Safety, tolerability, and effect of a single aural dose of Dornase alfa at the time of ventilation tube surgery for otitis media: A Phase 1b double randomized control trial.

BACKGROUND: One third of children require repeat ventilation tube insertion (VTI) for otitis media. Disease recurrence is associated with persistent middle ear bacterial biofilms. With demonstration that Dornase alfa (a DNase) disrupts middle ear effusion biofilms ex vivo, we identified potential for this as an anti-biofilm therapy to prevent repeat VTI. First, safety and tolerability needed to be measured. METHODS: This was a phase 1B double-blinded randomized control trial conducted in Western Australia. Children between 6 months and 5 years undergoing VTI for bilateral middle ear effusion were recruited between 2012 and 2014 and followed for two years. Children's ears were randomized to receive either Dornase alfa (1 mg/mL) or 0.9 % sodium chloride (placebo) at time of surgery. Children were followed up at 2 weeks post-VTI and at 3-monthly intervals for 2 years. Outcomes assessed were: 1) safety and tolerability, 2) otorrhoea frequency, 3) blocked or extruded ventilation tube (VT) frequency, 4) time to blockage or extrusion, 5) time to infection recurrence and/or need for repeat VTI. RESULTS: Sixty children (mean age 2.3 years) were enrolled with 87 % reaching study endpoint. Treatment did not change otorrhoea frequency. Hearing improved in all children following VTI, with no indication of ototoxicity. Dornase alfa had some effect on increasing time until VT extrusion (p = 0.099); and blockage and/or extrusion (p = 0.122). Frequency of recurrence and time until recurrence were similar. Fourteen children required repeat VTI within the follow-up period. CONCLUSION: A single application of Dornase alfa into the middle ear at time of VTI was safe, non-ototoxic, and well-tolerated. TRIAL REGISTRATION: ACTRN12623000504617.

The effect of ventilation tube insertion in pediatric cochlear implantation candidates with otitis media with effusion on postoperative complications.

OBJECTIVE: Otitis media with effusion (OME) is a common finding in pediatric cochlear implant(CI) candidates and may be managed by inserting ventilation tubes. This study aimed to compare postoperative complication rates in children who underwent CI without and with OME, including patients who were treated without and with ventilation tube insertion. METHODS: A population-based retrospective cohort study was conducted, including all CI patients, under ten years of age, at our institution, between 2007 and 2020. The study's population was divided into three groups based on their middle ear status at CI: 1) OME previously treated with VT, 2) untreated OME, and 3) normal-aerated ears. Postoperative complications of the groups were reviewed and served as our primary outcome measure. RESULTS: Of the 257 implanted ears included, 53, 42, and 162 ears belonged to the VT-treated OME, untreated OME, and aerated groups, respectively. Acute mastoiditis (AM) rate was significantly higher in the OME group compared to the aerated groups (9.5 % vs. 2.5 %, p = 0.0134) and in the VT-treated compared to the untreated OME groups (15.1 % vs. 2.3 %, p = 0.0356). Similarly, the rate of developing chronic suppurative otitis media without cholesteatoma (CSOMWC) was significantly higher in the OME compared to the aerated groups (12.6 % vs. 2.5 %, p = 0.0011) and in the VT-treated compared to the untreated OME groups (18.8 % vs. 4.7 %, p = 0.0366). Other complications rated were very low and similar between the groups. No other statistical difference was found between the groups. CONCLUSION: VT insertion in pediatric CI candidates with OME increased postoperative AM and CSOMWC. We believe that, at least in our population, VT introduction prior to CI, for OME, surgery should be avoided.

Global Otitis Media Incidence Changes During the COVID Pandemic: Systematic Review and Meta-Analysis.

