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采用 LARIAT+ 装置进行左心耳缝合结扎的欧洲集体经验。

A collective European experience with left atrial appendage suture ligation using the LARIAT+ device.

机构信息

Department of Electrophysiology, University Heart Center Lübeck, Cardiology, Angiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Ratzeburger Allee 160, 23562 Lübeck, Germany.

German Centre for Cardiovascular Research (DZHK), Partner Site, Hamburg/Kiel/Lübeck, Lübeck, Germany.

出版信息

Europace. 2020 Jun 1;22(6):924-931. doi: 10.1093/europace/euaa004.

Abstract

AIMS

We report the collective European experience of percutaneous left atrial appendage (LAA) suture ligation using the recent generation LARIAT+ suture delivery device.

METHODS AND RESULTS

A total of 141 patients with non-valvular atrial fibrillation and contraindication to oral anticoagulation (OAC), thrombo-embolic events despite OAC or electrical LAA isolation were enrolled at seven European hospitals to undergo LAA ligation. Patients were followed up by clinical visits and transoesophageal echocardiography (TOE) following LAA closure. Left atrial appendage ligation was completed in 138/141 patients (97.8%). Three patients did not undergo attempted deployment of the LARIAT device due to pericardial adhesion after previous epicardial ventricular tachycardia ablation (n = 1), a pericardial access-related complication (n = 1), and multiple posterior LAA lobes (n = 1). Serious 30-day procedural adverse events occurred in 4/141 patients (2.8%). There were two device-related LAA perforations (1.4%) not resulting in any corrective intervention as the LAA was completely sealed with the LARIAT. Minor adverse events occurred in 19 patients (13.5%), including two pericardial effusions due to procedure-related pericarditis requiring pericardiocentesis. Transoesophageal echocardiography was performed after LAA ligation in 103/138 patients (74.6%) after a mean of 181 ± 72 days. Complete LAA closure was documented in 100 patients (97.1%). Two patients (1.8% of patients with follow-up) experienced a transient ischaemic attack at 4 and 7 months follow-up, although there was no leak observed with TOE. There were two deaths during long-term follow-up which were both not device related.

CONCLUSION

Initial experience with the LARIAT+ device demonstrates feasibility of LAA exclusion. Further larger prospective studies with longer follow-up are warranted.

摘要

目的

我们报告了使用新一代 LARIAT+缝线输送装置进行经皮左心耳(LAA)缝合结扎的欧洲联合经验。

方法和结果

共有 7 家欧洲医院的 141 名非瓣膜性房颤、有口服抗凝剂(OAC)禁忌、尽管接受 OAC 治疗仍有血栓栓塞事件或电 LAA 隔离的患者入组,进行 LAA 结扎。LAA 闭合后,通过临床随访和经食管超声心动图(TOE)进行随访。在 141 例患者中,138 例(97.8%)完成了 LAA 结扎。由于先前的心外膜室性心动过速消融术后心包粘连(n=1)、心包介入相关并发症(n=1)和多个后 LAA 叶(n=1),有 3 例患者未能尝试部署 LARIAT 装置。141 例患者中有 4 例(2.8%)发生严重 30 天手术不良事件。有 2 例与器械相关的 LAA 穿孔(1.4%)并未导致任何矫正干预,因为 LAA 完全被 LARIAT 封闭。19 例患者(13.5%)出现轻微不良事件,包括 2 例因手术相关心包炎导致的心包积液,需要进行心包穿刺。138 例患者中有 103 例(74.6%)在平均 181±72 天后进行了 LAA 结扎后的 TOE 检查。100 例患者(97.1%)的 LAA 完全闭合。2 例患者(随访患者的 1.8%)在 4 个月和 7 个月随访时出现短暂性脑缺血发作,但 TOE 未观察到漏诊。在长期随访中有 2 例死亡,均与器械无关。

结论

使用 LARIAT+装置的初步经验表明 LAA 排除的可行性。需要进行更大规模的前瞻性研究和更长时间的随访。

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