解剖结构复杂的退行性二尖瓣反流患者的经导管缘对缘修复术
Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation.
作者信息
Hausleiter Jörg, Lim D Scott, Gillam Linda D, Zahr Firas, Chadderdon Scott, Rassi Andrew N, Makkar Raj, Goldman Scott, Rudolph Volker, Hermiller James, Kipperman Robert M, Dhoble Abhijeet, Smalling Richard, Latib Azeem, Kodali Susheel K, Lazkani Mohamad, Choo Joseph, Lurz Philipp, O'Neill William W, Laham Roger, Rodés-Cabau Josep, Kar Saibal, Schofer Niklas, Whisenant Brian, Inglessis-Azuaje Ignacio, Baldus Stephan, Kapadia Samir, Koulogiannis Konstantinos, Marcoff Leo, Smith Robert L
机构信息
Klinikum der Universität München, Munich, Germany.
University of Virginia Health System Hospital, Charlottesville, Virginia, USA.
出版信息
J Am Coll Cardiol. 2023 Feb 7;81(5):431-442. doi: 10.1016/j.jacc.2022.11.034.
BACKGROUND
Mitral valve transcatheter edge-to-edge repair is safe and effective in treating degenerative mitral regurgitation (DMR) patients at prohibitive surgical risk, but outcomes in complex mitral valve anatomy patients vary.
OBJECTIVES
The PASCAL IID registry assessed safety, echocardiographic, and clinical outcomes with the PASCAL system in prohibitive risk patients with significant symptomatic DMR and complex mitral valve anatomy.
METHODS
Patients in the prospective, multicenter, single-arm registry had 3+ or 4+ DMR, were at prohibitive surgical risk, presented with complex anatomic features based on the MitraClip instructions for use, and were deemed suitable for the PASCAL system by a central screening committee. Enrolled patients were treated with the PASCAL system. Safety, effectiveness, and functional and quality-of-life outcomes were assessed. Study oversight also included an echocardiographic core laboratory and clinical events committee.
RESULTS
The study enrolled 98 patients (37.2% ≥2 independent significant jets, 15.0% severe bileaflet/multi scallop prolapse, 13.3% mitral valve orifice area <4.0 cm, and 10.6% large flail gap and/or large flail width). The implant success rate was 92.9%. The 30-day composite major adverse event rate was 11.2%. At 6 months, 92.4% patients achieved MR ≤2+ and 56.1% achieved MR ≤1+ (P < 0.001 vs baseline). The Kaplan-Meier estimates for survival, freedom from major adverse events, and heart failure hospitalization at 6 months were 93.7%, 85.6%, and 92.6%, respectively. Patients experienced significant symptomatic improvement compared with baseline (P < 0.001).
CONCLUSIONS
The outcomes of the PASCAL IID registry establish the PASCAL system as a useful therapy for prohibitive surgical risk DMR patients with complex mitral valve anatomy. (PASCAL IID Registry within the Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID] NCT03706833).
背景
二尖瓣经导管缘对缘修复术在治疗手术风险极高的退行性二尖瓣反流（DMR）患者时安全有效，但在二尖瓣解剖结构复杂的患者中的治疗效果有所不同。
目的
PASCAL IID注册研究评估了PASCAL系统用于有严重症状性DMR且二尖瓣解剖结构复杂、手术风险极高的患者的安全性、超声心动图及临床结局。
方法
前瞻性、多中心、单臂注册研究中的患者存在3+或4+级DMR，手术风险极高，根据MitraClip使用说明具有复杂解剖特征，且经中央筛查委员会判定适合使用PASCAL系统。入组患者接受PASCAL系统治疗。评估安全性、有效性以及功能和生活质量结局。研究监督还包括一个超声心动图核心实验室和临床事件委员会。
结果
该研究入组98例患者（37.2%有≥2个独立的显著反流束，15.0%为严重双叶/多瓣叶脱垂，13.3%二尖瓣口面积<4.0 cm²，10.6%有大的连枷间隙和/或大的连枷宽度）。植入成功率为92.9%。30天复合主要不良事件发生率为11.2%。在6个月时，92.4%的患者二尖瓣反流（MR）≤2+，56.1%的患者MR≤1+（与基线相比，P<0.001）。6个月时生存、无主要不良事件以及未因心力衰竭住院的Kaplan-Meier估计值分别为93.7%、85.6%和92.6%。与基线相比，患者症状有显著改善（P<0.001）。
结论
PASCAL IID注册研究的结果表明，PASCAL系统对于手术风险极高、二尖瓣解剖结构复杂的DMR患者是一种有效的治疗方法。（爱德华兹PASCAL经导管瓣膜修复系统关键临床试验[CLASP IID]中的PASCAL IID注册研究，NCT03706833）
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