Airway fires in otolaryngologic surgery: A database review.

PURPOSE: An estimated 34 % of reported operating room fires involve the airway. Despite the inherent risks in otolaryngologic surgery, education regarding prevention and management of airway fires is limited in graduate medical training. One contributing factor is a lack of reporting of such rare events in our literature. METHODS: The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for reports of adverse events related to fires occurring during surgical procedures of the airway from January 1, 2010, to March 31, 2020. RESULTS: 3687 reports were identified and 49 unique reports of airway fire were included. Sustained fires were described in 16 (32.7 %) reports and 33 (67.3 %) described transient flares. 2 fires extended beyond the airway and 9 (18.4 %) were noted to have occurred at the start of the case. Fires were reported most commonly during tonsillectomy (n = 22 [44.9 %]), vocal fold excision (n = 5 [10.2 %]), and adenoidectomy (n = 4 [8.2 %]). 46 reports attributed flare initiation to a specific element of the fire triangle. 16 patient and 2 operator injuries were reported. Saline washing was utilized in 7 (14.3 %) cases overall. Patients were extubated immediately in 2 (12.5 %) of the 16 reports of sustained fires. 0 mortalities were reported. CONCLUSION: Airway fires were reported in a variety of upper airway procedures performed regularly by otolaryngologists. The triggering factor that led to fire was identified as a spark or char in about half of the reported cases, and only 2 reports described immediate removal of the endotracheal tube.

Complications associated with energy-based devices during thyroidectomy from 2010-2020.

Objective: Harmonic Focus (Ethicon, Johnson and Johnson, Cincinnati, OH, USA), LigaSure Small Jaw (Medtronic, Covidien Products, Minneapolis, MN, USA), and Thunderbeat Open Fine Jaw (Olympus, Japan) are electrosurgical instruments used widely in head and neck surgery. The study aims to compare device malfunctions, adverse events to patients, operative injuries, and interventions related to Harmonic, LigaSure, and Thunderbeat use during thyroidectomy. Methods: The US Food and Drug Administration's Manufacture and User Facility Device Experience (MAUDE) database was queried for adverse events associated with Harmonic, LigaSure, and Thunderbeat from January 2005 to August 2020. Data were extracted from reports pertaining to thyroidectomy. Results: Of the 620 adverse events extracted, 394 (63.5%) involved Harmonic, 134 (21.6%) LigaSure, and 92 (14.8%) Thunderbeat. The reported device malfunctions most frequently associated with Harmonic was damage to the blade (110 (27.9%)), LigaSure was inappropriate function (47 (43.1%)), Thunderbeat was damage to the tissue or Teflon pad (27 (30.7%)), respectively. Burn injury and incomplete hemostasis were the most commonly reported adverse events. The operative injury reported most frequently when using Harmonic and LigaSure was burn injury. No operator injuries were reported with Thunderbeat use. Conclusion: The most frequently reported device malfunctions were damage to the blade, inappropriate function, and damage to the tissue or Teflon pad. The most frequently reported adverse events to patients was a burn injury and incomplete hemostasis. Interventions aimed at improving physician education may help reduce adverse events attributed to improper use.

Complications associated with PEAK PlasmaBlade from 2010 to 2020 from MAUDE.

The pulse-electron avalanche knife (PEAK) PlasmaBlade 3.0 and 4.0 (Medtronic, Minneapolis, MN) is an electrosurgical technology that is widely used in surgery. Our study aimed to summarize device malfunctions, patient injuries, and interventions related to PEAK PlasmaBlade 3.0 and 4.0. The US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of PlasmaBlade adverse events from June 6, 2010, to August 30, 2020. Data were extracted from reports pertaining to PlasmaBlade 3.0 and 4.0. A total of 384 medical device reports were identified, from which 424 adverse events were extracted. Of those, 348 (82.1%) were device malfunctions, 53 (12.5%) were patient injuries, and 23 (5.4%) were operator injuries. Device malfunctions were most frequently caused by delaminated coating (110, 25.9%), followed by ignition or fire (56, 13.2%). Operator injury was most frequently caused by thermal injury (19, 4.5%), followed by laceration (4, 0.9%). Pacemakers (22, 57.9%) were the most common devices causing interference. PEAK PlasmaBlade 3.0 and 4.0 have demonstrated utility during surgeries but are associated with adverse events. Interventions that aim to educate physicians on potential risks may help reduce the incidence of complications. Future studies with standardized reporting protocols are warranted.

