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.

Auditory Outcomes Following Cochlear Implantation in Children with Unilateral Hearing Loss.

OBJECTIVE: Unilateral hearing loss (UHL) in children is associated with speech and language delays. Cochlear implantation (CI) is currently the only rehabilitative option that restores binaural hearing. This study aims to describe auditory outcomes in children who underwent CI for UHL and to determine the association between duration of hearing loss and auditory outcomes. STUDY DESIGN: Retrospective case series. SETTING: Three tertiary-level, academic institutions. PATIENTS: Children <18 years with UHL who underwent CI between 2018 and 2021. INTERVENTION: Cochlear implantation. MAIN OUTCOME MEASURES: Speech perception and Speech, Spatial and Qualities of Hearing Scale (SSQ) were assessed postimplantation. Scores >50% on speech perception and SSQ scores >8 points were considered satisfactory. Associations between duration of UHL and implantation age and outcomes were assessed using Spearman's rank correlation. RESULTS: Of the 38 children included, mean age at CI was 7.9 ± 3.2 years and mean UHL duration was 5.0 ± 2.8 years. Mean datalogging was 8.1 ± 3.1 hours/day. Mean auditory testing scores were SSQ, 7.9 ± 1.2; BABY BIO, 68.1 ± 30.2%; CNC, 38.4 ± 28.4%; WIPI, 52.5 ± 23.1%. Scores >50% on CNC testing were achieved by 40% of patients. SSQ scores >8 points were reported by 78% (7/9) of patients. There were no significant correlations between UHL duration and auditory outcomes. CONCLUSION: Overall, children with UHL who undergo CI can achieve satisfactory speech perception scores and SSQ scores. There were no associations between duration of hearing loss and age at implantation with auditory outcomes. Multiple variables may impact auditory outcomes, including motivation, family support, access to technology, and consistent isolated auditory training postactivation and should be taken into consideration in addition to age at implantation and duration of UHL in determination of CI candidacy.

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.

Upper Extremity Wounds Treated with Biodegradable Temporizing Matrix versus Collagen-Chondroitin Silicone Bilayer.

Objective This study aims to compare outcomes between Novosorb Biodegradable Temporizing Matrix (BTM) and Integra collagen-chondroitin silicone for upper-extremity wound reconstruction. Methods This retrospective study analyzed adult patients who underwent wound reconstruction with either BTM or Integra at our institution between 2015 and 2020. Results Forty-eight patients were included: 31 (64.6%) BTM and 17 (35.4%) Integra. Mean age was 44.0 (range: 18-68) years. Age, race, sex, smoking, comorbidities, and defect size were similar between groups. Wound etiologies included 12 (25.0%) burn, 22 (45.8%) trauma, and others. Median template size was 133 cm 2 for BTM and 104 cm 2 for Integra ( p = 0.526). Skin grafting was performed after 14 (45.2%) and 14 (82.4%) wounds treated with BTM and Integra, respectively ( p = 0.028). Template complications of infection and dehiscence were comparable. Skin-graft complications occurred in five (35.7%) and three (21.4%) wounds in BTM and Integra, respectively ( p = 0.031). Skin-graft failure rates were comparable ( p = 0.121). Mean number of secondary procedures required after template placement was higher in the Integra group (BTM, 1.0; Integra, 1.9; p = 0.090). Final healing was achieved in 17 (54.8%) BTM and 11 (64.7%) Integra wounds ( p = 0.694). Median time to healing was 4.1 months after BTM and 2.6 months after Integra placement ( p = 0.014). Conclusion Compared with Integra, BTM achieved comparable wound healing and complication rates. Fewer secondary procedures and skin grafts were observed in BTM wounds, likely as a result of the coronavirus disease 2019 pandemic. At our institution, 100 cm 2 of product costs $850 for BTM and $3,150 for Integra, suggesting BTM as an economical alternative to fulfill the high functional and aesthetic requirements of upper-extremity wounds.

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.

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.

Glycemic and metabolic sub-classification of prediabetes and risk factors for cardiovascular disease in the D2d cohort.

