Transcatheter Mitral Valve Replacement Versus Medical Therapy for Secondary Mitral Regurgitation: A Propensity Score-Matched Comparison.

Autor:	Ludwig S; Departments of Cardiology (S.L.), University Heart and Vascular Center Hamburg, Germany.; German Center for Cardiovascular Research, Partner site Hamburg/Kiel/Lübeck, Germany (S.L.).; Cardiovascular Research Foundation, New York City, NY (S.L., D.J.C., A.C., A.S., Z.Z., Y.L., B.R., J.F.G.)., Conradi L; Cardiovascular Surgery (L.C.), University Heart and Vascular Center Hamburg, Germany., Cohen DJ; Cardiovascular Research Foundation, New York City, NY (S.L., D.J.C., A.C., A.S., Z.Z., Y.L., B.R., J.F.G.).; St. Francis Hospital, Roslyn, New York (D.J.C.)., Coisne A; Cardiovascular Research Foundation, New York City, NY (S.L., D.J.C., A.C., A.S., Z.Z., Y.L., B.R., J.F.G.).; University Lille, Inserm, CHU Lille, Institut Pasteur de Lille, France (A.C.)., Scotti A; Cardiovascular Research Foundation, New York City, NY (S.L., D.J.C., A.C., A.S., Z.Z., Y.L., B.R., J.F.G.).; Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, NY (A.S., A.L.)., Abraham WT; Departments of Medicine, Physiology, and Cell Biology, Division of Cardiovascular Medicine, Davis Heart and Lung Research Institute, The Ohio State University, Columbus (W.T.A.)., Ben Ali W; Structural Valve Program, Montreal Heart Institute, Canada (W.B.A.)., Zhou Z; Cardiovascular Research Foundation, New York City, NY (S.L., D.J.C., A.C., A.S., Z.Z., Y.L., B.R., J.F.G.)., Li Y; Cardiovascular Research Foundation, New York City, NY (S.L., D.J.C., A.C., A.S., Z.Z., Y.L., B.R., J.F.G.)., Kar S; Los Robles Regional Medical Center, Thousand Oaks, CA (S.K.).; Bakersfield Heart Hospital, CA (S.K.)., Duncan A; Royal Brompton Hospital, London, United Kingdom (A.D.)., Lim DS; Division of Cardiology, University of Virginia, Charlottesville (D.S.L.)., Adamo M; Cardiac Catheterization Laboratory and Cardiology, ASST Spedali Civili and Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Italy (M. Adamo, M.M.).; Department of Cardiology, Heart Center, University of Cologne, Germany (M. Adam)., Redfors B; Cardiovascular Research Foundation, New York City, NY (S.L., D.J.C., A.C., A.S., Z.Z., Y.L., B.R., J.F.G.).; NewYork-Presbyterian Hospital/Columbia University Medical Center (B.R.).; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden (B.R.).; Wallenberg Laboratory, Institute of Medicine, University of Gothenburg, Sweden (B.R.)., Muller DWM; Cardiology Department, St. Vincent's Hospital, Sydney, Australia (D.W.M.M.).; School of Clinical Medicine, UNSW Medicine and Health UNSW Sydney, Australia (D.W.M.M.)., Webb JG; St. Paul's Hospital, Vancouver, British Columbia, Canada (J.G.W.)., Petronio AS; Cardiac Catheterization Laboratory, Cardiothoracic and Vascular Department, University of Pisa, Italy (A.S.P.)., Ruge H; Departments of Cardiovascular Surgery (H.R.), German Heart Center Munich, Germany.; Cardiovascular Surgery, INSURE-Institute for Translational Cardiac Surgery (H.R.), German Heart Center Munich, Germany., Nickenig G; Heart Center Bonn, Germany (G.N.)., Sondergaard L; Rigshospitalet, Copenhagen, Denmark (L.S.)., Adam M; Department of Cardiology, Heart Center, University of Cologne, Germany (M. Adam)., Regazzoli D; IRCCS Humanitas Research Hospital, Milan, Italy (D.R.)., Garatti A; IRCCS Policlinico San Donato, Milan, Italy (A.G.)., Schmidt T; Medical Clinic II, University Heart Center Lübeck, Germany (T.S.)., Andreas M; Department of Cardiac Surgery, Medical University of Vienna, Austria (M. Andreas)., Dahle G; Oslo University Hospital, Rikshospitalet, Norway (G.D.)., Walther T; Frankfurt University Hospital, Germany (T.W.)., Kempfert J; German Heart Institute Berlin, Germany (J.K.)., Tang GHL; Department of Cardiovascular Surgery, Mount Sinai Health System, New York, NY (G.H.L.T.)., Redwood S; St. Thomas' Hospital, London, United Kingdom (S.R.)., Taramasso M; HerzZentrum Hirslanden Zürich, Switzerland (M.T.)., Praz F; Universitätsklinik für Kardiologie, Inselspital Bern, Switzerland (F.P.)., Fam N; St. Michael's Hospital, University of Toronto, Canada (N.F.)., Dumonteil N; Groupe CardioVasculaire Interventionnel, Clinique Pasteur Toulouse, France (N.D.)., Obadia JF; Department of Cardiac Surgery, Louis Pradel Cardiologic Hospital, Lyon, France (J.-F.O.)., von Bardeleben RS; Heart Valve Center and Heart and Vascular Center, Universitätsmedizin Mainz, Germany (R.S.v.B.)