Comparison of Home Sleep Devices and Sleep Study Testing in Hypoglossal Nerve Stimulation Patients.

OBJECTIVE: Hypoglossal nerve stimulation (HGNS) is an implantable therapy for obstructive sleep apnea (OSA). Therapy efficacy is currently confirmed by a formal sleep study after empiric adjustment by the patient at home based on their subjective experience with the device. Home-based longitudinal apnea hypopnea index (AHI) measurements have the potential to refine HGNS therapeutic amplitude selection with objective data. Our objective was to compare AHI derived from routine sleep studies and two different home sleep devices in new HGNS recipients. METHODS: Prospectively enrolled patients receiving HGNS therapy were provided a Sleep Tracking Mat (Withings, Issy-les-Moulineaux, France) and NightOwl peripheral arterial tonometry (PAT) sensor (Ectosense, Leuven, Belgium) for longitudinal, home AHI monitoring from 1 to 6 months post-implant. Therapy efficacy was assessed at 3 and 6 months post-implant using in-lab polysomnography (PSG) or home sleep apnea test (HSAT). The sleep mat and PAT sensor AHI were compared against PSG and HSAT for accuracy of OSA severity identification. RESULTS: Sixty patients were enrolled across 5 centers and followed for 6 months. The sleep mat had sensitivity and specificity for identifying AHI <15 of 61% and 82% and AHI <30 of 77% and 100%. The PAT device had sensitivity and specificity for identifying AHI <15 of 57% and 77% and AHI <30 of 81% and 80%. CONCLUSIONS: The sleep mat and PAT sensor demonstrated high sensitivity and specificity for detection of mild and moderate OSA in patients with HGNS therapy and may enable longitudinal objective monitoring of HGNS efficacy in the home setting. LEVEL OF EVIDENCE: 3 Laryngoscope, 2024.

A comparison of caregiver-reported snoring and objective snoring in children from urban neighborhoods.

OBJECTIVE: Sleep Disordered Breathing (SDB) is both prevalent and under-recognized in pediatric minority populations. Recognition of SDB is often triggered by symptoms of caregiver-reported snoring. However, the validity and utility of caregiver reports likely vary across populations. Our objective is to assess the association between caregiver-reported snoring and objectively recorded snoring in a low-income urban community and explore factors associated with agreement between objective and subjective snoring. METHODS: 169 6 to 12 year old participants underwent at-home sleep studies with a WatchPAT device as part of the Environmental Assessment of Sleep in Youth (EASY) cohort study. Differences in subjective snoring, objective snoring, and concordance between subjective and objective snoring based on socioeconomic and clinical characteristics were assessed. RESULTS: The sample had a high proportion of non-white (78.9 %) and low income (39.6 %) children. Caregivers reported snoring for 20.7 % of the children and snoring was measured objectively for 21.9 %. Of those with objective snoring, only 29.7 % were identified as snorers by caregiver report (sensitivity: 0.30; specificity: 0.82). Primary Spanish language and co-sleeping were associated with increased caregiver reported snoring, and allergy was associated with increased objective snoring. Older child age and normal range BMI percentile were associated with higher concordance between caregiver and objective snoring. CONCLUSIONS: Among a community-based, predominantly minority sample, caregiver-reported snoring resulted in under-estimation of prevalence of objectively assessed snoring. Reliance on caregiver report may poorly identify children with snoring or SDB in clinical practice.

Comparison of clinical pathways for hypoglossal nerve stimulation management: in-laboratory titration polysomnography vs home-based efficacy sleep testing.

STUDY OBJECTIVES: We conducted this study to evaluate whether laboratory or home-based hypoglossal nerve stimulation (HNS) management would have equivalent objective and subjective obstructive sleep apnea outcomes 6 months after activation. METHODS: Patients undergoing standard-of-care HNS implantation were randomly assigned in a prospective, multicenter clinical trial to either a 3-month postactivation in-laboratory titration polysomnography (tPSG) or an efficacy home sleep study (eHST) with tPSG by exception for eHST nonresponders at 5 months. Both groups underwent an eHST 6 months postactivation. RESULTS: Sixty patients were randomly assigned. Patients experienced equivalent decreases in the apnea-hypopnea index (mean difference: -0.01 events/h [-8.75, 8.74]) across both groups with HNS; the selection of tPSG or eHST did not associate with therapy response rates (tPSG vs eHST: 63.2% vs 59.1%). The Epworth Sleepiness Scale (median of differences: 1 [-1, 3]) and device usage (median of differences: 0.0 hours [-1.3, 1.3]) outcomes were similar but did not meet a priori statistical equivalence criteria. CONCLUSIONS: This prospective, multicenter, randomized clinical trial demonstrated that patients undergoing HNS implantation experienced statistically equivalent improvements in objective obstructive sleep apnea outcomes and similar improvements in daytime sleepiness regardless of whether they underwent tPSG. HNS titration with tPSG may not be required for all postoperative patients. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Name: Inspire Home Study: Utilization of Home Monitoring During Therapy Optimization in Patients With an Inspire Upper Airway Stimulation System (Comparison of Home Sleep Testing vs. In-lab Polysomnography Testing) (HOME); URL: https://clinicaltrials.gov/ct2/show/NCT04416542; Identifier: NCT04416542. CITATION: Kent D, Huyett P, Yu P, et al. Comparison of clinical pathways for hypoglossal nerve stimulation management: in-laboratory titration polysomnography vs home-based efficacy sleep testing. J Clin Sleep Med. 2023;19(11):1905-1912.

