Post-approval upper airway stimulation predictors of treatment effectiveness in the ADHERE registry.

Upper airway stimulation (UAS) has been shown to reduce severity of obstructive sleep apnoea. The aim of this study was to identify predictors of UAS therapy response in an international multicentre registry.Patients who underwent UAS implantation in the United States and Germany were enrolled in an observational registry. Data collected included patient characteristics, apnoea/hypopnoea index (AHI), Epworth sleepiness scale (ESS), objective adherence, adverse events and patient satisfaction measures. Post hoc univariate and multiple logistic regression were performed to evaluate factors associated with treatment success.Between October 2016 and January 2018, 508 participants were enrolled from 14 centres. Median AHI was reduced from 34 to 7 events·h-1, median ESS reduced from 12 to 7 from baseline to final visit at 12-month post-implant. In post hoc analyses, for each 1-year increase in age, there was a 4% increase in odds of treatment success. For each 1-unit increase in body mass index (BMI), there was 9% reduced odds of treatment success. In the multivariable model, age persisted in serving as statistically significant predictor of treatment success.In a large multicentre international registry, UAS is an effective treatment option with high patient satisfaction and low adverse events. Increasing age and reduced BMI are predictors of treatment response.

Ethnic/racial and genetic influences on cerumen odorant profiles.

This report describes the volatile organic compounds (VOCs) associated with human cerumen (earwax) and the effects of ethnicity/race and variation on the ATP-binding cassette, sub-family C, member 11 gene (ABCC11). A single nucleotide polymorphism (SNP) in ABCC11 affects the cerumen VOC profiles of individuals from African, Caucasian, and Asian descent. Employing gas chromatography/mass spectrometry (GC/MS) we have identified the nature and relative abundance of cerumen VOCs from 32 male donors. Our results show that cerumen contains a complex mixture of VOCs and that the amounts of these compounds vary across individuals as well as across ethnic/racial groups. In six of the seven compounds whose detected concentrations were found to be statistically different across groups, individuals of African descent (AfD) > Caucasian descent (CaD) > Asians descent (AsD). Our findings also reveal that ABCC11 genotype alone does not predict the type and relative levels of volatiles found in human cerumen, and suggest that other biochemical pathways must be involved. Examination of the composition and diversity of external auditory canal microbiota in a small subset of our subject population revealed that the ear microbiota may not be directly correlated with either ethnic group membership or ABCC11 genotype.

Clinical outcomes and complications associated with TORS for OSAHS: a benchmark for evaluating an emerging surgical technology in a targeted application for benign disease.

BACKGROUND: The aim of this study was to create benchmarks for evaluating clinical outcomes and complications of transoral robotic surgeries (TORS) in a multicenter setting. METHODS: 243 TORS for obstructive sleep apnea/hypopnea syndrome (OSAHS) operations, carried out between 2008 and 2012, were analyzed at 7 different centers. The average hospitalization was 3.5 days. The mean patient age was 50 ± 12 years, the average BMI at the time of the procedure was 28.53 ± 3.87 and the majority of the patients were men (81%). RESULTS: The mean preoperative and postoperative apnea/hypopnea index was 43.0 ± 22.6 and 17.9 ± 18.4, respectively (p < 0.001). The mean preoperative and postoperative Epworth Sleepiness Scale score was 12.34 ± 5.19 and 5.7 ± 3.49, respectively (p < 0.001). The mean pre- and postoperative lowest O2 saturation was 79.5 ± 8.77 and 83.9 ± 6.38%, respectively (p < 0.001). CONCLUSIONS: Patients undergoing TORS as part of a multilevel approach for the treatment of OSAHS have a reasonable expectation of success with minimal long-term morbidity.

Characteristic Pressure Waveforms Can Distinguish Airway Collapse Patterns in Sleep Apnea Patients: A Pilot Study.

