Frazzetto Marco, Dallan Luis Augusto Palma, Texeira Pedro Soares, Taieb Philippe, Tirelli Julia, Feroze Rafey, Alhabdan Nawaf, Cove Alexander, Saeed Yusef, Ukaigwe Anene, Attizzani Guilherme, Filby Steven J
Division of Cardiology, Harrington Heart and Vascular Institute, University Hospitals Cleveland Medical Center, Cleveland, Ohio.
Department of Medicine, University Hospitals, Cleveland Medical Center, Cleveland, Ohio.
J Invasive Cardiol. 2025 Jun 18. doi: 10.25270/jic/25.00081.
This study evaluates the procedural outcomes and short-term follow-up of the WATCHMAN FLX Pro left atrial appendage occlusion (LAAO) device (Boston Scientific) using the EXPRESS-LAAO protocol at a high-volume center. The new device offers enhanced features, including a 40-mm size for large anatomies, additional radiopaque markers for improved positioning, and a hemocompatible coating for faster endothelization. The EXPRESS-LAAO protocol streamlines patient management with pre-procedure computed tomography or cardiac magnetic resonance imaging, intracardiac echocardiography guidance, conscious sedation, and same-day discharge for stable patients. Between June and September 2024, 109 patients (median age 78 years, 48.6% female) underwent LAAO with the WATCHMAN FLX Pro device. Key indications included recurrent falls (33%), gastrointestinal bleeding (29.4%), and very high bleeding risk (21.1%). Procedural success was high (99.1%), with 1 case of cardiac tamponade requiring pericardiocentesis and no in-hospital complications. The 40-mm device was used in 7.3% of cases, proving essential for larger anatomies. At an average follow-up of 49.7 days, there was 1 lacunar stroke without device-related complications and 1 minor bleeding event. The study demonstrates the safety and effectiveness of the WATCHMAN FLX Pro device using the EXPRESS-LAAO protocol. The TruSteer catheter (Boston Scientific) facilitated implantations in complex anatomies, reducing the number of maneuvers. While post-LAAO imaging surveillance was a limitation, this is the first study assessing peri-procedural outcomes with the new device. Findings support its clinical utility in high-risk patients requiring LAAO.
本研究在一个高容量中心使用EXPRESS-LAAO方案评估了WATCHMAN FLX Pro左心耳封堵(LAAO)装置(波士顿科学公司)的手术结果和短期随访情况。这种新装置具有增强的特性,包括适用于较大解剖结构的40毫米尺寸、用于改善定位的额外不透射线标记以及用于加速内皮化的血液相容性涂层。EXPRESS-LAAO方案通过术前计算机断层扫描或心脏磁共振成像、心腔内超声心动图引导、清醒镇静以及对稳定患者的当日出院来简化患者管理。在2024年6月至9月期间,109例患者(中位年龄78岁,48.6%为女性)接受了使用WATCHMAN FLX Pro装置的LAAO手术。主要适应证包括反复跌倒(33%)、胃肠道出血(29.4%)和极高出血风险(21.1%)。手术成功率很高(99.1%),有1例心包填塞需要进行心包穿刺,且无院内并发症。40毫米的装置在7.3%的病例中使用,证明对较大解剖结构至关重要。在平均49.7天的随访中,有1例腔隙性卒中且无装置相关并发症,还有1例轻微出血事件。该研究证明了使用EXPRESS-LAAO方案的WATCHMAN FLX Pro装置的安全性和有效性。TruSteer导管(波士顿科学公司)有助于在复杂解剖结构中进行植入,减少了操作次数。虽然LAAO术后成像监测是一个局限性,但这是第一项评估该新装置围手术期结果的研究。研究结果支持其在需要LAAO的高危患者中的临床应用。