Sleep physiology, pathophysiology, and sleep hygiene.

Despite sleep's fundamental role in maintaining and improving physical and mental health, many people get less than the recommended amount of sleep or suffer from sleeping disorders. This review highlights sleep's instrumental biological functions, various sleep problems, and sleep hygiene and lifestyle interventions that can help improve sleep quality. Quality sleep allows for improved cardiovascular health, mental health, cognition, memory consolidation, immunity, reproductive health, and hormone regulation. Sleep disorders, such as insomnia, sleep apnea, and circadian-rhythm-disorders, or disrupted sleep from lifestyle choices, environmental conditions, or other medical issues can lead to significant morbidity and can contribute to or exacerbate medical and psychiatric conditions. The best treatment for long-term sleep improvement is proper sleep hygiene through behavior and sleep habit modification. Recommendations to improve sleep include achieving 7 to 9 h of sleep, maintaining a consistent sleep/wake schedule, a regular bedtime routine, engaging in regular exercise, and adopting a contemplative practice. In addition, avoiding many substances late in the day can help improve sleep. Caffeine, alcohol, heavy meals, and light exposure later in the day are associated with fragmented poor-quality sleep. These sleep hygiene practices can promote better quality and duration of sleep, with corresponding health benefits.

Comparison of Caregiver- and Child-Reported Quality of Life in Children With Sleep-Disordered Breathing.

OBJECTIVE: Caregivers frequently report poor quality of life (QOL) in children with sleep-disordered breathing (SDB). Our objective is to assess the correlation between caregiver- and child-reported QOL in children with mild SDB and identify factors associated with differences between caregiver and child report. STUDY DESIGN: Analysis of baseline data from a multi-institutional randomized trial SETTING: Pediatric Adenotonsillectomy Trial for Snoring, where children with mild SDB (obstructive apnea-hypopnea index <3) were randomized to observation or adenotonsillectomy. METHODS: The Pediatric Quality of Life Inventory (PedsQL) assessed baseline global QOL in participating children 5 to 12 years old and their caregivers. Caregiver and child scores were compared. Multivariable regression assessed whether clinical factors were associated with differences between caregiver and child report. RESULTS: PedsQL scores were available for 309 families (mean child age, 7.0 years). The mean caregiver-reported PedsQL score was higher at 75.2 (indicating better QOL) than the mean child-reported score of 67.9 (P < .001). The agreement between caregiver and child total PedsQL scores was poor, with intraclass correlation coefficients of 0.03 (95% CI, -0.09 to 0.15) for children 5 to 7 years old and 0.21 (95% CI, 0.03-0.38) for children 8 to 12 years old. Higher child age and health literacy were associated with closer agreement between caregiver and child report. CONCLUSION: Caregiver- and child-reported global QOL in children with SDB was weakly correlated, more so for young children. In pediatric SDB, child-perceived QOL may be poorer than that reported by caregivers. Further research is needed to assess whether similar trends exist for disease-specific QOL metrics.

Sleep study measures on post-operative night one following expansion pharyngoplasty for obstructive sleep apnea.