OBJECTIVE: The aim was to analyze the global impact of the COVID-19 pandemic and national lockdowns on the incidence of otitis media (OM), a common otolaryngologic disease. DATA SOURCES: PubMed, Scopus, and CINAHL. REVIEW METHODS: A systematic review and meta-analysis were performed using PRISMA reporting guidelines. OM incidence (measured as newly diagnosed OM cases over total patients seen over a time period), OM antibiotic prescriptions (OM cases for which antibiotics were prescribed over total OM cases), and tympanostomy tube surgeries (all tympanostomy tube surgeries over total surgical cases) were extracted. Meta-analysis of proportions and comparison of proportions were performed. RESULTS: Of 1004 studies screened, 26 studies in 11 countries met inclusion criteria. The percentages of OM cases pre- and during-lockdown were 6.67%, 95% CI [4.68%, 8.99%], and 2.63% [2.02%, 3.31%], respectively, with an OR of 0.31 favoring during-lockdown [0.25, 0.39] (p < 0.00001). Antibiotic prescriptions per all OM episodes pre- and during-lockdown were 1.61% [0.17%, 8.46%] and 0.62% [0.07%, 3.32%], with an OR of 0.37 favoring during-lockdown ([0.35, 0.40], p < 0.00001). Tympanostomy tube surgery proportions pre- and during-lockdown were 31.64% [6.85%, 64.26%] and 29.99% [4.14%, 66.55%], with an OR of 0.94 favoring neither during- nor pre-lockdown [0.45, 2.00] (p = 0.88). CONCLUSION: The incidence of OM decreased significantly following international lockdowns due to the COVID-19 pandemic, with antibiotic prescriptions for OM episodes showing a corresponding decrease. Despite these reductions, numbers of tympanostomy tube procedures did not change significantly. These reductions are likely due to social distancing, decreased exposure through high transmission facilities such as day cares, decreased health care utilization, and even possibly decreased air pollution. Laryngoscope, 134:2028-2037, 2024.

Assessing Complication Risk of Pressure Equalizing Tube Placement in Children With Velocardiofacial Syndrome (22q11.2 Deletion Syndrome/DiGeorge Syndrome).

INTRODUCTION: Persistent tympanic membrane perforation is a known complication of pressure-equalizing (PE) tube insertion. Conductive hearing loss and otorrhea can necessitate surgical repair of these perforations. Long-term tympanostomy tube placement can increase the risk of these complications. Patients with velocardiofacial syndrome (VCFS) typically require prolonged PE tube placement and are thought to have higher risk of requiring additional otologic interventions after PE tube placement. To date, no work has established rates of post-PE tube complications requiring myringoplasty or tympanoplasty in patients with VCFS. METHODS: A retrospective case review including all patients with VCFS at a single large children's hospital between the years 2000 and 2020 was performed. Number of PE tube insertions required and additional otologic interventions performed were the primary endpoints assessed. RESULTS: Of 212 total patients with VCFS, 66 (31%) underwent PE tube placement. Of these children, 46 (70%) required 2 or more sets of PE tubes. A total of 53 patients (80.3%) required no otologic interventions apart from PE tube insertions. Of the 13 patients (19.7%) requiring additional otologic surgery, 6 (9.5%) underwent myringoplasty, and 9 patients (13.6%) required tympanoplasty. There was no significant difference in tympanoplasty (P > 1), myringoplasty (P > 1), or other surgical intervention rates (P = .7464) between VCFS patients with any type of cleft palate versus those with anatomically normal palates. CONCLUSION: This work suggests that most VCFS patients that require tubes, require at least 2 sets of PE tubes, and that the rate of post-PE tube complications requiring further otologic surgery is an order of magnitude higher than the rate established at this institution. Counseling for PE tube placement in VCFS patients may require specific dialogue regarding the substantially increased risk of complications and effort to build appropriate expectations for surgical outcomes regardless of palatal status.

Tympanomastoidectomy versus parenteral antibiotic therapy for pediatric otorrhea.

OBJECTIVE: To evaluate the efficacy of tympanomastoidectomy versus parenteral antibiotic therapy for otorrhea as a result of chronic suppurative otitis media (CSOM) without cholesteatoma in the pediatric population. METHODS: A retrospective review of 221 patients treated for otorrhea at a tertiary academic pediatric hospital was performed to evaluate the impact of tympanomastoidectomy versus parenteral antibiotic therapy on resolution of otorrhea. Inclusion criteria were age 0-18 years, prior treatment with otic and/or oral antibiotic, prior history of tympanostomy tube placement for recurrent otitis media, history of otorrhea, treatment with tympanomastoidectomy or parenteral antibiotic therapy, and follow-up of at least 1 month after intervention. Time to resolution was compared between the two modalities adjusting for age, bilateral ear disease status, and comorbidities using a Cox proportional hazard model. RESULTS: Eighty-three ears from 58 children met the inclusion criteria. Ears that initially underwent tympanomastoidectomy had a significantly shorter time to resolution of symptoms (median time to resolution) 9 months (95 % confidence interval CI: 6.2-14.8) vs. 48.5 months (95 % lower CI 9.4, p = 0.006). On multivariate analysis, however, only bilateral ear disease status was independently associated with time to resolution of symptoms (hazard ratio 0.4, 95 % CI 0.2-0.9, p = 0.03). There was no statistically significant difference in the rate of treatment-related complications when comparing tympanomastoidectomy to parenteral antibiotic therapy (p = 0.37). CONCLUSION: When adjusting for age, bilateral ear disease status, and comorbidities, there does not appear to be a significant difference in time to resolution of symptoms when comparing parenteral antibiotic therapy to tympanomastoidectomy. An informed discussion regarding risks and benefits of each approach should be employed when deciding on the next step in management for patients with CSOM who have failed more conservative therapies.

