Indications and outcomes of the MitraClip G4 device with controlled gripper actuation system.

IF 3.1 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Cardiovascular Intervention and Therapeutics Pub Date : 2024-06-04 DOI:10.1007/s12928-024-01018-0
Naoki Nishiura, Shunsuke Kubo, Mikitaka Fujita, Kazunori Mushiake, Sachiyo Ono, Kohei Osakada, Takeshi Maruo, Kazushige Kadota
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Abstract

The MitraClip G4 device has controlled gripper actuation (CGA) system, which allows the anterior and posterior grippers operate separately in transcatheter edge-to-edge repair (TEER). We investigated the indications and outcomes of the use of CGA system during TEER for significant mitral regurgitation (MR). We reviewed 158 patients undergoing TEER with MitraClip G4 from September 2020 to July 2023. The CGA indications were: (1) for grasping and (2) for leaflet insertion confirmation. Leaflet grasping was completed with CGA in 18 patients (11 and 7 patients for grasping and leaflet insertion confirmation, respectively). Patients with flail leaflets or coaptation gap more frequently required CGA, indicating more complex mitral valve anatomy. The procedural success and adverse event rates (death, leaflet tear and single leaflet device attachment) were not different between the CGA and non-CGA groups. In patients requiring CGA, single leaflet device attachment was observed in 1 patient and leaflet tear in 1 patient during follow-up. In these two cases, CGA was required for grasping, and the clip was moved over a large distance (6.5 and 12.4 mm, respectively). In patients who had undergone CGA for confirmation, no device-related adverse event or MR recurrence was noted. In patients with complex mitral valve anatomy, CGA may be a safe and effective method for confirming leaflet insertion. It should be noted that when using CGA for leaflet grasping, especially when the clip is moved significantly, attention should be paid to leaflet adverse events.

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MitraClip G4 装置的适应症和疗效,带可控夹持器驱动系统。
MitraClip G4设备具有可控夹持器驱动(CGA)系统,在经导管边缘到边缘修补术(TEER)中允许前后夹持器分开操作。我们研究了在治疗严重二尖瓣反流(MR)的 TEER 中使用 CGA 系统的适应症和结果。我们回顾了 2020 年 9 月至 2023 年 7 月期间接受 MitraClip G4 TEER 的 158 例患者。CGA 适应症包括(1)用于抓取;(2)用于确认瓣叶插入。18名患者通过CGA完成了小叶抓取(分别有11名和7名患者进行了小叶抓取和小叶插入确认)。二尖瓣瓣叶松弛或有合瓣间隙的患者更常需要 CGA,这表明二尖瓣解剖结构更为复杂。CGA 组和非 CGA 组的手术成功率和不良事件发生率(死亡、瓣叶撕裂和单瓣装置附着)没有差异。在需要进行 CGA 的患者中,随访期间观察到 1 名患者出现单叶装置附着,1 名患者出现瓣叶撕裂。在这两个病例中,需要使用 CGA 抓取,夹子移动的距离较大(分别为 6.5 毫米和 12.4 毫米)。在接受 CGA 确认的患者中,未发现与设备相关的不良事件或 MR 复发。对于二尖瓣解剖结构复杂的患者,CGA 可能是一种安全有效的瓣叶插入确认方法。需要注意的是,在使用 CGA 抓取瓣叶时,尤其是夹子大幅移动时,应注意瓣叶不良事件。
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来源期刊
Cardiovascular Intervention and Therapeutics
Cardiovascular Intervention and Therapeutics CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
6.30
自引率
12.50%
发文量
68
期刊介绍: Cardiovascular Intervention and Therapeutics (CVIT) is an international journal covering the field of cardiovascular disease and includes cardiac (coronary and noncoronary) and peripheral interventions and therapeutics. Articles are subject to peer review and complete editorial evaluation prior to any decision regarding acceptability. CVIT is an official journal of The Japanese Association of Cardiovascular Intervention and Therapeutics.
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