The article describes the development of a diagnostic procedure with a novel endoscopic cap to identify patients with vocal fold immobility who are eligible for implantation of future laryngeal pacing systems. The concept aims at transferring the examination to a gastroscopy setting.
Objective
Laryngeal pacing (LP) is a highly anticipated therapeutic option for patients suffering from bilateral vocal fold paralysis with synkinesis. Identification of candidate patients requires confirmation of a stimulable posterior cricoidarythenoid muscle (PCA) by neuromuscular electrical stimulation (NMES). A silicone endoscopic cap electrode (ECE50) was designed to be operated as an endoscopic extension tip for selective PCA stimulation and confirmation of a glottic opening movement in a setting comparable to a gastroscopy procedure.
Methods
A porcine animal model (n = 6) was applied to develop and test endoscopic cap prototypes in general anesthesia and sedation at a biomedical research center. Two ENT endoscopy experts evaluated and refined the cap design and performance in regard to procedure safety, endoscope handling, accessibility of the PCA by the transoral approach and selective muscle stimulation.
Results
Vocal fold opening movements could be evoked by the investigators in 9 of 12 PCA muscles to stimulate with similar electric parameters. The endoscopic approach using the ECE50 proved to be atraumatic and sufficiently controlled under sedation to locate the required hotspot for NMES of the PCA.
Conclusion
The functionality of the novel endoscopic cap concept has been proven in a porcine model. It can be expected to be transferable to human application and to be of diagnostic importance in the screening and identification of LP candidate patients in future.
Level of Evidence
NA Laryngoscope, 2022
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