Cancer Risk Associated with Continuous Positive Airway Pressure: A National Study.

OBJECTIVE: In 2021 the U.S. FDA issued a Class 1 safety recall notice for specific devices due to a risk of carcinogen exposure. The objective of this study was to evaluate reports of cancer linked to CPAP devices to understand implications for the field of sleep medicine. METHODS: Cases of cancer involving CPAP devices were retrieved from the MAUDE database from 2014 to 2021 and analyzed with descriptive statistics. RESULTS: A total of 2571 patient injuries were associated with CPAP. Reports of cancer (n = 209; 4.62%) were the second most commonly documented patient problem associated with CPAP, although 1950 (43.13%) patients had a device problem without an associated injury. Of the 209 cancer cases associated with CPAP, 200 (95.7%) of the adverse event reports were received by the FDA in 2021. There were 174 (9.15%) descriptions of the CPAP polyurethane sound abatement foam degrading in association with a cancer diagnosis, but degradation was more commonly not associated with malignancy (n = 1728; 90.85%). Other frequently documented CPAP device problems included broken devices (n = 279; 6.92%), fire (n = 182; 4.51%), and patient-device incompatibility (n = 144; 3.57%). CONCLUSION: Malignancy associated with CPAP devices has been reported; however, future studies are required to establish causation. Given 95.7% of those documented cases were reported in 2021, otolaryngologists should be prepared to discuss the risks of carcinogenesis associated with CPAP. The otolaryngology community should also be aware of the potential bandwagon effect and the implications for CPAP compliance. LEVEL OF EVIDENCE: 4 Laryngoscope, 132:2270-2274, 2022.

Considerations and Management of a Laryngeal Fracture after Sneezing.

Non-traumatic laryngeal fracture is uncommon but should be suspected whenever patients present with dysphonia, odynophagia, dysphagia, neck crepitus, or hemoptysis following a sneeze or coughing episode. Physical examination coupled with computed tomography is essential for making the diagnosis. Management can vary depending on the severity of the case, but the general approach is similar to any trauma. In this report, we describe a non-traumatic laryngeal fracture that occurred following a forceful sneeze. The case was notable for the presence of pneumomediastinum, independent mobility of the thyroid ala, and operative intervention was pursued to repair the fracture.

Upper Airway Stimulation versus Untreated Comparators in Positive Airway Pressure Treatment-Refractory Obstructive Sleep Apnea.

Rationale: Understand the impact of insurance coverage on sleep apnea outcomes for patients awaiting upper airway stimulation.Objectives: Examine the natural history of impact of upper airway stimulation treatment versus insurance denial (comparators) on sleep apnea outcomes.Methods: A parallel-arm experimental study design was used to compare objective sleep apnea measures and patient-reported outcomes in those who received upper airway stimulation approval versus denial in a multinational prospective study (NCT02907398). Wilcoxon rank-sum test and logistic regression models were used to assess for differences of objective and subjective outcome changes in those who underwent upper airway stimulation versus no treatment comparators.Results: A greater reduction in apnea-hypopnea index was observed in those who underwent upper airway stimulation (n = 230, follow-up: 360 ± 171 d) versus no treatment (n = 100, follow-up: 272 ± 278 d), that is, -19.1 ± 15.8 versus -8.1 ± 20.9, respectively, P < 0.001, with consistent findings observed with nocturnal hypoxia measures. Concordantly, a greater improvement noted with subjective measures of dozing propensity was observed in patients undergoing upper airway stimulation versus comparators (Epworth Score, -5.1 ± 5.5 vs. 1.8 ± 3.7, respectively, P < 0.001) and overall sleep-related patient-reported outcomes. Women and those with previous oral appliance use had a lower odds of insurance approval (odds ratio [OR], 0.40; 95% confidence interval [95% CI], 0.22-0.71 and OR, 0.35; 95% CI, 0.18-0.69, respectively).Conclusions: Objective and subjective sleep apnea burden was more improved in those receiving upper airway stimulation versus not. Results underscore the need to optimize clinical care pathways focused on effective treatment of patients with obstructive sleep apnea who are not upper airway stimulation-insurance eligible and prioritize public health policy initiatives to address insurance-based sex-specific disparities.

