medwireNews: Sex has no impact on the clinical effectiveness of pulsed field ablation (PFA) for atrial fibrillation (AF), nor does it affect the chance of experiencing major adverse side effects, report US researchers.
“[T]here are important differences in the incidence, presentation, and management of AF between male and female individuals,” explain the authors in JAMA Cardiology.
However, the team found no significant difference between the number of women and men who were free from clinically documented atrial arrhythmia lasting at least 30 seconds 3 months after receiving PFA in their retrospective analysis of 1568 patients in the MANIFEST-PF registry.
They say that PFA is a “novel, nonthermal cardiac ablation energy modality” that has not only “demonstrated preferential myocardial tissue ablation” but also a “unique safety profile with no reported instances of pulmonary vein stenosis or evidence of esophageal injury.”
Vivek Reddy, from Icahn School of Medicine at Mount Sinai in New York, USA, and colleagues calculated 1-year Kaplan-Meier estimates for freedom from atrial arrhythmia (AF, atrial flutter, and atrial tachycardia) after a single PFA procedure and found them to be similar between 553 women and 1015 men, at 76.3% versus 79.0%.
The research team found that while women in the cohort were older than the men (68.2 versus 62.5 years) and were more likely to have paroxysmal AF (70.2% versus 62.4%), they were also less likely to have comorbidities such as coronary heart disease (9.0 vs 15.9%), heart failure (10.5 vs 16.6%), and sleep apnea (4.7 vs 11.7%).
The researchers also conducted an adjusted propensity-matched analysis using data for 365 women and 365 men in the registry and found similar results, despite the women having a higher incidence of paroxysmal AF compared with men, at 70.1% versus 57.8%, whereas the men had higher rates of persistent AF (38.4% versus 27.9%).
Recurrence of atrial arrhythmia after the initial PFA occurred in a comparable 8.3% of women and 10.0% of men, all of whom underwent at least one repeat procedure. Among these individuals, Reddy et al also found that per-vein durability did not significantly differ between women and men (82.6 vs 68.1%), but that per-patient pulmonary vein isolation durability was significantly better among women than men, at 63.0% versus 37.8%.
“The reason for this difference in durability is unknown but possibly related to anatomic issues such as the left atrial size being somewhat smaller in female individuals,” remark the researchers.
The incidence of major adverse events including esophageal fistula, cardiac tamponade, stroke, and death after treatment was low, report Reddy et al, noting that such events occurred in just 2.5% of women and 1.5% of men overall – a nonsignificant difference.
In an accompanying commentary, Peter Kistler and Louise Segan, both from Alfred Hospital in Melbourne, Victoria, Australia, write that Reddy and colleagues’ study “helps to fill a previously porous field in AF ablation with electroporation.”
However, they warn that the lack of randomization in the MANIFEST-PF registry “may introduce a selection bias and allow for unmeasured confounders that could have biased the result.”
Despite this, they conclude: “It is reassuring to see that both in the overall and propensity-matched analyses there was no signal toward reduced treatment efficacy among women,” and that “procedural safety was comparable between sexes.”
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