Ultrasound-guided ethanol sclerotherapy for multifocal unilateral Warthin's tumor after partial parotidectomy.

Introduction: Warthin's tumor, also known as papillary cystadenoma lymphomatosum, is one of the most common benign salivary gland neoplasms. The current first-line treatment for Warthin's tumor is parotidectomy. However, surgical resection has the risk of complications including facial nerve weakness and Frey's syndrome. Recently, ultrasound-guided ethanol sclerotherapy (UGES) has been found to be efficacious in the treatment of a variety of head and neck lesions. Case report: We present a patient with multifocal Warthin's tumor who was managed with partial parotidectomy and two cycles of ultrasound-guided ethanol sclerotherapy. Discussion: Ethanol sclerotherapy has been used as a minimally invasive alternative to surgical excision or observation alone for a variety of head and neck masses. To our knowledge, this is the first case presented in the literature where sclerotherapy was used in conjunction with a partial parotidectomy. Minimizing the extent of surgical resection can reduce the risk of facial nerve weakness and Frey's syndrome and negate the need for fat grafting for defect reconstruction. Conclusion: UGES may serve as a safe and reliable procedure that can be performed in conjunction with partial parotidectomy for patients who wish to achieve definitive diagnosis while also minimizing the risk of complications associated with extensive parotidectomy.

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.

Adverse Events Associated With Ossicular Prostheses: Utility of a Federal Database.

OBJECTIVES: Ossicular prostheses have demonstrated utility in ossicular chain reconstruction, but their use also is associated with complications. This study aims to explore the utility of the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database for the systematic analysis of complications associated with ossicular prostheses. It also summarizes adverse events to patients (AEPs) and device malfunctions (DMs) reported in the MAUDE database, and attempts to examine the consequences brought about by these events and to identify likely root causes. STUDY DESIGN: Retrospective analysis of the MAUDE database. METHODS: The MAUDE database was queried for reports from January 2010 to May 2020. Data were extracted from reports involving the use of ossicular prostheses. RESULTS: Seventy-three medical device reports, reports submitted to the Food and Drug Administration detailing suspected device-associated malfunctions, injuries, and deaths, involved ossicular prostheses and were included for analysis, from which 126 adverse events were extracted. Of these, 50 (39.7%) were AEPs, while 76 (60.3%) were DMs. The most common AEPs were foreign body and hearing loss, while the DMs reported most commonly were broken prosthesis and displaced prosthesis. Of the 76 DMs, 19 (25%) were attributed to mishandling by the operator, while 6 (7.9%) were due to a defective device. Broken prosthesis was the DM most commonly attributed to mishandling by the operator in 16 (32.7%) cases. CONCLUSION: Ossicular prostheses are used extensively for ossicular chain reconstruction, but also are associated with adverse events. The MAUDE database in its current form does not appear sufficient for the systematic review of adverse events associated with ossicular prostheses. A more standardized reporting format with clearly defined categories and inclusion of relevant variables might improve the quality of information provided by the MAUDE database.

I'm All Ears: A Population-Based Analysis of Consumer Product Foreign Bodies of the Ear.

OBJECTIVES: The purpose of this study was to assess the nationwide incidence of ear foreign body (FB) presentations to the emergency department (ED) and analyze the most common FB consumer products encountered. METHODS: The National Electronic Injury Surveillance System (NEISS) was evaluated for ED visits that included "ear foreign bodies" from 2010 through 2019. The most frequent foreign bodies were identified and organized by demographics. RESULTS: A total of 20,545 ear FB cases were found, with an estimated 608,860 ED visits nationwide. Female patients (56%) were more likely to have jewelry and first aid equipment FBs. Males between the ages of 5 and 15 years were significantly (P < 0.05) more likely to have paper products, pens/pencils, and desk supplies in their ears. CONCLUSION: Ear FBs represent a substantial proportion of healthcare expenditures. Although children are the most commonly affected individuals, all ages require further education and preventive measures.

Complications Associated with PROPEL Mometasone Furoate Bioabsorbable Drug-eluting Sinus Stents From 2012 to 2020.

