PASCAL mitral valve repair system versus MitraClip: comparison of transcatheter edge-to-edge strategies in complex primary mitral regurgitation,Clinical Research in Cardiology

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PASCAL mitral valve repair system versus MitraClip: comparison of transcatheter edge-to-edge strategies in complex primary mitral regurgitation
Clinical Research in Cardiology ( IF 3.8 ) Pub Date : 2021-04-10 , DOI: 10.1007/s00392-021-01845-8
Muhammed Gerçek ₁ , Fabian Roder ₁ , Tanja K Rudolph ₁ , Vera Fortmeier ₁ , Armin Zittermann ₂ , Volker Rudolph ₁ , Kai P Friedrichs ₁

Affiliation

Background

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 cm², large flail gap (≥ 5 mm) or width (≥ 7 mm) or Barlow’s disease.

Methods

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.

Results

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] cm² (PASCAL) and 0.70 [0.50–0.90] cm² (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.

Conclusion

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.

Graphic abstract

中文翻译：

PASCAL 二尖瓣修复系统与 MitraClip：复杂原发性二尖瓣反流中经导管边缘到边缘策略的比较

背景

PASCAL 系统是一种用于二尖瓣反流 (MR) 边缘到边缘治疗的新型设备。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) 患者中的安全性和有效性，这些患者定义为有效反流口面积 (MR-EROA) ≥ 0.40 cm ²，大连枷间隙（≥ 5 毫米）或宽度（≥ 7 毫米）或巴洛病。

方法

38 名复杂 PMR 患者使用 PASCAL ( n = 22) 或 MitraClip ( n = 16) 进行二尖瓣介入治疗。主要疗效终点是手术成功和出院时残留 MR 的程度。根据二尖瓣学术联盟 (MVARC) 标准的主要不良事件 (MAE) 发生率被选为主要安全终点。

结果

患者群体在相关基线参数方面没有相关差异。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 MR-EROA 分别为 0.70 [0.68–0.83] cm ² (PASCAL) 和 0.70 [0.50–0.90] cm ² (MitraClip)。二尖瓣装置的 3D 超声心动图形态测量显示各组之间没有相关差异。手术成功率分别为 95.5% (PASCAL) 和 87.5% (MitraClip)。在 86.4% 的患者中，使用 PASCAL 时残留的 MR 等级 ≤ 1 +，而使用 MitraClip 时，有 62.5% 的患者达到 MR 等级 ≤ 1 +。植入装置的手术时间数量和二尖瓣梯度均无显着差异。根据 MVARC 未发生围手术期 MAE。