Pulse Field Ablation with PulseSelect Catheter achieved 100% acute PVI, 21.1% arrhythmia recurrence at 7 months, and 3.9% complication rate without hemolysis evidence.
Does Pulse Field Ablation using the circular multielectrode array catheter safely and effectively achieve pulmonary vein isolation in patients with atrial fibrillation?
Real-world data demonstrates that PFA using the PulseSelect catheter is safe and effective for first-time PVI in patients with paroxysmal or persistent AF, with a 100% acute success rate and no evidence of hemolysis.
Abstract Background Pulse Field Ablation (PFA) is an innovative, nonthermal ablation technology for the treatment of atrial fibrillation (AF). While data on the safety and efficacy of the circular multielectrode array catheter (PulseSelect, Medtronic, Minneapolis, MN) have been published, real-world data remain limited.. This study aimed to evaluate the procedural efficacy, safety, and outcomes, including redo pulmonary vein isolation (PVI), in patients undergoing PVI with this catheter. Methods Consecutive patients who underwent first time PVI using the circular multielectrode array catheter were included in this prospective analysis. A three-dimensional electroanatomical reconstruction was performed using the CARTO3 system (J 39.2% female) with paroxysmal (45.1%) or persistent AF were included in the study. The mean procedural time was 76.1 ± 17.4 minutes, and the mean left atrial dwell time was 60.5 ± 13.2 minutes. The mean ablation time was 30.2±12.5 minutes. Acute PVI was achieved in all patients. The mean number of PFA applications per pulmonary vein was 9.3, with no significant difference in application number among pulmonary veins. Complications occurred in two patients (3.9%), including one stroke within 48 hours post-procedure and one puncture site aneurysm. No pericardial effusion, pulmonary vein stenosis, or phrenic nerve injury was observed. After a mean follow-up of 7.0 months, recurrence of any AA beyond the blanking period was observed in 8 of 38 patients (21.1%), with six (75%) experiencing AF and two (25%) atrial tachycardia (AT). Three patients (two AT, one AF) underwent a second ablation procedure. In both AT cases, PVI was intact, whereas in the AF case, re-PVI was necessary. No significant differences in hemolysis biomarkers were observed before and after PFA. Conclusion In this prospective real-world study, Pulse Field Ablation using the circular multielectrode array catheter (PulseSelect Catheter) proved to be safe and effective in both paroxysmal and persistent AF patients. Additionally, no evidence of hemolysis was observed with this PFA system.
Tscholl et al. (2025) studied this question. Pulse Field Ablation with PulseSelect Catheter achieved 100% acute PVI, 21.1% arrhythmia recurrence at 7 months, and 3.9% complication rate without hemolysis evidence.