Division of Cardiology, Department of Medicine, University of California, San Diego, La Jolla.
Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.
JAMA Cardiol. 2021 Nov 1;6(11):1275-1284. doi: 10.1001/jamacardio.2021.3021.
Left atrial appendage occlusion (LAAO) has emerged as an alternative to anticoagulation for select patients with atrial fibrillation; however, women have been underrepresented in clinical trials of LAAO, and sex-specific subanalyses are limited.
To evaluate the sex differences in the baseline characteristics of patients undergoing LAAO implant and in the in-hospital outcomes after LAAO implant.
DESIGN, SETTING, AND PARTICIPANTS: A total of 49 357 patients in the National Cardiovascular Data Registry LAAO Registry undergoing LAAO with the Watchman device between January 1, 2016, and June 30, 2019, were included in this study.
Female or male sex.
The primary outcomes were aborted or canceled procedure, major adverse event, any adverse event, prolonged hospital stay longer than 1 day, and death. Unadjusted and multivariable adjusted logistic regression analyses were performed to assess sex differences in in-hospital adverse events.
In this cohort study of 49 357 patients (mean [SD] age, 76.1 [8.0] years), 20 388 women (41.3%) and 28 969 (58.7%) men underwent LAAO. Compared with men, women were older and had a higher prevalence of paroxysmal atrial fibrillation, prior stroke, and uncontrolled hypertension but a lower prevalence of congestive heart failure, diabetes, and coronary artery disease. After multivariable adjustment, there were no differences in aborted or canceled procedures between women and men (613 [3.0%] vs 851 [2.9%]; odds ratio [OR] 1.01, 95% CI, 0.90-1.13). Women were more likely than men to experience any adverse event (1284 [6.3%] vs 1144 [3.9%]; P < .001; OR, 1.63; 95% CI, 1.49-1.77; P < .001) or major adverse event (827 [4.1%] vs 567 [2.0%]; P < .001; OR, 2.06; 95% CI, 1.82-2.34; P < .001) owing to pericardial effusion requiring drainage (241 [1.2%] vs 144 [0.5%]) or major bleeding (349 [1.7%] vs 244 [0.8%]). Women were also more likely than men to experience a hospital stay longer than 1 day (3272 [16.0%] vs 3355 [11.6%]; P < .001; adjusted OR, 1.46; 95% CI, 1.38-1.54; P < .001) or death (adjusted OR, 2.01; 95% CI, 1.31-3.09; P = .001), although death was rare and absolute differences were minimal (58 [0.3%] vs 37 [0.1%]; P < .001).
This study suggests that, compared with men, women have a significantly higher risk of in-hospital adverse events after LAAO. Further research aimed at risk reduction, particularly strategies to reduce the risk of pericardial effusion and major bleeding, in women undergoing LAAO is warranted.
左心耳封堵术 (LAAO) 已成为房颤患者替代抗凝治疗的一种选择；然而，女性在 LAAO 的临床试验中代表性不足，并且关于 LAAO 的性别特异性亚分析有限。
评估接受 LAAO 植入的患者的基线特征以及 LAAO 植入后的住院期间结局在性别方面的差异。
设计、地点和参与者：本研究共纳入了 2016 年 1 月 1 日至 2019 年 6 月 30 日期间在全国心血管数据登记处 LAAO 登记处接受 Watchman 装置 LAAO 的 49357 名患者。
女性或男性。
主要结局为手术中止或取消、主要不良事件、任何不良事件、住院时间延长超过 1 天和死亡。进行了未调整和多变量调整的逻辑回归分析，以评估住院期间不良事件的性别差异。
在这项 49357 名患者（平均[标准差]年龄，76.1[8.0]岁）的队列研究中，20388 名女性（41.3%）和 28969 名男性（58.7%）接受了 LAAO。与男性相比，女性年龄更大，阵发性房颤、既往卒中以及未控制的高血压更为常见，但充血性心力衰竭、糖尿病和冠心病的患病率较低。在多变量调整后，女性与男性在手术中止或取消方面没有差异（613[3.0%]与 851[2.9%]；优势比[OR]1.01，95%CI，0.90-1.13）。女性发生任何不良事件（1284[6.3%]与 1144[3.9%]；P<0.001；OR，1.63；95%CI，1.49-1.77；P<0.001）或主要不良事件（827[4.1%]与 567[2.0%]；P<0.001；OR，2.06；95%CI，1.82-2.34；P<0.001）的可能性更大，原因是心包积液需要引流（241[1.2%]与 144[0.5%]）或主要出血（349[1.7%]与 244[0.8%]）。女性发生住院时间延长超过 1 天（3272[16.0%]与 3355[11.6%]；P<0.001；调整后的 OR，1.46；95%CI，1.38-1.54；P<0.001）或死亡（调整后的 OR，2.01；95%CI，1.31-3.09；P=0.001）的可能性也高于男性，尽管死亡罕见且绝对差异较小（58[0.3%]与 37[0.1%]；P<0.001）。
本研究表明，与男性相比，女性在 LAAO 后住院期间发生不良事件的风险显著更高。需要进一步研究旨在降低风险的策略，特别是降低心包积液和主要出血风险的策略，以用于接受 LAAO 的女性。
