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基于新型计算机断层血管造影的左心耳封堵术 WATCHMAN FLX 装置大小测量方法。

Novel computed tomography angiography-based sizing methodology for WATCHMAN FLX device in left atrial appendage closure.

机构信息

Division of Cardiology, Harrington Heart & Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.

Department of Medicine, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.

出版信息

J Cardiovasc Electrophysiol. 2022 Aug;33(8):1781-1787. doi: 10.1111/jce.15548. Epub 2022 May 26.

Abstract

BACKGROUND

While there is recent data suggesting an advantage of computed tomography angiography (CTA) over transesophageal echocardiography (TEE) for preprocedural left atrial appendage closure (LAAC) planning, there is limited published experience for sizing strategies. Device sizing for LAAC may be challenging and noninvasive algorithms that improve this selection process are warranted.

OBJECTIVES

We sought to evaluate the safety and the feasibility for the implementation of a novel CTA-based sizing methodology for WATCHMAN™ FLX device in a series of patients undergoing LAAC using the TruPlan™ software package.

METHODS

A prospective analysis of 136 consecutive patients who underwent LAAC over a 12-month period in a single, large academic hospital in the United States was conducted. CTA-guided preprocedural planning and intracardiac echocardiography (ICE) was performed in all. Procedural success, adverse events, length of procedure, number of devices used, and length of stay were evaluated.

RESULTS

A total of 136 patients who underwent LAAC procedure with WATCHMAN™ FLX platform between October 1, 2020 until September 30, 2021 were included. The pre-specified protocol using CTA and ICE was implemented in all patients (100%). Mean CHA DS VASc score was 4.4 ± 1.3 and the mean HAS-BLED score was 3.9 ± 0.8. ICE-guided 100% transseptal puncture success rate was 100% with 98.5% of overall procedural success rate. Preprocedural CTA sizing strategy accurately predicted the implanted size in 91.1% of patients. Ten patients (7.4%) required another sized device and 2 cases were aborted. At 45-day follow-up, only 1 patient (0.7%) had significant peri-device leak (≥5 mm) on TEE.

CONCLUSIONS

CTA-based preprocedural sizing methodology for WATCHMAN™ FLX in LAAC was safe, feasible and associated with excellent procedural outcomes. Further studies are warranted to confirm if the features specific to TruPlan™ may reduce the number of deployment attempts, the number of devices utilized in the procedure, and the risk of complications.

摘要

背景

虽然最近有数据表明计算机断层血管造影(CTA)在经食管超声心动图(TEE)用于左心耳封堵(LAAC)术前规划方面具有优势,但关于其尺寸测量策略的经验有限。LAAC 的器械尺寸测量可能具有挑战性,因此需要一种改进该选择过程的非侵入性算法。

目的

我们旨在评估一种新型基于 CTA 的 WATCHMAN™ FLX 器械尺寸测量方法在使用 TruPlan™软件包进行 LAAC 的一系列患者中的安全性和可行性。

方法

对在美国一家大型学术医院进行的为期 12 个月的 136 例连续 LAAC 患者进行前瞻性分析。所有患者均进行 CTA 引导的术前规划和心腔内超声(ICE)检查。评估手术成功率、不良事件、手术时间、使用的器械数量和住院时间。

结果

共纳入 2020 年 10 月 1 日至 2021 年 9 月 30 日期间使用 WATCHMAN™ FLX 平台进行 LAAC 的 136 例患者。所有患者均采用 CTA 和 ICE 预指定方案(100%)。平均 CHA2DS2-VASc 评分为 4.4±1.3,平均 HAS-BLED 评分为 3.9±0.8。ICE 引导的 100%经房间隔穿刺成功率为 100%,整体手术成功率为 98.5%。术前 CTA 测量策略准确预测了 91.1%患者的植入尺寸。10 例(7.4%)患者需要使用另一种尺寸的器械,2 例手术被中止。在 45 天的随访中,只有 1 例(0.7%)患者 TEE 显示存在明显的器械周围漏(≥5mm)。

结论

LAAC 中基于 CTA 的 WATCHMAN™ FLX 术前测量方法是安全可行的,并且与良好的手术结果相关。需要进一步研究以确认 TruPlan™的特定功能是否可以减少部署尝试次数、手术中使用的器械数量以及并发症的风险。

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