학술논문

Preclinical evaluation of a novel single‐shot pulsed field ablation system for pulmonary vein and atrial ablation.
Document Type
Article
Source
Journal of Cardiovascular Electrophysiology. Nov2023, Vol. 34 Issue 11, p2203-2212. 10p.
Subject
*INFERIOR vena cava surgery
*ESOPHAGUS
*BRAIN
*VENA cava superior
*SHEEP
*KIDNEYS
*ANIMAL experimentation
*CATHETER ablation
*ATRIAL fibrillation
*SWINE
*MAGNETIC resonance imaging
*TREATMENT effectiveness
*ELECTROPORATION
*RESEARCH funding
*DESCRIPTIVE statistics
*HEART function tests
*HISTOLOGICAL techniques
*PULMONARY veins
*PATIENT safety
*CATHETERS
*PHRENIC nerve
*DOGS
*LEFT heart atrium
*RIGHT heart atrium
Language
ISSN
1045-3873
Abstract
Introduction: Pulsed field ablation (PFA) is a nonthermal ablative strategy that achieves cell death via electroporation. Herein, we investigated the preclinical safety and efficacy of PFA using two novel 8‐French, 16‐electrode spiral PFA/mapping catheters (ElePulse; CRC EP, Inc.). Methods: Bipolar PFA (>1.8 kV) was performed using 30 s, single‐shot, QRS‐gated applications. Altogether, 94 atrial structures were ablated in 23 swine, one canine, and one ovine, including right and left atria and atrial appendages, pulmonary veins, and superior and inferior (IVC) vena cavae. We also examined the impact of PFA on the phrenic nerve (14 swine) and on a deviated esophagus after delivery of PFA from inside the IVC (five swine). Results: All applications were single‐shot without catheter repositioning. Minimal microbubbling was observed without significant skeletal muscle twitching/activation (mean acceleration: 0.05 m/s2). There was a marked reduction in post‐PFA versus pre‐PFA atrial electrogram amplitude (0.17 ± 0.21 vs. 1.18 ± 1.08 mV; p <.0001). Lesion durability was demonstrated up to 3 months in all targeted tissues. Histologically, lesions were contiguous and transmural, except in the atrial appendage, and without any thermal effects. Magnetic resonance, gross, and histologic examinations of the brain, rete mirabile, and kidneys revealed no thromboembolism. No acute/long‐term phrenic nerve dysfunction was encountered. Although within 2 h of ablation, histologic examinations of the esophagus revealed acute PFA‐related changes in the muscular layer, these completely resolved by 21 ± 5 days. Conclusion: A novel, single‐shot, spiral PFA system is capable of safely creating large, durable atrial lesions without significant adverse effects on the phrenic nerve or the esophagus. [ABSTRACT FROM AUTHOR]