Risk assessment of neuromuscular stimulation by energy-based transurethral resection devices: an ex vivo test standard

Autor: Ulrich Biber, Ovidiu Jurjut, Markus D. Enderle, Wilhelm K. Aicher
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: BMC Urology, Vol 20, Iss 1, Pp 1-10 (2020)
Druh dokumentu: article
ISSN: 1471-2490
DOI: 10.1186/s12894-020-00630-5
Popis: Abstract Background During transurethral resection of bladder tumours (TURB), radio-frequency (RF) currents can lead to adverse neuromuscular stimulation (NMS). Here we present a novel ex vivo method to determine the risk of RF generators and their bipolar TURB modes to cause NMS. We aimed to develop an experimental platform for safety evaluation of new RF generators and their modes with a newly established test standard, suitable for replacement or reduction of animal testing. Methods We tested four contemporary RF generators with their bipolar modes for TURB in saline. A two-stage ex vivo approach was pursued: First, we recorded voltages at possible positions of the obturator nerve behind a porcine bladder wall in a TURB model using 18 RF applications per generator. Second, these voltage records were used as stimuli to evoke nerve compound action potentials (CAPs) in isolated porcine axillary nerves. The NMS potential was defined as the ratio between the observed area under the CAPs and the theoretical CAP area at maximum response and a firing rate of 250 Hz, which would reliably induce tetanic muscle responses in most human subjects. The measurement protocol was tailored to optimise reproducibility of the obtained NMS potentials and longevity of the nerve specimens. Results As prerequisite for the clinical translation of our results, the robustness of our test method and reproducibility of the NMS potential are demonstrated with an excellent correlation (r = 0.93) between two sets of identical stimuli (n = 72 each) obtained from 16 nerve segments with similar diameters (4.2 ± 0.37 mm) in the nerve model. The RF generators differed significantly (p
Databáze: Directory of Open Access Journals