Objective: To use pharyngeal pressure recordings to distinguish different upper airway collapse patterns in obstructive sleep apnea (OSA) patients, and to assess whether these pressure recordings correlate with candidacy assessment for hypoglossal nerve stimulator (HGNS) implantation. Study Design: Prospective case series. Setting: Single tertiary-quaternary care academic center. Methods: Subjects with OSA prospectively underwent simultaneous drug-induced sleep endoscopy (DISE) and transnasal pharyngeal pressure recording with a pressure-transducing catheter. Pressure was recorded in the nasopharynx and oropharynx, and endoscopic collapse patterns were classified based on site, extent, and direction of collapse. Pressure recordings were classified categorically by waveform shape as well as numerically by inspiratory and expiratory amplitudes and slopes. Waveform shape, amplitude, and slope were then compared with the endoscopic findings. Results: Twenty-five subjects with OSA were included. Nasopharyngeal waveform shape was associated with the extent of collapse at the level of the palate (P = .001). Oropharyngeal waveform shape was associated with anatomical site of collapse (P < .001) and direction of collapse (P = .019) below the level of the palate. Pressure amplitudes and slopes were also associated with the extent of collapse at various sites. Waveform shape was also associated with favorable collapse pattern on endoscopy for HGNS implantation (P = .043), as well as surgical candidacy for HGNS (P = .004). Conclusion: Characteristic pharyngeal pressure waveforms are associated with different airway collapse patterns. Pharyngeal pressure is a promising adjunct to DISE in the sleep surgery candidacy evaluation.

Impact of Insomnia on Hypoglossal Nerve Stimulation Outcomes in the ADHERE Registry.

OBJECTIVE: We aimed to determine the preoperative prevalence of insomnia in the Adherence and Outcomes of Upper Airway Stimulation for OSA International Registry (ADHERE) and to examine serial sleep-related data longitudinally, in particular the Insomnia Severity Index (ISI), to compare outcomes between patients with no/subthreshold insomnia (ISI < 15) and moderate/severe insomnia (ISI ≥ 15) at baseline. METHODS: We analyzed observational data from ADHERE between March 2020 and September 2022. Baseline demographic and mental health (MH) data, apnea hypopnea index (AHI), ISI, and ESS (Epworth Sleepiness Scale) were recorded. At post-titration (PT) and final visits, AHI, ISI, ESS and nightly usage were compared between baseline ISI < 15 and ISI ≥ 15 subgroups. RESULTS: A baseline ISI was obtained in 928 patients (62% with ISI ≥ 15). Of the 578 and 141 patients reaching the 12- and 24-month time periods to complete PT and final visits, 292 (50.5%) and 91 (64.5%) completed the ISI, respectively. Baseline MH conditions were higher with ISI ≥ 15 than ISI < 15 (p < 0.001). AHI reduction and adherence did not differ between patients with baseline ISI ≥ 15 and ISI < 15. Patients with ISI ≥ 15 experienced greater improvement in ESS than ISI < 15 at post-titration and final visits (p = 0.014, 0.025). All patients had improved nocturnal, daytime, and overall ISI scores at follow-up visits (p < 0.001), especially for those with baseline ISI ≥ 15 compared with ISI < 15 (p < 0.05). CONCLUSION: HGNS therapy efficacy and adherence were similar between ISI severity subgroups at follow-up visits. Insomnia and sleepiness scores improved in all patients with HGNS therapy and to a greater degree in patients with baseline moderate/severe insomnia. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:471-479, 2024.

The Effect of Surgical Therapy for Obstructive Sleep Apnea on Blood Pressure and Peripheral Arterial Tonometry.