., Rudolph TK; Department of Interventional and General Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Ruhr University Bochum, Germany (T.K.R.)., Reardon MJ; Houston Methodist Hospital, TX (M.J.R.)., Metra M; Cardiac Catheterization Laboratory and Cardiology, ASST Spedali Civili and Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Italy (M. Adamo, M.M.)., Denti P; Ospedale San Raffaele, Milan, Italy (P.D.)., Mack MJ; Baylor Scott and White Heart Hospital Plano, TX (M.J.M.)., Hausleiter J; Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany (J.H.)., Asch FM; Cardiovascular Core Laboratories, MedStar Health Research Institute, Washington, DC (F.M.A.)., Latib A; Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Center, NY (A.S., A.L.)., Lindenfeld J; Advanced Heart Failure and Cardiac Transplantation Section, Vanderbilt Heart and Vascular Institute, Nashville, TN (J.L.)., Modine T; Centre Hospitalier Universitaire de Bordeaux, France (T.M.)., Stone GW; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (G.W.S.)., Granada JF; Cardiovascular Research Foundation, New York City, NY (S.L., D.J.C., A.C., A.S., Z.Z., Y.L., B.R., J.F.G.).
Jazyk:	angličtina
Zdroj:	Circulation. Cardiovascular interventions [Circ Cardiovasc Interv] 2023 Jun; Vol. 16 (6), pp. e013045. Date of Electronic Publication: 2023 May 16.
DOI:	10.1161/CIRCINTERVENTIONS.123.013045
Abstrakt:	Background: Transcatheter mitral valve replacement (TMVR) is an emerging therapeutic alternative for patients with secondary mitral regurgitation (MR). Outcomes of TMVR versus guideline-directed medical therapy (GDMT) have not been investigated for this population. This study aimed to compare clinical outcomes of patients with secondary MR undergoing TMVR versus GDMT alone. Methods: The CHOICE-MI registry (Choice of Optimal Transcatheter Treatment for Mitral Insufficiency) included patients with MR undergoing TMVR using dedicated devices. Patients with MR pathogeneses other than secondary MR were excluded. Patients treated with GDMT alone were derived from the control arm of the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation). We compared outcomes between the TMVR and GDMT groups, using propensity score matching to adjust for baseline differences. Results: After propensity score matching, 97 patient pairs undergoing TMVR (72.9±8.7 years; 60.8% men; transapical access, 91.8%) versus GDMT (73.1±11.0 years; 59.8% men) were compared. At 1 and 2 years, residual MR was ≤1+ in all patients of the TMVR group compared with 6.9% and 7.7%, respectively, in those receiving GDMT alone (both P <0.001). The 2-year rate of heart failure hospitalization was significantly lower in the TMVR group (32.8% versus 54.4%; hazard ratio, 0.59 [95% CI, 0.35-0.99]; P =0.04). Among survivors, a higher proportion of patients were in the New York Heart Association functional class I or II in the TMVR group at 1 year (78.2% versus 59.7%; P =0.03) and at 2 years (77.8% versus 53.2%; P =0.09). Two-year mortality was similar in the 2 groups (TMVR versus GDMT, 36.8% versus 40.8%; hazard ratio, 1.01 [95% CI, 0.62-1.64]; P =0.98). Conclusions: In this observational comparison, over 2-year follow-up, TMVR using mostly transapical devices in patients with secondary MR was associated with significant reduction of MR, symptomatic improvement, less frequent hospitalizations for heart failure, and similar mortality compared with GDMT. Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT04688190 (CHOICE-MI) and NCT01626079 (COAPT). Competing Interests: Disclosures Dr Ludwig reports travel compensation from Edwards; speaker honoraria from Abbott; and advisory fees from Bayer. Dr Conradi reports being on the advisory board at Abbott, Medtronic, and Boston Scientific and personal fees from Edwards. Dr Cohen reports research grant and consulting fees from Abbott, Edwards Lifesciences, Boston Scientific, and Medtronic AC; is a proctor at Abbott; and is a speaker at Abbott and General Electric Healthcare. Dr Scotti is a consultant for NeoChord. Dr Abraham reports research grant from the National Institutes of Health–National Heart, Lung, and Blood Institute (National Institutes of Health 1 UG3/UH3 HL140144-01, 08/01/18-07/31/22, LOFT-HF [Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Readmission/Mortality in Patients With Heart Failure and Central Sleep Apnea]); consulting at Abbott, Boehringer Ingelheim, and