Pathologic Features Associated With Molecular Subtypes of Well-Differentiated Thyroid Cancer.

OBJECTIVE: To determine the association between pathologic features and molecular classes (BRAF-like, RAS-like, and non-BRAF-like non-RAS-like [NBNR]). METHODS: Retrospective review of a merged database containing 676 patients, 84% (571/676) were assigned to a molecular class from publicly accessible sequenced data of thyroid neoplasms. RESULTS: The merged cohort included 571 neoplasms: 353 (62%) BRAF-like, 172 (30%) RAS-like, and 46 (8.1%) NBNR. Lymph node metastasis (any N1 disease) was present in 166/337 (49%) of BRAF-like, 23/164 (14%) of RAS-like, and 0/46 (0%) of NBNR and are significantly different (P < .001). Gross extra-thyroidal extension was observed in 27 patients, including 24/331 (7%) of BRAF-like, 2/160 (1%) of RAS-like, and 1/46 (2%) of NBNR (P = .01). N1B lymph node metastases or T4 disease was present in 74/333 (22%) of BRAF-like, 10/160 (6%) of RAS-like, and 1/46 (2%) of NBNR (P < .0001). Distant metastasis was present in 4/151 (2.6%) of BRAF-like, 2/50 (4%) of RAS-like and 0/46 for NBNR (P = .627). Angioinvasion was present in 0/81 (0%) of BRAF-like, 3/53 (6%) of RAS-like, and 3/46 (7%) of NBNR (P = .08); and multifocality was present in 27/81 (33%) of BRAF-like, 9/53 (17%) of RAS-like, and 1/46 (2%) for NBNR (P = .0001). CONCLUSION: Pathological features of metastasis, gross extra-thyroidal extension, and multifocality were more prevalent in BRAF-like samples compared to RAS-like and NBNR. A trend towards increased frequency of angioinvasion in RAS-like and NBNR cancers compared to BRAF-like samples was observed. Further studies are needed to evaluate if preoperative knowledge of molecular mutations in thyroid tumors aids in decision-making regarding extent of surgery.

Molecular testing for thyroid nodules: Review and current state.

Thyroid nodules affect nearly two-thirds of the world population. Fine-needle biopsy with cytologic evaluation remains the diagnostic test of choice to distinguish benign from malignant thyroid nodules yet fails to discriminate as benign or malignant in up to one-third of cases. This review discusses the limitation of current cytopathologic evaluation, the development of thyroid molecular testing, and the strengths and limitations of commercially available tests. Initial cytomolecular testing sought to identify specific gene mutations associated with thyroid cancer. Although the presence of a mutation was strongly associated with cancer, the likelihood of identifying a mutation was low; therefore, the test had low sensitivity. Subsequent tests developed have sought to improve the accuracy of cytomolecular testing for thyroid fine-needle aspirations, both to reassure patients and providers when malignancy may be absent and to confirm the malignancy when present. The development of cytomolecular testing for thyroid nodules has informed and improved current understanding of thyroid nodule formation and progression. When used appropriately and with clear understanding of the advantages and disadvantages, cytomolecular testing has the potential to improve patient care in the setting of indeterminate thyroid nodules by helping to guide both the need for and the extent of thyroid surgery. Cancer 2018;124:888-98. © 2017 American Cancer Society.

Upper-airway stimulation for obstructive sleep apnea.

