Repair reduces heart-failure events Transcatheter tricuspid-valve repair improved outcomes in high-risk severe tricuspid regurgitation.
*Randomized controlled superiority trial; Level 2 (OCEBM 2011).

Citation

Hausleiter J, Stocker TJ, et al. Tricuspid-Valve Intervention in Heart Failure. New England Journal of Medicine. Published August 30, 2026. doi:10.1056/NEJMoa2606934.

Background

Severe leakage of the tricuspid heart valve is linked to worsening heart failure and death. Prior randomized trials showed better quality of life after catheter-based repair, but effects on hospitalization and survival were uncertain.

Patients

360 adults with symptomatic severe tricuspid regurgitation despite at least 30 days of adjusted diuretic therapy, plus high risk for future heart-failure events. High risk meant recent heart-failure hospitalization or kidney or liver congestion. Detailed exclusions were in the supplement; all patients had catheter testing to avoid unsuitable pressure profiles.

Intervention

Catheter-based tricuspid-valve repair plus medical therapy.

Control

Medical therapy alone.

Outcome

Primary: death, heart-failure hospitalization, and quality-of-life improvement using the Kansas City Cardiomyopathy Questionnaire (0 to 100; higher is better).

Follow-up Period

Primary quality outcome: 1 year; clinical events: up to 3 years.

Results

OutcomeKey finding
Primary hierarchical outcome at 1 yearWin ratio 2.42 (95% CI 1.76 to 3.33), favoring repair
Death or heart-failure hospitalization through 3 yearsHazard ratio 0.40 (95% CI 0.29 to 0.55); event-free survival 52.4% vs 21.0%
Death through 3 yearsHazard ratio 0.62 (95% CI 0.40 to 0.96)
Heart-failure hospitalization through 3 yearsHazard ratio 0.35 (95% CI 0.25 to 0.50)
Quality-of-life score change at 1 yearMean difference 6.89 points (95% CI 1.76 to 12.02)
CI = confidence interval.
Analyses were by intention to treat. Number needed to treat to prevent one death or heart-failure hospitalization at 1 year was 4 (95% CI 3 to 6). A 15-point quality-of-life improvement was prespecified as clinically meaningful. Medical therapy alone was the current nonsurgical comparator. The composite benefit was mainly driven by fewer heart-failure hospitalizations, though death was also lower by 3 years.

Limitations

Open-label design may bias quality-of-life reporting. Crossovers from medical therapy complicate secondary outcomes. German expert centers may limit generalizability. Different repair devices prevent device-specific conclusions. Three-year follow-up was incomplete for later enrollees.

Funding

German public/academic funding; unrestricted Edwards Lifesciences grant, a bias concern.

Clinical Application

Consider early referral to experienced valve centers for selected high-risk patients with symptomatic severe tricuspid regurgitation despite optimized diuretics.