Pneumothorax during upper airway stimulation: Does experience make a difference?

OBJECTIVES: Upper airway stimulation is a treatment option for select patients with obstructive sleep apnea. Pneumothorax may occur with UAS implantation during placement of the respiratory sensor. This study aims to evaluate the incidence of pneumothorax during UAS device placement. We hypothesize that sleep surgeons with high implantation volumes experience lower rates of pneumothorax compared to the general population of surgeons. METHODS: We also aim to describe management of pneumothorax when it does occur. The incidence of pneumothorax during UAS implantation among the general population of surgeons was assessed using the TriNetX Research Network. Additionally, a select group of Otolaryngologist sleep surgeons with a high UAS implantation volume were surveyed regarding experiences with UAS related pneumothoraces. RESULTS: 8 pneumothoraces occurred among 3823 UAS procedures in the surveyed otolaryngologist sleep surgeon population. 4 required chest tube insertion. Among the general population cohort, 42 of 1233 patients developed pneumothorax after UAS implantation. The rates of pneumothorax between the otolaryngologist sleep surgeon cohort and general population of surgeons cohort were 0.21 % and 3.4 % respectively (p < 0.00001). CONCLUSION: Pneumothorax rarely occurs during UAS implantation. Surgeons with higher implantation volumes showed a lower incidence of pneumothorax. Pneumothorax management is dependent on patient stability, perioperative setting, and degree of injury. The use of needle decompression, chest tube placement, and suture placement also vary with clinical scenario.

Reduced gastroesophageal reflux disease symptom severity following upper airway surgery for comorbid obstructive sleep apnea.

PURPOSE: To evaluate patient-reported quality of life pertaining to gastroesophageal reflux disease symptoms in patients undergoing upper airway surgery for comorbid obstructive sleep apnea. MATERIALS AND METHODS: A prospective survey-based study was conducted on patients with gastroesophageal reflux disease and comorbid obstructive sleep apnea receiving surgery from July 2020-December 2020. Patients completed the Gastroesophageal Reflux Disease-Health Related Quality of Life Questionnaire at two time-points: one week before surgery and at 6 months following surgery. Disease-related symptoms were rated from 0 (no symptoms) to 5 (incapacitating symptoms). Patient survey scores, demographics, medications, and sleep study parameters were collected for analysis. A p-value <0.05 indicated statistical significance. RESULTS: Twenty-two patients completed the baseline preoperative and 6-month postoperative questionnaires. Median baseline vs. 6-month survey scores significantly decreased for symptoms including heartburn in general (3.0 vs. 2.0, p = 0.006), when lying down (2.5 vs. 1.5, p = 0.046), when standing (2.0 vs 1.0, p = 0.003), following meals (2.0 vs. 2.0, p = 0.042), and cumulative survey score (15.5 vs. 11.0, p = 0.029). Heartburn altering diet or sleep, odynophagia, dysphagia, and medication burden did not change following surgery (p > 0.05). More patients were satisfied with their postoperative condition compared to baseline, however this did not reach statistical significance (40.9% vs. 18.2%, p = 0.18). CONCLUSIONS: Our results suggest that upper airway surgery to treat obstructive sleep apnea may have a positive impact on patient-reported symptoms of gastroesophageal reflux disease, and further investigation into the role of surgery in this setting for improvement of both quality of life and true clinical disease severity is merited.

A systematic approach to the evaluation and management of obstructive sleep apnea: The Jefferson Protocol.

Obstructive sleep apnea (OSA) has become increasingly prevalent in the United States. While continuous positive airway pressure (CPAP) therapy remains the gold standard for treatment, surgical intervention can enhance compliance and improve outcomes for those intolerant of CPAP. Since the majority of OSA patients have multilevel obstruction, it is critical that otolaryngologists understand each patient's pattern and anatomic level of obstruction before solidifying a treatment plan. This publication serves as a comprehensive review of evaluation, characterization, and management of OSA. Further, the authors outline their departmental algorithm for identifying ideal surgical candidates and tailoring corresponding surgical interventions.

Upper airway stimulation: Fewer complications, ED presentations, readmissions, and increased surgical success.

