Pulmonary Vein Isolation with Single Pulse Irreversible Electroporation: A First in Human Study in 10 Patients with Atrial Fibrillation.

Loh, Peter; van Es, René; Groen, Marijn H A; Neven, Kars; Kassenberg, Wil; Wittkampf, Fred H M; Doevendans, Pieter A F M

Background - Irreversible electroporation (IRE) is a promising new non-thermal ablation technology for pulmonary vein (PV) isolation in patients with atrial fibrillation (AF). Experimental data suggest that IRE ablation produces large enough lesions without the risk of PV stenosis, artery, nerve or esophageal damage. This study aimed to investigate the feasibility and safety of single pulse IRE PV isolation in patients with AF. Methods - Ten patients with symptomatic paroxysmal or persistent AF underwent single pulse IRE PV isolation under general anesthesia. Three-dimensional reconstruction and electroanatomical voltage mapping (EnSite PrecisionTM, Abbott) of left atrium and PVs were performed using a conventional circular mapping catheter. PV isolation was performed by delivering non-arcing, non-barotraumatic 6 ms, 200 J direct current IRE applications via a custom non-deflectable 14-polar circular IRE ablation catheter with a variable hoop diameter (16-27 mm). A deflectable sheath (AgilisTM, Abbott) was used to maneuver the ablation catheter. A minimum of two IRE applications with slightly different catheter positions were delivered per vein to achieve circular tissue contact, even if PV potentials were abolished after the first application. Bidirectional PV isolation was confirmed with the circular mapping catheter and a post ablation voltage map. After a 30-minute waiting period, adenosine testing (30 mg) was used to reveal dormant PV conduction. Results - All 40 PVs could be successfully isolated with a mean of 2.4±0.4 IRE applications per PV. Mean delivered peak voltage and peak current were 2154 ± 59 V and 33.9 ± 1.6 A, respectively. No PV reconnections occurred during the waiting period and adenosine testing. No periprocedural complications were observed. Conclusions - In the 10 patients of this first-in-human study, acute bidirectional electrical PV isolation could be achieved safely by single pulse IRE ablation.