The Use of Balloon Eustachian Tuboplasty in Patients with Eustachian Tube Dysfunction: A Retrospective Pilot Usage Experience.
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SUBMITTER: Ramakrishnan N
PROVIDER: S-EPMC7374247 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:OBJECTIVES:Balloon Eustachian tuboplasty (BET) is a novel treatment method for Eustachian tube dilatory dysfunction (ETD). However, surgeons cannot identify the insertion depth of the catheter during BET, resulting in potential risks such as internal carotid artery (ICA) injury. Therefore, we developed an image-guided navigation balloon catheter to identify the insertion depth of the catheter and to establish awareness of the proximity of the ICA. This study aimed to evaluate the technical feasibility of this image-guided navigation balloon catheter system in patients with ETD. METHODS:Twenty-nine patients (38 ears; nine bilateral; 21 right ears, and 17 left ears) diagnosed with ETD were assessed. All patients who showed no improvement despite medical therapy with topical steroids, anti-reflux medication, and the Valsalva maneuver for a minimum of 6 weeks received image-guided navigation-assisted BET. The 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score and Valsalva maneuver were used to evaluate patients' symptoms preoperatively and at the postoperative follow-up. RESULTS:Image-guided navigation-assisted BET was safely performed in all patients. The mean total ETDQ-7 score was 25.4±7.1 preoperatively, 17.5±6.2 at 1 month, and 15.2±7.0 at 6 months (P<0.001). In total, a Valsalva maneuver was possible for 28 of 38 ears (73.7%) at the time of the patient's final visit at 6 months post-procedure. CONCLUSION:Image-guided navigation balloon catheters are a potentially valuable tool in patients with ETD. Their use is also technically feasible and safe when performing BET to treat ETD.
| S-EPMC7669314 | biostudies-literature
Project description:ObjectiveTo present the results after balloon eustachian tuboplasty (BET) in patients with obstructive Eustachian tube dysfunction (OETD) grouped up into: baro-challenge, chronic serous otitis media and adhaesive otitis media.MethodsA retrospective study was carried out on patients who underwent BET surgery. As outcome measures, otoscopy, tympanometry, Eustachian tube dysfunction questionnaire-7 (ETDQ-7) and ability to perform the Valsalva manoeuvre were recorded at baseline and at 3, 12 and 24 months after BET. A p value of 0.05 was used to indicate a statistically significant difference for all statistical tests.ResultsThree hundred and nineteen ears (248 patients) were included with a 3-month follow-up, 272 ears had a 12-month follow-up, and 171 ears had 24-month follow-up. Globally, a statistical significance improvement in all groups in all outcome measures was found. According to BET indication, in the baro-challenge group, there was no improvement in otoscopy, but ETDQ-7, Valsalva manoeuvre and tympanogram improved significantly. In the chronic serous otitis media group, otoscopy, ETDQ-7 and Valsalva manoeuvre were significantly improved in all the three timelines, including the avoidance of a new transtympanic tube after the BET in over 80% of cases. In the adhaesive otitis media group, Valsalva manoeuvre improved significantly, ETDQ-7 decreased and tympanogram improved but not significantly. Few mild complications were reported.ConclusionsBET is an effective method for the treatment of OETD in all etiologic groups. The greatest benefit was observed in patients with baro-challenge. A long-term follow-up is recommended since the benefit seems to increase over time.
| S-EPMC10382357 | biostudies-literature
Project description:Obstructive Eustachian tube dysfunction (OETD) is a common condition resulting from inadequate opening of the Eustachian tube (ET). A new surgical treatment involves high-pressure inflation of a balloon within the ET, with the aim of dilating the soft tissue structure. However, the mechanical effects of this intervention have not been established, nor the impact of changing device size or other technical parameters. A novel experimental technique allowed quantification of plastic and elastic tissue deformation in model materials and then human cadaver ETs during balloon dilation, based on the measured balloon inflation pressure-volume relationship. Plastic tissue deformation was found to be greater using larger balloons and deeper device insertion, but increasing the inflation pressure had a more limited effect, with most deformation occurring well below the clinically used pressures. Histological assessment of ET tissue suggested that mucosal tearing and cartilage cracking were in part responsible for the mechanical changes. Balloon dilation of the ET has huge potential if found to be clinically effective, but currently there is a need to understand and develop the technique further. The novel methods employed in this study will be valuable in future laboratory and in vivo studies of ET balloon dilation. Pressures are reported in Bar as this unit is used for medical balloon dilation procedures in clinical practice. 1 Bar = 100,000 Pa. Graphical abstract caption Dilation of the Eustachian tube for obstructive dysfunction is performed clinically with 3- and 6-mm-diameter balloons of approximately the same overall length. Our data suggest that dilation with a 6-mm balloon causes greater deformation of the soft tissue structure than dilation with a 3-mm balloon. This difference has yet to be demonstrated clinically. Plastic deformation was measured in terms of energy (J) dissipated during balloon inflation.