The practicality of a two-incision surgical approach for hypoglossal nerve stimulator implantation.

INTRODUCTION: Determine the feasibility of a two-incision surgical approach to hypoglossal nerve stimulator implantation based on anatomic considerations. METHODS: Upper airway stimulation (UAS) using the Inspire system uses three implanted devices-the implantable pulse generator (IPG), stimulation lead and sensing chest wall lead. The traditional surgical approach requires three skin incisions located on the submandibular neck, anterosuperior chest wall and inferolateral chest wall. Our surgical team sought to determine the anatomic considerations of combining the two chest wall incisions into one. In order to minimize morbidity and reduce operative time, the chest wall sensing lead was placed posterolateral to the IPG site via the same incision. RESULTS: Using an adult cadaver for anatomical analysis, access to the third and fourth intercostal spaces was made more difficult by the pectoralis major humeral head and upper arm. The intercostal space was narrower, the musculature along the anterior axillary line and anterior chest wall was devoid of the innermost intercostal muscle group found more laterally. Furthermore, there were much thinner external and internal intercostal muscle components as they transitioned to a membranous layer anteriorly in comparison to the inferolateral chest wall. CONCLUSION: Lack of the innermost intercostal muscle and thinning of the external and internal intercostal muscles lateral to the IPG site leaves little barrier between the thoracic musculature and parietal pleural increasing the risk of complications such as pleurisy and pneumothorax. Given the anatomical findings, a two-incision surgical approach for UAS therapy is at higher risk for complications.

Reconfiguration of Upper Airway Stimulation Devices Utilizing Awake Endoscopy.

OBJECTIVES: Determine the rates of, reasons for, and effectiveness of device reprogramming utilizing in-office awake endoscopy (AE) in subjects who underwent upper airway stimulation (UAS) surgery. STUDY DESIGN: Retrospective chart review. METHODS: Retrospective chart review at a tertiary care center on patients implanted with UAS devices from November 2015 to July 2018. RESULTS: Sixty patients were implanted with UAS devices. Average pre- and postsurgical total apnea-hypopnea index (AHI) was 40.6 and 4.2 with a 36.4 total AHI reduction. Treatment success based on Sher criteria was observed in 88% of patients. Postoperative titration polysomnography revealed an average functional threshold (FT) and minimum therapeutic amplitude (MTA) of 1.6 and 2.1 V, respectively. A total of 24 AEs were performed in 19 (32%) patients. The most common complaints and reasons for AE were perceived stimulus discomfort (42%), frequent awakenings (32%), and persistent fatigue or non-normalized AHI (21%). After first AE, there was a 0.87 (53%) and 0.93 (45%) V reduction in FT and MTA, respectively. CONCLUSION: Patients with obstructive sleep apnea continue to succeed with UAS. Fewer than one-third of patients had postsurgical complaints requiring device reconfiguration utilizing AE to assess the pharyngeal airway and optimize device settings. Reduction in the FT and MTA after AE may improve compliance by reducing discomfort and frequent awakenings. Periodic monitoring of patients with implanted UAS devices is necessary to optimize efficacy and maintain patient compliance. LEVEL OF EVIDENCE: 4 Laryngoscope, 130:2494-2498, 2020.

Preoperative Predictors of Response to Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea.

