Cardiovasc Revasc Med. 2025 Oct 17:S1553-8389(25)00545-7. doi: 10.1016/j.carrev.2025.10.010. Online ahead of print.
ABSTRACT
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
PMID:41145332 | DOI:10.1016/j.carrev.2025.10.010
