• Stephan Baldus, Torsten Doenst, Roman Pfister, Jan Gummert, Mirjam Kessler, Peter Boekstegers, Edith Lubos, Jörg Schröder, Holger Thiele, Thomas Walther, Malte Kelm, Jörg Hausleiter, Ingo Eitel, Ulrich Fischer-Rasokat, Alexander Bufe, Alexander Schmeisser, Hüseyin Ince, Philipp Lurz, Ralph Stephan von Bardeleben, Christian Hagl, Thilo Noack, Sebastian Reith, Harald Beucher, Hermann Reichenspurner, Wolfgang Rottbauer, P Christian Schulze, Wiebke Müller, Julia Frank, Martin Hellmich, Thorsten Wahlers, Volker Rudolph, and MATTERHORN Investigators.
• From the Department of Internal Medicine III (S.B., R.P.), the Institute of Medical Statistics and Computational Biology (W.M., J.F., M.H.), and Cardiothoracic Surgery (T. Wahlers), Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, the Department of Cardiothoracic Surgery (T.D.) and Cardiology (P.C.S.), Jena University Hospital, Friedrich-Schiller-University of Jena, Jena, Thoracic and Cardiovascular Surgery (J.G.) and General and Interventional Cardiology/Angiology (V.R.), Heart and Diabetes Center NRW, University Hospital of the Ruhr-University Bochum, Medical Faculty OWL, Bad Oeynhausen, the Department of Cardiology, Ulm University Heart Center, Ulm (M. Kessler, W.R.), the Faculty of Health, School of Medicine (P.B.), and Helios Klinikum Krefeld (A.B.), University Witten/Herdecke, Witten, Marienkrankenhaus (E.L.), the Department of Cardiology, University Hospital Eppendorf (E.L.), and the Department of Cardiothoracic Surgery, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf (H.R.), Hamburg, the Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen (J.S.), Cardiac Surgery (T.N.), Heart Center Leipzig at Leipzig University (H.T.), and Leipzig Heart Science (H.T.), Leipzig, the Department of Cardiovascular Surgery, University Hospital Frankfurt and Goethe University Frankfurt, Frankfurt (T. Walther), University Hospital Düsseldorf and CARID (Cardiovascular Research Institute Düsseldorf), Düsseldorf (M. Kelm), Medical Clinic and Polyclinic I (J.H.) and the Department of Cardiac Surgery (C.H.), Ludwig Maximilian University Munich, Munich, Medical Clinic II, University Heart Center Lübeck, and the German Center for Cardiovascular Research (DZHK), Lübeck (I.E.), the Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim (U.F.-R.), Otto-von-Guericke-University Magdeburg, Magdeburg (A.S.), the Department of Cardiology, University Medical Center Rostock, Rostock (H.I.), the Department of Cardiology, University Medical Center Mainz (P.L., R.S.B.), and the German Center for Cardiovascular Research (DZHK) partner site Rhine Main (P.L.), Mainz, St. Franziskus Hospital, Münster (S.R.), and the Department of Cardiology, Helios Klinikum Siegburg, Siegburg (H.B.) - all in Germany.
• N. Engl. J. Med. 2024 Nov 14; 391 (19): 178717981787-1798.

BackgroundCurrent treatment recommendations for patients with heart failure and secondary mitral regurgitation include transcatheter edge-to-edge repair and mitral-valve surgery. Data from randomized trials comparing these therapies are lacking in this patient population.MethodsIn this noninferiority trial conducted in Germany, patients with heart failure and secondary mitral regurgitation who continued to have symptoms despite guideline-directed medical therapy were randomly assigned, in a 1:1 ratio, to undergo either transcatheter edge-to-edge repair (intervention group) or surgical mitral-valve repair or replacement (surgery group). The primary efficacy end point was a composite of death, hospitalization for heart failure, mitral-valve reintervention, implantation of an assist device, or stroke within 1 year after the procedure. The primary safety end point was a composite of major adverse events within 30 days after the procedure.ResultsA total of 210 patients underwent randomization. The mean (±SD) age of the patients was 70.5±7.9 years, 39.9% were women, and the mean left ventricular ejection fraction was 43.0±11.7%. Within 1 year, at least one of the components of the primary efficacy end point occurred in 16 of the 96 patients with available data (16.7%) in the intervention group and in 20 of the 89 with available data (22.5%) in the surgery group (estimated mean difference, -6 percentage points; 95% confidence interval [CI], -17 to 6; P<0.001 for noninferiority). A primary safety end-point event occurred in 15 of the 101 patients with available data (14.9%) in the intervention group and in 51 of the 93 patients with available data (54.8%) in the surgery group (estimated mean difference, -40 percentage points; 95% CI, -51 to -27; P<0.001).ConclusionsAmong patients with heart failure and secondary mitral regurgitation, transcatheter edge-to-edge repair was noninferior to mitral-valve surgery with respect to a composite of death, rehospitalization for heart failure, stroke, reintervention, or implantation of an assist device in the left ventricle at 1 year. (Funded by Abbott Vascular; MATTERHORN ClinicalTrials.gov number, NCT02371512.).Copyright © 2024 Massachusetts Medical Society.

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