BACKGROUND: Till date, there have been no studies that have analyzed a database to examine postmarket adverse events associated with PROPEL mometasone furoate bioabsorbable drug-eluting sinus stents. OBJECTIVE: To determine the postmarket complications associated with PROPEL mometasone furoate bioabsorbable drug-eluting sinus stents. METHODS: The US Food and Drug Administration's Manufacturer and User Facility Device Experience database was searched for adverse events associated with PROPEL bioabsorbable drug-eluting sinus stents between January 1, 2012 and December 31, 2020. Data were extracted and analyzed from medical device reports (MDRs) that involved sinus stents. RESULTS: After 47 MDRs were identified, 25 reports involving PROPEL bioabsorbable drug-eluting sinus stents were reviewed, from which 40 adverse events were recorded. Of these, there were 32 adverse events to patients and 8 device malfunctions. The most common adverse events to patients included infection (21.8%), oropharyngeal obstruction (15.6%), and headache/pain (12.5%). The most common device malfunction reported was migration and expulsion of the stent (87.5%). CONCLUSIONS: PROPEL sinus stents have been shown to be effective in preventing sinus outflow obstruction after functional endoscopic sinus surgery. Both adverse events to patients and device malfunctions are reported infrequently. A more comprehensive understanding of rare postmarket complications seen with PROPEL sinus stents may further aid informed decision-making regarding their usage.

Adverse Events Associated With Electromyogram Endotracheal Tubes in Thyroid and Parathyroid Surgery.

OBJECTIVE: Thyroid and parathyroid surgeries are frequently performed with the aid of electromyogram endotracheal tubes. However, the most common adverse events have not been reported comprehensively. This study aimed to summarize the device adverse events, patient complications, and subsequent interventions related to electromyogram endotracheal tubes. METHODS: In this retrospective cross-sectional analysis, the US Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for electromyogram endotracheal tube adverse events between 2010 and 2020. Data were extracted for devices used in thyroid and parathyroid surgery. RESULTS: Of 198 included reports, the most common device-related adverse events were loss of response to nerve stimulation (34.8%), cuff perforation (18.2%), and tube lumen obstruction (13.6%). Of 98 patient complications, the most common included ventilation failure (n = 50), airway trauma (n = 22), and recurrent laryngeal nerve injury (n = 5). There was 1 periprocedural death reported. Reported interventions include reintubation performed in 60.1% of all device adverse events, extended hospitalization in 27.3% of airway trauma events, and 5 tracheostomies performed for ventilation failure events. Forty-one events resulted in case delays and 13 events led to aborted cases. The most reported adverse events occurred in 2018 (n = 35) and 2015 (n = 30). CONCLUSIONS: The most commonly reported adverse events associated with electromyogram endotracheal tubes include loss of response to nerve stimulation, cuff perforation, ventilation failure, and airway trauma. Subsequent interventions include reintubation, tracheostomy, extended hospitalization, and aborted cases. Surgical teams should consider these adverse events when consenting patients and using these devices in thyroid and parathyroid cases.

Head and neck osteosarcomas: Analysis of treatment trends and survival outcomes in the United States (2004-2016).

BACKGROUND: Head and neck osteosarcoma (HNOS) is a rare primary bone tumor with limited data to guide treatment approaches. METHODS: The NCDB was used to identify patients diagnosed with HNOS. Kaplan-Meier and Cox multivariate regression were used to examine the impact of each treatment on overall survival (OS). RESULTS: We identified 821 patients diagnosed with HNOS. Utilization of neoadjuvant chemotherapy + surgery increased from zero cases in 2004 to 24% of cases in 2016. Among surgically treated patients, 5-year OS was 55.8% (CI: 51.7-60.1%). No difference was seen in OS between each treatment cohort on multivariate analysis. However, neoadjuvant chemotherapy + surgery + adjuvant chemotherapy had improved 18-month survival compared to surgery alone (95.8% vs. 78.5%, p = 0.031). CONCLUSIONS: Our study demonstrated no survival benefit in perioperative chemotherapy or radiation therapy; however, short-term survival improvement in patients receiving both neoadjuvant and adjuvant chemotherapy displays promise and requires further investigation.

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.

Incorporating Sialendoscopy into the Otolaryngology Clinic.

