Outcomes of simplified left atrial appendage occlusion using the WATCHMAN FLX device: the ROSE-FLX study

作者：Wei Zhou, Qian Tang, Anning Zeng, Jiulin Chen, Fang Wang, Yi-Xiang Wang, J Chen, Linyan Shi, Ji Li, Yirong Zhang, Dawei Tian, Dandan Chen, Fuliang Luo, Zheyi Wu, Na Deng, Fei Yan, Qianjiang Pan, 廖忠荣, Yongxian Tian, Yifan Mao, Huimin Lu, Xing Zhou, Ya Yang, ZhenFa Zhang, Runze Huang, Weiwei Li · 发表于：EP Europace · 年份：2026 · DOI：10.1093/europace/euag045 · 研究领域：Atrial Fibrillation Management and Outcomes、Cardiovascular Function and Risk Factors、Cardiac Valve Diseases and Treatments

AIMS: Conventional left atrial appendage occlusion (LAAO) procedures typically require transoesophageal echocardiography and general anaesthesia, which may limit feasibility in resource-limited settings. Simplified LAAO (sLAAO) guided exclusively by fluoroscopy offers a practical and efficient alternative. This study evaluated procedural safety, efficacy, and short-term outcomes of sLAAO using the WATCHMAN FLX device under exclusive fluoroscopic guidance in a real-world, multicentre setting. METHODS AND RESULTS: The ROSE-FLX study was a prospective, multicentre, single-arm registry including 400 patients with non-valvular atrial fibrillation at high thromboembolic and bleeding risk. All underwent sLAAO under local anaesthesia and exclusive fluoroscopic guidance. Procedural data, peri-procedural complications, and follow-up outcomes were analysed. Predictors of adverse events were determined using Cox regression. Procedural success was 100%, with low major complication rates: pericardial effusion (0.5%), access-site complications (1.3%), and major bleeding (0.8%). Over median follow-up of 194.5 days [interquartile range (IQR) 129.0-265.0], all-cause mortality occurred in three patients (0.8%), transient ischaemic attacks in 13 patients (3.3%), and device-related thrombosis in one patient (0.3%). In multivariable Cox regression, chronic obstructive pulmonary disease (HR 2.86, 95% CI 1.98-4.11, P < 0.001) and higher CHA2DS2-VASc scores (HR 4.69, 95% CI 1.90-11.57, P < 0.001) ind...