Eustachian Tube Dysfunction Research Articles

Outcomes of Concurrent Balloon Eustachian Tuboplasty and Tympanostomy Tube Placement in Children.

Balloon dilation eustachian tuboplasty (BDET) has been proven to be a safe treatment option for children with eustachian tube dysfunction (ETD). This study aims to analyze the long-term outcomes of children who underwent concurrent BDET and tympanostomy tube (TT) placement. We hypothesize that patients who underwent simultaneous therapy have experienced a low overall rate of middle ear pathology and have consistent hearing quality at subsequent office visits. Retrospective chart review of 19 pediatric patients (36 ears) who previously underwent concurrent BDET and TT placement. Patient charts within the extended postoperative period were reviewed. Specific data points included need for reoperation, rates of middle ear pathology, audiological outcomes, and number of previous TT placements. Pediatric patients who underwent concurrent BDET and TT placement had long-term success in 34/36 ears (94.4%). All postoperative tympanograms and audiograms (100%) were normal when performed within 12 months after the procedure. Notably, 34/36 ears (94.4%) had history of tube placement in the past. Patients had an average of three sets of tympanostomy tubes prior to undergoing concurrent BDET and TT. Concurrent BDET and TT placement may be an effective treatment option for pediatric patients with persistent eustachian tube dysfunction. Specifically, BDET may be a useful adjunct tool in pediatric patients with refractory ETD despite having multiple sets of tympanostomy tubes. This study aims to strengthen the argument of performing multimodal therapy in pediatric patients with recurrent middle ear disease. 4 Laryngoscope, 134:4799-4802, 2024.

MAUDE database and Eustachian tube balloon dilation: Evaluation of adverse events and sales data

Study designReview of database. SettingTertiary care neurotology center. PatientsPatients undergoing adverse events. InterventionMAUDE database evaluation of Eustachian tube balloon dilation (ETBD) for the treatment of Eustachian tube dysfunction. Main outcome measuresMedical device reports (MDRs) from the MAUDE database were analyzed for adverse patient events (AE) and device malfunctions (DM) among different devices for ETBD. The objective of this analysis is to assess AE rates and compare them across different devices. Sales data was also used to calculate AE rates. ResultsThere were 18 MDRs noted in the MAUDE database for patients undergoing ETBD out of an initial 23 results. When separated into devices, the Aera had 9 total MDRs (50 %), Xpress had 8 (44.4 %) and Audion had 1 (5.6 %). There were 10 AE and 8 DM. When separated by device, Aera had 4 AEs and 5 DMs, Xpress had 5 AEs and 3 DMs, and Audion had 1 AE. The most common AE was subcutaneous emphysema (n = 4), in the head and neck region with one report of mediastinal involvement. Using this sales data, the Aera balloon has an MDR rate of 0.0128 % is established, with a rate of AE at 0.0058 %. The Audion balloon had an MDR and AE rate of 0.0164 %. ConclusionsETBD is a safe procedure with minimal complications, with subcutaneous emphysema being the most commonly reported adverse event, consistent with literature findings. A comprehensive analysis of AE, coupled with sales data, indicates a commendably low MDR rate of 0.0128 % for the Aera balloon while the Audion balloon had an MDR rate of 0.0164 %. These findings offer valuable insights on post-procedure expectations and engaging in informed consent discussions with patients, highlighting the overall safety of ETBD as an intervention.

Eustachian Tube Dysfunction After LeFort 1 Osteotomy Orthognathic Surgery.

The authors present a 24-year-old male with a history of class III occlusal deformity who underwent a maxillary advancement with LeFort I osteotomies. Eighteen months after surgery, he was diagnosed with bothersome Eustachian tube dysfunction (ETD). Anatomical shifts secondary to the LeFort osteotomies required for maxillary advancement result in vector changes of muscles that regulate the function of the Eustachian tube. This realignment of muscles is suspected to be a major contributing factor in causing this patient's new onset Eustachian tube dysfunction. This article represents a pilot project as data are collected for a retrospective and, ultimately, prospective studies on this topic.