Simple sialendoscopy procedures may be performed in the outpatient clinic with few complications. This process spares patients the risks, increased cost, and time burdens of sialendoscopy under general anesthesia. Sialendoscopy procedures may be incorporated into the outpatient practice after gaining experience with these procedures in the operating room. Diagnostic sialendoscopy, dilation of stenosis, and endoscopic sialolithotomies of small, freely mobile stones are appropriate for in-office sialendoscopy in many instances.

Efficacy of ethanol ablation as a treatment of benign head and neck cystic lesions.

OBJECTIVE: To evaluate the efficacy and safety of ethanol ablation in the treatment of benign head and neck cystic lesions. METHODS: A total of 25 patients who received ethanol ablation (EA) of head and neck cystic lesions by an otolaryngologist at a single institution between October 2017 and October 2020 were identified. Patient demographics, clinical characteristics, treatment details, and treatment outcomes at follow up visits were obtained by retrospective review of electronic medical records. RESULTS: 25 patients who underwent ethanol ablation of head and neck cystic lesions were included, with a mean age of 49.1 years old (Interquartile range (IQR),32.5-65.5 years) and 12 males (47.0%). The most common cysts treated with EA were thyroglossal duct cysts (n = 8, 32.0%) and lymphoepithelial parotid cysts (n = 7, 28.0%). The mean volume prior to treatment was 10.57 mL (IQR, 1.58-8.81 mL). Mean volume following EA was 1.30 mL (range, 0.10-0.97 mL) with 74.40% cyst reduction by volume (IQR, 48.56-96.29%) (p = 0.002). The mean time to the last follow-up was 5 months (range, 3-6 months). One patient received surgery despite treatment success to obtain a definitive diagnosis of the mass. No other patients received further surgical management. The treatment success of EA, as defined by >70% volume reduction or the resolution of symptoms, was 92.0%. All patients were satisfied with the outcome and had no reported complications. CONCLUSION: EA is an effective and safe alternative to surgery for the treatment of head and neck cystic lesions that can be performed in an outpatient setting by an otolaryngologist.

Feel the Burn! Fireworks-related Otolaryngologic Trauma.

OBJECTIVES: Fireworks are used commonly for celebrations in the United States, but can lead to severe injury to the head and neck. We aim to assess the incidence, types, and mechanisms of head and neck injuries associated with fireworks use from 2010 to 2019. METHODS: A retrospective cross-sectional study, using data from the National Electronic Injury Surveillance System, of individuals presenting to United States Emergency Departments with head and neck injuries caused by fireworks and flares from 2010 to 2019. Incidence, types, and mechanisms of injury related to fireworks use in the US population were assessed. RESULTS: A total of 541 patients (349 [64.5%] male, and 294 [54%] under 18 years of age) presented to emergency departments with fireworks-related head and neck injuries; the estimated national total was 20 584 patients (13 279 male, 9170 white, and 11 186 under 18 years of age). The most common injury diagnoses were burns (44.7% of injuries), laceration/avulsion/penetrating trauma (21.1%), and otologic injury (15.2%), which included hearing loss, otalgia, tinnitus, unspecified acoustic trauma, and tympanic membrane perforation. The remaining 19% of injuries were a mix, including contusion, abrasion, hematoma, fracture, and closed head injury. Associations between fireworks type and injury diagnosis (chi-square P < .001), as well as fireworks type by age group (chi-square P < .001) were found. Similarly, associations were found between age groups and injury diagnoses (chi-square P < .001); these included children 5 years and younger and adults older than 30 years. CONCLUSIONS: Fireworks-related head and neck injuries are more likely to occur in young, white, and male individuals. Burns are the most common injury, while otologic injury is a significant contributor. Annual rates of fireworks-related head and neck injuries have not changed or improved significantly in the United States in the past decade, suggesting efforts to identify and prevent these injuries are insufficient.

Transoral robotic surgery versus nonrobotic resection of oropharyngeal squamous cell carcinoma.

The aim of this study is to evaluate the impact of transoral robotic surgery (TORS) compared to nonrobotic surgery (NRS) on overall survival in oropharyngeal squamous cell carcinoma (OPSCC). We performed a retrospective study of patients with HPV+ and HPV- OPSCC undergoing TORS or NRS with neck dissection using the National Cancer Database from the years 2010-2016. Among patients with OPSCC in our cohort, 3167 (58.1%) patients underwent NRS and 2288 (41.9%) underwent TORS. TORS patients demonstrated better overall survival than NRS patients (HPV+ patients: aHR 0.74, p = 0.02; HPV- patients: aHR 0.58, p < 0.01). Subsite analysis showed TORS was correlated with improved survival in base of tongue (BoT) primaries for both HPV+ (aHR 0.46, p = 0.01) and HPV- (aHR 0.42, p = 0.01) OPSCC. Compared to NRS, TORS is associated with improved overall survival for HPV+ and HPV- OPSCC, as well as greater overall survival for BoT primaries.

