Double blind randomized controlled trial measuring the efficacy of nebulized steroid at half dose in comparison to high volume squeeze bottle steroid irrigation in management of patients with chronic rhinosinusitis.

KEY POINTS: Nebulized budesonide is effective at half dose compared to budesonide irrigation in CRS. Nasal nebulizers provide an alternative for delivery of topical steroids to the sinuses.

Sleep apnea multi-level surgery trial: long-term observational outcomes.

STUDY OBJECTIVES: The sleep apnea multi-level surgery (SAMS) randomized clinical trial showed surgery improved outcomes at 6 months compared to ongoing medical management in patients with moderate or severe obstructive sleep apnea (OSA) who failed continuous positive airway pressure therapy. This study reports the long-term outcomes of the multi-level surgery as a case series. METHODS: Surgical participants were reassessed >2 years postoperatively with the same outcomes reported in the main SAMS trial. Primary outcomes were apnea-hypopnea index (AHI) and Epworth sleepiness scale (ESS), with secondary outcomes including other polysomnography measures, symptoms, quality of life, and adverse events. Long-term effectiveness (baseline to long-term follow-up [LTFU]) and interval changes (6 month to LTFU) were assessed using mixed effects regression models. Control participants were also reassessed for rate of subsequent surgery and outcomes. RESULTS: 36/48 (75%) of surgical participants were reevaluated (mean (standard deviation)) 3.5 (1.0) years following surgery, with 29 undergoing polysomnography. AHI was 41/h (23) at preoperative baseline and 21/h (18) at follow-up, representing persistent improvement of -24/h (95% CI -32, -17; p < 0.001). ESS was 12.3 (3.5) at baseline and 5.5 (3.9) at follow-up, representing persistent improvement of -6.8 (95% CI -8.3, -5.4; p < 0.001). Secondary outcomes were improved long term, and adverse events were minor. Interval change analysis suggests stability of outcomes. 36/43 (84%) of the control participants were reevaluated, with 25 (69%) reporting subsequent surgery, with symptom and quality of life improvements. CONCLUSION: Multi-level upper airway surgery improves OSA burden with long-term maintenance of treatment effect in adults with moderate or severe OSA in whom conventional therapy failed. CLINICAL TRIAL: Multi-level airway surgery in patients with moderate-severe obstructive sleep apnea (OSA) who have failed medical management to assess change in OSA events and daytime sleepiness; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366019&isReview=true; ACTRN12614000338662.

Swallowing biomechanics in tracheostomised critically ill patients compared to age- and gender-matched healthy controls.

Objective: The mechanistic effects of a tracheostomy on swallowing are unclear. Pharyngeal high-resolution manometry with impedance (P-HRM-I) is a novel swallow assessment tool providing quantifiable metrics. This study aimed to characterise swallowing biomechanics in tracheostomised critically ill (non-neurological) patients. Design: Cohort study. Setting: Australian tertiary hospital intensive care unit. Participants: Tracheostomised adults, planned for decannulation. Main outcome measures: Swallowing assessment using P-HRM-I, compared to healthy age- and gender-matched controls. Results: In this tracheostomised cohort (n = 10), the Swallow Risk Index, a global measure of swallow function, was significantly elevated (p < 0.001). At the upper oesophageal sphincter (UOS), hypopharyngeal intrabolus pressure and UOS integrated relaxation pressure were significantly elevated (control 0.65 mmHg [-1.02, 2.33] v tracheostomy 13.7 mmHg [10.4, 16.9], P < 0.001; control -4.28 mmHg [-5.87, 2.69] v tracheostomy 12.2 mmHg [8.83, 15.6], P < 0.001, respectively). Furthermore, UOS opening extent and relaxation time were reduced (control 4.83 mS [4.60, 5.07] v tracheostomy 4.33 mS [3.97, 4.69], P = 0.002; control 0.52 s [0.49, 0.55] v tracheostomy 0.41 s [0.37, 0.45], P < 0.001, respectively). Total pharyngeal contractility (PhCI) measuring pharyngeal pressure generation was significantly elevated (control 199.5 mmHg cm.s [177.4, 221.6] v tracheostomy 326.5 mmHg cm.s [253.3, 399.7]; P = 0.001). Conclusion: In a critically ill tracheostomised cohort, UOS dysfunction was the prevalent biomechanical feature, with elevated pharyngeal pressures. Pharyngeal weakness is not contributing to dysphagia in this cohort. Instead, elevated pharyngeal pressures may represent a compensatory mechanism to overcome the UOS dysfunction. Further studies to extend these findings may inform the development of timely and targeted rehabilitation.