OBJECTIVE: To determine the effect of upper airway surgery on cardiovascular function in patients with obstructive sleep apnea (OSA). STUDY DESIGN: A prospective, self-controlled study from 2018 to 2023. SETTING: Two academic medical centers. METHODS: Seventy-four patients underwent surgery for OSA, including: tonsillectomy, adenoidectomy, epiglottidectomy, modified uvulopalatopharyngoplasty, maxillary expansion, and maxillomandibular advancement. Twenty-four-hour ambulatory blood pressure (BP), peripheral arterial tonometry (PAT)-based home sleep study, and sleep-related patient-reported outcomes (PROs) were captured preoperatively and at 6 months postoperatively. Paired T-tests evaluated changes in outcomes after surgery. RESULTS: Forty-one patients successfully completed preoperative and postoperative assessments. Patients were generally middle-aged (43.8 ± 12.5 years), obese (BMI 33.0 ± 5.8 kg/m2), male (68%), White (71%), and had severe OSA (apnea-hypopnea index [AHI] 33.9 ± 29.5 events/h). The 4% oxygen desaturation index (ODI) decreased from 30.7 ± 27.1 to 12.2 ± 13.6 events/h (P < .01) after surgery. There was no significant difference in 24-h BP following surgery, though clinically meaningful reductions in nocturnal systolic (-1.95 [-5.34, 1.45] mmHg) and nocturnal diastolic (-2.30 [-5.11, 0.52] mmHg) blood pressure were observed. Stratified analysis showed patients undergoing skeletal surgery (n = 17) demonstrated larger average reductions compared to those undergoing soft tissue surgery in nocturnal systolic (-4.12 [-7.72, -0.51] vs -0.10 [-5.78, 5.58] mmHg) and nocturnal diastolic (-3.94 [-7.90, 0.01] vs -0.90 [-5.11, 3.31] mmHg) pressures. No meaningful changes were observed in PAT Autonomic Index (PAI) measurements. CONCLUSION: Surgical therapy for OSA did not demonstrate statistically significant improvements in 24-h BP. However, clinically meaningful reductions in nocturnal BP were observed, particularly in skeletal surgery patients, supporting the need for larger studies of cardiovascular outcomes following OSA surgery.

Hypoglossal Nerve Stimulation and Cardiovascular Outcomes for Patients With Obstructive Sleep Apnea: A Randomized Clinical Trial.

Importance: Sham-controlled trials are needed to characterize the effect of hypoglossal nerve stimulation (HGNS) therapy on cardiovascular end points in patients with moderate-severe obstructive sleep apnea (OSA). Objective: To determine the effect of therapeutic levels of HGNS, compared to sham levels, on blood pressure, sympathetic activity, and vascular function. Design, Setting, and Participants: This double-blind, sham-controlled, randomized crossover therapy trial was conducted from 2018 to 2022 at 3 separate academic medical centers. Adult patients with OSA who already had an HGNS device implanted and were adherent and clinically optimized to HGNS therapy were included. Participants who had fallen asleep while driving within 1 year prior to HGNS implantation were excluded from the trial. Data analysis was performed from January to September 2022. Interventions: Participants underwent a 4-week period of active HGNS therapy and a 4-week period of sham HGNS therapy in a randomized order. Each 4-week period concluded with collection of 24-hour ambulatory blood pressure monitoring (ABPM), pre-ejection period (PEP), and flow-mediated dilation (FMD) values. Main Outcomes and Measures: The change in mean 24-hour systolic blood pressure was the primary outcome, with other ABPM end points exploratory, and PEP and FMD were cosecondary end points. Results: Participants (n = 60) were older (mean [SD] age, 67.3 [9.9] years), overweight (mean [SD] body mass index, calculated as weight in kilograms divided by height in meters squared, 28.7 [4.6]), predominantly male (38 [63%]), and had severe OSA at baseline (mean [SD] apnea-hypopnea index, 33.1 [14.9] events/h). There were no differences observed between active and sham therapy in 24-hour systolic blood pressure (mean change on active therapy, -0.18 [95% CI, -2.21 to 1.84] mm Hg), PEP (mean change on active therapy, 0.11 [95% CI, -5.43 to 5.66] milliseconds), or FMD (mean change on active therapy, -0.17% [95% CI, -1.88% to 1.54%]). Larger differences between active and sham therapy were observed in a per-protocol analysis set (n = 20) defined as experiencing at least a 50% reduction in apnea-hypopnea index between sham and active treatment. Conclusions and Relevance: In this sham-controlled HGNS randomized clinical trial, mean 24-hour systolic blood pressure and other cardiovascular measures were not significantly different between sham and active HGNS therapy. Several methodologic lessons can be gleaned to inform future HGNS randomized clinical trials. Trial Registration: ClinicalTrials.gov Identifier: NCT03359096.

Home Sleep Testing versus Traditional Polysomnography: Pros and Cons.