Objectives: Prediabetes represents a spectrum of metabolic abnormalities, including insulin resistance and secretory impairment, that carries increased cardiovascular disease (CVD) risk. It is unclear whether specific glycemic and metabolic sub-classifications are associated with CVD risk. This cross-sectional analysis of 3946 participants from the Vitamin D and Type 2 Diabetes (D2d) study cohort aimed to determine the associations between various baseline CVD risk factors, glycemic sub-classifications of prediabetes (FPG, 2hPG, and HbA1c), and measures of insulin sensitivity and secretion from an OGTT. Methods: The metabolic syndrome and atherosclerotic cardiovascular disease (ASCVD) risk scores were determined for tertiles of insulin sensitivity (HOMA2S) and insulinogenic index (IGI). Unadjusted analyses showed elevated CVD risk factors in the lowest tertile for both IGI and HOMA2S. Results: After adjustment for age, gender, race, obesity, and smoking status, the association remained between HOMA2S and ASCVD score (r = -0.11, p< 0.001) but not for IGI. Those who met at least 2 diagnosic criteria for prediabetes had the largest proportion (> 40%) of participants with high ASCVD risk score >20. A higher percentage of individuals that met all 3 criteria for prediabetes had metabolic syndrome and ASCVD risk score >20 (87.2% and 15.3%, respectively) than those who only met 1 prediabetes criterion (51.6% and 7.1%, respectively). Conclusions: In conclusion, multiple metabolic (HOMA2S, IGI) and glycemic criteria of prediabetes (FPG, 2hPG, & HbA1c) are needed to fully recognize the elevated CVD risk profile that can manifest in prediabetes.

A Cross-Sectional Evaluation of Publication Bias in the Plastic Surgery Literature.

BACKGROUND: Publication bias (PB) is the preferential publishing of studies with statistically significant results. PB can skew findings of systematic reviews (SR) and meta-analyses (MA), with potential consequences for patient care and health policy. This study aims to determine the extent by which SRs and MAs in the plastic surgery literature evaluate and report PB. METHODS: This cross-sectional study assessed PB reporting and analysis from plastic surgery studies published between January 1, 2015 and June 19, 2020. Full-texts of SRs and MAs were assessed by two reviewers for PB assessment methodology and analysis. Post-hoc assessment of studies that did not originally analyze PB was performed using Egger's regression, Duval and Tweedie's trim-and-fill, and Copas selection models. RESULTS: There were 549 studies evaluated, of which 531 full-texts were included. PB was discussed by 183 (34.5%) studies, and formally assessed by 97 (18.3%) studies. Among SR and MAs that formally assessed PB, PB was present in 24 (10.7%), not present in 52 (23.1%), and inconclusive in 8 (3.6%) studies; 141 (62.7%) studies did not report the results of their PB assessment. Funnel plots were the most common assessment method (n=88, 39.1%), and 60 (68.2%) studies published funnel plots. The post-hoc assessment revealed PB in 17/20 (85.0%) studies. CONCLUSION: PB is inadequately reported and analyzed amongst studies in the plastic surgery literature. Most studies that assessed PB found PB, as did post-hoc analysis of non-reporting studies. Increased assessment and reporting of PB amongst SRs and MAs would improve quality of evidence in plastic surgery.

Variations in Payer-Negotiated Prices for Head and Neck Reconstructive Surgery.