The impact of multifocal perineural invasion in predicting survival in patients with oral squamous cell carcinoma: A multicenter investigation.

BACKGROUND: Perineural invasion (PNI) in oral squamous cell carcinoma (OSCC) does not contribute to the current American Joint Committee on Cancer 8th edition (AJCC8) staging manual. This study seeks to validate the effect of multifocal PNI in a large cohort of patients. METHODS: Patients undergoing primary surgical treatment of OSCC with curative intent between 1995 and 2022 was retrieved from two Australian head and neck databases. PNI was categorized as a single focus or multiple foci. Study end points included disease-specific survival (DSS) and overall survival (OS). RESULTS: Complete data for survival analysis was available in 993 patients. Multifocal PNI was associated with a 61% increased risk of death due to OSCC (HR 1.61, 95% CI 1.11-2.33, p = 0.014) and a 32% increased risk of death from any cause (HR 1.32, 95% CI 1.01-1.73, p = 0.045). CONCLUSIONS: Multifocal PNI is a significant predictor of survival in OSCC.

The Indigenous Australian Human Papillomavirus (HPV) Cohort Study 2, Continuation for 5 to 10 Years: Protocol for a Longitudinal Study.

BACKGROUND: Human papillomavirus (HPV) infection, a common sexually transmitted disease, is associated with cancers of the cervix, vulva, vagina, penis, anus, and head and neck. Oropharyngeal squamous cell carcinoma (OPSCC; throat cancer) is a type of cancer involving the head and neck area that is rapidly increasing across the globe. There are higher rates of OPSCC among Indigenous populations relative to non-Indigenous Australian populations, although the HPV-attributable fraction remains unknown. For the first time at a global level, we plan to extend an Indigenous Australian adult cohort to monitor, screen, and ultimately prevent HPV-associated OPSCC and to undertake extensive cost-effectiveness modelling around HPV vaccination. OBJECTIVE: This study aims to (1) extend follow-up to a minimum of 7 years post recruitment to describe the prevalence, incidence, clearance, and persistence of oral HPV infection; and (2) conduct clinical examinations of the head and neck, oral cavity, and oropharynx and collect saliva samples for early-stage OPSCC testing. METHODS: We will continue to implement a longitudinal design for the next study phase, where we will ascertain the prevalence, incidence, clearance, and persistence of oral HPV infection at 48, 60, and 72 months; undertake clinical examinations/saliva assessments to detect early-stage OPSCC; and refer for treatment. The primary outcome measures are changes in oral HPV infection status, biomarker measures of early HPV-related cancer, and clinical evidence of early-stage OPSCC. RESULTS: Participant 48-month follow-up will commence in January 2023. The first results are expected to be submitted for publication 1 year after 48-month follow-up begins. CONCLUSIONS: Our findings have potential to change the way in which OPSCC among Australian Indigenous adults is managed, with desired impacts including cost-savings on expensive cancer treatments; improved nutritional, social, and emotional outcomes; and improved quality of life for both Indigenous adults and the Indigenous community more broadly. Continuing a large, representative Indigenous adult cohort to track oral HPV infection and monitor early OPSCC is essential to yield critical information to include in the management armamentarium of health and well-being recommendations for Australia's First Nations. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/44593.

BiZact™ tonsillectomy: Predictive factors for post-tonsillectomy haemorrhage from a 1717 case series.

OBJECTIVE: To determine primary and secondary post-tonsillectomy haemorrhage (PTH) rates and identify predictive factors in a cohort of consecutive adult and paediatric BiZact™ tonsillectomy cases. SETTING: Retrospective cohort study. Patients from Flinders Medical Centre, Noarlunga Hospital and private otolaryngology practices who underwent BiZact™ tonsillectomy from 2017 to 2020. DATA COLLECTED: patient age, indication for tonsillectomy, surgeon experience, time and severity of PTH, including return to theatre. Each secondary PTH was graded using the Stammberger classification. Logistic regression was utilised to identify predictors of secondary PTH. RESULTS: One thousand seven hundred and seventeen patient medical records were assessed (658 adults and 1059 children). The primary PTH rate was 0.1%, and secondary PTH rate was 5.9%. The majority of secondary PTH cases were Stammberger grade A (80/102, 78.4%) requiring observation only. Few secondary PTH required medical intervention (grade B; 9/102, 8.8%), return to theatre (grade C; 12/102, 11.8%), or blood transfusion (grade D; 1/102, 1.0%), with no death reported (grade E; 0/102, 0.0%). Recurrent secondary PTH occurred in 8 patients (0.5%). Predictive factors of secondary PTH in children were surgeon experience with trainees having greater chance of PTH (OR 2.502, 95% CI 1.345-4.654; p = .004) and age of child (OR 1.095, 95% CI 1.025-1.170; p = .007). Surgeon experience was a predictive factor for adults (OR 3.804, 95% CI 2.139-6.674; p < .001). CONCLUSIONS: BiZact™ tonsillectomy has a low primary PTH rate, with a secondary PTH rate comparable to other 'hot tonsillectomy' techniques. The majority of PTH events were minor and self-reported. There appears to be a learning curve for trainee surgeons.

