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Objective: Minor salivary gland carcinomas are challenging to study due to their rarity and heterogeneity. We aim to further characterize clinical characteristics, treatment, and outcomes over 20 years within a single institution., Study Design: Retrospective chart review was conducted on 210 patients who received primary treatment for minor salivary gland malignancy from 2000 to 2022., Setting: Single tertiary-care center., Methods: Multivariable Cox proportional hazards method was used to examine the relationship between pre-determined clinically important variables and outcomes., Results: Five-year overall survival was 77.8% (72.0-84.1). Advanced clinical T stage portended over a 2 times higher risk of death and recurrence. High pathologic grade was associated with a near 3 times higher risk of death and recurrence. There was a predominance of occult nodal metastases in level II for oral cavity and oropharynx site tumors., Conclusion: Clinical T stage and grade were important for overall survival, local, regional, and distant recurrence-free survival. Occult nodal metastases occurred most often in level II., Competing Interests: SAK receives research funding from Merck, BMS, Regeneron, and Castle Biosciences and consultant fees from Merck, Regeneron, and Castle Biosciences. He receives Honoraria from Uptodate. All other authors deny any conflict of interest., (© 2024 The Author(s). OTO Open published by Wiley Periodicals LLC on behalf of American Academy of Otolaryngology–Head and Neck Surgery Foundation.)

Background: Advancements in immunotherapy for recurrent head and neck cancer have necessitated a better understanding of salvage surgical outcomes. This study aimed to determine patterns of failure following salvage head and neck surgery., Methods: A retrospective cohort study was conducted of 280 patients who underwent salvage surgery for recurrent mucosal squamous cell carcinoma from 1997 to 2018. Cumulative incidence was calculated using the nonparametric Aalen-Johansen estimator. Time to recurrence (TTR) and overall survival (OS) were estimated using the Kaplan-Meier method and multivariable Cox proportional hazard models were used to evaluate associated factors., Results: The 2 and 5-year cumulative incidence rates of second recurrence were 48.3 % (95 % CI 42.4-54.3) and 54.9 % (95 % CI 48.9-60.8), respectively. At 5 years, second locoregional recurrence was twice as common as distant recurrence (41.5 % [95 % CI 35.6-47.4] vs. 21.7 % [95 % CI 16.8-26.6]). The median TTR was 21.1 months (95 % CI 4.4-34.8), which varied by site (38.2 larynx/hypopharynx, 13.9 oral cavity, 8.3 sinonasal, and 7.8 oropharynx, P=.0001). The median OS was 32.1 months (95 % CI 24.1-47.6) and was worse for patients who were Black (hazard ratio [HR] 2.15, 95 % CI 1.19-3.9), current smokers (HR 2.73, 95 % CI 1.53-4.88), former smokers (HR 2.00, 95 % CI 1.19-3.35), ≥ 60 years of age (HR 1.41, 95 % CI 1.01-1.97), or received multimodal primary therapy (HR 1.98, 95 % CI 1.26-3.13)., Conclusion: Rates of recurrence and mortality after salvage surgery were poor but worse for patients who were Black, older, smoked, had initial multimodal therapy, or had sinonasal or oropharyngeal cancers., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Objective: Mandibular osteoradionecrosis (MORN) is a morbid complication of head and neck radiation therapy. Recent advances in surgical and medical therapies underscore the need for a shift in traditional treatment paradigms and a disease grading system that can guide appropriate management., Data Sources: Pubmed/MEDLINE., Review Methods: We conducted a detailed review of publications related to MORN, specifically focusing on its staging and management techniques. Articles meeting inclusion criteria were synthesized into a final narrative review., Conclusion: There has been a paradigm shift away from hyperbaric oxygen therapy in the management of MORN. Growing evidence for the efficacy of pentoxifylline and tocopherol in early-stage disease and novel surgical techniques to manage moderate and late-stage disease warrant an updated staging stratification which is proposed., Implications for Practice: This review summarizes the clinical efficacy of established and novel therapeutic modalities currently available in treating MORN, emphasizing the significant advances achieved over the last decade. It introduces a contemporary staging and treatment algorithm which incorporates traditional, evidence-supported surgical and medical management with effective early intervention strategies., (© 2024 The Author(s). Otolaryngology–Head and Neck Surgery published by Wiley Periodicals LLC on behalf of American Academy of Otolaryngology–Head and Neck Surgery Foundation.)

