Abstract
The purpose of this study is to evaluate the preliminary safety and effect of a pulsed electric field (PEF) ablation system. The pulmonary veins (PVs) and superior vena cava (SVC) were isolated with the pulsed field ablation (PFA) system, which included a PEF generator and an electrode. The effects of PFA were investigated in six porcines using a novel circular catheter with combined functions (mapping/ablation) designed to work with a cardiac mapping system. The PEF generator delivered a train of biphasic pulsed electric pulses with a high amplitude (800-2000 V) and short pulse duration. The voltage mapping, PVs and SVC potentials, ostial diameters, and phrenic nerve and esophagus viability data were collected 4 weeks later, after which the animals were subsequently euthanized for gross histopathology analysis. PFA 100% isolated the PVs and SVC with four applications with a mean pulse number of 100-150 pulses, causing no muscle convulsion. PFA does not cause PV stenosis or phrenic nerve dysfunction. Histological analysis confirmed 100% transmurally without any venous stenoses or phrenic injuries. Pathology follow-up showed that PFA had selectively ablated cardiomyocytes but spared blood vessels, the esophagus, and phrenic nerves; after ablation, the myocardial tissue showed homogeneous fibrosis. The PFA system is safe and feasible in the preliminary porcine model, which can effectively isolate PVs and SVCs. Transmural tissue damage can be achieved without phrenic palsy or stenosis.
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