Breaking it down: Review and management of sialendoscopy device malfunctions.

PURPOSE: The present study was aimed at determining common causes of sialendoscopy device malfunctions and identifying a uniform algorithm to manage device failures. MATERIALS AND METHODS: The FDA Manufacturer and User Facility Device Experience (MAUDE) database was searched for various keywords related to sialendoscopy. Reports between the dates of December 1, 2009 to March 31, 2020 were downloaded for review and included in the study. Variables such as: device, the iatrogenic injury type, and subsequent surgical or medical intervention were collected and details of the malfunction were categorized based on the type of malfunction. RESULTS: 206 medical device reports were identified; 47 of them which met inclusion criteria (106 were duplicate cases and 53 were irrelevant to the present study). The majority of device malfunctions involved salivary stone extractor baskets (SSEBs), (40/47; 85.1%), followed by malfunctions of balloon dilators (3/47; 6.4%) and sialendoscopes (2/47; 4.3%). Retention of the SSEB was noted in 85% of the SSEB malfunctions. CONCLUSIONS: Given that sialendoscopy is an increasingly popular technique that relies on devices, it is inevitable that device failures will occur for a multitude of reasons. Working to prevent these malfunctions from occurring is the most effective method of harm reduction. Though it is important that sialendoscopists have a discrete, algorithmic approach to manage them when they occur.

Diagnostic performance of the second-generation molecular tests in the assessment of indeterminate thyroid nodules: A systematic review and meta-analysis.

OBJECTIVE: The objective of this systematic review and meta-analysis was to evaluate the diagnostic performance of the second-generation molecular tests in the diagnosis of thyroid nodules with indeterminate fine-needle aspiration biopsy results. METHODS: We searched PubMed, Google Scholar, Scopus, and Cochrane Library for studies published between January 2017 and March 2021. Inclusion criteria were indeterminate thyroid results from fine-needle aspiration (FNA) that included Bethesda categories III and IV, use of Afirma GSC, Thyroseq v3, and ThyGeNext as an index test, and conclusive histopathological results. Studies with no post-surgical diagnoses were excluded. For each included study, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were obtained. Sensitivity and specificity were pooled jointly using a bivariate binomial random-effects model. Statistical significance was indicated at p-value less than 0.05. RESULTS: Our search yielded 431 non-duplicate articles, of which 15 were included in the study (7 GSC, 6 Thyroseq v3, and 2 ThyGeNext). ThyGeNext studies were excluded from the meta-analysis due to the small sample size. Pooled data for GSC studies on 472 thyroid nodules showed a sensitivity of 96.6 (95% confidence interval: 89.7-98.9%), specificity of 52.9% (23.4-80.5%), PPV of 63% (51-74%), and NPV of 96% (94-98%). Pooled data for ThyroSeq studies on 530 thyroid nodules showed a sensitivity of 95.1% (91.1-97.4%), specificity of 49.6% (29.3-70.1%), PPV of 70% (55-83%), and NPV of 92% (86-97%). There was no statistically significant difference in diagnostic performances of the two tests (p-values for sensitivity = 0.89, specificity = 0.82, PPV = 0.43, NPV = 0.17). CONCLUSION: High sensitivity and high NPV in GSC and Thyroseq v3 have potential to help rule out malignancy among thyroid nodules with indeterminate cytology results. There was no difference in diagnostic performances between the two molecular tests indicating that either test is appropriate to determine the malignancy of thyroid nodules. Further long-term outcome data are warranted to make a clear recommendation.

Cost-analysis of in-office versus operating room sialendoscopy: Comparison of cost burden and outcomes.

