• N. Engl. J. Med. · Oct 2024

    Transcatheter Valve Replacement in Severe Tricuspid Regurgitation.

    • Rebecca T Hahn, Raj Makkar, Vinod H Thourani, Moody Makar, Rahul P Sharma, Christiane Haeffele, Charles J Davidson, Akhil Narang, Brian O'Neill, James Lee, Pradeep Yadav, Firas Zahr, Scott Chadderdon, Mackram Eleid, Sorin Pislaru, Robert Smith, Molly Szerlip, Brian Whisenant, Nishant K Sekaran, Santiago Garcia, Terri Stewart-Dehner, Holger Thiele, Robert Kipperman, Konstantinos Koulogiannis, D Scott Lim, Dale Fowler, Samir Kapadia, Serge C Harb, Paul A Grayburn, Anna Sannino, Michael J Mack, Martin B Leon, Philipp Lurz, Susheel K Kodali, and TRISCEND II Trial Investigators.
    • From Columbia University Irving Medical Center, New York (R.T.H., M.B.L., S.K.K.); Cedars-Sinai Medical Center, Los Angeles (R.M., M.M.), and Stanford University, Stanford (R.P.S., C.H.) - both in California; Piedmont Heart Institute, Marcus Heart Valve Center, Atlanta (V.H.T., P.Y.); Northwestern University Feinberg School of Medicine, Chicago (C.J.D., A.N.); Henry Ford Hospital, Detroit (B.O., J.L.); Oregon Health and Science University, Portland (F.Z., S.C.); Mayo Clinic, Rochester, MN (M.E., S.P.); Baylor Scott and White Heart Hospital Plano (R.S., M.S., P.A.G., M.J.M.) and Baylor Scott and White Research Institute Cardiac Imaging Core Laboratory (P.A.G., A.S.) - both in Plano, TX; Intermountain Medical Center, Murray, UT (B.W., N.K.S.); Christ Hospital, Cincinnati (S.G., T.S.-D.), and the Cleveland Clinic Foundation, Cleveland (S.K., S.C.H.); Heart Center Leipzig at Leipzig University, Leipzig (H.T.), and University Medical Center Mainz, Mainz (P.L.) - both in Germany; Morristown Medical Center, Morristown, NJ (R.K., K.K.); and the University of Virginia, Charlottesville (D.S.L., D.F.).
    • N. Engl. J. Med. 2024 Oct 30.

    BackgroundSevere tricuspid regurgitation is associated with disabling symptoms and an increased risk of death. Data regarding outcomes after percutaneous transcatheter tricuspid-valve replacement are needed.MethodsIn this international, multicenter trial, we randomly assigned 400 patients with severe symptomatic tricuspid regurgitation in a 2:1 ratio to undergo either transcatheter tricuspid-valve replacement and medical therapy (valve-replacement group) or medical therapy alone (control group). The hierarchical composite primary outcome was death from any cause, implantation of a right ventricular assist device or heart transplantation, postindex tricuspid-valve intervention, hospitalization for heart failure, an improvement of at least 10 points in the score on the Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS), an improvement of at least one New York Heart Association (NYHA) functional class, and an improvement of at least 30 m on the 6-minute walk distance. A win ratio was calculated for the primary outcome by comparing all possible patient pairs, starting with the first event in the hierarchy.ResultsA total of 267 patients were assigned to the valve-replacement group and 133 to the control group. At 1 year, the win ratio favoring valve replacement was 2.02 (95% confidence interval [CI], 1.56 to 2.62; P<0.001). In comparisons of patient pairs, those in the valve-replacement group had more wins than the control group with respect to death from any cause (14.8% vs. 12.5%), postindex tricuspid-valve intervention (3.2% vs. 0.6%), and improvement in the KCCQ-OS score (23.1% vs. 6.0%), NYHA class (10.2% vs. 0.8%), and 6-minute walk distance (1.1% vs. 0.9%). The valve-replacement group had fewer wins than the control group with respect to the annualized rate of hospitalization for heart failure (9.7% vs. 10.0%). Severe bleeding occurred in 15.4% of the valve-replacement group and in 5.3% of the control group (P = 0.003); new permanent pacemakers were implanted in 17.4% and 2.3%, respectively (P<0.001).ConclusionsFor patients with severe tricuspid regurgitation, transcatheter tricuspid-valve replacement was superior to medical therapy alone for the primary composite outcome, driven primarily by improvements in symptoms and quality of life. (Funded by Edwards Lifesciences; TRISCEND II ClinicalTrials.gov number, NCT04482062.).Copyright © 2024 Massachusetts Medical Society.

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