Risk Factors for Missed Follow-up Appointments among Facial Trauma Patients.

A retrospective case-control study was performed to characterize the rate of missed follow-up appointments after facial trauma and identify associated risk factors.Follow-up appointments for facial trauma over a 3-month period at a single, safety net hospital were analyzed. Appointment-specific, sociodemographic, trauma, and management data were compared between cases (missed appointments) and controls (attended appointments). Univariate testing and multivariable logistic regression were employed.A total of 116 cases and 259 controls were identified, yielding a missed appointment rate of 30.9% (116/375). Missed appointments were significantly associated with initial clinic appointments compared to return visits (odds ratio [OR] 2.21 [1.38-3.54]), afternoon visits compared to morning (OR 3.14 [1.94-5.07]), lack of private health insurance (OR 2.91 [1.68-5.18]), and presence of midface fractures (OR 2.04 [1.28-3.27]). Missed appointments were negatively associated with mandible fractures (OR 0.56 [0.35-0.89]), surgical management (OR 0.48 [0.30-0.77]), and the presence of nonremovable hardware (OR 0.39 [0.23-0.64]). Upon multivariable logistic regression, missed appointments remained independently associated with afternoon visits (adjusted OR [aOR] 1.95 [1.12-3.4]), lack of private health insurance (aOR 2.73 [1.55-4.8]), and midface fractures (aOR 2.09 [1.21-3.59]).Nearly one-third of facial trauma patients missed follow-up appointments, with the greatest risk among those with afternoon appointments, lacking private health insurance, and with midface fractures.

Beyond VOTE: The New Frontier of Drug-Induced Sleep Endoscopy.

Alternatives to positive airway pressure therapy, including surgery, represent an important area of research. Specifically, predictors of response to surgical therapy remain underdeveloped. Drug-induced sleep endoscopy (DISE) holds promise as a diagnostic tool to identify patient-specific causes of airway collapse. Herein, we present a novel, standardized approach which combines anatomic and physiologic measurements during DISE. Our DISE platform measures airflow, airway compliance, airway collapsibility, and structural drivers of collapse. Taken together, these inputs provide a comprehensive framework to further inform the surgeon in providing personalized care of the patient with obstructive sleep apnea.

Optimizing Flap Harvest in Auricular Reconstruction.

INTRODUCTION: The temporoparietal fascial (TPF) and occipital cranial fascial (OCP) flaps are the mainstay of implant coverage in alloplastic auricular reconstruction. Their optimal design is critical for elevating a robust flap that ultimately leads to favorable outcomes. MATERIALS AND METHODS: Sixteen TPF and OCP dissections were performed on 8 cadaveric specimens. Vascular anatomy and key landmarks were documented. The minimum flap size that incorporated ideal vasculature and would appropriately cover a porous polyethylene implant was measured. RESULTS: The minimum flap dimensions (length × width × base width) to cover a standard PPE auricular implants were on average 11×8.3×6.4 cm for TPF and 13.1×8.6×6.5 cm for OCP. The average axial length of the superficial temporal artery and occipital artery were 12.51 and 13.2 cm, respectively. An "occipital elbow" was located on average 8.2 cm posterior to the external acoustic canal. The postauricular fascia contained additional contributions from the occipital artery and mastoid emissary vein, which was located on average 5.9 cm posterior to the superficial temporal artery. CONCLUSIONS: This study highlights the anatomic features behind optimal TPF and OCP flap design for auricular reconstruction. Contributions to axial length and anatomic relationships of their primary arterial supply, significance of the occipital elbow as a reliable landmark for fascial dissection, and importance of the postauricular fascia and its vascular supply for flap viability are emphasized. Ultimately, the authors provide minimal dimensions for both TPF and OCP flaps to obtain adequate alloplastic implant coverage.

Hypoglossal nerve stimulation therapy on peripheral arterial tonometry in obstructive sleep apnea: a pilot study.