Obstructive sleep apnea (OSA) is associated with long-term cardiovascular and respiratory comorbidities and increased burden on the health-care system. Early and accurate diagnosis is essential to reduce physical and financial implications of the disease. Polysomnography uses neurophysiologic channels as well as basic respiratory and sleep parameters to best estimate the presence and/or severity of OSA. Although home sleep testing may have the potential for more variable results, it is a viable alternative to increase access to diagnosis of OSA and facilitate initiation of positive airway pressure.

Gender analysis of the top classic papers in otolaryngology head and neck surgery.

Objective: The aim of this study was to identify and analyze the gender breakdown of first authorship contributing to the most-cited papers in the field of otolaryngology, with a goal of identifying trends in gender representation in publishing. Methods: The top 150 most-cited papers were identified using the Science Citation Index of the Institute for Scientific Information. Among the first authors, gender, h-index, percentage of first, last, and corresponding authorship positions, total publications, and citations were analyzed. Results: The majority of papers were in the English language, from the United States, of clinical nature, and on otologic topics. Eighty-one percent of papers (n = 122) had men who were first authors, although there was no difference in h-index score, authorship position, number of publications, citations, and average citations/year between men and women first authors. Upon subgroup analysis by decade (1950s-2010s), there was no difference in the number of articles by women first authors (P = 0.11); however, there was a statistically significant increase in the percentage of women authors (P = 0.001) in papers published later compared to those published earlier. Conclusions: While a promising number of women otolaryngologists are publishing high-powered articles, future initiatives to promote academic inclusivity of women should be considered.

Enhanced drug-induced sleep endoscopy: Distinguishing central from obstructive apnea.

This case report describes a patient originally diagnosed with obstructive sleep apnea (OSA) who was later found to have central sleep apnea (CSA) during drug-induced sleep endoscopy, which was subsequently confirmed on an in-laboratory sleep study. The revised diagnosis resulted in a change in recommended therapy from hypoglossal nerve stimulation to phrenic nerve stimulation. This case report is a reminder that the sleep surgeon must be cognizant of the possibility of CSA being misclassified as OSA especially as home sleep studies become increasingly routine, and discusses ways to more easily distinguish between CSA and OSA. Laryngoscope, 133:706-708, 2023.

Hypoglossal nerve palsy missed and misinterpreted: the hidden skull base.

OBJECTIVE: Dysarthria and tongue swelling may be seen with hypoglossal nerve palsy, and on cross-sectional imaging studies, tongue denervation can be misinterpreted as a primary base-of-tongue mass. Understanding radiological patterns of tongue denervation is important to prevent misinterpretation. Close evaluation of the skull base is critical as hypoglossal palsies resulting from pathology here are often overlooked. METHODS: Neck and brain magnetic resonance imaging studies obtained in 7 adult patients referred to our institution with clinically and/or radiologically suspected tongue base masses were retrospectively reviewed. Outside imaging evaluations were misinterpreted as base-of-tongue tumors in 3 patients, incorrectly read as normal in 2, and skull base pathologies were missed in 5. RESULTS: All 7 patients showed magnetic resonance imaging findings typical of tongue denervation: T2-weighted hyperintensity of involved hemitongue, protrusion of the tongue into oropharynx, variable fatty infiltration. All 5 skull base masses involved hypoglossal canal (4 metastases, 1 multiple myeloma; 4 newly diagnosed cancers). Two patients had internal carotid artery dissections at the skull base. CONCLUSIONS: To avoid misinterpretation of tongue denervation for tongue base mass, understanding of tongue innervations and classic imaging findings of hypoglossal denervation are essential. Careful inspection of skull base is paramount to avoid overlooking these hidden pathologies.

Transoral robot-assisted lingual tonsillectomy and uvulopalatopharyngoplasty for obstructive sleep apnea.