Prognostic Value of 18 F-Fluoro-Deoxyglucose-Positron Emission Tomography Volumetric Parameters in Human Papillomavirus-Related Oropharyngeal Squamous Cell Carcinoma.

BACKGROUND: This study evaluates and compares the prognostic significance of 18 F-fluoro-deoxyglucose-positron emission tomography (18 F-FDG PET) volumetric parameters in human papillomavirus-related oropharyngeal squamous cell carcinoma (OPSCC). METHODS: A retrospective review of all patients treated for OPSCC with curative intent between 2012 and 2018 was performed. Volumetric parameters analyzed included the maximum standardized uptake value (SUVmax ), SUVpeak , metabolic tumor volume (MTV), and total lesion glycolysis (TLG) in both the primary tumor and nodal metastases. Prognostic significance was determined using Cox proportional hazards models for disease-free survival (DFS) and overall survival (OS). RESULTS: Primary tumor MTV and TLG significantly correlated with both DFS and OS however the commonly reported SUVmax was not found to be predictive. Nodal measures of SUVmax , MTV, and TLG were not significant predictors of survival outcomes. CONCLUSION: A higher burden of metabolically active primary tumor as measured on volumetric 18 F-FDG PET parameters is associated with poorer DFS and OS. This improved prognostication may be used to counsel patients and select those appropriate for treatment de-escalation in the future. LEVEL OF EVIDENCE: 3 Laryngoscope, 133:1667-1672, 2023.

An observational pragmatic quality-of-life study on paediatric tonsillectomy and waiting for surgery.

PURPOSE: To investigate parental perceptions of the effects of tonsillectomy on their child's quality of life while awaiting and following surgery in an Australian public health system. METHODS: An observational pragmatic study was undertaken at a tertiary Australian hospital. Parents of paediatric patients (2-16 years of age) listed for tonsillectomy completed a validated quality-of-life questionnaire (T-14 Paediatric Throat Disorders Outcome Test) at the initial consultation, on day of surgery, 6 weeks post-operatively and 6 months post-operatively. T-14 scores were compared using the Related-Samples Wilcoxon Signed Rank Test. RESULTS: Parents of 167 children participated in this study. There was a median wait time of 174 days (IQR 108-347) from the initial consultation until the day of surgery, with no significant change in median T-14 scores (35 [IQR 22-42] vs 36 [IQR 22-42]; n = 63; p > 0.05). There was a significant decrease from pre-operative T-14 scores to 6 weeks post-operatively (33.5 [IQR 22-42] vs 2 [IQR 0-5]; n = 160; p < 0.001), and this was sustained with a minor improvement at 6 months post-operatively (6 weeks 2 [IQR 0-5] vs 6 months 0 [IQR 0-2]; n = 148; p < 0.001). CONCLUSIONS: Paediatric tonsillectomy improves quality of life with a sustained benefit in the long term. There is no improvement to the patient's quality of life while awaiting tonsillectomy, thus patient welfare can be improved through reducing waiting times for surgery.

Anterior Pedicled Nasal Flap in Frontal Sinus Drill-Out Patients: A Randomised Controlled Pilot Study.

Background: The endoscopic modified Lothrop procedure (EMLP) is a common procedure performed in patients with frontal sinus pathology. While performing this procedure, large segments of bone are exposed, which may lead to the promotion of frontal sinus neo-ostium stenosis. Here we examine the peri-operative differences in time to achieve healing in patients where a mucosal flap is used to cover the exposed bone on one side of the neo-ostium. Design: A randomised pilot study with 12 patients undergoing EMLP surgery participated in this study. Methods: Patients were randomised to undergo a mucosal flap on either the left or right side of the neo-ostium. Prior to surgery, patients completed a SNOT-22 and smell identification test. Patients were reviewed until the neo-ostium had healed on both sides. Once healing had occurred, a post-operative SNOT-22 score and smell identification test were recorded. Results: Average time to healing for the frontal sinus neo-ostium was 4.7 vs. 4.2 (p = 0.3) on the flap vs. non-flap side, respectively. There was an average 24.4 point (range: -75 to +9) decrease in SNOT-22 scores post-surgery. The post-operative USPIT score demonstrated an average increase of 6.6 points (range -13 to +27). Conclusion: We did not detect significant differences in peri-operative time toward healing in neo-ostiums where a single flap is utilised. Further studies are needed to determine whether the usage of a single neo-ostium flap affords any benefit over no flap on either ostium. SNOT-22 and UPSIT scores improved post-surgery.

