Feasibility and safety of single-pulse ablation in 20 patients with atrial fibrillation

Single-pulse ablation leads to irreversible electroporation (IRE) and has been introduced as a nonthermal ablation technology for pulmonary vein isolation (PVI). First-in-human studies demonstrated the acute feasibility and safety of IRE PVI. This study aimed to further investigate the safety of sin...

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Bibliographic Details
Published in:Heart rhythm Vol. 22; no. 10; p. e866
Main Authors: Loh, Peter, Groen, Marijn H A, Taha, Karim, Velthuis, Birgitta K, Fidder, Herma H, Vink, A, Wittkampf, Fred H M, Doevendans, Pieter A F M, van Es, René
Format: Journal Article
Language:English
Published: United States 01.10.2025
Subjects:
Aged
Atrial Fibrillation - diagnosis
Atrial Fibrillation - physiopathology
Atrial Fibrillation - surgery
Catheter Ablation - adverse effects
Catheter Ablation - methods
Feasibility Studies
Female
Follow-Up Studies
Heart Conduction System - physiopathology
Heart Conduction System - surgery
Humans
Male
Middle Aged
Pulmonary Veins - surgery
Treatment Outcome
Electroporation
Atrial fibrillation
Catheter ablation
Pulsed field ablation
Pulmonary vein isolation
ISSN:1556-3871, 1556-3871
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Summary:Single-pulse ablation leads to irreversible electroporation (IRE) and has been introduced as a nonthermal ablation technology for pulmonary vein isolation (PVI). First-in-human studies demonstrated the acute feasibility and safety of IRE PVI. This study aimed to further investigate the safety of single-pulse ablation for PVI. Twenty patients with symptomatic atrial fibrillation underwent single-pulse PVI under conscious sedation. Nonarcing, nonbarotraumatic, 6 ms, 200 J IRE applications were delivered via a custom 14-polar circular IRE ablation catheter with a variable hoop diameter (16-27 mm). Adenosine testing was performed after a 30-minute waiting period. On day 1 after ablation, patients underwent esophagoscopy and brain magnetic resonance imaging (MRI) (diffusion-weighted imaging/fluid-attenuated inversion recovery). In 20 patients, all pulmonary veins could be successfully isolated with a mean of 11.8 ± 1.4 IRE applications per patient. One pulmonary vein reconnection occurred during adenosine testing; reisolation was achieved with 2 additional IRE pulses. No periprocedural complications were observed. Brain MRI on day 1 after ablation showed punctate asymptomatic lesions in 3 of 20 patients (15%). At follow-up MRI, the lesion disappeared in 1 patient whereas 1 lesion persisted in the other 2 patients. Esophagoscopy on day 1 showed an asymptomatic esophageal lesion in 1 of 20 patients (5%); at repeat esophagoscopy on day 22, the lesion had resolved completely. Acute electrical PVI could be achieved safely and rapidly. Acute silent cerebral lesions were detected in 3 of 20 patients (15%) and may be caused by ablation or changes of therapeutic and diagnostic catheters over a single transseptal access.
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ISSN:1556-3871
1556-3871
DOI:10.1016/j.hrthm.2025.05.054