Department of Internal Medicine III, Cardiology, University Hospital Heidelberg, Im Neuenheimer Feld 410, Heidelberg, 69120, Germany.
DZHK (German Centre for Cardiovascular Research), Partner Site Heidelberg/Mannheim, Heidelberg, Germany.
ESC Heart Fail. 2022 Apr;9(2):853-865. doi: 10.1002/ehf2.13849. Epub 2022 Feb 15.
Mitral valve transcatheter edge-to-edge repair (TEER) has been established as a suitable alternative to mitral valve surgery in patients with severe mitral regurgitation (MR) and high surgical risk. The PASCAL system represents a novel device, potentially augmenting the toolkit for TEER. The aim of this study was to assess and compare short and 1 year safety and efficacy of the PASCAL and MitraClip systems for TEER.
Procedural, short, and 1 year outcomes of a 1:2 propensity-matched cohort including 41 PASCAL and 82 MitraClip cases were investigated. Matching was based on clinical, laboratory, echocardiographic, and functional characteristics. The primary endpoints assessed were procedural success [as defined by the Mitral Valve Academy Research Consortium (MVARC)], residual MR, functional class, and a composite endpoint comprising death, heart failure hospitalization, and mitral valve re-intervention. We found for the PASCAL and the matched MitraClip cohort no significant differences in MVARC defined technical (90.2% vs. 95.1%, P = 0.44), device (90.2% vs. 89.0%, P = 1.0), or procedural (87.8% vs. 80.5%, P = 0.45) success rates. Accordingly, the overall MR reduction and improvement in New York Heart Association (NYHA) class were comparable (1 year follow-up: MR ≤ 2 95% vs. 93.6%, P = 1.0; NYHA ≤ 2 57.1% vs. 66.7%, P = 0.59). The composite outcome revealed no statistically significant difference between both devices (1 year follow-up: 31.7% vs. 37.8%, P = 0.55). Interestingly, we found at both short and 1 year follow-up a significantly higher rate of patients with none or trace MR in the PASCAL-treated cohort (short follow-up: 17.9% vs. 0%, P = 0.0081; 1 year follow-up: 25% vs. 0%, P = 0.0016). Conversely, the rate of aborted device implantations due to an elevated transmitral gradient was higher in PASCAL interventions (9.8% vs. 1.2%, P = 0.04).
Transcatheter edge-to-edge repair using the PASCAL or MitraClip device results in favourable and comparable outcomes regarding safety, efficacy, and clinical improvement after 1 year.
经导管二尖瓣缘对缘修复（TEER）已被确立为严重二尖瓣反流（MR）和高手术风险患者二尖瓣手术的合适替代方法。PASCAL 系统代表了一种新型装置，可能为 TEER 提供更多工具。本研究旨在评估和比较 PASCAL 和 MitraClip 系统用于 TEER 的短期和 1 年安全性和疗效。
研究纳入了 41 例 PASCAL 和 82 例 MitraClip 患者的 1:2 倾向匹配队列的手术、短期和 1 年的结果。匹配基于临床、实验室、超声心动图和功能特征。主要终点评估为经二尖瓣瓣膜协会研究联盟（MVARC）定义的手术成功率[定义为]、残余 MR、功能分级和包括死亡、心力衰竭住院和二尖瓣再介入的复合终点。我们发现，对于 PASCAL 和匹配的 MitraClip 队列，MVARC 定义的技术（90.2%对 95.1%，P=0.44）、设备（90.2%对 89.0%，P=1.0）或手术（87.8%对 80.5%，P=0.45）成功率没有显著差异。因此，整体 MR 减少和纽约心脏协会（NYHA）分级改善相当（1 年随访：MR≤295%对 93.6%，P=1.0；NYHA≤257.1%对 66.7%，P=0.59）。复合结果显示两种器械之间无统计学差异（1 年随访：31.7%对 37.8%，P=0.55）。有趣的是，我们发现 PASCAL 治疗组在短期和 1 年随访时均有更高比例的患者无或微量 MR（短期随访：17.9%对 0%，P=0.0081；1 年随访：25%对 0%，P=0.0016）。相反，由于跨二尖瓣梯度升高而中止器械植入的发生率在 PASCAL 介入治疗中更高（9.8%对 1.2%，P=0.04）。
使用 PASCAL 或 MitraClip 装置进行经导管缘对缘修复，在 1 年时安全性、疗效和临床改善方面均取得了良好且相当的结果。