Pharyngeal tongue base augmentation for dysphagia therapy: A prospective case series in patients post head and neck cancer treatment.

BACKGROUND: Dysphagia post head and neck cancer (HNC) multimodality treatment is attributed to reduced pharyngeal strength. We hypothesized that pharyngeal tongue base augmentation for dysphagia (PAD therapy) would increase pharyngeal pressures during swallowing thereby improving swallow symptoms. METHODS: Adults with moderate-severe dysphagia post-HNC treatment had PAD therapy using a temporary filler (hyaluronic acid [HA]), with follow-up long-lasting lipofilling. Swallowing preprocedure and postprocedure was assessed with the Sydney Swallow Questionnaire (SSQ), High-Resolution Pharyngeal Manometry (HRPM), and Videofluoroscopic Swallowing Study (VFSS). Statistical comparison utilized paired tests. RESULTS: Six participants (all male; median age 64 years [IQR 56, 71]) underwent PAD therapy at a median of 47 [IQR 8, 95] months post-treatment. SSQ scores reduced from baseline (mean 1069 [95%CI 703, 1434]) to post-HA (mean 579 [76, 1081], p > 0.05), and post-lipofilling (491 [95%CI 913, 789], p = 0.003, n = 4). Individual participants demonstrated reduced Swallow Risk Index, Bolus Presence Time, and increased Upper Esophageal Sphincter opening, but mesopharyngeal contractile pressures were unchanged. VFSS measures of aspiration, residue, and severity were unchanged. CONCLUSIONS: Novel PAD therapy is safe and improves dysphagia symptoms. Biomechanical swallowing changes are suggestive of more efficacious bolus propulsion with conservative filler volume, but this was unable to resolve residue or aspiration measures.

Delays in Time to Head and Neck Cancer Treatment: A South Australian Perspective.

Background and Objectives: In head and neck cancer, delays in time to treatment are associated with poorer clinical outcomes. Within Australia, it is recommended that primary treatment is initiated within 56 days of initial referral. The aim of this study was to assess whether head and neck cancer treatment was delivered within these timeframe guidelines at our institution and identify factors associated with treatment delays. Methods: This retrospective cohort study assessed patients newly diagnosed with head and neck cancer over a 24 months period (2018 to 2019) at Flinders Medical Centre, Australia. Time to treatment intervals were calculated for comparison to local timeframe guidelines. Results: A total of 72 patients met the inclusion criteria. The median time from specialist referral to treatment initiation was 45.5 days (IQR 29-61), with 72% meeting the 56 days guideline. On univariate logistic regression, patients undergoing primary radiotherapy treatment were less likely to meet this guideline than those undergoing primary surgery (OR 8.8, 95% CI 2.6-28.9, p < 0.001), as were those requiring prophylactic gastrostomy tube insertion (OR 3.1, 95% CI 1.1-9.0, p < 0.05). Treatment initiation beyond 56 days had no significant impact on 12 months overall survival or disease-free survival. Conclusions: The findings of this study demonstrate that primary radiotherapy treatment is associated with delays in head and neck cancer treatment initiation, likely related to time consuming pre-treatment factors such as gastrostomy tube insertion.

Ear microbiota and middle ear disease: a longitudinal pilot study of Aboriginal children in a remote south Australian setting.