OBJECTIVE: Little is known about pricing for reconstructive procedures of the head and neck. As of January 2021, the Centers for Medicare and Medicaid Services requires hospitals to disclose payer-negotiated prices for services, offering new insight into prices for privately insured patients. STUDY DESIGN: Cross-sectional analysis. SETTING: Turquoise database. METHODS: Payer-negotiated facility fees for 41 reconstructive surgeries were grouped by procedure type: primary closure, skin grafts, tissue rearrangement, locoregional flaps, or free flaps. Prices were normalized to account for local labor costs, then calculated as percent markup in excess of Medicare reimbursement. The mean percent markup between procedure groups was compared by the Kruskal-Wallis test. Subset analyses were performed to compare mean percent markup using a Student's t test. We also assessed price variation by calculating the ratio of 90th/10th percentile mean prices both across and within hospitals. RESULTS: In total, 1324 hospitals (85% urban, 81% nonprofit, 49% teaching) were included. Median payer-negotiated fees showed an increasing trend with more complex procedures, ranging from $379.54 (interquartile range [IQR], $230.87-$656.96) for Current Procedural Terminology (CPT) code 12001 ("simple repair of superficial wounds ≤2.5 cm") to $5422.60 ($3983.55-$8169.41) for CPT code 20969 ("free osteocutaneous flap with microvascular anastomosis"). Median percent markup was highest for primary closure procedures (576.17% [IQR, 326.28%-1089.34%]) and lowest for free flaps (99.56% [37.86%-194.02%]). Higher mean percent markups were observed for rural, for-profit, non-Northeast, nonteaching, and smaller hospitals. CONCLUSION: Wide variation in private payer-negotiated facility fees exists for head/neck reconstruction surgeries. Further research is necessary to better understand how pricing variation may correlate with out-of-pocket costs and quality of care.

Olfactory dysfunction incidence and resolution amongst 608 patients with COVID-19 infection.

PURPOSE: Olfactory dysfunction (OD) is a common presenting sign of coronavirus-19 (COVID-19) infection and remains persistent in up to 7 % of patients one year after diagnosis. However, demographic, socioeconomic, and medical risk factors for persistent OD are not well understood. This study aims to determine risk factors for development and persistence of OD amongst patients with COVID-19 infection. MATERIALS AND METHODS: This prospective, observational questionnaire study was performed at a tertiary-level, academic center. Patients with history of a positive COVID-19 diagnosis were sent an online questionnaire. Patients' self-reported survey responses for OD and resolution were assessed for associations with demographic variables, socioeconomic factors, and clinical data. RESULTS: In total, 608 of 26,094 patients (77.6 % women, mean age 42.7 ± 17.4 years, range 9 months-92 years) completed the survey. OD was reported by 220 (36.2 %) patients, and 139 (63.2 %) patients achieved resolution. Patients with OD were more likely to have other sinonasal and flu-like symptoms, and had a hospitalization rate of 2.7 %. There were no significant differences in age, gender, occupational or residential factors, or medical comorbidities incidence of OD development. Women reported higher rates of persistent OD (88.9 % vs 77.0 %, p = 0.045). The OD recovery rates amongst active and resolved COVID-19 infections was 27.0 % and 70.0 %, respectively (p < 0.001). CONCLUSIONS: There was a low hospitalization rate amongst patients reporting OD. One-third of patients with COVID-19 self-reported OD, and two-thirds of patients achieve OD resolution. Survey respondents with active COVID-19 infection and female gender were more likely to report persistent OD.

Predictors of Complications in Autologous Breast Reconstruction Using DIEP Flaps: Implications for Management.

BACKGROUND: Deep inferior epigastric perforator (DIEP) flaps are the standard for autologous breast reconstruction. This study investigated risk factors for DIEP complications in a large, contemporary cohort to optimize surgical evaluation and planning. METHODS: This retrospective study included patients who underwent DIEP breast reconstruction between 2016 and 2020 at an academic institution. Demographics, treatment, and outcomes were evaluated in univariable and multivariable regression models for postoperative complications. RESULTS: In total, 802 DIEP flaps were performed in 524 patients (mean age, 51.2 ± 9.6 years; mean body mass index, 29.3 ± 4.5). Most patients (87%) had breast cancer; 15% were BRCA -positive. There were 282 (53%) delayed and 242 (46%) immediate reconstructions and 278 (53%) bilateral and 246 (47%) unilateral reconstructions. Overall complications occurred in 81 patients (15.5%), including venous congestion (3.4%), breast hematoma (3.6%), infection (3.6%), partial flap loss (3.2%), total flap loss (2.3%), and arterial thrombosis (1.3%). Longer operative time was significantly associated with bilateral immediate reconstructions and higher body mass index. Prolonged operative time (OR, 1.16; P = 0.001) and immediate reconstruction (OR, 1.92; P = 0.013) were significant predictors of overall complications. Partial flap loss was associated with bilateral immediate reconstructions, higher body mass index, current smoking status, and longer operative time. CONCLUSIONS: Prolonged operative time is a significant risk factor for overall complications and partial flap loss in DIEP breast reconstruction. For each additional hour of surgical time, the risk of developing overall complications increases by 16%. These findings suggest that reducing operative time through co-surgeon approaches, consistency in surgical teams, and counseling patients with more risk factors toward delayed reconstructions may mitigate complications. CLINICAL QUESTION/LEVEL OF EVIDENCE: Risk, III.

