PO-04-042 GENDER DIFFERENCES IN CLINICAL OUTCOMES AFTER PULSED FIELD ABLATION OF ATRIAL FIBRILLATION: INTERIM ANALYSIS OF THE MANIFEST-PF EFFICACY REGISTRY

Abstract

Prior studies have shown that atrial fibrillation (AF) ablation with conventional thermal ablative modalities, radiofrequency (RF) or cryo, is associated with a higher risk of complications in women compared with men, and a lower success rate of freedom from AF recurrences. Pulsed-field ablation (PFA) is a novel AF ablation energy modality which, in first-in-human clinical trials, has demonstrated preferential myocardial tissue ablation with a unique safety profile. We performed an interim analysis of the MANIFEST-PF registry to explore gender differences in real-world outcomes after PFA of AF. MANIFEST-PF is a retrospective patient-level registry from the first 23 European centers performing clinical PFA procedures, including all consecutive patients who received first-ever ablation for paroxysmal or persistent AF between March to December 2021 using the pentaspline PFA catheter (Farawave, Farapulse-Boston Scientific Inc). We compared baseline and procedural characteristics, and clinical outcomes between men and women. The efficacy endpoint was freedom from atrial arrhythmia (AF/atrial flutter/atrial tachycardia) recurrence ≥30 seconds after a 3 month-blanking period. Safety endpoints included major/minor adverse events (AEs <7 days post-procedure). Binary logistic regression model was created using -- Age, CAD, CHF, Sleep apnea, LVEF, LAD, Non-parox AF, Female, diabetes, HTN and stroke/TIA. Of the 1,332 AF pts who underwent an AF ablation, 454 (34%) were female. Woman, compared to men, were older (67±10 vs 62±11 yrs) and had more paroxysmal AF (72% vs 61%), but less comorbidities such as coronary disease, heart failure and sleep apnea. (Figure A) Following ablation, there was no significant difference in major (2.6% vs 1.1%, p=0.14) or minor (3.3% vs 4.4%, p=0.18) AEs between groups. Multivariable analysis showed that women (Odds ratio 4.1, 95% CI [1.21–13.78], p=0.02) were more likely to have a higher risk of acute major AEs. After a mean follow-up of 196 days, there was no difference in recurrence of atrial arrhythmia (14.5% vs 18%, p=0.14) or redo-ablations (5.1% vs. 7.7%, p=0.07) between women and men, respectively, even after adjusting for the type of AF (ie, PAF vs PerAF). (Figure B) As compared with men, women undergoing PFA to treat AF experience more acute major procedural complications, though the overall rate of complications was low with PFA. On the other hand, women have a similar success rate of freedom from recurrent atrial arrhythmias.