OBJECTIVES: We assessed the use of transoral robot-assisted lingual tonsillectomy and uvulopalatopharyngoplasty for the surgical management of tongue base obstruction in patients with obstructive sleep apnea. METHODS: In a prospective, nonrandomized trial using historical controls, patients underwent drug-induced sleep endoscopy, transoral robot-assisted lingual tonsillectomy with uvulopalatopharyngoplasty, and preoperative and postoperative polysomnography. RESULTS: Twenty patients have completed the study to date. The rate of surgical success was 45%, and the rate of surgical response was 65%. The mean preoperative apnea-hypopnea index of 55.6 decreased by 56.7%, to a mean postoperative value of 24.1 (p < 0.001), and the minimum arterial oxygen saturation increased from the mean preoperative value of 75.8% to the mean postoperative value of 81.7% (p = 0.013). The mean Epworth Sleepiness Scale score improved from 13.4 to 5.9 (p = 0.003). One patient had postoperative bleeding that required cauterization, resulting in a major complication rate of 4.2%. CONCLUSIONS: Transoral robot-assisted lingual tonsillectomy with uvulopalatopharyngoplasty is a novel technique for the surgical management of obstructive sleep apnea that results in a significant decrease in the apnea-hypopnea index, a significant improvement in minimum arterial oxygen saturation, and a significant improvement in the Epworth Sleepiness Scale score and has an acceptable complication rate.

Financial impact of the COVID-19 pandemic on an academic otolaryngology department.

Objective: To quantify the financial impact of the coronavirus disease (COVID-19) pandemic on an academic otolaryngology department. Methods: A year-over-year comparison was used to compare department revenue from April 2020 and April 2021 as a percentage of baseline April 2019 activity. Results: At the onset of the COVID-19 pandemic in April 2020, total department charges decreased by 83.4%, of which outpatient clinic charges were affected to the greatest extent. One year into pandemic recovery, department charges remained down 6.7% from baseline, and outpatient clinic charges remained down 9.9%. The reduction in outpatient clinic charges was mostly driven by a decrease in in-office procedure charges. Conclusion: Given that precautions to mitigate the risk of viral transmission in the health care setting are likely to be long-lived, it is important to consider the vulnerabilities of our specialty to mitigate financial losses going forward.

Predictors of success in hypoglossal nerve stimulator implantation for obstructive sleep apnea.

OBJECTIVE: Current guidelines for hypoglossal nerve stimulator (HGNS) implantation eligibility include drug-induced sleep endoscopy (DISE) findings and other patient characteristics but lead to highly variable rates of surgical success across institutions. Our objective was to determine whether additional factors seen on preoperative evaluation could be used as predictors of surgical success. STUDY DESIGN: Retrospective chart review. SETTING: Single-institution academic tertiary care medical center. SUBJECTS: and Methods:This study included patients with obstructive sleep apnea (OSA) who underwent HGNS implantation between 2015 and 2018. Surgical success was defined as a postoperative apnea-hypopnea index (AHI) of less than 20 events per hour and an AHI reduction of at least 50%. Preoperative polysomnogram (PSG) results, DISE findings, and physical parameters were compared between surgical successes and failures. RESULTS: A total of 68 patients were included in the analysis. The overall surgical success rate was 79.4% (54/68). Elevated preoperative AHI was associated with an increased likelihood of treatment failure, with an AHI of (36.9 ± 16.8) events/hour in the success group compared to (49.4 ± 19.6) events/hour in the failure group (P = 0.05). Patients observed to have partial lateral oropharyngeal collapse on DISE was more frequently associated with the treatment failure group than in the success group (P = 0.04). CONCLUSION: Patients who underwent HGNS implantation overall had a very high treatment response rate at our institution. Factors that may predispose patients to surgical failure included the presence of lateral oropharyngeal collapse and a significantly elevated preoperative AHI. These should be considered when determining surgical candidacy for HGNS implantation.

Prospective Determination of Airway Response to Upper Airway Stimulation: A New Opportunity for Advanced Device Titration.