The DILATE Study: A Prospective Cohort Study of Balloon Dilatation for Eustachian Tube Dysfunction in patients with no middle ear disease.

The DILATE Study: A Prospective Cohort Study of Balloon Dilatation for Eustachian Tube Dysfunction in patients with no middle ear disease.

First Investigation of a Eustachian Tube Stent in Experimentally Induced Eustachian Tube Dysfunction.

Unmet needs in the treatment of chronic otitis media and Eustachian tube dysfunction (ETD) triggered the development of stents for the Eustachian tube (ET). In this study, for the first time, stents were placed in an artificially blocked ET to evaluate stent function. Eight adult female sheep were injected with stabilized hyaluronic acid (HA) on both sides to induce ETD. Subsequently, a tapered nitinol ET stent was inserted on one side, and animals were examined bilaterally by endoscopy, tympanometry, cone beam computed tomography, and final histology. Seven of the stents were placed in the desired cartilaginous portion of the ET. At the end of the study, one stented side appeared slightly open; all other ET orifices were closed. Tympanometry revealed re-ventilation of the middle ear in four out of seven correctly stented animals within 3 to 6 weeks after stent insertion. The major amount of HA was found at the pharyngeal orifice of the ET anterior to the stent. Thus, the stent position did not completely align with the HA position. While a functional analysis will require refinement of the experimental setup, this study provides first promising results for stent insertion in a sheep model of ETD.

Influence of septal deviation side on preoperative eustachian tube dysfunction and the effectiveness of septoplasty in alleviating eustachian tube dysfunction.

The Eustachian Tube Dysfunction Questionnaire 7 (ETDQ-7) serves as a valuable tool for assessing eustachian tube dysfunction (ETD). We investigated the impact of septal deviation side on ETD using preoperative ETDQ-7 scores and evaluated the effectiveness of septoplasty based on postoperative ETDQ-7 scores. We conducted a retrospective analysis of patients with septal deviation who were scheduled for septoplasty. ETDQ-7 surveys were conducted preoperative and 1 and 3 months postoperative. 120 patients were included, with 72 completing the ETDQ-7 at all three time points. The average prevalence of ETD was 29.2%. Preoperative ETDQ-7 scores showed no significant difference between convex and concave nasal sides. However, the prevalence of ETD was significantly higher on the convex side (28.3% vs. 15.8%), especially in unilateral ETD cases. Preoperatively, the positive ETD group had significantly higher ETDQ-7 scores on the convex side while no significant difference was found between concave and convex sides in the negative ETD group. Postoperatively, the positive ETD group showed significant improvement in ETDQ-7 scores with significantly higher on the convex side (66.7% vs. 33.3%). ETDQ-7 scores improved after septoplasty, with more improvement in the positive ETD group. Septoplasty significantly improves ETD, particularly in the preoperative positive ETD group, by reducing ETDQ-7 scores. The prevalence of ETD was higher on the convex side preoperatively, and the positive ETD group exhibited significant postoperative improvements, especially on the convex side. This suggests that the direction of septal deviation influences ETD prevalence and surgery outcomes, although septoplasty alleviates ETD on both sides.

Manajemen Rhinitis Alergi

Allergic rhinitis (AR) is an atopic disease characterized by symptoms of nasal congestion, clear rhinorrhea, sneezing, postnasal drop, and nasal pruritis. The disease affects one in six people and is associated with significant morbidity, loss of productivity, and health care costs. Historically, AR was considered a disease process in the nasal airways only, although it is not serious, allergic rhinitis should be considered as a quite serious condition because it can affect the sufferer's quality of life due to the severity of the symptoms experienced and can also cause various complications. However, the development of integrated airway theory has classified AR as a component of the systemic allergic response, with other related conditions, such as asthma and atopic dermatitis, having an underlying systemic pathology. Even though it is not serious, allergic rhinitis should be considered as a quite serious condition because it can affect the sufferer's quality of life due to the severity of the symptoms experienced and can also cause various complications. In addition to nasal symptoms, patients with AR may also experience allergic conjunctivitis, non-productive cough, Eustachian tube dysfunction, and chronic sinusitis. Once diagnosed, AR can be treated in a variety of ways, with intranasal glucocorticoids being the first line of therapy.

