Transcatheter Repair for Patients with Tricuspid Regurgitation

This international, randomized TRILUMINATE Pivotal trial evaluated transcatheter edge-to-edge repair (TEER) for symptomatic severe tricuspid regurgitation using the TriClip device. Across 350 patients randomized 1:1 to TEER or medical therapy, the primary hierarchical composite endpoint comprising all-cause death or tricuspid-valve surgery, heart failure hospitalization, and ≥15-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score favored TEER (win ratio 1.48; 95% CI, 1.06–2.13; P=0.02). Although mortality and hospitalization rates were similar between groups, quality-of-life scores improved significantly with TEER (mean change +12.3 vs. +0.6 points; P<0.001), and 87% of TEER patients had tricuspid regurgitation reduced to moderate or less at 30 days, compared to 4.8% with medical therapy. TEER was safe: 98.3% were free from major adverse events at 30 days. Improvements in KCCQ were strongly correlated with reductions in regurgitation severity. The procedure demonstrates promise for patients not eligible for surgery, with stable valve reduction and symptomatic benefit at 1 year.

This international, randomized TRILUMINATE Pivotal trial evaluated transcatheter edge-to-edge repair (TEER) for symptomatic severe tricuspid regurgitation using the TriClip device. Across 350 patients randomized 1:1 to TEER or medical therapy, the primary hierarchical composite endpoint comprising all-cause death or tricuspid-valve surgery, heart failure hospitalization, and ≥15-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score favored TEER (win ratio 1.48; 95% CI, 1.06–2.13; P=0.02). Although mortality and hospitalization rates were similar between groups, quality-of-life scores improved significantly with TEER (mean change +12.3 vs. +0.6 points; P<0.001), and 87% of TEER patients had tricuspid regurgitation reduced to moderate or less at 30 days, compared to 4.8% with medical therapy. TEER was safe: 98.3% were free from major adverse events at 30 days. Improvements in KCCQ were strongly correlated with reductions in regurgitation severity. The procedure demonstrates promise for patients not eligible for surgery, with stable valve reduction and symptomatic benefit at 1 year.