Nielsen-Kudsk Jens Erik, Berti Sergio, Caprioglio Francesco, Ronco Federico, Arzamendi Dabit, Betts Timothy, Tondo Claudio, Christen Thomas, Allocco Dominic J
Aarhus University Hospital, Aarhus, Denmark.
Fondazione Toscana Gabriele Monasterio, Massa, Italy.
JACC Cardiovasc Interv. 2023 Mar 27;16(6):643-651. doi: 10.1016/j.jcin.2022.10.024. Epub 2023 Feb 8.
Intracardiac echocardiography (ICE) is increasingly used to guide left atrial appendage closure (LAAC).
The aim of this study was to investigate the efficacy and safety of ICE-guided LAAC with the Watchman FLX device.
The ICE LAA (I Can See Left Atrial Appendage) study was a prospective, multicenter study with independent adjudication of echocardiographic data by a core laboratory and clinical events by a clinical events committee. Patients with atrial fibrillation with CHADS-VASc scores ≥2 and clinical indications for LAAC were eligible. Preplanning with either cardiac computed tomography or transesophageal echocardiography (TEE) within 7 days prior to LAAC was mandatory. Intraprocedural ICE was carried out from the left atrium. The primary outcome was the rate of significant peridevice leaks (>5 mm) at 45-day TEE.
A total of 100 patients were enrolled. The mean age was 76 ± 8 years, the mean CHADS-VASc score was 4.0 ± 1.5, and the mean HAS-BLED score was 2.5 ± 0.9. The incidence of the primary outcome of significant peridevice leak (>5 mm) was 0%; all patients evaluated by TEE at 45 days had effective LAAC. All patients received Watchman FLX devices, and technical success was 100%. The number of devices per case was 1.0 ± 0.1. ICE successfully guided the assessment of device release criteria, including device compression (19.2% ± 7.1%; recommended range: 10%-30%). No subject required conversion to TEE. Procedural complications were 4 access-site bleeds. There was no stroke, transient ischemic attack, systemic embolization, pericardial effusion, device embolization, or device-related thrombus during the procedure or 45-day follow-up.
ICE can be used to successfully guide LAAC with the Watchman FLX, with excellent procedural success, a high rate of effective LAAC, and minimal periprocedural complications. (I Can See Left Atrial Appendage [ICELAA] Clinical Study; NCT04196335).
心腔内超声心动图（ICE）越来越多地用于指导左心耳封堵术（LAAC）。
本研究旨在探讨使用Watchman FLX装置进行ICE引导下LAAC的有效性和安全性。
ICE LAA（我能看到左心耳）研究是一项前瞻性、多中心研究，由核心实验室独立判定超声心动图数据，由临床事件委员会判定临床事件。房颤患者CHADS-VASc评分≥2且有LAAC临床指征者符合入选标准。LAAC术前7天内必须进行心脏计算机断层扫描或经食管超声心动图（TEE）预规划。术中ICE从左心房进行。主要结局是45天TEE时显著的装置周围渗漏（>5mm）发生率。
共纳入100例患者。平均年龄为76±8岁，平均CHADS-VASc评分为4.0±1.5，平均HAS-BLED评分为2.5±0.9。显著装置周围渗漏（>5mm）这一主要结局的发生率为0%；45天时接受TEE评估的所有患者LAAC均有效。所有患者均接受了Watchman FLX装置，技术成功率为100%。每例使用的装置数量为1.0±0.1。ICE成功指导了装置释放标准的评估，包括装置压缩（19.2%±7.1%；推荐范围：10%-30%）。无一例患者需要转为TEE。手术并发症为4例穿刺部位出血。术中及45天随访期间无卒中、短暂性脑缺血发作、全身性栓塞、心包积液、装置栓塞或与装置相关的血栓形成。
ICE可成功用于指导使用Watchman FLX进行LAAC，手术成功率高，LAAC有效率高，围手术期并发症少。（我能看到左心耳[ICELAA]临床研究；NCT04196335）