The Role of Mucociliary Clearance Function of Eustachian Tube as an Outcome Predictor for Type 1 Tympanoplasty.

To evaluate the association between mucociliary function of the Eustachian tube using the Saccharin test preoperatively and its correlation with dynamic slow-motion video endoscopy on the outcome of Type-I Tympanoplasty in patients with inactive mucosal chronic otitis media. Eighty patients diagnosed with inactive mucosal chronic otitis media who underwent Type-I Tympanoplasty were included in the study. Preoperative assessment of Eustachian tube function was conducted using the Saccharin test. Results of this test were categorized as normal, partial, or gross dysfunction. Dynamic slow-motion video endoscopy was performed to assess motion and pathological factors of the Eustachian tube. Results were evaluated based on a previously validated Visual Analogue Score (VAS). Patients were followed up postoperatively for 3 months. The proportion of patients with surgical failure at the end of the 1st and 3rd month postoperatively was significantly higher in cases of gross Eustachian tube dysfunction compared to those with normal and partial dysfunction (p-value < 0.0001 and p-value = 0.0001, respectively). Preoperative VAS scores in normal Eustachian tubes were significantly higher compared to those with partial dysfunction and gross dysfunction. The Saccharin test is a valuable tool for preoperative evaluation of mucociliary clearance of the Eustachian tube, and dynamic slow-motion video endoscopy serves as a useful adjunct in predicting the outcome of Type-I Tympanoplasty. Routine evaluation of mucociliary clearance function of the Eustachian tube should be included in the preoperative workup for patients undergoing Tympanoplasty to achieve optimal surgical outcomes.

The case for balloon eustachian tuboplasty in children.

Balloon dilation of the cartilaginous portion of the Eustachian tube has increasingly gained acceptance among otolaryngologists in the treatment of obstructive Eustachian tube dysfunction. There is however little data on the procedure performed in children. The purpose of this study is to review the recent developments regarding balloon dilation in pediatric patients. Balloon dilation of the Eustachian tube is safe in pediatric patients. The effects of the procedure are durable during long term follow-up. Diagnosing obstructive dysfunction remains challenging. There is no single test or questionnaire for diagnosing the condition; instead a series of appropriate tests should be used. The pediatric Eustachian tube is very responsive to the effects of balloon dilation. While the treatment is effective, overtreatment can have unwanted results such as patulous symptoms. Reducing the time of dilation should therefore be considered. Otolaryngologists performing the procedure should be familiar with the effects of balloon dilation on the pediatric Eustachian tube and consider altering the duration of dilation accordingly. Further studies are needed especially regarding patient selection, optimal age for dilation and balloon parameters for pediatrics (e.g. dimensions, inflation duration, inflation pressure).

Causal relationship between allergic rhinitis and otitis media: A Mendelian randomization study.

