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Rationale and Objectives This study aims to evaluate the diagnostic accuracy, inter-reader, and intra-reader variability of the ACR Thyroid Imaging Reporting and Data System (TI-RADS) for risk-stratification of indeterminate thyroid nodules using next generation genetic sequencing and tissue histology as a reference standard. Materials and Methods Retrospective chart review was performed on all patients who underwent thyroid ultrasound for a nodule with subsequent fine-needle aspiration ± surgical resection from January 2017 to August 2018. Four radiologists with expertise in thyroid ultrasound assessed imaging twice, ≥1 month apart. Results of cytology and next generation genetic sequencing were used as a reference standard for high versus low risk of malignancy in each nodule. Inter-reader reliability between readers and intra-reader reliability between replicate self-reads for TI-RADS categorization were assessed. Univariate analysis, kappa statistics, and receiver operating characteristic curve were calculated. Results One hundred and thirty six nodules across 121 patients met inclusion criteria. 84.6% of patients were female and average age was 55.8 ± 14.1 years. One hundred and eighteen of 135 nodules (87%) had indeterminate cytology (Bethesda III or IV). One of 23 high-risk mutations was identified in 30.1% (42) of the nodules. Of the 52 patients who had surgery, 24 (47.1%) had confirmed malignant disease on surgical pathology. Inter-reader reliability between the four radiologists was marginal, κ = 0.293. Intra-reader reliability ranged from marginal to good, κ = 0.337 to κ = 0.560, respectively. The area under the receiver operating characteristic curve was 0.509, and no optimal TI-RADS Level for identifying high-risk nodules existed. Conclusion The ACR TI-RADS classification system performs with low inter-reader and intra-reader reliability when assessing the genetic risk of nodules with indeterminate cytology.

Upper airway stimulation (UAS) is used to treat patients with moderate to severe obstructive sleep apnea (OSA). The aim of this study is to report the incidence and potential predictors of elevated central and mixed apnea index (CMAI) after UAS.Retrospective chart review of patients undergoing UAS.Tertiary care center.Included patients underwent UAS for OSA at our institution between 2014 and 2018. Data collected included demographic information, implantation records, and pre- and postoperative polysomnography (PSG) results. CMAI ≥5 was considered elevated. Post hoc univariate analysis was performed to evaluate factors associated with elevated CMAI.In total, 141 patients underwent UAS at our institution. This included 94 men and 47 women with a mean age of 61.2 ± 11.0 years and a mean body mass index of 29.1 ± 3.9 kg/mThe occurrence of an elevated CMAI after surgery may represent treatment-emergent events. Demographics, comorbid conditions, and UAS device settings were not associated with central and mixed apneic events.4.

Background Sinonasal malignancies are a rare, heterogeneous group of tumors that often present at an advanced stage and require multimodal therapy. The presence of high-grade toxicity and sinonasal complications after treatment can negatively impact quality of life. In this study we aim to describe posttreatment morbidity in patients with sinonasal malignancy. Methods A retrospective analysis of all patients treated for sinonasal malignancy was conducted from 2005 to 2018 at a tertiary referral institution. A total of 129 patients met the inclusion criteria. Primary outcomes were treatment details, pathology, posttreatment complications, and radiation toxicity. Fisher's exact test, chi-square test, and Student t test were used for statistical analysis. Results Mean age was 58.4 (median, 61; range, 19-94) years. After diagnosis, 24 patients had surgery alone, 46 had surgery with radiation alone, 47 had surgery with chemoradiation, and 14 received definitive chemoradiation. Overall, 10.4% (n = 12) of patients had postoperative complications, and 21.0% (n = 22) had high-grade (grade 3-5) radiation toxicity. After radiation, 20% (n = 21) of patients had chronic sinusitis requiring functional endoscopic sinus surgery and 20% (n = 21) had symptomatic nasal obstruction requiring operative debridement. Conclusion Sinonasal complications, including nasal obstruction and chronic sinusitis, occur frequently after definitive treatment of sinonasal malignancy and should be addressed when considering quality of life in survivors. These complications occur more frequently in patients who undergo chemoradiation as opposed to surgery alone.

