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Sex Differences in Procedural Outcomes Among Patients Undergoing Left Atrial Appendage Occlusion: Insights From the NCDR LAAO Registry
JAMA Cardiology ( IF 14.8 ) Pub Date : 2021-11-01 , DOI: 10.1001/jamacardio.2021.3021
Douglas Darden 1 , Thao Duong 1 , Chengan Du 2, 3 , Muhammad Bilal Munir 1 , Frederick T Han 1 , Ryan Reeves 1 , Jacqueline Saw 4 , Emily P Zeitler 5 , Sana M Al-Khatib 6 , Andrea M Russo 7 , Karl E Minges 2, 3, 8 , Jeptha P Curtis 2, 3 , James V Freeman 2, 3 , Jonathan C Hsu 1
Affiliation  

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.



中文翻译:

左心耳闭塞患者手术结果的性别差异:来自 NCDR LAAO 登记处的见解

重要性 左心耳封堵术 (LAAO) 已成为选择性心房颤动患者抗凝治疗的替代方案;然而,女性在 LAAO 临床试验中的代表性不足,并且针对性别的子分析有限。

目的 评价LAAO植入患者基线特征和LAAO植入后住院结局的性别差异。

设计、设置和参与者 本研究纳入了 2016 年 1 月 1 日至 2019 年 6 月 30 日期间在国家心血管数据注册 LAAO 注册中使用 Watchman 设备接受 LAAO 的总共 49 357 名患者。

暴露 女性或男性。

主要结果和措施 主要结果是手术中止或取消、主要不良事件、任何不良事件、住院时间超过 1 天和死亡。进行未调整和多变量调整逻辑回归分析以评估院内不良事件的性别差异。

结果 在这项包含 49 357 名患者(平均 [SD] 年龄,76.1 [8.0] 岁)的队列研究中,20 388 名女性(41.3%)和 28 969 名(58.7%)男性接受了 LAAO。与男性相比,女性年龄更大,阵发性心房颤动、既往卒中和未控制的高血压患病率更高,但充血性心力衰竭、糖尿病和冠状动脉疾病的患病率较低。多变量调整后,女性和男性在中止或取消手术方面没有差异(613 [3.0%] vs 851 [2.9%];优势比 [OR] 1.01, 95% CI, 0.90-1.13)。女性比男性更容易发生任何不良事件(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%] 对 567 [2.0%];P < .001; 或者,2.06;95% CI,1.82-2.34;P  < .001),因为心包积液需要引流(241 [1.2%] vs 144 [0.5%])或大出血(349 [1.7%] vs 244 [0.8%])。女性住院时间超过 1 天的可能性也高于男性(3272 [16.0%] vs 3355 [11.6%];P  < .001;调整后的 OR,1.46;95% CI,1.38-1.54;P  < . 001)或死亡(调整后的 OR,2.01;95% CI,1.31-3.09;P  = .001),尽管死亡很少见,绝对差异很小(58 [0.3%] vs 37 [0.1%];P  < .001 )。

结论和相关性 本研究表明,与男性相比,女性在 LAAO 后发生院内不良事件的风险显着增加。进一步研究旨在降低风险,特别是降低接受 LAAO 女性心包积液和大出血风险的策略是必要的。

更新日期:2021-11-08
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