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Abstract

Background

There has been a recent increase in the publication of articles evaluating outcomes of balloon dilation of the eustachian tube (BDET) as a treatment for chronic eustachian tube dysfunction (ETD). Our objective was to evaluate the overall efficacy of BDET for treating ETD, with a subgroup analysis of BDET performed under local anesthesia (LA) versus general anesthesia.

Methods

PUBMED, EMBASE, and Cochrane databases were searched for English articles from January 2010 to October 2025. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines were followed. Only randomized controlled trials and prospective studies evaluating BDET for ETD were included. All articles evaluating BDET performed under LA were assessed.

Results

Our search identified a total of 23 articles after screening (365 articles). Only studies using homogeneous and validated outcome measures were included. A total of 6 studies met criteria for meta-analysis of preoperative and postoperative outcomes of BDET as assessed by the ETD Questionnaire (ETDQ-7). Other reported parameters include LA protocols and surgical complications. Seven studies used LA protocols. A meta-analysis using the random effects model demonstrated a decrease in mean ETDQ-7 scores by 2.03 up to a year following BDET (309 patients, CI −2.59 to −1.47, P < .001). Descriptive statistics were used to analyze studies where BDET was performed under LA due to outcome heterogeneity. The results demonstrate no significant differences in otologic post-BDET outcomes (tympanometry/ETDQ-7 scores), minimal complications, and high patient-reported willingness to choose LA.

Conclusions

BDET is effective for treating chronic ETD. BDET performed under LA with careful patient selection and an established LA protocol is safe and comparable to BDET in the operating room.

Graphical Abstract

Keywords

balloon dilation of the eustachian tube eustachian tube dysfunction Eustachian Tube Dysfunction Questionnaire

Background

Chronic obstructive eustachian tube dysfunction (ETD) results from the improper equalization of pressure between the middle ear and the outside environment.¹ Patients can experience a wide array of symptoms, including aural fullness, otalgia, tinnitus, and hearing loss. ETD accounts for a substantial number of healthcare visits annually.¹ While symptoms of ETD can be self-limiting, cases of chronic ETD (3 months or greater) can be difficult to manage.¹

Myringotomy with tympanostomy tube placement was the mainstay of treatment for medically refractory cases of ETD.² More recently, balloon dilation of the eustachian tube (BDET) has emerged as a treatment option.^3,4 During BDET, a catheter with a balloon is briefly inserted and inflated in the cartilaginous portion of the eustachian tube.² The 2019 American Academy of Otolaryngology—Head and Neck Surgery (AAO) Clinical Consensus Statement outlines the indications for BDET, which include chronic ETD with elevated scores on validated symptom assessment tools, persistent middle ear effusion, non-adherent atelectasis, abnormal tympanometry, and/or inflammation at the eustachian tube orifice.¹

The recent literature has shown an increase in the publication of higher-quality studies reporting on outcomes of BDET for the treatment of chronic ETD. Moreover, many studies are using validated assessment tools, such as the Seven-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7). Previous systematic reviews on this topic focused on heterogeneous, mixed-quality studies, which included retrospective case series, studies that did not report post-treatment ETDQ-7 scores for meta-analysis, and did not cover the emerging data on BDET performed in office-based settings.^2,5

Our study reports on recent advances in the applications of BDET for chronic ETD in higher-quality studies [randomized controlled trials (RCTs) or prospective], utilizing validated assessment tools and cumulates data on the role of performing BDET under local anesthesia (LA).

Materials and Methods

Protocol and Research Question

This systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. A focused research question was formulated using the patient/population, intervention, comparison, and outcomes (PICO) criteria: Population: Adults with chronic ETD; Intervention: BDET; Comparison: Pre- and post- treatment, LA and general anesthesia (GA); Outcomes: ETDQ-7 scores, tympanometry, complications.

