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Safety Recommendations for Evaluation and Surgery of the Head and Neck During the COVID-19 Pandemic

Givi, Babak; Schiff, Bradley A; Chinn, Steven B; Clayburgh, Daniel; Iyer, N Gopalakrishna; Jalisi, Scharukh; Moore, Michael G; Nathan, Cherie-Ann; Orloff, Lisa A; O'Neill, James P; Parker, Noah; Zender, Chad; Morris, Luc G T; Davies, Louise
Importance/UNASSIGNED:The rapidly expanding novel coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2, has challenged the medical community to an unprecedented degree. Physicians and health care workers are at added risk of exposure and infection during the course of patient care. Because of the rapid spread of this disease through respiratory droplets, health care workers who come in close contact with the upper aerodigestive tract during diagnostic and therapeutic procedures, such as otolaryngologists-head and neck surgeons, are particularly at risk. A set of safety recommendations was created based on a review of the literature and communications with physicians with firsthand knowledge of safety procedures during the COVID-19 pandemic. Observations/UNASSIGNED:A high number of health care workers were infected during the first phase of the pandemic in the city of Wuhan, China. Subsequently, by adopting strict safety precautions, other regions were able to achieve high levels of safety for health care workers without jeopardizing the care of patients. The most common procedures related to the examination and treatment of upper aerodigestive tract diseases were reviewed. Each category was reviewed based on the potential risk imposed to health care workers. Specific recommendations were made based on the literature, when available, or consensus best practices. Specific safety recommendations were made for performing tracheostomy in patients with COVID-19. Conclusions and Relevance/UNASSIGNED:Preserving a highly skilled health care workforce is a top priority for any community and health care system. Based on the experience of health care systems in Asia and Europe, by following strict safety guidelines, the risk of exposure and infection of health care workers could be greatly reduced while providing high levels of care. The provided recommendations, which may evolve over time, could be used as broad guidance for all health care workers who are involved in the care of patients with COVID-19.
PMID: 32232423
ISSN: 2168-619x
CID: 4370242

Human papillomavirus and survival of patients with sinonasal squamous cell carcinoma

Oliver, Jamie R; Lieberman, Seth M; Tam, Moses M; Liu, Cheng Z; Li, Zujun; Hu, Kenneth S; Morris, Luc G T; Givi, Babak
BACKGROUND:To the authors' knowledge, the question of whether human papillomavirus (HPV) infection is associated with outcomes in patients with sinonasal squamous cell carcinoma (SNSCC) is not well studied at this time. In the current study, the authors investigated patterns of HPV testing and its association with survival in patients with SNSCC using the National Cancer Data Base. METHODS:The authors selected all SNSCC cases diagnosed between 2010 and 2016. HPV testing practices, clinicodemographic factors, treatments, and survival were analyzed. Multivariable Cox regression and propensity score-matched survival analyses were performed. RESULTS:A total of 6458 SNSCC cases were identified. Of these, only 1523 cases (23.6%) were tested for HPV and included in the current study. The median patient age was 64 years and the majority had advanced stage tumors (overall AJCC stage III-IV, 721 patients; 62.1%). HPV-positive SNSCC comprised 31.5% (447 of 1418 cases) of the final study cohort. Among 15 hospitals that routinely tested nonoropharyngeal SCCs for HPV, the percentage of HPV-positive SNSCCs was smaller (24.6%; P = .04). Patients with HPV-positive SNSCC were younger (aged 60 years vs 65 years; P < .001), with tumors that were more likely to be high grade (55.3% vs 41.7%; P < .001), and attributed to the nasal cavity (62.2% vs 44.0%; P < .001). HPV-positive SNSCC was associated with significantly improved overall survival in multivariable regression analysis (hazard ratio, 0.45; 95% CI, 0.28-0.72 [P = .001]) and propensity score-matched (hazard ratio, 0.61; 95% CI, 0.38-0.96 [P = .03]) analyses controlling for clinicodemographic and treatment factors. CONCLUSIONS:Currently, only a minority of patients with SNSCC are tested for HPV. However, a sizable percentage of SNSCC cases may be HPV related; furthermore, HPV-positive SNSCC is associated with improved overall survival. Routine HPV testing may be warranted in patients with SNSCC.
PMID: 31886908
ISSN: 1097-0142
CID: 4251152