PURPOSE: Office-based procedures in otolaryngology are increasingly utilized to increase efficiency, reduce cost, and eliminate risks associated with surgery. Gland-preserving surgical management of sialadenitis and sialolithiasis are often performed in the operating room, although many surgeons are moving this practice to clinic. We aim to determine the difference in patient charges and perioperative outcomes for salivary gland procedures performed in the clinic versus the OR. METHODS: Retrospective series of patients presenting with sialolithiasis, acute or chronic sialadenitis, and stricture between 2010 and 2019. Demographics, perioperative variables, setting, and charge data were collected. RESULTS: 528 patients underwent operative intervention (n = 427 office, n = 101 OR). Cohort demographics were comparable. Sialolithiasis was the most common presenting diagnosis in both cohorts. Both cohorts had similar rates of complete (p = 0.09) and partial (p = 0.97) response to treatment. A higher percentage of patients in the OR group reported no improvement (21.4 vs 12.2%, p = 0.034). Overall complications were similar (p = 0.582). Mean charges were statistically greater in the OR ($5560.35 OR vs $1298.33 office, p < 0.001). Operative time was significantly reduced in the office group (21.8 min vs 60.85 min, p < 0.001). CONCLUSIONS: Appropriately selected patients can be successfully treated in outpatient clinic without compromising patient safety or quality while significantly reducing the financial burden to patients and the healthcare system.

Comparing postoperative outcomes using electrocautery versus cold-knife de-epithelialization of dermal fat graft in parotidectomy reconstruction.

PURPOSE: The present study was developed to evaluate the effectiveness of a simple rapid technique for de-epithelializing cutaneous flaps and grafts in parotidectomy reconstruction. MATERIALS AND METHODS: 109 patients who underwent a parotidectomy with abdominal free dermal fat graft (FDFG) reconstruction between 2018 and 2021 were evaluated based on demographic factors, past medical/surgical history, type of parotidectomy performed, operative factors, and post-operative complications. These data were then stratified based on de-epithelialization technique as well as tumor malignancy status to determine any differences in complication rates or perioperative factors between electrocautery (EC) and cold knife (CK) techniques within both benign and malignant subgroups. RESULTS: 77 of the 109 participants underwent FDFG de-epithelialization using monopolar electrocautery (EC) and the remaining 32 participants underwent de-epithelialization using traditional cold knife (CK) technique. There was no statistical difference among the two groups in overall complication rate. The EC group had a significantly shorter operation time ("EC vs. CK": 144.2 min vs. 174.7 min; p = 0.031). Additionally, histopathologic samples showed that both techniques left the underlying dermis intact and without damage. CONCLUSIONS: This study demonstrated that there is no difference in complication rate or histology of FDFGs de-epithelialized using EC compared to CK. It was also shown that when controlling for confounders by looking solely at the benign subgroup of patients, EC de-epithelialization was a faster technique than CK. These findings suggest that EC is just as effective as CK, and may actually be a more efficient surgical technique to accomplish de-epithelialization of FDFG.

Comparison of quality of life outcomes in a de-intensification treatment regimen for p16 + oropharyngeal cancer.

BACKGROUND: Platinum and taxane-based neoadjuvant chemotherapy with surgery (NAC + S) is a novel de-intensified treatment modality that is currently under investigation. METHODS: All patients treated for HPV positive OPSCC with NAC + S at a single institution between 2006 and 2020 were contacted to complete the University of Washington Quality of life questionnaire (UW-QOL) at least 2 years following the completion of treatment. RESULTS: The UW-QOL surveys were received from 25 of 48 eligible patients (52.1%). The mean follow-up time was 4.3 years (range 2.0-7.6 years). The overall mean score for the physical subscale was 92.4 (Standard deviation, SD = 10.9), and the social-emotional subscale was 91.1 (11.8). Compared to the normative cohort, the NAC + S cohort had a worse appearance (Mean scores Normative vs. NAC + S: 93 vs. 84.0, p = 0.009). CONCLUSION: NAC + S offers favorable long-term QOL, as evidenced by near-normal scores in most QOL domains.

Oncologic outcomes of human papillomavirus-associated oropharynx carcinoma treated with surgery alone: A 12-institution study of 344 patients.

