Transcatheter Valve Replacement in Severe Tricuspid Regurgitation

N Engl J Med. 2025 Jan 9;392(2):115-126. doi: 10.1056/NEJMoa2401918. Epub 2024 Oct 30.

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.).

Publication types

  • Randomized Controlled Trial
  • Multicenter Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Cardiac Catheterization* / adverse effects
  • Cardiac Catheterization* / instrumentation
  • Cardiac Catheterization* / methods
  • Female
  • Heart Failure* / epidemiology
  • Heart Failure* / etiology
  • Heart Failure* / therapy
  • Heart Transplantation / statistics & numerical data
  • Heart Valve Prosthesis Implantation* / adverse effects
  • Heart Valve Prosthesis Implantation* / instrumentation
  • Heart Valve Prosthesis Implantation* / methods
  • Heart Valve Prosthesis* / adverse effects
  • Heart-Assist Devices / statistics & numerical data
  • Hospitalization / statistics & numerical data
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Postoperative Hemorrhage* / epidemiology
  • Postoperative Hemorrhage* / etiology
  • Prospective Studies
  • Quality of Life
  • Severity of Illness Index
  • Treatment Outcome
  • Tricuspid Valve / surgery
  • Tricuspid Valve Insufficiency* / complications
  • Tricuspid Valve Insufficiency* / diagnosis
  • Tricuspid Valve Insufficiency* / mortality
  • Tricuspid Valve Insufficiency* / therapy

Associated data

  • ClinicalTrials.gov/NCT04482062