Introduction: Hypoalbuminemia, a marker for poor nutritional status, has been associated with postoperative complications, including head and neck cancer surgery. This study investigates the impact of hypoalbuminemia on head and neck microvascular free tissue transfer reconstruction., Methods: This retrospective cohort study queried the 2005-2021 American College of Surgeons National Surgical Quality Improvement Program databases. Reconstructive cases performed by otolaryngologists (CPT: 15756, 15757, 15758, 15842, 20955, 20956, 20957, 20962, 20969, 20970, 20972, 20973, 43116, 43496, 49006, and 49906) with available preoperative albumin, BMI, and age were included. Hypoalbuminemia was defined as a preoperative albumin <3.5 g/dL. Univariate and multivariable logistic regression were performed., Results: A total of 3,886 cases met the inclusion criteria, of which 835 (21.5%) had hypoalbuminemia. The hypoalbuminemia cohort was older, had lower BMI, had higher ASA classification, and had worse functional health status. Adjusted multivariable logistic regression showed that hypoalbuminemia was associated with unplanned return to the operating room within 30 days (OR: 1.36, p < 0.01), unplanned reoperation (OR: 1.36, p < 0.01), any complication (OR: 1.77, p < 0.01), surgical complications (OR: 1.94, p < 0.01), and medical complications (OR: 1.34, p = 0.01). Hypoalbuminemia was correlated with a longer hospital stay, superficial surgical site infection, wound dehiscence, transfusion, deep vein thrombosis, and acute renal failure., Conclusion: Hypoalbuminemia is a risk factor for postoperative complications after microvascular free tissue transfer for head and neck reconstruction. This study suggests that preoperative optimization of hypoalbuminemia may be beneficial for these patients., Level of Evidence: 3 Laryngoscope, 2024., (© 2024 The Author(s). The Laryngoscope published by Wiley Periodicals LLC on behalf of The American Laryngological, Rhinological and Otological Society, Inc.)

Objective: To evaluate national trends in racial disparities for patients undergoing head and neck reconstructive surgery., Methods: Retrospective analysis using the 2008 to 2021 American College of Surgeons National Surgical Quality Improvement Program database. Patients receiving microvascular free tissue transfer were eligible for inclusion. Pediatric patients and those treated by non-otolaryngologists were excluded. Outcomes were analyzed with univariate and multivariable models., Results: A total of 5831 head and neck free flap cases were analyzed, 4869 (83.5%) were White, 560 (9.6%) were Black or African American, and 402 (6.9%) were Asian, Native American, or other groups (ANAOG). The proportion of Black or African American patients and ANAOG patients undergoing free tissue transfer increased significantly over the time period (p = 0.047 and p = 0.010, respectively). However, there was a downtrend that started around 2017. In a multivariable model, Black or African American race was not associated with readmission (OR = 0.99 [95% CI 0.74, 1.31], p > 0.05), returning to the operating room (OR = 1.20 [95% CI 0.96, 1.49], p > 0.05), or any post-operative complication (OR = 0.83 [95% CI 0.68, 1.01], p > 0.05). There were also no significant associations found in the ANAOG population on multivariate analysis (p > 0.05 for all)., Conclusion: The percentage of free tissue transfer performed in patients from minority backgrounds with head and neck cancer has been increasing in the United States. Outcomes after head and neck microvascular reconstruction are similar when stratified by race. However, racial disparities remain and further work is necessary to reduce these disparities., Level of Evidence: Level IV Laryngoscope, 2024., (© 2024 The Author(s). The Laryngoscope published by Wiley Periodicals LLC on behalf of The American Laryngological, Rhinological and Otological Society, Inc.)

Objective: Given rising concern regarding antibiotic resistance, our objective was to evaluate antibiotic-resistant infections following leech therapy and to characterize the use of prophylactic antibiotics., Methods: All reports of adverse events involving hirudotherapy (product code "NRN") were retrieved from the U.S. Food and Drug Administration MAUDE database between 2012 and 2021. Antibiotic resistance was defined by bacterial culture or infection after antibiotic administration., Results: Nineteen cases of antibiotic resistance involving hirudotherapy were identified. Only three cases of antibiotic resistance were discovered on routine testing and the remaining 16 cases were associated with patient injury. Positive blood cultures or fever were present in 26.3 % (n = 5) of cases. Cultures of the infection grew Aeromonas hydrophilia (n = 13; 68.4 %), Vibrio vulnificus (n = 3; 15.8 %), Pseudomonas aeruginosa (n = 2; 10.5 %), and Proteus vulgaris (n = 1; 5.3 %). There were nine (47.4 %) multi-drug resistant infections. Infection was most commonly resistant to fluoroquinolones (n = 9; 47.4 %), trimethoprim-sulfamethoxazole (n = 9; 47.4 %) and ertapenem (n = 4; 21.1 %)., Conclusion: Antibiotic-resistant infections involving hirudotherapy are frequently resistant to multiple drugs, including fluoroquinolones and trimethoprim-sulfamethoxazole. Resistance to ertapenem, a drug of last resort, was also documented. The findings presented in this study support growing literature that the trend in multi-drug resistance is more severe than previously reported., Competing Interests: Declaration of competing interest The authors have no conflicts of interest to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objective: In light of the recent US Food and Drug Administration (FDA) Class 2 safety recall notice for anastomotic coupling devices, it is important to understand related adverse events. The aim of this study was to characterize adverse events in anastomotic coupling devices for microvascular reconstruction., Methods: A retrospective cross-sectional analysis using the 2011 to 2021 US FDA Manufacturer and User Facility Device Experience (MAUDE) database. All reports of adverse events involving anastomotic coupling devices were retrieved from the MAUDE database. Descriptive statistics were used to analyze categorized events., Results: There were a total of 293 documented adverse events related to anastomotic coupling devices. These adverse events resulted in 91 (31.1 %) patient injuries and 239 (81.6 %) device malfunctions. The most frequent patient problems were thrombosis/hematoma (n = 38; 41.8 %), unspecified injury (n = 31; 34.1 %), and failure to anastomose (n = 13; 14.3 %). Free flap necrosis was reported in 42 % of thrombosis/hematoma cases (n = 16). The most common malfunctions were devices operating differently than expected (n = 74; 31.0 %), connection problems (n = 41; 17.2 %), and twisted/bent material (n = 19; 7.9 %). There was no significant trend in the number of adverse events over the study period (p > 0.05)., Conclusions: Adverse events from anastomotic coupling devices represent an important and modifiable factor in free tissue failure. Adverse events are predominately related to devices operating differently than expected and may result in vascular compromise of the free flap. Reconstructive surgeons should be cognizant of defective anastomotic coupling devices and be prepared to utilize traditional hand-sewn anastomosis., Competing Interests: Declaration of competing interest The authors have no conflicts of interest to disclose., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objectives: Salivary gland malignancies comprise a heterogeneous group of pathologies, for which treatment of the clinically negative neck may vary depending on numerous factors. Herein we present data on occult nodal metastases (ONM) as well as survival and recurrence from a large series of cN0 salivary gland malignancies., Methods: Retrospective chart review was conducted on 532 patients, with 389 patients with major salivary gland cancers and 143 patients with minor salivary gland cancers. Demographic and treatment data were included and rates of ONM, overall survival, local recurrence, regional recurrence, and distant recurrence were analyzed., Results: We found that the overall rate of ONM for parotid was 27% (63/235), for submandibular/sublingual was 35% (18/52), and for minor was 15% (4/26). Analysis of ONM rate at each nodal level was also performed, finding higher rates of level IV and V ONM than prior studies. Submandibular/sublingual and minor salivary gland malignancies showed a predominance of ONMs at levels I-III. Our survival and recurrence rates were similar to those found in previous studies., Conclusion: Our data also demonstrate a predominance of ONM in levels I-III for submandibular/sublingual and minor salivary gland cancers, suggesting elective dissection in these levels., Level of Evidence: 4 Laryngoscope, 134:1705-1715, 2024., (© 2023 The Authors. The Laryngoscope published by Wiley Periodicals LLC on behalf of The American Laryngological, Rhinological and Otological Society, Inc.)

