Differences in Procedural Outcomes Among Patients Undergoing Left Atrial Appendage Occlusion Insights From the NCDR LAAO Registry
Differences in Procedural Outcomes Among Patients Undergoing Left Atrial Appendage Occlusion Insights From the NCDR LAAO Registry
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DOI：
10.1001/jamacardio.2021.3021
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发表时间：
2021-08-11
期刊：
影响因子：
24
通讯作者：
Hsu, Jonathan C.
中科院分区：
文献类型：
--
作者：
Darden, Douglas;Duong, Thao;Hsu, Jonathan C.
重要性左心耳封堵术（LAAO）已成为房颤患者抗凝治疗的替代方案;然而，在LAAO的临床试验中，女性的代表性不足，并且性别特异性亚组分析是有限的。目的评估接受LAAO植入的患者的基线特征和LAAO植入后的住院结局的性别差异。设计，环境，本研究纳入了2016年1月1日至2019年6月30日期间在美国国家心血管数据注册中心LAAO注册中心接受Watchman器械LAAO的49357例患者。暴露女性或男性。主要结局和指标主要结局为手术中止或取消、主要不良事件、任何不良事件、延长住院时间超过1天和死亡。未调整和多变量调整logistic回归分析进行评估性别差异在医院不良事件。结果在49 357例患者（平均[SD]年龄，76.1 [8.0]岁），20 388名女性（41.3%）和28 969（58.7%）男性接受LAAO的队列研究。与男性相比，女性年龄较大，阵发性房颤、既往卒中和未控制的高血压患病率较高，但充血性心力衰竭、糖尿病和冠状动脉疾病的患病率较低。在多变量调整后，女性和男性之间的流产或取消手术没有差异（613 [3.0%] vs 851 [2.9%];比值比[OR] 1.01，95%CI，0.90-1.13）。女性比男性更有可能经历任何不良事件（1284 [6.3%] vs 1144 [3.9%]; P < .001; OR，1.63; 95% CI，1.49-1.77; P < .001）或主要不良事件（827 [4.1%] vs 567 [2.0%]; P <0.001; OR，2.06; 95%CI，1.82-2.34; P <0.001），原因是心包积液需要引流（241 [1.2%] vs 144 [0.5%]）或大出血（349 [1.7%] vs 244 [0.8%]）。女性也比男性更有可能经历超过1天的住院时间（3272例[16.0%] vs 3355例[11.6%]; P < .001;校正OR，1.46; 95% CI，1.38-1.54; P < .001）或死亡（调整后OR，2.01; 95% CI，1.31-3.09; P = .001），尽管死亡罕见，绝对差异极小（58例[0.3%] vs 37例[0.1%]; P < .001）。结论和相关性这项研究表明，与男性相比，女性患者在LAAO术后发生院内不良事件的风险显著更高。进一步的研究旨在降低风险，特别是策略，以减少心包积液和大出血的风险，在妇女接受LAAO是必要的。
IMPORTANCE 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.OBJECTIVE 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.EXPOSURE Female or male sex.MAIN OUTCOMES AND MEASURES 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.RESULTS 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).CONCLUSIONS AND RELEVANCE 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.