A multicenter, randomized, active-controlled, clinical trial study to evaluate the efficacy and safety of navigation guided balloon Eustachian tuboplasty
Sung‐Won ChoiSe‐Joon OhYehree KimMin Young KwakMyung‐Whan SuhMoo Kyun ParkChi-Kyou LeeHong Ju ParkSoo‐Keun Kong
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Abstract 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.Keywords:
Eustachian tube
Valsalva maneuver
이관(Eustachian tube)은 뼈, 연골, 주위 근육 및 지 방조직으로 구성되어 있다. 정상적인 이관은 안정시에 닫혀있고 침을 삼키거나 하품을 하는 동작과 valsalva maneuver 등을 통해 열리게 된다. 이관의 연골부가 평 상시에도 비정상적으로 계속 열려 있게 되면 비인강과 중이강 사이를 자유롭게 공기와 소리가 들락거리면서 자 가강청(autophonia), 자신의 호吾음 청취, 이중만감 등 의 증상이 나타나게 되는데 이를 개방성 이관(Patulous Eustachian tube)으로 정의할 수 있다.
Eustachian tube
Valsalva maneuver
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Abstract Objectives: There is no study in the literature that patients with clinically-proven PET were evaluated by Valsalva CT. We aimed to evaluate the merit of Valsalva computed tomography (CT) in patients who had clinically-proven patulous Eustachian tube (PET). Design: Case-series Setting and participants: We recruited patients with clinically-proven PET. Participants: Main outcome measures: All participants underwent temporal bone CTs while they were performing the Valsalva maneuver in the supine position. Standard axial plane CT images, along with multiplanar reconstruction and 3D Air volume rendering, were used to visualize the ET in its entirety. Results: Three patients (2 females, one male) with a total of 6 ears were included in the study. All patients had suggestive symptoms of PET, including aural fullness, aerophony, and autophony and underwent clinical examination and audiologic tests. In all ears, the whole Eustachian tube could be visualized with Valsalva CT. Conclusion: For the first time, we demonstrated the merit of Valsalva CT in visualization of the Eustachian tube in its entirety in patients with clinically diagnosed PET.
Valsalva maneuver
Eustachian tube
Supine position
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Assess the feasibility of using the Valsalva maneuver to visualize the cartilaginous eustachian tube lumen with computed tomography (CT) in subjects with no ear disease.Prospective case series study.Thirty-eight consecutive patients undergoing CT of the sinuses for nose-related complaints with normal radiographic findings consented for a CT of the temporal bone while performing the Valsalva maneuver. Multiplanar reconstruction was performed along the axis of the tube. Images were assessed for visualization of the whole length of lumen of the tube, or partial visualization with ratio of visualized to nonvisualized segments.The Valsalva maneuver allowed visualization of the whole length of the tube in 27/76 (35%) ears examined. It consistently visualized the distal one-third of the cartilaginous tube in 71/76 (94%) ears. Paradoxical collapse of the eustachian tube was present in three ears along with evidence of poor Valsalva technique.Valsalva CT consistently allows visualization of the lumen of the distal one-third of the eustachian tube in a majority of patients with no eustachian tube-related complaints. This technique might be helpful in localizing eustachian tube pathology in patients with obstructive tube symptoms.
Eustachian tube
Valsalva maneuver
Lumen (anatomy)
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Endoscopic technique in patients undergoing chronic ear surgery allows visualization of protympanic (proximal) segment of the Eustachian tube (ET). The proximal cartilaginous ET is a common site of anatomical Obstruction in chronic otitis media and it is this proximal end of ET that is being observed, instrumented and dilated with transtympanic methods. The aim of this article is to discuss our approach to the assessment of the Eustachian tube using opening pressure measurement, endoscopic assessment of the protympanic segment of ET and Valsalva CT. And also to discuss detailed technique of transtympanic Eustachian tube dilatation.
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Valsalva maneuver
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Not many imaging techniques have been reported in Eustachian tube imaging.To investigate the role of selective Eustachian tubography (SET) and Valsalva computed tomography (CT) in patients who underwent Eustachian tube balloon dilation (ETBD).Eligible patients were aged 18 years and older with chronic Eustachian tube dysfunction who had failed medical treatment. On the day of the procedure, Valsalva CT and SET were performed. Participants underwent fluoroscopic ETBD with a 6×20-mm balloon catheter. Clinical examinations to check for the ability to perform the Valsalva maneuver and ETDQ-7 score change were conducted at one week and then at one, two, and six months. Follow-up Valsalva CT was performed in the one-month follow-up.A total of 30 ears in 23 patients (16 right ears, 14 left ears; 10 women, 13 men) underwent ETBD from August 2018 to November 2019. Positive CT patency was higher in follow-up Valsalva CT than baseline Valsalva CT (40% and 23.3%, respectively) (P = 0.006). In SET, positive patency was observed in 13 of 25 ears. Response to balloon dilation was observed in 18 of 25 patients. Clinical success was achieved in 16 of 27 ears. Response to balloon dilation was the only significant predictor of clinical success (P = 0.012).SET depicted the lumen of the Eustachian tube; thereby, it could be a potentially valuable tool in ETBD. Valsalva CT provides additional information about the cartilaginous portion of the Eustachian tube.
Valsalva maneuver
Eustachian tube
Balloon dilation
Dilation (metric space)
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This paper studied a simplified and quantified valsalva and reverse valsalva maneuver eustachian tube tympanometry with otoadmittance meter. In normal groups, the compliance changes were 0.57 +/- 0.23 ml with valsalva maneuver and 0.26 +/- 0.12 ml with reverse valsalva maneuver. Otherwise, the recordings were performed in various tympanic functions induced by various eustachian tube functions, and the results showed that this method was significant for the diagnosis of eustachian tube structure, obstruction or patency. The recording curves helped to determine the types and degrees of eustachian tube abnormality.
Tympanometry
Eustachian tube
Valsalva maneuver
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A 44-year-old woman with frequent bilateral ear fullness was given a diagnosis of atelectatic tympanic membranes several years ago. She was told to perform the Valsalva maneuver, which raises air pressure in the nasal cavity and aerates the middle ear through the eustachian tube.
Valsalva maneuver
Eustachian tube
Tympanic cavity
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Eustachian tube
Valsalva maneuver
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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.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.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.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.
Eustachian tube
Balloon dilatation
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Eustachian tube
Valsalva maneuver
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