Objective: To determine the rate of surgical complications, unplanned readmission, and functional status after open hypopharyngeal surgery for dysphagia with early return to oral diet and hospital discharge. Methods: Retrospective chart review of patients who underwent open hypopharyngeal surgery for management of dysphagia from March 2013 to June 2018 at a single academic institution. A clear liquid diet is restarted the day of surgery and is advanced to a soft diet on postoperative day one. Univariate and multivariate logistic regression was performed to identify risk factors for postoperative complications and unplanned readmission. Results: Ninety patients met eligibility criteria; 62 patients underwent open cricopharyngeal myotomy, 13 underwent Zenker’s diverticulectomy, 15 had a Zenker’s diverticulopexy. Mean inpatient length of stay was 2.0 ± 2.0 days (range 0-11 days); 57 patients (63.3%) were discharged on the same day as surgery or on postoperative day one. Seven patients (7.8%) had postoperative complications; the most common complication was esophageal leak (n = 6). Six patients (6.7%) had unplanned readmissions within 30 days. Mean time to unplanned readmission was 12 days (range 2-19 days). Open diverticulectomy was associated with an increased risk of unplanned readmission with an OR = 7.63 (95% CI 1.29, 45.45, P = .025). At last follow-up, 70% of patients had an increased functional oral intake by at least one scale score (FOIS) after surgery (mean follow-up 0.8 ± 1.1 years, range 0.02-5.1 years). Conclusion: An early diet and discharge may be safe for patients undergoing open surgery without a mechanical or suture closure of their esophageal mucosa, whereas in those undergoing diverticulectomy, NPO status and a radiological check before resuming drinking and eating are advised. Level of Evidence: 4

OBJECTIVES/HYPOTHESIS For patients with obstructive sleep apnea (OSA) undergoing sinonasal surgery, there is a lack of consensus on the risk and appropriate postoperative use of continuous positive airway pressure (CPAP). The aim of this study was to assess the tolerability of restarting CPAP on postoperative day one. STUDY DESIGN Prospective cohort study. METHODS A prospective study on patients with OSA on CPAP who required a septoplasty/turbinectomy and/or functional endoscopic sinus surgery (FESS) was performed. Data from the memory card of a patient's CPAP machine and subjective information were obtained on the day of surgery and at scheduled follow-up visits. All subjects were instructed to restart CPAP on the first postoperative night. RESULTS A total of 14 patients were analyzed; nine underwent FESS and five had a septoplasty/turbinectomy. There were no postoperative complications encountered. The only significant change in the first postoperative week was a reduction in the percentage of nights used over 4 hours (P

Background Aggressive squamous cell carcinomas (SCCs) present frequently in the context of chronic skin injury occurring in patients with the congenital blistering disease recessive dystrophic epidermolysis bullosa. Recently, these cancers were shown to harbor mutation signatures associated with endogenous deaminases of the active polynucleotide cytosine deaminase family, collectively termed APOBEC, and clock-like COSMIC [Catalogue of Somatic Mutations in Cancer] signatures, which are associated with normal aging and might result from cumulative DNA replication errors. We present a case of a nasal septal SCC arising in the context of recurrent injury, but also modest past tobacco use. Our genetic analysis of this tumor reveals unusually high APOBEC and clock-like but low tobacco-related COSMIC signatures, suggesting that chronic injury may have played a primary role in somatic mutation. This case report demonstrates how signature-based analyses may implicate key roles for certain mutagenic forces in individual malignancies such as head-and-neck SCC, with multiple etiological origins. Case presentation We report the case of a 43-year-old male former smoker who presented with congestion and swelling following a traumatic nasal fracture. During surgery, the mucosa surrounding the right nasal valve appeared abnormal, and biopsies revealed invasive keratinizing SCC. Frozen section biopsies revealed multiple areas to be positive for SCC. Gene sequencing showed loss of PTEN (exons 2–8), CDKN2A/B and TP53 (exons 8–9), MYC amplification, and BLM S338*. Exome sequencing data also revealed that 36% of mutations matched an APOBEC mutational signature (COSMIC signatures 2 and 13) and 53% of mutations matched the clock-like mutation signature (COSMIC signature 5). These proportions place this tumor in the 90th percentile bearing each signature, independently, in a reference data set combining cutaneous and The Cancer Genome Atlas (TCGA) head and neck SCC data. In contrast, few mutations harbored a tobacco-related COSMIC signature 4, representing about the 10th percentile in our reference SCC data set. The patient was treated with partial rhinectomy with local flap reconstruction, bilateral neck dissection, and adjuvant radiation therapy; the patient remains disease-free to date. Conclusion Based on comparative mutational signature analysis, we propose that the history of tobacco use and traumatic injury may have collaborated in activating APOBEC enzymes and the clock-like mutational process, ultimately leading to cancer formation. Clinical awareness of the relationship between epithelial injury and tumorigenesis should enhance earlier detection of this particularly aggressive type of cancer.