PURPOSE: To examine the changes in measures of sleep apnea severity and hypoxemia on the first post-operative night (PON1) following expansion pharyngoplasty as a means to assess the safety of same day discharge after surgery. MATERIALS AND METHODS: Prospective cohort study of subjects with moderate-severe obstructive sleep apnea who underwent expansion pharyngoplasty at a single academic sleep surgical practice. A WatchPAT study was performed on the night immediately following surgery (PON1) and comparisons were made to baseline sleep testing. RESULTS: Twenty subjects who had a mean age of 45.7 ± 10.8 years old and a mean body-mass index (BMI) of 31.4 ± 3.2 kg/m2 were enrolled. Patients had baseline severe OSA with mean apnea hypopnea index (AHI) 39.4 ± 19.5/h, O2 nadir 80.8 ± 6.1 % and time with oxygen saturation below 88 % (T88) 12.3 ± 13.2 min. Measures of sleep apnea and nocturnal hypoxemia were not significantly different on PON1. AHI was increased by >20 % in 11 (55.0 %) patients. One patient demonstrated a >10 % worsening in O2 nadir, and 8 patients (45.0 %) demonstrated a >20 % worsening in T88. BMI over 32 was associated with elevated odds of worsening in T88, and anesthesia involving ketamine was associated with lower odds of a 20 % worsening in AHI or T88. CONCLUSIONS: On PON1 following expansion pharyngoplasty, AHI and nocturnal hypoxemia are stable overall but variable on an individual basis. The decision for admission should therefore be made on a case-by-case basis. Further research is need to elucidate definitive predictors of worsening measures on PON1.

Neurobehavioral morbidity of pediatric mild sleep-disordered breathing and obstructive sleep apnea.

STUDY OBJECTIVES: Obstructive sleep apnea is associated with neurobehavioral dysfunction, but the relationship between disease severity as measured by the apnea-hypopnea index and neurobehavioral morbidity is unclear. The objective of our study is to compare the neurobehavioral morbidity of mild sleep-disordered breathing versus obstructive sleep apnea. METHODS: Children 3-12 years old recruited for mild sleep-disordered breathing (snoring with obstructive apnea-hypopnea index < 3) into the Pediatric Adenotonsillectomy Trial for Snoring were compared to children 5-9 years old recruited for obstructive sleep apnea (obstructive apnea-hypopnea 2-30) into the Childhood Adenotonsillectomy Trial. Baseline demographic, polysomnographic, and neurobehavioral outcomes were compared using univariable and multivariable analysis. RESULTS: The sample included 453 participants with obstructive sleep apnea (median obstructive apnea-hypopnea index 5.7) and 459 participants with mild sleep-disordered breathing (median obstructive apnea-hypopnea index 0.5). By polysomnography, participants with obstructive sleep apnea had poorer sleep efficiency and more arousals. Children with mild sleep-disordered breathing had more abnormal executive function scores (adjusted odds ratio 1.96, 95% CI 1.30-2.94) compared to children with obstructive sleep apnea. There were also elevated Conners scores for inattention (adjusted odds ratio 3.16, CI 1.98-5.02) and hyperactivity (adjusted odds ratio 2.82, CI 1.83-4.34) in children recruited for mild sleep-disordered breathing. CONCLUSIONS: Abnormal executive function, inattention, and hyperactivity were more common in symptomatic children recruited into a trial for mild sleep-disordered breathing compared to children recruited into a trial for obstructive sleep apnea. Young, snoring children with only minimally elevated apnea-hypopnea levels may still be at risk for deficits in executive function and attention. TRIAL REGISTRATION: Pediatric Adenotonsillectomy for Snoring (PATS), NCT02562040; Childhood Adenotonsillectomy Trial (CHAT), NCT00560859.

Evaluation of Upper Airway Stimulation for Adolescents With Down Syndrome and Obstructive Sleep Apnea.

Importance: Patients with Down syndrome have a high incidence of persistent obstructive sleep apnea (OSA) and limited treatment options. Upper airway hypoglossal stimulation has been shown to be effective for adults with OSA but has not yet been evaluated for pediatric populations. Objective: To evaluate the safety and effectiveness of upper airway stimulation for adolescent patients with Down syndrome and severe OSA. Design, Setting, and Participants: This prospective single-group multicenter cohort study with 1-year follow-up was conducted between April 1, 2015, and July 31, 2021, among a referred sample of 42 consecutive adolescent patients with Down syndrome and persistent severe OSA after adenotonsillectomy. Intervention: Upper airway stimulation. Main Outcomes and Measures: The prespecified primary outcomes were safety and the change in apnea-hypopnea index (AHI) from baseline to 12 months postoperatively. Polysomnographic and quality of life outcomes were assessed at 1, 2, 6, and 12 months postoperatively. Results: Among the 42 patients (28 male patients [66.7%]; mean [SD] age, 15.1 [3.0] years), there was a mean (SD) decrease in AHI of 12.9 (13.2) events/h (95% CI, -17.0 to -8.7 events/h). With the use of a therapy response definition of a 50% decrease in AHI, the 12-month response rate was 65.9% (27 of 41), and 73.2% of patients (30 of 41) had a 12-month AHI of less than 10 events/h. The most common complication was temporary tongue or oral discomfort, which occurred in 5 patients (11.9%). The reoperation rate was 4.8% (n = 2). The mean (SD) improvement in the OSA-18 total score was 34.8 (20.3) (95% CI, -42.1 to -27.5), and the mean (SD) improvement in the Epworth Sleepiness Scale score was 5.1 (6.9) (95% CI, -7.4 to -2.8). The mean (SD) duration of nightly therapy was 9.0 (1.8) hours, with 40 patients (95.2%) using the device at least 4 hours a night. Conclusions and Relevance: Upper airway stimulation was able to be safely performed for 42 adolescents who had Down syndrome and persistent severe OSA after adenotonsillectomy with positive airway pressure intolerance. There was an acceptable adverse event profile with high rates of therapy response and quality of life improvement. Trial Registration: ClinicalTrials.gov Identifier: NCT02344108.

