Balloon Dilation Eustachian Tuboplasty 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.

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.

Balloon dilation of the eustachian tube using endovascular balloon under local anesthesia-a case series and systematic literature review.

To report a novel technique in Balloon Dilation of Eustachian Tube (BDET) using an endovascular balloon (EVB), in a prospective cohort. The results are compared with reported outcomes using standard balloons. Demographic information and clinical parameters were collected prospectively fora series of patients with obstructive eustachian tube dysfunction (OETD). Balloon dilation Eustachian tuboplasty was performed under local anesthesia in a tertiary referral center, using the EVB. Systematic literature review was used for comparison, using Medline via "PubMed", "Embase", and "Web of Science". Eight OETD candidates (12 ears) were enrolled; 5 males and 3 females. Average age was 48 (range -23 to 63) years. The most common presenting symptom was aural fullness (9/12), followed by ear pressure (7/12), hearing loss (5/12) and tinnitus (4/12). Otoscopically, tympanic membrane retraction was evident in 10/12 ears, the majority of which was class II-Sade classification. Pre-operative tympanogram was type B and C in 7 and 5 ears, respectively. All BDETs were performed without complications. Post-operative tympanometry was A in 8/12 ears. Post-operatively, Eustachian Tube Dysfunction Questionnaire-7 results reduced to within normal limits (average score ≤3) in 11/12 ears (p = 0.0014). The systematic literature review included 6 papers (193 patients, 262 ETs) with comparable results, most also with little adverse effects. BDET using an EVB is a safe and effective option for OETD. It is well tolerated under local anesthesia in properly selected individuals. The reduced procedural cost may be an important factor in certain healthcare jurisdictions.

Balloon Dilation Eustachian Tuboplasty for Dilatory Dysfunction With and Without Effusion: A Comprehensive Outcome Analysis.

This study aimed (1) to demonstrate the efficacy of balloon dilation Eustachian tuboplasty (BDET) for dilatory Eustachian tube dysfunction (ETD) and (2) to determine whether adjunctive ventilation tube insertion (VTI) is superior to myringotomy in relieving symptoms for patients with ETD and concurrent middle ear effusion (MEE) treated with BDET. A retrospective cohort study. Tertiary care academic center. Patients with dilatory ETD undergoing BDET with a≥6-month follow-up period were enrolled and evaluated mainly using Eustachian tube function (ETF) tests and Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7). Participants with concurrent MEE were further classified into 2 subgroups, BDET with VTI and BDET with myringotomy. An intergroup comparison and comprehensive outcome evaluation were performed. In total, 35 patients with 50 symptomatic ears were enrolled. According to ETF test results, the normalized ETF rate was 94% on the last visit. The mean ETDQ-7 scores decreased significantly from 3.7 ± 1.4 to 2.0 ± 0.9 after interventions, with the most improvement in symptoms occurring for "ear fullness" and "muffled hearing." For the final visit, strong correlations among ETF tests, tympanometry, and Valsalva results were noted. The aforementioned assessment results did not significantly differ between (1) the patients with MEE and patients without MEE and (2) "BDET with VTI" subgroup and "BDET with myringotomy" subgroup. BDET was effective for dilatory ETD, even in cases with concurrent MEE. For patients with ETD and MEE, further research is required to evaluate the benefits of adjunctive myringotomy with or without VTI.

A Systematic Review of Eustachian Tube Procedures for Baro-challenge Eustachian Tube Dysfunction.

To examine the effectiveness of Eustachian tube procedures for the treatment of baro-challenge Eustachian tube dysfunction. Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, databases, including PubMed (National Library of Medicine, National Institutes of Health), Scopus (Elsevier), and CINAHL (EBSCO), were searched for articles examining the effectiveness of Eustachian tube procedures for baro-challenge Eustachian tube dysfunction. Outcome measures included symptom resolution, ability to return to work, equalization problems (EP) scores, Eustachian Tube Dysfunction Questionnaire (ETDQ-7) scores, and pressure chamber testing parameters. Pooled meta-analysis was performed for dichotomous measures and ETDQ-7 scores. Eleven articles with 81 patients were included. Seventy-two patients from 10 articles underwent balloon Eustachian tube dilation; nine patients in 1 study underwent laser Eustachian tuboplasty (LET). All 81 patients were preoperatively symptomatic with barometric pressure change, and 26/30 (86.7%) were unable to work due to symptoms. On meta-analysis, after balloon dilation Eustachian tuboplasty (BDET), 82.5% (n=30 [95% confidence interval: 42%-100%]) had improvement in ability to valsalva, 79.1% (n=16 [57.9%-94.1%]) in ability to return to work, and 84.3% (n=69 [69.8%-94.7%]) in any symptom. Of 25 patients with individual ETDQ-7 scores, 79.1% [51.4, 96.9] had improvements after BDET. For four case series with 36 patients, ETDQ-7 scores decreased by 1.2 [0.7, 1.7] (p < 0.00001). Of 20 patients with preoperative ETDQ-7 scores >2.0, there was a mean decrease of 2.1 [1.3, 2.8] (p < 0.00001). From the available evidence, Eustachian tube procedures appear to be effective at improving symptoms of baro-challenge Eustachian tube dysfunction. However, higher quality evidence is needed to support making definite recommendations for the use of balloon Eustachian tube dilation or LET for these patients. Laryngoscope, 132:2473-2483, 2022.

