University Heart Center Lübeck, Medical Clinic II (Cardiology, Angiology, Intensive Care Medicine) University Schleswig-Holstein (UKSH).
German Center for Cardiovascular Research (DZHK), Partner Site Hamburg-Kiel-Lübeck, Lübeck, Germany.
Catheter Cardiovasc Interv. 2023 Aug;102(2):283-292. doi: 10.1002/ccd.30759. Epub 2023 Jul 2.
Women with atrial fibrillation (AF) generally experience worse symptoms, poorer quality of life, and have a higher risk of stroke and death. There is limited availability of sex-related differences regarding left atrial appendage occlusion (LAAO).
The aim of this study was to evaluate the sex-related differences in patients undergoing LAAO in EWOLUTION.
A total of 1025 patients scheduled for elective LAAO therapy employing the WATCHMAN Gen 2.5 prospectively consented for participation; 1005 patients received a successful implant and were followed for 2 years. As we detected sex-related differences in baseline data we performed a propensity score matching. The primary endpoint is a combined endpoint of survival free from mortality, major bleeding, ischemic stroke, transitory ischemic attack (TIA) and systemic embolization (SE) up to 2-year clinical follow-up. Secondary Endpoints were periprocedural data and overall 2-year survival.
Women were older but had less often vascular disease and hemorrhagic stroke. There was no sex-related significant difference after LAAO at 2 years in the combined endpoint of survival free from mortality, major bleeding, ischemic stroke, TIA, and SE (female vs. male: 79% vs.76%, p = 0.24) or in overall survival (female vs. male: 85% vs. 82%, p = 0.16). Procedural data showed a higher sealing rate after the implantation in women (complete sealing female 94% vs. male 90%, p = 0.033), significantly more pericardial effusions (female 1.2% vs. male 0.2%, p = 0.031) and a similar periprocedural risk profile.
Females undergoing LAAO differ in various baseline variables, but after adjustment, we observed similar safety and efficacy of LAAO with no significant difference in long-term outcomes between women and men.
患有心房颤动（AF）的女性通常症状更严重、生活质量更差，且中风和死亡风险更高。左心耳封堵（LAAO）的性别相关差异的相关资料有限。
本研究旨在评估 EWOLUTION 中接受 LAAO 治疗的患者的性别相关差异。
共 1025 名计划接受前瞻性使用 WATCHMAN Gen 2.5 进行的 LAAO 治疗的患者同意参与研究；1005 名患者接受了成功的植入并随访了 2 年。由于我们在基线数据中检测到了性别相关差异，因此我们进行了倾向评分匹配。主要终点是 2 年临床随访期间无死亡、主要出血、缺血性中风、短暂性脑缺血发作（TIA）和全身性栓塞（SE）的生存复合终点。次要终点为围手术期数据和总 2 年生存率。
女性年龄较大，但血管疾病和出血性中风的发生率较低。LAAO 后 2 年，无死亡、主要出血、缺血性中风、TIA 和 SE 的生存复合终点（女性 vs. 男性：79% vs. 76%，p=0.24）或总生存率（女性 vs. 男性：85% vs. 82%，p=0.16）在性别间无显著差异。手术数据显示女性的植入后封闭率更高（女性完全封闭 94% vs. 男性 90%，p=0.033），心包积液发生率显著更高（女性 1.2% vs. 男性 0.2%，p=0.031），围手术期风险特征相似。
接受 LAAO 的女性在各种基线变量上存在差异，但经过调整后，我们观察到 LAAO 的安全性和疗效相似，女性和男性的长期结果无显著差异。