BACKGROUND: Otitis media (OM) is a major disease burden in Australian Aboriginal children, contributing to serious long-term health outcomes. We report a pilot analysis of OM in children attending an outreach ear and hearing clinic in a remote south Australian community over a two-year period. Our study focuses on longitudinal relationships between ear canal microbiota characteristics with nasopharyngeal microbiota, and clinical and treatment variables. RESULTS: Middle ear health status were assessed in 19 children (aged 3 months to 8 years) presenting in remote western South Australia and medical interventions were recorded. Over the two-year study period, chronic suppurative OM was diagnosed at least once in 7 children (37%), acute OM with perforation in 4 children (21%), OM with effusion in 11 children (58%), while only 1 child had no ear disease. Microbiota analysis of 19 children (51 sets of left and right ear canal swabs and nasopharyngeal swabs) revealed a core group of bacterial taxa that included Corynebacterium, Alloiococcus, Staphylococcus, Haemophilus, Turicella, Streptococcus, and Pseudomonas. Within-subject microbiota similarity (between ears) was significantly greater than inter-subject similarity, regardless of differences in ear disease (p = 0.0006). Longitudinal analysis revealed changes in diagnosis to be associated with more pronounced changes in microbiota characteristics, irrespective of time interval. Ear microbiota characteristics differed significantly according to diagnosis (P (perm) = 0.0001). Diagnoses featuring inflammation with tympanic membrane perforation clustering separately to those in which the tympanic membrane was intact, and characterised by increased Proteobacteria, particularly Haemophilus influenzae, Moraxella catarrhalis, and Oligella. While nasopharyngeal microbiota differed significantly in composition to ear microbiota (P (perm) = 0.0001), inter-site similarity was significantly greater in subjects with perforated tympanic membranes, a relationship that was associated with the relative abundance of H. influenzae in ear samples (rs = - 0.71, p = 0.0003). Longitudinal changes in ear microbiology reflected changes in clinical signs and treatment. CONCLUSIONS: Children attending the ear and hearing clinic in a remote Aboriginal community present with a broad spectrum of OM conditions and severities, consistent with other remote Aboriginal communities. Ear microbiota characteristics align with OM diagnosis and change with disease course. Nasopharyngeal microbiota characteristics are consistent with the contribution of acute upper respiratory infection to OM aetiology.

Effectiveness of reduced- versus standard-dose radiotherapy on survival and radiation-associated toxicity in patients with human papillomavirus-associated oropharyngeal squamous cell carcinoma: a systematic review protocol.

OBJECTIVE: The objective of this review is to investigate overall survival in patients with human papillomavirus positive oropharyngeal squamous cell carcinoma (HPV+ OPSCC) comparing standard- versus reduced-dose radiotherapy. INTRODUCTION: The improved survival of patients with HPV+ compared to HPV-negative OPSCC has raised the question of reducing the total radiation treatment dose delivered to patients with HPV+ OPSCC. A de-escalated radiotherapy protocol may provide equal oncological benefit, with reduced adverse events/toxicity. INCLUSION CRITERIA: We will include any adult patients aged 18years or older who have undergone curative intent treatment for HPV+ OPSCC. These patients can be at any stage at the time treatment is initiated. Exclusion criteria are as follows: pre-clinical or animal studies, patients with non-squamous cell carcinoma lesions of the oropharynx, patients with primary lesions in other head and neck sites, or patients receiving palliative treatment. METHODS: A three-step search strategy will be used to identify relevant articles for inclusion through MEDLINE, CINAHL, Embase, Web of Science, Scopus, and gray literature sources. These articles will be assessed against our inclusion and exclusion criteria at the title and abstract level as well as at full-text level. Remaining studies will be critically appraised based on their trial design. Data extraction will occur for all studies and, where possible, will be pooled with statistical meta-analysis. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42021252161.

Trans-oral robotic surgery for head and neck cancers using the Medrobotics Flex® system: the Adelaide cohort.

Trans-oral robotic surgery for head and neck cancers can be performed using rigid, multi-port robots with linear access but the Medrobotics Flex® system offers an alternative as it is endo-luminal, single-port, and uses flexible instruments. To assess the utility of the Medrobotics Flex® system for head and neck cancer (HNC) resections. A retrospective review of all HNC resections done over a 2.5-year period (Jan 2017-July 2019) at the Memorial Hospital, using the Flex® system. Data collected include patient demographics, tumour site, tumour stage, p16 status, smoking history, surgery performed, histologic margins, complications, overall survival, recurrence, and adjuvant treatments received. There were 49 head and neck cancer cases in total done using the Medrobotics Flex® system. Median age 60 years, with M:F ratio 3.5:1. Outcomes: oropharyngeal cancers (82%), p16 positive (89%), overall survival (94%), local recurrence (6%), and adjuvant treatment (84%). Cancer procedures done included lateral oropharyngectomy (43%), tongue base mucosectomy (27%), tongue base resection (18%), and others (12%) which include a single case each of supraglottic laryngectomy, hypopharyngeal tumour resection, partial pharyngectomy, partial glossectomy, and vocal cord tumour resection. Clear margins were related to tumour T stage and achieved for T1 tonsil cancer (75%), T2 tonsil cancer (70%), T3 tonsil cancer (50%), T1 tongue base cancer (80%), and T2 tongue base cancer (66.7%). Median operating time with neck dissection was 2 h 40 min, whilst median length of hospital stay was 1 day (IQR 1-7 days). Complications included a single case each of secondary haemorrhage (managed conservatively), oro-cervical fistula, wound infection, tongue numbness, and a medical event. There was no primary haemorrhage and no mortality. The Medrobotics Flex® system is a safe and reliable tool for head and neck cancer surgery.