OBJECTIVES: Evaluate the rate of complications, readmissions, emergency department presentations, and surgical success rates amongst three standard surgical treatment options for obstructive sleep apnea: upper airway stimulation, transoral robotic surgery, and expansion sphincter pharyngoplasty. STUDY DESIGN: Retrospective cohort. SETTING: Tertiary care center. METHODS: Patients were included who were aged ≥18 years old and underwent upper airway stimulation, transoral robotic surgery, or expansion sphincter pharyngoplasty between January 2011 and May 2020. RESULTS: 345 patients were identified: 58% (n = 201) underwent upper airway stimulation, 10% (n = 35) underwent transoral robotic surgery, and 32% (n = 109) patients underwent expansion sphincter pharyngoplasty. There were 22 emergency department presentations and 19 readmissions, most of which were experienced by patients receiving transoral robotic surgery (six emergencies, seven readmissions) and expansion sphincter pharyngoplasty (12 emergencies, 11 readmissions). Patients with upper airway stimulation had four emergencies and one readmission. Only 2% of the upper airway stimulation cohort had a complication, whereas this was 20% and 12% for the transoral robotic surgery and expansion sphincter pharyngoplasty cohorts, respectively. Patients experienced the highest surgical success rate with upper airway stimulation (69%), whereas patients who received transoral robotic surgery and expansion sphincter pharyngoplasty had success rates of 50% and 51%, respectively. CONCLUSION: Treating obstructive sleep apnea with upper airway stimulation led to lower rates of complications, emergency department presentations, and readmissions in this series. In those for whom upper airway stimulation is appropriate, it may be more effective in successfully treating obstructive sleep apnea than transoral robotic surgery and expansion sphincter pharyngoplasty.

Preferential use of total intravenous anesthesia in ambulatory otolaryngology surgery during the COVID-19 pandemic.

The novel coronavirus (SARS-CoV-2 or COVID-19) pandemic has impacted nearly every aspect of otolaryngologic practice. The transition from office-based evaluation to telemedicine and the number of postponed elective surgical cases is unprecedented. There is a significant need to resume elective surgical care for these patients at the appropriate time. As practices begin to move towards resuming elective and same day ambulatory surgery, safety of both the patient and healthcare team is of paramount importance. Usage of total intravenous anesthesia (propofol and remifentanil) over volatile gas anesthesia (e.g., sevoflurane) may increase the number of patients able to safely receive care by reducing potential spread of the virus through reduction in coughing and significantly decreasing the time spent in the recovery room.

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.

Open vs. endoscopic cricopharyngeal myotomy; Is there a difference?

INTRODUCTION: The upper esophageal sphincter (UES) is composed largely of the cricopharyngeus muscle (CP) and acts as the gatekeeper to the esophagus. There are multiple methods of treating UES dysfunction, but myotomy has been shown to be the most definitive means. We aim to evaluate the difference between open and endoscopic CP myotomy (CPM). METHODS: A retrospective review of all patients undergoing endoscopic and open CPM was undertaken. We recorded demographic, clinical, operative, hospital, and postoperative data for both groups from January 2010-March 2015. The endoscopic and open CPM groups were directly compared. RESULTS: Our cohort consisted of 38 open and 41 endoscopic CPM patients. There were 22 males and 16 females in the open group and 9 males and 32 females in the endoscopic group. The primary diagnosis for both groups was cricopharyngeal hyperfunction. We found a significant improvement in surgical time and symptomatic outcomes in the endoscopic group (p=0.008 and p=0.010). There was no difference in UES preop pressure, hospital stay, complication rate, time to oral intake, or length of follow-up between cohorts. CONCLUSION: Endoscopic CPM is a safe and effective alternative to the open approach. Patients undergoing endoscopic CPM have shorter operative times and improved outcomes when compared to the open approach.

Long-Term Outcomes in Patients With Trisomy 21 and Obstructive Sleep Apnea.

OBJECTIVE: To better understand the long-term health implications of obstructive sleep apnea (OSA) on patients with Trisomy 21 (T21) and the role of sleep surgery as a therapeutic intervention. STUDY DESIGN: Retrospective large database review. SETTING: The prevalence of OSA is as high as 75% in patients with T21. We sought to examine the cardiovascular, neurological, and endocrinological outcomes of patients with T21 10 years after their diagnosis of OSA. METHODS: TriNetX, an electronic medical record database, was queried for health outcomes in patients with T21 after diagnosis of OSA. The group was further analyzed to identify those who underwent sleep surgery, including hypoglossal nerve stimulation, palatopharyngoplasty, or adenotonsillectomy. RESULTS: Ten years after diagnosis, patients with OSA and T21 had a significantly higher incidence of death, myocardial infarction, cerebral infarction, heart failure, cardiac arrhythmia, ischemic heart disease, atrial fibrillation, essential hypertension, pulmonary hypertension, diabetes mellitus, and Alzheimer's disease compared to patients with T21 alone. Patients with OSA and T21 who underwent sleep surgery had significantly reduced incidence of adverse health outcomes compared to patients using continuous positive airway pressure. CONCLUSION: Our findings suggest that patients with T21 and OSA are at higher risk of poor health outcomes, which may require closer monitoring for earlier diagnosis and management of comorbid conditions. Sleep surgery is a suitable treatment modality for mitigating the risk of adverse outcomes in this population and should be considered in patients who are eligible surgical candidates.

