Artificial intelligence and ChatGPT: An otolaryngology patient's ally or foe?

BACKGROUND: As artificial intelligence (AI) is integrating into the healthcare sphere, there is a need to evaluate its effectiveness in the various subspecialties of medicine, including otolaryngology. Our study intends to provide a cursory review of ChatGPT's diagnostic capability, ability to convey pathophysiology in simple terms, accuracy in providing management recommendations, and appropriateness in follow up and post-operative recommendations in common otolaryngologic conditions. METHODS: Adenotonsillectomy (T&A), tympanoplasty (TP), endoscopic sinus surgery (ESS), parotidectomy (PT), and total laryngectomy (TL) were substituted for the word procedure in the following five questions and input into ChatGPT version 3.5: "How do I know if I need (procedure)," "What are treatment alternatives to (procedure)," "What are the risks of (procedure)," "How is a (procedure) performed," and "What is the recovery process for (procedure)?" Two independent study members analyzed the output and discrepancies were reviewed, discussed, and reconciled between study members. RESULTS: In terms of management recommendations, ChatGPT was able to give generalized statements of evaluation, need for intervention, and the basics of the procedure without major aberrant errors or risks of safety. ChatGPT was successful in providing appropriate treatment alternatives in all procedures tested. When queried for methodology, risks, and procedural steps, ChatGPT lacked precision in the description of procedural steps, missed key surgical details, and did not accurately provide all major risks of each procedure. In terms of the recovery process, ChatGPT showed promise in T&A, TP, ESS, and PT but struggled in the complexity of TL, stating the patient could speak immediately after surgery without speech therapy. CONCLUSIONS: ChatGPT accurately demonstrated the need for intervention, management recommendations, and treatment alternatives in common ENT procedures. However, ChatGPT was not able to replace an otolaryngologist's clinical reasoning necessary to discuss procedural methodology, risks, and the recovery process in complex procedures. As AI becomes further integrated into healthcare, there is a need to continue to explore its indications, evaluate its limits, and refine its use to the otolaryngologist's advantage.

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.

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.

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.

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.

Adverse events associated with the Inspire implantable hypoglossal nerve stimulator: A MAUDE database review.

BACKGROUND: Implantable hypoglossal nerve stimulation (HNS) has been found to be a safe and effective therapy for patients with obstructive sleep apnea, and patient adherence to treatment has been found to be as high as 86% after 12 months of therapy. OBJECTIVE: The purpose of this study is to review the medical device reports (MDRs) submitted to the Food and Drug Administration's (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events related to HNS therapy that could hinder compliance. METHODS: A search of the FDA MAUDE database was conducted using the product code "MNQ" for "Inspire stimulator for sleep apnea." Reports of adverse events associated with Inspire for sleep apnea from January 2000 to May 2020 were included for analysis. From these included reports, event variables were collected, including event setting, adverse event to patient, iatrogenic injury, device malfunction, interventions, and root causes. Results were compiled and reviewed. RESULTS: The search query yielded 180 reports that met inclusion criteria, containing a total of 196 adverse events. The most commonly reported adverse events to patients were infection (n = 50, 34.2%), neuropraxia (n = 22, 15.1%) and hematoma/seroma (n = 17, 11.6%). A total of 83 adverse events (42.3%) required reoperation. The most common reoperations performed for adverse events to patients were explantation (n = 30, 46.2%) and device repositioning/lead revision (n = 24, 36.9%), while the most common reoperation performed for device malfunctions was device replacement (n = 10, 55.6%). CONCLUSION: In attempting to further improve patient compliance, understanding these device malfunctions and adverse events related to HNS implantation or usage is crucial for the identification of potential causes of patient non-adherence.

Complications associated with tracheoesophageal voice prostheses from 2010 to 2020: A MAUDE study.

