Bipolar pulsed field ablation using a novel spiral catheter significantly reduced atrial electrogram amplitude (0.17 vs 1.18 mV; p<.0001) and created durable lesions without severe adverse effects.
Does a novel single-shot spiral PFA system safely and effectively create durable atrial lesions in a preclinical animal model?
A novel single-shot spiral PFA system demonstrates preclinical safety and efficacy in creating durable atrial lesions without significant collateral damage to the phrenic nerve or esophagus.
Absolute Event Rate: 0.17% vs 1.18%
p-value: p=<.0001
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: ). 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.
Aryana et al. (Tue,) reported a other. Bipolar pulsed field ablation (PFA) using 8-French, 16-electrode spiral catheters (ElePulse) was evaluated on Atrial electrogram amplitude (p=<.0001). Bipolar pulsed field ablation using a novel spiral catheter significantly reduced atrial electrogram amplitude (0.17 vs 1.18 mV; p<.0001) and created durable lesions without severe adverse effects.