Background: Sinonasal neoplasms, whether benign and malignant, pose a significant challenge to clinicians and represent a model area for multidisciplinary collaboration in order to optimize patient care. The International Consensus Statement on Allergy and Rhinology: Sinonasal Tumors (ICSNT) aims to summarize the best available evidence and presents 48 thematic and histopathology-based topics spanning the field., Methods: In accordance with prior International Consensus Statement on Allergy and Rhinology documents, ICSNT assigned each topic as an Evidence-Based Review with Recommendations, Evidence-Based Review, and Literature Review based on the level of evidence. An international group of multidisciplinary author teams were assembled for the topic reviews using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses format, and completed sections underwent a thorough and iterative consensus-building process. The final document underwent rigorous synthesis and review prior to publication., Results: The ICSNT document consists of four major sections: general principles, benign neoplasms and lesions, malignant neoplasms, and quality of life and surveillance. It covers 48 conceptual and/or histopathology-based topics relevant to sinonasal neoplasms and masses. Topics with a high level of evidence provided specific recommendations, while other areas summarized the current state of evidence. A final section highlights research opportunities and future directions, contributing to advancing knowledge and community intervention., Conclusion: As an embodiment of the multidisciplinary and collaborative model of care in sinonasal neoplasms and masses, ICSNT was designed as a comprehensive, international, and multidisciplinary collaborative endeavor. Its primary objective is to summarize the existing evidence in the field of sinonasal neoplasms and masses., (© 2023 The Authors. International Forum of Allergy & Rhinology published by Wiley Periodicals LLC on behalf of American Academy of Otolaryngic Allergy and American Rhinologic Society.)

Objective: Small molecule inhibitors (SMIs) are targeted therapies increasingly used in advanced thyroid carcinomas. This study aimed to evaluate the survival outcomes of thyroid cancer on SMI treatment, including in patients with brain metastases., Methods: This retrospective study included patients with thyroid carcinomas who received at least one SMI between 2008 and 2022 at a tertiary level, academic institution. SMI included lenvatinib, sorafenib, dabrafenib-trametinib, selpercatinib, and cabozantinib. Patients were grouped by the presence of brain metastasis. Kaplan-Meier and log-rank tests modeled the overall survival (OS), defined from detection of first metastasis., Results: In total, 116 patients (49.1% female, median age 61.1 years [IQR, 51.1-71.0]) were included. Thyroid cancer subtypes were: 57 (49.6%) papillary, 23 (19.8%) anaplastic, 23 (19.8%) medullary, and 13 (11.2%) follicular. There were 18 (15.5%) patients with brain metastases, and 98 (84.5%) with visceral metastases. Age, sex, thyroid subtype, SMI, and time to recurrence were not different between cohorts. OS was shorter in the brain metastasis cohort (31.7 vs 42.2 months, P =.44) and was not different after excluding anaplastic thyroid cancer (29.1 vs 62.3 months, P =.21). In the case of papillary thyroid cancer, patients with brain metastases trended toward worse OS (22.0 vs 59.9 months, P =.13). Nonanaplastic histology, total thyroidectomy (OR, 40.0; P <.001), number of unique therapies (OR, 10.9; P =.047), and mutation-directed therapy (OR, 24.7; P =.003) were associated with improved OS., Conclusion: This single-institutional analysis reports survival outcomes of 116 patients with advanced thyroid cancer on targeted therapies, including 18 patients with brain metastases. Mutation-directed therapy for BRAF V600E mutations, RET mutations, RET fusions, and NTRK fusions had superior survival., Competing Interests: Disclosure E.Y. serves in the advisory board for Astellas Pharma. S. A. K. received research support from Merck, Bristol-Myers Squibb, and Castle Biosciences, consulted for Merck, Regeneron, and Castle Biosciences, and received honoraria from UpToDate. J. L. G. received institutional funding from Merck, Alkermes, Debio, Regeneron, and Genentech and consulted or served in the advisory boards for Regeneron, Merck, and Exelixis. The other authors have no multiplicity of interest to disclose., (Copyright © 2023 AACE. Published by Elsevier Inc. All rights reserved.)

