Device-related outcomes following hypoglossal nerve stimulator implantation.

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: Postmarket surveillance data for HGNS implanted between January 1, 2018 and March 31, 2022, were collected. Event rates and risk were calculated using the postmarket 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 3-year postimplantation 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. CITATION: Moroco AE, Wei Z, Byrd I, et al. Device-related outcomes following hypoglossal nerve stimulator implantation. J Clin Sleep Med. 2024;20(9):1497-1503.

Dysfunctional hypoglossal nerve stimulator after electrical cardioversion: A case series.

OBJECTIVES/HYPOTHESIS: Upper airway stimulation has demonstrated marked improvements in apnea-hypopnea index, oxygen desaturation index, and quality-of-life measures in patients with moderate to severe obstructive sleep apnea (OSA) who cannot tolerate continuous positive airway pressure. Cardiac arrhythmias are common in patients with OSA and can require electrical cardioversion. We describe the first four reported cases of hypoglossal nerve stimulator (HGNS) dysfunction after electrical cardioversion and illustrate our operative approach to device troubleshooting and repair. STUDY DESIGN: Retrospective case series. METHODS: A retrospective review of 201 HGNS implantations performed at two academic institutions revealed four cases of HGNS device dysfunction after electrical cardioversion requiring surgical revision. Preoperative and postoperative device performance metrics and electrical cardioversion specifications were retrospectively assessed and compiled for this case series. The senior authors (R.J.S., M.S.B.) detail operative planning and approach for HGNS implantable pulse generator (IPG) replacement. RESULTS: At least two patients with HGNS device dysfunction had received cardioversion via anterolateral electrode pad placement. Three patients had received multiple shocks. All four patients experienced a change in device functionality or complete cessation of functionality after electrocardioversion. Operatively, each patient required replacement of the IPG, with subsequent intraoperative interrogation revealing proper device functionality. CONCLUSION: Counseling for patients with HGNS undergoing external electrical cardioversion should include possible device damage and need for operative replacement. Anteroposterior electrode pad placement should be considered for patients with HGNS who require electrocardioversion. Operative replacement of an HGNS system damaged by electrocardioversion begins with IPG replacement and intraoperative device interrogation. LEVEL OF EVIDENCE: 4 Laryngoscope, 129:1949-1953, 2019.