BACKGROUND: Obstructive sleep apnea is associated with considerable health risks. Although continuous positive airway pressure (CPAP) can mitigate these risks, effectiveness can be reduced by inadequate adherence to treatment. We evaluated the clinical safety and effectiveness of upper-airway stimulation at 12 months for the treatment of moderate-to-severe obstructive sleep apnea. METHODS: Using a multicenter, prospective, single-group, cohort design, we surgically implanted an upper-airway stimulation device in patients with obstructive sleep apnea who had difficulty either accepting or adhering to CPAP therapy. The primary outcome measures were the apnea-hypopnea index (AHI; the number of apnea or hypopnea events per hour, with a score of ≥15 indicating moderate-to-severe apnea) and the oxygen desaturation index (ODI; the number of times per hour of sleep that the blood oxygen level drops by ≥4 percentage points from baseline). Secondary outcome measures were the Epworth Sleepiness Scale, the Functional Outcomes of Sleep Questionnaire (FOSQ), and the percentage of sleep time with the oxygen saturation less than 90%. Consecutive participants with a response were included in a randomized, controlled therapy-withdrawal trial. RESULTS: The study included 126 participants; 83% were men. The mean age was 54.5 years, and the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 28.4. The median AHI score at 12 months decreased 68%, from 29.3 events per hour to 9.0 events per hour (P<0.001); the ODI score decreased 70%, from 25.4 events per hour to 7.4 events per hour (P<0.001). Secondary outcome measures showed a reduction in the effects of sleep apnea and improved quality of life. In the randomized phase, the mean AHI score did not differ significantly from the 12-month score in the nonrandomized phase among the 23 participants in the therapy-maintenance group (8.9 and 7.2 events per hour, respectively); the AHI score was significantly higher (indicating more severe apnea) among the 23 participants in the therapy-withdrawal group (25.8 vs. 7.6 events per hour, P<0.001). The ODI results followed a similar pattern. The rate of procedure-related serious adverse events was less than 2%. CONCLUSIONS: In this uncontrolled cohort study, upper-airway stimulation led to significant improvements in objective and subjective measurements of the severity of obstructive sleep apnea. (Funded by Inspire Medical Systems; STAR ClinicalTrials.gov number, NCT01161420.).

Preoperative diagnosis of benign thyroid nodules with indeterminate cytology.

BACKGROUND: Approximately 15 to 30% of thyroid nodules evaluated by means of fine-needle aspiration are not clearly benign or malignant. Patients with cytologically indeterminate nodules are often referred for diagnostic surgery, though most of these nodules prove to be benign. A novel diagnostic test that measures the expression of 167 genes has shown promise in improving preoperative risk assessment. METHODS: We performed a 19-month, prospective, multicenter validation study involving 49 clinical sites, 3789 patients, and 4812 fine-needle aspirates from thyroid nodules 1 cm or larger that required evaluation. We obtained 577 cytologically indeterminate aspirates, 413 of which had corresponding histopathological specimens from excised lesions. Results of a central, blinded histopathological review served as the reference standard. After inclusion criteria were met, a gene-expression classifier was used to test 265 indeterminate nodules in this analysis, and its performance was assessed. RESULTS: Of the 265 indeterminate nodules, 85 were malignant. The gene-expression classifier correctly identified 78 of the 85 nodules as suspicious (92% sensitivity; 95% confidence interval [CI], 84 to 97), with a specificity of 52% (95% CI, 44 to 59). The negative predictive values for "atypia (or follicular lesion) of undetermined clinical significance," "follicular neoplasm or lesion suspicious for follicular neoplasm," or "suspicious cytologic findings" were 95%, 94%, and 85%, respectively. Analysis of 7 aspirates with false negative results revealed that 6 had a paucity of thyroid follicular cells, suggesting insufficient sampling of the nodule. CONCLUSIONS: These data suggest consideration of a more conservative approach for most patients with thyroid nodules that are cytologically indeterminate on fine-needle aspiration and benign according to gene-expression classifier results. (Funded by Veracyte.).

A prospective assessment defining the limitations of thyroid nodule pathologic evaluation.

BACKGROUND: Clinical management of thyroid neoplasms is based on light microscopic diagnosis, but its accuracy and precision are poorly defined. OBJECTIVE: To assess inter- and intraobserver variability of preoperative cytopathologic and postoperative histopathologic thyroid diagnoses. DESIGN: Samples were collected in a prospective, multicenter trial validating a gene expression classifier between June 2009 and December 2010. SETTING: 14 academic and 35 community clinical sites. PATIENTS: 653 patients with 776 surgically resected thyroid nodules of 1 cm or greater. MEASUREMENTS: Intraobserver concordance among 2 or more central histopathologists who independently read histopathology slides was calculated. Interobserver concordance between the diagnoses made by the central histopathologists and those made by local pathologists were calculated. Intra- and interobserver concordance for cytopathology was similarly calculated by comparing diagnoses made by local pathologists with those made by a central panel of 3 cytopathologists. RESULTS: Concordance on the histopathologic distinction between benign and malignant diagnoses was 91% comparing local with central histopathologists and 90% comparing 2 central histopathologists. Using the 6-category Bethesda System, 64.0% of diagnoses made by local and central cytopathologists and 74.7% of intraobserver diagnoses were concordant. Central cytopathologists made fewer indeterminate diagnoses than local pathologists (41.2% vs. 55.0%). LIMITATIONS: Many local pathologists did not use the Bethesda System, so their reports were translated to allow comparison. The study required histopathology, and the study population and specimens did not encompass all newly evaluated patients with a thyroid nodule. CONCLUSION: Substantial inter- and intraobserver variability exists in the cytopathologic and histopathologic evaluation of thyroid nodules, confirming an inherent limitation of visual microscopic diagnosis. PRIMARY FUNDING SOURCE: Veracyte.