Analysis of Paparella Type 1 tympanostomy tubes in pediatric patients: A single-center retrospective review.

OBJECTIVE: This study aims to evaluate the demographic characteristics, indications for surgery, clinical follow-up results and complication rates of pediatric patients who have received a Paparella Type 1 tympanostomy tube (TT) insertion. METHODS: Retropective review of 816 ears of 442 pediatric patients who received Paparella type 1 tympanostomy tube insertions was performed. The patients' age, indication for surgery, middle ear effusion, time to extrusion and postoperative complications were analyzed retrospectively. Ears operated for chronic otitis media with effusion (COME) and recurrent acute otitis media (RAOM) were included in the study. Ears that underwent tympanostomy tube insertion for middle ear atelectasis and suppurative complications of acute otitis media were excluded from the study. Ears with middle ear effusion mucoid and serous were included. Ears without middle ear effusion or with purulent effusion were excluded from the study. Patients with a cleft palate, Down syndrome, craniofacial anomalies and those without regular follow-up until their tubes were extruded, were excluded from the study. RESULTS: The mean age of surgery was 5.11 years. 54.3 % of the patients were male and 45.7 % were female. 734 (90 %) tube insertions were performed for patients with COME and 82 (10 %) for those with RAOM. Mucoid middle ear effusion was observed in 86.9 % and serous in 13.1 %. The mean extrusion time of the tubes was 7.16 months. 93.1 % of the tubes were extruded spontaneously within 1 year and 99.9 % within 2 years. Postoperative complications of patients that were included were 8.7 % with otorrhea, 7.7 % premature extrusion, 8.2 % tube occlusion, 0.2 % displacement into the middle ear, 8.2 % tympanic membrane changes (5.4 % sclerosis, 2.3 % retraction and 0.5 % atrophy), 1.2 % permanent perforation, 0.1 % cholesteatoma and 0.1 % retained their tube. Premature extrusion was found to be significantly higher in the RAOM group compared with the COME group (p = 0.042). Tube extrusion time did not affect tympanic membrane changes (p = 0.061). CONCLUSIONS: Complication rates after Paparella Type 1 tube insertion are low. The incidence of complications such as otorrhea and tube occlusion were not significantly different between the indication and middle ear effusion groups. Compared to COME group, premature extrusion were found more frequently in the RAOM group. Complications of displacement into the middle ear, permanent perforation, cholesteatoma and retained tube were much rarer.

Audiometric Outcomes of Ventilation Drainage Treatment for Otitis Media with Effusion in Children: Implications for Speech Development and Hearing Loss.

BACKGROUND Otitis media with effusion is the most commonly recognized condition in childhood. Chronic otitis media with accompanying hearing loss is particularly unfavorable in the first years of the child's life because it can not only permanently damage the structure of the middle ear, but also adversely affect speech development and intellectual abilities in the child. MATERIAL AND METHODS This study, from a single center in Poland, included 201 children (372 ears) requiring surgical treatment due to otitis media with effusion. The condition was diagnosed by an ear, nose, and throat specialist, and each patient had a hearing test performed. The control group consisted of 21 patients (42 ears) with negative outcomes following an audiological interview. RESULTS Among all of the patients enrolled in the study, a normal tympanometry result was found in 60.6% of ears, and otoemission occurred in 63.3% of ears. The average hearing threshold in the study group was 22.01 Hz in the 500 Hz frequency range, while they were 16.76 Hz, 12.72 kHz, and 14.78 kHz for the corresponding 1 kHz, 2 kHz, and 4 kHz ranges, respectively. CONCLUSIONS Ventilation drainage is an effective treatment for otitis media with effusion. The presence of genetic disease has the greatest impact on the course of otitis media. These patients most often require reinsertion of a ventilation tube.

