Key result
Female gender was not associated with a higher rate of the primary safety composite endpoint compared to male gender (4.3% vs 5.0%, p=0.73) following left atrial appendage occlusion with a dual occlusive mechanism device.
Why the study?
Recent studies suggested increased adverse events in women after left atrial appendage occlusion with dual occlusive mechanism devices, warranting investigation of gender disparities.
Does gender affect in-hospital adverse events and short-term device-related outcomes in patients undergoing LAAO with dual occlusive mechanism devices?
Cohort (n=474)
No
Does gender affect in-hospital adverse events and short-term device-related outcomes in patients undergoing LAAO with dual occlusive mechanism devices?
Absolute Event Rate: 4.3% vs 5%
p-value: p=0.73
In an experienced center, gender was not associated with higher in-hospital complications or worse short-term device-related outcomes following LAAO with dual occlusive mechanism devices.
No gender-linked complications with dual-mechanism LAAO at experienced centers supports procedural safety in women; leaves open generalizability beyond single-center data.
Background: Recent studies have suggested an increased rate of adverse events in women following left atrial appendage occlusion (LAAO), particularly with dual occlusive mechanism devices. Objectives: This study aimed to investigate gender disparities in in-hospital adverse events and short-term device-related outcomes in an experienced center using dual occlusive mechanism devices exclusively. Methods: In a single-center retrospective study, patients who received dual occlusive mechanism devices (Amplatzer cardiac plug and Amulet) were analyzed. We assessed gender differences in patient characteristics, LAAO indications, procedural data, in-hospital complications, and short-term device-related outcomes in the form of one-month follow-up transesophageal echocardiography. Results: Among 474 patients, 211 (45%) were women. At device implantation, women were significantly older (77.45±6.98 years vs. 75.89±7.26; p = 0.01), with higher CHA2DS2Vasc scores (5.03±1.46 vs. 4.28±1.51; p < 0.01) and lower HASBLED scores (3.78±1.06 vs. 4.03±1.12; p = 0.01) compared to men. Men had a higher prevalence of coronary artery disease (52% vs. 32%; p < 0.01). LAAO indications did not significantly differ. Device success was 99% in men and 98% in women (p = 0.75). In-hospital complications, including deaths, major bleedings, and pericardial effusion, did not significantly vary by gender. Rates of device-related thrombus and device closure with a residual jet ≤ 5 mm were similar. Conclusions: In a large cohort of consecutive LAAO patients at an experienced center, gender was not linked to higher in-hospital complications.
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Heinrich et al. (2023) conducted a cohort in Atrial fibrillation with contraindications to oral anticoagulation (n=474). Female gender vs. Male gender was evaluated on Composite of procedure-related complications, all-cause death, or major bleeding until hospital discharge (p=0.73). Female gender was not associated with a higher rate of the primary safety composite endpoint compared to male gender (4.3% vs 5.0%, p=0.73) following left atrial appendage occlusion with a dual occlusive mechanism device.
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