Tracheotomy in COVID-19 Patients: A Systematic Review and Meta-analysis of Weaning, Decannulation, and Survival.

OBJECTIVES: A systematic review and meta-analysis was conducted to determine the cumulative incidences of decannulation and mechanical ventilation weaning in patients with coronavirus disease 2019 (COVID-19) who have undergone a tracheotomy. Weighted average mean times to tracheotomy, to decannulation, and to death were calculated from reported or approximated means. DATA SOURCES: PubMed, SCOPUS, CINAHL, and the Cochrane library. REVIEW METHODS: Studies were screened by 3 investigators independently. Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines were followed. Studies including patients with COVID-19 who underwent a tracheotomy were identified. Studies without reported mechanical ventilation weaning or decannulation were excluded. Data were pooled using a random-effects model. RESULTS: After identifying 232 unique studies, 18 articles encompassing outcomes for 3234 patients were ultimately included for meta-analysis, with a weighted mean follow-up time of 28.6 ± 6.2 days after tracheotomy. Meta-analysis revealed that 55.0% of tracheotomized patients were weaned successfully from mechanical ventilation (95% CI, 47.4%-62.2%). Approximately 34.9% of patients were decannulated successfully, with a mean decannulation time of 18.6 ± 5.7 days after tracheotomy. The pooled mortality in tracheotomized patients with COVID-19 was 13.1%, with a mean time of death of 13.0 ± 4.0 days following tracheotomy. CONCLUSION: At the current state of the coronavirus pandemic, over half of patients who have required tracheotomies are being weaned off of mechanical ventilation. While 13.1% patients have died prior to decannulation, over a third of all tracheotomized patients with COVID-19 reported in the literature have undergone successful decannulation.

Outpatient vs inpatient parotidectomy: Systematic review and meta-analysis.

The primary aim of this study was to conduct a systematic review and meta-analysis to compare complications between outpatient vs inpatient parotidectomy. A systematic review was performed to identify patients undergoing either outpatient or inpatient partodiectomy, in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines, using PUBMED, SCOPUS, CINAHL, and the Cochrane library. Risk of bias was assessed using the Newcastle-Ottawa Scale. Postoperative complications (hematoma, seroma/sialocele, salivary fistula formation, Frey syndrome, surgical site infection [SSI]) were compared. Our search yielded 4958 nonduplicate articles, of which 13 studies were ultimately included (11 retrospective cohort, 2 prospective cohort), encompassing a total of 1323 patients (outpatient 46.33% vs inpatient 53.67%). There was no significant difference in total complications, hematoma, seroma, salivary fistula, or SSI rates between outpatient and inpatient groups. No significant difference in total complications was found between outpatient and inpatient groups when stratified by surgical approach (partial/superficial and total parotidectomy). Our findings suggest outpatient parotidectomy may be as safe as inpatient parotidectomy in appropriately selected patients.

Outpatient Parotidectomy: A Retrospective Series.

OBJECTIVES: Recent literature suggests that outpatient head and neck surgery is safe and may decrease costs. This study assesses whether outpatient parotidectomy differs in complication type and rate from inpatient surgery. METHODS: Patients who underwent parotidectomy at our institution from 2011 to 2019 were retrospectively reviewed and divided by inpatient or outpatient status. Complications including infection, seroma, salivary fistula, hematoma, and flap necrosis, as well as readmission rates were tabulated. Drain placement, related to tumor size, was also analyzed using a receiver operating curve. RESULTS: 144 patients had available data for analysis. Nine of the 144 patients had complications. Seven of 98 outpatients and two of 46 inpatients had complications. There was no statistically significant difference in complication rate between the two groups (P = .518). Tumor size ≥4.62 cm3 was associated with drain placement (P = .044). CONCLUSION: Outpatient parotidectomy is a safe and viable alternative for carefully selected patients.