Clinic for General and Interventional Cardiology/Angiology, Herz- Und Diabeteszentrum NRW, Ruhr-Universität Bochum, Georgstraße 11, 32545, Bad Oeynhausen, Germany.
Clinic for Thoracic and Cardiovascular Surgery, Herz- Und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
Clin Res Cardiol. 2021 Dec;110(12):1890-1899. doi: 10.1007/s00392-021-01845-8. Epub 2021 Apr 10.
The PASCAL system is a novel device for edge-to-edge treatment of mitral regurgitation (MR). The aim of this study was to compare the safety and efficacy of the PASCAL to the MitraClip system in a highly selected group of patients with complex primary mitral regurgitation (PMR) defined as effective regurgitant orifice area (MR-EROA) ≥ 0.40 cm, large flail gap (≥ 5 mm) or width (≥ 7 mm) or Barlow's disease.
38 patients with complex PMR undergoing mitral intervention using PASCAL (n = 22) or MitraClip (n = 16) were enrolled. Primary efficacy endpoints were procedural success and degree of residual MR at discharge. The rate of major adverse events (MAE) according to the Mitral Valve Academic Consortium (MVARC) criteria was chosen as the primary safety endpoint.
Patient collectives did not differ relevantly regarding pertinent baseline parameters. Patients` median age was 83.0 [77.5-85.3] years (PASCAL) and 82.5 [76.5-86.5] years (MitraClip). MR-EROA at baseline was 0.70 [0.68-0.83] cm (PASCAL) and 0.70 [0.50-0.90] cm (MitraClip), respectively. 3D-echocardiographic morphometry of the mitral valve apparatus revealed no relevant differences between groups. Procedural success was achieved in 95.5% (PASCAL) and 87.5% (MitraClip), respectively. In 86.4% of the patients a residual MR grade ≤ 1 + was achieved with PASCAL whereas reduction to MR grade ≤ 1 + with MitraClip was achieved in 62.5%. Neither procedure time number of implanted devices, nor transmitral gradient differed significantly. No periprocedural MAE according to MVARC occured.
In this highly selected patient group with complex PMR both systems exhibited equal procedural safety. MitraClip and PASCAL reduced qualitative and semi-quantitative parameters of MR to an at least comparable extent.
PASCAL 系统是一种用于治疗二尖瓣反流（MR）的新型边缘对边缘设备。本研究的目的是比较 PASCAL 与 MitraClip 系统在一组高度选择的复杂原发性二尖瓣反流（PMR）患者中的安全性和疗效，这些患者的有效反流口面积（MR-EROA）≥0.40cm，瓣叶裂较大（≥5mm）或宽度（≥7mm）或巴氏病。
38 例接受 PASCAL（n=22）或 MitraClip（n=16）二尖瓣介入治疗的复杂 PMR 患者被纳入研究。主要疗效终点是手术成功率和出院时残余 MR 的程度。根据二尖瓣瓣膜学术联盟（MVARC）标准选择主要不良事件（MAE）发生率作为主要安全性终点。
患者群体在相关基线参数方面没有显著差异。患者的中位年龄为 83.0[77.5-85.3]岁（PASCAL）和 82.5[76.5-86.5]岁（MitraClip）。基线时 MR-EROA 分别为 0.70[0.68-0.83]cm（PASCAL）和 0.70[0.50-0.90]cm（MitraClip）。二尖瓣装置的 3D 超声心动图形态测量显示两组之间无明显差异。95.5%（PASCAL）和 87.5%（MitraClip）的患者达到手术成功率。86.4%的患者采用 PASCAL 获得残余 MR 分级≤1+，而采用 MitraClip 获得残余 MR 分级≤1+的患者为 62.5%。两组的手术时间和植入装置数量以及跨瓣梯度均无显著差异。根据 MVARC，无围手术期 MAE。
在这组高度选择的复杂 PMR 患者中，两种系统的手术安全性相当。MitraClip 和 PASCAL 将 MR 的定性和半定量参数降低到至少相当的程度。