Balloon dilation eustachian tuboplasty for dilatory dysfunction: Safety and efficacy analysis in an Australian cohort

Eustachian tube dysfunction (ETD) is a common clinical condition encountered by otolaryngologists. The severity and duration of symptoms range from the mild and transient to the chronic and severe along with secondary pathologies. Balloon dilation eustachian tuboplasty (BDET) as a treatment, was first described in 2010 and has been studied extensively. This study evaluates the efficacy and safety of BDET in an Australian cohort. Retrospective chart review on all patients who underwent BDET from September 2016 to March 2020 was performed. The Eustachian Tube Dysfunction Patient Questionnaire (ETDQ-7) was chosen as the primary outcome measure. Secondary outcome measures included subjective global assessment of presenting symptoms, ability to perform Valsalva maneuver and tympanometry. Any complications related to the procedures were reported. One hundred and nineteen eustachian tube operations were included in this study. The patient cohort showed statistically significant improvement of mean EDTQ-7 score from 0.7 to 2.9. Improvement in EDTQ-7 was achieved in 83.9% of the cases. All patients in the baro-challenge-induced subgroup achieved improvement in ETDQ-7 score. Complete resolution of symptoms with an ETDQ <2.1 was achieved in 37.1% of the cohort. There were no adverse safety events associated with the procedures. BDET resulted in improvement of the EDTQ-7 score in most of patients in this Australian cohort with no reported complications. BDET was most successful in baro-challenge-induced subgroup with universal improvement. Lower success rates were seen in patients with secondary pathology from their ETD.

Indications for Eustachian tube dilation.

Eustachian tube dilation is a controversial surgical procedure because the intended problem for which it is meant to address, obstructive Eustachian tube dysfunction, is a clinical diagnosis without a reliable diagnostic tool to test.In the past 10 years, balloon dilation Eustachian tuboplasty (BDET) has been the most commonly performed Eustachian tube dilation procedure. The present review seeks to identify the patients who may benefit from this procedure and thus propose the indications. Two randomized controlled trials for BDET published in the past 2 years showed statistically significant improvement in terms of symptomatic relief based on the ETDQ-7 scores and conversion of abnormal tympanograms (type B and type C) to normal tympanograms (type A). Based on the review of the evidence available so far, the proposed indication for Eustachian tube dilation using BDET is for a patient with ALL of the following: aural fullness greater than 12 weeks; type B or C tympanogram; ETDQ-7 mean score more than 2; and failed medical management including Valsalva maneuver and either 4 weeks of nasal steroids or 1 week of oral steroids.

Effect of balloon dilation eustachian tuboplasty combined with tympanic tube insertion in the treatment of chronic recurrent secretory otitis media.

To investigate the long-term clinical effect of balloon dilation eustachian tuboplasty (BET) combined with tympanic tube insertion (TTI) in the treatment of chronic recurrent secretory otitis media (CRSOM). A retrospective study of 30 cases of CRSOM treated with BET combined with TTI under general anesthesia between August 2014 and September 2016. Thirty cases of CRSOM treated with TTI in the same period were taken as the control group. All cases were followed over 24months. The scores of eustachian tube (ET) function preoperation, 1month, 6months, 12months, and 24months postoperation were collected and analyzed, respectively. A satisfaction questionnaire was used to evaluate the therapy at 24-months postoperation. The symptoms were significantly improved and the ET score was obviously increased postsurgery in most cases treated with BET plus TTI compared with those treated with TTI alone. The highest ET score was obtained at 6months post BET. Five (14%) cases (6 ears) of CRSOM recurred. The 24-month postoperation follow-up questionnaire showed that 84.6% of the patients were satisfied with the treatment, while ten cases (25%) in the TTI group recurred. BET combined with TTI surgery is an effective therapy for patients with CRSOM.