OBJECTIVE: Hypoglossal nerve stimulation (HGNS) is an effective treatment for patients with obstructive sleep apnea (OSA) who fail continuous positive airway pressure (CPAP). We assessed the relationship between patient characteristics and response to HGNS. STUDY DESIGN: Retrospective cohort study. SETTING: Single tertiary care institution. SUBJECTS AND METHODS: This study included CPAP-intolerant patients with moderate to severe OSA after HGNS system implantation from November 2015 to December 2017. Patient measures, drug-induced sleep endoscopy (DISE) findings, and apnea-hypopnea indices (AHIs) were recorded. RESULTS: Forty-eight patients underwent implantation with the following median measures: age, 66 years; body mass index, 28.6; and neck circumference, 41.0 cm. Patients were classified by Friedman tongue position (II, 27%; III, 56%; IV, 17%) and Mallampati grade (I, 25%; II, 50%; III, 23%; IV, 2%). By DISE, 71% had anterior-posterior palatal collapse. Additionally, 38% had lateral oropharynx collapse; 50%, tongue base collapse; and 27%, epiglottis collapse. Following implantation, median AHI improved from 38.5 to 2.7 (P < .001), and 92% of patients had no worse than mild OSA (8% moderate). Patients with Friedman tongue position grade II/III experienced greater change in AHI as compared with grade IV (94.2% vs 73.8%, P < .001). Patients with Mallampati score I/II experienced greater improvement versus score III/IV (94.7% vs 66.5%, P < .001). No DISE findings, including any obstruction or collapse, were associated with change in AHI. CONCLUSION: This study further confirms HGNS as an effective treatment of CPAP-intolerant OSA. Office measures such as Friedman tongue position IV and Mallampati III/IV were associated with mildly decreased response. DISE findings were not associated with patient response.

Uvulopalatopharyngoplasty vs CN XII stimulation for treatment of obstructive sleep apnea: A single institution experience.

OBJECTIVES: Hypoglossal nerve stimulation (HNS) therapy is an emerging surgical treatment for select patients with obstructive sleep apnea (OSA). This study aims to compare outcomes in patients with moderate to severe OSA who underwent HNS surgery (Inspire Medical Systems) and those who underwent traditional airway reconstructive surgery, specifically uvulopalatopharyngoplasty (UPPP). METHODS: Patients who underwent HNS implantation (n = 20), all with moderate to severe OSA, inability to adhere to positive pressure therapy, and compliant with previously published inclusion criteria, were compared to a historical cohort that were intolerant of CPAP with similar inclusion criteria who all underwent UPPP (n = 20) with some also undergoing additional procedures such as septoplasty/turbinate reduction. Data including body mass index (BMI), pre- and post-implant apnea-hypopnea index (AHI) were assessed. RESULTS: For patients who underwent HNS, mean preoperative BMI was 28.0. Mean AHI decreased significantly from 38.9 ±â€¯12.5 to 4.5 ±â€¯4.8. All patients achieved an AHI < 20 post implant with 65% (13/20) with an AHI ≤ 5. For patients who underwent traditional airway surgery, mean preoperative BMI was 27.5; mean AHI decreased from 40.3 ±â€¯12.4 to 28.8 ±â€¯25.4. CONCLUSION: While both traditional surgery and HNS are effective treatments for patients with moderate to severe OSA with CPAP intolerance, our study demonstrates that HNS is "curative" in normalizing the AHI to <5 in the majority of patients. For select patients, HNS therapy provides excellent objective improvement in outcome measures.

Voice and swallowing outcomes following hypoglossal nerve stimulation for obstructive sleep apnea.