Study Identification

A computerized search of EMBASE, PUBMED, and Cochrane Library databases from inception to November 20, 2024, was performed at Dalhousie University in Halifax, Nova Scotia, Canada (Figure 1). The search strategy included synonyms for balloon dilation of the eustachian tube. The literature search was initially conducted using the following equation: (Eustachian Tube) AND (Dilation OR Dilatation OR Tuboplasty). The articles were imported to Covidence (Melbourne, VIC, Australia) software for screening and data extraction. All duplicates were removed. Strict inclusion and exclusion criteria were outlined for all phases of article screening. The inclusion/exclusion criteria adhered to the PICO format to reflect the research question and included studies that used qualitative or quantitative methods for assessing outcomes. The inclusion criteria included studies that were designed as prospective or RCTs with exclusion of retrospective case series. However, retrospective studies that evaluated BDET under LA were included due to paucity of high-quality studies available in this subgroup. A reason was chosen for each article that was excluded. We excluded studies focusing primarily on barro-challenge/barotrauma or non-obstructive ETD, pediatric patients, and non-English articles with no available translation. Exceptions to the exclusion criteria were made only in select cases regarding surgical indications if the procedure was performed under LA, as the focus of this subgroup analysis was the feasibility of performing the procedure in an office setting. As it is unfeasible to completely remove all possible confounding indications or concurrent procedures, some studies could include a subset of patients with non-otologic procedures for active secondary disease. These studies were included only if non-primary ETD factors were in the minority and were not the primary objective of the article. Some RCTs as outlined in Tables 1 to 3 had overlapping data sets in the context of reporting short-term and long-term results of RCTs. Therefore, these studies were included to allow reporting of data in both time frames and were appropriately included in the analysis. All phases of article screening were performed by 2 reviewers (U.K. and J.N.) independently. A consensus meeting was held to discuss any conflicts.

Figure 1.

Literature search flow diagram based on the PRISMA. PRISMA, Preferred Reporting Items for Systematic Review and Meta-Analyses.

Table 1.

Randomized Controlled Trials of BDET for Chronic ETD.

Study (year)	Country	Anesthesia	N (groups)	Outcomes
Choi et al (2021)⁷	Republic of Korea	General	16 BDET, 15 MM	ETDQ-7, tympanometry, modified Valsalva, hearing levels
Poe et al (2018)³	USA	General	162 BDET, 80 MM	Tympanogram, ETDQ-7, modified Valsalva
Meyer et al (2018)¹¹	USA	General	31 BDET, 29 MM	ETDQ-7, complications
Cutler et al (2019)¹²	USA	General	47	ETDQ-7, revision dilation rate, middle ear assessment, patient satisfaction
Krogshede et al (2022)²²	Denmark	General	13 BDET, 11 MM	ETDQ-7, tympanogram, otoscopy (effusion/retraction), VAS symptom score, middle ear pressure
Laakso et al (2024)²³	Nordic	Local	14	ETDQ-7, tympanometry, safety/adverse events, feasibility, ETDQ-7 responder analysis

Abbreviations: BDET, balloon dilation of the eustachian tube; ETD, eustachian tube dysfunction; ETDQ-7, Eustachian Tube Dysfunction Questionnaire; MM, medical management.

Table 2.

Prospective Cohort Studies of BDET Under General Anesthesia.

Study (year)	Country	Anesthesia	N	Outcomes
Jansen et al (2020)⁸	Germany	General	13	ETDQ-7, tympanometry, modified Valsalva, hearing levels, pETOP, pETOD, pETOF
Singh et al (2017)⁹	UK	General	11	Pure tone audiometry, tympanometry, ETDQ-7
Anand et al (2019)⁴	USA	General	162 BDET + MM, 80 MM, 81 control	ETDQ-7, tympanogram, modified Valsalva
Formanek et al (2020)¹³	Czech Republic	General	11	ETDQ-7, tympanometry, Valsava/Toynbee, PTA
Bowles et al (2016)¹⁴	UK	General	39	ETDQ-7, tympanometry, Valsalva
McCoul and Anand (2011)²⁰	USA	General	22	ETDQ-7, tympanometry, SNOT-22
Standring et al (2021)²¹	USA	General	154	ETDQ-7, SNOT-22, work and activity impairment
Kaderbay et al (2023)¹⁶	France	Mixed (local + general)	28	ETS, ETDQ-7, audiometry, tympanometry
Azevedo et al (2023)²⁴	Portugal	Mixed (local + general)	30	ETDQ-7, tympanometry, Pure tone audiometry, otomicroscopy
Bae et al (2023)²⁷	Korea	General	40	ETDQ-7, tympanogram, 9-step test (ET function), PTA, safety

Abbreviations: BDET, balloon dilation of the eustachian tube; ETDQ-7, Eustachian Tube Dysfunction Questionnaire; ET, eustachian tube; ETS, eustachian tube score; pETOD, eustachian tube opening duration; pETOF, eustachian tube opening frequency; pETOP, eustachian tube opening pressure; PTA, pure tone audiometry; MM, medical management.

