Background: The present data aim to evaluate the feasibility of the orthotopic trans- catheter tricuspid valve replacement devices, echocardiographic, functional improve- ments, and mortality rates following replacement in patients with significant tricuspid valve regurgitation.

Methods: We systematically searched for the studies evaluating the efficacy and safety of transcatheter tricuspid valve replacement for significant tricuspid valve regurgitation. The efficacy and safety outcomes were the improvements in New York Heart Association functional class, 6-minute walking distance, all-cause death, and periprocedural andlong-term complications. In addition, a random-effect meta-analysis was performed comparing outcomes before and after transcatheter tricuspid valve replacement.

Results: Nine studies with 321 patients were included. The mean age was 75.8 years, and the mean European System for Cardiac Operative Risk Evaluation II score was 8.2% (95% CI: 6.1 to 10.3). Severe, massive, and torrential tricuspid valve regurgitation was diagnosed in 95% of patients (95% CI: 89% to 98%), and 83% (95% CI: 73% to 90%) of patients were in New York Heart Association functional class III or IV. At a weighted mean follow-up of 122 days, New York Heart Association functional class (risk ratio = 0.20; 95% CI: 0.11 to 0.35; P <.001) and 6-minute walking distance (mean difference = 91.1 m; 95% CI: 37.3 to 144.9 m; P <.001) significantly improved, and similarly, the prevalence of severe or greater tri- cuspid valve regurgitation was significantly reduced after transcatheter tricuspid valve replacement (baseline risk ratio = 0.19; 95% CI: 0.10 to 0.36; P <.001). In total, 28 patients (10%; 95% CI: 6% to 17%) had died. Pooled analyses demonstrated non-significant differ- ences in hospital and 30-day mortality and >30-day mortality than predicted operative mortality (risk ratio = 1.03; 95% CI: 0.41 to 2.59; P =.95, risk ratio = 1.39; 95% CI: 0.69 to 2.81; P =.35, respectively).

Conclusion: Transcatheter tricuspid valve replacement could be an emerging treatment option for patients with severe tricuspid regurgitation who are not eligible for transcath-eter repair or surgical replacement because of high surgical risk and poor prognosis.