Clinical outcomes following tricuspid transcatheter edge-to-edge repair with PASCAL: A meta-analysis

Abstract

Background: Patients with severe tricuspid regurgitation (TR) exhibit high morbidity and mortality. Tricuspid transcatheter edge-to-edge repair (T-TEER) is a rapidly evolving strategy to address the unmet clinical need of severe TR therapies.

Objective: Organize the current body of evidence on outcomes following use of the PASCAL (Edwards Lifesciences) system for T-TEER.

Methods: For this meta-analysis, we searched the MEDLINE/PubMed, Embase, and Cochrane databases for keywords ["tricuspid"] and ["transcatheter" or "edge-to-edge"] and ["PASCAL" or "leaflet repair" or "valve repair"] from the database inception until January 11, 2023. Primary outcomes of interest were procedural success, mortality, New York Heart Association (NYHA) functional class, 6-min walking distance (6MWD), and TR severity.

Results: A total of 549 patients undergoing PASCAL or PASCAL Ace T-TEER were included. The mean age ranged from 71.0 to 80.3 years, with 25.0 to 63.6% females. The follow-up duration ranged from 30 days to 1 year. The success rate was 83.5% (409/490). There was improvement in symptoms based on NYHA classification (at 1- to 6-months; NYHA ≥3 RR 0.27 [95% CI 0.19-0.39]; p < 0.001) and 6MWD (at 1-month; 50.96 [95% CI 32.34-69.59]; p < 0.001) post-procedure. On imaging, there was improvement in TR severity post-procedure (at 1- to 12-months; ≥ severe TR 0.21 [95% CI 0.14-0.31]; p < 0.001), which remained significant with each study removed.

Conclusion: PASCAL for T-TEER is associated with high procedural success rates along with improvements in NYHA functional class, TR severity, 6MWD, and patient-reported outcomes.

Keywords: MitraClip XTR; PASCAL; Transcatheter edge-to-edge repair; Tricuspid regurgitation.