Table 3.

Studies of BDET Under LA.

Study (year)	Study design	Country	Anesthesia	N	Outcomes
Luukkainen et al (2017)¹⁷	Retrospective	Finland	LA	13 BDET, 12 control	Pain (VAS)
Luukkainen et al (2018)¹⁸	Retrospective	Finland	LA	18	Pain (VAS)
Chen et al (2020)¹⁰	Retrospective	China	LA vs GA	25 LA, 24 GA	ETDQ-7, Valsalva
Toivonen et al (2022)¹⁵	Retrospective	USA	LA vs GA	58 LA, 133 GA	Tympanogram, valsalva, revision/redo rates, failure-free survival (Kaplan-Meier), safety/tolerance
Dean (2019)¹⁹	Retrospective	USA	LA	33	Tympanometry
Sheppard et al (2023)²⁶	Prospective	Switzerland	LA	30 Patients (47 ears)	ETDQ-7, tympanometry, ETMIS, VAS, audiometry
Ungar et al (2024)²⁷	Prospective	Canada	LA	8 Patients (12 ears)	ETDQ-7, tympanometry, safety/tolerability

Abbreviations: BDET, balloon dilation of the eustachian tube; ETDQ-7, Eustachian Tube Dysfunction Questionnaire; ETMIS, Eustachian Tube Mucosal Inflammation Scale; GA, general anesthesia; LA, local anesthesia.

Data Extraction

A standardized extraction form was generated for all articles. The form included the following items for data extraction: authors, country, participant number, sex distribution, age, study design, BDET technique, anesthesia, time to outcome assessment, outcome results, and statistics. Subjective and objective outcomes were collected. Quantitative data were recorded as mean or median values with standard deviation or quartile ranges when available. Significance was recorded as P values when available. The data extraction was conducted by 2 reviewers independently, and conflicts were resolved by a consensus meeting of all reviewers.

Quality Assessment

Studies that were not RCTs were assessed using the Methodological Index for Non-Randomized Studies (MINORS).⁶ This is a validated assessment tool designed specifically for non-RCT studies using 12 items, each of which is scored as 0 (not reported), 1 (reported but inadequate), or 2 (reported and adequate). The tool allows separate evaluation of comparative and noncomparative methods by assigning the first 8 items to noncomparative studies only (a total of 16 points) and an additional 4 items for comparative studies (a total of 24 points). Quality of RCTs was assessed using the Cochrane modified Risk of Bias Tool (RoB 2.0). The overall quality of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.

Synthesis of Results

A descriptive and meta-analysis approach was undertaken to report the results of this systematic review. Qualitative and quantitative data were tabulated. Univariate comparisons were conducted using a χ² test for categorical variables and Student’s t-test for continuous variables. Meta-analysis was performed using a random effects model with R statistical software (R Foundation for Statistical Computing, Vienna, Austria. https://www.R-project.org/). A meta-analysis was only performed on articles that allowed the calculation of a mean difference. Specifically, a pre- and post-treatment average score per question for the ETDQ-7 with appropriate standard deviations was required. To limit heterogeneity, we focused our analysis on 6 to 12 months following the procedure to highlight long-term results. Statistical significance was defined as P < .05. Some studies had overlapping patient cohorts (long-term follow-up results). Therefore, only one of the studies was included in the meta-analysis to prevent bias.

Results

Study Selection

The initial literature search identified a total of 365 articles following the removal of duplicates (Figure 1). Abstract screening led to the inclusion of 46 articles for full-text review. Twenty-nine articles were excluded during the full-text review for the following reasons: wrong study design or patient population (21) or non-English articles with no translations (4). Therefore, a total of 23 articles met the inclusion criteria for final synthesis.^3
-27 Wrong study designs included retrospective case series, cadaveric or animal studies, or technique papers without clinical subjects. Studies investigating a patient population that included pediatric subjects were also omitted.