Survival of oral tongue squamous cell carcinoma in young adults

Oliver, Jamie R; Wu, S Peter; Chang, Clifford M; Roden, Dylan F; Wang, Binhuan; Hu, Kenneth S; Schreiber, David; Givi, Babak
BACKGROUND:Small cohort studies have suggested oral tongue squamous cell carcinoma (OTSCC) could be associated with worse prognosis in individuals younger than 40. METHODS:We compared the survival of all OTSCC cases in the National Cancer Database under 40 years old with those older than 40, excluding patients over 70. Cox regression and propensity score matched (PSM) survival analyses were performed. RESULTS:A total of 22 930 OTSCC patients were identified. The under 40 group consisted of 2566 (9.9%) cases; 20664 were 40 to 70 (90.1%). Most were male (13 713, 59.8%), stage I-II (12 754, 72.4%), and treated by surgery alone (13 973, 63.2%). Survival in patients under 40 was higher (79.6% vs 69.5%, P < .001). In PSM analysis (n = 2928) controlling for all 10 significant factors in multivariate regression, patients under 40 had a 9% higher 5-year survival (77.1% vs 68.2%, P < .001). CONCLUSION/CONCLUSIONS:Contrary to the prior reports, younger patients with OTSCC did not have worse survival in the National Cancer Database.
PMID: 30985036
ISSN: 1097-0347
CID: 3810312

Transoral robotic surgery adoption and safety in treatment of oropharyngeal cancers

Oliver, Jamie R; Persky, Michael J; Wang, Binhuan; Duvvuri, Umamaheswar; Gross, Neil D; Vaezi, Alec E; Morris, Luc G T; Givi, Babak
BACKGROUND:Transoral robotic surgery (TORS) was approved by the Food and Drug Administration in 2009 for the treatment of oropharyngeal cancers (oropharyngeal squamous cell carcinoma [OPSCC]). This study investigated the adoption and safety of TORS. METHODS:All patients who underwent TORS for OPSCC in the National Cancer Data Base from 2010 to 2016 were selected. Trends in the positive margin rate (PMR), 30-day unplanned readmission, and early postoperative mortality were evaluated. Outcomes after TORS, nonrobotic surgery (NRS), and nonsurgical treatment were compared with matched-pair survival analyses. RESULTS:From 2010 to 2016, among 73,661 patients with OPSCC, 50,643 were treated nonsurgically, 18,024 were treated with NRS, and 4994 were treated with TORS. TORS utilization increased every year from 2010 (n = 363; 4.2%) to 2016 (n = 994; 8.3%). The TORS PMR for base of tongue malignancies decreased significantly over the study period (21.6% in 2010-2011 vs 15.8% in 2015-2016; P = .03). The TORS PMR at high-volume centers (≥10 cases per year; 11.2%) was almost half that of low-volume centers (<10 cases per year; 19.3%; P < .001). The rates of 30-day unplanned readmission (4.1%) and 30-day postoperative mortality (1.0%) after TORS were low and did not vary over time. High-volume TORS centers had significantly lower rates of 30-day postoperative mortality than low-volume centers (0.5% vs 1.5%; P = .006). In matched-pair analyses controlling for clinicopathologic cofactors, 30-, 60-, and 90-day posttreatment mortality did not vary among patients with OPSCC treated with TORS, NRS, or nonsurgical treatment. CONCLUSIONS:TORS has become widely adopted and remains safe across the country with a very low risk of severe complications comparable to the risk with NRS. Although safety is excellent nationally, high-volume TORS centers have superior outcomes with lower rates of positive margins and early postoperative mortality.
PMID: 34762303
ISSN: 1097-0142
CID: 5050682

Predictive Value of a Genomic Classifier in Indeterminate Thyroid Nodules Based on Nodule Size