Swallowing biomechanics before and following multi-level upper airway surgery for obstructive sleep apnea.

STUDY OBJECTIVES: The effect of contemporary multi-level upper airway surgery for obstructive sleep apnea on swallowing is unclear. This study assessed the biomechanical swallowing function in participants with obstructive sleep apnea pre- and post-modified uvulopalatopharyngoplasty and coblation channeling of the tongue. METHODS: In this prospective, longitudinal study, adults diagnosed with moderate-severe obstructive sleep apnea who underwent modified uvulopalatopharyngoplasty and coblation channeling of the tongue surgery had swallowing biomechanics assessed using high-resolution pharyngeal manometry and analyzed with swallowgateway.com. Symptomatic swallowing difficulty was evaluated using the Sydney Swallow Questionnaire (≥ 234). General linear mixed-model analysis was conducted to evaluate the difference pre- and post-modified uvulopalatopharyngoplasty and coblation channeling of the tongue. Data are presented as mean [95% confidence intervals]. RESULTS: High-resolution pharyngeal manometry assessments were conducted in 10 participants (7 men; median age 50 [interquartile range 36-65]) preoperatively and repeated postoperatively at 9 months [interquartile range 6-13]. Self-reported dysphagia was unchanged following surgery (Sydney Swallow Questionnaire =149 [53, 447] to 168 [54, 247]; P = .093). High-resolution pharyngeal manometry outcomes indicated reduced mesopharyngeal pressures (148 [135, 161] to 124 [112, 137] mm Hg s cm; P = .011), reduced hypopharyngeal pressures (113 [101, 125] to 93 [84, 102] mm Hg s cm; P = 0.011), and reduced upper esophageal sphincter relaxation pressure (5 [4, 6] to 2 [1,3] mm Hg; P = 0.001) but no change to velopharyngeal pressures (135 [123, 147] to 137 [117, 157] mm Hg s cm; P = .850) postsurgery. CONCLUSIONS: Modified uvulopalatopharyngoplasty may have less implications on the swallow mechanism than previously suspected. In contrast, the reduction in mesopharyngeal contractile pressures associated with coblation channeling of the tongue, although within normal limits, may affect bolus propulsion. Biomechanical alterations were insufficient to worsen self-reported swallowing function. CITATION: Schar MS, Omari TI, Woods CW, et al. Swallowing biomechanics before and following multi-level upper airway surgery for obstructive sleep apnea. J Clin Sleep Med. 2022;18(4):1167-1176.

Volumetric magnetic resonance imaging analysis of multilevel upper airway surgery effects on pharyngeal structure.

STUDY OBJECTIVES: The Sleep Apnea Multilevel Surgery (SAMS) trial found that modified uvulopalatopharyngoplasty with tonsillectomy (if tonsils present) combined with radiofrequency tongue ablation reduced obstructive sleep apnea (OSA) severity and daytime sleepiness in moderate-severe OSA. This study aimed to investigate mechanisms of effect on apnea-hypopnea index (AHI) reduction by assessing changes in upper airway volumes (airway space, soft palate, tongue, and intra-tongue fat). METHODS: This is a case series analysis of 43 participants of 51 randomized to the surgical arm of the SAMS trial who underwent repeat magnetic resonance imaging (MRI). Upper airway volume, length, and cross-sectional area, soft palate and tongue volumes, and tongue fat were measured. Relationships between changes in anatomical structures and AHI were assessed. RESULTS: The participant sample was predominantly male (79%); mean ± SD age 42.7 ± 13.3 years, body mass index 30.8 ± 4.1 kg/m2, and AHI 47.0 ± 22.3 events/hour. There were no, or minor, overall volumetric changes in the airway, soft palate, total tongue, or tongue fat volume. Post-surgery there was an increase in the minimum cross-sectional area by 0.1 cm2 (95% confidence interval 0.04-0.2 cm2) in the pharyngeal airway, but not statistically significant on corrected analysis. There was no association between anatomical changes and AHI improvement. CONCLUSIONS: This contemporary multilevel upper airway surgery has been shown to be an effective OSA treatment. The current anatomical investigation suggests there are not significant post-operative volumetric changes associated with OSA improvement 6-month post-surgery. This suggests that effect on OSA improvement is achieved without notable deformation of airway volume. Reduced need for neuromuscular compensation during wake following anatomical improvement via surgery could explain the lack of measurable volume change. Further research to understand the mechanisms of action of multilevel surgery is required. CLINICAL TRIAL: This manuscript presents a planned image analysis of participants randomized to the surgical arm or the clinical trial multilevel airway surgery in patients with moderate-severe obstructive sleep apnea (OSA) who have failed medical management to assess change in OSA events and daytime sleepiness. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=266019&isReview=true%20Australian%20New%20Zealand%20Clinical%20Trials%20Registry%20ACTRN12514000338662, prospectively registered on March 31, 2014.

