A multicenter, randomized, active-controlled, clinical trial study to evaluate the efficacy and safety of navigation guided balloon Eustachian tuboplasty

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.

Technical Feasibility and Histological Analysis of Balloon-Expandable Metallic Stent Placement in a Porcine Eustachian Tube

There is a clinical need to develop a stent to treat obstructive and refractory Eustachian tube dysfunction (ETD) after balloon Eustachian tuboplasty. An animal model for stent placement in the Eustachian tube (ET) is needed to develop optimal designs and materials, as stents for ETD have not been clinically applied. The purpose of this study was to evaluate the technical feasibility of stent placement and histological changes in a porcine ET model. Six ETs were evaluated in three pigs. Cobalt–chrome alloy stents with two different diameters were placed in the left and right ET of each animal (right, 3.5 mm; left, 2.5 mm). The outcomes were assessed by endoscopic and fluoroscopic imaging during the procedure, computed tomography after the procedure, and by histological examinations. Stent placement was technically successful in all specimens after metallic guiding sheaths were located in the nasopharyngeal end of the ET. The mean luminal diameters of the proximal, middle, and distal portions of the larger stents in the right ETs were 3.48 mm, 2.54 mm, and 2.15 mm, respectively. In the left ETs using smaller stents, these values were 2.49 mm, 1.73 mm, and 1.42 mm, respectively. The diameters of the inserted stents differed by stent location and the original diameter. Histological findings showed tissue hyperplasia with severe inflammatory cell infiltration at 4 weeks after stent placement. In conclusion, stent placement into the porcine ET was technically feasible, and stent-induced tissue hyperplasia was significantly evident. The luminal configuration of the placed ET stent changed according to its non-elastic nature and anatomical features of the porcine ET. Using this model, ET stents of various materials and designs with anti-inflammatory or anti-proliferative drugs can be optimized for future treatments of ET dysfunction.

Effect of Balloon Eustachian Tuboplasty in Adults That Only Have Symptoms of Chronic Eustachian Tube Dysfunction, With a 1-Year Follow-Up: Prospective Clinical Trial

Objectives: Balloon eustachian tuboplasty (BET) is a promising therapeutic option for eustachian tube (ET) dysfunction. However, data are lacking on the effect of BET in adults with symptoms of chronic ET dysfunction but without a contributing pathology. This study investigated the effect of BET in adult patients with only symptoms of chronic ET dysfunction. Methods: This prospective clinical trial included adult patients with aerated physiological middle ears and symptoms of ET dysfunction for more than 6 months. Compliance with follow-up was 93.3%. We evaluated the effects of BET with tympanometry, assessment of the Valsalva or Toynbee maneuver with tympanometry verification, a Eustachian Tube Dysfunction Questionnaire (ETDQ-7), and pure-tone audiometry. Data were recorded 1 day before surgery and 2, 6, and 12 months after BET. Therapy was considered successful when the patient exhibited a newly acquired ability to perform the Valsalva or Toynbee maneuver or when the ETDQ-7 score improved by 20% or more. Results: We included 14 ears in the analysis. After 2, 6, and 12 months, therapy was successful, according to the ETDQ-7, in 11/14 (78.6%; 95% CI: 48.8-94.3), 13/14 (92.9%; 95% CI: 64.2-99.6), and 12/14 (85.7%; 95% CI: 56.2-97.5) ears, respectively. These results were statistically significant. The ETDQ-7 scores also significantly decreased at 2, 6, and 12 months after the BET, when any change was observed. All patients experienced improvement. Only 1 patient reported temporary deterioration after 2 months. Treatment was more frequently successful in patients without nasal polyps or pollinosis. Conclusions: Adults with only symptoms of chronic ET dysfunction benefitted more and had longer lasting results from BET, compared to patients with pathologies caused by ET dysfunction. Balloon eustachian tuboplasty could be recommended for these patients.

Efficacy of balloon Eustachian tuboplasty as a first line treatment for otitis media with effusion in children

Objective This study aimed to compare the outcomes of ventilation tube insertion and balloon Eustachian tuboplasty as a first line treatment for otitis media with effusion in children. Method This was a retrospective evaluation of 62 children, 30 cases that underwent balloon Eustachian tuboplasty (group 1) and 32 cases that underwent ventilation tube insertion (group 2), from July 2016 to April 2018. Results The pre-operative air–bone gap of patients who underwent balloon Eustachian tuboplasty was 15–35 dB (mean: 27.6 ± 8.2 dB). The mean pre-operative air–bone gap decreased to 9.6 dB after a mean of 14.4 months (p < 0.05). The air–bone gap decreased from 25.6 dB to 17.6 dB in the ventilation tube group. There was a significant improvement in the air–bone gap values in both groups; however, this decrease was significantly higher in the balloon Eustachian tuboplasty group (p = 0.043). Conclusion Balloon Eustachian tuboplasty may be an effective and safe method for use as a first-line treatment of otitis media with effusion in children.

Balloon eustachian tuboplasty for patients with chronic eustachian tube dysfunction: a novel method for Iranian samples

Background and Aim: Balloon eustachian tub­oplasty (BET) is a recently developed and app­roved method for management of chronic eus­tachian tube dysfunction (ETD). In the present study we aimed to evaluate the safety and effi­cacy of this method in Iranian samples. Methods: In this prospective case-series study, we included 15 adult patients with chronic ETD who were resistant to previous medical manage­ments and/or ventilation tube use. All patients underwent baseline audiometry (pure tone audio­metry and tympanometry), Valsalva maneuver, EDT questionnaire-7 (ETDQ-7), and physical examination. Three to six months after the BET procedure, all patients underwent four evaluation methods again. Results: We found a significant improvement in the mean ETDQ-7 scores comparing pre- and post-test scores (p < 0.0001). There was also a statistically significant decrease in the average air-bone gap from 40.55 at baseline to 27.22 after treatment (p < 0.001). In the Valsalva test, 17 out of 18 study ears (92.3%) had a positive result after the surgery. Under tympanographic evalu­ation, 9 ears (50%) reported a conversion from type B to type A after treatment, 2 ears (11%) had a conversion from type B to C, and 7 ears (39%) showed no any change and stayed in type B after BET. Conclusion: As a novel method in Iran, BET can be an alternative safe treatment option for chro­nic ETD. Keywords: Balloon eustachian tuboplasty; eustachian tube dysfunction; Iranian

Navigation-Assisted Balloon Eustachian Tuboplasty for Eustachian Tube Dilatory Dysfunction

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 (<i>P</i><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.