Troubleshooting Upper Airway Stimulation Therapy Using Drug-Induced Sleep Endoscopy.

OBJECTIVE: This study assesses the utility of drug-induced sleep endoscopy (DISE) in guiding further treatment for patients with obstructive sleep apnea (OSA) who have difficulty tolerating upper airway stimulation (UAS) or have inadequate response to therapy. STUDY DESIGN: We conducted a retrospective analysis of UAS patients at our institution who underwent DISE, post-UAS, and evaluated the efficacy of different electrode configurations and maneuvers. SETTING: A tertiary care hospital. METHODS: Out of 379 patients who received UAS therapy, 34 patients who underwent DISE post-UAS (DISE-UAS) were included. Palatal coupling (PC) was assessed with UAS stimulation alone, jaw thrust alone, and both simultaneously during DISE. RESULTS: Among 34 patients, 5 had suboptimal adherence to UAS therapy, 19 had suboptimal therapy efficacy with residual OSA burden, and 10 had both. During DISE-UAS, PC was observed in 7 patients (21%) with UAS stimulation alone, 9 patients (26%) with jaw thrust alone, and 8 patients (24%) with both maneuvers combined. Notably, 10 patients (29%) did not exhibit PC with any maneuver. Based on DISE-UAS findings, 13 patients were recommended oral appliance therapy (OAT), and 8 patients underwent further surgical interventions. CONCLUSION: DISE-UAS is a valuable adjunct in troubleshooting UAS therapy for patients intolerant to CPAP or with suboptimal therapy efficacy. This study provides an algorithm for targeted multimodality therapy based on DISE findings, facilitating personalized management approaches.

Evaluating insomnia queries from an artificial intelligence chatbot for patient education.

STUDY OBJECTIVES: We evaluated the accuracy of ChatGPT in addressing insomnia-related queries for patient education and assessed ChatGPT's ability to provide varied responses based on differing prompting scenarios. METHODS: Four identical sets of 20 insomnia-related queries were posed to ChatGPT. Each set differed by the context in which ChatGPT was prompted: no prompt, patient-centered, physician-centered, and with references and statistics. Responses were reviewed by 2 academic sleep surgeons, 1 academic sleep medicine physician, and 2 sleep medicine fellows across 4 domains: clinical accuracy, prompt adherence, referencing, and statistical precision, using a binary grading system. Flesch-Kincaid grade-level scores were calculated to estimate the grade level of the responses, with statistical differences between prompts analyzed via analysis of variance and Tukey's test. Interrater reliability was calculated using Fleiss's kappa. RESULTS: The study revealed significant variations in the Flesch-Kincaid grade-level scores across 4 prompts: unprompted (13.2 ± 2.2), patient-centered (8.1 ± 1.9), physician-centered (15.4 ± 2.8), and with references and statistics (17.3 ± 2.3, P < .001). Despite poor Fleiss kappa scores, indicating low interrater reliability for clinical accuracy and relevance, all evaluators agreed that the majority of ChatGPT's responses were clinically accurate, with the highest variability on Form 4. The responses were also uniformly relevant to the given prompts (100% agreement). Eighty percent of the references ChatGPT cited were verified as both real and relevant, and only 25% of cited statistics were corroborated within referenced articles. CONCLUSIONS: ChatGPT can be used to generate clinically accurate responses to insomnia-related inquiries. CITATION: Alapati R, Campbell D, Molin N, et al. Evaluating insomnia queries from an artificial intelligence chatbot for patient education. J Clin Sleep Med. 2024;20(4):583-594.

How we measure hypoglossal nerve stimulator outcome matters: titration versus single amplitude efficacy sleep studies.

