Iberian experience with PASCAL transcatheter edge-to-edge repair for mitral valve regurgitation

• Published in: Revista española de cardiología (English ed.) 2023-01, Vol.76 (1), p.25-31
• Main Authors: Li, Chi-Hion Pedro, Estévez-Loureiro, Rodrigo, Freixa, Xavier, Teles, Rui, Molina-Ramos, Ana I., Pan, Manuel, Nombela-Franco, Luis, Melica, Bruno, Amat-Santos, Ignacio J., Cruz-González, Ignacio, Asmarats, Lluís, Alarcón, Robert, Sanchis, Laura, Fernández-Peregrina, Estefanía, Baz, José Antonio, Millán, Xavier, Menduiña, Irene, Arzamendi, Dabit
• Format: Article
• Language: English
• Subjects: Aged; Cardiac catheterization; Cardiac Catheterization - adverse effects; Dispositivo PASCAL; Female; Heart failure; Heart Valve Prosthesis Implantation - methods; Humans; Insuficiencia mitral; Male; Mitral Valve - surgery; Mitral valve insufficiency; Mitral Valve Insufficiency - diagnosis; Mitral Valve Insufficiency - surgery; Pascal device; Reparación percutánea borde a borde; Transcatheter edge-to-edge repair; Treatment Outcome
• ISSN: 1885-5857; 1885-5857
• DOI: 10.1016/j.rec.2022.05.003

The PASCAL system is a novel device for transcatheter mitral valve repair based on the edge-to-edge concept. The unique features of this device might have a relevant impact on the repair outcomes. There are few data on clinical outcomes in real-life registries. The aim of this study was to report the early Iberian experience (Spain and Portugal) of the PASCAL system. Procedural and 30-day outcomes were investigated in consecutive patients with symptomatic severe mitral regurgitation (MR) treated with the PASCAL system at 10 centers. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE) at 30 days. We included 68 patients (age, 75 [68-81] years; 38% women; EuroSCORE II 4.5%). MR etiology was degenerative in 25%, functional in 65%, and mixed in 10%. A total of 71% of patients were in New York Heart Association (NYHA) functional class≥III. Technical success was achieved in 96% and independent capture was used in 73% of procedures. In the treated population, MR at discharge was≤2+ in 100%, with no in-hospital deaths. At 30 days, the MAE rate was 5.9%, the all-cause mortality rate was 1.6%, 98% were in NYHA functional class≤II, and 95% had MR≤2+ (P