Health Related Quality of Life T-14 Outcomes for Pediatric Bizact Tonsillectomy.

Objectives: The objective of this study was to assess the T-14 outcomes of the BizactTM device for tonsillectomy in a pediatric population. Methods: A case series chart review was undertaken at a public tertiary teaching hospital and private otolaryngology practice, with data collected from pediatric patients who underwent a BizactTM tonsillectomy between July 2016 and October 2019 for any indication, whose parents consented to completing the T-14 questionnaire providing a parental perspective of the child's quality of life. Primary outcomes were T-14 scores recorded preoperatively and 6 weeks post-operatively. Secondary outcome measures were postoperative complications, including hemorrhage and readmission. Results: 146 patients were identified. There was a significant improvement in T-14 scores from a median of 24 (Interquartile range (IQR) 18-33) prior to surgery to 2 (IQR 0-4) at 6 weeks postoperatively (p < 0.001). The post-tonsillectomy hemorrhage rate was 6.1% (9/146 participants). Conclusions: Pediatric BizactTM tonsillectomy is effective in treating common indications for pediatric tonsillectomy, reflected by improved parent-reported health-related quality of life T-14 scores postoperatively.

Altered swallowing biomechanics in people with moderate-severe obstructive sleep apnea.

STUDY OBJECTIVES: Dysphagia is a common but under-recognized complication of obstructive sleep apnea (OSA). However, the mechanisms remain poorly described. Accordingly, the aim of this study was to assess swallowing symptoms and use high-resolution pharyngeal manometry to quantify swallowing biomechanics in patients with moderate-severe OSA. METHODS: Nineteen adults (4 female; mean (range) age, 46 ± 26-68 years) with moderate-severe OSA underwent high-resolution pharyngeal manometry testing with 5-, 10-, and 20-mL volumes of thin and extremely thick liquids. Data were compared with 19 age- and sex-matched healthy controls (mean (range) age, 46 ± 27-68 years). Symptomatic dysphagia was assessed using the Sydney Swallow Questionnaire. Swallow metrics were analyzed using the online application swallowgateway.com. General linear mixed model analysis was performed to investigate potential differences between people with moderate-severe OSA and controls. Data presented are means [95% confidence intervals]. RESULTS: Twenty-six percent (5 of 19) of the OSA group but none of the controls reported symptomatic dysphagia (Sydney Swallow Questionnaire > 234). Compared with healthy controls, the OSA group had increased upper esophageal sphincter relaxation pressure (-2 [-1] vs 2 [1] mm Hg, F = 32.1, P < .0001), reduced upper esophageal sphincter opening (6 vs 5 mS, F = 23.6, P < .0001), and increased hypopharyngeal intrabolus pressure (2 [1] vs 7 [1] mm Hg, F = 19.0, P < .05). Additionally, upper pharyngeal pressures were higher, particularly at the velopharynx (88 [12] vs 144 [12] mm Hg⋅cm⋅s, F = 69.6, P < .0001). CONCLUSIONS: High-resolution pharyngeal manometry identified altered swallowing biomechanics in people with moderate-severe OSA, which is consistent with a subclinical presentation. Potential contributing mechanisms include upper esophageal sphincter dysfunction with associated upstream changes of increased hypopharyngeal distension pressure and velopharyngeal contractility. CITATION: Schar MS, Omari TI, Woods CM, et al. Altered swallowing biomechanics in people with moderate-severe obstructive sleep apnea. J Clin Sleep Med. 2021;17(9):1793-1803.

Psychometric testing of the Skull Base Inventory health-related quality of life questionnaire in a multi-institutional study of patients undergoing open and endoscopic surgery.

