricuspid annuloplasty (TA). The primary 2-year end point was a composite of reoperation for tricuspid regurgitation, progression of tricuspid regurgitation by two grades from baseline or the presence of severe tricuspid regurgitation, or death.ResultsPatients who underwent mitral-valve surgery plus TA had fewer primary-end-point events than those who underwent mitral-valve surgery alone (3.9% vs. 10.2%) (relative risk, 0.37; 95% confidence interval [CI], 0.16 to 0.86; P = 0.02). Two-year mortality was 3.2% in the surgery-plus-TA group and 4.5% in the surgery-alone group (relative risk, 0.69; 95% CI, 0.25 to 1.88). The 2-year prevalence of progression of tricuspid regurgitation was lower in the surgery-plus-TA group than in the surgery-alone group (0.6% vs. 6.1%; relative risk, 0.09; 95% CI, 0.01 to 0.69). The frequencies of major adverse cardiac and cerebrovascular events, functional status, and quality of life were similar in the two groups at 2 years, although the incidence of permanent pacemaker implantation was higher in the surgery-plus-TA group than in the surgery-alone group (14.1% vs. 2.5%; rate ratio, 5.75; 95% CI, 2.27 to 14.60).ConclusionsAmong patients undergoing mitral-valve surgery, those who also received TA had a lower incidence of a primary-end-point event than those who underwent mitral-valve surgery alone at 2 years, a reduction that was driven by less frequent progression to severe tricuspid regurgitation. Tricuspid repair resulted in more frequent permanent pacemaker implantation. Whether reduced progression of tricuspid regurgitation results in long-term clinical benefit can be determined only with longer follow-up. (Funded by the National Heart, Lung, and Blood Institute and the German Center for Cardiovascular Research; ClinicalTrials.gov number, NCT02675244.).Copyright © 2021 Massachusetts Medical Society.
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