Dublin, Jared C; Papazian, Michael; Zan, Elcin; Oweity, Thaira; Sun, Wei; Jacobson, Adam; Patel, Kepal; Brandler, Tamar C; Givi, Babak
Importance/UNASSIGNED:Genomic classifiers were developed to better guide clinicians in the treatment of indeterminate thyroid nodules (ITNs). To our knowledge, whether there is variation in the diagnostic accuracy of these tests depending on ITN size has not been previously studied. Objective/UNASSIGNED:To analyze the diagnostic performance of a genomic classifier in relation to ITN size. Design, Setting, and Participants/UNASSIGNED:A case series study with medical records review was conducted including all patients with a cytologic diagnosis of ITN managed with genomic classifier testing and surgery from January 2015 to December 2018 at NYU Langone Health. Demographics, ITN characteristics, genomic profiles, treatment, and final pathologic findings were recorded. Data analysis was conducted from March to April 2021. Main Outcomes and Measures/UNASSIGNED:The primary aim was to assess the positive predictive value (PPV), negative predictive value (NPV), sensitivity, and specificity of a genomic classifier test (ThyroSeq) in relation to ITN size (<2, 2-4, and >4 cm). The secondary aim was to investigate the risk of cancer associated with genetic signatures. Results/UNASSIGNED:Of the 212 patients with 218 ITNs, 158 (74.5%) were women; median (SD) age was 49 (15.6) years. Genomic classifier results were positive in 173 ITNs (79.4%) treated with surgery. In this group of 173 positive ITNs, 46 (26.6%) were malignant on final pathologic testing. Overall, the observed cancer prevalence in the population was 23.9% (52 ITNs). In 45 ITNs that underwent surgery despite a negative genomic classifier interpretation, 6 (13.3%) were malignant. The PPV of a positive test was 27% and the NPV was 87%. The PPV and NPV findings improved as the ITN size increased (<2 cm [n = 98]: PPV, 25%; NPV, 79% vs >4 cm [n = 33]: PPV, 50%; NPV, 89%). Test specificity was higher in larger ITNs (<2 cm: 15% vs >4 cm: 40%; P = .01). Isolated RAS sequence variations were the most common variant identified in malignant nodules (11 [21.1%] of all ITNs), followed by BRAF variants (7 [13.5%] of all ITNs). Conclusions and Relevance/UNASSIGNED:In this case series, the performance of the ThyroSeq test improved for larger ITNs. The risk of cancer in large ITNs with negative test results was low. These data suggest that, in genomic classifier-negative ITNs larger than 4 cm, initial management of thyroid lobectomy may be sufficient.
PMID: 34734965
ISSN: 2168-619x
CID: 5038292

p16 immunostaining in fine-needle aspirations of the head and neck: determining the optimal positivity threshold in HPV-related squamous cell cancer

Wang, Qian; Zhou, Fang; Snow, Justin T; Simsir, Aylin; Hernandez, Osvaldo; Levine, Pascale; Szeto, Oliver; Sun, Wei; Givi, Babak; Brandler, Tamar C
INTRODUCTION/BACKGROUND:There is no consensus for interpretation of p16 immunohistochemistry (IHC) in cytology preparations. Our study aims to assess p16 IHC staining in formalin-fixed cytology cell blocks (CBs) from head and neck squamous cell carcinoma (HNSCC) fine-needle aspiration (FNA) specimens in comparison with surgical pathology p16 staining and to determine the reproducibility of p16 IHC scoring in CBs. METHODS:) was calculated to assess inter-rater reliability. RESULTS:= 0.79 (95% CI: 0.61-0.98). CONCLUSION/CONCLUSIONS:p16 IHC performed on cytology CBs can serve as a surrogate marker for the detection of HPV with high sensitivity and specificity levels. Using a threshold lower than that recommended for surgical pathology for the interpretation of p16 positivity may be appropriate for FNA cytology CB preparations. All cytopathologists in our study displayed reproducible high sensitivity and specificity values at the >10% threshold.
PMID: 34326027
ISSN: 2213-2945
CID: 4950022

