Adverse events associated with anastomotic coupling devices in microvascular reconstruction.

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.

Survival Outcomes of Advanced Thyroid Cancer Enriched in Brain Metastases Following Treatment With Small Molecule Inhibitors.

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 BRAFV600E mutations, RET mutations, RET fusions, and NTRK fusions had superior survival.

The profunda artery perforator flap for head and neck reconstruction.

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.

Rethinking the 10-pack-year rule for favorable human papillomavirus-associated oropharynx carcinoma: A multi-institution analysis.

BACKGROUND: De-intensified treatment strategies for early human papillomavirus-positive (HPV+) oropharynx cancer (OPC) rely on selecting patients with an excellent prognosis. The criterion for enrollment in current de-intensification trials is ≤10 pack-years. More nuance to the pack-year criteria may expand enrollment, improve patient outcomes, and prevent overtreatment. It was hypothesized that patients with more than 10 pack-years may experience favorable outcomes if smoking cessation has been achieved. METHODS: From an institutional review board-approved database, patients with HPV+ oropharyngeal squamous carcinoma treated definitively with radiation with or without chemotherapy were retrospectively identified. Patients with a history of smoking who were eligible for national de-intensification trials were included (cT1-2N1-2b or T3N0-2b [American Joint Committee on Cancer, seventh edition]). Cox regression with penalized smoothing splines was used to evaluate nonlinear effects of cessation. Recursive partitioning analysis (RPA) was used to objectively search for relationships between the 2 colinear variables (pack-years and time since cessation). RESULTS: Among 330 patients meeting the inclusion criteria, 130 (40%) were never smokers, 139 (42%) were former smokers, and 61 (18%) were current smokers. With standard therapy, all former smokers achieved a progression-free survival (PFS) rate higher than 91%, regardless of pack-year exposure. Nonlinear Cox regression demonstrated that more recent cessation was associated with significantly worse PFS even among those with ≤20 pack-years. RPA demonstrated that only current smokers experienced a 2-year PFS rate lower than 91%; former smokers, regardless of pack-years, experienced a 2-year PFS rate higher than 91%. CONCLUSIONS: The 10-pack-year rule may not apply to all early HPV+ OPCs, particularly for former smokers. Future randomized de-intensification trials should consider a broader and more nuanced approach until the predictive role of smoking status is established.

Does neck dissection affect post-operative outcomes in parotidectomy? A national study.

OBJECTIVE: To characterize post-operative complications in parotidectomy with neck dissection. METHODS: Patients age ≥ 18 receiving a parotidectomy or parotidectomy with neck dissection between 2005 and 2017 were eligible for inclusion. Patients with unknown demographic variables were excluded. Univariate and multivariable logistic regression analyses were performed. RESULTS: A total of 13,609 parotidectomy patients were analyzed, 11,243 (82.6%) without neck dissection and 2366 (17.4%) with neck dissection. Both length of surgery (mean minutes ± standard deviation [SD] = 335.9 ± 189.2 vs. 152.9 ± 99.0, p < 0.001) and length of hospital stay (mean days ± SD = 3.90 ± 4.76 vs. 1.04 ± 2.14, p < 0.001) were greater with dissection. 13.9% of parotidectomies with neck dissection and 3.5% without dissection (p < 0.001) had at least one complication, which remained significant after multivariable adjustment (Odds Ratio[OR] = 1.565 (95%CI = 1.279-1.914), p < 0.001). The increase in post-operative complications was predominately driven by an increased transfusion rate (7.4% vs. 0.5%, p < 0.001). Multivariable analysis also demonstrated no significant difference in rates of returning to the operating room (OR = 1.122 (95%CI 0.843-1.493), p > 0.05) or rates of readmission (OR = 1.007 (95%CI 0.740-1.369), p > 0.05). Parotidectomy with neck dissection was more likely to be inpatient (OR = 4.411 (95%CI 3.887-5.004), p < 0.001) and to be ASA class 3 (OR = 1.367 (95%CI 1.194-1.564), p < 0.001). CONCLUSIONS: Nationwide data demonstrates that parotidectomy with neck dissection is associated with increased rates of post-operative complications; however, neck dissection did not significantly impact readmission or reoperation rates. These findings indicate that neck dissection is a relatively safe addition to parotidectomy and provide novel evidence in the management of parotid malignancies.

