Abstract
Objective: Obstructive sleep apnea (OSA) is a common disorder associated with multiple abnormal health outcomes. Failure of surgical treatment may be secondary to obstruction at the level of the tongue. To assess the non-disease related outcomes of an implantable hypoglossal nerve (CN XII) stimulating system (Inspire, Inspire Medical, Minneapolis, Minnesota).
Method: Multicenter academic prospective trial of a unilateral hypoglossal nerve implant system (stimulation lead, sense lead and pulse generator). Implant procedure, technical details of stimulation titration, directed functional examinations, tongue EMG studies, and complications were reviewed from 31 implanted subjects.
Results: Follow up averaged 424 days. Serious adverse events included delayed infection with explantation (n = 1), insufficient stimulation with explantation (n = 1), explantation per patient request (n = 1), and acute infection/inflammation (n = 1). Minor local pain/stiffness (n = 7), transient odynophagia (n = 4), stitch abscess (n = 1), local swelling (n = 1), fever (n = 1) were observed. Stimulation thresholds for sensation, morphologic change, and sub-discomfort (1.6 ± 0.6, 2.1 ± 0.7, 2.6 ± 0.8 respectively) did not change at 2, 4 and 6 months post-implant). At over 1 year follow-up, no abnormal findings in speech, swallowing, tongue morphology, or hypoglossal nerve function were observed.
Conclusion: Placement of a CN XII implant system is technically feasible. Serious adverse outcomes occurred in 6% (delayed infection, inadequate stimulation requiring explantation). At over one year, placement of a CN XII implant for treatment of OSA demonstrates stable stimulation thresholds and is functionally well tolerated.
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