‘Single-shot’ pulmonary vein isolation using a novel lotos pulsed field ablation catheter: a preclinical evaluation of the feasibility, safety and 30-day efficacy

Abstract

Aims Pulsed field ablation (PFA) is emerging as a nonthermal, tissue-specific technique for pulmonary vein isolation (PVI) in atrial fibrillation therapy. This preclinical study aimed to investigate the feasibility and safety of PVI using a novel PFA system including a nanosecond-scale PFA generator, a novel lotos PFA catheter, and a customized 12-French steerable sheath. Methods and Results A total of 11 Yorkshire swine were included in this study, with 4 in the acute cohort and 7 in the chronic cohort. Under general anesthesia, transseptal puncture and pulmonary vein (PV) angiography was initially performed. The PFA catheter was navigated to position at the right and left PV antrum after the electroanatomic reconstruction of left atrium. Biphasic PFA applications were performed on PVs in both the spindle-shaped and lotos-shaped poses. PVI and PFA-associated safety was assessed 30 minutes after ablation in both cohorts and 30 days later in the chronic cohort. Detailed necropsy and histopathology were performed. Additional intracardiac echocardiography and coronary angiogram were evaluated for safety. All target pulmonary veins (n = 20) were successfully isolated on the first attempt. No spasm of coronary artery or microbubble was seen during the procedure. Eleven of 12 PVs (91.6%) remained isolation at 30-day invasive study. No evidence of PV stenosis was observed in any targets. However, transient diaphragm capture occurred in 17.6%. Histopathological examinations showed no evidence of collateral injury. Conclusion This study provides scientific evidence demonstrating the safety and efficacy of the novel PFA catheter and system for single-shot PVI, which shows great potential.