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.

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.

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.

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.

Adverse Events Associated With Laser Use in the Upper Airway.

OBJECTIVE: Surgical lasers are used extensively in head and neck surgery. Laser use in the upper airway offers many advantages but also presents risks to patients and operators that are not reported comprehensively. This study aims to summarize device malfunctions, patient complications, and subsequent interventions related to laser use in the upper airway. METHODS: The US Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for reports of surgical laser adverse events from January 2010 to March 2020. Data were extracted from reports pertaining to the upper airway. RESULTS: Sixty-two reports involving upper airway laser use in an operating room were identified, from which 95 events were extracted. Of these, 40 (42.1%) were adverse events to patients, 2 (2.1%) adverse events to operators, and 53 (55.8%) device malfunctions. Dislodgement of laser fiber in the airway (23 [57.5%]), burn (8 [20%]), and scar (5 [12.5%]) were the most common adverse events to patients. Two incidents of eye exposure through unfiltered microscope lenses were the only adverse events to operators. Fiber break (26 [49.1%]) and flare (12 [22.6%]) were the most common device malfunctions. DISCUSSION: Surgical lasers have demonstrated utility in head and neck surgery but are associated with risks. This study discusses adverse events and device malfunctions associated with airway laser surgery and emphasizes shortcomings in current reporting. IMPLICATIONS FOR PRACTICE: Standardized reporting and multi-institutional research are needed to better understand adverse events related to surgical laser use and to allow accurate estimation of their prevalence.

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.

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.

Complications associated with PlasmaBlade TnA during tonsillectomy and adenoidectomy from 2010 to 2020: A MAUDE study.

PURPOSE: The pulsed-electron avalanche knife (PEAK) PlasmaBlade TnA (Medtronic, n.d.) is a relatively new electrosurgical technology that is used widely in head and neck surgery (Medtronic Manuals, n.d.). This study aims to summarize device malfunctions, patient complications, and subsequent interventions related to PEAK PlasmaBlade TnA during tonsillectomy and adenoidectomy. MATERIALS AND METHODS: The US Food and Drug Administration's Manufacture and User Facility Device Experience database was queried for reports of PlasmaBlade TnA adverse events from June 6, 2009, to August 30, 2020. Data were extracted from reports pertaining to tonsillectomy with or without adenoidectomy. RESULTS: 128 reports were identified, from which 163 adverse events were extracted. Of these, 23 (14.6%) were related to patients, and 140 (85.4%) were related to device malfunction. The most frequently reported patient-related adverse event was a burn injury (17 [73.9%]). The most common device malfunctions were dislodgment of device component (39 [27.9%]), followed by tip ignition (32 [22.9%]), damaged tip or wire during operation (28 [20%]), and melted device (24 [17.1%]). CONCLUSIONS: PEAK PlasmaBlade TnA have demonstrated utility in tonsillectomy with or without adenoidectomy but are associated with adverse events. Interventions aimed at improving both physician and patient education may help reduce adverse events attributed to improper use. Further study is needed to clarify optimal approaches to education.

Ultrasound-guided ethanol sclerotherapy for non-surgical treatment of Warthin's tumor.

BACKGROUND: Currently, the first line treatment for Warthin's tumor (WT) is parotidectomy. There is a paucity of data evaluating the safety and efficacy of non-surgical treatments for patients not amenable to surgery. Ultrasound guided ethanol sclerotherapy (UGES) has been successfully used for the management of lymphangiomans of the head and neck, thyroid nodules, and thyroid cysts. This is the first study to implement and assess the success of UGES for management of WT. METHODS: We report two patients with WT, with a total of 3 masses, who underwent UGES. All procedures were performed in the clinic. The primary outcome measured was the tumor volume reduction rate (VRR), patient satisfaction, and complications observed at follow-up. RESULTS: Both patients experienced a significant reduction in tumor size upon follow up. VRR for the three treated tumors were 67.30%, 98.32%, and 55.73%. Patient were very satisfied with the results and noted significant cosmetic improvement. No complications were observed at follow-up. CONCLUSIONS: Ultrasound guided ethanol sclerotherapy may be a viable option for conservative treatment of Warthin's tumor in patients unsuitable or unwilling to undergo surgical resection.

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.

Pediatric head and neck rhabdomyosarcoma: An analysis of treatment and survival in the United States (1975-2016).

INTRODUCTION: Rhabdomyosarcoma (RMS) is the most common soft tissue head and neck sarcoma in children. Stringent analysis of survival data is imperative to optimize treatment. METHODS: The National Cancer Database (NCDB, 2004-2016) and the Surveillance, Epidemiology, and End Results Program (SEER, 1975-2016) were queried for patients ages 0-19 with RMS of the head and neck. Survival trends were analyzed using univariable logistic regression and Chi-square pairwise comparisons. Survival by treatment was analyzed using log-rank tests, Kaplan Meier, and multivariable Cox-proportional hazards regression. RESULTS: 1147 (63.3% age <10 years, 54.3% male) and 459 (71.4% age <10 years, 53.6% male) patients were identified in NCDB and SEER, respectively. In NCDB, embryonal (n = 625, 54.5%) and alveolar (n = 300, 26.2%) were the most common histology and nonparameningeal/non-orbital (n = 634, 55.3%), followed by parameningeal (n = 303, 26.4%) and orbital (n = 210, 18.3%) the most common location. Five-year overall survival (OS) was 70.3% with lower mortality risk for embryonal histology (adjusted HR [aHR] = 0.69, p = 0.0038). Orbital tumors had greatest survival (5-year OS = 92.4%) of all sites, and their mortality risk was higher with chemotherapy and radiation compared to surgery and radiation (aHR = 6.27, p = 0.0302). SEER analysis showed average increased survival by 4% per year (p < 0.0001), but no significant 5-year OS difference when comparing 1976-1980 and 2006-2010 (p = 0.0843). CONCLUSIONS: Major prognostic factors for survival in childhood RMS of the head and neck were embryonal histology, orbital site, extent of disease, and use of SRT for orbital tumors. Larger population studies are required to demonstrate survival differences between treatment modalities for other sites.