Balloon dilation of Eustachian tube combined with tympanostomy tube insertion and middle ear pressure equalization therapy for recurrent secretory otitis media

ObjectiveTo report outcomes of balloon dilation Eustachian tuboplasty combined with tympanostomy tube insertion and middle ear pressure equalization therapy in treatment of recurrent secretory otitis media. MethodsFifty one patients with recurrent secretory otitis media (62 ears) underwent balloon dilation of Eustachian tube and tympanic tube insertion under general anesthesia, followed by long term middle ear pressure equalization therapies. The Eustachian tube score (ETS) and Eustachian tube function questionnaire (ETDQ-7) were used for pre- and postoperative (up to 12 months) evaluation of Eustachian tube functions. ResultsThe mean ETS score was 2.34 ± 0.97 preoperatively, and 6.17 ± 1.54, 7.23 ± 1.62, 8.24 ± 1.97, and 7.63 ± 1.86 at 1, 3, 6 and 12 months postoperatively, respectively (P < 0.05). The ETDQ-7 score was 4.82 ± 1.07 preoperatively, and 2.20 ± 0.54, 2.32 ± 0.68, 2.53 ± 0.79, and 2.67 ± 0.76 at 1, 3, 6 and 12 months postoperatively, respectively (P < 0.05). ConclusionBalloon dilation of Eustachian tube combined with tympanostomy and catheterization resulted in significant improvement of subjective symptoms and objective evaluation of Eustachian tube functions in most patients with recurrent secretory otitis media, as indicated by the ETS and ETDQ-7 scores, demonstrating high levels of efficacy and patient satisfaction.

Investigation of balloon dilation devices for treatment of Eustachian tube dysfunction

Abstract The presented three different balloon dilation devices for treating Eustachian tube dysfunction were compared regarding their geometries and designs. The balloon dilation behaviour was investigated by an in vitro test setup consisting of a test chamber with 37 °C water, a 2-axis laser scanner and a pressure controller. All balloons could be properly dilated up to the given nominal pressure (NP) or to rated burst pressure (RBP). The balloons reached their expected balloon diameter and length. The compliance data were 1.07 %/atm (TubaVent short), 1.16 %/atm (Acclarent Aera) and 1.28 %/atm (XprESS LoProfile). The measured profile and compliance data can be used for development of new devices for balloon dilation Eustachian tuboplasty.

Preliminary exploration for recurrent secretory otitis media treatment by balloon dilation Eustachian tuboplasty combined with tympanotomy tube insertion

Preliminary exploration for recurrent secretory otitis media treatment by balloon dilation Eustachian tuboplasty combined with tympanotomy tube insertion

The efficacy of the Eustachian Tube Dysfunction Questionnaire (ETDQ-7) for patulous Eustachian tube patient

Objective: To assess the efficacy of the Eustachian Tube Dysfunction Questionnaire (ETDQ-7) for patulous Eustachian tube (PET) patients.Methods: A prospective survey of medical records identified 36 patients and 47 ears with PET, and 15 patients and 15 ears as control. The ETDQ-7, patulous Eustachian tube handicap inventory-10 (PHI-10) and Likert scale were evaluated. PET patients were divided into two groups based on severity of symptoms using the PHI score.Results: The Cronbach α value of the PET group was 0.765. The average total score of the ETDQ-7 in the control group was 7.6 ± 1.1 and 22.5 ± 10.0 in the PET group (p < .01). No correlation was found between ETDQ-7 and Likert scale (r = 0.248, p = .09). The average total score of the ETDQ-7 in the mild or moderate PET group was 19.9 ± 9.0 and 25.3 ± 11.1 in the severe PET group and this was not statistically different (p = .08).Conclusion: The highest ETDQ-7 score was also observed in PET patients and in ET dysfunction patients. These findings necessitate careful discrimination between ET dysfunction and PET in balloon dilation Eustachian tuboplasty (BET) based on ETDQ-7.

Balloon Eustachian tuboplasty treatment of longstanding Eustachian tube dysfunction.

Eustachian tube dysfunction is a poorly defined condition associated with various symptoms and it can predispose to middle-ear disease. Balloon dilation Eustachian tuboplasty has been proposed as a treatment for Eustachian tube dysfunction. To evaluate the subjective and objective outcomes of balloon dilation Eustachian tuboplasty in patients with recurrent, previously treated chronic Eustachian tube dysfunction. The study was conducted on 11 patients (13 ears) who had undergone previous unsuccessful medical and surgical treatment. Tympanometry was the primary outcome measure. Secondary outcome measures included pure tone audiogram assessment and seven-item Eustachian Tube Dysfunction Questionnaire score. Balloon dilation Eustachian tuboplasty resulted in significant improvements in 11 patients' subjective but not objective outcome measures. The objective abnormality and subjective symptoms in Eustachian tube dysfunction may represent two distinct pathological processes, which may nevertheless influence and exacerbate each other.

