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Untreated obstructive sleep apnea (OSA) is associated with excessive daytime sleepiness, decreased quality of life, and cardiovascular disease. Positive airway pressure is the first-line therapy for OSA; however, adherence is difficult. Upper airway stimulation is a Food and Drug Administration-approved treatment of OSA. The objective of this study was to evaluate for a difference in treatment efficacy and adherence of upper airway stimulation therapy for OSA between individuals who are White and non-White using data from the ADHERE registry.ADHERE registry is a multicenter prospective study of real-world experience of upper airway stimulation for treatment of OSA in the United States and Europe. Propensity score matching was used to create a balanced dataset between the White and non-White groups.There were 2,755 participants of the ADHERE registry: 27 were excluded due to not having a race identified, 125 participants identified as non-White, 2,603 identify as White, and 27 did not provide race information. Propensity score matching was used to select 110 participants, with 55 White and 55 non-White for the noninferiority analysis. We did not find a difference in adherence, treatment apnea-hypopnea index, changes in Epworth Sleepiness Scale score, or clinical global impression after intervention score between White and non-White individuals.Our study found that there was no statistically significant difference in adherence or efficacy with upper airway stimulation therapy between White and non-White individuals. However, the percent of non-White people implanted is low, which suggests a need to expand access to this therapy for non-White populations with OSA who cannot tolerate positive airway pressure therapy.Khan M, Stone A, Soose RJ, et al. Does race-ethnicity affect upper airway stimulation adherence and treatment outcome of obstructive sleep apnea?

ImportanceEvidence is lacking from randomized clinical trials of hypoglossal nerve stimulation in obstructive sleep apnea (OSA).ObjectiveTo evaluate the safety and effectiveness of targeted hypoglossal nerve stimulation (THN) of the proximal hypoglossal nerve in patients with OSA.Design, Setting, and ParticipantsThis randomized clinical trial (THN3) was conducted at 20 centers and included 138 patients with moderate to severe OSA with an apnea-hypopnea index (AHI) of 20 to 65 events per hour and body mass index (calculated as weight in kilograms divided by height in meters squared) of 35 or less. The trial was conducted from May 2015 through June 2018. Data were analyzed from January 2022 through January 2023.InterventionImplant with THN system; randomized 2:1 to activation at month 1 (treatment) or month 4 (control). All received 11 months of THN with follow-up at months 12 and 15, respectively.Main Outcomes and MeasuresPrimary effectiveness end points comprised AHI and oxygen desaturation index (ODI) responder rates (RRs). Treatment responses at months 4 and 12/15 were defined as a 50% or greater reduction in AHI to 20 or less per hour and an ODI decrease of 25% or greater. Coprimary end points comprised (1) month 4 AHI and ODI RR in the treatment greater than the control group and (2) month 12/15 AHI and ODI RR in the entire cohort exceeding 50%. Secondary end points included sleep apnea severity (AHI and ODI) and patient-reported outcomes (Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, and EQ-5D visual analog scale).ResultsAmong 138 participants, the mean (SD) age was 56 (9) years, and 19 (13.8%) were women. Month 4 THN RRs were substantially greater in those in the treatment vs control group (AHI, 52.3% vs 19.6%; ODI, 62.5% vs 41.3%, respectively) with treatment-control standardized mean differences of 0.725 (95% CI, 0.360-1.163) and 0.434 (95% CI, 0.070-0.843) for AHI and ODI RRs, respectively. Months 12/15 RRs were 42.5% and 60.4% for AHI and ODI, respectively. Improvements in AHI, ODI, Epworth Sleepiness Scale, Functional Outcomes of Sleep Questionnaire, and EQ-5D visual analog scale scores were all clinically meaningful (medium to large effect size). Two serious adverse events and 100 nonserious related adverse events were observed from the implant procedure or study protocol.Conclusions and RelevanceThis randomized clinical trial found that THN demonstrated improvements in sleep apnea, sleepiness, and quality of life in patients with OSAs over an extended AHI and body mass index range without prior knowledge of pharyngeal collapse pattern. Clinically meaningful improvements in AHI and patient-reported responses compared favorably with those of distal hypoglossal nerve stimulation trials, although clinically meaningful differences were not definitive for ODI.Trial RegistrationClinicalTrials.gov Identifier: NCT02263859