Relevance of cleft palatal width in short-term otologic outcomes.

OBJECTIVE: Children with cleft palate are at increased risk for Eustachian tube dysfunction (ETD) and conductive hearing loss from chronic otitis media. While it has been proposed that the severity of ETD is related to the severity of cleft palate, data are lacking to support this hypothesis. An improved understanding of the relevance of cleft width may have prognostic value that could inform decisions on the timing of tympanostomy tube placement and choice of tympanostomy tube design. The objective of this study was to assess severity of ETD in children with narrow, moderate, and wide cleft palate, with examination of hearing outcomes, number of tympanostomy procedures, and incidence of otologic complications. METHODS: Retrospective chart review was conducted on 58 patients with primary palatoplasty performed at a single academic medical center from January 1, 2016-December 31, 2019. The primary outcome was the number of otologic procedures performed after the initial palatoplasty. Secondary outcomes included audiometric findings, number of tympanostomy tube placements, presence of effusion at the time of myringotomy, and occurrence of any postoperative otologic complication. Outcomes were compared for patients with narrow (<10 mm), moderate (10-15 mm), and wide (>15 mm) cleft palate. Analysis included consideration of cleft palatal morphology (Veau I - IV), presence of Robin sequence or syndromes, and risk factors for otitis media. RESULTS: Patients with moderate and wide cleft palate underwent higher mean numbers of otologic procedures [narrow: 1.3 (95% confidence interval [CI] 0.9, 1.7); moderate: 1.6 (95% CI 1.1, 2.1); wide: 1.8 (95% CI 1.2, 2.4)]. Moderate and wide cleft palate were less likely to have normal hearing after their first tympanostomy (narrow: 50%, 10/20; moderate: 25%, 6/24; wide: 36%, 5/14). Patients with a wide cleft palate had a shorter median time between first and second tympanostomy procedures (median, IQR; narrow: 27.0, 20.8-35.7; moderate 20.4, 16.3-25.9; wide 17.3, 11.5-23.4). CONCLUSION: Our findings suggest that patients with wider cleft palate may be more susceptible to severe ETD. Further large-scale study may help to allow for more informed and personalized clinical decision making for management of cleft palate, incorporating cleft width for prognosis of risks for persistent middle ear dysfunction.

Ensuring tympanostomy tube follow-up during the COVID-19 pandemic.

OBJECTIVES: The impact of the COVID-19 pandemic on surgical practice was widespread. Local health restrictions in many communities limited the number and types of patients seen and treated. Our goal is to understand the discrepancies in follow-up for bilateral myringotomy with tubes (BMT) and understand whether the pandemic made it more difficult for certain patient populations to continue routine follow up. METHODS: This cross-sectional study abstracted demographic and clinical data from the medical charts of randomized pediatric patients who underwent a BMT procedure between 2017 and 2022 at a tertiary pediatric academic care center site. Suboptimal follow-up was defined as no clinic visits within the first 6 months of surgery, and less than 3 follow-ups within a 24-month period after surgery. Data regarding secondary surgeries, clinical variables, race, zip code, and dates and number follow-ups were recorded from randomly chosen eligible charts. Complications were defined as need for revision surgery or development of post-tympanostomy sequalae such as perforation, cholesteatoma, or granuloma. RESULTS: Pre-pandemic (N = 150) patients from 2017 to 2019 and post-pandemic (N = 150) patients from 2020 to 2022 cohorts were analyzed. No significant differences were identified between the groups regarding age, presence of combined surgery, anesthesia class, diagnosis, or race. There was no significant difference in rate of complications or need for revision surgery between either cohort nor when stratified for demographics. CONCLUSION: Limitations imposed upon medical care including outpatient clinics due COVID restrictions did not have an impact on tympanostomy tube follow-up regarding frequency of visits and risk of complication or revision surgery. LEVEL OF EVIDENCE: IV.

High frequency hearing 25 years after transmyringeal ventilation tube treatment.