Long-term stability of hypoglossal nerve stimulation for the treatment of obstructive sleep apnea in children with Down syndrome.

IMPORTANCE: Obstructive sleep apnea (OSA) occurs in 55-97% of people with Down syndrome (DS). Even after adenotonsillectomy, residual OSA often persists into adulthood due, in part, to tongue base collapse. Implantable hypoglossal nerve stimulators are being investigated in children and young adults with DS and persistent, moderate to severe OSA. However, the long-term necessity for such an intervention-especially as patients mature and voltage adjustment becomes warranted-has not been previously reported in the pediatric DS population. OBJECTIVE: To assess the long-term need for implantable hypoglossal nerve stimulators and the necessity for voltage adjustment in children and young adults with Down syndrome. DESIGN: This is a case series from an ongoing clinical trial assessing safety and efficacy of hypoglossal nerve stimulation among 42 children and young adults with DS and persistent OSA, despite adenotonsillectomy and trialed positive airway pressure (PAP) therapy. We focus here on the first 4 participants who have undergone implantation by age 13 and have completed at least 44 months of follow-up. PARTICIPANTS: 4 participants (2 male, 2 female; ages 10-13 years) with DS and persistent, severe OSA (AHI > 10 events/h) underwent hypoglossal nerve stimulator implantation and were followed for 44-58 months. SETTING: Participants completed in-lab sleep studies at baseline (before implantation), 1 year postoperatively, and 44-58 months postoperatively. During their most recent follow-up, 2 participants completed split-night sleep studies in which assessment was done with the device both on and off. INTERVENTIONS: Hypoglossal nerve stimulator implantation. MAIN OUTCOMES AND MEASURES: Stability in titrated and untitrated OSA as measured by the apnea-hypopnea index (AHI); growth measures including BMI; and quality of life as measured by the OSA-18 questionnaire. RESULTS: Compared to baseline, all 4 participants maintained reductions of at least 50% in AHI over the course of follow-up. At recent follow-up, two participants had persistent, moderate OSA despite stimulation therapy. The other two participants achieved 100% reductions in AHI with stimulation therapy; when they underwent split-night sleep studies, the severe OSA persisted with the device turned off. Improvement in OSA-18 quality of life scores was observed in three of the four participants. CONCLUSION: and Relevance: Hypoglossal nerve stimulation continues to effectively control OSA in children with DS as they mature, while their underlying untitrated OSA appears to persist into adulthood. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT2344108.

Characteristics of the Dual Board-Certified Sleep Otolaryngology Workforce.

OBJECTIVE: Sleep medicine is a multidisciplinary field that includes otolaryngology. After 2011, sleep medicine board eligibility required completion of a dedicated sleep medicine fellowship. The objective of our study is to describe the characteristics and geographic distribution of the dual board-certified sleep otolaryngology workforce and to assess the impact of the 2011 change. METHODS: A cross-sectional analysis of sleep-certified otolaryngologists registered with the American Board of Otolaryngology-Head and Neck Surgery in 2019 was performed to characterize the sleep otolaryngology workforce. County and regional analysis of provider density was conducted by comparing provider characteristics with county-level data from the United States Census Bureau. RESULTS: There were 275 active dual board-certified sleep otolaryngologists, or approximately 1 for every 1.12 million Americans. 77.8% were in private practice and 2.9% had American Society of Pediatric Otolaryngology membership. Eighty-eight percent were male, with females more likely than males to be in an academic setting (36.4% for females compared to 20.2% for males; P = .045). The South Atlantic and South Central regions had the highest number of sleep board-certified otolaryngologists per capita. Before 2011, an average of 75.7 otolaryngologists took the sleep board exam per 2-year cycle, compared to 14.3 otolaryngologists after 2011 (P = .029). CONCLUSION: There are few dual board-certified sleep otolaryngologists across the country, which may affect care for patients with sleep-disordered breathing. Increased resident exposure and otolaryngology training in sleep medicine can strengthen the otolaryngology contribution to the multidisciplinary care of these patients. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:E2712-E2717, 2021.