Intraoperative Neural Response Telemetry and Auditory Outcomes in Pediatric Cochlear Implantation.

OBJECTIVE: To evaluate the relationship between intraoperative neural response telemetry (NRT) and postoperative auditory testing outcomes in children. STUDY DESIGN: Retrospective study. SETTING: Tertiary-care academic center. METHODS: Children who underwent cochlear implantation using the Cochlear Corporation device between 2010 and 2019 were included. Associations of average NRT and the slope of amplitude with postoperative auditory outcomes including functional auditory measure Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS), and speech perception testing (consonant-nucleus-consonant [CNC], Pediatric AzBio [BABY BIO], Hearing In Noise Test [HINT], and Northwestern University Children's Perception of Speech [NU-CHIPS]), measured between 6 and 57 months after implantation, were assessed using Spearman's rank correlation (ρ). RESULTS: Thirty-eight patients (19 female, 19 male) and 54 ears were included. The median age of implantation was 20.6 months (range 9.6 months to 10.6 years). Eight (21%) children had neurologic disorders such as stroke, epilepsy, cerebral palsy, and other causes. Thirteen (34%) children had connexin mutations. Average NRT was not significantly correlated with postoperative auditory outcomes (IT-MAIS [ρ = -0.08, p = .74], CNC [ρ = 0.19, p = .32], BABY BIO [ρ = 0.21, p = .29], HINT [ρ = 0.05, p = .83]) and NU-CHIPS (ρ = 0.21, p = .28). The average slopes of amplitude and comfort level were not strongly correlated with any auditory outcomes (p > .05). CONCLUSIONS: Intraoperative NRT was not correlated with any postoperative functional auditory outcomes. Patient counseling should include discussions that a subpar intraoperative cochlear response does not preclude favorable speech and auditory outcomes.

Auditory Outcomes in Children Who Undergo Cochlear Implantation Before 12 Months of Age: A Systematic Review.

OBJECTIVE: To systematically review the literature to determine auditory outcomes of cochlear implantation in children ≤12 months old. DATA SOURCE: PubMed, EMBASE, Medline, CINAHL, Cochrane, Scopus, and Web of Science databases were searched from inception to 9/1/2021 using PRISMA guidelines. REVIEW METHODS: Studies analyzing auditory outcomes after cochlear implantation (CI) in children ≤12 months of age were included. Non-English studies and case reports were excluded. Outcome measures included functional and objective auditory results. Two independent reviewers evaluated each abstract and article. Heterogeneity and bias across studies were evaluated. RESULTS: Of 305 articles identified, 17 met inclusion criteria. There were 642 children ages 2 to 12 months at CI. The most common etiologies of hearing loss were congenital CMV, meningitis, idiopathic hearing loss, and GJB2 mutations and other genetic causes. All studies concluded that early CI was safe. Overall, outcomes improved following early CI: IT-MAIS (9 studies), LittlEARS (4 studies), PTA (3 studies), CAP (3 studies), GASP (3 studies), and LNT (3 studies). Nine studies compared outcomes to an older implantation group (>12 months); of these (n = 450 early CI, n = 1189 late CI), 8 studies showed earlier CI achieved comparable or better auditory outcomes than later implantation, whereas 1 study (n = 120) concluded no differences in speech perception improvement. CONCLUSION: Auditory outcomes were overall improved in children ≤12 months old undergoing CI. Studies that compared early to late CI demonstrated similar or better auditory outcomes in early implantation group. Given the comparable safety profile and critical time period of speech and language acquisition, earlier CI should be considered for infants with hearing loss.