Study Characteristics

A total of 23 studies, encompassing 1443 patients (including non-surgical control groups) evaluated BDET for chronic ETD. These investigations were conducted across diverse international institutions, including the United States (n = 8), Canada (n = 1), Nordic (n = 1), Germany (n = 1), Republic of Korea (n = 2), United Kingdom (n = 2), Switzerland (n = 1), China (n = 1), Denmark (n = 1), Portugal (n = 1), Finland (n = 2), France (n = 1), and the Czech Republic (n = 1). Seven studies (N = 207) assessed BDET under LA (Table 3), while the remainder utilized GA (Tables 1 and 2).

Across studies, outcomes were primarily assessed using the ETDQ-7, tympanometry, and eustachian tube opening parameters such as pressure, duration, and frequency. Additional measures included hearing levels, pure tone audiometry, patient satisfaction, revision and complication rates, and, in studies under LA, pain levels. Although the diagnostic inclusion criteria varied—ranging from ETDQ-7, tympanometry, otoscopy, and/or otologic symptoms—there was consistency in defining chronic ETD as persisting for more than 3 months and refractory to medical management. Due to outcome heterogeneity, tympanometry results were not pooled in the analysis.

Quality Assessment

The quality assessment of RCTs using RoB 2.0 demonstrated that the majority of RCTs had “low risk” or “some concerns” for risk of bias. Most non-RCT studies were assessed as good quality using the MINORS criteria with an average score of 14/24. However, areas where bias was high were the patients lost to follow-up, prospective calculation of study size, and blinding of assessors.

ETDQ-7 results

The ETDQ-7 score was the most reported outcome measure across included studies (Tables 4 –6). For our study, we looked at normalization of ETDQ-7 scores, which we defined as achieving a mean score <2.1 on the ETDQ-7 post-treatment. Follow-up durations varied widely, ranging from as early as 3 weeks to several years post-treatment. While all studies demonstrated improvement in mean ETDQ-7 scores following BDET, not all provided specific post-treatment values, which limited the ability to perform pooled analyses across the entire dataset.

Table 4.

ETDQ-7 Outcomes From Randomized Controlled Trials of BDET for Chronic ETD.

Study (year)	Pre-treatment	Post-treatment/follow-up
Choi et al (2021)⁷	3.28 ± 0.96	Significant improvement at 6 wk (P < .001)
Poe et al^a (2018)³	4.7 ± 1.1	56.2% normalized ETDQ-7 at 6 wk (P < .001)
Meyer et al^a (2018)¹¹	4.87 ± 1.74	2.13 ± 1.13
Cutler et al^a (2019)¹²	4.5 ± 0.8	2 ± 1
Krogshede et al (2024)²²	No values (graphical)	No significant difference in mean ETDQ-7 score at 6 mo follow-up
Laakso et al (2024)²³	31.44 ± 10.83	19.33 ± 9.53 (3 mo), 20.11 ± 5.65 (12 mo)

Abbreviations: BDET, balloon dilation of the eustachian tube; ETD, eustachian tube dysfunction; ETDQ-7, Eustachian Tube Dysfunction Questionnaire.

Studies with overlapping datasets due to reporting of initial short-term results followed by long-term results.

Table 5.

ETDQ-7 Outcomes From Prospective Studies of BDET for Chronic ETD.

Study (year)	Pre-treatment	Post-treatment/follow-up
Jansen et al (2020)⁸	28.3 ± 10.5	14.9 ± 6 at 4 wk
Singh et al (2017)⁹	4.04 ± 0.72	2 ± 0.6
Anand et al^a (2019)⁴	-	Normalization: 35.2% (6 wk), 33.6% (12 wk), 39.6% (24 wk), 38.7% (54 wk)
Formanek et al (2020)¹³	34.1 ± 5.58	17.8 ± 8.26 (6 wk), 14.4 ± 6.27 (3 mo), 13.9 ± 5.6 (6 mo)
Bowles et al (2016)¹⁴	4.87 ± 0.8	1.98 ± 0.8
Kaderbay et al (2023)¹⁶	4.21 ± 1.27	3.43 ± 0.95
McCoul and Anand (2011)²⁰	4.5 ± 1.2	2.7 ± 1.5 (3 wk), 2.6 ± 1.1 (6 wk), 2.8 ± 1.7 (12 wk), 2.8 ± 1.3 (6 mo)
Standring et al (2021)²¹	4.6 ± 0.09	2.5 ± 0.11
Azevedo et al (2023)²⁴	27 (median), IQR 16.5	11 (median), IQR 6.25 (8 mo)
Bae et al (2023)²⁷	27.5 ± 9.75	14.0 ± 9.25 (1 mo)

Abbreviations: BDET, balloon dilation of the eustachian tube; ETD, eustachian tube dysfunction; ETDQ-7, Eustachian Tube Dysfunction Questionnaire; IQR, interquartile range.

