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经皮左心耳封堵术在房颤中的应用。

Left atrial appendage occlusion using LAmbre Amulet and Watchman in atrial fibrillation.

机构信息

Frankfurt Academy For Arrhythmias (FAFA), Cardioangiologisches Centrum Bethanien (CCB) Frankfurt am Main, Medizinische Klinik III, Agaplesion Markus Krankenhaus, Frankfurt am Main, Germany.

Frankfurt Academy For Arrhythmias (FAFA), Cardioangiologisches Centrum Bethanien (CCB) Frankfurt am Main, Medizinische Klinik III, Agaplesion Markus Krankenhaus, Frankfurt am Main, Germany.

出版信息

J Cardiol. 2019 Apr;73(4):299-306. doi: 10.1016/j.jjcc.2018.10.010. Epub 2018 Dec 21.

Abstract

BACKGROUND

Left atrial appendage closure (LAAC) has been suggested as an alternative to anticoagulation in non-valvular atrial fibrillation (AF). The present study aimed to compare a LAmbre LAA occluder system [Lifetech Scientific (Shenzhen) Co. Ltd., Shenzhen, China] with the most investigated Amulet (St. Jude Medical Inc., St. Paul, MN, USA) and Watchman (Boston Scientific, Plymouth, MN, USA) devices in terms of peri-procedural and short-term outcomes.

METHODS

This is a prospective observational study.

RESULTS

Overall, 140 patients (50 female, mean age 76.2±8.4 years) were consecutively enrolled. Mean CHA2DS2-VASc score was 3.8±1.5, and mean HAS-BLED score was 3.9±1.1. Baseline clinical characteristics were comparable between the three groups (LAmbre, n=30; Amulet, n=74; Watchman, n=36); the LAmbre group had significantly more patients with complicated LAA morphology (p=0.006). The implant success rate was 100% in LAmbre, 99% in Amulet, and 100% in Watchman group (p=0.638). The number of device repositions was not significantly different between groups (0.7±1.1 in LAmbre, 1.0±2.0 in Amulet, and 1.4±1.8 in Watchman group, p=0.345). Fluoroscopic and procedural times were similar between groups. Major peri-procedural adverse events did not differ between groups (0% vs. 0% vs. 2.8%, p=0.233). Six months' follow-up showed good device stability and patients' clinical condition in all groups.

CONCLUSION

LAmbre, Amulet, and Watchman exhibit remarkable implant success rate, low risk of peri-procedural adverse events, and good clinical outcomes.

摘要

背景

左心耳封堵术(LAAC)已被提议作为非瓣膜性心房颤动(AF)抗凝的替代方法。本研究旨在比较 LAmbre LAA 封堵器系统[深圳乐普(深圳)医疗器械有限公司]与研究最多的 Amulet(圣犹达医疗公司,明尼苏达州圣保罗)和 Watchman(波士顿科学公司,明尼苏达州普利茅斯)装置在围手术期和短期结果方面的差异。

方法

这是一项前瞻性观察研究。

结果

共有 140 名患者(50 名女性,平均年龄 76.2±8.4 岁)连续入组。平均 CHA2DS2-VASc 评分为 3.8±1.5,平均 HAS-BLED 评分为 3.9±1.1。三组间基线临床特征相似(LAmbre 组 n=30;Amulet 组 n=74;Watchman 组 n=36);LAmbre 组患者左心耳形态复杂者明显更多(p=0.006)。LAmbre、Amulet 和 Watchman 组的植入成功率均为 100%(p=0.638)。三组间装置重新定位次数无显著差异(LAmbre 组 0.7±1.1,Amulet 组 1.0±2.0,Watchman 组 1.4±1.8,p=0.345)。透视和手术时间在各组间相似。各组间主要围手术期不良事件无差异(0% vs. 0% vs. 2.8%,p=0.233)。6 个月随访显示三组均有良好的装置稳定性和患者临床状况。

结论

LAmbre、Amulet 和 Watchman 均具有较高的植入成功率、较低的围手术期不良事件风险和良好的临床结果。

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