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经心腔内超声心动图引导植入 Watchman FLX 左心耳封堵装置。

Intracardiac echocardiography-guided implantation of the Watchman FLX left atrial appendage closure device.

机构信息

Department of Cardiovascular Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.

Department of Cardiovascular Medicine, Homolka Hospital, Prague, Czech Republic.

出版信息

J Cardiovasc Electrophysiol. 2021 Mar;32(3):717-725. doi: 10.1111/jce.14927. Epub 2021 Feb 10.

Abstract

BACKGROUND

The next-generation Watchman FLX left atrial appendage closure (LAAC) device has: (1) an atraumatic closed distal end, (2) reduced height, (3) a recessed screw hub to decrease device-related thrombus (DRT), (4) two rows of J-shape anchors so redeployment is possible after full recapture, and (5) ability to treat a greater size range of LAA ostia.

OBJECTIVE

To report, for the first time, the feasibility and safety of intracardiac echocardiography (ICE)-guided Watchman FLX implantation.

METHODS

A single-center prospective registry of atrial fibrillation patients planned for LAAC with the FLX device underwent ICE-guided implantation with conscious sedation. Transesophageal echocardiography (TEE) imaging was done preprocedure (to assess LAA size and exclude thrombus) and at clinical follow-up at 6-12 weeks. Clinical outcomes were LAA closure success, complications, leak, or DRT on follow-up TEE and major safety events.

RESULTS

The study included 30 patients: age 75 ± 8 years, 53% men, CHA DS -VASc 4.6 ± 1.6, and HAS-BLED 3.4 ± 1.1. The primary indication was prior bleeding in 60% (72% GI bleeding). The LAA orifice width and length were 22.7 ± 3.1 and 25.7 ± 5.7 mm, respectively. Technical success was 100% (the first-choice device was used in 28 of 30). Procedure time was less than 30 min in 27 of 30 cases, with 36 ± 15 ml contrast used. The final device size was 29.2 ± 4.7 mm with 21.6 ± 4.5% compression. There were no procedure-related complications. Follow-up TEE at a median 47 days follow-up showed 100% device success with no DRT or peridevice leak ≥5 mm. Major safety events occurred in 6.6% (2/30).

CONCLUSION

The Watchman FLX device can be safely implanted with intraprocedural ICE imaging instead of TEE.

摘要

背景

新一代 Watchman FLX 左心耳封堵(LAAC)装置具有以下特点:(1)无创伤的封闭远端;(2)高度降低;(3)凹入式螺丝轴,以减少器械相关血栓(DRT);(4)两排 J 形锚定,以便在完全回收后重新部署;(5)能够治疗更大范围的 LAA 口。

目的

首次报告经心腔内超声(ICE)引导的 Watchman FLX 植入术的可行性和安全性。

方法

一项前瞻性、单中心房颤患者注册研究计划使用 FLX 装置进行 LAAC,采用清醒镇静下的 ICE 引导植入。术前进行经食管超声心动图(TEE)检查(评估 LAA 大小并排除血栓),并在 6-12 周的临床随访时进行。临床结果包括 LAA 封堵成功、并发症、漏诊或随访 TEE 上的 DRT 以及主要安全性事件。

结果

研究纳入 30 例患者:年龄 75±8 岁,53%为男性,CHA2DS2-VASc 评分为 4.6±1.6,HAS-BLED 评分为 3.4±1.1。主要适应证为 60%(72%为胃肠道出血)的既往出血。LAA 口宽度和长度分别为 22.7±3.1 和 25.7±5.7mm。技术成功率为 100%(30 例中有 28 例首选该装置)。30 例中有 27 例手术时间<30 分钟,使用造影剂 36±15ml。最终装置大小为 29.2±4.7mm,压缩率为 21.6±4.5%。无手术相关并发症。中位随访 47 天的随访 TEE 显示 100%的器械成功,无 DRT 或≥5mm 的器械周围漏诊。主要安全性事件发生率为 6.6%(2/30)。

结论

使用术中 ICE 成像而非 TEE 引导,可安全植入 Watchman FLX 装置。

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