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.

The "bowtie" reconstruction flap: A unique solution to cervical esophageal discontinuity repair.

OBJECTIVES: Describe a novel technique for repair of cervical esophageal discontinuity. STUDY DESIGN: A 66-year-old female underwent hiatal hernia repair with a Nissen fundoplication. This was complicated by ischemic necrosis of the proximal stomach requiring urgent return to the operative suite for partial gastrectomy, esophageal diversion and subsequent esophagectomy repaired with a colonic interposition graft by Thoracic Surgery. This was further complicated by a cervical esophageal colonic anastomotic leak maturing to a cervical esophageal fistula and necessitating jejunostomy tube placement and consultation to Head and Neck Surgery. METHODS: Case report. RESULTS: In a team approach with Otolaryngology and Thoracic Surgery, she underwent a unique, multilevel repair with a salivary bypass stent bridging the gap between the proximal esophagus and distal colonic conduit. Bilateral local advancement flaps were elevated using the skin lateral to the fistula on each side with a random blood supply pedicled medially. Each flap was rotated medially over the stent and imbricated at midline. Next, a left myogenous pectoralis flap was raised and rotated over the site of imbrication. Lastly, a split thickness skin graft from the thigh was harvested and sutured over the pectoralis flap. Three months postoperatively, the salivary bypass stent was removed and by five months, the fistula was completely closed. With cervical esophageal dilations bimonthly, the patient has graduated to an oral diet without need of her jejunostomy tube for nearly four months. CONCLUSION: This case report describes a novel and efficacious solution to cervical esophageal discontinuity.

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.

Incidence of squamous cell carcinomas of the head and neck following prolonged pegylated liposomal doxorubicin.

Despite numerous case reports, the incidence of a secondary diagnosis of head and neck squamous cell carcinoma (HNC) following pegylated liposomal doxorubicin (PLD) treatment is unknown. Computerized pharmacy records were searched at a large, multi-center healthcare system for patients who received PLD. Electronic medical records were searched to identify the patient's age at treatment initiation of PLD, diagnosis for which they were treated with PLD, number of courses and total cumulative dose of PLD (TCDPLD) and secondary malignancies. Published PLD associated HNC was utilized to determine the lowest and median TCDPLD doses associated with HNC. One thousand two hundred ninety eligible patients who had been treated with PLD were identified. The lowest TCDPLD associated HNC in the literature is 405 mg/m2. In our healthcare system, 275 patients received more than 400 mg/m2 yielding a risk of 0.004%. One hundred fifty-one patients received the lowest TCDPLD associated with HNC cancer in our series which was 640 mg/m2 yielding a risk of 0.007%. Four of 30 patients (13.3%) developed HNC who received the median TCDPLD associated with HNC in the literature of 1440 mg/m2. Five of 20 patients (25%) receiving 1650 mg/m2 developed HNC in our healthcare system. Prolonged therapy with PLD is associated with an increased risk of HNC. This risk appears to be related to the cumulative dose varying from 0.004 to 13.3% at the lowest and median TCDPLD of reported cases in the literature, respectively. Oncologists need to be aware of this risk and to screen patients appropriately.

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.

Post-treatment sequelae and management of primary laryngeal NK/T-cell lymphoma: A case report.

OUTCOME OBJECTIVES: METHODS: Case Report, April 2016. RESULTS: A 27-year-old female presented with a three-week history of flu-like symptoms including sore throat, myalgia and insidious nasal congestion. Her hospital course was complicated by pancytopenia, extensive GI bleed of unknown origin and fever. Radiographic studies revealed multifocal centrilobular ground-glass lung nodules, splenomegaly, frontal and paranasal sinus opacification and mucosal thickening and inflammatory process of false and true vocal cords with concentric multi-level narrowing. Extensive rheumatologic, hematologic and infectious workup failed to demonstrate an etiology. Flexible laryngoscopic and bronchoscopic examinations with biopsies exhibited a diffuse supraglottic and glottic exophytic, "heaped-up" infiltration; limited vocal cord motion; and airway narrowing to 3 mm. Pathology yielded NK/T-Cell lymphoma with PET/CT confirming nasopharyngeal and laryngeal involvement sparing the brain and other distant structures. During treatment, the patient's airway became increasingly compromised requiring tracheostomy. Flexible laryngoscopic examination after four rounds of SMILE (dexamethasone, methotrexate, ifosfamide, l-asparaginase, and etoposide) chemotherapy and subsequent radiotherapy with 50 Gy in 25 fractions revealed complete glottic stenosis with alteration of the laryngeal anatomy and a pin-hole aperture seen posteriorly through the tracheostomy. Two dilation procedures performed one month apart, improved her airway considerably which allowed for successful decannulation. She continues to be disease-free post treatment but has persistent supraglottic and glottic scar and has developed tracheal stenosis at her tracheostomal site. CONCLUSIONS: NK/T-Cell lymphoma of the larynx has been rarely described. Herein, we describe the sequalae of treatment and the requisite airway management.

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.

Tumor-derived mutations in the gene associated with retinoid interferon-induced mortality (GRIM-19) disrupt its anti-signal transducer and activator of transcription 3 (STAT3) activity and promote oncogenesis.