Objective: To evaluate treatment outcomes of upper airway stimulation (UAS) in obstructive sleep apnea (OSA) patients based on patient age, gender, and preoperative disease severity. Methods: Retrospective chart review of patients undergoing UAS from 2014 to 2018 at a tertiary care center. Data collected included demographic information, implantation records, and pre- and postoperative polysomnography (PSG) results. Profound OSA was defined as AHI >65 and age ≥65 was considered advanced age. The primary outcome measured was initial treatment response, defined as a post-operative AHI 50% reduction from baseline. Results: 145 patients underwent UAS at our institution including 98 males and 47 females with a mean age of 61.7 ± 11.5 years, mean BMI of 29.1 ± 3.9 kg/m2, and mean preoperative AHI of 34.1 ± 18.2 events/hour. After surgery, patients had a significantly lower mean AHI of 8.6 ± 15.0 events/hour (Conclusion: Although the overall OSA population showed significant postoperative AHI reduction with UAS, patients age ≥65 years were less likely to have an initial response to treatment, when compared to their younger counterparts. A larger proportion of elderly patients and patients with profound OSA had residual moderate disease (AHI > 15) after UAS. Level of Evidence: 4

Background For patients with obstructive sleep apnea (OSA), there is a lack of knowledge regarding the impact of continuous positive airway pressure (CPAP) on the nasal cavity. There is a significant need for evidence-based recommendations regarding the appropriate use of CPAP following endoscopic sinus and skull base surgery. Objective The goal of this study is to translate a previously developed cadaveric model for evaluating CPAP pressures in the sinonasal cavity by showing safety in vivo and quantifying the effect of positive pressurized air flow on the nasal cavity of healthy individuals where physiologic effects are at play. Methods A previously validated cadaveric model using intracranial sensor catheters has proved to be a reliable technique for measuring sinonasal pressures. These sensors were placed in the nasal cavity of 18 healthy individuals. Pressure within the nose was recorded at increasing levels of CPAP. Results Overall, nasal cavity pressure was on average 85% of delivered CPAP. The amount of pressure delivered to the nasal cavity increased as the CPAP increased. The percentage of CPAP delivered was 77% for 5 cmH2O and increased to 89% at 20 cmH2O. There was a significant difference in mean intranasal pressures between all the levels of CPAP except 5 cmH2O and 8 cmH2O ( P Conclusion On average, only 85% of the pressure delivered by CPAP is transmitted to the nasal cavity. Higher CPAP pressures delivered a greater percentage of pressurized air to the nasal cavity floor. Our results are comparable to the cadaver model, which demonstrated similar pressure delivery even in the absence of anatomic factors such as lung compliance, nasal secretions, and edema. This study demonstrates the safety of using sensors in the human nasal cavity. This technology can also be utilized to evaluate the resiliency of various repair techniques for endoscopic skull base surgery with CPAP administration.

Objective Patients undergoing endoscopic endonasal surgery have historically been restricted from using straws postoperatively, due to the concern that this activity generates negative pressure. The objective of this study is to evaluate the pressure dynamics in the sinonasal cavity associated with the use of a straw. Methods Intracranial pressure catheters were placed in the nasal cavity of 20 healthy individuals. Pressure measurements were then recorded while participants drank liquids of different viscosities from a cup and from a straw. Measurements were recorded with and without subjects occluding their nose to simulate postoperative nasal obstruction. Results The average pressure in the nasal cavity while drinking water from a cup was −0.86 cmH2O, from a straw was −1.09 cmH2O, and while occluding the nose and using a straw was −0.81 cmH2O. The average pressure in the nasal cavity while drinking a milkshake from a cup was −0.98 cmH2O, from a straw was −1.88 cmH2O, and while occluding the nose and using a straw was −1.37 cmH2O. There was no statistically significant difference in pressure measurements when comparing either task or consistency (p > 0.05). Conclusion Straw use is not associated with the generation of significant negative pressure in the nasal cavity. The pressure generated when drinking from a straw is not significantly different from that of drinking from a cup. This data suggest that straw use may be safe for patients following endoscopic skull base surgery, but further investigation is warranted.

Objective: Type 1 thyroplasty is an established procedure for the treatment of vocal fold paralysis to improve voice and swallowing outcomes. At our institution, we commonly perform this procedure on an outpatient basis in medically stable patients. With this study, we assess the safety of outpatient thyroplasty by examining complication and readmission rates, need for revision surgery, and predictors of these outcome measures. Methods: We performed a retrospective review of patients undergoing outpatient type 1 thyroplasty for vocal fold paralysis between 2013 and 2018 at our institution. We documented the etiology of paralysis, comorbidities, and demographic data. Our primary outcome measures were complications, need for readmission, and need for revision surgery. Results: During the study period, 160 patients met our inclusion criteria. Mean age at time of surgery was 62.1 ± 13.9 years; there were 82 (51%) males and 78 (49%) females. Nine (5.6%) patients experienced major complications after surgery and 7 (4.4%) patients required unplanned readmission. Mean time to complication was 6.9 ± 9.7 days. There were no instances of postoperative airway compromise requiring intervention. There were no mortalities. Of those who underwent primary surgery, 22 (14%) patients required revision surgery. Conclusion: Given that complications tend to occur in a delayed fashion rather than in the acute postoperative period, same-day discharge seems reasonable as compared to overnight observation in medically stable patients undergoing type 1 thyroplasty. Level of Evidence: IV