Otitis media and allergic rhinitis are prevalent conditions. Some data posit a significant association between the 2 ailments, proposing mechanisms such as allergic rhinitis-induced Eustachian tube dysfunction or concurrent allergic pathophysiology affecting both the nasal and aural cavities. Observational studies hint at an association between allergic rhinitis (AR) and nonsuppurative otitis media, yet definitive causality remains elusive. Thus, to elucidate the causal impact of AR on otitis media, a 2-sample Mendelian randomization study was undertaken. Data on AR, acute suppurative otitis media, chronic suppurative otitis media, and nonsuppurative otitis media were sourced from the Genome for Extensive Association Study, encompassing individuals of European ancestry. Single nucleotide polymorphisms linked with AR were utilized as instrumental variables. The inverse-variance weighting (IVW) method, alongside sensitivity analyses employing the weighted median and Mendelian randomization-Egger methods, was employed to assess causal effects. Our analysis revealed a significant causal effect of AR on nonsuppurative otitis media (IVW, odds ratio [OR] = 12.22, 95% confidence interval, 1.38-107.93, P = .024) and indicated an association with acute suppurative otitis media (IVW, OR = 6.95, 95% confidence interval, 0.80-60.35, P = .078). However, no causal effect of AR on chronic suppurative otitis media was discerned. Our findings delineate a measurable causal link between AR and nonsuppurative otitis media (OR = 12.22) and suggest an association with acute suppurative otitis media (OR = 6.95), though lacking evidence for a causal effect on chronic suppurative otitis media. These results underscore the propensity of AR to correlate with diverse forms of otitis media and furnish high-quality causal evidence pertinent to clinical management.

Attic retraction pocket: a review

Attic retraction pocket (ARP) is one of the important sequelae of eustachian tube dysfunction or otitis media with effusion. It is associated with the loss of original histological and anatomical structure at the attic region. Clinical observation usually shows that negative nasopharyngeal pressure is associated with the development of ARP. However, LaPlace’s law states that the pressure within a sphere varies with the inverse of the radius, which gives a dynamic explanation for why the pars flaccida retract more frequently than the pars tensa leading to the development of ARP. It may develop ossicular chain erosion, cholesteatoma formation, and potentially life-threatening complications due to cholesteatoma. It is thought that blockade of the tympanic isthmus results in isolation of the attic and adjacent middle ear spaces and that subsequent makes negative pressure in these spaces leading to pars flaccida retraction. The severity of ARP with cholesteatoma varies from well-localized pathology to advanced involvement with complications. The choice of treatment is surgery that depends on the initial pathology, which is also associated with hearing outcomes and the rate of recurrence. This review article discusses on epidemiology, etiopathology, classification, clinical manifestations, diagnosis, treatment, and prognosis of ARP.

Clinical Outcomes After Innovative Multipoint Impedance-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve for Treatment of Chronic Rhinitis.

Objective: Chronic rhinitis substantially impacts a person's quality of life. We evaluated a novel, multipoint, impedance-controlled, radiofrequency ablation device for the treatment of chronic rhinitis. Methods: This was a prospective, multicenter, single-arm clinical study of posterior nasal nerve ablation in adults with chronic rhinitis. The primary efficacy endpoint was the change in reflective Total Nasal Symptom Score (rTNSS) at 6-month follow-up. Additional assessments included the Eustachian Tube Dysfunction Questionnaire (ETDQ-7), Nasal Obstruction Symptom Evaluation (NOSE), and mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini-RQLQ). The primary safety endpoint was the incidence of related serious adverse events. Results: Seventy-nine of 80 enrolled participants completed 6-month follow-up. Statistically significant improvements were observed for mean change in rTNSS (-4.2), ETDQ-7 (-1.2), NOSE (-33.5), and mini-RQLQ (-1.8; P < .0001 for all). Allergic and nonallergic rhinitis subgroups demonstrated significant improvement in all assessments (P < .0001) with no significant differences between subgroups. Higher baseline rTNSS was associated with greater improvements at follow-up. One serious adverse event of epistaxis was reported. Conclusions: The results of this study demonstrate the efficacy and safety of a multipoint, impedance-controlled, radiofrequency ablation device for the treatment of chronic rhinitis. Significant improvements were observed in rTNSS, ETDQ-7, NOSE, and mini-RQLQ assessments.Study registration: www.clinicaltrials.gov. Unique identifier NCT05591989.

Quantifying the Domino Effect of Septoplasty on Eustachian Tube Function and Nasal Resistance in Patients With Chronic Otitis Media: A Cross-Sectional Study.