OBJECTIVES: The main aim of the study was to compare hearing outcome between a healthy control group and patients treated with transmyringeal ventilation tubes, 25 years after primary surgery. Another aim was to analyse the relation between ventilation tube treatment in childhood and the occurrence of persistent middle ear pathology 25 years later. METHODS: In 1996, children treated with transmyringeal ventilation tubes were recruited for a prospective study on the outcome of ventilation tube treatment. In 2006, a healthy control group were recruited and examined together with the original participants (case group). All participants in the 2006 follow-up were eligible for this study. A clinical ear microscopy examination including eardrum pathology grading and high frequency audiometry (10-16 kHz) was carried out. RESULTS: A total of 52 participants were available for analysis. Hearing outcome was worse in the treatment group (n = 29) compared to the control group (n = 29), both in regard to standard frequency range hearing, (0.5-4 kHz), and high frequency hearing (HPTA3 10-16 kHz). Almost half the case group (48%) had eardrum retraction to some extent, compared to 10% in the control group. No case of cholesteatoma was found in this study and eardrum perforation was rare (<2%). CONCLUSION: In the long term, high frequency hearing (HPTA3 10-16 kHz) was more often affected in the patients with transmyringeal ventilation tube treatment during childhood compared with the healthy controls. Middle ear pathology of greater clinical significance was rare.

Association of Diet Patterns and Post-Operative Tympanostomy Tube Otorrhea: A Pilot Study.

OBJECTIVE: The objective of this study was to explore diet patterns in children with tympanostomy tube placement (TTP) complicated by postoperative tympanostomy tube otorrhea. STUDY DESIGN: Cross-sectional survey and retrospective cohort study. METHODS: Caregivers of children (0-12 years old), at a tertiary-care pediatric hospital who underwent TTP within 6 months to 2 years prior to enrollment were included. Children with a history of Down syndrome, cleft palate, craniofacial syndromes, known immunodeficiency, or a non-English-speaking family were excluded. Our primary outcome variable was the number of otorrhea episodes. The primary predictor was diet patterns, particularly dessert intake, which was captured through a short food questionnaire. RESULTS: A total of 286 participants were included in this study. The median age was 1.8 years (IQR, 1.3, 2.9). A total of 174 (61%) participants reported at least one episode of otorrhea. Children who consumed dessert at least two times per week had a higher risk of otorrhea compared to children who consumed one time per week or less (odds ratio [OR], 3.22, 95% Confidence Interval [CI]: 1.69, 6.12). The odds ratio increase continued when considering more stringent criteria for otorrhea (multiple episodes or one episode occurring 4 weeks after surgery), with a 2.33 (95% CI: 1.24, 4.39) higher odds of otorrhea in children with dessert intake at least 2 times per week. CONCLUSIONS: Our pilot data suggest that episodes of otorrhea among children with TTP were associated with more frequent dessert intake. Future studies using prospectively administered diet questionnaires are necessary to confirm these findings. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:3575-3581, 2023.

Otorhinologic Disorders in 22q11.2 Deletion Syndrome.

OBJECTIVE: Investigate incidence and natural history of otologic and sinonasal disease associated with 22q11.2 deletion syndrome. STUDY DESIGN: Case series. SETTING: Tertiary care children's hospital. METHODS: Charts from consecutive children born 2000 to 2018 with a diagnosis of 22q11.2 deletion, DiGeorge, or velocardiofacial syndrome based on the International Classification of Diseases (ICD)-9 and ICD-10 codes were reviewed. Otologic and rhinologic diagnoses and surgeries and immune and microbiologic laboratory findings were collected from the medical record. RESULTS: After the exclusion of patients with no 22q11.2 deletion (n = 101), otologic care at an outside hospital (n = 59), and loss to follow-up prior to 3 years of age (n = 22), 128 were included. Males comprised 80 (62.5%) patients, 115 (89.8%) were white, and the median age at genetic confirmation of 22q11.2 deletion was 119 days (range 0 days to 14.6 years). Recurrent acute otitis media (RAOM), chronic otitis media with effusion, chronic rhinosinusitis, and recurrent acute sinusitis were diagnosed in 54 (42.2%), 37 (28.9%), 10 (7.8%), and 8 (6.3%), respectively. Tympanostomy tubes were placed in 49 (38.3%). Adenoidectomy and sinus surgery were performed in 38 (29.7%) and 4 (3.1%), respectively. Neither immunoglobulin nor cluster of differentiation deficiency increased the odds of RAOM diagnosis, tympanostomy tube placement, or chronic/recurrent sinusitis. Methicillin-resistant Staphylococcus aureus was the most common organism in sinus cultures (4/13, 30.8%). Streptococcus pneumonia dominated otorrhea cultures (11/21, 52.4%). CONCLUSION: Approximately half of children with 22q11.2 deletion may experience otologic disease that often requires surgical management. Future studies will utilize a larger cohort to examine the role of immunodeficiency in otologic and rhinologic disease in this population.

