Background: Tricuspid valve transcatheter edge-to-edge repair (T-TEER) has emerged as a valuable treatment option for patients with severe tricuspid regurgitation (TR).
Objectives: The study aims to investigate the safety and effectiveness of the PASCAL transcatheter valve repair system in treating severe TR in an all-comers, real-world patient population.
Methods: The PASTE (PASCAL for Tricuspid Regurgitation – a European registry) study is an investigator-initiated, multicenter, retro- and prospective observational cohort analysis conducted across 16 European heart valve centers including consecutive patients treated with the PASCAL transcatheter valve repair system from 02/2019 to 11/2023 without application of exclusion or inclusion criteria. Echocardiographic assessments were performed at baseline, discharge, and follow-up, and were all subjected to centralized analysis.
Results: The study included 1059 high-risk patients (mean age 79±9 years, 53% female, TRI-SCORE risk 23±18%) with a high burden of comorbidities and symptoms (87% NYHA III/IV, 61% previously hospitalized for heart failure within 12 months). Severe or higher graded TR was observed in 96% of patients. Intraprocedural success according to the Tricuspid Valve Academic Research Consortium (TVARC) criteria was achieved in 85%, and TR reduced to ≤moderate in 87%. A post-procedural residual TR of >moderate was linked to worse clinical outcome. Independent predictors for more than moderate residual TR were coaptation gaps ≥8 mm (OR 1.67, 95%CI 1.03-2.72, p=0.038), tenting height ≥10mm (OR 2.18, CI 1.30-3.65, p=0.003), the presence of a transvalvular lead (OR 1.91, CI 1.19-3.05, p=0.007), right ventricular dilatation >42mm (OR 3.35, CI 1.37-9.1, p=0.009) and massive/torrential TR at baseline (OR 4.59, CI 2.35-8.96 p<0.001). TR reduction was sustained at 1-year with 83% of patients showing ≤moderate TR. Significant clinical improvements included enhanced NYHA class (66% class I/II vs. 17% at baseline, p<0.001) as well as improved functional status (follow-up: 293±114 m, ∆ improvement 40±86 m, p<0.001 [367 patients]) and quality of life (MLHFQ follow-up: 28±19 points, ∆ improvement -9±20 pts, p<0.001 [188 patients]) in a subset of patients. Patients treated with the 1st generation PASCAL system (570 patients) and with the new PASCAL Precision system (489 patients) had similar clinical profiles and TR severity at baseline. However, the Precision cohort showed greater TR reduction to trace/mild (63 vs. 49%, p<0.001), shorter procedure times (median 93 min [IQR 69-130] vs. 120 min [82-165], p<0.001), and higher clinical success rates according to TVARC at 30 days and 1 year (87 vs. 81% [p=0.021] and 56 vs. 50% [p=0.044], respectively). Higher center experience (≥20 patients/year) resulted in higher intraprocedural and clinical success.
Conclusions: The PASCAL system effectively treats severe TR in high-risk patients, offering sustained TR reduction and significant clinical improvements at 1-year follow-up.