PURPOSE: Hypoglossal nerve stimulation (HGNS) is being increasingly utilized in the setting of moderate-severe obstructive sleep apnea (OSA). While moderate-severe OSA confers excess cardiovascular risk, the impact of HGNS on cardiovascular requires further investigation. With the advent of peripheral arterial tonometry (PAT), one can non-invasively study real-time changes to the autonomic nervous system. This study evaluates the effect of HGNS therapy on autonomic output, using PAT-integrated polysomnography. METHODS: Subjects included adult patients undergoing 2-month post-operative HGNS titration studies with PAT-integrated polysomnography. Apneic and hypopneic events with arousal during stage 2 sleep were identified at increasing levels of stimulation. With each event, PAT signal attenuations were recorded, processed, and analyzed. RESULTS: Nine subjects were enrolled, and eight met inclusion criteria (mean age 67.8 ± 12.4 years; 50% female). The PAT signal did not significantly change before and during stimulation (mean pre-stimulation 43.4 ± 1.7, mean intra-stimulation 41.1 ± 22.5, p = 0.53) in any patient. The ratio of the PAT signal maximum and minimum amplitudes during sleep breathing events largely demonstrated very weak correlation (R2 = <0.12). Across all subjects, poor linear correlation was present between HGNS and PAT signal attenuation (R2 = 0.028) in both adjusted and unadjusted analyses. CONCLUSIONS: Using PAT-integrated polysomnography, PAT output does not appear to be affected by HGNS stimulation at clinical thresholds. These findings support the absence of autonomic system alterations by twelfth nerve stimulation and support the clinical use of PAT-based devices for post-HGNS monitoring. Larger studies examining hard cardiovascular endpoints with HGNS are needed.

Cleft Rhinoplasty: Strategies for the Multiply Operated Nose.

Rhinoplasty, as a surgical procedure to improve the appearance of the nose while preserving or improving function, is complicated and difficult to master. Revision cleft rhinoplasty offers another tier of challenge. The symmetry, proportions, and definition of the nose are affected by the native cleft deformity but also previous surgical scars, cartilage grafts, and skin excisions. Our preferred approach is to use structural cartilage grafting to establish septal and lower lateral cartilage resiliency. Internal lining deficiency is addressed with skin or lining transfer, while excess nasal tip thickness is contoured to improve definition. Of the utmost importance, the cleft nasal deformity cannot be considered in isolation, but rather a combined amalgamation of the lip muscle and scar, dentofacial occlusion, and skeletal maxillary deficiency.

Scapular osteocutaneous free flap for total lower lip and mandible reconstruction.

PURPOSE: Total lower lip and mandible defects following tumor resection present challenging reconstructions. The use of dual free flaps leads to increased donor-site morbidity and risk of flap failure. We present a single scapular free flap approach with unique use of osteotomies for lip reconstruction in a small series of patients. METHODS: A case series was conducted from 2007 to 2012 on three patients with squamous cell carcinoma of the oral cavity requiring large resection. Patients ranged in age from 34 to 64 years. A scapular free flap was used for reconstruction of mandible, floor of mouth, total lower lip and chin defects ranging in size from 7 × 4 cm to 11 × 7 cm. Harvested bone was extended medially beyond the lateral border of scapula. Osteotomies were oriented to support the soft tissue flap to rebuild lip height and restore oral competence. RESULTS: Skin paddles ranged in size from 10-11 cm × 18-25 cm. Bone flap size was not reported but vertical height of osteotomies ranged from 3-4 cm. All flaps survived microvascular transfer. One patient suffered from shoulder dysfunction and sialorrhea necessitating a second procedure. A second patient developed exposed hardware after radiation. Follow-up ranged from 10 to 36 months. All patients achieved good oral competence and cosmesis by 9 months post-operative. CONCLUSIONS: This single-flap approach may provide an alternative to dual free flap reconstruction of total lower lip and mandible. © 2016 Wiley Periodicals, Inc. Microsurgery 36:480-484, 2016.

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

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

Mechanistic insights from sleep endoscopy related to oronasal mask failures: a case report.

A 71-year-old male with severe obstructive sleep apnea (OSA) and nasal septal deviation presented to a positive airway pressure (PAP) alternatives clinic due to persistent obstructive events on both continuous PAP (CPAP) and bilevel PAP (BPAP) therapy delivered via oronasal mask. He underwent drug-induced sleep endoscopy with PAP titration (DISE-PAP) to determine the mechanism of oronasal mask failure. A nasal mask was also applied and titrated for comparison. DISE-PAP showed tongue base collapse which resolved at low pressure using a nasal mask. Application of an oronasal mask increased minimum therapeutic PAP level. Tightening the mask worsened tongue base collapse, which was not resolved by increasing the PAP level. Following nasal surgery, the patient was able to tolerate nasal CPAP at low therapeutic pressure, which resulted in both objective and subjective improvement is his OSA. This case highlights the ability of DISE-PAP to determine the mechanistic cause of oronasal mask failure.

State-Dependent Biomechanical Behavior of Oropharyngeal Structures in Apneic and Control Subjects: A Proof-of-Concept Study.