Management of Already Inserted Ventilation Tubes During Pediatric Cochlear Implantation: To Remove or Leave the Tube?

OBJECTIVE: Ventilation tube (VT) insertion is usually recommended before cochlear implantation (CI) in pediatric cochlear implant candidates with recurrent acute otitis media (AOM) or chronic otitis media with effusion (OME). However, there is no consensus on whether the VT is beneficial even after CI, that is, whether the tube should be removed or left in place during CI. This study aimed to assess the effect of tube placement after CI, especially on the incidence of post-CI AOM, in pediatric cochlear implant recipients who had undergone VT insertion before CI because of recurrent AOM or chronic OME. STUDY DESIGN: A retrospective medical record review. SETTING: A tertiary referral cochlear implant center. PATIENTS: This study recruited 58 consecutive ears of children who underwent VT insertion followed by CI at age 7 years or younger between 2004 and 2021. Before October 2018, we removed the VT simultaneously with CI (removed group, 39 ears), while since then, the tube has remained in place during CI (retained group, 19 ears). INTERVENTION: Therapeutic. MAIN OUTCOME MEASURE: The primary outcome was the proportion of ears that developed AOM at post-CI 6 months in the removed and retained groups. RESULTS: The age at CI was significantly higher in the removed group than in the retained group (mean [standard deviation]: the removed group, 2.9 [1.2] yr; the retained group: 1.5 [0.8] yr; p < 0.001). The removed group showed a significantly higher proportion of ears with post-CI AOM (8 of 39 ears; 20.5%) than the retained group (none of 19 ears; 0%) 6 months after CI ( p = 0.044). The AOM-free proportion at post-CI 12 months was 76.9% in the removed group and 83.3% in the retained group, demonstrating no significant difference ( p = 0.49), probably because the VT was spontaneously extruded in the retained group at a median of 6.5 months after CI. Throughout the study period, 17 ears (13 from the removed group) were affected by post-CI AOM. Of these, three ears in the removed group and two in the retained group after spontaneous extrusion of the VT were hospitalized and treated with intravenous antibiotics for AOM that had failed to respond to oral antibiotic therapy. Only one ear in the removed group required an explanation of the infected implant. None suffered from chronic perforation of the tympanic membrane or secondary cholesteatoma after VT insertion or meningitis associated with post-CI AOM. CONCLUSION: Our results suggest that in CI for children who already have a VT because of a recurrent AOM or chronic OME, retaining the tube in position, rather than removing the tube, may decrease the incidence of AOM at least within 6 months after CI, during which most cochlear implant device infection was reported in the pediatric population.

Laser, radiofrequency or tympanostomy knife? Comparison of surgical methods in tympanostomy treatment of young children and predictive value of tympanometry.

OBJECTIVES: To investigate tympanostomy tube (TT) treatment in young children, with special interest in bloodless surgical methods (laser and radiofrequency), myringosclerosis formation and tympanometric testing. METHODS: This prospective study includes 76 children whose 121 ears with middle ear effusion were treated with tympanostomy tubes. Myringotomy was performed with CO2 laser in 37, radiofrequency in 40 and myringotomy knife in 44 ears. The ears were evaluated with otomicroscopy and tympanometry preoperatively and postoperatively every 3-4 months until spontaneous tube extrusion. RESULTS: All tubes extruded spontaneously (mean 12.8 months, range 3-36 months), with no persistent perforations or cholesteatomas. CO2 laser and radiofrequency inserted tympanostomy tubes extruded faster (mean 11 months) compared to incisional myringotomy (mean 15 months, p = 0.002). Myringosclerosis was noted in 25 (21%) ears after treatment. There was a tendency to less myringosclerosis with bloodless techniques, but the difference was not significant. Flat tympanograms on the day of procedure predicted continuation of ventilation problems also after TT treatment (p = 0.003). Ears with preoperative type B tympanogram had significantly more myringosclerosis 21/75 (28%) compared with type A and C tympanograms 4/41 (10%) (p = 0.032). CONCLUSIONS: While all myringotomy methods were effective and safe, the traditional incisional myringotomy with a tympanostomy knife is still a good, feasible and cost-effective myringotomy method. No surgical removal of tympanostomy tubes is needed before 3 years of uncomplicated tympanostomy treatment. Tympanometry turned out to be a useful tool in prediction of post TT treatment ventilation problems of the middle ear.