BACKGROUND: The oncologic outcomes of surgery alone for patients with American Joint Committee on Cancer 7th edition (AJCC 7th) pN2a and pN2b human papillomavirus-associated oropharynx squamous cell carcinoma (HPV+OPSCC) are not clear. METHODS: The authors performed a 12-institution retrospective study of 344 consecutive patients with HPV+OPSCC (AJCC 7th pT0-3 N3 M0) treated with surgery alone with 6 months or more of follow-up using univariate and multivariate analyses. RESULTS: The 2-year outcomes for the entire cohort were 91% (182 of 200) disease-free survival (DFS), 100% (200 of 200) disease-specific survival (DSS), and 98% (200 of 204) overall survival (OS). The 18 recurrences within 2 years were 88.9% (16 of 18) local and/or regional recurrences and 11.1% (2 of 18) distant metastases. Recurrences were not significantly associated with smoking, pT stage, or pN stage. The 16 patients with locoregional recurrences within 2 years all underwent successful salvage treatments (median follow-up after salvage: 13.1 months), 43.8% (7 of 16) of whom underwent salvage surgery alone for a 2-year overall salvage radiation need of 4.5% (9 of 200). The 2-year outcomes for the 59 evaluable patients among the 109 AJCC 7th pT0-2 N2a-N2b patients with 1 to 3 pathologic lymph nodes (LNs) were as follows: local recurrence, 3.4% (2 of 59); regional recurrence, 8.4% (5 of 59); distant metastases, 0%; DFS, 88.1% (52 of 59); DSS, 100% (59 of 59); OS, 96.7% (59 of 61); and salvage radiation, 5.1% (3 of 59). CONCLUSIONS: With careful selection, surgery alone for AJCC 7th pT0-T2N0-N2b HPV+OPSCC with zero to 3 pathologic LNs without perineural invasion, extranodal extension, or positive margins results in high DFS, DSS, OS, and salvage treatment success. Because of the short-term follow-up, these data support further investigation of treatment de-escalation in this population.

Postoperative Complications After Thyroidectomy: Time Course and Incidence Before Discharge.

BACKGROUND: Although complication rates after thyroidectomy are well described in the literature, the timing of these events is less understood. This study delineates the timeline and risk factors for early adverse events after thyroidectomy. MATERIALS AND METHODS: This study included a retrospective review of 161,534 patients who underwent thyroidectomy between 2005 and 2018 using the American College of Surgeons National Surgical Quality Improvement Program database. Time to specific complications was analyzed for all patients undergoing thyroidectomy, with further stratification of hemithyroidectomy and total thyroidectomy cohorts. Univariate analyses were conducted to analyze demographics, preoperative comorbidities, and complications. A multivariate logistic regression model was generated to identify significant risk factors for 7-day postoperative complications. RESULTS: The overall complication rate was 3.28%. A majority of complications arose before discharge including the following: blood transfusion (96%), hematoma formation (68%), pneumonia (53%), and cardiac arrest (67%). Approximately 37% of unplanned reoperations occurred before discharge in the hemithyroidectomy versus 63% in the total thyroidectomy cohort. Greater than 65% of mortalities occurred after discharge in both groups. Complications generally occurring within 7 d for the entire cohort included the following: pneumonia (3; 2-8 [median postoperative day; interquartile range]), pulmonary embolism (6; 2-12), cardiac arrest (1; 0-5), myocardial infarction (2; 1-6), blood transfusions (0; 0-1), and hematoma formation (0; 0-2). Superficial surgical site infection (9; 6-16) occurred later. Patients who underwent outpatient surgery had a decreased risk of complications (odds ratio 0.41) in the 7-day postoperative period. CONCLUSIONS: Although early complications after thyroidectomy are rare, they have a distinct time course, many of which occur after discharge. However, in selected patients undergoing outpatient thyroidectomy, overall risk of complications is decreased. Understanding timing helps establish better preoperative communication and education to improve postoperative expectations for the provider and patient.

Adverse Effects of Chronic Steroid use Following Thyroidectomy.