| S-EPMC7156363 | biostudies-literature
Project description:ObjectiveTo perform a systematic review to determine if a total score of ≥14.5 (mean score ≥ 2.1) on the ETDQ-7 accurately identifies patients with obstructive Eustachian tube dysfunction (OETD) on impedance tympanometry (peak compliance <0.2 mL or middle ear pressure of -100 daPa) or other objective measures of OETD.MethodsA systematic review without a meta-analysis was performed of studies in four electronic databases (Pubmed, Embase, Web of Science, and Scopus) that used the ETDQ-7 and at least one objective measure of OETD.ResultsSix-hundred and fifty-two studies were identified in the initial literature search. Abstracts from 337 studies were screened, followed by full-text review of 61 studies, and qualitative synthesis of 12 studies. Tympanometry was used as an objective measure in ten studies. Eight of the 12 included studies had patient cohort selection bias. Eight studies administered the ETDQ-7 in cohorts of patients with or without OETD, already confirmed on tympanometry, and found a sensitivity of 91%-100% and specificity of 67%-100%. Four studies administered the ETDQ-7 to patients who had not previously undergone objective testing and found a sensitivity of 49%-80% and specificity of 24%-78%.ConclusionsThe ETDQ-7 is an important patient-reported outcome measure. However, based upon existing literature, the ETDQ-7 appears limited as a diagnostic tool for OETD or as an objective measure of Eustachian tube function.
| S-EPMC8356874 | biostudies-literature
Project description:ObjectiveIn patients with cleft palate, a high incidence of chronic obstructive Eustachian tube dysfunction (ETD) is assumed after surgery. Consequently, an increased rate of retracted eardrum or cholesteatoma is expected. Even though no common standard for investigating ETD is available, the development of objective tests has increased during the past 10 years. This study aimed to investigate the incidence of persisting chronic obstructive ETD in adult patients with cleft palate surgically treated in early childhood by using a combination of diagnostic tools.MethodsAdult participants with cleft palate repair in early childhood were invited for a follow-up examination and compared to a control group. Examination included tympanometry, tubomanometry, the Eustachian Tube Dysfunction Questionnaire (ETDQ-7), and the Eustachian Tube Score 7 (ETS-7).ResultsA total of 16 adult patients were re-examined after cleft palate surgery and compared to a control group of 40 healthy individuals. Significant differences were found in the median ETS‑7 (p < 0.0001) score but not in the median ETDQ‑7 (p = 0.09) score. Only 2 of the 32 investigated ears (6%) had pathologic scores in ETS‑7 and ETDQ‑7 (p = 0.09), whereas 5 (31%) cleft palate patients showed symptoms of chronic obstructive ETD according to ETS‑7. No patient had examination findings indicating a requirement for further treatment.ConclusionBy combining diagnostic tools for ETD, a lower rate of persisting obstructive ETD in adults after cleft palate surgery was found than previously reported. Successful surgical treatment of cleft palate seems to lead to physiological Eustachian tube function in long-term follow up.
