More adverse events, longer hospital stays for women undergoing LAA occlusion vs. men
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Women who underwent left atrial appendage occlusion for nonvalvular atrial fibrillation experienced more adverse in-hospital outcomes and longer hospital stays compared with men, according to data published in JAMA Cardiology.
In this study that evaluated sex differences in baseline characteristics and in-hospital outcomes after left atrial appendage (LAA) occlusion implant (Watchman, Boston Scientific), researchers reported that the primary driver of adverse outcomes among women was a greater occurrence of pericardial effusion requiring drainage and major bleeding, compared with men.
For this analysis, Douglas Darden, MD, electrophysiology fellow at the University of California, San Diego, and colleagues included 49,357 patients (mean age, 76 years; 59% men) from the National Cardiovascular Data Registry LAAO Registry who underwent LAA occlusion for nonvalvular AF from 2016 to June 2019. Outcomes of interest included aborted or canceled LAA occlusion procedure, major adverse event, any adverse event, hospital stay of more than 1 day and death.
Differences in baseline characteristics
According to the study, women who underwent LAA occlusion for nonvalvular AF were more often older (P < .001) with greater prevalence of paroxysmal AF (P < .001), prior stroke (P = .003) and uncontrolled hypertension compared with men (P < .001).
Men, however, had a greater prevalence of congestive HF, diabetes and CAD compared with women (P for all < .001).
Occurrence of in-hospital adverse events
There were no differences between women and men for the outcome of aborted or canceled LAA occlusion procedures (3% vs. 2.9%, respectively; OR = 1.01; 95% CI, 0.9-1.13).
Researchers reported that women were more likely to experience any adverse event (OR = 1.63; 95% CI, 1.49-1.77; P < .001) or major adverse event (OR = 2.06; 95% CI, 1.82-2.34; P < .001) compared with men. This finding was primarily driven by the greater prevalence among women compared with men of pericardial effusion requiring drainage (1.2% vs. 0.5%) or major bleeding (1.7% vs. 0.8%).
Moreover, women were more likely to experience a hospital stay of more than 1 day (adjusted OR = 1.46; 95% CI, 1.38-1.54; P < .001) or death (aOR = 2.01; 95% CI, 1.31-3.09; P = .001) compared with men; however, death was not common among patients who underwent LAA occlusion, and the absolute difference was minimal (women: 0.3% vs. men: 0.1%; P < .001).
“Anatomical differences between women and men, such as smaller vessel diameter, thinner myocardial wall or a more friable LAA in women, may predispose women to increased risk of complications,” the researchers wrote. “In the present study, women had a slightly smaller LAA maximal width ... however, other characteristics, such as left atrial size, LAA morphology and number of device deployment attempts, may have important risk implications with regard to pericardial effusion that are not captured in the registry.
“Although we cannot fully elucidate the causes of the increased risk of adverse events experienced by women, several strategies may mitigate procedural risk, including ultrasonography-guided venous access, preprocedural imaging to evaluate cardiac function, LAA size and morphology to guide equipment and device selection, developing proficiency with LAAO devices, and continued development of safer devices,” the researchers wrote. “We must continue to advocate for increased participation of women in clinical trials to better inform clinical decision-making and adequately delineate sex-based safety and efficacy outcomes.”
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