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; TRISCEND II Trial Investigators

doi:10.1056/NEJMoa2401918

Transcatheter Valve Replacement in Severe Tricuspid Regurgitation

N Engl J Med. 2024 Oct 30. doi: 10.1056/NEJMoa2401918. Online ahead of print.

Authors

Rebecca T Hahn¹, Raj Makkar¹, Vinod H Thourani¹, Moody Makar¹, Rahul P Sharma¹, Christiane Haeffele¹, Charles J Davidson¹, Akhil Narang¹, Brian O'Neill¹, James Lee¹, Pradeep Yadav¹, Firas Zahr¹, Scott Chadderdon¹, Mackram Eleid¹, Sorin Pislaru¹, Robert Smith¹, Molly Szerlip¹, Brian Whisenant¹, Nishant K Sekaran¹, Santiago Garcia¹, Terri Stewart-Dehner¹, Holger Thiele¹, Robert Kipperman¹, Konstantinos Koulogiannis¹, D Scott Lim¹, Dale Fowler¹, Samir Kapadia¹, Serge C Harb¹, Paul A Grayburn¹, Anna Sannino¹, Michael J Mack¹, Martin B Leon¹, Philipp Lurz¹, Susheel K Kodali¹; TRISCEND II Trial Investigators

Affiliation

¹ 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.).

PMID: 39475399
DOI: 10.1056/NEJMoa2401918

Abstract

Background: Severe tricuspid regurgitation is associated with disabling symptoms and an increased risk of death. Data regarding outcomes after percutaneous transcatheter tricuspid-valve replacement are needed.

Methods: In 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.

Results: A 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).

Conclusions: For 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.).

Associated data

ClinicalTrials.gov/NCT04482062