Rationale: Apneic individuals have reduced airway caliber during sleep. The biomechanical changes in upper airway anatomy contributing to this airway narrowing are largely unknown. Objectives: We sought to investigate the state-dependent (wake vs. sleep) biomechanical behavior of the upper airway soft-tissue and craniofacial structures. Methods: Upper airway magnetic resonance imaging was performed in 15 sleep-deprived control subjects (apnea-hypopnea index, <5; 0.3 ± 0.5 events per hour) and 12 sleep-deprived apneic subjects (apnea-hypopnea index, ⩾5; 35.2 ± 18.1 events per hour) during wake and sleep and analyzed for airway measures and soft-tissue/mandibular movement. Results: In the retropalatal region, control subjects showed sleep-dependent reductions (P ⩽ 0.037) in average cross-sectional airway area (CSA), minimum CSA, and anteroposterior and lateral dimensions. Apneic subjects showed sleep-dependent reductions (P ⩽ 0.002) in average CSA, minimum CSA, and anteroposterior and lateral dimensions. In the retroglossal region, control subjects had no sleep-dependent airway reductions. However, apneic subjects had sleep-dependent reductions in minimal CSA (P = 0.001) and lateral dimensions (P = 0.014). Control subjects only showed sleep-dependent posterior movement of the anterior-inferior tongue octant (P = 0.039), whereas apneic subjects showed posterior movement of the soft palate (P = 0.006) and all tongue octants (P ⩽ 0.012). Sleep-dependent medial movement of the lateral walls was seen at the retropalatal minimum level (P = 0.013) in control subjects and at the retropalatal and retroglossal minimum levels (P ⩽ 0.017) in apneic subjects. There was posterior movement of the mandible in apneic subjects (P ⩽ 0.017). Conclusions: During sleep, control and apneic subjects showed reductions in retropalatal airway caliber, but only the apneic subjects showed retroglossal airway narrowing. Reductions in anteroposterior and lateral airway dimensions were primarily due to posterior soft palate, tongue and mandibular movement and to medial lateral wall movement. These data provide important initial insights into obstructive sleep apnea pathogenesis.

The Whimsical Nature of Airway Obstruction during Drug-Induced Sleep Endoscopy.

A 47-year-old male patient diagnosed with severe obstructive sleep apnea (OSA) sought alternatives to positive airway pressure, prompting evaluation with drug-induced sleep endoscopy (DISE). He underwent a specialized DISE with nasal airflow and pharyngeal pressure monitoring. During obstructive apneas, airflow and pressure signals demonstrated dynamic, multilevel upper airway collapse, with shifting sites of airflow obstruction as respiratory effort increased. This case report illustrates how quantitative airflow and pressure measurements can complement the standard DISE exam and aid in surgical decision-making. Laryngoscope, 2024.

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

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

The Association Between Transverse Maxillary Deficiency and Septal Deviation in Adults with Obstructive Sleep Apnea.

OBJECTIVES: Recent evidence suggests that environmental factors impact craniofacial development. Specifically, the height and width of the maxilla may impact the degree of septal deviation. We sought to determine the relationship between transverse maxillary deficiency and severity of septal deviation. METHODS: A prospective cohort of adult sleep surgery patients were evaluated by standardized CT imaging. Primary outcomes evaluated the relationship of a narrow, high-arched palate (the palatal height to width ratio) with the degree of septal deviation at the level of the 1st premolar and 1st molar. Secondary outcome evaluated the relationship of the palatal height-to-width ratio and nasal obstruction. Both adjusted and unadjusted linear regression were performed, including correction for multiple hypothesis testing. RESULTS: Ninety-three patients were included. On average, the cohort was middle aged (54.7 ± 12.7 years), obese (BMI 30.1 ± 4.5 kg/m2), predominantly male (74.2%), White (73.1%), and with severe obstructive sleep apnea (OSA) (AHI 30.0 ± 18.7 events/h). A moderate correlation was observed between both the relative and absolute inter-premolar palatal height and the degree of septal deviation at the inter-molar region. No significant correlation was observed between palatal dimensions and NOSE score. CONCLUSION: This study found that transverse maxillary deficiency is moderately associated with greater degree of septal deviation among a sample of OSA patients. This contributes to the concept that craniofacial development impacts the nasal airway, promoting a comprehensive evaluation of both endonasal and extranasal structures. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:2464-2470, 2024.

