A comparison of new single shot pulsed field ablation systems

Abstract Background Pulsed field ablation (PFA) is a new modality of catheter ablation for atrial fibrillation (AF) that uses rapid, high-voltage electrical pulses to cause irreversible electroporation of myocytes 1. The ADVENT trial showed PFA to be non-inferior to thermal ablation methods for patients with paroxysmal atrial fibrillation 1. However, given the presence of multiple approved systems, including PulseSelect and FARAPULSE, there is need to compare clinical outcomes between available devices. Purpose To compare clinical outcomes between two PFA systems (PulseSelect and FARAPULSE) with secondary aim to evaluate the impact of post-ablation mapping using a high-density mapping catheter (PAHDMC). Methods This IRB-approved retrospective cohort study included patients who underwent PFA at our institution in 2024. Patients with prior AF ablations were excluded. Data collected included patient demographics, PFA system used (PulseSelect vs FARAPULSE), PAHDMC use, and clinical outcomes. Primary outcome was arrhythmia recurrence following the one-month blanking period, defined as any of the following: ongoing anti-arrhythmic medication use, need for cardioversion, AF on electrocardiogram (ECG), hospitalisation for AF, or repeat ablation. Procedure length and fluoroscopy time were also analysed. Data were sorted by PFA system (PulseSelect vs FARAPULSE) and use of PAHDMC. Odds ratios and means were used, adjusting for covariates using multiple logistic regression for dichotomous outcomes and multiple linear regression for continuous outcomes. Results There were 676 patients included: 138 in PulseSelect group vs 538 in FARAWAVE and 329 undergoing PAHDMC vs 347 not. PulseSelect and FARAWAVE groups were not significantly different with respect to the odds of recurrence, odds of repeat ablation, or odds of hospitalisation for atrial fibrillation. There was no significant difference in the odds of recurrence, repeat ablation, or hospitalisation with PAHDMC. PAHDMC was associated with a shorter average procedure time (71.6 vs 85.2; p=0.010) and fluoroscopy time (7.9 vs 15.3; p0.001) in the PulseSelect group, and longer average procedure time (64.9 vs 43.6; p0.001) and fluoroscopy time (14.9 vs 12.1; p0.001) in the FARAWAVE group. The odds of recurrence in the FARAWAVE group was 1.8 times greater (95% CI: 1.21-2.55) for every 15-minute increase in fluoroscopy time. The other analyses surrounding procedure or fluoroscopy time and PFA system on recurrence were not significant. Neither procedure time nor fluoroscopy time were significant predictors of repeat ablation or hospitalisation. Conclusion No significant differences in clinical outcomes were observed between the PulseSelect and FARAPULSE systems, nor the use of PAHDMC to confirm pulmonary vein isolation. To our knowledge, this is the first study to compare clinical outcomes between the two FDA-approved PFA systems. It also represents the outcomes of PFA in a high-volume, community hospital.