Objectives/hypothesis For patients with submandibular sialolithiasis, there are many gland-preserving treatment options including sialendoscopy. Sialendoscopy, however, requires expensive instrumentation with limited availability, which may not be required for routine cases. The objective of this study is to compare the outcomes of patients with submandibular sialolithiasis undergoing sialendoscopy versus those undergoing transoral incisional sialithotomy. Study design Longitudinal, prospective study of patient undergoing gland-preserving therapy for submandibular sialolithiasis. Methods The study was a prospective, nonrandomized trial of 30 patients with submandibular sialolithiasis who received gland-preserving treatment by either sialendoscopy-assisted techniques (Scope group; 14 patients) or transoral sialithotomy with or without dochoplasty (No Scope group; 16 patients). Factors analyzed between the two groups included age, race, gender, size of stone, location of stone, gland(s) involved, surgical method, and modified salivary Oral Health Impact Profile (sOHIP) scores before and after therapy. Results There were no significant differences between the Scope and No Scope groups regarding age, race, or gender. There was a significant difference in stone size between the groups, with the No Scope group having larger stones on average. Both treatments led to statistically significant symptomatic improvement in sOHIP scores. There was no statistically significant difference in salivary quality of life improvement between the Scope and No Scope groups (P = .33). Conclusions Sialendoscopy is an important diagnostic and therapeutic tool in the management of salivary disorders, but is not associated with improved outcomes in gland-preserving treatments for routine submandibular sialolithiasis. Transoral stone removal alone may have equivalent symptomatic outcomes in the management of select sialoliths. Level of evidence III Laryngoscope, 2021.

Objective To evaluate the feasibility and outcomes of porcine submucosal allograft (Biodesign Sinonasal Repair Graft [Cook Medical, Bloomington, IN]) in oral cavity and oropharynx reconstruction after ablative surgery. Methods We conducted a prospective and retrospective review of patients who underwent Biodesign Sinonasal Repair Graft reconstruction for oral and oropharyngeal surgical defects at a single institution between 2018 and 2020. A total of 11 patients were included in the study. Data points included their perioperative medical and demographic data, immediate postoperative course, and follow‐up visits at 10 days and at 2 months. The clinicopathologic characteristics of their disease, postoperative esthetic, and functional outcomes were recorded and analyzed. Results Eleven procedures have been performed, and all patients received Biodesign reconstruction either immediately after ablation or after they failed a previous reconstruction. None of the patients had bone exposure. The subsites included oral tongue (n = 6), floor of the mouth (n = 3), buccal mucosa (n = 1), and soft palate (n = 1). In all cases, the operations and the postoperative course were uneventful. The mean defect size was 22 cm2. The median start of oral intake was at 2 days postoperatively. The Biodesign graft healed well in all patients with no total graft loss. There was one complication that required revision surgery due to obstruction of Wharton's duct by the Biodesign material. Conclusions Biodesign can be a viable option for small and medium‐sized oral and oropharyngeal defects in patients who are medically unfit or do not want to undergo a free flap surgery. Level of Evidence 4., This is a case series of 11 subjects describing a single‐institution experience with the use of Biodesign synthetic porcine material for reconstruction of oral cavity and soft palate (oropharyngeal) defects. This graft material has been used in the head and neck previously including the ear and the nose as well as other non‐head and neck locations around the body. This is the first article discussing its clinical use in the oral cavity.

BackgroundEvaluation and interpretation of the literature on obstructive sleep apnea (OSA) allows for consolidation and determination of the key factors important for clinical management of the adult OSA patient. Toward this goal, an international collaborative of multidisciplinary experts in sleep apnea evaluation and treatment have produced the International Consensus statement on Obstructive Sleep Apnea (ICS:OSA). MethodsUsing previously defined methodology, focal topics in OSA were assigned as literature review (LR), evidence-based review (EBR), or evidence-based review with recommendations (EBR-R) formats. Each topic incorporated the available and relevant evidence which was summarized and graded on study quality. Each topic and section underwent iterative review and the ICS:OSA was created and reviewed by all authors for consensus. ResultsThe ICS:OSA addresses OSA syndrome definitions, pathophysiology, epidemiology, risk factors for disease, screening methods, diagnostic testing types, multiple treatment modalities, and effects of OSA treatment on multiple OSA-associated comorbidities. Specific focus on outcomes with positive airway pressure (PAP) and surgical treatments were evaluated. ConclusionThis review of the literature consolidates the available knowledge and identifies the limitations of the current evidence on OSA. This effort aims to create a resource for OSA evidence-based practice and identify future research needs. Knowledge gaps and research opportunities include improving the metrics of OSA disease, determining the optimal OSA screening paradigms, developing strategies for PAP adherence and longitudinal care, enhancing selection of PAP alternatives and surgery, understanding health risk outcomes, and translating evidence into individualized approaches to therapy.

