Laryngology Outcomes Following Implantable Vagus Nerve Stimulation.

ABSTRACT

Importance Vagus nerve stimulation (VNS) devices have gained widespread acceptance for treatment of resistant epilepsy and depression. The increasing number of procedures has resulted in an increasing number of iatrogenic injuries to the vagus nerve, which can have a significant effect on vocalization and quality of life. Objective: To determine the relative frequency of laryngeal adverse effects reported to the US Food and Drug Administration (FDA) after VNS implantation and to analyze associated VNS device problems. Design, Setting, and Participants: This retrospective cross-sectional analysis queried the FDA Manufacturer and User Facility Device Experience database of adverse events in the US between 1996 and 2020. Main Outcomes and Measures: The primary outcome was the percent of adverse events reported to the FDA that included patients who received VNS with laryngeal adverse effects and the associated proportion of device problems after VNS surgery. Results: A total of 12 725 iatrogenic vagus nerve issues were documented after VNS implantation, with apnea (n = 395; 3.1%) being the most common patient problem. Overall, 187 reports of laryngeal adverse effects associated with VNS devices were identified and represented the eighth most common iatrogenic vagus nerve problem reported to the FDA. Laryngeal adverse effects included 78 reports of voice alteration and 57 reports of paresis/paralysis. The VNS device problems frequently associated with laryngeal adverse effects were high impedance (n = 15, 8.02%), incorrect frequency delivery (n = 10, 5.35%), and battery problems (n = 11, 5.88%). The number of laryngeal adverse effect reports per year peaked in 2012 with 43 cases. Conclusions and Relevance This cross-sectional study found that although the literature demonstrates that vocal changes occur with nearly all VNS devices, the FDA receives adverse event reports of voice changes. Our results emphasize a potential need to improve patient counseling prior to VNS surgery to better set patient expectations regarding vocal changes and to prevent unnecessary patient concern. In addition, reports of vocal fold paresis/paralysis potentially suggest that patients may benefit from preoperative laryngeal assessment to differentiate preexisting vocal fold paralysis from that caused by VNS surgery.