Navigation-Assisted Balloon Eustachian Tuboplasty for Eustachian Tube Dilatory Dysfunction

Choi, Sung-Won; Lee, Seokhwan; Oh, Se-Joon; Kong, Soo-Keun

doi:10.21053/ceo.2019.01305

Cited by 11 publications

(12 citation statements)

References 29 publications

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“…Navigation-guided BET was technically successful and safely performed in all patients. During all the BET procedures, we were able to confirm the insertion depth of the catheter and establish awareness of the proximity of the internal carotid artery 15 . This prospective, multicenter, RCT study suggests that navigation-guided BET is a superior treatment option compared to MM alone in patients with chronic ETD.…”

Section: Discussionmentioning

confidence: 92%

“…Each patient underwent BET using both the Naviloon (balloon and guide catheter) (Mega Medical, Seoul, Korea) and the Mega Navigation (image-guided navigation system; Mega Medical, Seoul, Korea). The balloon was inflated once with sterile water to a target pressure of up to 12 atm for 2 min, deflated and then reinflated for 1 min 15 . Methods related to detailed description of this navigation guided balloon Eustachian tuboplasty are described in supplementary methods and supplementary Fig.…”

Section: Methodsmentioning

confidence: 99%

“…Navigation-guided BET involves an image-guided navigation balloon catheter that provides surgeons with real-time feedback on the position of the catheter tip during BET. This novel procedure is technically feasible and safe 15 .…”

Section: Introductionmentioning

confidence: 93%

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

Choi

Kim

et al. 2021

Sci Rep

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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.

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Section: Discussionmentioning

confidence: 92%

Section: Methodsmentioning

confidence: 99%

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

Choi

Kim

et al. 2021

Sci Rep

Self Cite

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“…There were nine prospective studies (three case‐control, six cohort studies) encompassing 1336 patients with CRS and patients with CRS and ETD (CRS+ETD) 1,8–15 . There were seven studies (one RCT, four prospective case series, and two retrospective case series) including 161 patients with primary ETD 3,16–19 2122. Risk of bias assessment can be found in Figure 2.…”

Section: Resultsmentioning

confidence: 99%

Eustachian tube dysfunction (ETD) in chronic rhinosinusitis with comparison to primary ETD: A systematic review and meta‐analysis

Chen

Shih

Edwards

et al. 2022

Int Forum Allergy Rhinol

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Background Otologic symptoms consistent with Eustachian tube dysfunction (ETD) are common in patients with chronic rhinosinusitis (CRS), but can also occur independently of CRS as primary ETD. It is unclear if CRS+ETD is similar to primary ETD or how treatment outcomes compare. Methods A systematic search of PubMed, CINAHL, Scopus, and Cochrane Library was conducted following Preferred Reporting Items for Systematic Reviews and Meta‐analyses (PRISMA). Any study describing ETD in CRS was included. Primary ETD studies were limited to those with preoperative and postoperative Eustachian Tube Dysfunction Questionnaire (ETDQ‐7) scores in ETD treated only with Eustachian tube balloon dilation (ETBD). Results Sixteen studies were included: nine studies with 1336 consecutive patients with CRS and seven studies with 161 patients with primary ETD. In studies with specific data, 225 (47.2%) patients with CRS had a score >14.5, consistent with ETD. In CRS+ETD, baseline mean ± standard deviation (SD) ETDQ‐7 score was 20.7 ± 8.4 and did not differ by polyp status. In primary ETD, mean ETDQ‐7 score was significantly higher than CRS+ETD (29.5 ± 8.1, p < 0.0001). Regarding treatment outcomes, CRS+ETD treated with endoscopic sinus surgery (ESS) alone resulted in mean ETDQ‐7 in the normal range (13.2 ± 5.3), with a mean change of −7.4 (95% confidence interval [CI], −10.82 to −3.99) (p < 0.00001). Patients with primary ETD treated with ETBD had postoperative ETDQ7 scores of 14.9 ± 7.5 with mean change of −13.9 (95% CI, −18.01 to −9.88), p < 0.00001. Conclusion ETD is noted in approximately half of patients with CRS. Outcomes of CRS+ETD treated with ESS alone are similar to those of patients with primary ETD treated with ETBD.

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“…Moreover, Ungar et al [38] assured the safety, feasibility, and accuracy of BET as a method for treating diving-induced ETD and documented that BET can significantly reduce symptoms ETDQ-7 score and pressure-equalizing sensation in all ears, and so enables patients to resume diving. Also, Choi et al [39] concluded that Image-guided navigation balloon catheters are a potentially valuable tool, technically feasible and safe when performing BET to treat ETD and resulting in progressive decrease of ETDQ-7 scores with PO time of follow-up increase frequency of positive Valsalva maneuver at 6-m post-procedure.…”

Section: Chronic Rhinosinusitis [Crs] Especially If Associated With Nasal Polyposis [Crswnp]mentioning

confidence: 99%

Combined Endoscopic Sinus Surgery and Eustachian Tube Balloon dilatation improves Eustachian Tube Functions in patients had Chronic rhinosinusitis with nasal polyposis and Eustachian tube dysfunction

Alahmer

Wahba

2021

International Journal of Medical Arts

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Background: Chronic rhinosinusitis [CRS] is a distressing disease that affects patients' mental and physical health. Eustachian tube dysfunction [ETD] affects approximately 1% of the adult population, especially patients with rhinosinus diseases.Transnasal Balloon Eustachian tuboplasty [BET] is a safe intervention for adult patients with chronic ETD. Aim of the work:To evaluate the impact of combined Function endoscopic sinus surgery [FESS] for CRS and BET on ETD manifestations compared to FESS only.Patients and Methods: 45 patients were randomly allocated into Group C underwent FESS, and Group-I underwent FESS and BET. ETD was evaluated using the 7-item Eustachian Tube Dysfunction Questionnaire [ETDQ-7] score, Otoscopy, Valsalva maneuver, and tympanometry. BET was performed using the XprESS ENT Dilation System with balloon inflation to 12 atmospheres for 2-min. Study outcomes were determined after 6-wk.Results: At 6-wk, the frequency of normal TM position and positive Valsalva's maneuver was significantly higher, and ETDQ-7 scores were significantly improved in all patients, while the frequency of tympanogram type-A was significantly and non-significantly higher in groups I and C, respectively. ROC curve and Regression analyses defined the application of FESS with BET as the significant predictor for normalization of tympanogram to type-A. Conclusion:Coupling Balloon Eustachian tuboplasty with Function endoscopic sinus surgery provided outcome more superior to Function endoscopic sinus surgery alone. Balloon Eustachian tuboplasty in experienced hands can be performed with a 100% technical success rate

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Navigation-Assisted Balloon Eustachian Tuboplasty for Eustachian Tube Dilatory Dysfunction

Cited by 11 publications

References 29 publications

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

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

Eustachian tube dysfunction (ETD) in chronic rhinosinusitis with comparison to primary ETD: A systematic review and meta‐analysis

Combined Endoscopic Sinus Surgery and Eustachian Tube Balloon dilatation improves Eustachian Tube Functions in patients had Chronic rhinosinusitis with nasal polyposis and Eustachian tube dysfunction

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