Transcatheter tricuspid valve intervention compared to optimal medical therapy: Meta-analysis of randomized...

Tricuspid regurgitation (TR) is a common valvular disorder linked to significant morbidity and mortality. Transcatheter tricuspid valve intervention (TTVI) has emerged as a novel therapeutic option for high-risk patients. However, randomized controlled trials (RCTs) evaluating its clinical efficacy remain limited in sample size, making it difficult to draw definitive conclusions.

We conducted a systematic review of studies comparing outcomes between TTVI vs. optimal medical therapy (OMT) published between January 2000 to June 2025 in PubMed, Cochrane, and Embase. The primary outcomes were all-cause mortality and heart failure hospitalization (HFH). The secondary outcomes included cardiovascular death, TR severity, NYHA class improvement, and Kansas City Cardiomyopathy Questionnaire (KCCQ) score.

Three RCTs, including 1264 patients (TTVI: 696; OMT: 568), were analyzed. At one year, there was no significant difference in all-cause mortality (RR: 1.12; 95 % CI: 0.77-1.63; p = 0.55), HFH (RR: 0.83; 95 % CI: 0.64-1.07; p = 0.15) and cardiovascular death (RR: 1.11; 95 % CI: 0.7-1.77; p = 0.65) between groups. Patients in TTVI group significantly improved at least 1 class in NYHA functional classification (RR: 2.77; 95 % CI: 1.72-4.49; p < 0.0001), had greater changes in KCCQ scores (+15.23 points; 95 % CI: 12.03-18.44; p < 0.0001), and markedly reduced the incidence of ≥ severe TR at follow-up (RR: 0.09; 95 % CI: 0.03-0.27; p < 0.0001) compared to OMT.

Although TTVI has not demonstrated statistically significant reductions in all-cause mortality or HFH, it is associated with substantial improvements in functional class, quality of life, and TR severity, supporting its role in select high-risk patients.