Importance: Positive margins and margin clearance are risk factors for recurrence in oral cavity squamous cell carcinoma (OCSCC), and these features are used to guide decisions regarding adjuvant radiation treatment. However, the prognostic value of intraoperative tumor bed vs resection specimen sampling is not well defined., Objective: To determine the prognostic implications of intraoperative margin assessment methods (tumor bed vs resection specimen sampling) with recurrence among patients who undergo surgical resection for OCSCC., Design, Setting, and Participants: This was a retrospective study of patients who had undergone surgical resection of OCSCC between January 1, 2000, and December 31, 2021, at a tertiary-level academic institution. Patients were grouped by margin assessment method (tumor bed [defect] or resection specimen sampling). Of 223 patients with OCSCC, 109 patients had localized tumors (pT1-T2, cN0), 154 had advanced tumors, and 40 were included in both cohorts. Disease recurrence after surgery was estimated by the cumulative incidence method and compared between cohorts using hazard ratios (HRs). Data analyses were performed from January 5, 2023, to April 30, 2023., Main Outcome and Measures: Recurrence-free survival (RFS)., Results: The study population comprised 223 patients (mean [SD] age, 62.7 [12.0] years; 88 (39.5%) female and 200 [90.0%] White individuals) of whom 158 (70.9%) had defect-driven and 65 (29.1%) had specimen-driven margin sampling. Among the 109 patients with localized cancer, intraoperative positive margins were found in 5 of 67 (7.5%) vs 8 of 42 (19.0%) for defect- vs specimen-driven sampling, respectively. Final positive margins were 3.0% for defect- (2 of 67) and 2.4% for specimen-driven (1 of 42) margin assessment. Among the 154 patients with advanced cancer, intraoperative positive margins were found in 29 of 114 (25.4%) vs 13 of 40 (32.5%) for defect- and specimen-driven margins, respectively. Final positive margins were higher in the defect-driven group (9 of 114 [7.9%] vs 1 of 40 [2.5%]). When stratified by margin assessment method, the 3-year rates of local recurrence (9.7% vs 5.1%; HR, 1.37; 95% CI, 0.51-3.66), regional recurrence (11.0% vs 10.4%; HR, 0.85; 95% CI, 0.37-1.94), and distant recurrence (6.4% vs 5.0%; HR, 1.10; 95% CI, 0.36-3.35) were not different for defect- vs specimen-driven sampling cohorts, respectively. The 3-year rate of any recurrence was 18.9% in the defect- and 15.2% in the specimen-driven cohort (HR, 0.93; 95% CI, 0.48-1.81). There were no differences in cumulative incidence of disease recurrence when comparing defect- vs specimen-driven cases., Conclusions and Relevance: The findings of this retrospective cohort study indicate that margin assessment methods using either defect- or specimen-driven sampling did not demonstrate a clear association with the risk of recurrence after OCSCC resection. Specimen-driven sampling may be associated with reduced surgical margin positivity rates, which often necessitate concurrent chemotherapy with adjuvant radiation therapy.

Background: Resected oral cavity carcinoma defects are often reconstructed with osteocutaneous or soft-tissue free flaps, but risk of osteoradionecrosis (ORN) is unknown., Methods: This retrospective study included oral cavity carcinoma treated with free-tissue reconstruction and postoperative IMRT between 2000 and 2019. Risk-regression assessed risk factors for grade ≥2 ORN., Results: One hundred fifty-five patients (51% male, 28% current smokers, mean age 62 ± 11 years) were included. Median follow-up was 32.6 months (range, 1.0-190.6). Thirty-eight (25%) patients had fibular free flap for mandibular reconstruction, whereas 117 (76%) had soft-tissue reconstruction. Grade ≥2 ORN occurred in 14 (9.0%) patients, at a median 9.8 months (range, 2.4-61.5) after IMRT. Post-radiation teeth extraction was significantly associated with ORN. One-year and 10-year ORN rates were 5.2% and 10%, respectively., Conclusions: ORN risk was comparable between osteocutaneous and soft-tissue reconstruction for resected oral cavity carcinoma. Osteocutaneous flaps can be safely performed with no excess concern for mandibular ORN., (© 2023 The Authors. Head & Neck published by Wiley Periodicals LLC.)