Studies with overlapping datasets due to reporting of initial short-term results followed by long-term results.

Table 6.

ETDQ-7 Outcomes of BDET Under LA for Chronic ETD.

Study (year)	Groups	Normalization rate
Chen et al (2020)¹⁰	LA vs GA	12 wk: 71.9% (LA), 81.3% (GA)52 wk: 63.3% (LA), 80% (GA)
Sheppard et al (2023)²⁶	LA	Pre-procedure: 2.83 ± 1.0515 wk: 2.14 ± 0.85
Ungar et al (2024)²⁷	LA	Pre-procedure: 4.4 ± 0.46 mo follow-up: 2.3 (±0.5)

Abbreviations: BDET, balloon dilation of the eustachian tube; ETD, eustachian tube dysfunction; ETDQ-7, Eustachian Tube Dysfunction Questionnaire; GA, general anesthesia; LA, local anesthesia.

RCTs (Table 4) consistently reported significant improvement in ETDQ-7 scores, with some studies noting normalization rates and strong statistical significance at 6 weeks post-treatment. Prospective studies (Table 5) similarly showed improvements, with reported normalization rates ranging from 28% to 39% at different follow-up points. Retrospective data (Table 6) also confirmed substantial normalization rates, with differences observed between LA and GA groups.

A total of 6 RCTs and prospective studies that met the inclusion criteria for meta-analysis provided mean ETDQ-7 scores 6 to 12 months post BDET (309 patients). Pooled analysis using a random-effects model demonstrated a significant mean difference of 2.03 (95% CI 1.47-2.59; P < .0001). However, heterogeneity was considerable (I² = 92.9%; Figure 2). This result demonstrates a significant improvement in subjective ETDQ-7 scores for ETD patients undergoing BDET.

Figure 2.

Forrest plot showing ETDQ-7 scores 6 to 12 months post BDET (309 patients) for studies (general anesthesia) providing mean ETDQ-7 scores pre- and post-treatment. BDET, balloon dilation of the eustachian tube; ETDQ-7, Eustachian Tube Dysfunction Questionnaire-7.

Valsalva Maneuver

The ability to perform the Valsalva maneuver was reported less commonly, and a summary is presented in Table 7. Overall, most studies reported improvements in the ability to perform the Valsalva maneuver post-BDET (Table 7). One study investigating LA versus GA for BDET and 1 study investigating LA for BDET reported improvements in Valsalva for both cohorts (Table 7).¹⁵

Table 7.

Valsalva Maneuver Outcomes from Prospective Studies of BDET for Chronic ETD.

Study	Valsalva results
Choi et al (2021)⁷	There was a 31.6% (6/19) vs 15.8% (3/19) with a positive modified Valsalva maneuver in the BET group compared to the control group at the 6-wk follow-up (P = .014).
Poe et al (2017)³	There was a 32.8 vs 3.1 percentage point increase in the number of ears with positive modified Valsalva maneuver in the BETD group compared to the control group at 6-wk follow-up, respectively (P < .001).
Chen et al (2020)¹⁰	At 12-wk follow-up, more patients reported a positive Valsalva maneuver in the GA group compared with the LA group [93.8% (30/32) vs 65.6% (21/32), P = .011].At 52-wk follow-up, the percentage of patients who could perform a positive Valsalva maneuver in the GA group increased to 100% (30/30), which remained higher than the LA group [80.0% (24/30), P = .024]
Anand et al (2019)⁴	BDET + Medical Management: 173 of 220 ears (78.6%) and 185 of 230 ears (80.4%) had positive Valsalva at 6 and 52 wks, respectively (P = NS)
Meyer et al (2018)¹¹	47.1% (8/17) of tested patients had significant improvement in the Valsalva maneuver at 6 wks (P = .005) vs 14.3% (2/14) of the participants in the control arm.
Standring et al (2021)²¹	Positive Valsalva maneuver in 97 of 161 (60.2%) at 6 wks (P < .0001) and 96 of 142 (67.6%) at 6 mo after BDET (P < .0001).
Cutler et al (2019)¹²	Valsalva maneuver improved from 28.3% of participants at baseline to 73.9% (P < .0001) at the 6-mo follow-up after BETD.
Bowles et al (2016)¹⁴	The proportion of ears in which patients reported being able to perform an effective Valsalva maneuver increased from 0% (n = 0) preoperatively to 82% (n = 45) at 6 wks and 96% (n = 53) at 3 and 6 mo
Toivonen et al (2022)¹⁵	LA: 96% of patients (25/26) had positive Valsalva at 6 moGA: 84% of patients (57/68) had positive Valsalva at 6 mo
Laakso et al (2023)²³	There were no differences from preoperative values at 6 and 12 mo of follow-ups