Prognostic Significance of Singular RAS Mutations in Cytologically Indeterminate Thyroid Nodules [Meeting Abstract]

Dublin, J C; Papazian, M; Zan, E; Oweity, T; Sun, W; Hodak, S; Baldwin, C K; Patel, K N; Brandler, T C; Givi, B
Introduction: The prognostic significance of a singular RAS mutation in cytologically indeterminate thyroid nodules (ITN) is unclear. This study aimed to analyze the incidence of malignancy and clinical outcomes of ITNs diagnosed on fine needle aspiration (FNA) cytology with RAS mutations.
Method(s): All FNA ITNs that underwent ThyroSeq testing and thyroidectomy from 2014-2018 were reviewed. ITNs with RAS (N-, H-, or K-RAS) mutations identified on ThyroSeq testing were selected. Demographics, Bethesda classifications, genomic profiles, treatment, final pathology, and clinical outcomes were recorded.
Result(s): During the study period, 93 patients with cytologic diagnosis of ITN and RAS mutations were identified. The mean nodule size was 2.2 cm (range: 0.5-6.6 cm). Most nodules were classified as Bethesda III (77, 82.8%). NRAS mutations were the most common (53, 57%), followed by HRAS (24, 25.8%), and KRAS (16, 17.2%). The majority of patients were treated with thyroid lobectomy (67, 72%). On final pathology, 9 (10%) were diagnosed as malignant (follicular variant of papillary thyroid carcinoma [FVPTC]) and were distributed among all 3 RAS variants (NRAS: 4 [7.5%]; HRAS: 4 [16.7%]; KRAS: 1 [6.3%]; p=0.4). Most FVPTCs were encapsulated (8, 88.9%). With a median follow up of 19 months (interquartile range = 8-35), no recurrences or progression was seen.
Conclusion(s): The risk of malignancy in ITNs with singular RAS mutations is low. All malignancies were low-risk. Our findings demonstrate a low incidence of high-risk malignancy in ITNs with RAS mutations, suggesting that initial management with conservative approaches such as thyroid lobectomy may be justified.
ISSN: 1879-1190
CID: 5024622

Concordance of Initial and Repeat Molecular Analysis in Cytologically Indeterminate Thyroid Nodules [Meeting Abstract]

Papazian, M; Dublin, J C; Zan, E; Oweity, T; Baldwin, C; Jacobson, A S; Hodak, S; Patel, K N; Brandler, T C; Givi, B
Introduction: Molecular tests such as ThyroSeq are recommended in the workup of cytologically indeterminate thyroid nodules (ITN). While repeat molecular testing is often performed after repeat fine needle aspiration (FNA) yields persistently indeterminate cytology, ThyroSeq's inter-test reliability is unclear. We assessed consistency of initial and repeat ThyroSeq analyses performed on samples from the same thyroid nodules.
Method(s): All thyroid nodules diagnosed as ITN on consecutive FNAs that received ThyroSeq with both biopsies from 2014-2018 at our institution, were reviewed. Initial analysis was ThyroSeq v2 while repeat was v2 or v3. Nodules with gene mutations, fusions, or copy number alterations (CNA) were considered ThyroSeq-positive.
Result(s): During the study period, 30 patients underwent ThyroSeq analysis on initial and repeat FNA samples (median interval=21 months). On initial testing, 27 (90%) nodules were ThyroSeq-negative and 3 (10%) low-risk mutations (RAS, EIF1AX, TSHR) were identified. Repeat ThyroSeq re-identified these 3 nodules and also interpreted 9 initially ThyroSeq-negative nodules as positive (kappa=0.286). All 9 molecular alterations were low-risk, most were identified on v3 (7, 77.8%), and CNA was the most common change (6, 66.7%). Of 12 patients with ThyroSeq-positive nodules, 8 underwent lobectomy. Final pathology identified low-risk malignancy in 3 nodules; the remainder were benign.
Conclusion(s): New findings on repeat ThyroSeq are possible. Whether these findings were detected by expanded panel or are the result of de-novo changes is unknown. The risk of missing high-risk changes appears to be low. More studies are needed to characterize the concordance of ThyroSeq analyses and natural evolution of ITNs.
ISSN: 1879-1190
CID: 5024612