Airway Collapsibility during Drug-Induced Sleep Endoscopy Relates with Clinical Features of Obstructive Sleep Apnea.

INTRODUCTION: Increased pharyngeal collapsibility leads to obstructive sleep apnea (OSA). Positive airway pressure titration during drug-induced sleep endoscopy (DISE-PAP) provides objective collapsibility metrics, the pharyngeal opening pressure (PhOP), and active pharyngeal critical pressure (PcritA ). We examined the interrelationships between risk factors of OSA, airway collapsibility measures, and clinical manifestations of the disease. METHODS: This is a cross-sectional analysis of consecutive OSA patients undergoing DISE-PAP. Nasal PAP was increased stepwise until inspiratory flow limitation was abolished, signifying PhOP. PcritA was derived from the resulting titration pressure-flow relationships. Clinical data including demographics, anthropometrics, sleep studies, and patient-symptom questionnaires were obtained from the electronic medical record. Multivariate regression was used to evaluate the relationship between risk factors, airway collapsibility, and clinical data. RESULTS: On average, the 164 patients meeting inclusion criteria were middle-aged (54.2 ± 14.7 years), overweight/obese (BMI 29.9 ± 4.5 kg/m2 ), male (72.6%), White (79.3%) and had severe OSA (AHI 32.0 ± 20.5 events/hour). Mean PhOP was 7.5 ± 3.3 cm H2 O and mean PcritA was 0.80 ± 3.70 cm H2 O. Younger age (Standardized ß = -0.191, p = 0.015) and higher BMI (Standardized ß = 0.176, p = 0.028) were associated with higher PhOP, but not PcritA . PhOP and PcritA were both associated with AHI, supine AHI, and SpO2 nadir. Higher PhOP was associated with higher snoring scores (Standardized ß = 0.246, p = 0.008), but not other patient-reported outcomes. CONCLUSION: Objective assessment of passive and active airway mechanics during DISE relates with clinical risk factors for OSA. Quantitative measures of collapsibility provide accessible and meaningful data, enhancing the standard sleep surgery evaluation. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:1978-1985, 2024.

Posterior Palatal Expansion via Subnasal Endoscopy (2PENN) for Maxillary Deficiency: A Pilot Study.

OBJECTIVE: Surgically assisted rapid palatal expansion (SARPE) addresses transverse maxillary deficiency, a known contributor to nasal obstruction. The purpose of this study was to assess the feasibility, preliminary outcomes, and safety of posterior palatal expansion via subnasal endoscopy (2PENN), a modified SARPE procedure, aimed at achieving anterior and posterior maxillary expansion. METHODS: This prospective case series included consecutive adult patients with findings of transverse maxillary deficiency that underwent the 2PENN procedure from 4/2021 to 4/2022. Patients completed pre- and post-operative clinical evaluations, Nasal Obstruction and Septoplasty Effectiveness (NOSE) questionnaires, and computed tomography (CT), with measures including expansion at the level of the posterior nasal spine (PNS), first maxillary inter-molar distance (IMD), and anterior nasal spine (ANS). RESULTS: The cohort (N = 20) was middle-aged (39 ± 11 years), predominantly male (80%), and overweight (BMI 28 ± 4 kg/m2 ). The majority (85%) of patients had sleep breathing issues, of which 10 (59%) had polysomnography-confirmed obstructive sleep apnea (OSA). Full anterior-posterior separation of the mid-palatal suture line was evident on all post-operative CT scans, with mean expansion at the PNS of 3.6 ± 1.3 mm, IMD of 6.1 ± 1.6 mm and ANS of 7.0 ± 1.6 mm (p < 0.001). Following surgery, mean NOSE scores improved from 57 ± 23 to 14 ± 13 (p < 0.001). One patient required maxillary antrostomy for post-operative sinusitis. CONCLUSION: 2PENN is an effective and safe technique for achieving both anterior and posterior maxillary expansion in patients with transverse maxillary deficiency. Further study is warranted to better understand the effect of 2PENN in patients with OSA, particularly as it relates to improving pharyngeal patency. LEVEL OF EVIDENCE: 4 Laryngoscope, 134:1970-1977, 2024.

Differences in Positive Airway Pressure Requirements in Obstructive Sleep Apnea Between Black and White Patients.

