Sex Differences in Procedural Outcomes Among Patients Undergoing Left Atrial Appendage Occlusion: Insights From the NCDR LAAO Registry

Abstract

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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Du reported receiving salary support to provide analytic services for the American College of Cardiology National Cardiovascular Data Registry (NCDR) during the conduct of the study. Dr Saw reported receiving personal fees from Abbott Vascular, Boston Scientific, and Gore; unrestricted research grant supports from the Canadian Institutes of Health Research, Heart & Stroke Foundation of Canada, National Institutes of Health, AstraZeneca, Abbott Vascular, St Jude Medical, Boston Scientific, and Servier; salary support from Michael Smith Foundation for Health Research; speaker honoraria from AstraZeneca, Abbott Vascular, Boston Scientific, and Bayer; consultancy and advisory board honoraria from AstraZeneca, Boston Scientific, Abbott Vascular, Gore, Baylis, and Abiomed; and proctorship honoraria from Abbott Vascular and Boston Scientific outside the submitted work. Dr Al-Khatib reported receiving research support from Boston Scientific, Medtronic, and Abbott; speaking fees from Medtronic and Abbott; and consulting fees from Medtronic outside the submitted work. Dr Russo reported receiving grants and personal fees from Boston Scientific; research support (funding to hospital) from Boston Scientific, Kestra, and Medilynx; honoraria for consulting from Medtronic; and serving on research steering committees for Boston Scientific and Medtronic outside the submitted work. Dr Minges reported receiving salary support to provide analytic services for the American College of Cardiology NCDR during the conduct of the study. Dr Curtis reported receiving salary support from the American College of Cardiology and the Centers for Medicare & Medicaid Services during the conduct of the study; and equity ownership in Medtronic outside the submitted work. Dr Freeman reported receiving grants from the National Heart, Lung, and Blood Institute and the American College of Cardiology NCDR during the conduct of the study; and personal fees from Boston Scientific, Medtronic, Janssen Pharmaceuticals, and Biosense Webster outside the submitted work. Dr Hsu reported receiving personal fees from Medtronic, Boston Scientific, Abbott, Biotronik, Janssen Pharmaceutical, Bristol Myers Squibb, Pfizer, Biosense Webster, Altathera Pharmaceuticals, and Zoll Medical; grants from Biotronik and Biosense Webster; and equity interest in Acutus Medical Equity and Vektor Medical outside the submitted work. No other disclosures were reported.

Figures

Figure.. Unadjusted and Adjusted Outcomes of In-Hospital Adverse Events for Women and Men After Receiving Watchman Implant

Any in-hospital major adverse event included death, cardiac arrest, ischemic stroke, hemorrhagic stroke, undetermined stroke, transient ischemic attack, intracranial hemorrhage, systemic arterial embolism, major bleeding, major vascular complication, myocardial infarction, pericardial effusion requiring intervention, and device embolization. Multivariable models adjusted for age, race/ethnicity, body mass index, congestive heart failure, hypertension, diabetes, stroke, vascular disease, glomerular filtration rate, P2Y12 inhibitor prescription, oral anticoagulant prescription, coronary artery disease, left ventricular ejection fraction, and hospital region.