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

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

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

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

Home Sleep Testing versus Traditional Polysomnography: Pros and Cons.

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

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

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

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

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

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

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

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

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

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

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

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

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

Snapshot Impact of COVID-19 on Mental Wellness in Nonphysician Otolaryngology Health Care Workers: A National Study.

OBJECTIVE: Nonphysician health care workers are involved in high-risk patient care during the COVID-19 pandemic, placing them at high risk of mental health burden. The mental health impact of COVID-19 in this crucial population has not been studied thus far. Thus, the objective of this study is to assess the psychosocial well-being of these providers. STUDY DESIGN: National cross-sectional online survey (no control group). SETTING: Academic otolaryngology programs in the United States. SUBJECTS AND METHODS: We distributed a survey to nonphysician health care workers in otolaryngology departments across the United States. The survey incorporated a variety of validated mental health assessment tools to measure participant burnout (Mini-Z assessment), anxiety (Generalized Anxiety Disorder-7), distress (Impact of Event Scale), and depression (Patient Health Questionnaire-2). Multivariable logistic regression analysis was performed to determine predictive factors associated with these mental health outcomes. RESULTS: We received 347 survey responses: 248 (71.5%) nurses, 63 (18.2%) administrative staff, and 36 (10.4%) advanced practice providers. A total of 104 (30.0%) respondents reported symptoms of burnout; 241 (69.5%), symptoms of anxiety; 292 (84.1%), symptoms of at least mild distress; and 79 (22.8%), symptoms of depression. Upon further analysis, development of these symptoms was associated with factors such as occupation, practice setting, and case load. CONCLUSION: Frontline otolaryngology health care providers exhibit high rates of mental health complications, particularly anxiety and distress, in the wake of COVID-19. Adequate support systems must be put into place to address these issues.

History and Acceptance of Transoral Robotic Surgery.

The development and acceptance of transoral robotic surgery from an experimental procedure to widespread acceptance in the management of head and neck cancers and other disease states occurred over the course of about a decade, from 2005 to 2015. Transoral robotic surgery has cemented its' place in the treatment of pharyngeal and laryngeal cancer. Education and training was key to broad use and acceptance. This article traces the history and evolution of transoral robotic surgery to its current practice. The process of surgical innovation in this arena is followed from early cadaveric studies to recent large systemic reviews of outcomes.

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.

Base of Tongue Surgery for Obstructive Sleep Apnea in the Era of Neurostimulation.

Retroglossal collapse is commonly seen in patients with obstructive sleep apnea. The role of upper airway stimulation surgery for these patients continues to evolve. However, base of tongue reduction surgery continues to have usefulness for appropriately selected patients with obstructive sleep apnea. Specific tongue base approaches may vary in response to patient and surgeon preferences and be used in multilevel surgery where appropriate. Key factors include patient age, willingness to undergo device implantation, and preferences for outpatient versus inpatient procedure, single procedure versus multiple, and tolerance for various procedure-specific postoperative restrictions and potential complications.

Upper airway stimulation therapy and sleep architecture in patients with obstructive sleep apnea.

OBJECTIVES/HYPOTHESIS: To quantify changes in sleep architecture before and after upper airway stimulation (UAS) therapy in patients with obstructive sleep apnea. STUDY DESIGN: Retrospective chart review. METHODS: This study was performed at a single-institution tertiary academic care center. Patients who responded successfully to UAS implantation were selected for this study. Preoperative and postoperative sleep studies were compared to determine sleep architecture changes. Primary outcomes included sleep architecture parameters such as N1, N2, N3, and rapid eye movement (REM) in addition to others. Secondary outcomes included body mass index. RESULTS: Thirty-five patients met inclusion criteria for this study. There was significant improvement across several sleep architecture parameters. N1 sleep percent decreased from 16.7% ± 2.1% preoperatively to 10.1% ± 1.6% postoperatively (P = .023). Time spent in N2 increased from 148.0 ± 12.4 minutes to 185.5 ± 10.4 minutes (P = .030), whereas N3 increased from 21.9 ± 5.0 minutes to 57.0 ± 11.1 minutes (P = .013). No significant changes were observed in REM sleep. Arousal index decreased from 38.8 ± 4.0 to 30.3 ± 4.0 (P = .050). CONCLUSIONS: There was significant improvement across several sleep architecture parameters among patients who responded successfully to UAS implantation. LEVEL OF EVIDENCE: 4 Laryngoscope, 130:1085-1089, 2020.

Hypoglossal Nerve (Cranial Nerve XII) Stimulation.