BACKGROUND Surgery with adjuvant radiotherapy is the accepted standard for treatment of advanced oral cavity squamous cell carcinoma (OCSCC); however, alternative evidence suggests that definitive (chemo)radiotherapy may have similar outcomes. METHODS Systematic review was performed to assess the therapeutic value of radiotherapy or chemoradiotherapy as a primary modality for treating OCSCC. Meta-analysis of outcomes was performed between articles comparing radiotherapy and primary surgical treatment. RESULTS Meta-analysis showed less favorable results of radiotherapy compared to surgery: overall survival at 3-years (odds ratio [OR] = 0.51; 95% confidence interval [CI] = 0.34-0.77) and 5-years (OR = 0.42; 95% CI = 0.29-0.60); disease-specific survival at 3-years (OR = 0.55; 95% CI = 0.32-0.96) and 5-years (OR = 0.55; 95% CI = 0.32-0.96). Odds of feeding tube dependency were higher in primary radiotherapy group (OR = 2.67; 95% CI = 1.27-5.64). CONCLUSIONS Results of this study support the current perspective favoring primary surgical treatment for OCSCC in the absence of surgical contraindications.

Duct scar in the form of stenoses or stricture is the second leading cause of obstructive sialadenitis after stone. Over the past decade, there has been a growing experience demonstrating the effectiveness of endoscopic techniques in the minimally invasive management of salivary duct stenosis. Less information, however, is available with regard to open approaches for recurrent or complex ductal stenoses. This article reports on a case of gland preservation using an open ductal technique that originally was applied in cases of traumatic Stensen's duct injury.

Sialoendoscopy is a valuable technique for a variety of obstructive and nonobstructive disorders of the major salivary glands. However, the utility of sialoscopes is limited for salivary stones, which frequently required open removal. Transoral sialolithotomy without scopes is an efficient, low-cost alternative with excellent outcomes available for most of the submandibular stones.

OBJECTIVE/HYPOTHESIS The objective of this study was to perform a systematic review and meta-analysis to determine the impact of dental care on head and neck (H&N) cancer survival. METHODS A comprehensive literature search was performed using PubMed, MEDLINE, and CINAHL to find all relevant studies from the date of inception to March 2020. Systematic review was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, and meta-analysis was performed using the random effects logistic regression model. Primary outcomes of interest were 5-year survival and hazard ratios comparing survival between dental care subgroups. RESULTS H&N cancer survival rates strongly correlate with dental care adherence. Patients with good dental care had significantly better survival than patients with poor dental care (HR = 0.67, 95% CI: 0.55-0.83), with similar improved survival among patients with moderate versus poor dental care (HR = 0.67, 95% CI: 0.57-0.80). In addition, patients with good dental care had significantly decreased mortality than those with moderate dental care (HR = 0.81, 95% CI: 0.69-0.96), indicating an exposure-response gradient. CONCLUSIONS For patients with H&N cancer, survival is significantly higher in those who receive recommended dental care compared with those who do not. LEVEL OF EVIDENCE N/A Laryngoscope, 2021.

Objectives/hypothesis This study is a systematic review of the literature which seeks to estimate the expected treatment outcomes of a patient with Sjogren's syndrome (SS) undergoing therapeutic sialendoscopy. Study design Systematic Review. Methods PubMed, Scopus, and Cochrane library databases were used to search for studies published as of August 2020 regarding the treatment outcomes of SS with sialendoscopy. The key search terms included "Sjogren's syndrome" and "sialendoscopy." Only studies in the English language involving more than one human patient were included. PRISMA guidelines were followed in study inclusion and data extraction. The primary outcome assessed was improvement in patient symptoms. Results Six studies met criteria and were analyzed in this review, including 125 patients undergoing sialendoscopy of parotid and/or submandibular glands as well as 25 controls. Of these patients, 90% were female with an age range of 18 to 79 years. There was significant diversity in outcome reporting tools. The outcomes of symptom improvement were pooled qualitatively based on improvement noted in each study. Outcomes were defined as partial improvement if the measured outcomes improved and complete improvement if measured outcomes resolved entirely. Despite the limited number of studies on this topic, this meta-analysis suggests that a similar study of therapeutic sialendoscopy could expect to provide at least temporary improvement of symptoms 90% to 99% of the time. Conclusions This review provides support for the application of sialendoscopy in the treatment of SS salivary disease. Larger studies with consistent outcome reporting tools and control groups are needed to validate these results and provide a consistent therapy protocol. Laryngoscope, 131:1474-1481, 2021.