OBJECTIVE: There are disparities between Black and White patients in the utilization of positive airway pressure (PAP) alternatives for obstructive sleep apnea (OSA). Given low utilization rates among Black patients, there is limited knowledge of PAP alternative outcomes in this group. Therapeutic PAP levels are clinically accessible measures that have been shown to predict PAP alternative outcomes. Herein, we examined differences in PAP requirements between Black and White patients in a large clinical sample. STUDY DESIGN: Cross-sectional. SETTING: Academic sleep center. METHODS: We included OSA patients prescribed autoadjusting PAP between January 2018 and 2020 with baseline apnea-hypopnea index (AHI) ≥ 10. Mean and 90th percentile PAP levels were compared between White and Black patients who used PAP for ≥1 hour daily using linear regression controlling for age, sex, body mass index (BMI), AHI, oxygen saturation nadir, and mask type. RESULTS: There were 157 Black and 234 White patients who were generally obese (BMI, 37.3 ± 8.7) with severe OSA (AHI, 36.9 ± 25.6). Black patients had a 0.68 cm higher (95% confidence interval [CI]: 0.36, 1.35) mean PAP level and 0.85 cm H2O higher (95% CI: 0.36, 1.35) 90th percentile PAP level than white patients. Although statistically significant, differences were small and not clinically meaningful. CONCLUSION: Black and White OSA patients had clinically insignificant differences in PAP requirements, suggesting comparable upper airway collapsibility. Considering the predictive value of therapeutic PAP levels, our findings suggest Black and White patients may have comparable PAP alternative responses from a collapsibility standpoint. Future studies should explore reasons for low utilization of PAP alternatives among Black patients.

The Prevalence of Sentinel Central Events (SCent) During Drug-Induced Sleep Endoscopy.

OBJECTIVE: With the recent addition of airflow and respiratory effort channels, our group has observed central and mixed apnea events during drug-induced sleep endoscopy (DISE). We measured the frequency and timing of sentinel central and/or mixed events (SCents), as well as assessed for differences in velum, oropharynx, tongue, and epiglottis (VOTE) classification compared to obstructive events. STUDY DESIGN: Prospective single-cohort study. SETTING: Tertiary Care Academic Medical Center. METHODS: Patients underwent DISE between June 2020 and November 2022. Nasal airflow, thoracoabdominal effort belt signals, and videoendoscopy were simultaneously captured. Demographics, sleep study, and DISE data were compared among patients with and without SCents using Student's T tests or χ2 tests. RESULTS: On average, the cohort (n = 103) was middle-aged (53.5 ± 12.1 years), overweight (body mass index of 29.7 ± 5.3 kg/m2), and had severe obstructive sleep apnea (apnea-hypopnea index of 30.7 ± 18.7 events/h). Forty-seven patients (46%) were found to have at least 1 SCent. Among those with SCent, 45 (95.7%) transitioned to obstructive pathology after an average of 7.91 ± 2.74 minutes, with at least 95% of patients expected to do so within 12.57 minutes. Twenty-nine out of 47 patients (61.2% [95% confidence interval: 46.4.9%, 75.5%]) with SCent had meaningful differences between central/mixed and obstructive VOTE scores. CONCLUSION: Central events were present in almost half of our cohort. At least 95% of patients were expected to transition to obstructive events within 12 to 13 minutes of propofol initiation. In addition, over half of patients demonstrate significantly different VOTE scores between central and obstructive events. These factors should raise awareness of central events and scoring passive apneas during DISE and consider delaying VOTE scoring.

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.

Association Between Soft Tissue Measures From Computed Tomography and Upper Airway Collapsibility on Drug-Induced Sleep Endoscopy.