Zoll; honoraria from Impulse Dynamics; and salary from V-Wave Medical. Dr Ben Ali reports grants from Medtronic and Edwards. Dr Kar reports grants and consulting from Abbott, Boston Scientific, Edwards, and 4TECH and stock at 4TECH. Dr Scott Lim reports grants from Abbott, Boston Scientific, Corvia, Edwards, Medtronic, Trisol, and V-Wave and is a consultant at Ancora, Philips, Valgen, and Venus. Dr Duncan is a consultant at Abbott, Edwards, and Medtronic. Dr Adamo reports personal fees from Edwards and Boston Scientific and grants and honoraria from Medtronic. Dr Muller is on the advisory board at Abbott, Medtronic, and Edwards. Dr Petronio is a consultant at Medtronic, Boston Scientific, and Abbott. Dr Ruge is on the advisory board at Abbott and is a proctor at Abbott and Edwards. Dr Sondergaard reports grants and consulting at Edwards and Medtronic. Dr Adam reports grants and honoraria from Medtronic and personal fees from Boston Scientific and Edwards. Dr Dahle is a proctor/speaker at Abbott and Edwards. Dr Kempfert reports honoraria from Edwards, Medtronic, Abbott, and CryoLife. Dr Garatti is a proctor at Abbott. Dr Schmidt reports honoraria and travel support from Abbott and Cardiovalve. Dr Tang is a proctor/consultant at Medtronic; consultant/advisory board at Abbott; consultant at NeoChord; advisory board at JenaValve; and honoraria from Siemens and EastEnd Medical. Dr Redwood is a proctor at and reports personal fees from Edwards and is on the advisory board at Medtronic. Dr Taramasso is a consultant at Abbott, Edwards, Boston Scientific, Shenqi Medical, Simulands, Occlufit, MTEx, Medira, 4tech, and CoreMedic and reports personal fees from Cardiovalve. Dr Praz is a consultant at Edwards. Dr Fam is a consultant at Edwards, Abbott, and Cardiovalve. Dr Dumonteil is a consultant/proctor at Abbott, Boston Scientific, Edwards, and Medtronic. Dr von Bardeleben reports consulting/honoraria from Abbott, Edwards, and Medtronic and research grants to the university from Abbott and Edwards. Dr Rudolph reports honoraria from Abbott. Dr Reardon is a consultant at Medtronic, Boston, Abbott, and Gore (all funds to the department). Dr Metra reports personal fees from Actelion, Amgen, Livanova, Servier, Vifor Pharma as member of the Executive or Data Monitoring Committees of sponsored clinical trials, AstraZeneca, Abbott, Bayer, Boheringer Ingelhelm, and Edwards Therapeutics for participation to advisory boards and speeches at sponsored meetings. Dr Denti reports personal fees from Abbott and Edwards. Dr Mack reports being a co-Principal Investigator for the PARTNER trial (Placement of Aortic Transcatheter Valve Trial; Edwards) and COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation; Abbott) and is a study chair for the APOLLO trial (Transcatheter Mitral Valve Replacement With the Medtronic Intrepid TMVR System in Patients With Severe Symptomatic Mitral Regurgitation; Medtronic). Dr Hausleiter reports consulting fees, speaker honoraria, and research support to the institution from Abbott and Edwards. Dr Asch reports institutional contracts from Abbott, Neovasc, Ancora, Mitralign, Medtronic, Boston Scientific, Edwards Lifesciences, Biotronik, and Livanova. Dr Latib is on the advisory board at Medtronic, Boston Scientific, Philips, Edwards, and Abbott. Dr Lindenfeld reports grant support from AstraZeneca and consulting at Abbott, Alleviant, AstraZeneca, Cordio, CVRx, Edwards, Boehringer Ingelheim, Merck, Medtronic, Vascular Dynamics, and V-Wave. Dr Modine is a consultant at Abbott, Edwards, and Medtronic. Dr Stone reports honoraria from Medtronic, Pulnovo, and Infraredx; is a consultant at Valfix, TherOx, Robocath, HeartFlow, Ablative Solutions, Vectorious, Miracor, Neovasc, Abiomed, Ancora, Elucid Bio, Occlutech, CorFlow, Apollo Therapeutics, Impulse Dynamics, Cardiomech, Gore, Amgen, Adona Medical, and Millennia Biopharma; and reports equity/options at Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter. Dr Stone’s daughter is an employee at Medtronic. Dr Stone’s employer, Mount Sinai Hospital, receives research support from Abbott, Abiomed, Bioventrix, Cardiovascular Systems, Inc, Phillips, Biosense Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-wave. Dr Granada is the President and Chief Executive Officer of Cardiovascular Research Foundation. The other authors report no conflicts.
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