In recent years, sleep-disordered breathing (SDB) has been recognized as a prevalent but under-diagnosed condition in adults and has prompted the need for new and better diagnostic and therapeutic options. To facilitate the development and availability of innovative, safe and effective SDB medical device technologies for patients in the United States, the US Food and Drug Administration collaborated with six SDB-related professional societies and a consumer advocacy organization to convene a public workshop focused on clinical investigations of SDB devices. Sleep medicine experts discussed appropriate definitions of terms used in the diagnosis and treatment of SDB, the use of home sleep testing versus polysomnography, clinical trial design issues in studying SDB devices, and current and future trends in digital health technologies for diagnosis and monitoring SDB. The panel’s breadth of clinical expertise and experience across medical specialties provided useful and important insights regarding clinical trial designs for SDB devices. CITATION: Mann EA, Nandkumar S, Addy N, et al. Study design considerations for sleep-disordered breathing devices. J Clin Sleep Med. 2020;16(3):441–449.

The prevalence of sleep-disordered breathing has greatly increased in the geriatric population. The pathophysiology of sleep-disordered breathing for this population varies from younger populations due to consequences of aging such as loss of neuromuscular tone, soft tissue hypertrophy, and tissue laxity. The importance of treating obstructive sleep apnea is obvious as it is linked to detrimental cardiovascular and cerebrovascular risks with additional effects on quality of life. Treatment of older patients is best met by evaluating their goals of treatment and meeting it with options that are minimally invasive, cost-effective, and with low pain and morbidity. Non-surgical options such as continuous positive airway pressure and oral appliances are beneficial to those who can tolerate them, but for those that cannot, various surgical options including nasal surgery, palatal stiffening procedures, hyoid suspension, radiofrequency ablation, and upper airway stimulation can provide improvement in their disease and meet their expectations for treatment.

Objective Demonstrate the safety and effectiveness of palatal foreshortening and stiffening in reducing snoring severity in nonobstructive sleep apnea (non‐OSA) patients complaining of chronic disruptive snoring. Methods In a US‐based 8‐center, open‐label, prospective, single‐arm cohort study, 52 consenting adults with chronic disruptive snoring (snoring impacting a patient's life and causing patient or bed partner to seek medical intervention) were treated via office‐based placement of resorbable, bidirectional, barbed suture implants into the soft palate under local anesthesia. Prior to intervention, home sleep tests (HSTs) were performed to rule out OSA and to document snoring noise level. Both subject and their bed/sleep partners (also consented) completed questionnaires including: bed/sleep partner's scored visual analog scale (VAS) for subjects' snoring severity, and subject scoring for Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI). Following intervention, HSTs, VAS, ESS and PSQI were repeated at 30, 90 and 180 days. Results Mean baseline bed/sleep partner VAS was 7.81 ± 1.59. Mean postimplant VAS scores decreased significantly at each measured interval; to 5.77±2.35 (P

Metastases to the parotid nodal basin in patients with high-risk cutaneous squamous cell carcinoma (HRcSCC) impact disease specific survival (DSS) and overall survival (OS).A writing group convened by the Salivary Section of the American Head and Neck Society (AHNS) developed contemporary, evidence-based recommendations regarding management of the parotid nodal basin in HRcSCC based on available literature, expert consultation, and collective experience. The statements and recommendations were then submitted and approved by the AHNS Salivary Committee.These recommendations were developed given the wide variation of practitioners who treat HRcSCC in order to streamline management of the parotid nodal basin including indications for imaging, surgery, radiation, and systemic treatment options as well.This clinical update represents contemporary optimal management of the parotid nodal basin in HRcSCC and is endorsed by the Salivary Section of the AHNS.