Redefining Success by Focusing on Failures After Pediatric Hypoglossal Stimulation in Down Syndrome.

OBJECTIVES/HYPOTHESIS: Patients with Down syndrome have a high incidence of obstructive sleep apnea (OSA) and limited treatment options. Hypoglossal stimulation has shown efficacy but has not yet been approved for pediatric populations. Our objective is to characterize the therapy response of adolescent patients with down syndrome and severe OSA who underwent hypoglossal stimulation. STUDY DESIGN: Prospective longitudinal trial. METHODS: We are conducting a multicenter single-arm trial of hypoglossal stimulation for adolescent patients with Down syndrome and severe OSA. Interim analysis was performed to compare objective sleep and quality of life outcomes at 12 months postoperatively for the first 20 patients. RESULTS: The mean age was 15.5 and baseline AHI 24.2. Of the 20 patients, two patients (10.0%) had an AHI under 1.5 at 12 months; nine patients of 20 (45.0%) under five; and 15 patients of 20 (75.0%) under 10. The mean decrease in AHI was 15.1 (P < .001). Patients with postoperative AHI over five had an average baseline OSA-18 survey score of 3.5 with an average improvement of 1.7 (P = .002); in addition, six of these patients had a relative decrease of apneas compared to hypopneas and seven had an improvement in percentage of time with oxygen saturation below 90%. CONCLUSIONS: Patients with persistently elevated AHI 12 months after hypoglossal implantation experienced improvement in polysomnographic and quality of life outcomes. These results suggest the need for a closer look at physiologic markers for success beyond reporting AHI as the gold standard. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:1663-1669, 2021.

The Impact of Nasal Obstruction and Functional Septorhinoplasty on Sleep Quality.

Importance: Functional septorhinoplasty (FSRP) has been shown to improve both global and disease-specific quality of life (QOL). However, the mechanism by which FSRP improves QOL has not been fully defined. We reasoned that NAO may impact sleep quality and, therefore, studied the relationship using validated patient-reported outcome measures. Objective: To investigate the correlation between NAO and sleep quality using Nasal Obstruction Symptom Evaluation (NOSE) and Functional Outcomes of Sleep Quality (FOSQ-10) questionnaires, and to evaluate the effect of FSRP on NAO and sleep quality. Design, Setting, and Participants: This is a prospective longitudinal study of 125 patients undergoing FSRP for the repair of NAO between November 2017 and April 2019 in a university-based tertiary care medical center. The individuals (mean age = 38 ± 15.6 years, 65 females; 52%) were invited to complete the FOSQ-10 survey preoperatively and at 2, 4, 6, and 12 months postoperatively, and 122 of these patients also completed the NOSE questionnaire. Sixty individuals who reported a history of snoring also completed the Snoring Outcomes Survey (SOS). Twelve of 125 patients had obstructive sleep apnea. Patient demographics, nasal surgery, and medical histories and outcomes were analyzed. Intervention: Functional septorhinoplasty. Main Outcomes and Measures: Comparison of pre- and postoperative sleep and NAO scores to determine the correlation between the severity of NAO and sleep quality and the impact of correction of NAO on sleep quality. Results: A total of 125 patients completed FOSQ-10 questionnaire with a median score of 18.00 (IQR = 15.33-19.66) at baseline. Among these individuals, 122 patients completed the NOSE questionnaire with a median score of 65 (IQR = 45-75). A negative correlation between NOSE and FOSQ-10 scores was found at baseline (r = -0.380, p < 0.001). There was a significant difference in baseline FOSQ-10 scores between individuals with (n = 12, mean FOSQ-10 score = 13.28 ± 3.19) (p < 0.001) and without sleep apnea (n = 100, mean FOSQ-10 score = 17.24 ± 3.21). After FSRP, the NOSE and FOSQ-10 scores improved at each postoperative follow-up time point. The change in FOSQ-10 scores was statistically significant at months 2, 4, and 6 (p < 0.001) but not at month 12 (p = 0.161). The NOSE scores were statistically different from baseline level for each postoperative follow-up visits (p < 0.001-months 2, 4, and 6 and p = 0.031-month 12). The distribution of NOSE scores was not different statistically (p = 0.984). The negative correlation between NOSE and FOSQ-10 mean scores that was demonstrated at baseline increases postoperatively (r = 0.508, p < 0.001). Conclusions and Relevance: FSRP can improve both symptoms of NAO and sleep quality. The increased correlation between NAO and sleep quality after surgery is consistent with the hypothesis that improvement in NAO improves sleep quality and QOL.