Tympanostomy Tubes: Are They Necessary? A Systematic Review on Implementation in Cleft Care.

OBJECTIVE: To understand the indication for and the effects of early ventilation tube insertion (VTI) on hearing and speech for patients with cleft lip and/or palate (CLP). DESIGN: We conducted a Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA)-guided systematic review of relevant literature. SETTING: Setting varied by geographical location and level of clinical care across studies. PATIENTS, PARTICIPANTS: Patients with CLP who underwent VTI were included. INTERVENTIONS: No interventions were performed. MAIN OUTCOME MEASURE(S): Primary outcome measures were hearing and speech following VTI. Secondary outcome measures were tube-related and middle ear complications. Early VTI occurred before or at time of palatoplasty while late VTI occurred after palatoplasty. RESULTS: Twenty-three articles met inclusion criteria. Articles varied among study design, outcome measures, sample size, follow-up, and quality. Few studies demonstrated support for early VTI. Many studies reported no difference in hearing or speech between early and late VTI. Others reported worse outcomes, greater likelihood of complications, or needing repeat VTI following early tympanostomy placement. Several studies had significant limitations, including confounding variables, small sample size, or not reporting on our primary outcome. CONCLUSIONS: No consistency was found regarding which patients would benefit most from early VTI. Given the aforementioned variability and sub-optimal methodologies, additional studies are warranted to provide stronger evidence regarding VTI timing in cleft care.

Factors Related to Ventilation Tube Extrusion Time in Children and Adults.

BACKGROUND AND OBJECTIVE: The aim of this study was to investigate the factors affecting extrusion time in both children and adults with ventilation tube (VT) insertion, providing useful information for clinicians for better decision-making, follow strategy, and potentially improve clinical outcomes for these patients. METHODS: Data from patients receiving myringotomy with VT insertion from January 1, 2007, to June 30, 2012, were retrospectively collected and analyzed by the end of 2018. Various factors, including age, gender, history of VT insertion, tympanogram, size of VT used, local finding of tympanic membrane, hypertension, diabetes mellitus, hyperlipidemia, and postoperative ear infection, were included and analyzed to examine the effects of these factors on extrusion time. RESULTS: A total of 447 patients were included in this study (Child group-Adult group = 237:210). The overall average extrusion time was 225.85 days. In the subgroup analysis, the average time was 221.3 days and 231.0 days for children and adults, respectively. The results showed that the VT extrusion time was significantly longer in participants without a history of VT insertion and in those where larger sized VTs were inserted in both age-groups. Male gender had an influence on extrusion time in children. In addition, a history of VT insertion and VT size were determined to be factors related to extrusion before 12 months in children. CONCLUSION: History of VT insertion and VT size were significantly related to VT extrusion time in both children and adults and defined as factors associated with extrusion before 12 months in children. The findings suggest avoiding VT with a diameter < 1 mm and considering an appropriately larger size in patients with a history of VT insertion to optimize VT retention.

Formula Otorrhea in Pediatric Patients With Cleft Palate.

The case series details 2 unusual cases of male newborns with cleft lip and palate (CLP) that later developed formula otorrhea. Both patients underwent bilateral myringotomies with the insertion of pressure equalizing (PE) tubes for chronic otitis media with effusion (OME). Chronic otorrhea associated with feeding occurred post-PE tube insertion and the otorrhea was later confirmed to be due to reflux of formula. Patients were treated with antibiotic ear drops, routine ear cleaning, anti-reflux medication, and reflux precautions. After definite cleft palate repair, formula otorrhea completely resolved. When patients with CLP develop chronic OME or otorrhea following PE tube placement, reflux of formula into the middle ear should be considered and treated accordingly.

Clinical Factors Associated With the Outcomes of Long-Term Middle Ear Ventilation Tube Insertion in Pediatric Patients.