Is tracheotomy on the decline in otolaryngology? A single institutional analysis.

OBJECTIVE: A recent study reported decreasing trends in tracheotomy procedures by its otolaryngology service. We set out to determine whether the previously reported decrease in otolaryngology performed tracheotomies by one institution is a local or generalizable phenomenon. DESIGN: Retrospective cohort study from 2010 to 2015. SETTING: Tertiary care hospital and affiliated regional hospitals. SUBJECT AND METHODS: All patients who received tracheotomy during the period of analysis were included. Performing specialty, surgical technique, and procedure location were recorded. Procedures were stratified by year and specialty to generate incidence rate ratios for otolaryngologists and non-otolaryngologists. Incidence rate ratios were estimated with negative binomial regression across services. RESULTS: The otolaryngology service demonstrated a yearly decrease of 3.4% in the total number of tracheotomies (95% CI -7.9% to +1.4, P=0.17). While the thoracic service remained constant (+0.3%, 95% CI -2.6% to +3.3%, p=0.83), general surgery demonstrated the greatest increase in procedures (+4.4%, 95% CI -6.0% to +15.8%, P=0.42). Thoracic and general surgery both dramatically increased the number of percutaneous tracheotomies performed, with general surgery also performing a greater number of bedside procedures. CONCLUSIONS AND RELEVANCE: We observed a similar decline in the number of tracheotomies otolaryngology over six years. Our trend is likely due to changes in consultations patterns, increasing use of the percutaneous method, and an increase in adjunctive gastrostomy tube placements. Investigations on the impact of a greater number of non-otolaryngology performed tracheotomies on follow up care is warranted.

Perioperative cardiac complications in patients undergoing head and neck free flap reconstruction.

BACKGROUND: Limited data exists on cardiac complications following head and neck free flaps. DESIGN: A retrospective review was performed on patients that underwent free flap reconstruction from 2012 to 2015. RESULTS: 368 flaps were performed. 12.5% of patients experienced a cardiac event. Hypertension, coronary artery disease, heart failure, venous thromboembolism, and anticoagulation were associated with cardiac complications. ASA class was not predictive of cardiac events. 7.6% of patients required anticoagulation, which exhibited a strong association with surgical site hematoma. Cardiac complications led to a significantly increased length of stay. CONCLUSIONS: There is a significant rate of cardiac events in this cohort. When estimating risk, a patient's total burden of comorbidities is more important than any one factor. ASA Class fails to demonstrate utility in this setting. Cardiac events have implications for quality-related metrics including length of stay and hematoma rate.

Occult Nodal Metastases in Individuals with Clinically Node-Negative Salivary Gland Malignancies.

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.

Primary fit tracheoesophageal puncture in primary versus salvage laryngectomy: Short-term and long-term complications and functional outcomes.

BACKGROUND: Primary fit tracheoesophageal puncture (TEP) is widely preferred for individuals who have not undergone prior radiation. However, there is no consensus on the relative utility of primary-fit TEP in the setting of salvage laryngectomy. METHODS: A retrospective, single-center review was conducted of individuals undergoing laryngectomy with primary fit TEP between 2012 and 2018. Multivariable analysis was conducted to compare short-term and long-term complications, as well as speech and swallowing outcomes, of those who underwent primary versus salvage laryngectomy. RESULTS: In this study, 134 patients underwent total laryngectomy with primary fit TEP. Aside from a higher rate of peristomal dehiscence (13.1% vs. 1.4%) found in the salvage group, there was no difference in incidence of all other complications, including pharyngocutaneous fistula formation. The groups had comparable speech and swallow outcomes. CONCLUSION: Primary fit TEP is a safe and effective surgical choice for individuals undergoing salvage laryngectomy who desire a voice prosthesis.