Improving Quality and Safety of Thyroidectomy [Meeting Abstract]

Papazian, M; Roland, J T; Shao, Q; Vaezi, A; DeLacure, M; Tran, T; Persky, M J; Persky, M S; Jacobson, A; Givi, B
Introduction: Thyroidectomy is commonly performed in otolaryngology. Complications such as recurrent laryngeal nerve (RLN) injury and severe hypocalcemia have reported incidences in national studies as high as 3% and 8%, respectively. Narcotic pain medications are commonly used for postoperative pain management. Here, we present the long-term results of a thyroidectomy quality and safety improvement program, with an emphasis on reducing narcotic use.
Method(s): All surgeons who perform thyroidectomy established standards for antibiotic administration, postoperative calcium management, and narcotics use. The program was established in 2018 and data on adverse events, length of stay, antibiotic and narcotic use were recorded prospectively from June 2018 to January 2021. Data trends were analyzed throughout the course of the study.
Result(s): During the study period, 542 thyroidectomies were performed by 14 surgeons. The average length of stay was less than 24 hours. Five (0.9%) adverse events were recorded: 1 (0.2%) temporary RLN dysfunction, 3 (0.6%) hematomas, 1 (0.2%) surgical site infection, and 1 (0.2%) temporary hypocalcemia. The average number of narcotics prescribed declined from 18 doses (95%CI: 16.8-18.5) in 2019 to 9 in 2020 (95%CI: 8.5-9.6) (p<0.0001), without an increase in need for refills. No instances of permanent hypocalcemia or permanent RLN injury were identified.
Conclusion(s): By implementing a thyroidectomy quality improvement program, we achieved extremely low rates of adverse events and significantly reduced the use of narcotics without adverse effects. These data can inform practitioners and the public about expected outcomes of thyroid surgery, and establish benchmarks for quality and safety.
ISSN: 1879-1190
CID: 5024602

Current Trainee and Workforce Patterns for Thyroid and Parathyroid Surgery in the US

Davies, Louise; Chen, Amy Y; Givi, Babak; Saunders, Brian; Walker, Elizabeth; Polacco, Marc A; Terris, David; Randolph, Gregory
OBJECTIVE:Thyroid and parathyroid surgery is performed by both general surgeons and otolaryngologists. We describe the proportion of surgeries performed by specialty, providing data to support decisions about when and to whom to direct research, education and quality improvement interventions. METHODS:Tabulation of case numbers for patients privately insured patients undergoing thyroid and parathyroid surgery in Marketscan: 2010-2016, and trainee case logs for residents and fellows in general surgery and otolaryngology. Summary statistics and tests for trends and differences were calculated. RESULTS:Marketscan data captured 114,500 thyroid surgeries. The proportion performed by each specialty was not significantly different (p >0.13.) Otolaryngologists performed 58,098 (50.74% of all thyroidectomies, 95% CI 6,495 - 10,103) and general surgeons performed 56,402 (49.26% of all thyroidectomies, 95% CI 6,070 - 10,044). Otolaryngologists more commonly performed hemithyroidectomy (n=25,148, 43.29% of all thyroid surgeries performed by otolaryngologists) compared to general surgeons (n=20,353, 36.09% of all thyroid surgeries performed by general surgeons). Markestscan data captured 21,062 parathyroid surgeries: 6,582 (31.25%) were performed by otolaryngologists, and 14,480 (68.75%) were performed by general surgeons. The case numbers of otolaryngology and general surgery trainees completing residency and fellowship vary six to nine fold across different sites. The wide variation may reflect both the level of exposure a particular training program offers and trainee level of interest. CONCLUSIONS:Thyroid surgical care is equally provided by general surgeons and otolaryngologists. Both specialties contribute significantly to parathyroid surgical care. Both specialties should provide input into and be targets of research, quality and education interventions.
PMID: 33636394
ISSN: 1530-891x
CID: 4795172