Kushnir Alexander, Barbhaiya Chirag R, Jankelson Lior, Holmes Douglas, Aizer Anthony, Park David, Spinelli Michael, Bernstein Scott, Garber Leonard, Yang Felix, Ro Richard, Chinitz Larry A
Leon H. Charney Division of Cardiology, Cardiac Electrophysiology, NYU Langone Health, New York University Grossman School of Medicine, 424 East 34th Street, KP 4th Floor, New York, NY, 10016, USA.
J Interv Card Electrophysiol. 2025 Feb 12. doi: 10.1007/s10840-025-02011-0.
Left atrial appendage occlusion (LAA-O) with Amulet and Watchman FLX are approved for reducing stroke risk in patients with atrial fibrillation when oral anticoagulation is not tolerated. Real world clinical outcomes reported along with imaging data are needed to help clinicians choose between these two technologies and manage device-related complications.
The study retrospectively analyzed clinical, transesophageal (TEE), and available computed tomography (CT) data from 364 FLX and 292 Amulet procedures performed at an academic medical center over a 4-year period.
LAA-O procedures were successful in 96.7% FLX and 97.3% Amulet cases. FLX implant success rate increased to 98.9% when only patients with LAA diameter to depth ratio < 1.8 and LAA area < 4.4 cm were included. TTE LAA-orifice area correlated with CT-derived measurements. There were more late pericardial effusions for Amulet (3.1%) compared to FLX (0.3%), though the majority were conservatively managed. Mean procedure times were similar (FLX 64 ± 24, Amulet 65 ± 21 min) as were the rates of device related thrombus (FLX 1% and Amulet 1.4%). Clinically relevant peridevice leak (PDL) on follow-up TEE imaging was greater for FLX (16%) compared to Amulet (10%). Combined AF ablation-LAA-occlusion procedures exhibited lower rates of PDL and late pericardial effusions compared to solo procedures.
Based on retrospective analysis, an initial strategy with Watchman FLX in patients with favorable LAA anatomy would reduce the risk of late pericardial effusions at the expense of a higher rate of clinically relevant PDL compared to Amulet. Combined AF ablation and LAA-O procedures exhibit less PDL.
当患者无法耐受口服抗凝治疗时，使用Amulet和Watchman FLX进行左心耳封堵术（LAA - O）已被批准用于降低房颤患者的中风风险。需要结合影像学数据报告的真实世界临床结果，以帮助临床医生在这两种技术之间做出选择并处理与设备相关的并发症。
该研究回顾性分析了在一所学术医疗中心4年期间进行的364例FLX和292例Amulet手术的临床、经食管超声心动图（TEE）和可用的计算机断层扫描（CT）数据。
LAA - O手术在96.7%的FLX病例和97.3%的Amulet病例中成功。当仅纳入左心耳直径与深度比＜1.8且左心耳面积＜4.4 cm²的患者时，FLX植入成功率提高到98.9%。经胸超声心动图（TTE）测量的左心耳口面积与CT测量结果相关。与FLX（0.3%）相比，Amulet出现更多的晚期心包积液（3.1%），不过大多数通过保守治疗。平均手术时间相似（FLX为64±24分钟，Amulet为65±21分钟），与设备相关的血栓形成率也相似（FLX为1%，Amulet为1.4%）。随访TEE成像显示，与Amulet（10%）相比，FLX的临床相关器械周围渗漏（PDL）发生率更高（16%）。与单独手术相比，联合房颤消融 - LAA封堵术的PDL和晚期心包积液发生率更低。
基于回顾性分析，对于左心耳解剖结构良好的患者，初始采用Watchman FLX策略可降低晚期心包积液的风险，但与Amulet相比，临床相关PDL发生率较高。联合房颤消融和LAA - O手术的PDL较少。
