Sex differences in procedural outcomes after pulsed field ablation to treat atrial fibrillation. Sub-analysis of the global FARADISE registry

Abstract Background Recent evidence has demonstrated an increased risk of adverse events lower efficacy in women following catheter ablation of atrial fibrillation (AF). With the introduction of a new energy modality, pulsed field ablation (PFA), there is a need for contemporary, real-world data to understand if there is a sex gap in safety and effectiveness of PFA to treat AF. Purpose Evaluate sex differences in procedural outcomes of PFA using the pentaspline catheter to treat AF. Methods FARADISE is a prospective, global registry that enrolled 1173 subjects clinically indicated for an AF ablation procedure using the pentaspline PFA catheter. Procedural characteristics and acute safety and efficacy were collected and compared between men and women. Long-term follow-up is still ongoing. Results Overall, 1160 patients with complete procedural data were included in this sub-analysis with 384 (33%) women. Baseline demographics between groups revealed that women more often had paroxysmal AF (74.9% vs 64.6%, p<0.01), had fewer patients with a history of cardiac ablation (12.0% vs 16.6%, p=0.04), and had a higher left ventricular ejection fraction (59.0% vs 57.5%, p=0.02). The ablation strategies did not differ between men and women, with a similar percent of cases being pulmonary vein isolation (PVI)-only. Procedure times (56.4 ± 22.4 vs 57.9 ± 25.7 minutes, p=0.84) and fluoroscopy times (13.1 ± 7.6 vs 14.2 ± 8.9 minutes, p=0.10) were similar between women and men, respectively. The acute safety event rate was not statistically different in women (1.8%) as in men (1.2%; p = 0.36). Conclusion In this real-world registry, no differences were seen in acute procedural success, safety and procedural characteristics between men and women. Long-term follow-up will help evaluate the impact of gender on arrhythmia recurrence and the effectiveness of PFA.