1207Pulsed Field Ablation: Acute and Chronic Safety and Lesion Efficacy

Introduction Thermal ablation methods are the cornerstone of treatment for atrial fibrillation. However, they pose a risk to extra-cardiac structures and may result in inadequate efficacy. Nonthermal, pulsed-field ablation (PFA) delivery to cardiac tissues may create durable, efficacious lesions while avoiding collateral damage. Purpose The purpose of this preclinical GLP study was to assess acute and chronic electrical isolation combined with a pathology assessment of chronic lesion extent in response to PFA delivery to cardiac tissue, and to document any collateral damage. Methods Six pigs were treated with biphasic, bipolar PFA doses through a circular multi-electrode catheter. PFA was delivered at four locations at specified voltages: superior vena cava (SVC at 700V), right atrial appendage (RAA at 1500V), left atrial appendage (LAA at 1200V), and right pulmonary vein (RPV at 1500V). Phrenic nerve pacing thresholds and electrical block at SVC, RPV, and RAA sites were investigated acutely, and electrical block at the SVC sites chronically. Pigs were survived for 4 weeks. After euthanasia, necropsies and histopathological assessments documented the findings at the lesion sites and collateral tissues. Results Post PFA, entrance block was achieved in all SVC, RPV, and RAA sites. Histopathology showed characteristic replacement fibrosis of the myocardium at all ablation sites. The PFA lesions in the SVC and RPV were all continuously circumferential and histopathology did not detect any remaining myofiber conduits across the post-ablation fibrosis (consistent with the electrical assessments). PFA of the appendages caused wide-ranging fibrosis in the RAA, and limited fibrosis in the LAA. Histologically, the atrial fibrosis was almost exclusively transmural in both, with the RAA lesions overall diagnosed as circumferentially complete in all but one case. The right phrenic nerve (RPN) pacing thresholds were unchanged from baseline to the end of the procedure and were all <1.0V. The examined juxtaposed RPN segments exposed to PFA at the SVC and RPV sites were normal. None of the ablated targets was associated with stenosis, aneurysms, luminal thrombus or collateral damage on the abluminal side. Continuous lesion sites Conclusions This limited preclinical study evaluated the acute and chronic safety and efficacy of PFA in multiple cardiac and vascular treatment sites. In this porcine model, PFA results in acute and chronic electrical isolation, confirmed by pathology data, for all of the RPV and SVC targets. Pathology findings of the RAA revealed the ability to achieve chronic transmural lesions in highly trabeculated cardiac tissue. No collateral damage was seen to the adjacent RPN. Acknowledgement/Funding Medtronic