Objective: There have been case reports of adverse events of hypoglossal nerve stimulator (HNS) implantation not seen in previous clinical trials, including pneumothorax and pleural effusion. The purpose of this study was to determine the rates of these complications and potential risk factors.
Study design: Retrospective case-control study during 2014 to 2021.
Setting: Twenty-five health care organizations across the United States.
Methods: The TriNetX Research Network was queried by using disease codes to retrospectively identify patients with obstructive sleep apnea who underwent HNS implantation. Rates of pneumothorax, pleural effusion, other complications, and need for revision/replacement or explant were determined.
Results: We identified 1813 patients from 25 health care organizations who underwent HNS implantation. The average age was 60 years, and there were 68% males and 32% females. Of the cohort, 2.4% (n = 44 from 7 implant centers) experienced a pneumothorax, and 0.6% (n = 11) were diagnosed with a pleural effusion on the day of surgery. Patients who experienced pneumothorax were more likely to have a history of chronic lower respiratory diseases when compared with those who did not (odds ratio, 2.2; 95% CI, 1.1-4.1; P = .02).
Conclusion: The incidence of intraoperative pneumothorax and pleural effusion during HNS implantation may be greater than initially thought. Patients with chronic lower respiratory diseases may be at increased risk. This should be communicated with patients during the informed consent process.
Keywords: Inspire; hypoglossal nerve stimulation; pleural effusion; pneumothorax.
© 2022 The Authors. Otolaryngology-Head and Neck Surgery published by Wiley Periodicals LLC on behalf of American Academy of Otolaryngology-Head and Neck Surgery Foundation.