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.

Voice outcomes following surgical treatment for pediatric vocal fold nodules: A systematic review and meta-analysis.

OBJECTIVES: This study aimed to systematically review the literature to determine outcomes following surgical treatment of pediatric vocal fold nodules. METHODS: Studies with patients ≤18 years with nodules who underwent surgery were reviewed for dysphonia improvement and recurrence in PubMed, EMBASE, Medline, CINAHL, Cochrane, Scopus, and Web of Science databases, searched from inception to November 1, 2022 using PRISMA guidelines. Non-English studies and case reports were excluded. Two evaluators independently reviewed each abstract and article. Heterogeneity and bias across studies were evaluated and meta-analysis was performed. RESULTS: The literature search yielded 655 articles; 145 underwent full-text screening and eight were selected for systematic review and meta-analysis. There were 311 children with nodules, aged 2-18 years, with male-to-female ratio of 3.6:1. There were no surgical complications. Voice therapy was inconsistently reported. Follow-up time ranged from 1 month to 10 years. One study concluded that neither surgery nor voice therapy was effective, while five studies concluded that dysphonia improved with surgery. Voice grading by GRBAS, objective voice measures, and lesion size were improved following surgery, when reported. Meta-analysis of six studies demonstrated improvement in dysphonia in 90% of children post-operatively (95% CI: 74-99%). Meta-analysis of four studies showed that recurrence occurred in 19% of children (95% CI: 13-23%). CONCLUSION: This systematic review suggests possible post-operative improvement in dysphonia for pediatric patients with vocal fold nodules; however, study measures, methods, and surgery utilized were heterogeneous and results should be interpreted cautiously. In order to better understand surgical outcomes, future studies should include standardized definition of nodules and objective measures of voice.

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.

Incidence of Venous Thromboembolism Based on Caprini Score in Deep Inferior Epigastric Perforator Flap Breast Reconstruction.

BACKGROUND: Deep inferior epigastric perforator (DIEP) flaps are commonly used for autologous breast reconstruction, but reported rates of venous thromboembolism (VTE) are up to 6.8%. This study aimed to determine the incidence of VTE based on preoperative Caprini score following DIEP breast reconstruction. METHODS: This retrospective study included patients who underwent DIEP flaps for breast reconstruction between January 1, 2016 and December 31, 2020 at a tertiary-level, academic institution. Demographics, operative characteristics, and VTE events were recorded. Receiver operating characteristic analysis was performed to determine the area under the curve (AUC) of the Caprini score for VTE. Univariate and multivariate analyses assessed risk factors associated with VTE. RESULTS: This study included 524 patients (mean age 51.2 ± 9.6 years). There were 123 (23.5%) patients with the Caprini score of 0 to 4, 366 (69.8%) with scores 5 to 6, 27 (5.2%) with scores 7 to 8, and 8 (1.5%) patients with scores >8. Postoperative VTE occurred in 11 (2.1%) patients, at a median time of 9 days (range 1-30) after surgery. VTE incidence by the Caprini score was 1.9% for scores 3 to 4, 0.8% for scores 5 to 6, 3.3% for scores 7 to 8, and 13% for scores >8. The Caprini score achieved an AUC of 0.70. A Caprini score >8 was significantly predictive of VTE on multivariable analysis relative to scores 5 to 6 (odds ratio = 43.41, 95% confidence interval = 7.46-252.76, p < 0.001). CONCLUSION: In patients undergoing DIEP breast reconstruction, VTE incidence was highest (13%) in Caprini scores greater than eight despite chemoprophylaxis. Future studies are needed to assess the role of extended chemoprophylaxis in patients with high Caprini scores.

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.

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.