Pulsed Field Ablation Integrated With 3D Mapping System for Pulmonary Vein Isolation in a Swine Model

Background Pulsed field ablation (PFA) is a breakthrough therapeutic modality for atrial fibrillation that employs nonthermal irreversible electroporation to selectively ablate cardiomyocytes. This preclinical study evaluated the safety and efficacy of a novel PFA system for pulmonary vein isolation (PVI). Objectives This study aimed to assess the safety and efficacy of a preclinical used PFA system in achieving acute and durable PVI. Methods The PFA system—comprising two flexible circular catheters, a three‐dimensional mapping system (3DMS), and a pulsed field generator—was utilized for PVI. Bipolar, biphasic waveforms were delivered in six swine using a 7‐electrode circular catheter at the right superior pulmonary vein (RSPV) and a 14‐electrode catheter at the common inferior pulmonary vein (CIPV). All animals underwent repeat electrophysiological mapping immediately post‐procedure and at 3‐month follow‐up to assess lesion durability and procedural safety, followed by gross necropsy and histology. Results All targeted pulmonary veins were successfully isolated. A total of 22.7 ± 5.3 applications were delivered per animal, comprising 11.0 ± 1.9 applications using the 7‐electrode catheter and 11.7 ± 4.7 applications using the 14‐electrode catheter. Acute and durable PVI at 3‐month follow‐up was achieved in all swine. Histopathology assessment revealed 100% of transmural fibrotic lesions with a mean depth of 2.7 ± 0.6 mm at RSPV and 3.3 ± 1.4 mm at CIPV ( p = 0.372) with no evidence of inflammation, or thrombus formation. No ventricular arrhythmias occurred during PFA delivery, and no periprocedural adverse events were observed. Furthermore, no collateral damage—including esophageal injury or phrenic nerve paralysis—was detected at the 3‐month evaluation. Conclusions The 3DMS integrated PFA system demonstrated excellent acute and chronic efficacy in achieving PVI, with durable lesion formation and a favorable safety profile free from collateral tissue injury.