Background Eustachian tube dysfunction is characterized by insufficient dilation, leading to secondary pathologies in the middle ear. By comparing pre- and post-operative grades of Eustachian tube functionand nasal resistance measurements, this study seeks to determine if septoplasty can improve Eustachian tube function in cases where nasal septal deviation is likely to cause mechanical dysfunction. We also aim to validate the JainBhalerao endoscopic classification of nasal septal deviation by assessing its utility in identifying septal deviations at a higher risk of causing Eustachian tube dysfunction. The ultimate goal is to establish guidelines for aural indications of septoplasty in treating Eustachian tube dysfunction-related middle ear disorders. Material and methods This prospective observational study was carried out from 1stJune 2022 to 31st March 2024 in the Department of Otorhinolaryngology at Acharya Vinoba Bhave Rural Hospital, involving 66 patients diagnosed with chronic otitis media and a deviated nasal septum with Eustachian tube dysfunction. Pre-operative and post-operative improvement in Eustachian tube function and Nasal resistance and their correlation werestudied using dynamic slow-motion video endoscopy and active anterior rhinomanometry, respectively. Statistical analysis included the chi-square test. Results Sixty-six patients diagnosed with chronic otitis media and deviated nasal septum with Eustachian tube dysfunction included in this study had a mean age of 35.6 years with 43 (65.2%) male predominance. Gross luminal narrowing and discrepancy of the volume of both nasal cavities led to higher degrees of Eustachian tube dysfunction due to pressure drop on the affected side, as observed in types 6, 7, and 8 as per Jain Bhalerao classification of deviated nasal septum. Nasal resistance measured using active anterior Rhinomanometry (Rhinodebitometry) showed a positive association of severity of nasal resistance in the types 6, 7, and 8 DNS of the Jain Bhalerao classification of deviated nasal septum. It demonstrated an improvement in the grade of Eustachian tube function and nasal resistance post-septoplasty. Conclusion The deviated nasal septum is one of the causes of Eustachian tube dysfunction and increased nasal resistance. Certain types of DNS are adversely associated with the causation of greater degrees of Eustachian tube dysfunction of mechanical type. Nasal septal deviation correction improved Eustachian dysfunction and nasal resistance after septoplasty.

The AMSA® manosonic nebulizer for ENT disease among children in Poland

IntroductionThe AMSA® manosonic nebulizer uses acoustic vibration and a flow of air to create an aerosol from a solution or suspension of a drug. The aerosol created this way is claimed to have enhanced penetration and drug delivery. It is administered under short-term overpressure, meaning that the aerosol is able to penetrate into the middle ear through the Eustachian tube (ET). Purposeof the study: The aim of this study is to identify the active substances used in AMSA® manosonic nebulization for treating common ENT diseases in children aged 2–17 years and to evaluate the overall effectiveness of AMSA® manosonic nebulization in this context. Assessments were done by comparing conditions before and after nebulization using the following tests: (1) Eustachian tube function test, (2) tympanometry, and (3) otoscopy. Material and methodsThis study was a retrospective study with ethics committee consent. 129 children, comprising 56 girls and 73 boys. They were aged between 2 and 17 years, with a mean age of 6.9 years (SD = 3.0). There were 74 children up to 6 years and 55 children over 6 years of age. Children had the following conditions: (1) chronic otitis media with effusion, OME (n = 86), (2) Eustachian tube dysfunction, ETD (n = 34) (3) Other conditions (e.g. cholesteatoma, retraction pocket), (n = 9). Combination of medicines administered in this study was: Budesonide + ambroxol (with or without NaCl), Budesonide (with or without NaCl), Budesonide + N-acetylcysteine (with or without NaCl), Budesonide + hyaluronic acid, Budesonide + ambroxol (with hyaluronic acid), Ambroxol (with or without NaCl). ResultsThe number of nebulizations ordered was between 1 and 20 treatments, but most commonly, pa-tients were given a nebulization series of 10 treatments. This was the case for 80.6 % of the patients. Most patients with OME and ETD had 10 treatments ordered (79 % and 79.5 %, respectively), while all patients with other conditions had 10 treatments. Analysis of the tympanometry results was done in terms of the number of affected ears (not by individual). There were 210 ears with complete tympanometry (both pre and post), including 142 ears with OME, 54 with ETD, and 14 others. Statistically significant changes (improvements) after AMSA nebulizations were found for statistic compliance and middle ear pressure. Otoscopy assessments were done in all ears. The results were abnormal in 155 ears (73.8 %) and normal in 55 ears (26.2 %). After AMSA nebulizations, the number of abnormal results decreased to 117 ears (55.7 %) and normal results were found in 93 ears (44.7 %). ConclusionUse of the AMSA manosonic nebulizer appears to be an effective way of improving chronic medical conditions in children – such as chronic otitis media with effusion and Eustachian tube defect – but only if patient compliance can be achieved. The most frequently used active substance was budesonide, irrespective of whether additional secretolic/mucolytic agent was administered.

