Key result
Female patients undergoing left atrial appendage occlusion had a higher rate of severe periprocedural complications than males (6.9% vs. 3.1%, p=0.032), but similar 1-year efficacy and safety.
Why the study?
Limited data exist on gender-related outcomes in patients undergoing left atrial appendage occluder implantation for atrial fibrillation.
Do periprocedural and 1-year outcomes differ between male and female patients undergoing left atrial appendage occluder (LAAO) implantation?
Cohort (n=641)
Yes
Do periprocedural and 1-year outcomes differ between male and female patients undergoing left atrial appendage occluder (LAAO) implantation?
Absolute Event Rate: 6.9% vs 3.1%
p-value: p=0.032
While female patients experience a higher rate of severe periprocedural complications during LAAO implantation, their 1-year efficacy and safety outcomes are comparable to those of male patients.
INTRODUCTION: Gender-based differences in atrial fibrillation have been identified, but limited data exist for patients undergoing left atrial appendage occluder (LAAO) implantation. This study reports gender-related periprocedural and 1-year outcomes of the prospective, multicenter German left atrial appendage occlusion registry (LAARGE). METHODS: LAARGE enrolled 641 patients who were scheduled for LAAO implantation from July 2014 to January 2016 in 38 hospitals in Germany. The data collected included demographics, clinical characteristics, details of implantation, and outcome. Efficacy and safety at 1-year follow-up were assessed by the occurrence of thrombembolic and bleeding events, as well as mortality. RESULTS: -VASc score: 4.9 ± 1.5 vs. 4.3 ± 1.5, p < .001). In contrast, males suffered more often from coronary artery (33.1% vs. 53.8%, p < .001) and vascular disease (18.5% vs. 31.0%, p < .001). Technical success was high and similar for both genders (98.4% vs. 97.2%, p = .33). Severe periprocedural complications (6.9% vs. 3.1%, p = .032) occurred more often in females. At 1-year follow-up the rates of all-cause stroke (0.5% vs. 1.3%, p = .65) and severe bleeding (0.0% and 1.0%, p = .29) were low and comparable between the genders. Also, one-year all-cause mortality (9.2% vs. 13.1%, p = .14) did not differ significantly. CONCLUSION: LAARGE documented in this elderly patient population undergoing LAAO implantation a higher rate of severe periprocedural complications in females. At 1-year follow-up similar efficacy and safety outcomes were observed for both genders.
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Kleinecke et al. (2021) conducted a cohort in Atrial fibrillation (n=641). Female gender vs. Male gender was evaluated on Severe periprocedural complications (p=0.032). Female patients undergoing left atrial appendage occlusion had a higher rate of severe periprocedural complications than males (6.9% vs. 3.1%, p=0.032), but similar 1-year efficacy and safety.
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