Department of Cardiology, Heart Centre, Faculty of Medicine, University of Cologne, Cologne, Germany.
Department of Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.
JACC Cardiovasc Interv. 2020 Dec 14;13(23):2769-2778. doi: 10.1016/j.jcin.2020.08.025.
The aim of this study was to investigate the procedural and short-term safety and efficacy of a new leaflet-based transcatheter mitral valve repair system.
The PASCAL repair system has been recently approved for percutaneous treatment of mitral regurgitation (MR). Novel characteristics are broad paddles positioned around a central spacer and the ability for independent leaflet capture.
Procedural and 30-day outcomes were investigated in the first 309 patients with symptomatic MR 3+/4+ treated with the PASCAL repair system at 10 sites. 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).
Among the 309 patients (mean age 77 ± 10 years, 42% women, mean European System for Cardiac Operative Risk Evaluation II score 5.8 ± 4.5%) included in this study, MR etiology was degenerative in 33%, functional in 52%, and mixed in 16%. Eighty-six percent of patients were in New York Heart Association functional class III or IV. The technical success rate was 96%. Of 308 patients discharged alive, MR was ≤2+ in 93.5%. At 30 days, the MAE rate was 4.1%, with an estimated all-cause mortality rate of 2.0%, and 72% of patients were in New York Heart Association functional class ≤II (p < 0.001). Rates of device success and CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) trial-defined clinical success were 81.9% and 86.9%, respectively. Single-leaflet device attachment occurred in 7 patients (2.3%).
Mitral valve repair with the PASCAL system in the early post-approval phase was effective and safe, with high procedural success rates and low rates of MAE. MR was significantly reduced, accompanied by significant improvement in functional status.
本研究旨在探讨一种新型基于瓣叶的经导管二尖瓣修复系统的手术过程和短期安全性及有效性。
PASCAL 修复系统最近已被批准用于经皮治疗二尖瓣反流（MR）。其新颖的特点是中央间隔周围有宽阔的叶片，以及独立捕获瓣叶的能力。
在 10 个中心，对 309 例症状性 MR 3+/4+的患者使用 PASCAL 修复系统进行了研究，评估了手术过程和 30 天的结果。主要疗效终点是技术成功率和出院时残余 MR 的程度。主要安全性终点是主要不良事件（MAE）的发生率。
在这项研究中，纳入了 309 例患者（平均年龄 77 ± 10 岁，42%为女性，平均欧洲心脏手术风险评估系统 II 评分 5.8 ± 4.5%），MR 的病因分别为退行性 33%、功能性 52%和混合性 16%。86%的患者处于纽约心脏协会功能分级 III 或 IV 级。技术成功率为 96%。在 308 例存活出院的患者中，93.5%的患者 MR 为≤2+。在 30 天时，MAE 的发生率为 4.1%，估计全因死亡率为 2.0%，72%的患者处于纽约心脏协会功能分级≤II 级（p<0.001）。器械成功率和 CLASP（爱德华兹 PASCAL 经导管二尖瓣修复系统研究）试验定义的临床成功率分别为 81.9%和 86.9%。7 例（2.3%）患者发生单叶瓣装置附着。
在批准后早期阶段，使用 PASCAL 系统进行二尖瓣修复是有效且安全的，具有较高的手术成功率和较低的 MAE 发生率。MR 明显减少，同时功能状态显著改善。