| S-EPMC9242949 | biostudies-literature
Project description: Not available
| S-EPMC10809091 | biostudies-literature
Project description:BackgroundObstructive eustachian tube dysfunction is a common pathology, generally accepted as the underlying cause for chronic ear diseases. Eustachian tube dilation has shown promising results in randomized controlled trials, but is a costly procedure. The aim of the current study was to assess the feasibility of transnasal balloon dilatation of the eustachian tube with an endovascular balloon in the context of ease of use, maneuverability, and safety.MethodsClinical pilot study carried out at a university tertiary care facility. In total, twelve patients, were included over a period of 6 months. All patients underwent tympanoplasty or tympanomastoidectomy surgeries. Eustachian tube dilation was carried out transnasal using an endovascular balloon. A computed tomography was carried out after surgery to assess for any potential damages and compared to preoperative imaging studies. Postoperative endoscopy was performed intraoperatively and at follow up to assess for any potential damages.ResultsAll eustachian tube dilations were carried out successfully. No severe adverse events were noted during the procedure, in the postoperative period, or on imaging studies. Minor adverse events such as mild intraoperative bleeding was managed in a routine fashion.ConclusionsBalloon dilation of the eustachian tube with the endovascular balloon was feasible and safe in all cases. It is likely a more cost-effective alternative to commercially available balloons with similar designs and specifications. Trial registration The study was registered at clinicaltrials.gov; NCT04809753, initial release February 24th, 2021.
| S-EPMC9976517 | biostudies-literature
Project description:To assess the safety and efficacy of navigation-guided balloon Eustachian tuboplasty (BET) compared to medical management (MM) alone in patients with chronic Eustachian tube dilatory dysfunction (ETD). This is a prospective, multicenter, 1:1 parallel-group, randomized controlled trial (RCT). It aims to assess the efficacy of navigation-guided BET compared to MM alone in patients with chronic ETD. The primary outcome measure was an improvement in the Eustachian tube dysfunction questionnaire (ETDQ)-7 score at the 6-week follow-up compared with baseline. Secondary outcome measures included changes in the signs and symptoms during the follow-up, changes in the score for each subcategory of ETDQ-7, type of tympanometry, pure tone audiometry, and the availability of a positive modified Valsalva maneuver. Navigation-guided BET was safely performed in all patients. A total of 38 ears of 31 patients (19 ears of 16 patients in the BET group and 19 ears of 15 patients in the control group) completed the planned treatment and 6 weeks of follow-up. More patients in the BET group (1.99 ± 0.85) had less symptomatic dysfunction than in the control group (3.40 ± 1.29) at 6 weeks post-procedure (P = 0.001). More patients experienced tympanogram improvement in the BET group at 6 weeks compared to the control group (36.5% vs. 15.8%) with a positive modified Valsalva maneuver (36.6% vs. 15.8%, P = 0.014). Additionally, air-bone gap change was significantly decreased in the BET group compared to the control group at the 6-week follow-up visit (P = 0.037). This prospective, multicenter, RCT study suggests that navigation-guided BET is a safe and superior treatment option compared to MM alone in patients with chronic ETD.
| S-EPMC8639820 | biostudies-literature
Project description:OBJECTIVE:Compare Eustachian tube balloon dilation versus continued medical therapy (control) for treating persistent Eustachian tube dysfunction (ETD). STUDY DESIGN:Prospective, multicenter, randomized controlled trial. SETTING:Tertiary care academic center and private practice. PATIENTS:Diagnosed with medically refractory persistent ETD. INTERVENTIONS:1:1 Randomization to balloon dilation or control. After 6 weeks, control participants had the option to undergo balloon dilation if symptoms persisted. MAIN OUTCOME MEASURES:Primary efficacy endpoint was the comparison between treatment arms in the mean change from baseline in the 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score. Primary safety endpoint was complication rate. RESULTS:Sixty participants were randomized (31 balloon dilation, 29 control). Mean (SD) change in overall ETDQ-7 score at 6 weeks was -2.9 (1.4) for balloon dilation compared with -0.6 (1.0) for control: balloon dilation was superior to control (p?<?0.0001). No complications were reported in either study arm. Among participants with abnormal baseline assessments, improvements in tympanogram type (p?<?0.006) and tympanic membrane position (p?<?0.001) were significantly better for balloon dilation than control. Technical success was 100% (91 successful dilations/91 attempts) and most procedures (72%) were completed in the office under local anesthesia. Improvements in the ETDQ-7 scores were maintained through 12 months after balloon dilation. CONCLUSIONS:Balloon dilation is a safe and effective treatment for persistent ETD. Based on improved ETDQ-7 scores, balloon dilation is superior to continued medical management for persistent ETD. Symptom improvement is durable through a minimum of 12 months. Procedures are well tolerated in the office setting under local anesthesia.
| S-EPMC6075883 | biostudies-literature
Project description: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 .
| S-EPMC11363521 | biostudies-literature