Overview of Thyroid and Parathyroid Disease: The Otolaryngology Perspective.

The management of thyroid and parathyroid pathology varies widely, with unifying goals of symptomatic control and mitigating patient morbidity. In general, surgery is indicated when addressing malignancy or when medical management is insufficient. Over the last few decades, treatment paradigms for patients with head and neck endocrine disease have shifted significantly as our understanding of disease processes has expanded and with the advent of numerous relevant technologies. Here we provide a general overview of thyroid and parathyroid disease that may be managed by the otolaryngologist, with attention to emerging strategies in diagnosis and treatment.

A multi-institutional study evaluating and describing atypical parathyroid tumors discovered after parathyroidectomy.

Objective: To describe common intraoperative and pathologic findings of atypical parathyroid tumors (APTs) and evaluate clinical outcomes in patients undergoing parathyroidectomy. Methods: In this multi-institutional retrospective case series, data were collected from patients who underwent parathyroidectomy from 2000 to 2018 from three tertiary care institutions. APTs were defined according to the AJCC eighth edition guidelines and retrospective chart review was performed to evaluate the incidence of recurrent laryngeal nerve injury, recurrence of disease, and disease-specific mortality. Results: Twenty-eight patients were identified with a histopathologic diagnosis of atypical tumor. Mean age was 56 years (range, 23-83) and 68% (19/28) were female. All patients had an initial diagnosis of primary hyperparathyroidism with 21% (6/28) exhibiting clinical loss of bone density and 32% (9/28) presenting with nephrolithiasis or renal dysfunction. Intraoperatively, 29% (8/28) required thyroid lobectomy, 29% (8/28) had gross adherence to adjacent structures and 46% (13/28) had RLN adherence. The most common pathologic finding was fibrosis 46% (13/28). Postoperative complications include RLN paresis/paralysis in 14% (4/28) and hungry bone syndrome in 7% (2/28). No patients with a diagnosis of atypical tumor developed recurrent disease, however there was one patient that had persistent disease and hypercalcemia that is being observed. There were 96% (27/28) patients alive at last follow-up, with one death unrelated to disease. Conclusion: Despite the new AJCC categorization of atypical tumors staged as Tis, we observed no recurrence of disease after resection and no disease-specific mortality. However, patients with atypical tumors may be at increased risk for recurrent laryngeal nerve injury and incomplete resection.

Steroids for improving recovery following tonsillectomy in children.

