Hygeia Hospital, Athens, Greece.
University of Virginia Health System Hospital, Charlottesville, Virginia, USA.
Catheter Cardiovasc Interv. 2023 Jul;102(1):145-154. doi: 10.1002/ccd.30686. Epub 2023 May 13.
Mitral valve transcatheter edge-to-edge repair (M-TEER) is an effective option for treatment of mitral regurgitation (MR). We previously reported favorable 2-year outcomes for the PASCAL transcatheter valve repair system.
We report 3-year outcomes from the multinational, prospective, single-arm CLASP study with analysis by functional MR (FMR) and degenerative MR (DMR).
Patients with core-lab determined MR ≥ 3+ were deemed candidates for M-TEER by the local heart team. Major adverse events were assessed by an independent clinical events committee to 1 year and by sites thereafter. Echocardiographic outcomes were evaluated by the core laboratory to 3 years.
The study enrolled 124 patients, 69% FMR; 31% DMR (60% NYHA class III-IVa, 100% MR ≥ 3+). The 3-year Kaplan-Meier estimate for survival was 75% (66% FMR; 92% DMR) and freedom from heart failure hospitalization (HFH) was 73% (64% FMR; 91% DMR), with 85% reduction in annualized HFH rate (81% FMR; 96% DMR) (p < 0.001). MR ≤ 2+ was achieved and maintained in 93% of patients (93% FMR; 94% DMR) and MR ≤ 1+ in 70% of patients (71% FMR; 67% DMR) (p < 0.001). The mean left ventricular end-diastolic volume (181 mL at baseline) decreased progressively by 28 mL [p < 0.001]. NYHA class I/II was achieved in 89% of patients (p < 0.001).
The 3-year results from the CLASP study demonstrated favorable and durable outcomes with the PASCAL transcatheter valve repair system in patients with clinically significant MR. These results add to the growing body of evidence establishing the PASCAL system as a valuable therapy for patients with significant symptomatic MR.
二尖瓣经导管缘对缘修复术（M-TEER）是治疗二尖瓣反流（MR）的有效选择。我们之前报道了 PASCAL 经导管瓣膜修复系统的 2 年良好结果。
我们报告了多中心、前瞻性、单臂 CLASP 研究的 3 年结果，并进行了功能性 MR（FMR）和退行性 MR（DMR）的分析。
由当地心脏团队判定，核心实验室确定的 MR≥3+的患者为 M-TEER 候选者。主要不良事件由独立临床事件委员会在 1 年时评估，并由各中心在此后评估。核心实验室在 3 年时评估超声心动图结果。
该研究纳入了 124 名患者，69%为 FMR；31%为 DMR（60% NYHA 心功能分级 III-IVa；100% MR≥3+）。3 年 Kaplan-Meier 生存率估计为 75%（66%为 FMR；92%为 DMR），无心力衰竭住院（HFH）率为 73%（64%为 FMR；91%为 DMR），HFH 年发生率降低 85%（81%为 FMR；96%为 DMR）（p<0.001）。93%（93%为 FMR；94%为 DMR）的患者达到并维持 MR≤2+，70%（71%为 FMR；67%为 DMR）的患者达到并维持 MR≤1+（p<0.001）。左心室舒张末期容积（基线时为 181mL）逐渐降低 28mL（p<0.001）。89%的患者达到 NYHA 心功能分级 I/II（p<0.001）。
CLASP 研究的 3 年结果表明，PASCAL 经导管瓣膜修复系统在具有临床意义的 MR 的患者中具有良好和持久的疗效。这些结果增加了越来越多的证据，证明 PASCAL 系统是治疗有症状的严重 MR 患者的一种有价值的治疗方法。