Introduction THN3 was the first reported parallel-arm, randomized controlled trial (RCT) of hypoglossal nerve stimulation (HGNS), wherein targeted HGNS (THN) was shown to be safe and efficacious at ameliorating sleep disordered breathing in patients with moderate to severe OSA and BMI≤35kg/m2 without screening with drug-induced sleep endoscopy. Unique among reported HGNS trials, separate cohorts of patients receiving early and late THN were followed longitudinally. Methods Measurements of apnea-hypopnea index (AHI) were available Pre-enrollment, Baseline (2 nights), Month 4 and Month 12/15. Except for Pre-enrollment, AHI values were calculated by an independent core laboratory from polysomnographic recordings. All subjects with complete data were included for analysis. AHI trajectories were constructed for early and late THN activation (Treatment[T], N=83, Month 1 and Control[C], N=45, Month 4, respectively) by computing median values. Confidence intervals were calculated by bootstrapping each median (N=30,000). Patient-reported outcome measures (PROMs) were treated similarly. Results AHI (Median (95% CI)) trajectories demonstrated a consistent pattern of pre-implant alignment (Pre-enrollment T:39.1 (36.0-45.0), C:38.0 (32.0-41.0); Baseline 1 T:36.1 (33.0-39.9), C:31.3 (27.2-38.6); Baseline 2 T:37.0 (34.3-41.0), C:35.2 (32.3-38.2)), divergence at the conclusion of the randomization period (Month 4 T:15.6 (11.9-25.3), C:30.6 (23.7-38.6)) and reconvergence following 11 months of treatment (Month 12/15 T:20.7 (16.0-26.4), C:18.1 (16.3-23.3)). Non-standardized Pre-enrollment AHI was slightly higher than Baseline values. Trajectories were similar for oxygen desaturation index (Baseline 1 T:35.3 (31.9-38.0),C:34.3 (27.5-40.3); Baseline 2 T:37.1 (33.4-39.3),C:36.8 (33.9-38.3); Month 4 T:19.5 (16.2-28.5), C:33.8 (25.4-41.1); Month 12/15 T:19.5 (16.0-25.6), C:19.7 (16.3-26.0)), the Epworth Sleepiness Scale (Baseline T:11.0 (10.0-13.0),C:11.5 (8.5-14.0); Month 4 T:6.0 (5.0-7.0), C:11.5 (8.0-12.5); Month 12/15 T:6.0 (4.0-7.0), C:5.5 (4.5-6.0)), the Functional Outcomes of Sleep Questionnaire (Baseline T:15.3 (14.0-16.5),C:14.7 (13.3-16.6); Month 4 T:18.3 (17.7-18.8), C:16.7 (14.9-17.7); Month 12/15 T:18.8 (18.3-19.3), C:18.5 (17.5-19.5)) and the Snore Outcomes Survey (Baseline T:26.6 (21.9-31.3),C:21.9 (18.8-31.3); Month 4 T:60.9 (56.3-67.9), C:29.7 (23.4-42.9); Month 12/15 T:62.5 (59.4-68.8), C:68.8 (62.5-71.9)). Conclusion Group trajectories of sleep-disordered breathing and PROMs further demonstrate the robust effects of THN in patients with moderate to severe OSA and the value of parallel-arm RCTs. Similar results may be expected in the ongoing OSPREY confirmatory trial of THN. Support (If Any) LivaNova

Sialoendoscopy is a valuable technique for a variety of obstructive and nonobstructive disorders of the major salivary glands. However, the utility of sialoscopes is limited for salivary stones, which frequently required open removal. Transoral sialolithotomy without scopes is an efficient, low-cost alternative with excellent outcomes available for most of the submandibular stones.

Introduction THN3 was the first reported parallel-arm, randomized controlled trial of hypoglossal nerve stimulation (HGNS), wherein targeted HGNS (THN) was shown to be safe and efficacious at ameliorating sleep disordered breathing in selected patients with moderate to severe OSA and BMI≤35kg/m2 without screening with drug-induced sleep endoscopy. A secondary THN3 objective was to identify baseline characteristics which enhance therapeutic response. Methods Predictors of long-term (Month 12/15) apnea-hypopnea index (AHI) response (reduction ≥50% to ≤20/hr) were identified in stages. Baseline characteristics, including polysomnography parameters, were screened one at a time using univariate logistic regression. Variables significant at α=0.25 were further selected using stepwise multivariate logistic regression. Candidate predictors were then optimized by manual, incremental threshold adjustment to maximize AHI response rate (RR). Optimized predictors were ranked according to the AHI RR and size of the corresponding subpopulation, with a goal of capturing at least 40% of the overall THN3 cohort. Results Baseline sleep efficiency (SE) in the normal range (>85%) achieved the highest AHI RR while retaining 42% (58/138) of the THN3 cohort. Similar to the overall study population, subgroup subjects were predominantly middle-aged (age 54±7 years), male (83%), Caucasian (86%) and overweight/obese (BMI 30±3 kg/m2). Short-term (Month 4) AHI RRs in the Treatment and Control groups were 59.5% and 20.0%, respectively, with long-term AHI RR at 50.9%. Median AHI was reduced from 35.1 to 16.0, as compared to 29.3 to 9.0 in the STAR trial of distal HGNS. ODI RRs (reduction ≥25%) for Treatment and Control were respectively 73.0% and 30.0% at Month 4 and 64.9% at Month12/15. Enhanced response carried through to larger point estimates for improvement in secondary variables, including the Epworth Sleepiness Scale and the Functional Outcomes of Sleep Questionnaire, exceeding minimum clinically important differences thresholds of 2-3 and 1.7-2.0, respectively. Conclusion Normal SE at Baseline was associated with enhanced AHI and ODI RR as well as patient-reported outcome measures for patients receiving THN therapy, providing results similar to those obtained with distal HGNS. Future studies, including the ongoing OSPREY trial, will be needed to prospectively validate these findings. Support (If Any) LivaNova