Importance: Survival outcomes for anaplastic thyroid cancer (ATC), the most aggressive subtype of thyroid cancers, have remained poor. However, targeted therapies and immunotherapies present new opportunities for treatment of this disease. Evaluations of survival outcomes over time with new multimodal therapies are needed for optimizing treatment plans., Objective: To evaluate the association of treatment strategies and tumor characteristics with overall survival (OS) among patients with ATC., Design, Setting, and Participants: This retrospective case series study evaluated the survival outcomes stratified by treatment strategies and tumor characteristics among patients with ATC treated at a tertiary level academic institution from January 1, 2000, to December 31, 2021. Demographic, tumor, treatment, and outcome characteristics were analyzed. Kaplan-Meier method and log rank test modeled OS by treatment type and tumor characteristics. Data were analyzed in May 2022., Main Outcomes and Measures: Overall survival (OS)., Results: The study cohort comprised 97 patients with biopsy-proven ATC (median [range] age at diagnosis, 70 [38-93] years; 60 (62%) female and 85 [88%] White individuals; 59 [61%] never smokers). At ATC diagnosis, 18 (19%) patients had stage IVA, 19 (20%) had stage IVB, and 53 (55%) had stage IVC disease. BRAF status was assessed in 38 patients; 18 (47%) had BRAF-V600E variations and 20 (53%), BRAF wild type. Treatment during clinical course included surgery for 44 (45%) patients; chemotherapy, 41 (43%); definitive or adjuvant radiation therapy, 34 (RT; 35%); and targeted therapy, 28 (29%). Median OS for the total cohort was 6.5 (95% CI, 4.3-10.0) months. Inferior OS was found in patients who did not receive surgery (hazard ratio [HR], 2.12; 95% CI, 1.35-3.34; reference, received surgery), chemotherapy (HR, 3.28; 95% CI, 1.99-5.39; reference, received chemotherapy), and definitive or adjuvant RT (HR, 2.47; 95% CI, 1.52-4.02; reference, received definitive/adjuvant RT). On multivariable analysis, age at diagnosis (HR, 1.03; 95% CI, 1.01-1.06), tumor stage IVC (HR, 2.65; 95% CI, 1.35-5.18), and absence of definitive or adjuvant RT (HR, 1.90; 95% CI, 1.01-3.59) were associated with worse OS., Conclusions and Relevance: This retrospective single-institution study found that lower tumor stage, younger age, and the ability to receive definitive or adjuvant RT were associated with improved OS in patients with ATC.

Introduction: The profunda artery perforator (PAP) fasciocutaneous flap is underutilized in head and neck reconstruction, with advantages including ease of harvest and minimal donor site morbidity., Methods: Cadaveric dissection of cutaneous perforators to origin at profunda femoris system to characterize vascular anatomy., Results: 22 PAP flaps were studied. Each contained 1-6 cutaneous perforators originating from the profunda system, designated into A, B, or C vascular pedicle systems. Muscular perforators did not consistently extend to skin in systems A and C, but all dissections demonstrated myocutaneous perforator in system B. Average distance from groin crease to cutaneous perforators of A, B, and C respectively was 8 cm (range 3-15 cm), 11.4 cm (range 5-17 cm), and 17.5 cm (range 12.5-22 cm). Average pedicle length was 11.07 cm (range 7-16 cm), 11.78 cm (range 9-16 cm), and 11.23 cm (range 9-15 cm). Average vena comitans diameter at origin was 3.14 mm (range 1.27-4.46 mm). Average arterial diameter at origin was 2.07 mm (range 1.27-3.82 mm). Range of maximal primary closure was 6-11 cm., Conclusion: PAP free flap demonstrates reliable vascular anatomy in cadavers, with adequate pedicle length and vessel diameter. All specimens contained adequate myocutaneous perforator to support free tissue transfer., Competing Interests: Declaration of competing interest The authors of this manuscript have no disclosures., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objectives: To determine the influence of major head and neck procedures on readmission and complication rates following tracheostomy., Methods: A retrospective cohort study using the 2005 to 2017 National Surgical Quality Improvement Program (NSQIP) database. Current Procedural Terminology codes were used to identify tracheostomy patients and to define the underlying head and neck procedure. Patients under the age of 18 and with unknown pre-operative variables were excluded. Univariate and multivariable analyses were performed., Results: A total of 3240 tracheostomy patients undergoing major head and neck surgery were identified in NSQIP. The 30-day mortality rate was 104 (3.2%) and 258 (9.0%) patients were readmitted. 637 (19.7%) patients had an unplanned return to the operating room. There were 1606 (49.6%) non-tracheostomy specific complications, which included 850 (26.2%) medical and 1142 (35.2%) surgical complications. On multivariable analysis, we found that the underlying procedures did not impact the risk of readmission ( P  > .05 for all). The underlying procedure was also not associated with unplanned return to the operating room except for thyroidectomies, which had a lower risk than free tissue graft reconstruction (OR = 0.53 (95%CI 0.31, 0.88), P  = .018)., Conclusion: While almost 1 in every 2 patients had a complication following major head and neck surgery that included creation of a tracheostomy, the rate of readmission is comparatively low and is not associated with the underlying procedure. These findings should reassure head and neck surgeons that properly managed tracheostomies do not constitute a disproportionate risk of readmission.

