Hypoglossal Nerve Stimulation: Outcomes in Veterans with Obstructive Sleep Apnea and Common Comorbid Post-traumatic Stress Disorder.

OBJECTIVES/HYPOTHESIS: Veterans have an increasing prevalence of obstructive sleep apnea (OSA) and high levels of intolerance to positive airway pressure (PAP). The hypoglossal nerve stimulator (HNS) is a promising alternative surgical treatment for OSA in these patients, many of whom suffer from mental health conditions such as post-traumatic stress disorder (PTSD) that may negatively affect their ability to use PAP. Our aims were: 1) to assess postoperative changes in OSA severity and sleepiness in a veteran only population after HNS; 2) to compare postoperative changes in OSA severity, sleepiness and HNS adherence between veterans with and without PTSD; and 3) to compare HNS adherence in our population to HNS adherence in the current literature as well as published PAP adherence data. STUDY DESIGN: Retrospective and prospective case series. METHODS: Clinical data on consecutive patients undergoing HNS in a Veterans Affairs hospital were examined for demographic data as well as medical, sleep, and mental health comorbidities. The overall cohort as well as subsets of patients with and without PTSD were examined for postoperative changes in OSA severity (apnea hypopnea index [AHI], lowest oxygen saturation (LSAT]), and sleepiness (Epworth sleepiness scale [ESS]), as well as for device adherence. PTSD and depression symptomatology were measured using the PTSD Checklist 5 (PCL-5) and Patient Health Questionnaire 9 (PHQ-9). RESULTS: Forty-six veterans were included. Forty-four patients were male (95.6%), 45 were white (97.8%), and the mean age was 61.3 years. Twenty-six patients met PCL-5 criteria for PTSD and 17 did not. OSA severity and sleepiness improved significantly in the overall cohort after HNS; median (IQR) AHI decreased from 39.2 (24.0, 63.0) to 7.4 (1.2, 20.8) events/hour (P < .0001), mean LSAT increased from 81% to 88% (P < .0001) and mean ESS decreased from 10.9 to 6.7 (P < .0001). These improvements were similar between patients with and without PTSD (P = .434-.918). Overall device adherence was 6.1 hours/night for the overall cohort and was not significantly different between patients with and without PTSD (P = .992). CONCLUSIONS: HNS is an efficacious therapy in a veteran population, providing patients with significant improvements in OSA severity and sleepiness. Veterans with and without PTSD benefited similarly from HNS when comparing improvements in sleep apnea severity and sleepiness as well as device usage. Adherence was similar to previously published HNS adherence data and better than PAP adherence reported in the literature. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:S1-S11, 2021.

Hypoglossal Nerve Stimulator Outcomes for Patients Outside the U.S. FDA Recommendations.

OBJECTIVES: The hypoglossal nerve stimulator (HGNS) is currently approved for the treatment of obstructive sleep apnea (OSA) in patients with an apnea-hypopnea index (AHI) of >15 to ≤65 events/hour, and a central apnea index (CAI) <25% of the AHI, no complete concentric collapse on drug-induced sleep endoscopy, and a recommended body mass index (BMI) <32 kg/m2 . We present 18 patients implanted as a salvage procedure despite being outside these guidelines. METHODS: We included all patients who underwent HGNS but who did not meet all FDA guidelines. Demographic data, previous OSA treatments, polysomnographic (PSG) parameters from baseline and HGNS titration PSG, Epworth sleepiness score (ESS), and BMI were compared before and after surgery. RESULTS: Eighteen patients were identified: 94.4% male, median age 63 years. Seven underwent previous sleep surgery. Four had an AHI <15 (mean 10.5 events/hour), four had an AHI >65 (mean 86.9 events/hour), two had an elevated CAI (mean 31.3% of AHI), and 12 had a BMI >32 kg/m2 (range 32.1-39.1). Median AHI decreased from 25.3 to 3.75 events/hour on titration polysomnography (P = .0006), oxyhemoglobin saturation nadir increased from 82% to 88.5% (P = .0001) and median ESS dropped from 11 to 7.5 (P = .0016). Fifteen (83.3%) patients achieved surgical success (decrease in AHI >50% and AHI <20 events/hour) and 12 (66.7%) had an AHI <5 events/hour. Neither patient with CAI >25% was successfully treated. Median adherence = 33.5 hours/week. CONCLUSION: Our success rate for patients outside the Food and Drug Administration guidelines for HGNS (67%) was similar to the 1-year STAR trial results (66%). Future studies are necessary to consider expansion of these guidelines. LEVEL OF EVIDENCE: 4 Laryngoscope, 130:866-872, 2020.

Hypoglossal Nerve Stimulation in Veterans with Obstructive Sleep Apnea.

OBJECTIVES: The hypoglossal nerve stimulator (HNS) is an effective treatment for obstructive sleep apnea (OSA) in a relatively healthy subset of the population. Our aim was to determine the efficacy of HNS in a veteran population with a high incidence of chronic disease and mental health disorders. Our secondary aim was to compare subjective outcomes and adherence between veterans with and without mental health disorders. METHODS: We included all patients who underwent HNS at our institution to date. Veterans were divided into two groups based on whether or not they carried a diagnosis of anxiety, depression, and/or post-traumatic stress disorder. Demographics, comorbidities, previous OSA treatments, adverse events, and adherence to therapy were recorded. Baseline and treatment outcome data were collected and analyzed including polysomnographic parameters, Epworth sleepiness scale score (ESS), and body mass index. RESULTS: Thirty-one patients were identified: 93.5% male, median age = 63.0 years. Median apnea hypopnea index (AHI) decreased from 30.0 to 3.0 events/hour (P < .001) and median ESS dropped from 11.0 to 6.5 (P < .001). There was no difference between groups with regard to change in AHI or ESS (P = .31 and .61). Twenty-six (89.7%) patients achieved surgical success (decrease in AHI > 50% and AHI < 20 events/hour) and 21 (72.4%) had AHI < 5 events/hour. The mean device usage was 5.4 hours/night which was not significantly different between groups (P = .55). CONCLUSION: Our cohort exhibited similar declines in AHI and ESS compared to published studies with adequate adherence to HNS. There were no significant differences in ESS or adherence to therapy between veterans with and without mental health disorders. LEVEL OF EVIDENCE: 4 Laryngoscope, 130:2275-2280, 2020.