BACKGROUND: This is an update of a Cochrane Review first published in The Cochrane Library in Issue 1, 2003.Tonsillectomy continues to be one of the most common surgical procedures performed worldwide. Despite advances in anesthetic and surgical techniques, post-tonsillectomy morbidity remains a significant clinical problem. OBJECTIVES: To assess the clinical efficacy of a single intraoperative dose of dexamethasone in reducing post-tonsillectomy morbidity. SEARCH STRATEGY: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ISRCTN; and additional sources for published and unpublished trials. The date of the most recent search was 29 October 2010, following a previous search in September 2002. SELECTION CRITERIA: Randomized, double-blind, placebo-controlled trials of a single dose of intravenous, intraoperative corticosteroid for pediatric patients (age < 18 years) who underwent tonsillectomy or adenotonsillectomy. DATA COLLECTION AND ANALYSIS: The first author extracted data regarding the primary outcome measures and measurement tools from the published studies. The first author also recorded data regarding study design, patient ages, procedures performed, dose of corticosteroid and method of delivery, as well as methodological quality. When data were missing from the original publications, we contacted the authors for more information. We performed data analysis with a random-effects model, using the RevMan 5.1 software developed by the Cochrane Collaboration. MAIN RESULTS: We included 19 studies (1756 participants). We selected only randomized, placebo-controlled, double-blinded studies to minimize inclusion of poor quality studies. However, the risk of bias in the included studies was not formally assessed. Children receiving a single intraoperative dose of dexamethasone (dose range = 0.15 to 1.0 mg/kg) were half as likely to vomit in the first 24 hours compared to children receiving placebo (risk ratio (RR) 0.49; 95% confidence interval (CI) 0.41 to 0.58; P < 0.00001). Routine use in five children would be expected to result in one less patient experiencing post-tonsillectomy emesis (risk difference (RD) -0.24; 95% CI -0.32 to -0.15; P < 0.00001). Children receiving dexamethasone were also more likely to advance to a soft/solid diet on post-tonsillectomy day one (RR 1.45; 95% CI 1.15 to 1.83; P = 0.001) than those receiving placebo. Finally, postoperative pain was improved in children receiving dexamethasone as measured by a visual analog scale (VAS, 0 to 10) (MD -1.07; 95% CI -1.73 to -0.41; P = 0.001), which correlates clinically to a reduction in pain (on a VAS of 0 to 10) from 4.72 to 3.65. No adverse events were noted in the included studies. AUTHORS' CONCLUSIONS: The evidence suggests that a single intravenous dose of dexamethasone is an effective, safe and inexpensive treatment for reducing morbidity from pediatric tonsillectomy.

Do Ultrasound Patterns and Clinical Parameters Inform the Probability of Thyroid Cancer Predicted by Molecular Testing in Nodules with Indeterminate Cytology?

Background: Molecular testing (MT) is commonly used to refine cancer probability in thyroid nodules with indeterminate cytology. Whether or not ultrasound (US) patterns and clinical parameters can further inform the risk of thyroid cancer in nodules predicted to be positive or negative by MT remains unknown. The aim of this study was to test if clinical parameters, including patient age, sex, nodule size (by US), Bethesda category (III, IV, V), US pattern (American Thyroid Association [ATA] vs. American College of Radiology Thyroid Image Reporting and Data System [TI-RADS] systems), radiation exposure, or family history of thyroid cancer can modify the probability of thyroid cancer or noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) predicted by MT. Methods: We studied 257 thyroid nodules in 232 patients from 10 study centers with indeterminate fine needle aspiration cytology and informative MT results using the ThyroSeq v3 genomic classifier (TSv3). Univariate and multivariate logistic regression was used for data analysis. Results: The presence of cancer/NIFTP was associated with positive TSv3 results (odds ratio 61.39, p < 0.0001). On univariate regression, patient sex, age, and Bethesda category were associated with cancer/NIFTP probability (p < 0.05 for each). Although ATA (p = 0.1211) and TI-RADS (p = 0.1359) US categories demonstrated positive trends, neither was significantly associated with cancer/NIFTP probability. A multivariate regression model incorporating the four most informative non-MT covariates (sex, age, Bethesda category, and ATA US pattern; Model No. 1) yielded a C index of 0.653; R2 = 0.108. When TSv3 was added to Model number 1, the C index increased to 0.888; R2 = 0.572. However, age (p = 0.341), Bethesda category (p = 0.272), and ATA US pattern (p = 0.264) were nonsignificant, and other than TSv3 (p < 0.0001), male sex was the only non-MT parameter that potentially contributed to cancer/NIFTP risk (p = 0.095). The simplest and most efficient clinical model (No. 3) incorporated TSv3 and sex (C index = 0.889; R2 = 0.588). Conclusions: In this multicenter study of thyroid nodules with indeterminate cytology and MT, neither the ATA nor TI-RADS US scoring systems further informed the risk of cancer/NIFTP beyond that predicted by TSv3. Although age and Bethesda category were associated with cancer/NIFTP probability on univariate analysis, in sequential nomograms they provided limited incremental value above the high predictive ability of TSv3. Patient sex may contribute to cancer/NIFTP risk in thyroid nodules with indeterminate cytology.

A Thyroid Genetic Classifier Correctly Predicts Benign Nodules with Indeterminate Cytology: Two Independent, Multicenter, Prospective Validation Trials.

