Long-term outcomes are similar between men and women who undergo left atrial appendage occlusion (LAAO) for nonvalvular atrial fibrillation (NVAF), according to new research published in JACC: Cardiovascular Interventions.[1]
“Concerns have been raised about the safety of LAAO among women.” wrote first author Mohamad Alkhouli, MD, an interventional cardiologist with Mayo Clinic in Rochester, Minnesota, and colleagues. “In the LAAO registry, women had a two-fold higher risk-adjusted rate of major adverse events than men with the previously approved Watchman device. Similarly, data from the National Readmission Database showed that women had significantly higher rates of in-hospital complications, nonhome discharges and unplanned 30-day readmissions.”
Long-term data on the outcomes of these patients remains limited. Alkhouli et al. explored findings from the recently completed Amulet IDE clinical trial to learn more, focusing on 917 patients treated with the Amplatzer Amulet Left Atrial Appendage Occluder (Abbott) and another 916 patients treated with the Watchman Left Atrial Appendage Closure Device (Boston Scientific).
Forty percent of patients included in the analysis were women. The mean age among men was 74.7 years old, and the mean age among women was 75.6 years old. Patients were followed for 18 months after the initial procedures.
Overall, device success was nearly identical among men (97.4%) and women (97.1%). In-hospital adverse events were more common among women (4.4% vs. 1.9%), confirming the findings of previous studies. Bleeding events appeared to be the primary reason for this difference, occurring in 3.7% of women and just 1% of men.
However, there were no significant differences between men and women in the long-term rates of ischemic stroke, systemic embolism, transient ischemic attack, hemorrhagic stroke, major bleeding, cardiovascular death or all-cause death.
“These findings have important implications, as they suggest comparable effectiveness for LAAO in men and in women despite the higher risk for immediate complication with the procedure in women,” the authors wrote. “Hence, LAAO remains an effective stroke-preventive measure in selected women with NVAF, although more effort should be devoted to identifying effective mitigation strategies to reduce periprocedural complications among them.”
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.