Balloon dilation—GA versus LA

BDET was performed under LA protocols in several studies.^10,15,17
-19 A meta-analysis was not feasible for this subgroup as the data were heterogeneous. The different protocols are summarized in Table 8. The procedures were performed in the office or under Monitored Anesthesia Care (MAC) for safety or research purposes. In some cases, diazepam was given prior to any LA to prevent vestibular events.¹⁹ Local nasal decongestant was used by all groups. Local decongestant was frequently applied with a LA intranasally, such as lidocaine, lidocaine/tetracaine, or cocaine.^10,15,17
-19 In some cases, LA drops of lidocaine/tetracaine were applied to an intact tympanic membrane.^15,19 LA was also applied to the eustachian tube orifice using a catheter device.¹⁰ Most commonly, a lidocaine-prilocaine cream or lidocaine-tetracaine cream was used for this purpose. Most patients (>90%) were able to complete the procedure under LA with no significant adverse events. Rare events of abortion from the procedure occurred due to discomfort, pain, or coughing associated with ET dilation.^10,15,17
-19

Table 8.

Anesthesia and Procedural Setting From Prospective Studies of BDET for Chronic ETD.

Study (year)	N (ears)	Protocol
Toivonen et al (2022)¹⁵ and Dean et al (2019)¹⁹	33 (43)58 (107)	Procedures performed in the office. Ten mg of diazepam prior to the procedure to prevent vestibular events. Four sprays of oxymetazoline followed by 5 drops of 7% tetracaine/7% lidocaine compounded into an otic solution are placed onto the intact ipsilateral tympanic membrane. Cottonoids soaked in 2% tetracaine were placed along the nasal floor bilaterally. Zero point five cc of compounded 7% Tetracaine/7% Lidocaine cream was applied to the ET orifice. Cottonoids were then replaced for an additional 10-15 min
Luukkainen et al (2017)¹⁷ and Luukkainen et al (2018)¹⁸	1318	Procedures performed under MAC. Xylometazoline drops to both nares and 50-200 mg cocaine in 1 mL of 0.01%-0.1% adrenaline in 3-5 small absorbent cotton pads for 15-20 min on each side. One mL of lidocaine-prilocaine cream (5 mL syringe filled with 25/25 mg/g lidocaine-prilocaine cream) was applied to the eustachian tube lumen under endoscopic control for 5 min, or 20 mg of cocaine in 0.1% adrenaline solution soaked in a cotton pad
Chen et al (2020)¹⁰	LA: 25 (32)GA: 24 (32)	Procedures performed under MAC. Three to 5 small absorbent cotton pads with 1% lidocaine and 0.01% adrenaline are placed into the nasal cavity for 10 min. Zero point five mL of lidocaine cream applied to the eustachian tube lumen through a balloon dilatation catheter and a 10-mL syringe under endoscopy for 10 min
Sheppard et al (2023)²⁶	30 (47)	Procedures performed in the office. Two puffs of 10% xylocaine spray were administered to the indicated nostril. Nasal packing soaked in 1% oxybuprocain and 0.1% xylometazoline was placed for 15 min; for narrow noses, local anesthesia was applied to the contralateral nostril to allow endoscope passage. If needed, 1% rapidocaine infiltration anesthesia was administered
Ungar et al (2024)²⁷	8 (12)	Procedures performed in the office. Patients fasted for 2 h and were positioned at a 45° angle. Two sprays of oxymetazoline were administered to each nostril, followed by cottonoids soaked in 2% tetracaine for 15 min. No systemic steroids, anxiolytics, or vestibular suppressants were given. The eustachian tubes and tympanic membranes were not anesthetized
Laakso et al (2023)²³	14	Procedures performed in the operating room. Patients were blinded to the procedure. Small doses of intravenous opioids and sedation were given if needed, and eyes were covered. Regional nerve block anesthesia was administered with cotton patches soaked in cocaine-epinephrine solution for 10 min. For ET local anesthesia, 1 mL lidocaine-prilocaine cream was applied to the ET lumen orifice under endoscopic guidance for 5 min

Abbreviation: MAC, Monitored Anesthesia Care.