OBJECTIVES/HYPOTHESIS: Response to upper airway stimulation (UAS) is associated with the degree of airway opening during stimulation. UAS programming may affect this opening. The objective of this study was to examine airway changes in response to five different electrode configurations programmable within the Inspire UAS system. STUDY DESIGN: Prospective single-arm cohort study. METHODS: Subjects who underwent UAS implantation were recruited for a prospective single-arm cohort study during UAS device activation. Functional thresholds were recorded for all settings. Awake nasopharyngoscopy was performed to examine the retropalatal (RP) and retroglossal (RG) regions at rest and during activation with all settings at their functional thresholds. Cross-sectional measurements were made by two blinded reviewers and reported as percent change in airway size. RESULTS: Sixteen patients were included. The standard setting (+-+) resulted in the greatest change in RP area in 43.8% of patients. An alternative setting resulted in greatest change in 56.2% of patients (--- and o-o in 18.8% each, -o- in 12.5%, and -+- in 6.3% of patients). Average response to all five settings was utilized to classify degree of palatoglossal coupling. Most patients had some enlargement (20%-70% change in RP area, 43.8%) or no enlargement (<20% change, 43.8%), whereas a minority of patients (12.5%) had marked enlargement (>70% change). RP and RG expansion were not correlated. CONCLUSION: Degree of RP expansion varied among patients and settings. Although the standard setting resulted in greatest RP change in a plurality of patients, over half had a greater response to an alternative setting. Future studies should address whether choice of setting based on RP expansion results in improved outcomes. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:218-223, 2021.

Effect of Electrode Configuration and Impulse Strength on Airway Patency in Neurostimulation for Obstructive Sleep Apnea.

OBJECTIVES/HYPOTHESIS: Hypoglossal nerve stimulation (HNS) has gained increasing interest for the treatment of patients with obstructive sleep apnea (OSA). Drug-induced sleep endoscopy (DISE) can both exclude improper airway collapse patterns and visualize airway changes under stimulation. Stimulation outcome effects depend on the impulse voltage and electric field resulting from the electrode configuration of the implanted device. The effects of various combinations of voltage and electric field on DISE airway patterns in contrast to awake endoscopy are unknown. STUDY DESIGN: Cohort study. METHODS: During therapy adjustment about 6 months after implantation, patients underwent a DISE and awake endoscopy with 100% and 125% of functional voltage in three typical electrode configurations (+ - +, o - o, - - -). All videos were analyzed by two separate persons for the opening of the airway at velum, tongue base, and epiglottis level. RESULTS: Thirty patients showed typical demographic data. The opening effects were visible in all patients, but there were changes between different electrode configurations. Several demographic or therapeutic aspects such as obesity, OSA severity, or prior soft palate surgery were associated with changes arising from different electrode configurations, but none resulted in a consistently better airway opening. CONCLUSIONS: In patients with poor results during the therapy adjustment, electric configuration changes can improve airway patency-an independent variable from increasing voltage. As these effects can only be seen in awake endoscopy or DISE, both endoscopies with live stimulation may be considered in cases with insufficient improvement in apnea-hypopnea index after initiation of HNS therapy. LEVEL OF EVIDENCE: Prospective case series; level 4. Laryngoscope, 131:2148-2153, 2021.

Sialendoscopy for sialodocholithiasis following submandibular gland excision: six variations on a theme.

Sialendoscopy is a minimally invasive technique that facilitates the diagnosis and treatment of sialolithiasis. This case series presents the novel use of sialendoscopy to treat sialodocholithiasis in six patients with a non-functional or surgically absent submandibular gland by a single surgeon at the University of Pennsylvania Health System between March 2013 and December 2019. The four female and two male patients had a median age of 56 years and mean follow-up of 16.2 months (range 1-44.5). All stones were successfully removed using sialendoscopy, and in 5 patients a combined approach was utilized. All patients remain asymptomatic at last clinical follow-up. We conclude that sialendoscopy is a viable, minimally invasive method for managing sialodocholithiasis in patients with prior submandibular gland excision or atretic gland. It is also useful as an assistive tool when approaching complex transcervical or transoral procedures in previously instrumented patients.

Comparison of Traditional Upper Airway Surgery and Upper Airway Stimulation for Obstructive Sleep Apnea.