PURPOSE: Tracheoesophageal puncture with voice prosthesis placement remains the gold standard for voice restoration following total laryngectomy, but may cause various complications. This study aims to summarize patient-related and device-related adverse events associated with tracheoesophageal puncture and voice prosthesis placement. MATERIALS AND 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 tracheoesophageal puncture with voice prosthesis placement from January 1, 2010, to April 30, 2020. Data were extracted from reports pertaining to tracheoesophageal prostheses. RESULTS: Seventy-seven reports involving tracheoesophageal voice prostheses were identified, from which 111 adverse events were extracted. Of these, 58 (52.3%) were patient-related, while 53 (47.7%) were device-related. The most frequently reported patient-related adverse events were aspirated prosthesis (24 [41.4%]), foreign body during placement (11 [19.0%]), aspiration pneumonia (9 [15.5%]), and aspirated brush tip (8 [13.8%]). The most common device-related adverse events were detached brush tip (15 [28.3%]), leak (14 [26.4%]), and torn esophageal flange (11 [20.8%]). CONCLUSIONS: While tracheoesophageal puncture with voice prosthesis placement has revolutionized voice rehabilitation following total laryngectomy, the procedure may be associated with adverse events both at the time of placement and later. Interventions aimed at improving both physician and patient education may help reduce adverse events attributed to improper use. Further research is needed to clarify optimal approaches to education.

Otolaryngology-related Google Search trends during the COVID-19 pandemic.

OBJECTIVE: To assess trends of Google Search queries for symptoms and complaints encountered commonly in otolaryngology practices during the coronavirus disease 2019 (COVID-19) pandemic when in-person care has been limited. MATERIALS AND METHODS: In this cross-sectional study, data on Google Search queries in the United States for 30 otolaryngology-related terms were obtained from Google Trends. The means of relative search volume from the COVID-19 period (March 29, 2020 through May 16, 2020) were compared to similar periods from 2016 to 2019 using a t-test of two independent samples. RESULTS: In total, 16.6% of search terms had significant increases in relative search volume during the COVID-19 period, with the largest percentage increase for "can't smell" (124.4%, p = .006), followed by "allergies" (30.3%, p = .03), "voice pain" (26.1%, p = .008), and "ears ringing" (19.0%, p < .001). Of all search terms, 26.7% had significant decreases in relative search volume, including the largest percentage decrease for "laryngitis" (59.8%, p < .001), followed by "thyroid nodule" (54.4%, p < .001), "thyroid cancer" (45.6%, p < .001), and "ENT" (34.9%, p < .001). CONCLUSION: This study demonstrates that Google search activity for many otolaryngology-related terms during the COVID-19 pandemic has increased or decreased significantly as compared to previous years. With reduced access to in-office otolaryngology care in the United States during the COVID-19 pandemic, these are important considerations for otolaryngology practices to meet the needs of patients who lack access to care.

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.

Use of the 445-nm Blue Laser for Management of Early Glottic Carcinoma: Preliminary 1-Year Results.

OBJECTIVE: To analyze oncological efficacy and voice outcomes of the 445-nm blue laser (BL) in the treatment of early glottic carcinoma and compare results with the 532-nm potassium-titanyl-phosphate (KTP) laser. STUDY DESIGN: Single institution, retrospective chart review. METHODS: All patients who underwent microlaryngoscopic KTP or BL laser excision of early glottic carcinoma from 2018 to the present day with at least 1-year follow-up were included. Primary and recurrent disease, including radiation and surgical failures, were included. Demographic data, voice outcomes and oncologic outcomes were compared between the two laser groups. RESULTS: Forty-nine patients met the inclusion criteria for the BL group and 88 for the KTP group, with average follow-up of 635 and 1236 days, respectively. Oncologic outcomes were not significantly different, with disease-specific survival rates of 95.9% for BL and 100% for KTP (p = 0.13), organ preservation rates of 98.0% for BL and 95.6% for KTP (p = 0.39), and local control rates of 93.9% for BL and 92.1% for KTP (p = 0.81). Both BL and KTP groups showed significant improvement in CAPE-V (p = 0.04, 0.006 respectively) and VHI-10 scores (p = 0.003, <0.00001) following surgery. CONCLUSIONS: Photoangiolytic removal of early glottic carcinoma with BL appears to be equally safe and effective as with KTP laser at minimum one-year follow-up, and with excellent voice outcomes. Additional study will be warranted over time to assess long-term outcomes in BL patients. LEVEL OF EVIDENCE: 3 Laryngoscope, 2024.

Cost-Effectiveness of Steroids for Prolonging the Surgery-Free Interval in Subglottic Stenosis.

