In the first year of its approval in the U.S., transcatheter tricuspid valve replacement (TTVR) in patients with severe tricuspid regurgitation (TR) was found to be safe and effective by STS/ACC TVT Registry data, showing 30-day outcomes consistent with the TRISCEND II pivotal trial, according to a study published April 13 in JAMA.

Raj R. Makkar, MD, FACC, et al., evaluated 1,034 patients (mean age 77 years, 69% female, 11% Black) undergoing TTVR at 82 centers in the U.S. from February 2024 to March 2025. Primary outcomes were 30-day event rates, including all-cause death, stroke, bleeding, new cardiac implantable electronic device (CIED) implantation, and heart failure (HF) hospitalization, as well as TR reduction and changes in health status measured by NYHA functional class and Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score.

Successful valve implantation was observed in 98.4% of patients, with 98.4% achieving mild or less TR following the procedure. This rate decreased slightly to 97.7% at 30 days. Other 30-day outcomes include 3.1% experiencing all-cause mortality, 0.2% stroke, 7.9% bleeding, 15.9% new CIED, and 3.1% HF hospitalization.

When comparing health status at baseline vs. 30 days post TTVR, authors noted "significant improvements" in both NYHA functional class (class I/II, 82.7%; p<0.001) and mean KCCQ-OS score (22.4 points; p<0.002). "The magnitude of TR elimination and improvements in patient-reported and echocardiographic outcomes align with those reported in TRISCEND II, supporting generalizability of the treatment effect outside of clinical trial settings," state the authors.

When stratifying patients by baseline CIED status, Makkar and colleagues found no difference in 30-day mortality, HF hospitalization and functional outcomes. They add "...outcomes were broadly consistent across major clinical subgroups, including those stratified by presence of CIED at baseline, TR etiology and dialysis. Taken together, the findings suggest that introduction of TTVR after regulatory approval in the U.S. has been safe and effective."