Do Short- and Long-Term Results of Left Atrium Appendage Closure Differ Between Men and Women?

Left atrium appendage closure (LAAC) is a major strategy to prevent stroke in patients with nonvalvular atrial fibrillation (AF).

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LAAC registries to date show that women present twice the risk for major events and higher rates of in-hospital complications and hospital re-hospitalization at 30 days when compared with men. However, long-term results according to sex are not available.

The aim of this study was to perform a post hoc analysis of the randomized AMULET IDE study to examine the short- and long-term difference in LAAC outcomes between men and women.

The following outcomes were assessed: in-hospital complications, peri-device leak at 45 days, device-related thrombus at 18 months, and long-term events (death, thromboembolism, and bleeding).

Out of 1833 patients, Amulet devices were implanted in 917, while 916 received Watchman devices. Of these, 40% were women.

A demographic analysis established that the men were younger, had higher rates of permanent and persistent AF, and a history of cardiovascular or cerebrovascular procedures. They also had lower ejection fraction and a more history of acute myocardial infarction, diabetes, vascular disease, and heart failure.

Procedural success was about 97%, with no differences between sexes. The in-hospital event rate was higher in women (4.4% vs. 1.9%; p < 0.01), driven by the rates for major bleeding (3.7% vs. 1.0%; p < 0.01) and pericardial effusion requiring intervention (2.0% vs. 0.5%; p < 0.01).

The rates of leak and device-related thrombus were similar between men and women (18.3% vs 18.9% [p = 0.78] and 3.3% vs. 5.0% [p = 0.10], respectively).

When long-term outcomes were analyzed, there were no differences between sexes in the rates of stroke or systemic embolism, transient ischemic attack, hemorrhagic stroke, major bleeding, cardiovascular death, and all-cause mortality.

Conclusion

The long-term outcomes of patients undergoing LAAC are similar between men and women, despite the increased rate of in-hospital complications observed in women due to higher rates of major bleeding and pericardial effusion requiring intervention.