Importance: Vagus nerve stimulation (VNS) devices have gained widespread acceptance for treatment of resistant epilepsy and depression. The increasing number of procedures has resulted in an increasing number of iatrogenic injuries to the vagus nerve, which can have a significant effect on vocalization and quality of life., Objective: To determine the relative frequency of laryngeal adverse effects reported to the US Food and Drug Administration (FDA) after VNS implantation and to analyze associated VNS device problems., Design, Setting, and Participants: This retrospective cross-sectional analysis queried the FDA Manufacturer and User Facility Device Experience database of adverse events in the US between 1996 and 2020., Main Outcomes and Measures: The primary outcome was the percent of adverse events reported to the FDA that included patients who received VNS with laryngeal adverse effects and the associated proportion of device problems after VNS surgery., Results: A total of 12 725 iatrogenic vagus nerve issues were documented after VNS implantation, with apnea (n = 395; 3.1%) being the most common patient problem. Overall, 187 reports of laryngeal adverse effects associated with VNS devices were identified and represented the eighth most common iatrogenic vagus nerve problem reported to the FDA. Laryngeal adverse effects included 78 reports of voice alteration and 57 reports of paresis/paralysis. The VNS device problems frequently associated with laryngeal adverse effects were high impedance (n = 15, 8.02%), incorrect frequency delivery (n = 10, 5.35%), and battery problems (n = 11, 5.88%). The number of laryngeal adverse effect reports per year peaked in 2012 with 43 cases., Conclusions and Relevance: This cross-sectional study found that although the literature demonstrates that vocal changes occur with nearly all VNS devices, the FDA receives adverse event reports of voice changes. Our results emphasize a potential need to improve patient counseling prior to VNS surgery to better set patient expectations regarding vocal changes and to prevent unnecessary patient concern. In addition, reports of vocal fold paresis/paralysis potentially suggest that patients may benefit from preoperative laryngeal assessment to differentiate preexisting vocal fold paralysis from that caused by VNS surgery.

Importance: Tall cell morphology (TCM) is a rare and aggressive variant of papillary thyroid carcinoma (PTC) that has been associated with poor outcomes; however, the risk factors for worse survival are not well characterized., Objective: To identify prognostic factors associated with cancer recurrence and death in patients with PTC-TCM., Design, Setting, and Participants: All patients treated for PTC-TCM at a single tertiary-level academic health care institution from January 1, 1997, through July 31, 2018, were included. Tall cell variant (TCV) was defined as PTC with TCM of 30% or more; and tall cell features (TCF) was defined as PTC with TCM of less than 30%. Patients with other coexisting histologic findings and/or nonsurgical management were excluded. Clinicopathologic features associated with worse outcomes were identified using Kaplan-Meier and Cox proportional-hazards model. Data were analyzed from March 1, 2018, to August 15, 2018., Main Outcomes and Measures: Locoregional recurrence-free survival (LRRFS), distant recurrence-free survival (DRFS), and overall survival (OS) after surgery., Results: A total of 365 patients (median [range] age, 51.8 [15.9-91.6] years; 242 [66.3%] female) with PTC-TCM (TCV, 32%; TCF, 68%) were evaluable. Total thyroidectomy was performed in 336 (92%) patients; 19 (5.2%) received radiotherapy; and 15 (4.1%) received radioactive iodine. Clinical features were pT3 or T4, 65%; node-positive, 53%; and positive surgical margins, 24%. LRRFS at 1-, 3-, 5-, and 10-year was 95%, 87%, 82%, and 73%, respectively. On multivariable analysis, male sex and age were not independent predictors of inferior 5-year LRRFS, whereas positive surgical margins (HR, 3.5; 95% CI, 2.0-6.3), positive lymph nodes (HR, 2.8; 95% CI, 1.4-5.8), and primary tumor size of 3 cm or more (HR, 3.3; 95% CI, 1.4-7.8) were strongly associated with worse LRRFS. Age 55 years or older (HR, 3.2; 95% CI, 1.5-7.0), male sex (HR 4.5; 95% CI, 2.1-10.0), positive surgical margins (HR, 2.7; 95% CI, 1.2-6.0), nodal positivity (HR, 3.1; 95% CI, 1.3-7.7), tumor diameter of 1.5 cm or more (HR, 20.6; 95% CI, 2.8-152.1), and TCV vs TCF (HR, 3.1; 95% CI, 1.5-6.7) were associated with worse DRFS. Male sex (HR, 3.1; 95% 1.4-6.8) and tumor diameter of 1.5 cm or more (HR, 2.8; 95% CI, 1.0-7.4) were associated with worse OS. A findings-based nomogram was constructed to predict 10-year LRRFS (C index, 0.8)., Conclusions and Relevance: This retrospective cohort study found that in patients with PTC-TCM, positive surgical margins, node positive disease, and tumor size of 3 cm or more were risk factors for worse LRRFS. Intensified locoregional therapy, including adjuvant radiation, may be considered for treating these patients.