The Role of Body Mass Index on Hearing Outcomes After Stapes Surgery.

BACKGROUND: Increased body mass index (BMI) has been associated with postoperative complications in multiple surgical specialties. In otologic surgery involving the stapes, where appropriate patient positioning and surgical dexterity are necessary for proper prosthesis placement, patients with higher BMI could make surgery more challenging. The purpose of this study is to evaluate the impact of BMI on outcomes after stapes surgery. METHODS: Medical records were examined from January 2015 to December 2017 in patients undergoing stapedectomy or stapedotomy at two tertiary care facilities. A retrospective cohort analysis comparing hearing outcomes on postoperative audiogram following procedural intervention with BMI was performed. The primary outcome was postoperative air-bone gap (dB) on audiogram. RESULTS: Two hundred sixty three stapedotomy and stapedectomy patients were included in the study. Six percent had BMI less than 18.5 (underweight), 30% had BMI between 18.6 and 24.9 (normal weight), 38% had BMI between 25 and 29.9 (overweight), 24% had BMI above 30 (obese). The mean preoperative and postoperative air-bone gap (ABG) was 27.0 dB (standard deviation [SD] 15) and 10.4 dB (SD 10.6), respectively, with a postoperative ABG less than or equal to 20 dB in 87% of cases. There were no significant differences in postoperative ABG results when comparing the BMI categories (p = 0.11). CONCLUSIONS: Stapedotomy and stapedectomy are effective surgeries that can be performed by experienced surgeons with successful hearing improvement. While high BMI patients may be a challenge to position appropriately for their surgery, this does not translate to altered otologic outcomes for these patients.

A Comparative Health Utility Value Analysis of Outcomes for Patients Following Septorhinoplasty With Previous Nasal Surgery.

IMPORTANCE: Using health utility values (HUVs) as an outcome measure for surgical procedures, including rhinoplasty, allows for a standardized measurement of the qualitative and financial benefit of that procedure on overall health. OBJECTIVE: To use Euroqol 5-Dimension (EQ-5D)-derived HUVs to evaluate nasal obstruction outcomes following surgery between primary rhinoplasty (PSRP) and rhinoplasty with previous nasal surgery (RNS) in a prospective cohort study. DESIGN, SETTING, AND PARTICIPANTS: A single-institution prospective cohort study between 2013 and 2017 was carried out including 185 patients who underwent RNS before functional rhinoplasty and 278 patients who underwent PSRP for nasal obstruction. The analysis was carried out between December 2018 and February 2019. MAIN OUTCOMES AND MEASURES: Patients in the RNS cohort and PSRP cohort who completed the EQ-5D questionnaire immediately prior to surgery and postoperatively at 2, 4, 6, and 12 months were included in the study. The EQ-5D scores were converted to HUV scores and compared to evaluate for improvement in health status following surgery. RESULTS: Of the 185 patients in the RNS cohort, 97 (52%) were women and the mean (SD) age was 42.6 (13.4) years. Of the 278 in the PSRP cohort, 156 (55%) were women and the mean (SD) age was 36.0 (15.8) years. Both cohorts experienced significant improvement in HUV postoperatively. The mean (SD) HUV values were decreased in the RNS cohort versus the PSRP cohort both preoperatively (0.85 [0.16] versus 0.89 [0.14]) and postoperatively at 1 year (0.92 [0.14] versus 0.94 [0.11]); however, the difference in HUV was not statistically significant after 6 months postoperatively. Patients in the RNS cohort were typically older (76 [41%] older than 40 years vs 84 [31%], P = .02) and more likely to have sleep apnea (31 [19%] vs 24 [10%], P = .01) than in the PSRP cohort. On multivariable analysis, the use of spreader grafts and alar rim grafts in the PSRP cohort was significantly associated with improved HUV at 12 months. (r = -0.06; 95% CI, -0.11 to -0.01, P = .03). CONCLUSIONS AND RELEVANCE: Patients with a history of prior nasal surgery may represent a unique cohort when assessing health utility outcomes. Euroqol 5-dimension questionnaire-derived HUVs are a valid predictor of outcomes in all patients who undergo septorhinoplasty. Although outcomes were significantly improved for both cohorts, previous surgical history should be considered when performing cost utility analysis on the benefits of functional rhinoplasty. LEVEL OF EVIDENCE: 3.

