ADHERE Registry InvestigatorsObjectives/Hypothesis: To provide the ADHERE registry Upper Airway Stimulation (UAS) outcomes update, including analyses grouped by body mass index (BMI) and therapy discomfort.Study Design: Prospective observational study. Methods: ADHERE captures UAS outcomes including apnea-hypopnea index (AHI), Epworth sleepiness scale (ESS), therapy usage, patient satisfaction, clinician assessment, and safety over a 1-year period. BMI ≤32 kg/m 2 (BMI 32 ) and 32 < BMI ≤35 kg/m 2 (BMI 35 ) group outcomes were examined.Results: One thousand eight hundred forty-nine patients enrolled in ADHERE, 1,019 reached final visit, 843 completed the visit. Significant changes in AHI (À20.9, P < .0001) and ESS (À 4.4, P < .0001) were demonstrated. Mean therapy usage was 5.6 AE 2.2 hr/day. Significant therapy use difference was present in patients with reported discomfort versus no discomfort (4.9 AE 2.5 vs. 5.7 AE 2.1 hr/day, P = .01). Patients with discomfort had higher final visit mean AHI versus without discomfort (18.9 AE 18.5 vs. 13.5 AE 13.7 events/hr, P = .01). Changes in AHI and ESS were not significantly different. Serious adverse events reported in 2.3% of patients. Device revision rate was 1.9%. Surgical success was less likely in BMI 35 versus BMI 32 patients (59.8% vs. 72.2%, P = .02). There was a significant therapy use difference: 5.8 AE 2.0 hr/day in BMI 32 versus 5.2 AE 2.2 hr/day in BMI 35 (P = .028).Conclusions: Data from ADHERE demonstrate high efficacy rates for UAS. Although surgical response rate differs between BMI 32 and BMI 35 patient groups, the AHI and ESS reduction is similar. Discomfort affects therapy adherence and efficacy. Thus, proper therapy settings adjustment to ensure comfort is imperative to improve outcomes.

4. Laryngoscope, 126:627-631, 2016.

Objective Insomnia and sleep apnea frequently co-occur, with additive effects of both disorders presenting clinicians with unique treatment challenges compared to one disorder alone. The hypoglossal nerve stimulator (HNS) is a promising treatment for patients with comorbid insomnia and sleep apnea (COMISA), many of whom have positive airway pressure (PAP) intolerance. Our aim was to determine adherence to and efficacy of HNS in veterans with COMISA refractory to PAP therapy compared to those with obstructive sleep apnea alone (OSA only). Study Design Retrospective case series. Setting A single, academic Veterans Affairs medical center. Methods Review of clinical records, pre- and postoperative polysomnography, and clinical measures of obstructive sleep apnea (OSA), sleepiness, and insomnia was conducted in 53 consecutive cases of veterans with OSA undergoing HNS implantation. HNS adherence was obtained at postoperative visits. HNS adherence and efficacy were compared between individuals with COMISA and OSA only. Results COMISA was noted in 30 of 53 (56.6%) veterans studied. There was no significant difference between HNS adherence in patients with COMISA and OSA only (5.6 vs 6.4 h/night, P = .17). HNS implantation improved polysomnographic and clinical measures of OSA and sleepiness in both COMISA and OSA only, and 56.5% (13/23) of patients with COMISA self-reported improvement in insomnia after surgery. Conclusion HNS was successful in treating a complex veteran population with COMISA refractory to PAP when examining measures of treatment adherence and efficacy. Future studies of patients with COMISA undergoing HNS will examine effective combination therapy targeting insomnia and a multidisciplinary effort to optimize treatment adherence.

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

Objective/Hypothesis Functional recovery after a recurrent laryngeal nerve or facial nerve injury may be impaired due to aberrant reinnervation. Previous work in a rat peripheral nerve injury model found vincristine to be a potent inhibitor of reinnervation, and it has since been used to effectively block neural regeneration in other animal models. However, vincristine’s narrow therapeutic index may limit its utility; therefore, another microtubule inhibitor, paclitaxel, which has a higher therapeutic index, was tested. Study Design Animal (rat) study. Methods After controlled injury to the rat posterior tibial (PT) nerve, the gasctrocnemius/soleus complex was injected with saline (control, n=14), vincristine (n=30), or paclitaxel (n=20). Injections without a crush injury were performed using saline (n=5) or paclitaxel (n=9). The functional recovery (FR) of the posterior tibial nerve was assessed using walking track analysis. Results At six weeks, controls had already recovered to baseline (FR=1.0) while the paclitaxel group had FR =0.724 ±0.064 and the vincristine group had FR =0.709 ±0.078. At six months the paclitaxel rats had FR = 0.798 ±0.167 and the vincristine rats had FR =0.754 ±0.240. These differences were significantly different from baseline, but the two agents were not different from each other. Paclitaxel did not affect the FR in the absence of a nerve injury. Conclusion Intramuscular paclitaxel and vincristine both significantly inhibit regeneration of the PT nerve after crush injury for at least 6 months. Potential clinical uses of inhibition of reinnervation are discussed. Level of Evidence NA

ObjectivesThe 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.MethodsWe 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.ResultsThirty‐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).ConclusionOur 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 Evidence4 Laryngoscope, 130:2275–2280, 2020

Fleming JJ. The decline of venture capital investment in early-stage life sciences poses a challenge to continued innovation.

Objective: To investigate the integration of and barriers to the utilization of telehealth technology and its components (telemedicine, e-Health, m-health) in daily otolaryngologic practice before the SARS CoV-2 (COVID-19) pandemic. Methods: This cross-sectional study was conducted at a tertiary academic center. A national survey of members of the American Academy of Otolaryngology-Head and Neck Surgery was administered. Descriptive analyses were performed to determine how telehealth was employed in otolaryngologists' practices. Results: A total of 184 surveys were completed. Telehealth technology was used by 50% of otolaryngologists surveyed. Regions with the largest percentage of physicians using telehealth were the Mid-Atlantic region (84%) and West Coast (67%). Most otolaryngologists indicated that they were familiar with telehealth or any of its components and how it is used in practice (52-83%), they had heard of telehealth or any of its components but were unsure what the terms specifically entailed (17-42%); 53% were satisfied with their current use of telehealth and electronic medical record (EMR); and 72% were comfortable utilizing smart devices for patient care. Most otolaryngologists (65%) indicated reimbursement as the biggest limitation to implementing telehealth, and 67% believed that typing was a hindrance to EMR utility. Conclusion:Half of the surveyed otolaryngologists used some form of telehealth at the time of the survey. The most commonly cited obstacle to physician adoption of telehealth was reimbursement. Although the adoption of telehealth technology was still limited in the field of otolaryngology based on this study, we are now seeing significant change due to the COVID-19 pandemic.