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.
J Cardiovasc Electrophysiol. 2021 Mar;32(3):717-725. doi: 10.1111/jce.14927. Epub 2021 Feb 10.
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.
To report, for the first time, the feasibility and safety of intracardiac echocardiography (ICE)-guided Watchman FLX implantation.
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.
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).
The Watchman FLX device can be safely implanted with intraprocedural ICE imaging instead of TEE.
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。
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。
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。
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）。
使用术中 ICE 成像而非 TEE 引导，可安全植入 Watchman FLX 装置。