Prognostic Case Volume Thresholds in Patients With Head and Neck Squamous Cell Carcinoma.

IMPORTANCE: Though described as an important prognostic indicator, facility case volume thresholds for patients with head and neck squamous cell carcinoma (HNSCC) have not been previously developed to date. OBJECTIVE: To identify prognostic case volume thresholds of facilities that manage HNSCC. DESIGN, SETTING, AND PARTICIPANTS: Retrospective analysis of 351 052 HNSCC cases reported from January 1, 2004, through December 31, 2014, by Commission of Cancer-accredited cancer centers from the US National Cancer Database. Data were analyzed from August 1, 2018, to April 5, 2019. EXPOSURES: Treatment of HNSCC at facilities with varying case volumes. MAIN OUTCOMES AND MEASURES: Using all-cause mortality outcomes among adult patients with HNSCC, 10 groups with increasing facility case volume were created and thresholds were identified where group survival differed compared with each of the 2 preceding groups (univariate log-rank analysis). Groups were collapsed at these thresholds and the prognostic value was confirmed using multivariable Cox regression. Prognostic meaning of these thresholds was assessed in subgroups by category (localized [I/II] and advanced [III/IV]), without metastasis (M0), with metastasis (M1), and anatomic subsites (nonoropharyngeal HNSCC and oropharyngeal HNSCC with known human papillomavirus status). RESULTS: Of 250 229 eligible patients treated at 1229 facilities in the United States, there were 185 316 (74.1%) men and 64 913 (25.9%) women and the mean (SD) age was 62.8 (12.1) years. Three case volume thresholds were identified (low: ≤54 cases per year; moderate: >54 to ≤165 cases per year; and high: >165 cases per year). Compared with the moderate-volume group, multivariate analysis found that treatment at low-volume facilities (LVFs) was associated with a higher risk of mortality (hazard ratio [HR], 1.09; 99% CI, 1.07-1.11), whereas treatment at high-volume facilities (HVFs) was associated with a lower risk of mortality (HR, 0.92; 99% CI, 0.89-0.94). Subgroup analysis with Bonferroni correction revealed that only the moderate- vs low- threshold had meaningful differences in outcomes in localized stage (I/II) cancers, (LVFs vs moderate-volume facilities [MVFs]: HR, 1.09 [99% CI, 1.05-1.13]; HVF vs MVF: HR, 0.95 [99% CI, 0.90-1.00]), whereas both thresholds were meaningful in advanced stage (III/IV) cancers (LVF vs MVF: HR, 1.09 [99% CI, 1.06-1.12]; HVF vs MVF: HR, 0.91 [99% CI, 0.88-0.94]). Survival differed by prognostic thresholds for both M0 (LVF vs MVF: HR, 1.09 [99% CI, 1.07-1.12]; HVF vs MVF: HR, 0.91 [99% CI, 0.89-0.94]) and nonoropharyngeal HNSCC (LVF vs MVF: HR, 1.10 [99% CI, 1.07-1.13]; HVF vs MVF: HR, 0.93 [99% CI, 0.90-0.97]) site cases, but not for M1 (LVF vs MVF: HR, 1.00 [99% CI, 0.92-1.09]; HVF vs MVF: HR, 0.94 [99% CI, 0.83-1.07]) or oropharyngeal HNSCC cases (when controlling for human papillomavirus status) (LVF vs MVF: HR, 1.10 [99% CI, 0.99-1.23]; HVF vs MVF: HR, 1.07 [99% CI, 0.94-1.22]). CONCLUSIONS AND RELEVANCE: Higher volume facility threshold results appear to be associated with increases in survival rates for patients treated for HNSCC at MVFs or HVFs compared with LVFs, which suggests that these thresholds may be used as quality markers.

Postoperative care in an intermediate-level medical unit after head and neck microvascular free flap reconstruction.