Objective: In 2021 the U.S. FDA issued a Class 1 safety recall notice for specific devices due to a risk of carcinogen exposure. The objective of this study was to evaluate reports of cancer linked to CPAP devices to understand implications for the field of sleep medicine., Methods: Cases of cancer involving CPAP devices were retrieved from the MAUDE database from 2014 to 2021 and analyzed with descriptive statistics., Results: A total of 2571 patient injuries were associated with CPAP. Reports of cancer (n = 209; 4.62%) were the second most commonly documented patient problem associated with CPAP, although 1950 (43.13%) patients had a device problem without an associated injury. Of the 209 cancer cases associated with CPAP, 200 (95.7%) of the adverse event reports were received by the FDA in 2021. There were 174 (9.15%) descriptions of the CPAP polyurethane sound abatement foam degrading in association with a cancer diagnosis, but degradation was more commonly not associated with malignancy (n = 1728; 90.85%). Other frequently documented CPAP device problems included broken devices (n = 279; 6.92%), fire (n = 182; 4.51%), and patient-device incompatibility (n = 144; 3.57%)., Conclusion: Malignancy associated with CPAP devices has been reported; however, future studies are required to establish causation. Given 95.7% of those documented cases were reported in 2021, otolaryngologists should be prepared to discuss the risks of carcinogenesis associated with CPAP. The otolaryngology community should also be aware of the potential bandwagon effect and the implications for CPAP compliance., Level of Evidence: 4 Laryngoscope, 132:2270-2274, 2022., (© 2022 The Authors. The Laryngoscope published by Wiley Periodicals LLC on behalf of The American Laryngological, Rhinological and Otological Society, Inc.)

Objectives: Investigate outcomes following oral cavity and oropharyngeal salvage surgery., Methods: Adult patients who underwent salvage surgery for recurrent squamous cell carcinoma of the oral cavity and oropharynx from 1996 to 2018 were analyzed using multivariable Cox proportional hazards regression. Disease-free survival (DFS), overall survival (OS), associated factors, and basic quality measures were analyzed., Results: One hundred and eight patients (72% oral cavity, 28% oropharynx) were followed for a median of 17.9 months. Median DFS and OS were 9.9 and 21 months, respectively. Surgery with adjuvant chemoradiotherapy compared to surgery alone (hazard ratio [HR] = 0.15, 95% confidence interval [CI]: 0.03-0.78) and negative margins (HR = 0.36, 95% CI: 0.14-0.90) were associated with better DFS, while lymphovascular space invasion (LVSI) (HR = 2.66, 95% CI: 1.14-6.19) and higher stage (III vs. I-II, HR = 3.94, 95% CI: 1.22-12.71) were associated with worse DFS. Higher stage was associated with worse OS (HR = 3.79, 95% CI: 1.09-13.19). Patients were hospitalized for a median of 8 days with 24% readmitted within 30 days. A total of 72% and 38% of patients, respectively, underwent placement of a feeding tube or tracheostomy., Conclusions: After oral cavity and oropharyngeal salvage surgery, adjuvant chemoradiotherapy, negative margins, negative LVSI, and lower stage were associated with a lower risk of recurrence. Only lower-stage disease was associated with improved survival. The majority of patients had feeding tubes, half underwent free tissue transfer, a third required tracheostomy, and a quarter was readmitted., Level of Evidence: 3 Laryngoscope, 132:1984-1992, 2022., (© 2022 The American Laryngological, Rhinological and Otological Society, Inc.)

Background/aim: Hypofractionated radiation therapy is not commonly used in head and neck cancers (HNC) due to increased toxicity observed in historical cohorts. This study reviews our institutional experience using hypofractionated intensity modulated radiation therapy (H-IMRT) for HNC., Patients and Methods: A retrospective cohort study of 56 patients with HNC treated with H-IMRT with ≥50 Gy in 20 fractions was conducted. The primary outcomes were acute and late toxicity., Results: Two-year locoregional control was 87% and median overall survival was 46 months. There were no acute or late grade 4 or 5 toxicities. Acute grade 2 and 3 toxicity was seen in 79% (N=44) and 25% (N=14), respectively. Late grade 2 toxicity was seen in 9% (N=5). No patients required the placement of a feeding tube or tracheostomy., Conclusion: H-IMRT for the definitive or post-operative treatment of HNC using ≥50 Gy in 20 fractions appears safe and well tolerated with modest toxicity., (Copyright © 2022 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background: The prognostication of Epstein-Barr virus (EBV) and human papillomavirus (HPV) status in nasopharyngeal cancer (NPC) is unclear., Methods: This retrospective study analyzed NPC from 2000 to 2019., Results: Seventy-eight patients were included: 43 EBV + , 12 HPV + , 23 EBV - /HPV - , and 0 EBV + /HPV + . All p16 + tumors were also positive for HPV-CISH. Baseline characteristics were not different between groups except age, N-classification, and Karnofsky Performance Scale (KPS) (p < 0.05). For EBV + , HPV + , and EBV - /HPV - respectively, 3-year overall survival (OS) was 89.9%, 69.8%, and 52.5% (p = 0.006). EBV - /HPV - status was significantly associated with worse OS but not freedom from progression (FFP) on univariate analysis, and did not remain a significant predictor of OS after adjusting for KPS, age, and group stage., Conclusions: EBV + NPC tumors were seen in younger, healthier patients than HPV + and EBV - tumors, and there were no cases of coinfection. The association of viral status with OS was insignificant after adjusting for KPS and age., (© 2022 Wiley Periodicals LLC.)

