Efficacy and Safety of Transcatheter Therapy for Patients With Tricuspid Regurgitation: A Systematic Review and Meta‐Analysis of Randomized Controlled Trials

ABSTRACT Severe tricuspid regurgitation (TR) is a prevalent valvular disorder associated with significant morbidity, impaired quality of life, and increased mortality. This meta‐analysis evaluates the safety and efficacy of transcatheter therapies (TCT) that have emerged as promising alternatives to surgical intervention, especially in the high‐risk population. This study aimed to assess the safety and clinical outcomes of TCT compared with optimal medical therapy (OMT) for severe TR. Multiple databases, including MEDLINE, Embase, Scopus, and ClinicalTrials.gov were searched from inception to March 2025. We assessed the clinical outcomes of TCT compared with OMT using mean difference (MD) and risk ratio (RR) with 95% confidence intervals (CI) and I 2 for heterogeneity. Outcomes included all‐cause mortality (ACM), cardiovascular death (CV death), heart failure hospitalizations (HFH), cardiac remodeling, functional capacity, and quality of life score. We included four RCTs of TCT on severe TR versus OMT, involving 1292 patients, of whom 710 (55%) underwent TCT. In the pooled analysis, ACM was not affected by the intervention therapy compared to OMT (RR = 1.12; 95% CI 0.65−1.93; p = 0.54), nor were CV death (RR = 0.87; 95% CI 0.50−1.51; p = 0.49), stroke (RR = 1.54; 95% CI 0.27−8.76; p = 0.39), and HFH (RR = 0.86; 95% CI 0.61−1.22; p = 0.21). However, secondary outcomes were robustly affected in the TCT group, as demonstrated by the six–minute walk distance test (6MWD) (MD = 33.55 m; 95% CI 17.04−50.07; p < 0.01) and the Kansas City cardiomyopathy questionnaire (KCCQ) (MD = 14.46; 95% CI 11.42−17.49; p < 0.01). In high‐risk patients with severe TR, TCT effectively improves functional status and enhances quality of life compared with OMT, while survival benefits remain unproven.