Tissue Radiologic and Pathologic Response to Biphasic Pulsed Electric Field Technology in a Porcine Model

To evaluate the radiologic, pathologic, and safety characteristics of a commercially available pulsed electric field (PEF) ablation system in a porcine model.

Monopolar biphasic PEF ablation was delivered to the liver, kidney, and longissimus dorsi muscle through a single needle via a percutaneous or open approach with the Aliya System (Galvanize Therapeutics, Redwood City, California). Six animals were ablated and evaluated in 2 cohorts (Day 3 and Day 28). Muscle, kidney, and liver were ablated in each animal. Intraprocedural cone-beam computed tomography (CT), follow-up weekly CT, blood serology, gross pathology, and histopathology were performed to characterize the radiographic evolution and tissue response.

There were no adverse events and no findings of electrocardiographic abnormalities, and serologic values returned to baseline by Day 28. Ablation zones were visible on unenhanced CT images during follow-up. Most identified zones became radiographically smaller over time, with some fully resolved by Day 28. The relative decrease in gross ablation zone diameter in the liver and skeletal muscle was 20% and 26%, respectively, whereas kidney sites grew in diameter by 22%. Ablation sites were focal and contained within the intended target tissue without extension to nontarget tissues or collateral structures.

The biphasic PEF system evaluated here resulted in a safe and predictable ablation response, with preservation of structural tissues in an animal model, offering an alternative to thermal ablative modalities, particularly near critical structures.