Gender Differences In Outcomes With Patients Undergoing Percutaneous Left Atrial Appendage Occlusion: Insights From The Ncdr Laao Registry

Introduction: Left atrial appendage occlusion (LAAO) has emerged as an alternative to anticoagulation in select patients with atrial fibrillation (AF), however women are underrepresented in trial data and sex-specific sub analyses are limited. Hypothesis: Women will be more likely than men to experience adverse events following left atrial appendage occlusion (LAAO) procedure. Methods: Using the National Cardiovascular Data Registry LAAO Registry, patients undergoing Watchman implantation between January 2016 and December 2018 were included. Unadjusted and multivariable adjusted logistic regression analyses were performed to assess the association between gender and in-hospital outcomes, including any complication, major adverse events (pericardial effusion, major bleeding, stroke, and device embolization), hospital stay > 1 day, and mortality. Results: A total of 20,388 (41.3%) women and 28,969 (58.7%) men underwent Watchman implantation. Compared with male patients, women were older (76.5 vs 75.8 years, p<0.001) with a higher CHA2DS2-VASc score (1.5 vs 1.4, p<0.001), and higher prevalence of paroxysmal atrial fibrillation (59.0% vs 50.0%, p<0.001), prior stroke (27.5% vs 26.7%, p=0.003) and uncontrolled hypertension (29.3% vs 26.7%, p<0.001). Women had a lower prevalence of congestive heart failure (34.5% vs 39.7%, p<0.001), diabetes (34.8 vs 39.7%, p<0.001), and coronary artery disease (35% vs 55.7%, p<0.001). There were no differences with increased thromboembolic risk or history of major bleed, while women were more likely to have a high fall risk (39.8% vs 33.5%, p<0.001) and labile INR (9.1% vs 8.3%, p=0.003) as an indication for occlusion. After multivariable adjustment, women were more likely to have any complication (OR 1.62, 95% CI 1.62 - 1.77, p<0.001), major adverse event (OR 1.81, 95% CI 1.61 - 2.04, p<0.001), hospital stay >1 day (OR 1.46, 95% CI 1.38 - 1.54, p<0.001), and higher mortality (2.01, 95% CI 1.31 - 3.09, p=0.001). Conclusion: Women have a significantly higher risk than men of in-hospital adverse events and mortality following Watchman implantation. Further examination of the risk-benefit relationship of LAAO in women is warranted.