There were no significant differences in major outcomes for BDET performed under GA versus LA (Table 9). Normalization of tympanometry and ETDQ-7 scores was present in both groups. Most patients would undergo LA again if given the choice.¹⁰ The indications for BDET varied, with a minority of patients being treated for barro-challenge ETD. For patients undergoing procedures under MAC, the operative times were significantly lower in the LA group.¹⁰

Table 9.

Clinical Outcomes From Prospective Studies of BDET for Chronic ETD.

Study (year)	N (ears)	Results
Dean et al (2019)¹⁹	33 (43)	• 87.1% (27/31) normalization of tympanogram after 6 wks• 94% tolerated the procedure
Toivonen et al (2022)¹⁵	58 (107)	• Pre-operative tympanogram B/C to post-operative type A at 12 mo. LA vs GA: 88% vs 74%• All patients in the LA group would undergo LA again• Valsalva maneuver improved in both groups• Only 1 patient aborted the procedure
Luukkainen et al (2017)¹⁷ and Luukkainen et al (2018)¹⁸	1318	• No significant differences in pain levels between devices or anesthesia protocols• 83% of patients would do LA again
Chen et al (2020)¹⁰	LA: 25 (32)GA: 24 (32)	• Normalization of ETDQ-7 (12 wk): 71.9% (23/32) of LA group and 81.3% (26/32) of GA group• -The duration of surgery (median) was 39.4 min in the LA group and 95 min in the GA group• 96% of patients in the LA group and 92% of patients in the GA group would choose LA• Positive Valsalva maneuver greater in the GA group vs the LA group• All patients completed the procedure
Sheppard et al (2023)²⁶	30 (47)	• Normalization of ETDQ-7 at 15 wks• No significant change in tympanometry
Ungar et al (2024)²⁷	8 (12)	• 11/12 ears had ETDQ-7 normalization on follow-up• 8/12 ears had type A tympanogram post-operatively

Abbreviations: ETDQ-7, Eustachian Tube Dilation Questionnaire; GA, general anesthesia; LA, local anesthesia.

Discussion

BDET demonstrates an improvement in short- and long-term outcome measures of chronic ETD and can be safely employed under LA in select patients using an established protocol.^{9,15,17
-19,23} Our systematic review builds on the emerging role of BDET in the treatment of chronic ETD, particularly with robust prospective and RCT data for assessing overall efficacy, and provides a summary of strategies for expanding the role of BDET in the office setting.

The 2019 AAO clinical consensus statement on BDET emphasizes the role of the ETDQ-7 in the evaluation of chronic ETD in clinical settings.¹ Therefore, our systematic review and meta-analysis focused on this outcome measure in prospective studies. Our results corroborate previous research on this topic, while adding a meta-analysis of 6 prospective studies or RCTs demonstrating a mean decrease in score by 2.03. The scores in most studies reached a near normal value of <2.1 (Tables 4 –6). The data presented in this study also outline the sustained improvement in ETDQ-7 at and beyond the 12-month mark, as demonstrated in Tables 4 and 5, and Figure 2. The improvement in ETDQ-7 scores across the most consistent RCTs in our meta-analysis suggests the clinical benefit of BDET as a procedure for chronic ETD. This also emphasizes the need for careful patient selection criteria and standardization of chronic ETD diagnosis. For instance, some studies that were excluded included many patients who had a confounding otologic history, such as the presence of active middle ear effusion. While the normalization of ETDQ-7 scores is reported, there is also a high heterogeneity in the data. There may be several reasons for this, including the subjectivity of the ETDQ-7 score, variance in ETDQ-7 symptoms among patients, length of follow-up, and confounding otologic symptoms (eg, chronic tinnitus, ie, unrelated to ETD but is mentioned on the questionnaire).