BACKGROUND: Prior to thyroid surgery, a subset of patients chronically uses steroids to manage medical conditions such as Grave's disease, auto-immune conditions, or organ transplantation. Existing literature describes adverse effects of prolonged steroid use on surgical outcomes, however there remains a paucity of data investigating the specific effects of steroid use on postoperative outcomes after thyroidectomy. This study aims to identify complication risks steroid users are predisposed to after thyroidectomy. MATERIALS AND METHODS: The American College of Surgeons National Surgical Quality Improvement Program Database (ACS-NSQIP) was queried to identify and isolate all patients who had undergone thyroidectomy procedures by Current Procedure Terminology codes from 2005 through 2018. Univariate analysis was performed to compare steroid uses and non-steroid users. Coarsened exact matching was utilized to homogenize the two cohorts based on demographics and preoperative comorbidities. RESULTS: A total of 153,595 thyroidectomies were initially included. After Coarsened exact matching, 116,861 patients were categorized as non-steroid users, and 2,965 as steroid users. The steroid cohort demonstrated significantly higher rates of any complication (P < 0.001) as well as overall surgical, cardiopulmonary, and renal complications. Individual complications such as superficial surgical site infections (P = 0.013), pulmonary embolism (P = 0.016), deep vein thrombosis (P = 0.011), progressive renal insufficiency (P = 0.006), and unplanned readmission (P = 0.026) were also increased. CONCLUSIONS: Patients with chronic steroid use undergoing thyroidectomy are at an increased risk for surgical, cardiopulmonary, and renal complications. Further research on preoperative steroid management is necessary for optimizing outcomes in this population.

Minimum fascia tumor distance for selection of extracapsular dissection for benign parotid tumors: A preliminary study.

OBJECTIVE: There is increasing literature supporting the use of extracapsular dissection (ECD) for the treatment of select superficial lobe parotid tumors, though no objective criteria for selection has been proposed. Prior studies have suggested the minimum distance between the parotideomasseteric fascia and the tumor edge or minimum fascia-tumor distance (MFTD) as a useful measurement for the identification of superficial parotid tumors. The objective of this study is to demonstrate the utility of the minimum fascia-tumor distance in selecting candidates for extracapsular dissection of benign parotid tumors. METHODS: This is a retrospective case-control study at a tertiary academic otolaryngology clinic. Twenty-three patients with prior surgical excision of benign parotid tumors that underwent surgeon-performed ultrasonography prior to excision of tumor were identified. Ultrasound images were reviewed and the minimum fascia-tumor distance was recorded and categorized by less than 3 mm or as 3 mm or greater. The primary outcome was successful completion of extracapsular dissection versus more extensive resection. RESULTS: Thirteen patients had a minimum fascia-tumor distance less than 3 mm; eleven of thirteen (84.6%) successfully underwent extracapsular dissection. Ten patients had a minimum fascia-tumor distance of 3 mm or greater; one of ten (10%) successfully underwent extracapsular dissection. A minimum fascia-tumor distance less than 3 mm was sensitive, specific, and accurate in predicting successful ECD at 91.7%, 81.8%, and 87.0% respectively (OR 49.5, 95% CI 3.4-573.2). CONCLUSION: Minimum fascia-tumor distance may be a useful measurement in identifying candidates for removal of benign parotid tumors with extracapsular dissection.

Obesity is a predictor of increased morbidity after tracheostomy.

OBJECTIVE: The purpose of this study was to analyze the relationship between body mass index (BMI) and 30-day morbidity and mortality risk in patients undergoing tracheostomy using the American College of Surgeons National Quality Improvement Program (ACS-NSQIP). STUDY DESIGN: This is a retrospective, cross-sectional, cohort study. SETTING: Patients were identified with Current Procedural Terminology codes in the ACS-NSQIP database. SUBJECTS AND METHODS: Patients who underwent tracheostomy from 2005 to 2018 were queried. They were stratified into four BMI classes and matched to normal BMI cohorts. Multivariate logistic regression was used to identify independent predictors for complications, readmissions, and unplanned reoperations within 30 days. RESULTS: Among 3784 patients meeting inclusion and exclusion criteria, obesity was shown to be a significant independent risk factor for overall complications (OR 1.439, 95% CI 1.226-1.689, p < 0.001), postoperative acute renal failure (OR 10.715, 95% CI 1.213-94.646, p = 0.033), and unplanned readmissions (OR 1.702, 95% CI 1.095-2.647, p = 0.018). A significantly lower rate of postoperative transfusions was observed for obese patients (OR 0.581, 95% CI 0.432-0.781, p < 0.001). CONCLUSIONS: Obesity was found to be independently associated with an increased risk of overall complication, developing acute renal failure, and having an unplanned 30-day readmission following tracheostomy. The risk of postoperative transfusion appears to be lower in obese patients. LEVEL OF EVIDENCE: 4.