Readmission Rates Following Major Head and Neck Surgery With Concurrent Tracheostomy.

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.

Laryngology Outcomes Following Implantable Vagus Nerve Stimulation.

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.

Rates of osteoradionecrosis in resected oral cavity cancer reconstructed with free tissue transfer in the intensity-modulated radiotherapy era.

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.

Margin Assessment Methods in Oral Cavity Squamous Cell Carcinoma and Recurrence: Tumor Bed vs Resection Specimen Sampling.

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.

Risk Factors Associated With Recurrence and Death in Patients With Tall Cell Papillary Thyroid Cancer: A Single-Institution Cohort Study With Predictive Nomogram.

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.

Association of Treatment Strategies and Tumor Characteristics With Overall Survival Among Patients With Anaplastic Thyroid Cancer: A Single-Institution 21-Year Experience.

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.

Role of positron emission tomography in management of sinonasal neoplasms--a single institution's experience.

OBJECTIVE: The objective of the study is to examine the utility of positron emission tomography (PET) for staging and restaging after treatment of paranasal sinus carcinomas. STUDY DESIGN: Retrospective data review was done. SUBJECTS AND METHODS: Patients selected underwent PET for sinonasal neoplasms from 2003 to 2008 at a tertiary care referral center. RESULTS: Seventy-seven scans were reviewed from 31 patients. The pathologies included olfactory neuroblastoma (n = 9), squamous cell carcinoma (n = 6), sinonasal undifferentiated carcinoma (n = 6), sinonasal melanoma (n = 6), and minor salivary gland carcinomas (n = 4). The positive predictive value of studies performed for restaging at the primary, neck, and distant sites were 56%, 54%, and 63%; negative predictive values were 93%, 100%, and 98%, respectively. During restaging, 32% of patients were accurately upstaged secondary to neck or distant site involvement. CONCLUSION: Positron emission tomography serves as a useful adjunct to conventional imaging in the management of sinonasal malignancies. Negative studies are effective in predicting absence of disease as seen in the consistently high-negative predictive values. Positive studies need to be viewed cautiously given the high rate of false-positive studies. When viewed in conjunction with clinical examination, endoscopic assessment, and focused biopsies, they may effectively result in a more accurate assessment of the extent of disease.

Intended single-modality management of T1 and T2 tonsillar carcinomas: retrospective comparison of radical tonsillectomy vs radiation from a single institution.

BACKGROUND: T1 and T2 tonsillar squamous cell cancer with limited neck disease can be managed with single-modality radiation or surgery. Over 11 years, 17 patients underwent radical tonsillectomies; and 33 patients underwent radiation-based treatments for T1 and T2 and N0 to N2a tonsil cancer. Patients were intended to receive single-modality treatment based on presentation; however, some ultimately received adjuvant treatments. METHODS: A retrospective chart review to compare overall survival (OS), disease-specific survival (DSS), and locoregional control (LRC) between the groups was used. RESULTS: In surgical group, of 17 patients, 11 underwent surgery alone, 3 underwent surgery and radiation, and 3 underwent surgery with concurrent chemoradiation. Five-year OS for the surgical and radiation groups was 93% and 72%, respectively (no significance achieved). Five-year DSS rates (93% and 80%) and LRC (69% and 89%) similarly did not yield any significant difference. CONCLUSION: Surgery remains a viable option in the management of T1 and T2 tonsillar cancers with comparable LRC, OS, and DSS.

Cancer Risk Associated with Continuous Positive Airway Pressure: A National Study.

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.

Association between hypertension requiring medication and 30-day outcomes in head and neck microvascular surgery.

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.

Outcomes After Oral Cavity and Oropharyngeal Salvage Surgery.

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.