Sex‐related differences in outcome after left atrial appendage occlusion: Insights from Europe and the EWOLUTION registry

Abstract

Background Women with atrial fibrillation (AF) generally experience worse symptoms, poorer quality of life, and have a higher risk of stroke and death. There is limited availability of sex‐related differences regarding left atrial appendage occlusion (LAAO). Aims The aim of this study was to evaluate the sex‐related differences in patients undergoing LAAO in EWOLUTION. Methods A total of 1025 patients scheduled for elective LAAO therapy employing the WATCHMAN Gen 2.5 prospectively consented for participation; 1005 patients received a successful implant and were followed for 2 years. As we detected sex‐related differences in baseline data we performed a propensity score matching. The primary endpoint is a combined endpoint of survival free from mortality, major bleeding, ischemic stroke, transitory ischemic attack (TIA) and systemic embolization (SE) up to 2‐year clinical follow‐up. Secondary Endpoints were periprocedural data and overall 2‐year survival. Results Women were older but had less often vascular disease and hemorrhagic stroke. There was no sex‐related significant difference after LAAO at 2 years in the combined endpoint of survival free from mortality, major bleeding, ischemic stroke, TIA, and SE (female vs. male: 79% vs.76%, p = 0.24) or in overall survival (female vs. male: 85% vs. 82%, p = 0.16). Procedural data showed a higher sealing rate after the implantation in women (complete sealing female 94% vs. male 90%, p = 0.033), significantly more pericardial effusions (female 1.2% vs. male 0.2%, p = 0.031) and a similar periprocedural risk profile. Conclusions Females undergoing LAAO differ in various baseline variables, but after adjustment, we observed similar safety and efficacy of LAAO with no significant difference in long‐term outcomes between women and men.

Choosing Appropriate Candidates for Left Atrial Appendage Occlusion

“…Although there is only a limited number of studies targeting whether gender has any effect on the long-term outcomes after LAAO, the current data appear to suggest that LAAO could introduce a neutralizing effect and provide similar efficacy for both sexes in stroke prevention—this comes after several previous studies found no significant differences in the 1–2-year stroke and mortality rates between sexes [ 28 , 29 , 30 , 31 ]. However, special attention should be given to women during the periprocedural phase as they may experience more procedural adverse events, including pericardial effusion, major bleeding, and vascular complications [ 28 , 29 , 30 , 32 ]. This could be attributed to factors such as smaller and thinner atrial appendage walls, more friable tissue, smaller vessel diameter, and other unmeasured confounding factors.…”