Impact of Intracardiac echocardiography on safety outcomes during pulsed field ablation for atrial fibrillation: sub-analysis of the global FARADISE registry

Abstract Background Intracardiac echocardiography (ICE) can be used during atrial fibrillation (AF) ablation to provide real-time anatomical information on relevant atrial structures, visualize catheter placement and tissue contact, and monitor for possible complications. Using ICE provides an adjunction to fluoroscopy-guidance and helps reduce radiation exposure. Evidence demonstrating the acute safety and effectiveness of pulsed field ablation (PFA) with ICE which is limited. Purpose To characterize real-world procedural outcomes using the pentaspline PFA catheter with and without ICE to treat AF. Methods FARADISE is a prospective, non-randomized, global registry (NCT05501873) to evaluate the real-world use of the pentaspline PFA catheter. All subjects enrolled were clinically indicated for an ablation procedure using the pentaspline PFA catheter per medical judgement and hospital standard-of-care. Procedures were performed based on center standard-of-care and operator preference, which optionally included the use of ICE. All subjects have been enrolled and have undergone ablation. Acutely, device- and procedure-related serious adverse events are monitored up to 7-days post-ablation. Three-year follow-up is ongoing. Results Of the 1173 patients enrolled across 48 centers in 21 countries, 1160 patients with complete procedural data are included in this sub-analysis. ICE was used in186 (16%) procedures, which was strongly influenced by regional standards (Figure). There were no clinically meaningful differences between patient baseline characteristics in these two groups. Procedure time and left atrial dwell time were significantly longer when ICE was used (65.0 ± 22.7 vs. 56.0 ± 24.8 minutes; p < 0.001; 38.3 ± 14.8 vs. 34.2 ± 16.6 minutes, p < 0.001), but there was no significant difference between fluoroscopy time (p = 0.09). These differences were, in part, driven by the ablation strategy. For procedures where ICE was used, patients more often received PVI plus additional extra-PV ablation compared to procedures performed without ICE (42.7% vs 24.5%, p < 0.001). Overall, there were 16 major acute adverse events (9 vascular site complications, 1 stroke, 2 tamponade, 2 pericarditis, 1 pulmonary edema, and 1 pericardial effusion). There was a numerical difference between acute safety event rate between the ICE and no ICE groups, but this was not statistically significant (no ICE 1.5% (15) vs. ICE 0.5% (1), p=0.28). Conclusion In this real-world registry, procedures performed using ICE were significantly longer than those without ICE, which is most likely due to the more complex lesion sets delivered in these cases. There were no differences in the acute safety between groups.