Background: Although most thyroid nodules with indeterminate cytology are benign, in most of the world, surgery remains as the most frequent diagnostic approach. We have previously reported a 10-gene thyroid genetic classifier, which accurately predicts benign thyroid nodules. The assay is a prototype diagnostic kit suitable for reference laboratory testing and could potentially avoid unnecessary diagnostic surgery in patients with indeterminate thyroid cytology. Methods: Classifier performance was tested in two independent, ethnically diverse, prospective multicenter trials (TGCT-1/Chile and TGCT-2/USA). A total of 4061 fine-needle aspirations were collected from 15 institutions, of which 897 (22%) were called indeterminate. The clinical site was blind to the classifier score and the clinical laboratory blind to the pathology report. A matched surgical pathology and valid classifier score was available for 270 samples. Results: Cohorts showed significant differences, including (i) clinical site patient source (academic, 43% and 97% for TGCT-1 and -2, respectively); (ii) ethnic diversity, with a greater proportion of the Hispanic population (40% vs. 3%) for TGCT-1 and a greater proportion of African American (11% vs. 0%) and Asian (10% vs. 1%) populations for TGCT-2; and (iii) tumor size (mean of 1.7 and 2.5 cm for TGCT-1 and -2, respectively). Overall, there were no differences in the histopathological profile between cohorts. Forty-one of 155 and 45 of 115 nodules were malignant (cancer prevalence of 26% and 39% for TGCT-1 and -2, respectively). The classifier predicted 37 of 41 and 41 of 45 malignant nodules, yielding a sensitivity of 90% [95% confidence interval; CI 77-97] and 91% [95% CI 79-98] for TGCT-1 and -2, respectively. One hundred one of 114 and 61 of 70 nodules were correctly predicted as benign, yielding a specificity of 89% [95% CI 82-94] and 87% [95% CI 77-94], respectively. The negative predictive values for TGCT-1 and TGCT-2 were 96% and 94%, respectively, whereas the positive predictive values were 74% and 82%, respectively. The overall accuracy for both cohorts was 89%. Conclusions: Clinical validation of the classifier demonstrates equivalent performance in two independent and ethnically diverse cohorts, accurately predicting benign thyroid nodules that can undergo surveillance as an alternative to diagnostic surgery.

Clinical use of the STOP-BANG questionnaire to determine postoperative risk in veterans.

OBJECTIVES: To determine whether STOP-BANG (snoring, tiredness, observed apnea, high blood pressure, body mass index, age, neck circumference, gender) scores are associated with immediate postoperative adverse events in veterans undergoing surgery. METHODS: In this prospective cohort study, veterans presenting to the presurgical clinic at a Veterans Affairs hospital answered the STOP-BANG questionnaire, which was scored as high risk (5-8), intermediate risk (3-4), and low risk (0-2) for obstructive sleep apnea (OSA), during a 6-month study period. Immediate postoperative respiratory and cardiovascular adverse events were recorded. RESULTS: The patient population included 1,080 veterans. Ninety-five patients (8.8%) experienced adverse events, of which 74 (6.9%) were respiratory and 21 (1.9%) were cardiovascular in nature. Patients with high-risk STOP-BANG scores (5-8) had significantly greater odds of having an adverse event odds ratio (OR) 2.1 (95% confidence interval [CI]: 1.4, 3.3) and hypoxia OR 2.8 (95% CI: 1.7, 4.6) compared to those with low- to intermediate-risk scores (0-4). Among patients with OSA, those with high-risk scores (5-8) had greater odds of an adverse event OR 3.9 (95% CI: 1.1, 13.9) and hypoxia OR 3.7 (95% CI: 1.1, 13.0) compared to those with low- to intermediate-risk scores (0-4). Patients without a history of OSA with high-risk scores (5-8) did not have significantly greater odds of an adverse event OR 1.5 (95% CI: 0.82, 2.6) or a hypoxic event OR 1.7 (95% CI: 0.87, 3.4) compared to those with low- to intermediate-risk scores (0-4). CONCLUSION: The STOP-BANG questionnaire was useful in the veteran population because high-risk scores were predictive of adverse events, in particular, hypoxia for patients with a previous diagnosis of OSA. In the future, this may direct studies and clinical activities aimed at optimizing safe and effective perioperative practices. LEVEL OF EVIDENCE: 2b Laryngoscope, 129:259-264, 2019.

