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STUDY OBJECTIVES: Hypoglossal nerve stimulation (HGNS) has been widely used to treat obstructive sleep apnea in selected patients. Here we evaluate rates of revision and explant related to HGNS implantation and assess types of adverse events contributing to revision and explant. METHODS: Post-market surveillance data for HGNS implanted between January 1, 2018 and March 31, 2022, were collected. Event rates and risk were calculated using the post-market surveillance event counts and sales volume over the same period. Indications were categorized for analysis. Descriptive statistics were reported and freedom from explant or revision curves were grouped by year of implantation. RESULTS: Of the 20,881 HGNS implants assessed, rates of explant and revision within the first year were 0.723% and 1.542%, respectively. The most common indication for explant was infection (0.378%) and for revision was surgical correction (0.680%). Of the 5,820 devices with three-year post-implantation data, the rate of explant was 2.680% and of revision was 3.557%. During this same interval, elective removal (1.478%) was the most common indication, and for revisions, surgical correction (1.134%). CONCLUSIONS: The efficacy of HGNS is comparable in the real world setting to published clinical trial data. Rates of explant and revision are low, supporting a satisfactory safety profile for this technology.
RESUMEN
OBJECTIVES: Implantable hypoglossal nerve stimulation (HNS) therapy is an evolving therapeutic alternative for patients with refractory obstructive sleep apnea (OSA). The muscular anatomy of this region has implications for surgical access through this zone as well as positioning and anchoring of hardware in this area. The purpose of this study was to radiologically describe the topography of the mylohyoid muscle and adjacent structures across a wide age spectrum. METHODS: We retrospectively evaluated computed tomography scans of the neck in 102 patients who were imaged for reasons unrelated to the floor of mouth or submental space. Patients with prior surgery or pathology in the area of interest were excluded. Fourteen relevant muscle measurements were made on a midline sagittal image and a coronal image positioned at the midpoint between the hyoid bone and the mandible. RESULTS: We included 49 men and 53 women with an average age of 44 years (range 19-70). The average mylohyoid length was 42 mm; the average distance between the anterior digastric bellies was 17 mm. The average angle of the central mylohyoid was 174° in the sagittal plane and 164° in the coronal plane. Several measurements were significantly correlated with patient age, including the angle measurements and the distance between the digastric muscles. Aberrant digastric anatomy was common. CONCLUSIONS: The mylohyoid muscle has multiple radiologically distinct segments with predictable curvatures. An understanding of submental muscular anatomy, along with its variability between patients, may be beneficial to the development of bilateral implantable neurostimulation technology for the treatment of refractory OSA. LEVEL OF EVIDENCE: N/A Laryngoscope, 134:2970-2975, 2024.