Background: Primary management of advanced head/neck cancers involves concurrent chemoradiotherapy . Subsequently, regional and local failures are managed with resection but there have been few reports that describe the morbidity and disease control outcomes of surgical salvage in this setting. Methods: Retrospective analysis describes complications, survival, and patterns of failure after salvage resection of isolated local and/or regional failures of head/neck cancer following definitive concurrent chemoradiotherapy. Results: Sixteen patients were identified for inclusion: laryngectomy in 11 patients, oral cavity/oropharynx resection in 2 patients, and neck dissection alone in 4 patients. Ten patients required graft tissue reconstruction (6 pedicle and 4 free flap). Median post-operative hospitalization was 7 days (range 3-19), and 4 patients required hospital re-admission. At a median survivor follow-up of 15.8 months (range 4.3-34.9), 10 patients were alive (6 without evidence of disease). Seven patients experienced disease recurrence at a median 6.7 months (range 0-12.6) following salvage resection (2 with isolated distant failures). Estimated 2-year local/regional control, freedom from failure, and overall survival were 58%, 39%, and 58%, respectively. Conclusions: Surgical salvage after primary definitive concurrent chemoradiotherapy is feasible with toxicity and outcomes similar to prior radiotherapy alone or sequential chemotherapy and radiation. Local andregional recurrence remains the predominant pattern of failure.

To compare the effectiveness of transoral robotic surgery (TORS) versus plasma ablation (PA) in tongue base reduction surgery for obstructive sleep apnea (OSA).PubMed, Scopus, Cochrane Library, OVID.Keywords searched included OSA, tongue base surgery, TORS, and coblation. Outcomes included pre- to postoperative apnea-hypopnea index, Epworth Sleepiness Scale (ESS), and lowest oxygen saturation. Additional outcomes included surgical success rate, postoperative bleeding, operative time, and length of stay.A total of 690 unique articles were identified, of which 60 underwent full-text review. Twenty-six articles were included in final analysis, comprising 18 studies on TORS (834 patients) and 11 studies on PA (294 patients). Mean differences of apnea-hypopnea index, ESS, and lowest oxygen saturation for TORS were -23.92, -7.6, and 5.83% (allTongue base reduction with TORS or PA each effectively treats OSA and provides comparable results. The choice between techniques might depend on patient factors, availability of technology, and associated costs.

Objectives/hypothesis Obstructive sleep apnea (OSA) and sickle cell disease (SCD) represent two complex disease processes. Current guidelines recommend that children with SCD receive polysomnography (PSG) after presenting with signs or symptoms of sleep-disordered breathing (SDB). Recent studies suggest a disproportionately elevated prevalence of SDB in the population of children with SCD, and traditional risk factors may not be evident within these patients. Further objective testing might be needed to screen all pediatric patients with SCD, even in the absence of overt signs or symptoms of OSA to prevent complications of both conditions. Study design Prospective cohort study. Methods Institutional review board approval was obtained. An eight-question OSA risk assessment screening questionnaire was presented prospectively to 100 consecutive patients with SCD in the pediatric hematology clinic regardless of complaints of SDB. Results Out of 100 patients, 51 were female. The average age, body mass index (BMI), BMI percentile, and I'M SLEEPY score of the entire cohort were 3.97 years, 15.97%, 55.4%, and 1.63%, respectively. Nineteen patients had a positive sleep apnea screening score and were referred for PSG. The average age BMI, BMI percentile, and I'M SLEEPY score for those 19 patients were 3.77%, 16.67%, 65%, and 3.95%, respectively. Ten patients completed PSG, with seven diagnosed with OSA. Conclusions This pilot study demonstrates a higher incidence of SDB and OSA in children with SCD relative to the general pediatric population. Although more PSG reports and further testing is needed to determine whether the results hold, preliminary data indicate that children with SCD should at least undergo OSA screening in the office regardless of overt symptoms. Level of evidence 3 Laryngoscope, 131:E1022-E1028, 2021.

