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
Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, IIB Sant Pau, Barcelona, Spain; Facultat de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Valladolid, Spain.
Servicio de Cardiología, Hospital Universitario Alvaro Cunqueiro, Vigo, Spain.
Rev Esp Cardiol (Engl Ed). 2023 Jan;76(1):25-31. doi: 10.1016/j.rec.2022.05.003. Epub 2022 Jun 10.
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<.001).
Transcatheter mitral valve repair with the PASCAL system was safe and effective, with high procedural success and low rates of MAE. At 30 days, MR was significantly reduced, with a significant improvement in functional status.
PASCAL系统是一种基于边缘对边缘概念的新型经导管二尖瓣修复装置。该装置的独特特性可能会对修复结果产生重大影响。现实生活中的注册研究中关于临床结果的数据较少。本研究的目的是报告PASCAL系统在伊比利亚半岛（西班牙和葡萄牙）的早期应用经验。
对10个中心接受PASCAL系统治疗的有症状重度二尖瓣反流（MR）的连续患者的手术过程和30天结果进行了调查。主要疗效终点是技术成功率和出院时的残余MR程度。主要安全终点是30天时的主要不良事件（MAE）发生率。
我们纳入了68例患者（年龄75[68-81]岁；38%为女性；欧洲心脏手术风险评估系统II为4.5%）。MR病因中，退行性病变占25%，功能性病变占65%，混合性病变占10%。共有71%的患者纽约心脏协会（NYHA）心功能分级≥III级。技术成功率为96%，73%的手术使用了独立捕获技术。在治疗人群中，出院时MR均≤2+，无住院死亡病例。30天时，MAE发生率为5.9%，全因死亡率为1.6%，98%的患者NYHA心功能分级≤II级，95%的患者MR≤2+（P<0.001）。
使用PASCAL系统进行经导管二尖瓣修复安全有效，手术成功率高，MAE发生率低。30天时，MR显著降低，功能状态显著改善。