OBJECTIVE: The need for intensive care unit (ICU) admission and mechanical ventilation after head and neck microvascular free flap reconstructive surgery remains controversial. Our institution has maintained a longstanding practice of immediately taking patients off mechanical ventilation with subsequent transfer to intermediate, non-ICU level of care with specialized otolaryngologic nursing. Our objective was to describe postoperative outcomes for a large cohort of patients undergoing this protocol and to examine the need for routine ICU transfer. MATERIALS AND METHODS: We performed a retrospective review of 512 consecutive free flaps treated with a standard protocol of immediate postoperative transfer to an intermediate-level care unit with specialized otolaryngology nursing. Outcome measures included ICU transfer, ventilator requirement, flap failure, postoperative complications, and length of stay. Predictors of ICU transfer were identified by multivariable logistic regression. RESULTS: The vast majority of patients did not require intensive care. Only a small fraction (n = 18 patients, 3.5%) subsequently transferred to the ICU, most commonly for respiratory distress, cardiac events, and infection. The most common complications were delirium/agitation (n = 55; 10.7%) and pneumonia (n = 51; 10.0%). Sixty-five cases (12.7%) returned to the OR, most commonly for hematoma/bleeding (n = 41; 8.0%) and anastomosis revision (n = 20; 3.9%). Heavy alcohol consumption and greater number of medical comorbidities were significant predictors of subsequent ICU transfer. CONCLUSIONS: Among head and neck free flap patients, routine cessation of mechanical ventilation and transfer to intermediate-level care with specialized ENT nursing was found to be safe with infrequent subsequent ICU transfer and low complication rates. Routine transfer to intermediate-level care in this population may prevent unnecessary ICU utilization and facilitate the delivery of high-value, disease-centered care. LEVEL OF EVIDENCE: 3b.

Prognostic Value of Lymph Node Yield and Density in Head and Neck Malignancies.

Objective Studies have suggested that the lymph node yield and lymph node density from selective or elective neck dissections are predictive of patient outcomes and may be used for patient counseling, treatment planning, or quality measurement. Our objective was to systematically review the literature and conduct a meta-analysis of studies that investigated the prognostic significance of lymph node yield and/or lymph node density after neck dissection for patients with head and neck cancer. Data Sources The Ovid/Medline, Ovid/Embase, and NLM PubMed databases were systematically searched on January 23, 2017, for articles published between January 1, 1946, and January 23, 2017. Review Methods We reviewed English-language original research that included survival analysis of patients undergoing neck dissection for a head and neck malignancy stratified by lymph node yield and/or lymph node density. Study data were extracted by 2 independent researchers (S.C. and M.O.). We utilized the DerSimonian and Laird random effects model to account for heterogeneity of studies. Results Our search yielded 350 nonduplicate articles, with 23 studies included in the final synthesis. Pooled results demonstrated that increased lymph node yield was associated with a significant improvement in survival (hazard ratio, 0.833; 95% CI, 0.790-0.879). Additionally, we found that increased lymph node density was associated with poorer survival (hazard ratio, 1.916; 95% CI, 1.637-2.241). Conclusions Increased nodal yield portends improved outcomes and may be a valuable quality indicator for neck dissections, while increased lymph node density is associated with diminished survival and may be used for postsurgical counseling and planning for adjuvant therapy.

Treatment deintensification in human papillomavirus-positive oropharynx cancer: Outcomes from the National Cancer Data Base.

BACKGROUND: The growing epidemic of human papillomavirus-positive (HPV+) oropharyngeal cancer and the favorable prognosis of this disease etiology have led to a call for deintensified treatment for some patients with HPV+ cancers. One of the proposed methods of treatment deintensification is the avoidance of chemotherapy concurrent with definitive/adjuvant radiotherapy. To the authors' knowledge, the safety of this form of treatment de-escalation is unknown and the current literature in this area is sparse. The authors investigated outcomes after various treatment combinations stratified by American Joint Committee on Cancer (AJCC) eighth edition disease stage using patients from the National Cancer Data Base. METHODS: A retrospective study of 4443 patients with HPV+ oropharyngeal cancer in the National Cancer Data Base was conducted. Patients were stratified into AJCC eighth edition disease stage groups. Multivariate Cox regressions as well as univariate Kaplan-Meier analyses were conducted. RESULTS: For patients with stage I disease, treatment with definitive radiotherapy was associated with diminished survival compared with chemoradiotherapy (hazard ratio [HR], 1.798; P = .029), surgery with adjuvant radiotherapy (HR, 2.563; P = .002), or surgery with adjuvant chemoradiotherapy (HR, 2.427; P = .001). For patients with stage II disease, compared with treatment with chemoradiotherapy, patients treated with a single-modality (either surgery [HR, 2.539; P = .009] or radiotherapy [HR, 2.200; P = .030]) were found to have poorer survival. Among patients with stage III disease, triple-modality therapy was associated with improved survival (HR, 0.518; P = .024) compared with treatment with chemoradiotherapy. CONCLUSIONS: Deintensification of treatment from chemoradiotherapy to radiotherapy or surgery alone in cases of HPV+ AJCC eighth edition stage I or stage II disease may compromise patient safety. Treatment intensification to triple-modality therapy for patients with stage III disease may improve survival in this group. Cancer 2018;124:717-26. © 2017 American Cancer Society.