Adverse events related to suction electrocautery devices in adenotonsillectomy: Analysis of the MAUDE database.

OBJECTIVE: To identify adverse events (AEs) related to suction electrocautery use during adenotonsillectomy. METHODS: The US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was searched using the terms "suction cautery," "suction electrocautery," "suction Bovie," and "suction coagulator" from January 2014 to December 2023. RESULTS: 165 AE reports were gathered from the MAUDE database medical device reports (MDRs). 36 met inclusion criteria. Patient injuries were found in 22 (61.1 %) reports and device malfunction events were found in 14 (38.9 %) reports. All patient injuries were thermal burns (N = 22, 100 %). Location of burn injuries included the lip (N = 6, 27.3 %), oral commissure (N = 5, 22.7 %), and tongue (N = 4, 18.2 %). The most common cause of an AE was inadequate device insulation (N = 7, 19.4 %). CONCLUSION: The suction electrocautery apparatus may malfunction and cause patient burn injuries. Device failures mainly result from inadequate device insulation, coagulation problems, and detachment of device components. Surgeons must be aware of these potential complications and counsel parents and patients regarding AEs.

Second opinions: Do otolaryngologist demographics matter?

OBJECTIVE: Pediatric patients and their caregivers may receive information from their primary care physician (PCP) that does not match current American Academy of Otolaryngology (AAO) guidelines. The purpose of this study is to evaluate the frequency of parents deciding to seek a second opinion based on the demographics of pediatric otolaryngologists who deliver guideline supported advice, contrary to advice from their child's PCP. METHODS: A survey was distributed to parents in a pediatric otolaryngology clinic between June 2021 and July 2023. Demographics included parent age category, gender, race, and age of youngest child. The survey included a scenario depicting recurrent otitis media with clear ears and a suggestion to defer tympanostomy tube insertion per AAO guidelines after their child's PCP recommended tubes. Thirteen variations of otolaryngologist photos were used in the case, including a control case with no picture. RESULTS: Of the 658 participants, 460 (69.9 %) were female. 551 (83.7 %) were aged 30-49 years, 70 (10.7 %) were younger, and 37 (5.6 %) were older. 545 (82.8 %) were White, 30 (4.6 %) were Black, 20 (3.0 %) were Asian, and 31 (4.7 %) were Hispanic. 39.9 % of parents would seek a second opinion if an otolaryngologist recommended watchful waiting following evaluation of their child's otitis media. Participants given the control case were 2.23 times more likely to listen to the otolaryngologist's advice (p = .025). If a picture was provided, respondents were more likely to follow advice given if the pictured otolaryngologist was female (p = .025, OR = 1.47) or Asian (p = .042, OR = 1.53). CONCLUSION: In this group, there is evidence that physician race and gender may influence decision making when considering action versus monitoring in the context of recurrent otitis media.

Are children with unilateral sensorineural hearing loss receiving cochlear implants?

INTRODUCTION: The US Food and Drug Administration (FDA) granted its first approval for cochlear implants (CI) in children with bilateral sensorineural hearing loss (SNHL) in 1990. In 2019, the FDA expanded CI indications to include children with unilateral SNHL. OBJECTIVE: The aim of this study was to assess the prevalence of children with unilateral SNHL in the population of new pediatric CI recipients between 2012 and 2021. METHODS: A retrospective analysis using the American College of Surgeons National Surgical Quality Improvement Pediatric database examined patients under 18 years of age with bilateral or unilateral SNHL who underwent CI between 2012 and 2021. Current Procedural Terminology code 69930 identified patients with 'cochlear device implantation, with or without mastoidectomy.' The percentage of children undergoing CI for unilateral versus bilateral SNHL during the study period was calculated and subjected to statistical analysis. RESULTS: 9863 pediatric CI patients were included with a mean age of 5.1 (95 % CI 5.1-5.2) years at the time of implantation. 7.5 % (N = 739) of patients had unilateral SNHL and 92.5 % (N = 9124) had bilateral SNHL. Children with bilateral SNHL undergoing CI were significantly younger (5.0 years versus 6.9 years for those with unilateral SNHL, p < .001). There was a statistically significant difference in the percentage of children receiving CI for unilateral versus bilateral SNHL (3.3 % in 2012 to 14.3 % in 2021, p < .001) before and after the FDA changes. CONCLUSIONS: The proportion of CIs placed for unilateral SNHL has increased annually even before 2019 when the FDA expanded its CI indications to include children with unilateral SNHL for the first time.

Otolaryngologic sequelae of Ehlers Danlos Syndrome in pediatric patients.

OBJECTIVE: As outlined by the NIH, Ehlers Danlos Syndrome (EDS) is a group of hereditary connective tissue disorders characterized by skin hyperelasticity, joint hypermobility, atrophic scarring, and blood vessel fragility, with no otolaryngological criteria for diagnosis. We aimed to compare otolaryngological disorders between children with EDS and those not affected by EDS. METHODS: A retrospective chart review was conducted using the US collaborative network within TriNetX. The EDS group was defined by ICD-10 code G47.33, while the non-EDS group excluded any patients with an EDS diagnosis. Cohorts were matched by age, sex, and race using propensity score matching. Pathologies analyzed included hearing loss (ICD-10H90, H91), otitis media (ICD-10H66, H65), allergic rhinitis, acute tonsillitis (ICD-10 J03), sinusitis (ICD-10 J32, J01), and obstructive sleep apnea (OSA) (ICD-10 G47.33). Chi-square and relative risk within a 95 % confidence interval were calculated. RESULTS: Propensity score matching yielded 6440 patients (male: N = 2,523, 39.2 %; female: N = 3,893, 60.5 %; unknown: N = 24, 0.37 %) with a mean age of 9.28 years (SD = 4.38). Children with EDS were 2.04 times more likely to be diagnosed with hearing loss, occurring in 286 (4.4 %) EDS children versus 140 (2.1 %) controls (P < 0.001). Children with EDS were 1.6 times more likely to be diagnosed with allergic rhinitis, occurring in 436 (6.8 %) EDS children versus 274 (4.2 %) controls (P < 0.001). Children with EDS were also 1.52 times (EDS: N = 350, 5.4 %; control: N = 231, 3.6 %) and 4.24 times (EDS: N = 335, 5.2 %; control: N = 79, 1.2 %) more likely to develop sinusitis and be diagnosed with OSA, respectively, compared to children without EDS (P < 0.001). However, children with EDS were only 0.71 times as likely to develop acute tonsillitis, with 101 (1.6 %) of EDS children compared to 142 (2.2 %) of control children being diagnosed (P = 0.009). No statistical difference was found in risk of developing otitis media. CONCLUSIONS: Children with EDS are at higher risk of developing hearing loss, allergic rhinitis, acute sinusitis, and OSA, possibly due to underlying immune dysfunction. Pediatric otolaryngologists should be vigilant about these otolaryngologic sequela in EDS patients.