Adverse Events Associated with Implantable Dopplers during Microvascular Surgery.

BACKGROUND: Implantable Dopplers (IDs) are widely used for postoperative free flap vascular monitoring. However, IDs may contribute to free flap complications or failure and better understanding of device malfunctions is needed. METHODS: The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for all reports of ID adverse events from two leading manufacturers (Cook Vascular and Synovis Life Technologies) in free flap surgery from January 2010 to March 2020. Reports were reviewed and categorized. A comparison of reoperations within select categories was performed using Chi-square analysis. RESULTS: Of 209 included reports, the most common device malfunctions were venous anastomotic coupler misalignment (35.4%) and coupler ring detachment (24.4%). Synovis devices were used in 100% of reports of vessel compression and Cook Vascular devices were used in 77.7% of reports of probe detachment. Of 74 patient-related adverse events, the most common were reoperation (47.3%) and vessel occlusion (28.4%). Of five reported events of flap failure, two were associated with loss of ID signal. The proportion of Doppler signal loss events leading to reoperation was significantly greater than the proportion of any other Doppler-related event leading to reoperation. Intraoperative coupler replacement was the most commonly reported intervention (n = 86), and venous anastomosis with hand-suturing occurred in 30 device malfunctions. CONCLUSION: This study demonstrates a variety of ID-related malfunctions. One-third of device malfunctions were associated with patient complications, and false-positive Doppler signal loss contributed substantially to the requirement of surgical re-exploration. These are important considerations for surgical teams utilizing IDs in free tissue transfer procedures.

Salivary gland ultrasound training: Improving anatomic identification in residents.

OBJECTIVES/HYPOTHESIS: The aim of the study was to introduce and study the role of standardized views for ultrasound of the major salivary glands in resident learning and retention. STUDY DESIGN: Methods description and prospective case series. METHODS: Five otolaryngology residents and two patient models were recruited for this study. The participants were timed on their identification of the submandibular gland, sublingual gland, and parotid gland and associated key anatomic structures. Participants were then timed again immediately after being presented a standardized view for each salivary gland: the longitudinal submandibular gland, transverse parotid gland, and submental transverse views. The same participants were then timed one month later to determine retention. A Wilcoxon signed-rank test was used to evaluate whether time to identification was equal pre- and post-standardized view instruction. RESULTS: There was a significant improvement from pre- to post-standardized view instruction in all glands, which was sustained one month later. Practically speaking, assessment times for all participants at the one-month measurement were reasonable, with averages of 71, 42, and 114 s for the submandibular gland, sublingual gland, and parotid gland respectively. CONCLUSIONS: Standardized views provided otolaryngology ultrasonography learners with a reliable, fast, and memorable way to assess the salivary glands and their related structures. LEVEL OF EVIDENCE: 4.

Surgical management and outcomes of accessory parotid gland neoplasms: A systematic review.

OBJECTIVE: To evaluate surgical approaches and outcomes associated with accessory parotid gland neoplasms. DATA SOURCES: MEDLINE, SCOPUS, and the Cochrane Central Register of Controlled Trials. REVIEW METHODS: A systematic review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was performed. Studies were included if they reported surgical management and outcomes of patients with accessory parotid gland neoplasms. RESULTS: After screening 3532 records, 15 studies were included with a total of 187 patients. Benign tumors consisted of 61.5% of cases. External open, transoral, and preauricular endoscopic approaches were used for 82.3%, 11.3%, and 6.5% of cases, respectively. Accessory lobe resection alone, concurrent with partial parotidectomy, and concurrent with total parotidectomy were used in 54.8%, 43.0%, and 2.2% of cases, respectively. Complication rates were similar between histology groups (7.8% benign vs. 8.3% malignant, p = 0.82). Accessory lobe resection with concurrent partial parotidectomy had the lowest overall complication rate (6.3%). Resections limited to the accessory lobe were found to have an overall complication rate of 8.7%. CONCLUSION: The results offer an overview of the surgical management and complications for accessory parotid gland tumors. Overall surgical complication rates found in these case series may be lower for management of accessory gland tumors than rates available in the literature for tumors within the main parotid gland.

