Transcatheter tricuspid-valve replacement reduced severe tricuspid regurgitation to mild or less in 72.6% of patients at one year, according to results from the TRISCEND II trial. The study evaluated the EVOQUE transcatheter valve system in patients with severe symptomatic tricuspid regurgitation.

This randomized, controlled trial enrolled 400 patients across 45 centers in the U.S. and Germany. Participants were assigned in a 2:1 ratio to transcatheter valve replacement plus medical therapy or medical therapy alone. The hierarchical composite primary endpoint assessed all-cause mortality, tricuspid-valve reintervention, hospitalization for heart failure, and improvements in Kansas City Cardiomyopathy Questionnaire overall summary scores, New York Heart Association (NYHA) class, and six-minute walk distance.

At one year, the win ratio for valve replacement versus medical therapy was 2.02 (95% CI, 1.56–2.62; P<0.001), driven primarily by improvements in quality-of-life measures and functional capacity. A clinically meaningful improvement of at least 10 points in the Kansas City Cardiomyopathy Questionnaire overall summary score was achieved by 66.4% of patients in the valve-replacement group, compared to 36.5% in the control group. The valve replacement group also showed significant gains in NYHA class improvement (≥1 class: 10.2% vs. 0.8%) and six-minute walk distance (1.1% vs. 0.9%). Severe regurgitation was reduced to 0.9% in the valve-replacement group, compared to 41.4% in the control group.

Mortality (12.6% vs. 15.2%) and hospitalization rates (20.9% vs. 26.1%) numerically favored valve replacement but did not reach statistical significance. Adverse events included severe bleeding (15.4% vs. 5.3%; P=0.003) and the need for permanent pacemaker implantation (17.4% vs. 2.3%; P<0.001).

The study, published in The New England Journal of Medicine, found that transcatheter tricuspid-valve replacement improved functional and quality-of-life measures in patients with severe symptomatic tricuspid regurgitation. Reported risks included bleeding and pacemaker implantation, underscoring the importance of perioperative management.

Full disclosures can be found in the published study.