Cardiac Arrhythmia Service, Mercy General Hospital and Dignity Health Heart and Vascular Institute, Sacramento, California, USA.
COR Healthcare, Torrance, California, USA.
J Cardiovasc Electrophysiol. 2023 Nov;34(11):2203-2212. doi: 10.1111/jce.16010. Epub 2023 Jul 18.
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.).
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).
All applications were single-shot without catheter repositioning. Minimal microbubbling was observed without significant skeletal muscle twitching/activation (mean acceleration: 0.05 m/s ). 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.
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.
脉冲场消融（PFA）是一种非热消融策略，通过电穿孔实现细胞死亡。在此，我们使用两种新型 8 French、16 电极螺旋 PFA/标测导管（ElePulse；CRC EP，Inc.）研究了 PFA 的临床前安全性和疗效。
使用 30 秒、单次、QRS 门控应用进行双极 PFA（>1.8 kV）。总共在 23 头猪、1 只犬和 1 只羊的右心房和左心房及心房附件、肺静脉、上腔静脉和下腔静脉进行了 94 次消融。我们还研究了 PFA 对膈神经（14 头猪）和从 IVC 内部输送 PFA 后对偏离的食管的影响（5 头猪）。
所有应用均为单次无导管重新定位。观察到最小的微泡，没有明显的骨骼肌抽搐/激活（平均加速度：0.05 m/s）。与 PFA 前相比，PFA 后的心房电图幅度明显降低（0.17±0.21 对 1.18±1.08 mV；p<0.0001）。在所有靶向组织中，直至 3 个月时均显示出持久的消融效果。组织学上，除了心房附件外，病变是连续的和贯穿的，没有任何热效应。磁共振、大体和组织学检查大脑、奇异网和肾脏均未发现血栓栓塞。未发现急性/长期膈神经功能障碍。尽管在消融后 2 小时内，食管的组织学检查显示出与 PFA 相关的肌肉层急性改变，但这些改变在 21±5 天内完全消退。
一种新型的单次螺旋 PFA 系统能够安全地创建大的、持久的心房病变，而不会对膈神经或食管产生显著的不良影响。