Objective To evaluate the association between findings of blinded reviews of preoperative drug-induced sleep endoscopy (DISE) examinations using the VOTE Classification and obstructive sleep apnea (OSA) surgical outcomes in a large multicenter, international cohort. Methods Retrospective, multi-center cohort study of adults without tonsillar hypertrophy who underwent pharyngeal surgery for OSA. The study included only participants without enlarged tonsils. Four independent reviewers performed blinded review of preoperative DISE videos using the VOTE Classification system and scoring of a primary structure contributing to airway obstruction. DISE findings were examined for an association with surgical outcomes with univariate analyses and multiple regression. Results Two hundred seventy-five study participants were included from 14 centers. Mean age was 51.4 ± 11.8 years, and body mass index was 30.1 ± 5.2 kg/m2 . There was moderate interrater reliability (kappa = 0.40-0.60) for DISE findings. Oropharyngeal lateral wall-related obstruction was associated with poorer surgical outcomes (adjusted odds ratio (AOR) 0.51; 95% CI 0.27, 0.93). Complete tongue-related obstruction was associated with a lower odds of surgical response in moderate to severe OSA (AOR 0.52; 95% CI 0.28, 0.98), with findings that were similar but not statistically significant in other analyses. Surgical outcomes were not clearly associated with the degree and configuration of velum-related obstruction or the degree of epiglottis-related obstruction. Surgical response was associated with tonsil size and body mass index (inversely). Conclusion DISE findings concerning the oropharyngeal lateral walls and tongue may be the most important findings of this evaluation technique. Level of evidence 2B Laryngoscope, 129:761-770, 2019.

BACKGROUND Sialoendoscopy is the standard treatment for sialolithiasis; however, some patients may be unlikely to benefit from an endoscopic approach. This study assesses predictors of failure in the endoscopic management of sialoliths. METHODS Patients treated for sialolithiasis from 2012 to 2017 at two centers were stratified into 3 groups: successful interventional sialendoscopy, incisional sialolithotomy, and gland excision. Patient, disease, and surgical factors were compared. RESULTS Interventional sialendoscopy was attempted in 156 of 206 cases and successful for 42 (27%). Endoscopically retrieved calculi were smaller (4.96 mm) compared to incisional sialolithotomy (7.90 mm). Nonendoscopic approaches were required more often in submandibular cases 87% (P ≤ .005). Palpable stones were present in 74% of incisional sialolithotomies (P

Objective: To present 5-year outcomes from a prospective cohort of patients with obstructive sleep apnea (OSA) who were treated with upper airway stimulation (UAS) via a unilateral hypoglossal nerve implant. Study Design: A multicenter prospective cohort study. Setting: Industry-supported multicenter academic and clinical trial. Methods: From a cohort of 126 patients, 97 completed protocol, and 71 consented to a voluntary polysomnogram. Those having continuous positive airway pressure failure with moderate to severe OSA, body mass index 2, and no unfavorable collapse on drug-induced sleep endoscopy were enrolled in a phase 3 trial. Prospective outcomes included apnea-hypopnea index (AHI), oxygen desaturation index, and adverse events, as well as measures of sleepiness, quality of life, and snoring. Results: Patients who did and did not complete the protocol differed in baseline AHI, oxygen desaturation index, and Functional Outcomes of Sleep Questionnaire scores but not in any other demographics or treatment response measures. Improvement in sleepiness (Epworth Sleepiness Scale) and quality of life was observed, with normalization of scores increasing from 33% to 78% and 15% to 67%, respectively. AHI response rate (AHI 50% reduction) was 75% (n = 71). When a last observation carried forward analysis was applied, the responder rate was 63% at 5 years. Serious device-related events all related to lead/device adjustments were reported in 6% of patients. Conclusions: Improvements in sleepiness, quality of life, and respiratory outcomes are observed with 5 years of UAS. Serious adverse events are uncommon. UAS is a nonanatomic surgical treatment with long-term benefit for individuals with moderate to severe OSA who have failed nasal continuous positive airway pressure.

To determine the incidence, duration, and predictors of swallowing-related symptoms following upper airway surgery for obstructive sleep apnea.Adults (age 18 years or older) who underwent surgery for obstructive sleep apnea at a tertiary care institution from January 2012 to December 2015 were retrospectively reviewed. The incidence, duration, and associated factors of postoperative swallowing complaints were evaluated.A total of 130 patients (135 surgical encounters) met criteria for inclusion. There were 91 men (70.0%) and 39 women (30.0%) with a median age of 60 years (range: 19-79). Presurgical diagnosis of gastroesophageal reflux disease was present in 57 patients (43.8%). An average of 2.1 procedures (± 0.8) were conducted at each encounter. Uvulopalatopharyngoplasty (54.8%) was the most common followed by radiofrequency ablation of the soft palate (34.8%) and tongue base (29.6%). Postoperatively, 25 patients (19.8%) complained of dysphagia, 14 (10.9%) of globus, and 9 (6.7%) of odynophagia. Preoperative gastroesophageal reflux (odds ratio [OR] 4.09, 95% confidence interval [CI] 1.41-11.91) and hyoid myotomy with suspension (OR 4.88, 95% CI 1.34-17.77) were significant predictors for dysphagia. Radiofrequency ablation of the tongue base (OR 5.00, 95% CI 1.28-19.50) was a predictor for globus sensation. Median symptom durations, in months, were 4.0 for dysphagia, 7.3 for globus, and 3.0 for odynophagia.Preoperative gastroesophageal reflux and hyoid myotomy with suspension procedure were associated with postoperative dysphagia whereas radiofrequency ablation of the tongue base was associated with globus. These findings can assist surgeons in providing preoperative counseling and postoperative supportive measures regarding dysphagic symptoms following sleep surgery.