OBJECTIVE: Hypoglossal nerve stimulation is an effective treatment for a subset of patients with Obstructive Sleep Apnea (OSA). Although multiple clinical trials demonstrate its efficacy, no previous literature explores the potential impact the stimulator has on swallowing and voice. Our primary objective is to evaluate patient reported post-operative changes in voice or swallowing following hypoglossal nerve stimulator placement. STUDY DESIGN: Prospective cohort study. SETTING: Tertiary care hospital. SUBJECT AND METHODS: Patients scheduled to receive a hypoglossal stimulator were enrolled. Participants completed baseline Voice Handicap Index-10 (VHI-10) and Eating Assessment Tool-10 (EAT-10) questionnaires preoperatively and again at 1week, 3months, and 6months post-operatively following placement of a hypoglossal nerve stimulator. RESULTS: 9 males and 5 females completed the study. The mean pre-operative VHI-10 and EAT-10 score was 3 and 0.8 respectively. Using linear mixed models, a clinically and statistically significant increase in the mean EAT-10 score was observed post-operatively at 1week (p=0.007), which was not observed at the time points the stimulator was active. A clinically and statistically significant decrease in VHI-10 score was observed following 2months of active stimulator use (p=0.02), which was not observed at any other time point. CONCLUSION: The implantation and use of the hypoglossal nerve stimulator over 5months did not demonstrate any sustained, patient reported changes in voice handicap and swallowing function. While larger studies are warranted, our findings can be used to provide further informed consent for hypoglossal nerve stimulator implantation.

Healthcare usage after uvulopalatopharyngoplasty - Impact of analgesic regimen.

OUTCOME OBJECTIVES: 1) Analyze differences in healthcare usage between subjects receiving different perioperative analgesic medications after uvulopalatopharyngoplasty (UPPP) surgery. 2) Comment on the impact of perioperative analgesic medication on length of hospital stay and complications after UPPP. METHODS: A retrospective cohort study of 120 UPPPs conducted by a single surgeon in the past 5years was conducted. Subjects were grouped based on perioperative pain medication regimen into three groups; narcotics alone (n=83), narcotics with gabapentin (n=27), or narcotics with ketorolac tromethamine (n=10). The primary outcome variable was total number of clinic/emergency room and/or telephone encounters related to post-UPPP pain. Secondary outcomes included length of post-operative hospital stay, number of telephone and/or clinical encounters in which the patient complained specifically of pain or requested a refill for analgesics, and post-operative complications. RESULTS: No significant difference was found between the three analgesic regimens in post-operative hospital stay length (p=0.28, median stay 23.5h), number of clinic or telephone encounters related to pain (p=0.26, mean value 0.71 encounters), or post-operative complication rate (p=0.82, 5.9% complication rate). CONCLUSION: This study shows no significant difference in post-operative healthcare usage between patients with peri-operative analgesic regimens including narcotics alone, gabapentin with narcotics, or ketorolac with narcotics. Post-operative complication rate and length of stay did not differ between groups. These data suggest that these three medication regimens have similar impact on post-operative course for UPPP patients. Therefore, the most affordable or simplest options have equivalent effects on post-operative healthcare usage.

Variability of Ratings in the Otolaryngology Standardized Letter of Recommendation.

OBJECTIVE: To determine the variability of ratings given to students on the otolaryngology standardized letter of recommendation (SLOR). STUDY DESIGN: Retrospective review. SETTING: Academic otolaryngology training program. SUBJECTS AND METHODS: 496 SLORs to the Cleveland Clinic Otolaryngology Training Program were reviewed. The SLORs were extracted from the applications and analyzed. The distributions of ratings across the 10 categories were statistically analyzed including distribution and standard deviation. Rankings were grouped into deciles for this analysis. RESULTS: Ratings across the 10 domains revealed clustering of results across the top 2 deciles. The distribution of the bell-shaped curve was shifted significantly to the left, representing the upper deciles. No evidence of gender or geographic bias was found. Longer length of time of association between the applicant and the letter writer correlated to a higher ranking. CONCLUSION: The explosion of applications being sent out by candidates for otolaryngology residency programs has prompted the implementation of the SLOR. The lack of variation in the ratings across the 10 domains does not allow for differentiation among student applicants. Reliance on the narrative letter of recommendation attached to the SLOR still remains the most significant way to differentiate among applicants. Refinements will need to be made in either the structure or use of the SLOR for it to be a more useful tool.