Performance of a Multigene Genomic Classifier in Thyroid Nodules With Indeterminate Cytology: A Prospective Blinded Multicenter Study.

Importance: Approximately 20% of fine-needle aspirations (FNA) of thyroid nodules have indeterminate cytology, most frequently Bethesda category III or IV. Diagnostic surgeries can be avoided for these patients if the nodules are reliably diagnosed as benign without surgery. Objective: To determine the diagnostic accuracy of a multigene classifier (GC) test (ThyroSeq v3) for cytologically indeterminate thyroid nodules. Design, Setting, and Participants: Prospective, blinded cohort study conducted at 10 medical centers, with 782 patients with 1013 nodules enrolled. Eligibility criteria were met in 256 patients with 286 nodules; central pathology review was performed on 274 nodules. Interventions: A total of 286 FNA samples from thyroid nodules underwent molecular analysis using the multigene GC (ThyroSeq v3). Main Outcomes and Measures: The primary outcome was diagnostic accuracy of the test for thyroid nodules with Bethesda III and IV cytology. The secondary outcome was prediction of cancer by specific genetic alterations in Bethesda III to V nodules. Results: Of the 286 cytologically indeterminate nodules, 206 (72%) were benign, 69 (24%) malignant, and 11 (4%) noninvasive follicular thyroid neoplasms with papillary-like nuclei (NIFTP). A total of 257 (90%) nodules (154 Bethesda III, 93 Bethesda IV, and 10 Bethesda V) had informative GC analysis, with 61% classified as negative and 39% as positive. In Bethesda III and IV nodules combined, the test demonstrated a 94% (95% CI, 86%-98%) sensitivity and 82% (95% CI, 75%-87%) specificity. With a cancer/NIFTP prevalence of 28%, the negative predictive value (NPV) was 97% (95% CI, 93%-99%) and the positive predictive value (PPV) was 66% (95% CI, 56%-75%). The observed 3% false-negative rate was similar to that of benign cytology, and the missed cancers were all low-risk tumors. Among nodules testing positive, specific groups of genetic alterations had cancer probabilities varying from 59% to 100%. Conclusions and Relevance: In this prospective, blinded, multicenter study, the multigene GC test demonstrated a high sensitivity/NPV and reasonably high specificity/PPV, which may obviate diagnostic surgery in up to 61% of patients with Bethesda III to IV indeterminate nodules, and up to 82% of all benign nodules with indeterminate cytology. Information on specific genetic alterations obtained from FNA may help inform individualized treatment of patients with a positive test result.

Minimally invasive video-assisted thyroidectomy.

BACKGROUND: Minimally invasive video-assisted thyroidectomy (MIVAT) has been developed and successfully used in Italy to perform thyroidectomy and central node dissection through an incision of 2 to 3 cm. OBJECTIVES: Determine the safety, utility, and complication rates of MIVAT in a university setting within the United States. STUDY DESIGN: Single surgeon series of MIVAT performed during an 18-month period. RESULTS: Two hundred fifty thyroidectomies were performed between January 2006 and June 2007. Ninety-two (37%) met eligibility criteria for MIVAT. Six (7%) procedures were converted to open thyroidectomy (incision 4-5 cm) because of extent of the disease (3 strap muscle invasions, 1 thyroiditis, and 2 excessive size goiters). Eighty-six (93%) procedures were completed via the MIVAT technique. There was one case of transient and no cases of permanent recurrent laryngeal nerve paralysis (0.7% of nerves at risk). There were two cases of transient hypocalcemia (3.6% of total/completion cases). There were no hematomas or seromas. There were five (5.8%) cases of minor superficial skin burn. Mean operative times were significantly reduced during the study period (67 to 42 min for hemithyroidectomy, P = .0005; 110 to 77 min for total thyroidectomy, P = .02). Mean incision length measured after wound closure was 2.5 cm. CONCLUSION: We found implantation of MIVAT to be safe, with rates of hypocalcemia, vocal cord paresis, and hematoma comparable with those reported for the traditional open approach. Procedure times varied based on extent of thyroidectomy, patient factors, and experience of the operator and were significantly reduced during the study period.