How to Disclose Internal Carotid Artery Dehiscence in Patients With Eustachian Tube Dysfunction: Cone Beam Computed Tomography or High-resolution Computed Tomography?

Objective: To compare the prevalence of internal carotid artery dehiscence (ICAD) on high-resolution computed tomography (HRCT) and cone beam computed tomography (CBCT) in patients with Eustachian tube dysfunction (ETD). Study Design: A prospective, cohort study. Setting: The outpatient clinic at the Department of Otorhinolaryngology, Head and Neck Surgery at Gødstrup Hospital, Denmark (tertiary referral center). Patients: Patients &gt;18 years of age diagnosed with long-standing ETD undergoing HRCT and/or CBCT prior to balloon Eustachian tuboplasty. Intervention(s): Patients had either initially HRCT and later CBCT performed (HRCT + CBCT group) or solely CBCT (CBCT group). Main Outcome Measure(s): Prevalence of ICAD assessed with HRCT and CBCT. Results: A total of 23 patients were included in the HRCT + CBCT group and 36 patients in the CBCT group. In the HRCT + CBCT group, ICAD was found in 13 temporal bones (28.3%) with HRCT and 7 temporal bones (15.2%) with CBCT (P = 0.0003). No new cases of ICAD were found with CBCT. In the CBCT group, ICAD was found in 6 temporal bones (8.3%). In both HRCT and CBCT, patients suffered from ETD in 61.5% of the ears where ICAD was found. Conclusions: CBCT has a higher specificity than HRCT in diagnosing ICAD in patients with ETD while at the same time using less radiation.

Intra-operative Measurement of Eustachian Tube Orifice, and Its Correlation With Post-operative Surgical Outcome in Chronic Suppurative Otitis Media Patients.

Background Chronic suppurative otitis media (CSOM) is the inflammation of the middle ear mucosa for more than two weeks, resulting in ear discharge. It is associated with hearing loss and the presence of a perforation in the tympanic membrane. Tympanoplasty is performed to place a graft and clear the disease in the middle ear. Despite adequate disease clearance and proper graft placement, graft failure and disease persistence occur due to Eustachian tube (ET) dysfunction. The ET plays a significant role in the ventilation of the middle ear. Hence, this study was conducted to determine the significance of ET size for post-operative graft uptake. Methodology A total of 55 patients with inactive CSOM were included in the study. Their demographic data were recorded. Patients previously operated on for CSOM, cases with traumatic perforation of the tympanic membrane, congenital anomalies (e.g., cleft lip/cleft palate), and atticoantral disease were excluded. Thorough history taking and examination, including otoscopy and examination of the nose, throat, and oropharynx, were conducted. Once the patient was deemed fit for surgery, they underwent tympanoplasty. Intraoperatively, the ET size was measured using the tip of the suction cannulas. They were followed up after three months to assess graft uptake. Results Out of 55 patients included in the study, 42 (76%) had good graft uptake, while 13 (24%) had defects in graft uptake. Graft uptake failed in patients with an ET diameter of <3 mm. Post-operative graft uptake was observed in the majority of patients with a wider ET diameter, ranging between 3 mm and 6 mm, with a statistically significant p-value of 0.00 (0.05), as determined by Pearson's Chi-square test. Conclusion In our study, we found that there is an association between the ET diameter and post-operative graft uptake. Hence, a wider ET may improve middle ear ventilation and play an important role in post-operative graft uptake.