STUDY OBJECTIVES: Hypoglossal nerve stimulation (HGNS) is a common treatment for obstructive sleep apnea (OSA). Objective assessment of HGNS efficacy measures apnea-hypopnea index (AHI) by multi-amplitude titration polysomnography (tPSG) and/or a single amplitude efficacy sleep study (eHST). Both tests have been used to determine efficacy despite significantly different protocols. This project's aim was to determine differences in objective outcomes in HGNS patients who underwent both tPSG and eHST post-operatively. METHODS: Data from 379 consecutive HGNS patients were retrospectively reviewed. Inclusion requirements were a pre-operative sleep study, a post-operative tPSG, and then an eHST, which at our institution is a type 3 home study. AHI mean and differences were calculated. Wilcoxon rank sum tests were used to analyze differences between tPSG and eHST. Sher15 criteria (post-operative AHI≤15 events/hour and ≥50% reduction from baseline) was calculated and compared by χ2 tests. RESULTS: Ultimately 61 patients met inclusion criteria with an average pre-operative AHI=33.2. When comparing the subject's tPSG versus eHST, tPSG AHI was significantly lower (AHI=8.8 versus AHI=17.6; respectively, p<0.001). There was also a difference in the percentage of patients that met Sher15 criteria when using tPSG (80.3%) versus eHST AHI (45.9%). CONCLUSIONS: HGNS patient's postoperative tPSG AHI was significantly lower than their eHST outcome. This work highlights the importance of reporting the type of post-operative study used in evaluating HGNS efficacy and the need for single amplitude, full-night studies to assess HGNS efficacy more accurately.

Comparing cadaveric and 3D-printed laryngeal models in transcutaneous injection laryngoplasty.

Background: There is increasing focus on the development of high-quality simulation models for medical education. Cadaveric models, although considered more realistic, may be difficult to obtain and costly. The advent of three-dimensional (3D) printing has offered a low-cost, reliable, and reproducible alternative. This study sought to compare the utility of 3D-printed to cadaveric models for training in transcutaneous injection laryngoplasty (TIL). Methods: A simulation course with a cross-over design was employed. Video laryngoscopes were utilized for both the 3D and cadaveric models to assess the accuracy of injection into the vocal fold. Pre-procedure and post-procedure surveys were administered to evaluate understanding and comfort level on a Likert scale of 1-10. Each model was also rated on a 1-5 Likert scale for self-efficacy, fidelity, and educational value. Results: Pre- and post-survey data were completed by 15 otolaryngology residents and medical students. Mean pre-seminar understanding and comfort level were 3.7 and 2.2, respectively, compared to 6.9 and 5.9 (p < .05) following use of the 3D model and 6.4 and 4.7 (p < .05) following use of the cadaver model. When comparing 3D and cadaveric models, no significant differences were observed regarding self-efficacy, fidelity, and educational value. Conclusion: There was a similar mean increase in understanding and comfort following use of the 3D and cadaveric models. 3D-printing can provide an excellent adjunct to, and eventually a potential replacement for hands-on cadaveric training in medical education, particularly for TIL. Level of Evidence: Level III.

The relationship between positive airway pressure tolerance and adherence: defining a new metric.

STUDY OBJECTIVES: Positive airway pressure (PAP) therapy adherence rates range from 30% to 60%, yet adherent patients may still express dissatisfaction with treatment. The identification of factors affecting PAP tolerance could provide insight into its impact on adherence. METHODS: Patients with obstructive sleep apnea presenting for first follow-up visit after newly initiating PAP therapy were given a 10-question PAP tolerance survey encompassing domains of psychosocial perception, practical issues, and side effects, utilizing 10-point visual analog scales. Relationships between adherence data, tolerance scores, and patient variables (demographics, sleep-related factors, comorbidities, usage data) were explored via 2-tailed t tests, multivariable regression analysis, and recursive partitioning regression trees with a significance level of P ≤ .05. RESULTS: For 105 patients, tolerance scores were higher in patients considered adherent to therapy (P = .033), as were scores for individual survey questions addressing the ability to fall asleep (P = .013) and sleep through the night (P = .020). Depression positively (P = .006) and insomnia medication use negatively (P = .010) predicted tolerance score. Data-driven tolerance score cutoffs were identified to correlate with PAP adherence, with higher tolerance scores correlating with greater adherence rates. CONCLUSIONS: PAP tolerance may play an important role in therapy adherence. Tolerance can be statistically defined and categorized based on prior adherence data. Its utility as a predictive tool in assessing future adherence is warranted. CITATION: Tekumalla S, Plawecki A, Kaffenberger T, et al. The relationship between positive airway pressure tolerance and adherence: defining a new metric. J Clin Sleep Med. 2024;20(7):1033-1038.