Minimally invasive video-assisted thyroidectomy: a multi-institutional North American experience.

OBJECTIVE: To report the results of a multi-institutional experience with the minimally invasive video-assisted thyroidectomy, which was conceived in Europe and Asia and has only recently been embraced in the United States. DESIGN: Prospective, nonrandomized analysis. SETTING: Four academic thyroid surgical practices. PATIENTS: Consecutive series of 228 patients who required thyroid surgery and were deemed at surgeon discretion to be eligible for a minimal access surgery. INTERVENTIONS: Minimally invasive video-assisted thyroidectomy was performed in 216 patients. MAIN OUTCOME MEASURES: The data, which were recorded prospectively, included age, sex, indication for surgery, incision length, and complications of surgery. RESULTS: Because conversion to an open approach was required in 12 of the 228 patients, the study group comprised 216 patients (25 men and 191 women; mean [SD] age, 44.5 [14.1] years). There were no hematomas and no cases of permanent hypoparathyroidism or permanent vocal cord paralysis. Nine patients had a transient vocal cord paresis (3.2% of nerves at risk); 5 patients experienced temporary hypocalcemia (8.1% of total thyroidectomies); 1 patient reported a change in voice pitch; and 1 patient required a scar revision. CONCLUSIONS: Use of the minimally invasive video-assisted thyroidectomy technique has been adopted cautiously in the United States. The safety of the procedure represented by the data from this multi-institutional experience would support its expanded adoption by high-volume thyroid surgeons.

Palate implants for obstructive sleep apnea: multi-institution, randomized, placebo-controlled study.

OBJECTIVE: To determine efficacy of Pillar palate implants for mild to moderate obstructive sleep apnea (OSA) syndrome. DESIGN: Multi-institution, randomized, double-blind, placebo-controlled study. METHODS: One hundred patients with mild to moderate OSA and suspected retropalatal obstruction were randomly assigned treatment with three palatal implants or sham placebo. RESULTS: Final apnea-hypopnea index (AHI) increased for both groups at 3 months, correlating with increased percentage of supine sleep but was less in the implant group (P = 0.05). A clinically meaningful reduction in AHI (> or =50% reduction to <20) was more common in the implant group (26% vs 10%, P = 0.05). Significant differences were noted for changes in lowest oxyhemoglobin saturation (P = 0.007) and Functional Outcomes of Sleep Questionnaire (P = 0.05). Improvement in Epworth Sleepiness Score did not differ from that of sham (P = 0.62). Partial implant extrusion occurred in two patients (4%). CONCLUSION: Palate implants for mild to moderate obstructive sleep apnea demonstrated efficacy over placebo for several important outcomes measures with minimal morbidity, but overall effectiveness remains limited. Further study is needed.

Adequacy of surgeon-performed ultrasound-guided thyroid fine-needle aspiration biopsy.

OBJECTIVE: To determine the diagnostic accuracy of specimens obtained by a surgeon performing office-based ultrasound (US)-guided fine-needle aspiration biopsy (FNAB) of thyroid nodules. SUBJECTS AND METHODS: From 2003 to 2006, a single surgeon performed 447 consecutive office-based US-guided FNABs without on-site cytological specimen evaluation. Adequate specimens had at least six clusters of follicular cells from at least two separate needle passes. RESULTS: Non-diagnostic specimens occurred in 16 of 447 (3.6%) nodules, whereas suboptimal specimens occurred in 17 of 447 (3.8%). Adequate samples were obtained in 413 of 447 (92.6%) of specimens. Malignancy was present in 20 of 447 (4.5%) and atypical features were present in 37 of 447 (8.3%). Benign diagnoses were rendered in 357 of 447 (79.9%) of specimens, of which four of 357 (1.1%) represented false-negative results. CONCLUSION: Prior publications recommend that obtaining adequate thyroid cytology specimens requires use of US-guided FNAB and on-site evaluation of cytology adequacy. This study demonstrates that a combination of experienced US guidance, both capillary and aspiration sampling, and three to four needle passes produce comparable results while conserving costs and resources.

Randomized placebo-controlled trial of pantoprazole for daytime sleepiness in GERD and obstructive sleep disordered breathing.