OBJECTIVE: To compare patients with moderate-severe obstructive sleep apnea (OSA) undergoing traditional single and multilevel sleep surgery to those undergoing upper airway stimulation (UAS). STUDY DESIGN: Case control study comparing retrospective cohort of patients undergoing traditional sleep surgery to patients undergoing UAS enrolled in the ADHERE registry. SETTING: 8 multinational academic medical centers. SUBJECTS AND METHODS: 233 patients undergoing prior single or multilevel traditional sleep surgery and meeting study inclusion criteria were compared to 465 patients from the ADHERE registry who underwent UAS. We compared preoperative and postoperative demographic, quality of life, and polysomnographic data. We also evaluated treatment response rates. RESULTS: The pre and postoperative apnea hypopnea index (AHI) was 33.5 and 15 in the traditional sleep surgery group and 32 and 10 in the UAS group. The postoperative AHI in the UAS group was significantly lower. The pre and postoperative Epworth sleepiness scores (ESS) were 12 and 6 in both the traditional sleep surgery and UAS groups. Subgroup analysis evaluated those patients undergoing single level palate and multilevel palate and tongue base traditional sleep surgeries. The UAS group had a significantly lower postoperive AHI than both traditional sleep surgery subgroups. The UAS group had a higher percentage of patients reaching surgical success, defined as a postoperative AHI <20 with a 50% reduction from preoperative severity. CONCLUSION: UAS offers significantly better control of AHI severity than traditional sleep surgery. Quality life improvements were similar between groups.

Evaluation of Surgical Learning Curve Effect on Obstructive Sleep Apnea Outcomes in Upper Airway Stimulation.

OBJECTIVE: An increasing number of facilities offer Upper Airway Stimulation (UAS) with varying levels of experience. The goal was to quantify whether a surgical learning curve exists in operative or sleep outcomes in UAS. METHODS: International multi-center retrospective review of the ADHERE registry, a prospective international multi-center study collecting UAS outcomes. ADHERE registry centers with at least 20 implants and outcomes data through at least 6-month follow-up were reviewed. Cases were divided into two groups based on implant order (the first 10 or second 10 consecutive implants at a given site). Group differences were assessed using Mann-Whitney U-tests, Chi-squared tests, or Fisher's Exact tests, as appropriate. A Mann-Kendall trend test was used to detect if there was a monotonic trend in operative time. Sleep outcome equivalence between experience groups was assessed using the two one-sided tests approach. RESULTS: Thirteen facilities met inclusion criteria, contributing 260 patients. Complication rates did not significantly differ between groups (P = .808). Operative time exhibited a significant downward trend (P < .001), with the median operative time dropping from 150 minutes for the first 10 implants to 134 minutes for the subsequent 10 implants. The decrease in AHI from baseline to 12-month follow-up was equivalent between the first and second ten (22.8 vs 21.2 events/hour, respectively, P < .001). Similarly, the first and second ten groups had equivalent ESS decreases at 6 months (2.0 vs 2.0, respectively, P < .001). ESS outcomes remained equivalent for those with data through 12-months. CONCLUSIONS: Across the centers' first 20 implants, an approximately 11% reduction operative time was identified, however, no learning curve effect was seen for 6-month or 12-month AHI or ESS over the first twenty implants. Ongoing monitoring through the ADHERE registry will help measure the impact of evolving provider and patient specific characteristics as the number of implant centers increases.

Impact of Body Mass Index and Discomfort on Upper Airway Stimulation: ADHERE Registry 2020 Update.

OBJECTIVES/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/m2 (BMI32 ) and 32 < BMI ≤35 kg/m2 (BMI35 ) 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 (-20.9, P < .0001) and ESS (- 4.4, P < .0001) were demonstrated. Mean therapy usage was 5.6 ± 2.2 hr/day. Significant therapy use difference was present in patients with reported discomfort versus no discomfort (4.9 ± 2.5 vs. 5.7 ± 2.1 hr/day, P = .01). Patients with discomfort had higher final visit mean AHI versus without discomfort (18.9 ± 18.5 vs. 13.5 ± 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 BMI35 versus BMI32 patients (59.8% vs. 72.2%, P = .02). There was a significant therapy use difference: 5.8 ± 2.0 hr/day in BMI32 versus 5.2 ± 2.2 hr/day in BMI35 (P = .028). CONCLUSIONS: Data from ADHERE demonstrate high efficacy rates for UAS. Although surgical response rate differs between BMI32 and BMI35 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. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:2616-2624, 2021.