Prednisone Decreases Opioid Use in Adults Undergoing Benign Oropharyngeal Surgery.

OBJECTIVE: This study sought to analyze the efficacy and safety of postoperative prednisone to reduce reliance on opioids in adult benign oropharyngeal surgery. STUDY DESIGN: Prospective cohort study. SETTING: Single tertiary-care facility. METHODS: Patients undergoing tonsillectomy (T), tonsillectomy and adenoidectomy (T&A), and/or modified uvulopalatopharyngoplasty (UPPP) from December 2020 to January 2023 received the standard of care postoperative management. A prednisone taper was dependent on surgeon preference. Cohorts were based on the prescription of postoperative steroids. Patients completed a survey to assess opioid usage, pain scores, and steroid compliance. RESULTS: Seventy-two patients were included. The nonsteroid cohort (N = 29) received an average of 467 ± 94.1 morphine milligram equivalents (MME), and the steroid cohort (N = 43) received an average of 285 ± 128 MME (P < 0.001). The nonsteroid cohort consumed 1.62 times more opioids than the steroid cohort (P < 0.002). There were no significant differences in complication or refill rates between treatment groups. There were no significant differences in pain scores on the day of surgery or postoperative days 1, 5, or 10 (P = 0.34, P = 0.66, P = 0.62, and P = 0.22, respectively). Patients undergoing T&A (p = 0.019) or who had current psychiatric medication use (P < 0.006) consumed significantly more opioids. Patients who received a total opioid prescription of >300 MME (40 5-mL doses of 5 mg/5 mL liquid oxycodone) consumed 2.27 times more postoperative opioids than patients with opioid prescriptions ≤300 MME (P < 0.001). CONCLUSION: Patients who did not receive steroids consumed 1.62 times more postoperative opioids compared to those who completed a steroid taper. Corticosteroid use was not associated with changes in pain scores, refill rates, or complication rates and may be considered in a multimodal approach to pain management in adults undergoing benign oropharyngeal surgery, although further study is warranted.

Safety of Ambulatory Surgery For Obstructive Sleep Apnea: A Retrospective Review.

OBJECTIVE: Assess the safety of ambulatory surgery performed for obstructive sleep apnea. STUDY DESIGN: Retrospective chart review. SETTING: Tertiary care hospital. METHODS: Demographic data including age, gender, race, body mass index, insurance status, socioeconomic status, and distance traveled for surgery was collected, as well as comorbidities, and apnea-hypopnea index (AHI). Outcome variables included continuous positive airway pressure reinitiation, planned/unplanned postoperative admission, emergency department (ED) presentation, or readmission within 7 and 14 days of surgery. RESULTS: A total of 601 patients were included, who underwent sleep surgery between 2017 and 2022. The median age was 55 years [interquartile range: 19]. A total of 437 patients (73%) were male, 502 (84%) were Caucasian, and the median distance traveled was 20 miles [27]. The median AHI was 27.1 [26]. A total of 286 hypoglossal nerve stimulators, 12 tonsillectomies, 160 expansion sphincteroplasties (ESP), and 201 nasal procedures were performed. There were 9 (1%) planned and 23 (4%) total admissions postoperatively. Sixteen patients (2%) presented to ED within 7 days, and 22 (3%) within 14 days. Nine (1%) were readmitted within 7 days, and 12 (2%) within 14 days. There were significantly more planned admissions, unplanned admissions, ED presentations, and readmissions for ESP. There were no significant differences in demographic or clinical data between patients who underwent single versus multiple surgeries. CONCLUSION: Outpatient sleep surgery is generally safe. Close postoperative monitoring is necessary and overnight observation should be considered in those with very severe sleep apnea and/or significant comorbidities. The distance a patient travels should also be considered for overnight admission.

Transoral Robotic Surgery Versus Hypoglossal Nerve Stimulation for OSA: A Cost Analysis Study.

