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Journal Article Ahead of print 15 citations

PubMed: 42670975 DOI: 10.1056/NEJMoa2606934

Tricuspid-Valve Intervention in Heart Failure.

N Engl J Med

Authors: Jörg Hausleiter, Thomas J Stocker, Tobias Geisler, Philipp Lurz, Wolfgang Rottbauer, Edith Lubos, Niklas Schofer, Christian Frerker, Johanne Frank, Holger Thiele, Rico Osteresch, Volker Rudolph, Alexander Lauten, Erion Xhepa, Jürgen Rothe, Tienush Rassaf, Stephan Baldus, Georg Nickenig, David M Leistner, Eike Tigges, Victoria Kehl, Mirjam Kessler, Tobias Kister, Tobias Ruf, Muhammed Gerçek, Meinrad Gawaz, Derk Frank, Ingo Eitel, Ralph Stephan von Bardeleben, Daniel Kalbacher, Osama Soliman, Michael Näbauer, Steffen Massberg

Affiliations

  • Department of Medicine I, LMU University Hospital, LMU Medizin, Ludwig-Maximilians-Universität München, Munich, Germany.
  • German Center for Cardiovascular Research (DZHK) Partner Site Munich Heart Alliance, Munich.
  • Department of Cardiology and Angiology, Eberhard Karls University Tübingen, Tübingen, Germany.
  • Department of Cardiology, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.
  • DZHK Partner Site Rhine-Main, Germany [several locations].
  • Department of Cardiology, University Heart Center, Ulm, Germany.
  • Department of Cardiology, Asklepios Klinik Barmbek, Hamburg, Germany.
  • Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
  • Department of Cardiology, Electrophysiology, Pulmonology, and General Internal Medicine, Friedrich-Ebert-Krankenhaus Neumünster, Neumünster, Germany.
  • DZHK Partner Site North, Hamburg-Kiel-Luebeck, Germany.
  • University of Luebeck, Heart Center, Luebeck, Germany.
  • Department of Cardiology, Angiology, and Intensive Care Medicine, University Hospital Schleswig-Holstein, Luebeck, Germany.
  • Department of Cardiology and Internal Intensive Medicine, University Medical Center Schleswig-Holstein Campus Kiel, Kiel, Germany.
  • Department of Cardiology, Heart Center Leipzig, Leipzig University, Leipzig, Germany.
  • Bremen Institute for Heart and Circulation Research, Klinikum Links der Weser, Bremen, Germany.
  • Heart and Diabetes Center North Rhine-Westphalia, Department of General and Interventional Cardiology/Angiology, Ruhr University Bochum, Bad Oeynhausen, Germany.
  • Department of General and Interventional Cardiology and Rhythmology, Helios Klinikum Erfurt, Health and Medical University Erfurt, Erfurt, Germany.
  • Department of Cardiovascular Diseases, TUM Klinikum Deutsches Herzzentrum, Technical University of Munich, Germany.
  • Department of Cardiology and Angiology, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.
  • Department of Medicine, Freiburg University, Freiburg im Breisgau, Germany.
  • Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen, Essen, Germany.
  • Department of Cardiology, University Hospital Cologne, Cologne, Germany.
  • Heart Center University Hospital Bonn, Bonn, Germany.
  • Department of Cardiology and Angiology, Goethe University, Frankfurt am Main, Germany.
  • Department of Cardiology and Intensive Care Medicine, Asklepios Clinic St. Georg, Hamburg, Germany.
  • Münchner Studienzentrum, TUM School of Medicine and Health, Technical University of Munich, Munich, Germany.
  • Biostatistics and Clinical Epidemiology, Institute for AI and Informatics in Medicine, TUM School of Medicine and Health, Technical University of Munich, Munich, Germany.
  • Royal College of Surgeons in Ireland University of Medicine and Health Sciences, Dublin.
  • Cardiovascular Research Institute Dublin, Mater Private Network, Dublin.
  • Department of Cardiology, Mater Private Network, Dublin.

Abstract

BACKGROUND

The effect of transcatheter tricuspid-valve repair on clinical outcomes, including death and hospitalization for heart failure, in patients with severe tricuspid regurgitation remains uncertain.

METHODS

We randomly assigned patients with symptomatic severe tricuspid regurgitation and an increased risk of future heart-failure events in a 2:1 ratio to tricuspid-valve repair plus medical therapy (tricuspid-repair group) or medical therapy alone (medical-therapy group). The first primary end point was a hierarchical composite of death from any cause, hospitalization for heart failure, and quality-of-life improvement at 1 year, assessed by win ratio. If the between-group difference was significant, a second primary end point would be tested: a composite of death from any cause or hospitalization for heart failure through 3 years.

RESULTS

A total of 360 patients underwent randomization (237 patients were assigned to the tricuspid-repair group and 123 to the medical-therapy group). The mean (±SD) age of the patients was 80.3±6.4 years, and 56.4% were women. The win ratio for the first primary end point was 2.42 (95% confidence interval [CI], 1.76 to 3.33; P<0.001), favoring tricuspid-valve repair. The Kaplan-Meier estimate for freedom from death from any cause or hospitalization for heart failure (second primary end point) through 3 years was 52.4% (95% CI, 43.2 to 63.6) in the tricuspid-repair group and 21.0% (95% CI, 12.7 to 34.6) in the medical-therapy group (hazard ratio for death from any cause or hospitalization for heart failure, 0.40; 95% CI, 0.29 to 0.55; P<0.001). Major adverse events within 30 days occurred in 14 patients (5.9%) in the tricuspid-repair group.

CONCLUSIONS

Among patients with symptomatic severe tricuspid regurgitation, transcatheter tricuspid-valve repair plus medical therapy was superior to medical therapy alone with respect to a hierarchical composite of death from any cause, hospitalization for heart failure, and quality-of-life improvement at 1 year and was also associated with a lower risk of a composite of death from any cause or hospitalization for heart failure through 3 years. (Funded by the German Center for Cardiovascular Research and others; TRIC-I-HF ClinicalTrials.gov number, NCT04634266.).

MeSH

Hospitalization, Heart Failure, Heart, Tricuspid Valve, Therapeutics, Tricuspid Valve Insufficiency

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