While tympanometry remains an essential component of diagnosing chronic ETD, the post-operative improvement can be difficult to quantify in a meaningful meta-analysis. A controversial point in the 2019 AAO clinical consensus statement on BDET is the lack of consensus regarding tympanometry as an outcome measure, while the role of ETDQ-7 did reach consensus.¹ Although Froehlich et al have previously presented the proportional improvement or normalization in tympanometry following BDET, this remains an understudied outcome measure following BDET in more recent prospective studies.² The role of the Valsalva maneuver is also critical for assessing BDET outcomes; however, this is not well represented in the current literature despite reaching consensus agreement in the most recent guidelines.¹

Recent publications have demonstrated the efficacy and safety of BDET performed using LA protocols.^{9,15,17-19,23} While these studies were limited and of a lower quality, they provide insights into the expansion of BDET in an office-based setting.^{10,15,17-19,23,26,27} Our study pools data from several articles emphasizing the lack of significant adverse events. Most adverse events were asymptomatic hemodynamic changes or pain that did not lead to significant abortions of LA procedures.^{10,15,17
-19,23,26,27} In addition, there was a high patient-reported willingness to choose LA (Table 8).^{10,15,17
-19,23,26,27} The protocols for LA shared similarities. All surgeons used a combination of a decongestant such as oxymetazoline with a LA (lidocaine, tetracaine, or cocaine) intranasally, followed by an anesthetic cream (lidocaine with tetracaine or prilocaine) placed in the eustachian tube orifice under endoscopic guidance.^{10,15,17
-19,23,26,27} The otologic outcomes (ETDQ-7 and tympanometry normalization) were also similar in studies comparing GA versus LA. There is potential for patient selection bias that might skew results in the LA cohort, given that surgeons are choosing which patients would be able to tolerate in-office-based procedures. While patient inclusion criteria are important consideration when providing in-office based BDET, there needs to be more evidence on what criteria can be used to determine which patients are eligible for in-office BDET. These criteria can include the anatomical factors, such as the feasibility of performing trans-nasal endoscopy, but also medical (comorbidities) and psychosocial (phobias). More research is required in this area to help standardize criteria for patient selection.

Assessment of study quality has identified several limitations in the current literature evaluating BDET, resulting in an overall low to moderate certainty in evidence using the GRADE approach. There remains a lack of control groups when evaluating BDET in chronic ETD. The indications for BDET are also variable among studies, with a minority including barro-challenge ETD.²¹ A minority of groups also performed BDET alongside other endoscopic procedures, which can confound results.²¹ The definition of chronic ETD is not consistent among studies, and there is varying concordance with the AAO guidelines, both in terms of evaluation of ETD and implementation of BDET. The ETDQ-7 score itself is a subjective measure that can harbor confounding otologic symptoms, and variance in interpretation of the questions can skew the quality of the data. Future studies should also aim toward a multi-variable comparison of LA versus GA outcomes using a randomized approach.

Conclusion

BDET demonstrates an improvement in outcome measures of chronic ETD and is being utilized in the office-based setting in a safe manner. However, LA protocols require further optimization to maximize patient comfort. Higher-quality studies that directly compare LA and GA outcomes are required to strengthen the evidence base regarding BDET in office-based settings.

Footnotes

Author Contributions

U.K. participated in data collection, data analysis, statistical analysis, and writing of the manuscript. J.N. was involved with data collection, data analysis, and writing of the manuscript. C.M. was involved in data analysis and writing of the manuscript. N.S. participated in study conceptualization, study design, manuscript writing, and editing.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Ethical Considerations

Not applicable.

Consent to Participate

Not applicable.

ORCID iDs

Usman Khan

You Sung (Jon) Nam

Colin MacKay

Data Availability Statement

Datasets are available upon reasonable request.

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Balloon Dilation for Chronic Eustachian Tube Dysfunction Under Local and General Anesthesia: A Systematic Review and Meta-Analysis

Abstract

Background

Methods

Results

Conclusions

Keywords

Background

Materials and Methods

Protocol and Research Question

Study Identification

Data Extraction

Quality Assessment

Synthesis of Results

Results

Study Selection

Study Characteristics

Quality Assessment

ETDQ-7 results

Valsalva Maneuver

Balloon dilation—GA versus LA

Discussion

Conclusion

Footnotes

Author Contributions

Declaration of Conflicting Interests

Funding

Ethical Considerations

Consent to Participate

ORCID iDs

Data Availability Statement

References