BACKGROUND: Transoral robotic surgery (TORS) lingual tonsillectomy and hypoglossal nerve stimulation (HGNS) are effective surgical interventions for well-selected patients with obstructive sleep apnea (OSA) intolerant to continuous positive airway pressure (CPAP) therapy. Previous publications have demonstrated that HGNS patients have a lower postoperative apnea-hypopnea index (AHI) and length of hospital stay than TORS patients. No prior study has investigated the differences in costs between HGNS and TORS. OBJECTIVES: This study aims to compare surgery-related costs in patients undergoing HGNS versus TORS lingual tonsillectomy for OSA intolerant to CPAP. METHODS: A retrospective study on OSA patients intolerant to CPAP that underwent HGNS or TORS from 2015 to 2022 at a tertiary care center. Cost was defined as the dollar amount associated with providing a specific service prior to the application of insurance. RESULTS: This study included 395 patients (375 UAS and 20 TORS). Average total cost was significantly higher in the UAS group than the TORS group (UAS: $25,582.60; TORS: $5832.60; p < 0.001). Operating room costs were also significantly higher in the UAS group (UAS: $1978.20; TORS: $1490.90; p = 0.001). The TORS cohort averaged higher costs for pharmacy (UAS: $201.30; TORS: $416.60; p < 0.001) and anesthesia (UAS: $139.00; TORS: $307.60; p < 0.001). DISCUSSION: The total cost was significantly higher in the UAS group compared to the TORS group. When making management decisions, it is important to consider the cost of care provided as well as patient-centered outcomes to optimize the value of care. LEVEL OF EVIDENCE: N/A Laryngoscope, 2024.

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.

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.

Analysis of Recent Sleep Surgery Fellowship Training.

OBJECTIVE: Since 2011, otolaryngologists aiming to become certified in sleep medicine have had to complete an ACGME accredited sleep medicine fellowship. In addition to standard sleep medicine and sleep surgery fellowships, several institutions have developed hybrid ACGME sleep medicine programs that incorporate sleep surgery training. Our primary aims were to understand the balance between sleep medicine and surgical training requirements and the surgical volume of recent graduates across the three pathways. Our secondary aim was to assess their employment post-graduation. An improved understanding of the current state of sleep surgeon training could better inform both applicants and programs and be used to guide fellowship curriculum development. METHODS: Between 2017 and 2023, we identified 26 surgeons who completed a sleep focused fellowship. An anonymous survey was developed and emailed to them. The survey assessed clinic and operating balance, procedures completed during fellowship, and comfort with these procedures as attendings. Finally, the survey assessed the job prospects of graduates. Data were analyzed with Prism 10. RESULTS: There were 19 respondents with 52.6% completing a hybrid fellowship, 21.3% completing a sleep medicine fellowship, and 31.6% completing a sleep surgery fellowship. Approximately 84.8% completed ACGME accredited otolaryngology training prior to fellowship. The three most common surgeries were hypoglossal nerve stimulators, pharyngoplasty, and nasal surgeries. Respondents on average received 2.4 job offers, 55% returned to their residency institution, and 89.5% were in academics. CONCLUSION: Our survey demonstrates a wide variability in sleep-focused fellowships for surgeons, but the employment market for these trainees is robust. LEVEL OF EVIDENCE: N/A Laryngoscope, 2024.

Comparison of CPAP and Expansion Sphincter Pharyngoplasty using the Mean Disease Alleviation Concept.

OBJECTIVE: Continuous Positive Airway Pressure (CPAP) is the typical first treatment for Obstructive Sleep Apnea (OSA); however, patient adherence is often suboptimal. Expansion Sphincter Pharyngoplasty (ESP) is an alternative treatment option for patients with OSA who demonstrate signs of palatal and lateral pharyngeal collapse. The aim of this study is to compare therapeutic outcomes, using the mean disease alleviation concept, for patients who underwent ESP to patients undergoing CPAP therapy. DATA SOURCES: Single-institution retrospective cohort study. METHODS: All patients who underwent ESP from 2018 to 2021 or were prescribed CPAP from December to June 2021 at our institution were assessed for inclusion. ESP patients who had pre- and post-operative sleep studies available and CPAP patients who followed up at our institution's sleep clinic were included for analysis. Charts were reviewed for demographic information and sleep study results, and treatment outcomes were measured by calculating mean disease alleviation. RESULTS: There were 77 patients in the ESP group and 107 patients in the CPAP group. AHI reduction was greater in the CPAP group (p = 0.016); however, mean disease alleviation was similar between groups (p = 0.076). One-way ANCOVA demonstrated similar MDA between groups when controlling for patient age, BMI, gender, and pre-operative AHI (F [1,177] = 2,931.6, p = 0.104). CONCLUSION: CPAP therapy provided superior reduction in AHI compared to ESP; however, overall treatment efficacy as measured by mean disease alleviation was similar for both groups. LEVEL OF EVIDENCE: 3 Laryngoscope, 133:1513-1517, 2023.