OBJECTIVE: Positive airway pressure (PAP) titration during drug-induced sleep endoscopy (DISE) provides objective measures of upper airway collapsibility. While skeletal measurements relate to collapsibility measures on DISE, the influence of soft tissue dimensions on upper airway collapsibility is not known. We analyzed the relationship of measures of upper airway soft tissue volumes, specifically soft palate, pharyngeal lateral walls, and tongue, with metrics of collapsibility. STUDY DESIGN: Cross-sectional analysis from a prospective cohort. SETTING: Academic medical center. METHODS: Patients seeking PAP alternative therapies for obstructive sleep apnea (OSA) underwent standardized supine computed tomography (CT) acquisition and DISE protocols. The CT analysis primarily focused on soft tissue volumes and, secondarily, on airway and skeletal volumetric measures. DISE with PAP administration (DISE-PAP) enabled the determination of the pressure at which inspiratory airflow first commenced (pharyngeal critical pressure, PcritA) and the pressure at which inspiratory flow limitation was abolished (pharyngeal opening pressure, PhOP). Both unadjusted and adjusted correlation analyses were performed to understand the relationship between upper airway anatomy and either PcritA or PhOP. RESULTS: One hundred thirty-nine subjects completed both CT and DISE-PAP. On average, patients were male (70.5%), white (84.2%), middle-aged (56.6 ± 13.5 years), and overweight (29.6 ± 4.7 kg/m2), with moderate-severe apnea-hypopnea index (29.7 ± 21.3 events/h). Adjusted for age, sex, body mass index, and skeletal volumes, soft palate, and lateral pharyngeal wall volumes were not associated with PhOP or PcritA, but a larger tongue was associated with more positive PhOP (⍴ = 0.20, P = .02), and more positive PcritA (⍴ = 0.16, P = .07). Exploratory analyses revealed smaller minimum cross-sectional retropalatal area and intramandibular volume were also associated with increased collapsibility measures. CONCLUSION: After controlling for clinical factors and skeletal volume, greater tongue volume was associated with more severe collapsibility during DISE. These results, in concert with previous work, suggest that greater tongue volume in a smaller skeletal dimensions contribute to the severity of airway collapsibility, a key driver of OSA pathogenesis.

The Accuracy and Reliability of Visually Assessed Pharyngeal Opening Pressures During Drug-Induced Sleep Endoscopy.

OBJECTIVE: To examine the accuracy and interrater reliability of a visually assessed vs airflow-based measure of pharyngeal collapsibility obtained in patients with obstructive sleep apnea undergoing drug-induced sleep endoscopy (DISE). STUDY DESIGN: Prospective observational study. SETTING: Academic tertiary care practice. METHODS: Patients underwent DISE with airflow monitoring and nasal positive airway pressure titration to determine visual and airflow-based levels of pharyngeal opening pressure (PhOP). Visual DISE-PhOP was assessed by 2 blinded independent raters and defined as the pressure at which visual confirmation of airway collapse, including snoring, was abolished. Airflow-based DISE-PhOP was defined as the minimally effective positive airway pressure that abolished inspiratory flow limitation. Equivalence testing between visual and airflow DISE-PhOP of each rater was performed with the two one sided T-test (TOST) with an a priori equivalence bound of ±1 cm H2 O. Interrater reliability was evaluated with the intraclass correlation coefficient. RESULTS: One hundred patients were enrolled in the study and 77 completed the full evaluation. The population was predominantly male (74%) with an average age of 54.8 years, body mass index of 30.1 kg/m2 , and apnea-hypopnea index of 30.7 events/h. Equivalence testing showed that both raters were within ±1 cm H2 O of airflow-based DISE-PhOP (-0.43 to 0.09 cm H2 O and -0.32 to 0.48 cm H2 O). Interrater reliability of visual DISE-PhOP between the raters was also good to excellent with an intraclass correlation coefficient of 0.895 (95% CI, 0.84-0.932). CONCLUSION: DISE-PhOP, a measure of upper airway collapsibility, was equivalent between airflow-based and visual assessments with strong interrater reliability, supporting its adoption as a standardized objective parameter in clinical DISE.

Balloon Sinuplasty and Stenting in the Management of Complex Frontal Sinus Outflow Tract Fractures.

OBJECTIVE: Classical management of complex fractures involving the frontal sinus outflow tract (FSOT) favors obliteration or cranialization to avoid delayed complications. We aim to exhibit success with a novel application of balloon sinuplasty and frontal stenting in the management of complex injuries disrupting the FSOT, which might have otherwise required more invasive interventions. STUDY DESIGN: Retrospective review. SETTING: Single institution, level 1 trauma center. METHODS: Retrospective review of patients presenting to a level 1 trauma center with fractures involving the FSOT. Outcomes include patency of the FSOT on imaging and endoscopy, rate of complications, degree of residual tabular displacement, and need for revision surgery. RESULTS: Twenty-five patients met inclusion criteria, with complete FSOT obstruction seen in all cases on computed tomography. All patients underwent balloon sinuplasty with frontal sinus stenting; 48% underwent concurrent anterior table repair, and 36% open repair of nasoorbitoethmoid complex fractures. The mean follow-up length was 13.9 months, at which time 91.3% of patients demonstrated radiographic and endoscopic FSOT patency. No residual sinus opacification or pneumocephalus was observed. CONCLUSION: Balloon sinuplasty with frontal sinus stenting is a straightforward and minimally invasive technique that can create a safe sinus in complex fractures disrupting the FSOT while avoiding the need for more invasive procedures.