Hypoglossal nerve stimulation is a novel strategy for the treatment of obstructive sleep apnea (OSA). Its anatomy allows for easy surgical access, and its function as a motor nerve allows for tolerable neurostimulation. It has shown success as a therapy for the treatment of OSA with a greater than 80% success rate. Patients who use the device not only show improvement in symptoms but also tolerate the device well with high rates of adherence to therapy as well as a high majority preferring it over continuous positive airway pressure therapy.

Techniques for developing and viewing stereoscopic three-dimensional teaching videos for transoral robotic surgery (TORS).

Advances in three-dimensional (3D) video recording and playback have expanded the availability of stereoscopic videos for consumption with specialized televisions, computer monitors, and virtual reality (VR) headsets. The built-in stereoscopic vision of the da vinci surgical system (Intuitive Surgical, Sunnyvale, CA) enables the recording of both camera views. However, medical-grade devices for direct stereoscopic video recording can be cost-prohibitive. We describe methods of producing and viewing 3D videos in transoral robotic surgery (TORS) without acquisition of dedicated 3D recording equipment. The video output from the left and right cameras of the da Vinci Si endoscope were recorded during a TORS radical tonsillectomy using non-stereoscopic media devices. Raw video was processed using commercially available video-editing software to create stereoscopic videos clips. 3D videos were successfully observed using a low-cost mobile phone VR headset. 3D stereoscopic surgical videos were successfully developed using widely available software, applications, computer peripherals, and mobile devices. The methods described confer significant cost savings when compared to the purchase of specialized recording equipment despite the requirements of time and intermediate computer skills. Future studies will investigate the utility of stereoscopic videos in medical student and resident education.

Outcomes of Hypoglossal Nerve Upper Airway Stimulation among Patients with Isolated Retropalatal Collapse.

OBJECTIVE: To examine whether patients with isolated retropalatal collapse perform as well as others following implantation with an upper airway stimulation (UAS) device. STUDY DESIGN: Retrospective review. SETTING: Single-institution tertiary academic care medical center. SUBJECTS AND METHODS: Following drug-induced sleep endoscopy, subjects who met inclusion criteria for implantation with a UAS device received an implant per industry standard. Subjects with isolated retropalatal collapse were compared with those having other patterns of collapse. Outcome measures included apnea-hypopnea index (AHI) and nadir oxyhemoglobin saturation (NOS). RESULTS: Ninety-one patients were implanted during the duration of the study, and 82 met inclusion criteria for analysis. Twenty-five had isolated retropalatal collapse, while the remaining 57 had other patterns of collapse on drug-induced sleep endoscopy. For all patients, mean preoperative AHI and NOS were 38.7 (95% CI, 35.0-42.4) and 78% (95% CI, 75%-80%), respectively; these improved postoperatively to 4.5 (95% CI, 2.3-6.6) and 91% (95% CI, 91%-92%). There was no significant preoperative difference between groups with regard to demographics, AHI, or NOS. Group comparison showed postoperative AHI to be 5.7 (95% CI, 0.57-10.8) for patients with isolated retropalatal collapse and 3.9 (95% CI, 1.7-6.1) for other patients ( P = .888). Postoperative NOS was 92% (95% CI, 90%-94%) among patients with isolated retropalatal collapse and 91% (95% CI, 90%-92%) for others ( P = .402). CONCLUSIONS: All patients showed significant improvement following implantation with UAS. Patients with isolated retropalatal collapse showed similar improvement to other types of collapse with regard to AHI and NOS.

Wound odor: current methods of treatment and need for objective measures.

Chronic wounds are an enormous burden to society, costing billions of dollars annually in the USA alone. Despite the extensive research into methods to heal chronic wounds, many remain unhealed for months to years. There is a need to focus on patient reported outcomes to improve quality of life in patients with non-healing wounds. Wound odor has a significant impact on patient quality of life; however, relatively little information is available on the management of wound odor. We review the current data available on wound odor and discuss the need for standardized objective measures of odor to improve research quality. An independent search of the PubMed and Embase databases was conducted using combinations of the following words or phrases: "wounds," "chronic wounds," "diabetic ulcers," "venous leg ulcers (VLUs)," "malignant ulcers," "odor," "odour," "smell," "malodor," "artificial olfaction," "electronic nose," and "e-nose." Article references were also searched for significance. There are few overall studies on wound odor, and fewer randomized controlled trials. Current trials on odor have consistent weaknesses such as subjective measures and poor methodology. No single odor treatment modality has been demonstrated to be widely effective for wound odor or superior to other methods. Future research should incorporate objective measures of odor such as electronic noses into clinical trials.