EFFICACY AND SAFETY OF COMPOUND STEEP-PULSE IRREVERSIBLE ELECTROPORATION FOR ABLATION OF THE PROSTATE IN BEAGLE DOGS
Keywords:
Prostate Gland; Compound Steep Pulse; Irreversible Electroporation; AblationAbstract
Purpose This study aims to explore the optimal ablation parameters for ablating the prostate of Beagle dogs with the compound steep pulse therapeutic apparatus, as well as evaluate the safety and efficacy of the device. Material and methods 20 healthy male purebred Beagles were used in this study. In the first step (n=5), we determined the safe ablation voltage by monitoring the muscle contraction during ablation and the ablation pattern (single pulse width or compound pulse width) by comparing the ablation area. In the second step (n=15), we set different ablation parameters, needle spacings and depths for ablation of the left and right lobes of the dog. Then we determined the optimal parameters by ablation area and evaluated the efficacy of the device. This study also evaluated the safety of the device by intraoperative observation of muscle tremors, postoperative general and gross observation, histopathological observation, routine blood, blood biochemistry and routine urine test. Results The optimal ablation mode for the first step of the study was confirmed as the compound pulse. The ablation area was 307.27 mm2. In the second step of the study, the average ablation areas of the low, medium, and high parameter groups were 39.74±43.45 mm2, 175.46±94.08 mm2, and 228.49±41.26 mm2, respectively. Combined with the degree of muscle jitter, the medium parameter was determined to be the optimal ablation parameter. Under the optimal ablation parameters, the average ablation areas of the 10, 14 and 18 mm groups were 83.93±25.31 mm2, 226.25±108.25 mm2 and 216.20±64.17 mm2 respectively, and the 14 mm group had the best ablation area. The ablation area of the 10 and 20 mm groups regarding needle depth was 83.93±25.31 mm2 and 90.10±32.92 mm2, respectively. The ablation area of the 20 mm group was the most optimal. During the observation period, there were no abnormalities in the general and gross observations, blood routine, blood biochemistry and urine routine. Conclusion In this study, the optimal ablation mode was compound pulse width and the optimal parameters were determined as "5 μs, 1500 V/cm & 50 μs, 1000 V/cm", with a needle spacing of 14 mm and a needle depth of 20 mm. Under the optimal parameter ablation, no serious adverse events occurred and the safety was good. This study verified that the compound steep pulse therapeutic apparatus has good safety and efficacy.