AI-Assisted 3D Intracardiac Echocardiography for Pulsed Field Ablation of Atrial Fibrillation Using a Novel Variable Loop Circular Catheter: A Multicenter Evaluation

Background: The VARIPULSE platform is an advanced Pulsed Field Ablation (PFA) system fully integrated with electro-anatomical mapping system, employing a variable loop circular catheter (VLCC) for atrial fibrillation (AF) ablation. The objective of the study is to assess for the first time the feasibility, safety, and procedural impact of AI (artificial intelligence)-assisted ICE (intracardiac echocardiography) mapping with the CARTOSOUND FAM Module compared with conventional electroanatomical mapping during PFA. Methods: In this retrospective, multicenter study, 157 consecutive patients undergoing PFA for paroxysmal or persistent AF were included. Patients were divided into two groups: ICE-guided cohort (n = 64) and non-ICE-guided cohort (n = 93). Propensity score matching (PSM) was used to adjust for baseline differences. Results: AI-assisted ICE mapping was feasible in all cases. Compared with conventional mapping, it significantly reduced LA (left atrium) mapping time (median 5 vs. 8 min; p < 0.001), LA dwell time (33.5 vs. 38.5 min; p = 0.001), and fluoroscopy time (7.5 vs. 14 min; p < 0.001). The total number of PFA applications was similar across groups (p = 0.136). No major adverse events occurred in either cohort during the procedure or within the first month of follow-up. Conclusions: AI-assisted ICE mapping using the CARTOSOUND FAM Module enables accurate anatomical reconstruction and significantly optimizes procedural efficiency in PFA. This approach supports further development toward radiation-sparing and potentially fluoroscopy-free PFA workflows. For the first time, it addresses a gap in the current evidence regarding the use of ICE in PFA, building on evidence already established for radiofrequency ablation procedures.