Clinical Characteristics and Outcomes of Patients Undergoing Transcatheter Tricuspid Valve Replacement Stratified by...

Clinical trials for transcatheter tricuspid valve replacement (TTVR) use strict eligibility criteria that often exclude real-world patients, who may have more advanced disease and different outcomes. We compared characteristics and short-term results between patients who would have been eligible versus noneligible for the TRISCEND II trial.

We analyzed a single-center cohort of 112 patients undergoing TTVR for symptomatic tricuspid regurgitation (TR). Patients were stratified according to TRISCEND II inclusion and exclusion criteria. Baseline demographics and 30-day outcomes were compared between eligible (n = 47) and noneligible (n = 65) groups.

Eligible patients were older (83.2 years [IQR, 77.4-86.7] vs 76.3 years [IQR, 69.6-83.1]), while sex distribution and New York Heart Association (NYHA) class III/IV were similar (female: 68.1% vs 64.6%; NYHA III/IV: 76.6% vs 75.4%). TR severity was comparable. Noneligible patients had lower ejection fraction (56% vs 60%) and more prior heart failure hospitalizations (13.8% vs 4.3%). At 30 days, both groups showed significant TR reduction, but noneligible patients remained more symptomatic (NYHA III/IV: 31.0% vs 11.9%) and had lower Kansas City Cardiomyopathy Questionnaire scores (65.63 vs 70.83). All-cause mortality (8.2% vs 2.0%) and major bleeding (17% vs 12.3%) were numerically higher in the noneligible group, whereas stroke, pacemaker implantation, and reintervention rates were low and similar.

Eligible patients had better cardiac function and were less symptomatic post-TTVR. Noneligible patients remained more symptomatic despite similar TR reduction, highlighting the need to consider real-world patient complexity when interpreting trial outcomes.