IMPORTANCE: Thyroid nodules are common incidental findings. Ultrasonography and molecular testing can be used to assess risk of malignant neoplasm. OBJECTIVE: To examine whether a model developed through automated machine learning can stratify thyroid nodules as high or low genetic risk by ultrasonography imaging alone compared with stratification by molecular testing for high- and low-risk mutations. DESIGN, SETTING, AND PARTICIPANTS: This diagnostic study was conducted at a single tertiary care urban academic institution and included patients (n = 121) who underwent ultrasonography and molecular testing for thyroid nodules from January 1, 2017, through August 1, 2018. Nodules were classified as high risk or low risk on the basis of results of an institutional molecular testing panel for thyroid risk genes. All thyroid nodules that underwent genetic sequencing for cytological results with Bethesda System categories III and IV were reviewed. Patients without diagnostic ultrasonographic images within 6 months of fine-needle aspiration or who received definitive treatment at an outside medical center were excluded. MAIN OUTCOMES AND MEASURES: Thyroid nodules were categorized by the model as high risk or low risk using ultrasonographic images. Results were compared using genetic testing. RESULTS: Among the 134 lesions identified in 121 patients (mean [SD] age, 55.7 [14.2] years; 102 women [84.3%]), 683 diagnostic ultrasonographic images were selected. Of the 683 images, 556 (81.4%) were used for training the model, 74 (10.8%) for validation, and 53 (7.8%) for testing. Most nodules had no mutation (75 [56.0%]), whereas 43 nodules (32.1%) had a high-risk mutation and 16 (11.9%) had an unknown or a low-risk mutation (χ(2) = 39.060; P

Objective: To understand differences in patient demographics, insurance-related treatment delays, and average waiting times for Medicare and private insurance patients undergoing upper airway stimulation (UAS) for treatment of obstructive sleep apnea (OSA). Methods: Retrospective chart review of all Medicare and private insurance patients undergoing upper airway stimulation (UAS) from 2015 to 2018 at a single academic center. Primary outcomes were insurance-related procedure cancellation rate and time from drug induced sleep endoscopy (DISE) and UAS treatment recommendation to UAS surgery in Medicare versus private insurance patients. Results: In our cohort 207 underwent DISE and were recommended treatment with UAS. Forty-four patients with Medicare and 30 patients with private insurance underwent UAS procedure. Patients with Medicare undergoing UAS were older (67.4 ± 11.1 years) than patients with private insurance (54.9 ± 8.1 years). Medicare patients had a shorter mean wait time of 121.9 ± 75.8 days (range, 15-331 days) from the time of UAS treatment recommendation to UAS surgery when compared to patients with private insurance (201.3 ± 102.2 days; range, 33-477 days). Three patients with Medicare (6.4%) and 8 patients with private insurance (21.1%) were ultimately denied UAS. Conclusion: Medicare patients undergoing UAS have shorter waiting periods, fewer insurance-related treatment delays and may experience fewer procedure cancellations when compared to patients with private insurance. The investigational status of UAS by private insurance companies delays care for patients with OSA. Level of Evidence: 4

Objectives: The aim of this research is to understand the importance of female career mentors, research mentors, co-residents, and program directors/chairs to current female otolaryngology residents when applying to residency. The importance of safety in the workplace was also investigated. Methods: Surveys were sent via electronic mail to 119 programs, and program directors were asked to distribute them to female residents. Using the Likert scale, participants ranked the importance of various factors when creating a rank list, in particular, importance of safety in the workplace and importance of female mentors in various leadership positions. Demographic information, geographic location, LGBTQ identification, and fellowship plans were also collected. Results: There were 62 participants nationally. Eighty-seven percent (n = 54) of participants stated that having at least 1 female attending and having female co-residents was “very important” or “important” when ranking programs. A number of respondents replied that having a female career development mentor (38.7% [n = 24] and 43.5% [n = 27]), female program director or chair (4.8% [n = 3] and 16.1% [n = 10]), and female research mentor (12.9% [n = 8] and 29% [n = 18]) was “very important” or “important,” respectively. Ninety-three percent (n = 58) replied that feeling safe in their training environment was “very important” or “important.” Conclusion: Having female mentors as well as safety in the workplace in residency is important to a vast majority of residents and applicants when creating a rank list. Programs with women in these roles may gain a disproportionate number of female residents because they may be more desirable places than those without women in these roles.

Etelcalcetide (Parsabiv) for hyperparathyroidism in adults with chronic kidney disease on hemodialysis.