Focal Pulsed Field Ablation for Pulmonary Vein Isolation and Linear Atrial Lesions: A Preclinical Assessment of Safety and Durability.

BACKGROUND

A novel ablation and mapping system can toggle between delivering biphasic pulsed field (PF) and radiofrequency energy from a 9-mm lattice-tip catheter. We assessed the preclinical feasibility and safety of (1) focal PF-based thoracic vein isolation and linear ablation, (2) combined PF and radiofrequency focal ablation, and (3) PF delivered directly atop the esophagus.

METHODS

Two cohorts of 6 swine were treated with pulsed fields at low dose (PF) and high dose (PF) and followed for 4 and 2 weeks, respectively, to isolate 25 thoracic veins and create 5 right atrial (PF), 6 mitral (PF), and 6 roof lines (radiofrequency+PF). Baseline and follow-up voltage mapping, venous potentials, ostial diameters, and phrenic nerve viability were assessed. PF and radiofrequency lesions were delivered in 4 and 1 swine from the inferior vena cava onto a forcefully deviated esophagus. All tissues were submitted for histopathology.

RESULTS

Hundred percent of thoracic veins (25 of 25) were successfully isolated with 12.4±3.6 applications/vein with mean PF times of <90 seconds/vein. Durable isolation improved from 61.5% PF to 100% with PF (=0.04), and all linear lesions were successfully completed without incurring venous stenoses or phrenic injury. PF sections had higher transmurality rates than PF (98.3% versus 88.1%; =0.03) despite greater mean thickness (2.5 versus 1.3 mm; <0.001). PF lesions demonstrated homogenous fibrosis without epicardial fat, nerve, or vessel involvement. In comparison, radiofrequency+PF sections revealed similar transmurality but expectedly more necrosis, inflammation, and epicardial fat, nerve, and vessel involvement. Significant ablation-related esophageal necrosis, inflammation, and fibrosis were seen in all radiofrequency sections, as compared with no PF sections.

CONCLUSIONS

The lattice-tip catheter can deliver focal PF to durably isolate veins and create linear lesions with excellent transmurality and without complications. The PF lesions did not damage the phrenic nerve, vessels, and the esophagus.