The American Academy of Otolaryngology-Head and Neck Surgery Foundation has published a supplement to this issue of Otolaryngology-Head and Neck Surgery featuring the "Clinical Practice Guideline: Evaluation of the Neck Mass in Adults." To assist in implementing the guideline recommendations, this article summarizes the rationale, purpose, and key action statements. The 12 recommendations developed emphasize reducing delays in diagnosis of head and neck squamous cell carcinoma; promoting appropriate testing, including imaging, pathologic evaluation, and empiric medical therapies; reducing inappropriate testing; and promoting appropriate physical examination when cancer is suspected.

Objectives: Analyze the obstructive sleep apnea (OSA) treatment history in a group of participants who enrolled in a hypoglossal nerve stimulation trial. Methods: Moderate-severe OSA patients with difficulty adhering to CPAP presented for enrollment in a multicenter trial. Self-reported history on prior OSA medical therapy was collected at enrollment, including OSA diagnosis date, CPAP start and stop dates, oral appliance trial, and reasons for discontinuation or non-adherence. Results: The cohort consisted of 929 participants, 83% male, with a mean age (53.9 ± 10.5) years. Ninety percent (n = 835) had complete CPAP information including 47% (n = 435) who discontinued therapy prior to enrollment and 43% (n = 400) who were still attempting CPAP but had inadequate adherence. Abandonment rates were 60% at 1-year, 73% at 3-years, and 86% at 5-years. Oral appliance therapy was attempted by 171 patients for mean (1.8 ± 2.3) years, with 81% abandonment at 1 year, 89% at 3-years, and 94% at 5-years. Conclusions: In this CPAP-refractory cohort, high rates of CPAP abandonment were reported in the first several years with approximately half of the participants not receiving any treatment despite being diagnosed for >5 years. Close clinical follow-up and consideration of alternative treatment options is indicated in all OSA patients in order to ensure adequate longitudinal care. Keywords: Upper airway stimulation, Hypoglossal nerve stimulation, STAR trial, Obstructive sleep apnea, CPAP failure

Objective: Determine the effects of hyoid myotomy and suspension (HMS) without concurrent palatal or tongue base sleep surgery for obstructive sleep apnea (OSA). Method: Patients with OSA treated with HMS were identified using CPT code (21685) at an academic and private sleep surgery clinic. Those who underwent concurrent palatal or tongue base sleep surgery were excluded. Outcomes included simultaneous procedures, apnea-hypopnea index (AHI), lowest oxyhemoglobin saturation (LSAT), and Epworth Sleepiness Scale (ESS). Results: Nineteen patients with OSA underwent HMS without palatal or tongue base sleep surgery. The average age at surgery was (55.3 ± 13.5) years with a majority of patients being male (71%). Concurrent procedures included the following: torus mandibularis excision (n = 1), endoscopic sinus surgery (n = 4), septoplasty (n = 10), inferior turbinate reduction (n = 12), and nasal valve repair (n = 2). AHI improved significantly from (39.7 ± 21.2) events/h to (22.6 ± 22.7) events/h after HMS (P 30 events/h) had an improvement in AHI from (49.9 ± 16.6) events/h to (29.1 ± 24.9) events/h, P

Objective: To assess patient-based outcomes of participants in a large cohort study—the STAR trial (Stimulation Therapy for Apnea Reduction)—48 months after implantation with an upper airway stimulation system for moderate to severe obstructive sleep apnea.Study Design: A multicenter prospective cohort study. Setting: Industry-supported multicenter academic and clinical setting. Subjects: Participants (n = 91) at 48 months from a cohort of 126 implanted participants. Methods: A total of 126 participants received an implanted upper airway stimulation system in a prospective phase III trial. Patient-reported outcomes at 48 months, including Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), and snoring level, were compared with preimplantation baseline.Results: A total of 91 subjects completed the 48-month visit. Daytime sleepiness as measured by ESS was significantly reduced (P =.01), and sleep-related quality of life as measured by FOSQ significantly improved (P =.01) when compared with baseline. Soft to no snoring was reported by 85% of bed partners. Two patients required additional surgery without complication for lead malfunction. Conclusion: Upper airway stimulation maintained a sustained benefit on patient-reported outcomes (ESS, FOSQ, snoring) at 48 months in select patients with moderate to severe obstructive sleep apnea.