OBJECTIVES: Repeat endoscopic dilation (ED) in the operating room for subglottic stenosis (SGS) remains an economic burden to patients. The cost-effectiveness (CE) of adjuvant serial intralesional steroid injections (SILSI) to prolong the surgery-free interval (SFI) in SGS patients requiring ED has yet to be studied. METHODS: Details of the cost of SILSI and ED were received from our tertiary academic center. SFI, cost of intervention, and the effect of SILSI on prolonging SFI were collected from a systematic review by Luke et al. SGS etiologies in the review included idiopathic, iatrogenic, or autoimmune. A break-even analysis, comparing the cost of SILSI alone with the cost of repeat ED, was performed to determine if SILSI injections were cost-effective in prolonging the SFI. RESULTS: Average extension of the SFI with SILSI was an additional 219.3 days compared to ED alone based on a systematic review of the literature. 41/55 (74.5%) cases did not require further ED once in-office SILSI management began. SILSI administered in a 4-dose series in 3-to-7-week intervals (~$7,564.00) is CE if the reported recurrence rate of SGS requiring ED (~$39,429.00) has an absolute risk reduction (ARR) of at least 19.18% with the use of SILSI. Based on the literature, SILSI prevents ~3 out of every 4 cases of SGS at sufficient follow-up from undergoing repeat ED, resulting in an ARR of ~75%. CONCLUSIONS: SILSI is economically reasonable if it prolongs the SFI of at least one case of recurrence out of 5. SILSI, therefore, can be CE in extending the interval for surgical ED. LEVEL OF EVIDENCE: NA Laryngoscope, 133:3436-3442, 2023.

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.

An Updated Review of Subglottic Stenosis: Etiology, Evaluation, and Management.

Purpose of Review: To assimilate the newly published literature regarding subglottic stenosis (SGS), including basic science and translational research on mechanisms of etiology, clinical diagnostics, and therapeutic treatments. Recent Findings: The role of inflammation in development of iatrogenic and idiopathic SGS (iSGS) is continuing to be studied. The IL-23/IL-17A inflammatory axis appears to be a potential mechanism for development of iSGS. Additionally, as anticipated in an inflammatory milieu, PD-1/PD-L1 expression is upregulated. If the PD-1/PD-L1 axis is important in SGS pathogenesis, then it may represent a potential target for immunotherapeutic inhibition, given its success in cancer treatment. In terms of surgical management, prospective studies show that endoscopic approaches have more frequent recurrence compared to open techniques. Summary: SGS arises from various etiologies, and further understanding of its pathogenesis can aid in the development of novel therapies. It is imperative to obtain a thorough history for each patient presenting with respiratory complaints, as misdiagnosis can delay proper treatment. Endoscopic and open surgical techniques continue to be investigated in a growing number of prospective clinical trials to determine optimal treatment protocols. In-office injections are gaining popularity and show promise in the treatment of SGS.

Sex Bias in Laryngology Research and Publishing.

OBJECTIVE: To investigate sex bias in laryngology research and publishing. MATERIALS AND METHODS: Articles published in 2019 in seven mainstream otolaryngology journals were reviewed. Original manuscripts were included. Study type (medical, speech-language pathology, basic science, or pedagogy), subject sex, ≥50% sex-matching (SM≥50), sex-based analysis, and bibliometric data including author sex were recorded. RESULTS: Of 1619 publications reviewed, 259 patient-centered original laryngology studies were included, totaling 7,130,991 subjects (3,411,741 [47.8%] male; 3,718,694 [52.1%] female; 556 [0.0%] unreported). 29 studies included subjects of a single sex and 14 did not report sex. 114 (44%) studies met SM≥50, and 95 (37%) used sex-based analysis; no differences were found among study types or location. Sex-based analysis was used less in single-institution (33%) than database studies (62%, P = 0.01). No difference in SM≥50 was found among single or multi-institution, or database. There were 1340 total authors (578 [43%] female). First, corresponding, and senior authors were 47%, 39%, and 35% female, respectively. Studies that had female first and/or senior authors did not differ in rates of SM≥50 or sex-based analysis or mean enrollment of females compared to studies with male first and senior authors. The proportion of female physician first and senior authors did not differ from the proportion of female Association of American Medical Colleges otolaryngology faculty, but was non-significantly smaller than the proportion of female laryngology fellows at four academic institutions. CONCLUSION: Laryngology research exhibits sex bias in subject enrollment and sex-based analysis. Female authorship was representative of national demographics and author sex did not influence the rate of sex bias.

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.

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.

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.

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.