In-office Eustachian Tube Dilation Reduces Symptoms Among Patients With Barometric Challenges.

Balloon dilation of the eustachian tube has gained ground in the treatment of chronic dysfunction. A new indication for a larger group of patients has emerged, which is characterized by barochallenge only, which affects even more patients. Given the recent validation of the balloon dilation, we set out to explore if this procedure could be useful in treating this specific sub-group of patients in an in-office setting. Balloon dilation was performed using inly nasal cottonoids soaked in 2% tretracainephenylephrine combined with xylocaine nasal spray and lidocaine/prilocaine gel and a mild oral sedative. The effect of eustachian tube balloon dilation on the function of the eustachian tube was evaluated by using the eustachian tube dysfunction questionnaire-7 (ETDQ-7) and a VAS score. The questionnaires were completed beforehand and 3 months and 12 months postoperatively to determine subjective surgical success. Two hundred and forty-six balloon dilation were performed in 132 participants. The results from the ETDQ-7 questionnaire and VAS scores showed a significant improvement in symptoms during pressurization after eustachian tube balloon dilation (p = 0.0001). A mean pain score during procedure in local anesthesia was 3.4 on a scale from 1 to 10. Eustachian tube balloon dilation significantly reduced symptoms of eustachian tube dysfunction during non-physiological pressure, which was determined by ETDQ-7 and Vas scores. Additionally, we found that the procedure is well suited for private practice or the outpatient clinic, using local anesthetics and a mild sedative. 4 Laryngoscope, 2024.

The long-term efficacy and safety of balloon dilation eustachian tuboplasty combined with tympanostomy tube insertion for patients with otitis media with effusion: study protocol for a prospective randomized controlled trial

BackgroundOtitis media with effusion (OME) is a common disease in ear, nose, and throat clinics characterized by aural fullness and hearing loss and mainly caused by eustachian tube dysfunction (ETD). Tympanostomy tube insertion (TTI) is a conventional surgical treatment option that can alleviate symptoms but does not provide a definitive cure, and it is prone to recurrence. Balloon dilation eustachian tuboplasty (BDET) has become a novel procedure for the treatment of ETD, demonstrating significant potential in addressing the aforementioned limitations. However, it is not widely available in the clinic and few high-quality randomized clinical trials was conducted to investigate its long-term efficacy and security in OME. Therefore, the purpose of this study is to verify the efficacy of BDET combined with TTI for patients with OME and its prospects for providing a definitive cure.Methods and analysisThis is a prospective, parallel-group, single-blind, randomized controlled prospective trial. Totally 124 patients with OME will be randomized into either group A or B. Group A will receive conventional therapy (TTI) while group B will use BDET therapy in addition to TTI. Outcome assessments will take place at baseline and at the 3rd, 6th, 12th, and 24th months after surgery. The primary outcome is eustachian tube function, which will be measured by the eustachian tube dysfunction questionnaire (ETDQ-7) and eustachian tube score (ETS). The secondary outcomes include middle ear function, hearing situation, and quality of life, which will be measured by acoustic impedance measurement, pure-tone audiometry, and Chinese-version Chronic Ear Survey (CCES). The main analysis of change in the outcomes will use mixed-model with repeated measures (MMRM) analyses of variance (ANOVAs).DiscussionThis is the first prospective trial in Chinese populations that aims to validate the long-term efficacy and safety of BDET-combined TTI therapy in patients with OME. This parallel-group, single-blind, randomized controlled trial may provide an opportunity to decrease the recurrence rate of OME and explore a definitive cure for patients with OME. This trial’s rigorous design enhances the reliability of the findings, ensuring a robust answer to the research question. In the future, the research team will further expand upon the clinical evidence and applications of the BDET combined therapy.Trial registrationChinese Clinical Trial Registry ChiCTR2400079632. Registered on 8 January 2024, https://www.chictr.org.cn/bin/project/edit?pid=214452.