PURPOSE: The skull base inventory (SBI) was developed to better assess health-related quality of life (HR-QOL) in patients with anterior and central skull base neoplasms treated by endoscopic and open approaches. The primary objective of this study was to prospectively assess the psychometric properties of the SBI. METHODS: This study is part of a multi-center study of patients undergoing endoscopic and open procedures completed between 2012 and 2018. Participants were eligible if they were over 18 years of age; had benign or malignant anterior, antero-lateral, or central skull base tumors; and required either an open or endoscopic skull base surgical approach. In order to assess the psychometric properties of the SBI, patients completed the instrument at six time points (preoperative, 2 weeks, 3 months, 6 months, 12 months postoperative). Patients also completed the Anterior Skull Base (ASB) questionnaire and the Sinonasal Outcome Test (SNOT-22) to allow comparison to the SBI. RESULTS: One hundred and eighty-seven patients were included across five centers, with 121 having an endoscopic procedure. Internal consistency (Cronbach's alpha = 0.95) and test-retest at 12 months and 12 months plus 2 weeks (intraclass correlation > 0.90) were excellent. Concurrent validity was demonstrated by very strong correlation between total SBI scores and ASB scores (r = 0.810 to 0.869, p < 0.001) and moderate correlation between nasal domain SBI scores and SNOT-22 scores (r = - 0.616 to - 0.738, p < 0.001). Convergent validity was demonstrated by moderate correlation between change in SBI scores and global QOL change (rs = 0.4942, p < 0.001). The minimally important clinical difference (global HR-QOL change of "a little better" or "a little worse") was 6.0. CONCLUSION: The SBI questionnaire is reliable and valid for patients treated by both endoscopic and open approaches and can be used for assessment of HR-QOL in these settings.

Effect of Multilevel Upper Airway Surgery vs Medical Management on the Apnea-Hypopnea Index and Patient-Reported Daytime Sleepiness Among Patients With Moderate or Severe Obstructive Sleep Apnea: The SAMS Randomized Clinical Trial.

Importance: Many adults with obstructive sleep apnea (OSA) use device treatments inadequately and remain untreated. Objective: To determine whether combined palatal and tongue surgery to enlarge or stabilize the upper airway is an effective treatment for patients with OSA when conventional device treatment failed. Design, Setting, and Participants: Multicenter, parallel-group, open-label randomized clinical trial of upper airway surgery vs ongoing medical management. Adults with symptomatic moderate or severe OSA in whom conventional treatments had failed were enrolled between November 2014 and October 2017, with follow-up until August 2018. Interventions: Multilevel surgery (modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction; n = 51) or ongoing medical management (eg, advice on sleep positioning, weight loss; n = 51). Main Outcomes and Measures: Primary outcome measures were the apnea-hypopnea index (AHI; ie, the number of apnea and hypopnea events/h; 15-30 indicates moderate and >30 indicates severe OSA) and the Epworth Sleepiness Scale (ESS; range, 0-24; >10 indicates pathological sleepiness). Baseline-adjusted differences between groups at 6 months were assessed. Minimal clinically important differences are 15 events per hour for AHI and 2 units for ESS. Results: Among 102 participants who were randomized (mean [SD] age, 44.6 [12.8] years; 18 [18%] women), 91 (89%) completed the trial. The mean AHI was 47.9 at baseline and 20.8 at 6 months for the surgery group and 45.3 at baseline and 34.5 at 6 months for the medical management group (mean baseline-adjusted between-group difference at 6 mo, -17.6 events/h [95% CI, -26.8 to -8.4]; P < .001). The mean ESS was 12.4 at baseline and 5.3 at 6 months in the surgery group and 11.1 at baseline and 10.5 at 6 months in the medical management group (mean baseline-adjusted between-group difference at 6 mo, -6.7 [95% CI, -8.2 to -5.2]; P < .001). Two participants (4%) in the surgery group had serious adverse events (1 had a myocardial infarction on postoperative day 5 and 1 was hospitalized for observation following hematemesis of old blood). Conclusions and Relevance: In this preliminary study of adults with moderate or severe OSA in whom conventional therapy had failed, combined palatal and tongue surgery, compared with medical management, reduced the number of apnea and hypopnea events and patient-reported sleepiness at 6 months. Further research is needed to confirm these findings in additional populations and to understand clinical utility, long-term efficacy, and safety of multilevel upper airway surgery for treatment of patients with OSA. Trial Registration: Australian New Zealand Clinical Trials Registry: ACTRN12614000338662.