Related Experiment Video
Updated: May 28, 2026
Robotic Ablation of Atrial Fibrillation
Published on: May 29, 2015
Pulsed Field Ablation Integrated With 3D Mapping System for Pulmonary Vein Isolation in a Swine Model
Zheyi Gong1, Yiqi Lu1, Caijie Shen2
1Health Science Center, Ningbo University, Ningbo, China.
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.
