Left atrium appendage closure (LAAC) is a major strategy to prevent stroke in patients with nonvalvular atrial fibrillation (AF).
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.
Read also: Left Atrial Appendage Closure Is a Valid Option.
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).
Read also: TCT 2022 | AMULET IDE: Events at 3 Years Using the AMULET Appendage Closure Device.
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.
Dr. Andrés Rodríguez.
Member of the Editorial Board of SOLACI.org.
Original title: Sex Differences in Safety and Effectiveness of Left Atrial Appendage Occlusion Insights From the Amulet IDE Trial.
Reference: Mohamad Alkhouli, MD et al J Am Coll Cardiol Intv 2022.
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