The signal transducer and activator of transcription 3 (STAT3) protein is critical for multiple cytokine and growth factor-induced biological responses in vivo. Its transcriptional activity is controlled by a transient phosphorylation of a critical tyrosine. Constitutive activation of STAT3 imparts resistance to apoptosis, promotes cell proliferation, and induces de novo micro-angiogenesis, three of the six cardinal hallmarks of a typical cancer cell. Earlier we reported the isolation of GRIM-19 as a growth suppressor using a genome-wide expression knockdown strategy. GRIM-19 binds to STAT3 and suppresses its transcriptional activity. To understand the pathological relevance of GRIM-19, we screened a set of primary head and neck tumors and identified three somatic mutations in GRIM-19. Wild-type GRIM-19 suppressed cellular transformation by a constitutively active form of STAT3, whereas tumor-derived mutants L71P, L91P and A95T significantly lost their ability to associate with STAT3, block gene expression, and suppress cellular transformation and tumor growth in vivo. Additionally, these mutants lost their capacity to prevent metastasis. These mutations define a mechanism by which STAT3 activity is deregulated in certain human head and neck tumors.

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.

Evaluating the impact of the degree of extranodal extension on outcomes in locally advanced oral cavity cancer.

BACKGROUND: Evaluate whether extranodal extension (ENE) extent impacts outcomes in patients with oral cavity squamous cell carcinoma (OCSCC). METHODS: From an institutional database, patients with OCSCC and pathologic ENE who received adjuvant treatment were included. Surgical slides were reviewed to confirm ENE extent. Multivariable Cox regression was used to relate patient/treatment characteristics with disease-free survival (DFS) and overall survival (OS). ENE was analyzed as both a dichotomous and continuous variable. RESULTS: A total of 113 patients were identified. Between major (>2 mm) versus minor ENE (≤2 mm), there was no significant difference in DFS (HR 1.18, 95%CI 0.72-1.92, p = 0.51) or OS (HR 1.17, 95%CI 0.70-1.96, p = 0.55). There was no significant association between ENE as a continuous variable and DFS (HR 0.97 per mm, 95%CI 0.87-1.4, p = 0.96) or OS (HR 0.96 per mm, 95%CI 0.83-1.11, p = 0.58). CONCLUSION: No significant relationship was seen between ENE extent and DFS or OS in individuals with OCSCC.

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.

Factors Leading to Gastrostomy Tube and Tracheostomy Requirements in Patients Treated Initially With Radiotherapy and Salvaged With Surgery and Free Flap Reconstruction.

OBJECTIVE: Patients with recurrent oropharyngeal cancer can achieve survival benefits from surgical salvage, and often require simultaneous free-flap reconstruction. Resection and reconstruction can impact function, leading to tube dependence. PRIMARY OBJECTIVE: describe rates of tracheostomy and gastrostomy tube dependence after oropharyngeal resection and free flap after prior radiation. SECONDARY OBJECTIVE: evaluate patient, tumor, and treatment factors associated with tube dependence. STUDY DESIGN: Retrospective, multi-institutional cohort study. Patients treated from 2003 to 2020. Average follow-up 21.4 months. SETTING: Five tertiary care centers. METHODS: Consecutive cohort of patients undergoing resection and simultaneous free-flap reconstruction for oropharyngeal squamous cell carcinoma after head and neck radiation. PRIMARY OUTCOMES: gastrostomy tube dependence and tracheostomy or tracheostoma 1 year after surgery. Univariable and multivariable logistic regression were performed to identify factors associated with dependence. RESULTS: 89 patients underwent oropharyngectomy and free-flap reconstruction; 18 (20%) underwent total laryngectomy as part of tumor extirpation. After surgery, 51 patients (57%) lived 12 months. Among patients alive at 12 months, 22 (43%) were at least partially-dependent on gastrostomy tube, and 15 (29%) had either tracheostomy or tracheostoma. On multivariable analysis, extensive glossectomy (OR 16.6, 95% CI 1.83-389, p = 0.026) and total laryngectomy (OR 11.2, 95% CI 1.71-105, p = 0.018) were associated with long-term gastrostomy tube. No factors were associated with long-term tracheostomy on multivariable analysis. CONCLUSION: Even among long-term survivors after salvage resection and free-flap reconstruction, rates of tube dependence are significant. This multi-institutional review is the largest such study to the date and may help inform shared decision-making. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:2141-2147, 2023.

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.

Primary Total Laryngectomy versus Organ Preservation for Locally Advanced T3/T4a Laryngeal Cancer.

OBJECTIVE: Organ preservation (OP) treatment for advanced laryngeal cancer has increased compared to primary total laryngectomy. Our study compares oncologic and functional outcomes between these approaches. STUDY DESIGN: Retrospective cohort study. SETTING: Single tertiary care institution. METHODS: Retrospective review of patients receiving primary total laryngectomy or OP for laryngeal cancer between 1/1/2000 and 12/31/2018. RESULTS: A total of 118 patients received primary total laryngectomy and 119 received OP. Overall survival was similar between total laryngectomy and OP. When stratified by T stage, disease-free survival was worse among T3 patients receiving OP versus total laryngectomy. In T3 patients, 28 OP patients experienced local recurrence (28.9%) compared to 3 total laryngectomy patients (7.1%; p < 0.01). In total, 20 OP patients with local recurrence received salvage surgery. These patients had similar overall survival to patients who underwent initial total laryngectomy (TL). About 14 OP patients with local recurrence did not receive salvage surgery. About 89 (75.4%) TL patients achieved normal diet as compared to 64 (53.8%) OP patients (p < 0.001). In TL patients, 106 (89.8%) received primary or secondary tracheoesophageal-prosthesis, 82 (77.4%) of whom achieved completely understandable speech. CONCLUSIONS: There was no difference in survival by treatment in T4 patients, possibly because of strict patient selection. However, disease-free survival was worse in T3 patients receiving OP, likely due to a high local recurrence rate. Approximately 40% of patients with local recurrence were not eligible for salvage laryngectomy. TL patients had comparable swallowing and speech outcomes with OP patients. LEVEL OF EVIDENCE: 3 Laryngoscope, 133:1122-1131, 2023.