Safety assessment of the use of ultrasonic energy in the proximity of the recurrent laryngeal nerve in a porcine model

Background

Advanced bipolar and ultrasonic energy have demonstrated reduction of operating time and blood loss in thyroidectomy. However, these devices generate heat and thermal dispersion that may damage adjacent structures such as the recurrent laryngeal nerve (RLN). This study was designed to evaluate the safety profile of the Harmonic Focus+^® (HF+) device through the evaluation of thermal injury to the RLN using different algorithms of distance and time with state of the art technology.

Methods

25 Vietnamese pigs underwent activation of HF+ in the proximity of their RLN. They were divided into 4 groups according to activation distance (3 mm, 2 mm, 1 mm and on the RLN). Time of activation, time between tones of the ultrasonic generator, changes in the electromyographic signal using continuous nerve neuromonitoring, vocal fold mobility assessed by direct laryngoscopy and histological thermal damaged were evaluated.

Results

None of the pigs had loss of signal in the electromyography during the procedure; only one pig had isolated transient decrease in amplitude and one increase in latency. One pig had transient vocal fold paresis in the group with activation on the nerve. Evaluation of the nerves by histology and immunohistochemistry did not show significant changes attributed to thermal injury.

Conclusions

The use of ultrasonic energy close to the RLN is safe, provided that activation time does not exceed the necessary time to safely transect the tissue.