Real-world single-center experience: initial 100 cases of pulmonary vein isolation and ablation of non-pulmonary vein sites using a novel circular pulsed field ablation system

Various pulsed field ablation (PFA) ablation systems are currently being developed. Recently, a novel CE-approved circular array PFA catheter (PulseSelect PFA System) was introduced. Data on this commercially available system is sparse. The aim was to elucidate real-world data assessing the feasibility, safety, and acute efficacy of pulmonary vein isolation (PVI) and ablation beyond PVI with this novel ablation system.

Consecutive patients with paroxysmal and persistent atrial fibrillation (AF) undergoing first-time ablation with the circular PFA catheter were enrolled in this study. In patients with persistent AF and left atrial (LA) enlargement (LA area > 20 cm²), additional left atrial roof ablation (LARA) was performed. Those with concomitant typical atrial flutter received adjunctive cavo-tricuspid isthmus (CTI) ablation. A total of 100 AF patients were included (29% female, 50% persistent AF). Of these, 33 patients (33%) underwent adjunctive LARA, 1 patient (1%) received posterior wall isolation, and 6 patients (6%) required additional CTI ablation. The skin-to-skin procedural time averaged 66.3 ± 13.8 minutes, while fluoroscopy time and dose area product were 13.7 ± 4.7 minutes and 6.8 ± 4.9 Gycm², respectively.

Acute PVI was achieved in 100% of pulmonary veins. Bidirectional conduction block of the LARA and CTI lines was confirmed in all patients, and no major adverse events were reported.

In patients who underwent additional CTI ablation, we observed stable renal function parameters both before and 24 hours post-ablation. This suggests a potential absence of hemoglobinuria-induced acute kidney injury.

These real-world data demonstrate feasibility, safety, and acute efficacy of PVI and ablation beyond PVI using a novel circular array PFA catheter in patients with atrial fibrillation and flutter. The system can easily be integrated with standard PVI workflows.