Local spikes in COVID-19 cases: Recommendations for maintaining otolaryngology clinic operations.

The Coronavirus Disease-2019 (COVID-19) pandemic has created an unprecedented economic and public health crisis in the United States. Following efforts to mitigate disease spread, with a significant decline in some regions, many states began reopening their economies. As social distancing guidelines were relaxed and businesses opened, local outbreaks of COVID-19 continue to place person on healthcare systems. Among medical specialties, otolaryngologists and their staff are among the highest at risk for becoming exposed to COVID-19. As otolaryngologists prepare to weather the storm of impending local surges in COVID-19 infections there are several practical measures that can be taken to mitigate the risk to ourselves and our staff.

Sialendoscopy as a management tool in patients with foreign body impaction of the salivary gland.

PURPOSE: It has been long known that sialendoscopy has both diagnostic and therapeutic benefits in the identification and treatment of sialadenitis. Sialendoscopy can also be used to triage patients with traumatic injury or foreign bodies lodged in the parotid gland. PROCEDURES: We present a case of traumatic insertion a fishbone into the parotid gland parenchyma that was evaluated with sialendoscopy and successfully managed on the basis of stable endoscopy findings that correlated with improving symptomatology. MAIN FINDINGS: We find that sialendoscopy presents a useful tool to help guide management. CONCLUSIONS: We demonstrate that in an asymptomatic patient, foreign body impaction with absence of ductal obstruction on endoscopy can successfully be followed with simple observation.

Transoral submandibular ganglion neurectomy: an anatomical feasibility study.

BACKGROUND: The management of sialorrhea can be difficult for both the patient and the clinician. Current management includes behavioral modification, anticholinergics, botulinum injections, and a variety of surgical options, which all have demonstrated some efficacy. As minimally invasive procedures flourish, we explore the feasibility of highly selective transoral submandibular neurectomy (TOSN) for the management of sialorrhea. METHODS: Ten human cadaver dissections of the floor of mouth were performed bilaterally, for a total of 20 separate cases. An intraoral technique for highly selective, submandibular ganglion neurectomy is demonstrated. RESULTS: A transoral submandibular ganglion neurectomy was performed in 10 cadavers (20 neurectomies) easily and reliably, without injury to the submandibular duct or the main trunk of the lingual nerve. CONCLUSION: Transoral submandibular neurectomy is an attractive addition to the armamentarium of surgical options for the treatment of medically intractable sialorrhea. Further study in selected patients would need to be performed to demonstrate clinical feasibility.

Feasibility of purely endoscopic intramedullary fixation of mandibular condyle fractures.

The investigators of this study hypothesized that fractures of the mandibular condyle can be repaired using short-segment intramedullary implants and purely endoscopic surgical technique, using a basic science, human cadaver model in an academic center. Endoscopic instrumentation was used through a transoral mucosal incision to place intramedullary implants of 2 cm in length into osteotomized mandibular condyles. The surgical maneuvers that required to insert these implants, including condyle positioning, reaming, implant insertion, and seating of the mandibular ramus, are described herein. Primary outcome was considered as successful completion of the procedure. Ten cadaveric mandibular condyles were successfully repaired with rigid intramedullary internal fixation without the use of external incisions. Both insertion of a peg-type implant and screwing a threaded implant into the condylar head were possible. The inferior portion of the implant remained exposed, and the ramus of the mandible was manipulated into position on the implant using retraction at the sigmoid notch. The results of this study suggest that purely endoscopic repair of fractures of the mandibular condyle is possible by using short-segment intramedullary titanium implants and a transoral endoscopic approach without the need for facial incisions or punctures. The biomechanical advantages of these intramedullary implants, including improved strength and resistance to mechanical failure compared with miniplates, have been recently established. The combination of improved implant design and purely endoscopic technique may allow for improved fixation and reduced surgical- and implant-related morbidity in the treatment of condylar fractures.