The clinical application of balloon dilation Eustachian tuboplasty in patients with Eustachian tube dysfunction

Objective:To evaluate the clinical application of balloon dilation Eustachian tuboplasty (BET) in patients with Eustachian tube dysfunction (ETD). Method:Twenty-five patients who were diagnosed as ETD and reserved BET surgery were retrospectively analyzed in this study. Result:After 1-year's follow-up, among 25 ETD patients, the total cure rate was 55.9% and the effective rate was 85.3%. The cure rate and effective rate was 52.9% and 76.5% in the delayed opening of the ET group; 58.8% and 94.1% in the unopened group, which was higher than the other one. Conclusion:BET surgery is safe and effective in the treatment of BET patients.

Clinical evaluation of balloon dilation eustachian tuboplasty surgery in adult otitis media with effusion

Conclusion: BDET might be effective for the patients with OME, and proved to be an efficacious and mini-invasive treatment for OME. Objectives: To evaluate the therapeutic benefits of balloon dilation eustachian tuboplasty (BDET) in the treatment of adult patients with otitis media with effusion (OME) caused by eustachian tube dysfunction (ETD). Methods: After informed consent, eight adult patients with OME were included in this study. After investigated patients’ case history and oto-function, all patients underwent BDET treatment. Then four criteria including tympanic membrane, pure tone audiometry (PTA), tympanometry, and subjective symptoms were adopted to evaluate the therapeutic benefits of BDET. Results: None of the involved patients complained of problems or complications during the post-operative period, or with absence of pain and bleeding after the operation. Prominent post-operative improvement was observed in tympanic membrane and otoscopic appearance. In addition, cure rates after 3 months and 6 months post-operatively were gradually increased.

Clinical evaluation of balloon dilation Eustachian tuboplasty in the Eustachian tube dysfunction

The development of minimally invasive procedures such as the balloon dilation Eustachian tuboplasty (BET) is an alternative to the grommet tympanum membrane. BET is applied in the cases where, after elimination of all factors influencing the ET and middle ear functioning, no sufficient improvement is observed. The aim of this study was to present the therapeutic benefits of the BET method in the treatment of ETD caused by disorders in the middle ear ventilation. The BET procedure was offered to four patients (3 men and 1 woman) after subjective, physical, otorhinolaryngological and audiometric examinations including pure tone audiometry, tympanometry and pressure-swallow test. As the method was novel, preinterventional CT angiography of the carotid arteries was performed in all patients. Any complications were noticed during and after the procedure (bleeding or damage of regional mucosa) in any patients. Our clinical studies assessed the feasibility and safety of the BET during a short-term period—only a 6-week observation. Although patients revealed a significant improvement of ET score, longer long-term studies are necessary to determine whether this method will demonstrate lasting benefits and safety in the treatment of chronic Eustachian tube dysfunction. In other investigations, improvement was found to be time dependent.

Eustachian tube balloon dilation surgery

Eustachian tube dysfunction (ETD) is a common condition without an effective, accepted treatment. Balloon dilation Eustachian tuboplasty (BDET) has been recently proposed for the management of ETD. Previous studies of Eustachian tube function and treatment have not included a validated assessment of patient symptoms. We report for the first time the outcomes of BDET using a validated disease-specific symptom score, the 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7). Consecutive patients undergoing BDET were prospectively enrolled from an otolaryngology practice at a tertiary care medical center. Inclusion criteria were adults with a diagnosis of ETD based on symptoms and abnormal tympanogram. Patients with craniofacial abnormalities or active infection were excluded from study. Primary outcome measures included the ETDQ-7 score, tympanometry, and otoscopic appearance. Secondary measures included the 22-item Sinonasal Outcome Test (SNOT-22) score. Twenty-two consecutive patients underwent 35 BDET procedures. Significant postoperative improvement was seen in tympanometry and otoscopic appearance (p < 0.001). ETDQ-7 scores at 3 weeks, 6 weeks, 12 weeks, and 6 months postoperatively were significantly improved over baseline (p < 0.001). ETDQ-7 scores showed fair correlation with SNOT-22 scores (r > 0.65). ETDQ-7 change scores demonstrated good responsiveness and sensitivity to clinical change following BDET. BDET is an effective surgical intervention for the treatment of ETD in adults. Postoperative improvements were observed using objective and subjective measures. The ETDQ-7 is a valid, disease-specific instrument for the assessment of treatment outcomes and may be applied for clinical use in patients with ETD. Further study is necessary to determine long-term effectiveness.

Balloon Dilation Eustachian Tuboplasty

To assess the feasibility and safety of balloon dilation Eustachian tuboplasty (BET) as an option for treatment of patients with Eustachian tube dysfunction. A cadaveric study of 5 temporal human bones was performed. Each bone underwent transnasal balloon dilation Eustachian tuboplasty (BET) with computed tomography and post-dilation histology. The procedure involved the dilation of the cartilaginous and bony portion of the Eustachian tube with a balloon catheter. BET is technically easy to perform. No damage to essential structures, particularly the carotid canal, was found. This newly introduced method seems to be a feasible and safe procedure to dilate the Eustachian tube.