Assessment of efficacy and safety of advanced endoscopic irreversible electroporation catheter in the esophagus

Abstract

Nonthermal irreversible electroporation (NTIRE) is emerging as a promising tissue ablation technique. However, maintaining irreversible electroporation (IRE) electrodes against displacement during strong esophageal spasms remains an obstacle. The present study aimed to evaluate the efficacy and safety of newly designed balloon-type endoscopic IRE catheters. Six pigs were randomly allocated to each catheter group, and each pig was subjected to four ablations at alternating voltages of 1500 V and 2000 V. Esophagogastroscopy was performed during the IRE. The ability of balloon-type catheters to execute complete IRE with 40 pulses was assessed. The success rate was higher for the balloon-type catheter than that for the basket-type (12/12 [100%] vs. 2/12 [16.7%], p < 0.001). Following gross inspection and histologic analysis of the 1500-V vs. 2000-V balloon-type catheter revealed a larger mucosal damage area (105.3 mm(2) vs. 140.8 mm(2), p = 0.004) and greater damage depth (476 mu m vs. 900 mu m, p = 0.02). Histopathology of the ablated tissue revealed separated epithelium, inflamed lamina propria, congested muscularis mucosa, necrotized submucosa, and disorganized muscularis propria. Balloon-type catheters demonstrated efficacy, achieving full electrical pulse sequences under NTIRE conditions, and a safe histological profile below 2000 V (1274 V/cm). Optimal electrical conditions and electrode arrays pose ongoing challenges.