Department of Cardiology, St Antonius Ziekenhuis Nieuwegein/AUMC Amsterdam, the Netherlands (L.V.B.).
Department of Cardiology, Vivantes Klinikum Urban (H.I.).
Circ Arrhythm Electrophysiol. 2019 Apr;12(4):e006841. doi: 10.1161/CIRCEP.118.006841.
Left atrial appendage occlusion with WATCHMAN has emerged as viable alternative to vitamin K antagonists in randomized controlled trials. Evaluating real-life clinical outcomes in atrial fibrillation patients receiving the WATCHMAN left atrial appendage closure technology was designed to collect prospective multicenter outcomes of thromboembolic events, bleeding, and mortality for patients implanted with a WATCHMAN in routine daily practice.
One thousand twenty patients with a WATCHMAN implant procedure were prospectively followed in 47 centers. Left atrial appendage occlusion indication was based on the European Society of Cardiology guidelines. Follow-up and imaging were performed per local practice up to a median follow-up of 2 years.
Included population was old (age 73.4±8.9 years), at high risk for stroke (311 prior ischemic stroke/transient ischemic attack and 153 prior hemorrhagic stroke) and bleeding (318 prior major bleeding), with CHADS-VASc score ≥5 in 49%, hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, Labile international normalized ratio, elderly, drugs/alcohol concomitantly ≥3 in 40% and oral anticoagulation contraindication in 72%. During follow-up, 161 patients (16.4%) died, 22 strokes were observed (1.3/100 patient-years, 83% reduction versus historic data), and 47 major nonprocedural bleeding events (2.7/100 patient-years, 46% reduction versus historic data). Stroke and bleeding rates were consistently lower than historic data in those with prior ischemic (-76% and -41%) or hemorrhagic (-81% and 67%) stroke and prior bleeding (-85% and -30%). Lowest bleeding rates were seen in patients with early discontinuation of dual antiplatelet therapy. Patients with early discontinuation of antithrombotic therapy showed lower bleeding rates, while they were highest for those with prior bleeding. Device thrombus was observed in 34 patients (4.1%) and was not correlated to drug regimen during follow-up ( P=0.28).
During the complete 2-year follow-up of Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology, patients with a WATCHMAN left atrial appendage occlusion device had consistently low rates of stroke and nonprocedural bleeding, although most were contraindicated to oral anticoagulation and used only single antiplatelet therapy or nothing.
URL: https://clinicaltrials.gov . Unique identifier: NCT01972282.
在随机对照试验中，左心耳封堵术（WATCHMAN）已成为维生素 K 拮抗剂的可行替代方法。本研究旨在收集接受 WATCHMAN 左心耳封堵术的房颤患者的前瞻性多中心血栓栓塞事件、出血和死亡率结果，以评估该技术在房颤患者中的真实临床结局。
在 47 个中心前瞻性随访了 1020 例接受 WATCHMAN 植入术的患者。左心耳封堵术的适应证基于欧洲心脏病学会指南。根据当地实践进行随访和影像学检查，中位随访时间为 2 年。
入选人群年龄较大（73.4±8.9 岁），中风风险较高（311 例既往缺血性中风/短暂性脑缺血发作和 153 例既往出血性中风）和出血（318 例既往大出血），CHADS-VASc 评分≥5 占 49%，高血压、肝肾功能异常、中风、出血史或倾向、INR 不稳定、年龄较大、合并使用≥3 种药物/酒精以及抗凝禁忌证占 72%。随访期间，161 例患者（16.4%）死亡，观察到 22 例中风（1.3/100 患者年，与历史数据相比降低 83%）和 47 例主要非手术性出血事件（2.7/100 患者年，与历史数据相比降低 46%）。既往缺血性（-76%和-41%）或出血性（-81%和 67%）中风和既往出血患者的中风和出血发生率均持续低于历史数据。早期停用双联抗血小板治疗的患者出血发生率最低。早期停用抗血栓治疗的患者出血发生率较低，而既往有出血史的患者出血发生率最高。34 例（4.1%）患者观察到器械血栓，但在随访期间与药物方案无关（P=0.28）。
在接受 WATCHMAN 左心耳封堵术的房颤患者的真实临床结局评估的 2 年完整随访期间，尽管大多数患者存在抗凝禁忌证，仅使用单一抗血小板治疗或未进行抗血栓治疗，但使用 WATCHMAN 左心耳封堵装置的患者中风和非手术性出血发生率始终较低。
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