Objectives: To explore the influence of treatment package time(TPT) in high-risk oral cavity squamous cell carcinoma(OCSCC) receiving adjuvant radiotherapy with concurrent chemotherapy(CRT)., Materials and Methods: We queried our multi-institutional OCSCC collaborative database for cases diagnosed between 2005 and 2015 who underwent surgery followed by adjuvant CRT. All patients had high-risk features: extranodal extension(ENE) and/or positive surgical margin(PM). TPT was days between surgery to last radiotherapy fraction. Kaplan-Meier curves, log-rank p-values and multivariate analysis(MVA) were used to investigate the impact of TPT on overall(OS), disease-free(DFS), locoregional failure-free(LRFS) and distant metastases-free(DMFS) survival., Results: We identified 187 cases: median age 58 (range, 24-87 years), males 66%, and ever smokers 69%. ENE and PM were detected in 85% and 32%, and oral tongue and floor of the mouth constituted 49% and 18%, respectively. Median radiotherapy and cisplatin doses received were 66 Gy and 200 mg/m2. Overall, median TPT was 98 (range, 63-162 days). OS was worse for TPT > 90-days (n = 134) than TPT ≤ 90 (n = 53) at two-(65% vs. 71%) and five-years (45% vs. 62%); p = 0.05, with similar results for DFS. No influence on LRFS or DMFS was noted. More lymph nodes(LN) dissected(P = 0.039), T3-4 disease(P = 0.017), and unplanned reoperations(P = 0.037) occurred with TPT > 90-days. On MVA, TPT in 10-day increments was independently detrimental for OS (Hazard Ratio: 1.14; 95 %Confidence Interval [1-1.28]; P = 0.043), perineural invasion, age and positive LN (p < 0.05 for all)., Conclusion: In one of the largest multi-institutional cohorts, TPT > 90-days predicted worse OS for high-risk OCSCC receiving adjuvant CRT. All efforts are needed to optimize perioperative care and baseline conditions for favorable outcomes., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Background: Hypertension has been shown to be both a protective factor and a risk factor for complications in head and neck reconstructive surgery., Methods: Retrospective analysis of microvascular free tissue transfer patients using the National Surgical Quality Improvement Program database., Results: Hypertensive patients (n = 1598; 46.9%) had a significantly higher rate of complications, including pneumonia (p < 0.001), myocardial infarction (p = 0.003), and intra/post-operative transfusion (p < 0.001). In a multivariable model, hypertension was associated with returning to the operating room (OR = 1.45 [95% CI 1.20, 1.76], p < 0.001), post-operative medical complications (OR = 1.53 [95% CI 1.24, 1.90], p < 0.001), and surgical complications (OR = 1.17 [95% CI 1.00, 1.37], p = 0.047). However, no difference in 30-day readmission was found (p > 0.05)., Conclusions: Hypertension is a modifiable risk factor for post-operative complications in head and neck free tissue transfer, in which prospective studies are required to establish causation. This study may serve as an impetus for proactive recommendations to manage hypertension before undergoing head and neck microvascular surgery., (© 2021 Wiley Periodicals LLC.)

Objectives: To assess risk factors and non-thyroid specific postoperative complications for thyroid lobectomy compared to total thyroidectomy., Methods: A retrospective, cross-sectional study of adults undergoing a lobectomy or total thyroidectomy using the National Surgical Quality Improvement Program database between 2005 and 2017. Patients not treated by otolaryngologists or general surgeons and with unknown demographic variables were excluded., Results: A total of 106 915 patients were analyzed, 64 763 total thyroidectomies and 42 152 lobectomies. Multivariable analysis demonstrated that total thyroidectomy patients were half as likely to return to the operating room (OR = 0.491 (95%CI 0.445-0.542), P  < .001). Within this cohort, patients at greater risk for reoperation had a history of hypertension (OR = 1.225 (95%CI 1.090-1.376), P  < .001), a malignant pathology (OR = 1.921 (95%CI 1.734-2.128), P  < .001), and smoked (OR = 1.237 (95%CI 1.087-1.407), P  = .001). Conversely, diabetes and body mass index did not impact the rate of reoperation when assessing total thyroidectomy and lobectomy. The most frequent non-thyroid specific complications in total thyroidectomy were unplanned intubation (0.5%), urinary tract infection (0.3%), and superficial surgical site infection (0.3%). In thyroid lobectomy, the most common complications were superficial surgical site infection (0.3%) and urinary tract infection (0.2%)., Conclusions: Our multi-institutional study indicates specific risk factors for returning to the operating room that may warrant closer follow up after surgery for total thyroidectomy or thyroid lobectomy. We also identified the most common post-operative complications. During pre-operative planning, these findings should be considered by thyroid surgeons to help mitigate risk to patients.