Genome-wide association study indicates novel associations of annexin A13 to secretory and GAS2L2 with mucous otitis media

To evaluate the genetics of chronic nonsuppurative otitis media (OM). We performed a genome-wide association study of 429,599 individuals included in the FinnGen study using three different case definitions: combined chronic nonsuppurative OM (7034 cases) (included serous and mucous chronic OM), mucous chronic OM (5953 cases), and secretory chronic OM (1689 cases). Individuals without otitis media were used as controls (417,745 controls). We used immunohistochemistry (IHC) of the murine middle ear to evaluate the expression of annexin A13. Four loci were significantly associated (p < 1.7 × 10−8) with nonsuppurative OM. Three out of the four association signals included missense variants in genes that may play a role in otitis media pathobiology. According to our subtype-specific analyses, one novel locus, located near ANXA13, was associated with secretory OM. Three loci (near TNFRSF13B, GAS2L2, and TBX1) were associated with mucous OM. Immunohistochemistry of murine middle ear samples revealed annexin A13 expression at the apical pole of the Eustachian tube epithelium as well as variable intensity of the secretory cells of the glandular structure in proximity to the Eustachian tube. We demonstrated that secretory and mucous OM have distinct and shared genetic associations. The association of GAS2L2 with ciliary epithelium function and the pathogenesis of dysfunctional mucosa in mucous OM is suggested. The abundant expression of annexin A13 in the Eustachian tube epithelium, along with its role in apical transport for the binding and transfer of phospholipids, indicates the role of annexin A13 and phospholipids in Eustachian tube dysfunction.

Endoscopic cartilage underlay myringoplasty with or without balloon Eustachian tuboplasty for chronic perforation with Eustachian tube dysfunction

ObjectiveThe objective of this study was to compare the outcomes of endoscopic cartilage underlay myringoplasty(CNM) with or without balloon Eustachian tuboplasty (BET) for the treatment of chronic perforation with Eustachian tube dysfunction (ETD). Materials and methodsA total of 50 ears diagnosed with chronic perforation and ETD were randomly divided into receiving alone CNM and CNM + BET. During the 12 months follow-up, the Eustachian tube score (ETS), Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7), ET inflammation scale, hearing results and graft success rate of the patients were recorded and analyzed. ResultsThe improvement in the ETDQ-7 score was 6.23 ± 2.51 in the CNM + BET group, which was significantly higher than that in the CNM group (4.22 ± 3.85, P < 0.01) at postoperative 3 months, however, no significant between-group difference was found at post-12 months.The graft success rate was 88.0 % in the CNM group and 92.0 % in the CNM + BET group at postoperative 3 months (P > 0.05). Also, no significant difference was found among two groups (84.0 % vs 88.0 %, P > 0.05).The ABG improvement was 13.16 ± 3.19 dB in the CNM + BET group and 9.74 ± 2.56 dB in the CNM group, with a statistically significant between-group difference (P < 0.01)at postoperative 3 months. However, no significant between-group difference was found at postoperative 12 months. During followup process, neither complications nor patulous symptoms were noted. No patients developted atelectasis or otitis media with effusion. However, myringitis was seen in 8 % patients in the CNM group and 12 % patients in the CNM + BET group. ConclusionsAlthough BET combined with endoscopic cartilage myringoplasty had better short-term improvement of hearing and ETDQ-7 scores compared with endoscopic cartilage myringoplasty for the treatment of chronic large perforation with ETD, the long-term outcomes was not satisfactory. Also, BET did not improve the 3-and 12 months graft success rate.