Sex differences in long-term clinical effectiveness after pulsed field ablation to treat atrial fibrillation. Sub-analysis of the global FARADISE registry

Background Recent evidence has demonstrated an increased risk of adverse events and lower long-term efficacy in female patients 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 difference in safety and long-term effectiveness between male and female patients treated with PFA. 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 subjects clinically indicated for an AF ablation procedure using the pentaspline PFA catheter. Procedural characteristics, acute safety, and one-year clinical effectiveness, defined as freedom from AF/atrial flutter/atrial tachycardia recurrence, cardioversion, and repeat ablation were collected and compared between male and female patients. Results Overall, 1160 patients were treated with the pentaspline PFA catheter with 384 (33%) female. Baseline demographics between groups revealed that females more often had paroxysmal AF (74.9% vs 64.6%, p<0.01) and less frequent history of cardiac ablation (12.0% vs 16.6%, p=0.04). Ablation strategies did not differ between groups, with a similar percent of cases being pulmonary vein isolation (PVI)-only (female: 74.3% vs male: 71.8%, p=0.37). 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 females and males, respectively. There was no difference in the number of primary safety events between females (1.8%, 7 events) and males (1.2%, 9 events; p = 0.36). In this interim analysis, one-year follow-up has been completed in 513 (66.1%) male patients and 249 (64.8%) female patients. There was no difference in the one-year Kaplan-Meier estimates for clinical effectiveness for females (76.7%) versus males (79.6%; p=0.31). Conclusion In this real-world registry, no differences were seen in acute procedural success, safety and procedural characteristics between male and female patients. Interim results of the one-year follow-up demonstrates no impact of sex on long-term clinical effectiveness with the pentaspline PFA catheter. Follow-up out to 3 years is still ongoing.