Targeted Ablation of Epicardial Ganglionated Plexi During Cardiac
Surgery with Pulsed Field Electroporation ( NEURAL AF )
Abstract
Background: Modulation of the cardiac autonomic nervous system
(ANS) is a promising adjuvant therapy in the treatment of atrial
fibrillation (AF). In pre-clinical models, pulsed field (PF) energy has
the advantage of selectively ablating the epicardial ganglionated plexi
(GP) that govern the ANS. Objective: This study aims to demonstrate the
feasibility and safety of epicardial ablation of the GPs with PF during
cardiac surgery with a primary efficacy outcome of prolongation of the
atrial effective refractory period (AERP). Methods: In a
single-arm, prospective analysis, patients with or without a history of
AF underwent epicardial GP ablation with PF during coronary artery
bypass grafting (CABG). AERP was determined immediately pre- and post-
GP ablation to assess cardiac ANS function. Holter monitors were
performed to determine rhythm status and Heart Rate Variability (HRV) at
baseline and at 1 month post-procedure. Conclusions: This
study demonstrates the safety and feasibility of epicardial ablation of
the GP using PF to modulate the ANS during cardiac surgery. Large,
randomized analyses are necessary to determine whether epicardial PF
ablation can offer a meaningful impact on the cardiac ANS and reduce AF.
Results: Of 24 patients, 23 (96%) received the full ablation
protocol. No device-related adverse effects were noted. GP ablation
resulted in a 20.7% ± 19.9% extension in AERP (P < 0.001).
Post-operative AF was observed in 7 (29%) patients. Holter monitoring
demonstrated an increase in mean heart rate (74.0±8.7 vs
80.6±12.3, P=0.01). There were no significant changes in HRV. There were
no study-related complications.