BACKGROUND: Ventilation tube (VT) insertion is the most common treatment for otitis media with effusion (OME). However, OME recurrence and persistent tympanic membrane (TM) perforation after VT removal are encountered in a certain percentage of such children. METHODS: This study was performed to determine the outcomes of children who underwent long-term VT insertion. A total of 326 ears from 192 patients were analyzed. The associations among the patient age, sex, history of OME, history of repeated acute otitis media, placement duration, whether the VT had been removed intentionally or spontaneously, and the outcome (persistent TM perforation or OME recurrence) were analyzed. The outcomes of multiple VT tube insertions were also reviewed. We also analyzed whether or not local or general anesthesia was associated with the early spontaneous extrusion of the VT. RESULT: The OME recurrence and TM perforation rates were 29% (96/326 sides) and 17% (57/326 sides), respectively, for first insertions. In addition, 96 (29%) sides underwent ≥2 insertions. The shorter the duration for which the VT was retained in the middle ear, the more significant the rate of increase in OME recurrence. The OME recurrence was observed more often when VT was spontaneously removed than when intentionally removed. The rate of persistent TM perforation was significantly associated with male sex. Persistent TM perforation was not observed in patients who underwent 4 or 5 insertions. The anesthesia method did not significantly influence the timing of spontaneous extrusion of VT. CONCLUSION: The retention period of VT should be at least 2 years, and VT removal at the age of 7 might be a viable strategy. Multiple VT insertions are recommended for patients with recurrent OME. Ventilation tube under local anesthesia is an effective option for tolerable children.

The association between Helicobacter pylori and chronic otitis media with effusion.

PURPOSE: Chronic otitis media with effusion (COME) is a common condition in children and a leading cause for hearing loss and ventilation tubes (VT) insertion. Among other risk factors, it is suggested that Helicobacter pylori (H. pylori) infection may have a role in the pathogenesis of COME. Previous studies have reached different results, and therefore, there is a need for further data on the relationship between H. pylori infection and COME development in children. Our objective is to investigate the presence of H. pylori in the middle-ear fluid (MEF) from children with COME. METHODS: A Comparative cross-sectional study. Children ≤ 18 years were included. The study group included children diagnosed with COME and required VT insertion. The control group included children with acute otitis media (AOM) who required myringotomy in the emergency room. Middle-ear fluid samples were sent for both culture and bacterial identification using polymerase chain reaction (PCR) testing. RESULTS: A total of 43 children were included. Eighteen with COME (median age 4 years, IQR 3-6), and 25 with AOM (median age 1 year, IQR 1-2). All samples were cultured for H. pylori. Twenty-two samples underwent H. pylori PCR testing of them, 12 samples from children with COME, and 10 from children with AOM. All cultures and PCR tests results were negative for H. pylori. CONCLUSIONS: Our results suggest that H. pylori does not have a role in the pathogenesis of COME. Future larger studies are needed to investigate whether H. pylori has a role in the pathogenesis of COME.

Transmyringeal ventilation tube insertion for unilateral Menière's disease: a protocol for a prospective, sham-controlled, double-blinded, randomized, clinical trial.

BACKGROUND: Menière's disease is an idiopathic disorder characterized by recurrent episodes of vertigo lasting more than 20 min, unilateral sensorineural hearing loss, and tinnitus. If vertigo attacks occur frequently, the patient is usually severely incapacitated. Currently, there is no consensus on the treatment of Menière's disease. The evidence regarding most treatment options is sparse due to a lack of randomized trials together with an often-spontaneous relief over time and a considerable placebo effect. Insertion of a transmyringeal tube is a simple and relatively safe, minimally invasive procedure and previous open-label trials have shown promising results. STUDY DESIGN: This is a prospective, sham-controlled, double-blinded, randomized, clinical trial. AIM: This trial aims to assess the effects of inserting a ventilation tube into the tympanic membrane compared with sham treatment for definite or probable unilateral Menière's disease according to the criteria formulated by the Classification Committee of the Bàràny Society. OUTCOMES: The primary outcome will be the number of spontaneous vertigo attacks lasting more than 20 min and time to treatment failure. In addition to the primary outcome, we will assess various secondary outcomes related to hearing, ear fullness, dizziness, and serious adverse events. SAMPLE SIZE: An estimated 104 participants in total or 52 participants in each group will be necessary. The primary analysis will be according to the intention-to-treat principle. The trial will be initiated in 2021 and is expected to end in 2025. TRIAL STATUS: ClinicalTrials.gov : NCT04835688 . Registered on April 8, 2021. PROTOCOL VERSION: 1.8, 26-09-2022. Date of first enrollment: October 1st, 2021. End of study: anticipated January 2025.