OBJECTIVE: To determine the efficacy of pantoprazole therapy for daytime somnolence, psychomotor vigilance, and quality of life in patients with mild-moderate obstructive sleep disordered breathing (OSDB) and gastroesophageal reflux disease (GERD). STUDY DESIGN: Randomized, double-blind, placebo-controlled crossover trial. METHODS: Sixty patients with daytime sleepiness, mild-moderate OSDB and GERD were randomly assigned a 2-week treatment with pantoprazole 40 mg or placebo followed by a 2-week washout period and crossover respectively to 2-week treatment with placebo or pantoprazole. Outcomes included Epworth Sleepiness Score (ESS), sleep-related quality-of-life (FOSQ), and reaction time. RESULTS: With pantoprazole, patients reported statistically significantly greater improvement of overall reflux symptoms (P = 0.0003) and in ESS (P = 0.04). A significant improvement was noted in FOSQ for both treatments with a trend toward greater improvement with pantoprazole (P = 0.058). No improvement in reaction times was observed. CONCLUSION: Patients with coexistent GERD and OSDB noted significant improvement in daytime sleepiness after treatment with pantoprazole over placebo likely related to a reduction in nocturnal reflux-related arousals.

Fine-Needle Aspiration Utilization for Malignant Thyroid Neoplasms in the Community Hospital Setting: A Quality Improvement Study.

BACKGROUND: Thyroid nodules are increasingly common. Although guidelines have been published, it is unclear whether recommendations for the use of fine-needle aspiration (FNA) and ultrasonography are followed. OBJECTIVE: To evaluate the impact of a quality improvement initiative regarding utilization of FNA and ultrasonography before resection of malignant thyroid neoplasms at a community-based hospital. METHODS: A retrospective medical record review of patients who received thyroidectomy with histologically proven malignant thyroid neoplasms at a community-based teaching center in the Midwest in 2014 revealed inconsistent use of FNA and ultrasonography per national guidelines. Thus, a quality improvement initiative was conducted using the PDSA (Plan, Do, Study, Act) method and included both an intradepartmental outreach effort and an interdisciplinary hospital cancer committee presentation. To determine the success of the initiative, medical records were reviewed from January 1, 2015, through July 1, 2016 (after the initiative) and compared with findings from 2014 (before the initiative). RESULTS: The medical records of 366 patients were reviewed over a 2.5-year period, and 23 records (12 in 2014 and 11 in 2015-2016) met the inclusion criteria. In 2014, FNA was performed on 58% of patients before operative management of thyroid malignancy. After the quality improvement initiative, FNA was performed on 100% of patients before operative management of thyroid malignancy (P=.0155). Before the quality improvement initiative, 75% of patients undergoing an operation for malignant thyroid neoplasms underwent preoperative ultrasonography, compared with 100% after the initiative (P=.0753). CONCLUSION: A performance improvement initiative that used the PDSA framework effectively influenced physician adherence to national guidelines for thyroid neoplasms.

AHNS Series: Do you know your guidelines? Optimizing outcomes in reoperative parathyroid surgery: Definitive multidisciplinary joint consensus guidelines of the American Head and Neck Society and the British Association of Endocrine and Thyroid Surgeons.

BACKGROUND: Revision parathyroid is challenging due to possible diagnostic uncertainty as well as the technical challenges it can present. METHODS: A multidisciplinary panel of distinguished experts from the American Head and Neck Society (AHNS) Endocrine Section, the British Association of Endocrine and Thyroid Surgeons (BAETS), and other invited experts have reviewed this topic with the purpose of making recommendations based on current best evidence. The literature was also reviewed on May 12, 2017. PubMed (1946-2017), Cochrane SR (2005-2017), CT databases (1997-2017), and Web of Science (1945-2017) were searched with the following strategy: revision and reoperative parathyroidectomy to ensure completeness. RESULTS: Guideline recommendations were made in 3 domains: preoperative evaluation, surgical management, and alternatives to surgery. Eleven guideline recommendations are proposed. CONCLUSION: Reoperative parathyroid surgery is best avoided if possible. Our literature search and subsequent recommendations found that these cases are best managed by experienced surgeons using precision preoperative localization, intraoperative parathyroid hormone (PTH), and the team approach.