Introduction
The Eustachian tube (ET) functions to regulate middle ear pressure, enable mucociliary clearance of secretions and protect the middle ear from sounds and secretions from the nasopharynxReference Bluestone and Bluestone1. Obstructive Eustachian tube dysfunction (ETD) describes a failure of this functional valve that results in insufficient opening. Baro-challenge-induced ETD describes obstructive symptoms that occur with rapid ambient pressure changes, such as when diving or flying. The overall incidence of ETD in adults in the United Kingdom is 0.9 per centReference Browning and Gatehouse2.
Obstructive ETD symptoms include muffled hearing, fullness and crackling within the ears. The Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) (Appendix 1) is a validated disease-specific patient-reported outcome tool for the assessment of ETD. Eustachian tube dysfunction is defined as a mean ETDQ-7 score greater than or equal to 2.13,Reference McCoul, Anand and Christos4. The European consensus statement on the diagnosis of obstructive ETD advises that patient-reported symptoms should be used alongside evidence of negative pressure in the middle ear, demonstrated by either a retracted tympanic membrane or tympanogramReference Schilder, Bhutta, Butler, Holy, Levine and Kvaerner5. In baro-challenge-induced ETD, otoscopy, tympanometry and ETDQ-7 score may be normal when the patient is at normal ambient atmospheric pressure and therefore, diagnosis relies on patient history.
Eustachian tube balloon dilatation (ETBD) was first described by Ockermann et al. in 20096. Dilatation is hypothesised to cause microfractures of the cartilaginous ET that alter the connective-tissue architectureReference Catalano, Jonnalagadda and Yu7, subsequently allowing easier opening by the pharyngeal muscles. Several studies have demonstrated that ETBD can lead to a decrease in the mean ETDQ-7 scoreReference Froehlich, Le, Nguyen, McRackan, Rizk and Meyer8. Historically, ETBD was performed under general anaesthetic (GA). However, a study by Catalano et al. in 2012 demonstrated that ETBD could be performed successfully under local anaesthetic (LA) in an office-based setting with no increased risk of complicationsReference Catalano, Jonnalagadda and Yu7. This has since been supported by multiple studies reporting equivalent efficacy, low rates of complications and lower financial costs using LAReference Meyer, O’Malley, Schlosser, Soler, Cai and Hoy9–Reference Chen, Xie, Zeng, Xu and Xiong12. In this study, we describe the LA protocol we use to perform ETBD in the out-patient setting and report the outcomes for our case series.
Materials and methods
We conducted a prospective analysis of all patients undergoing ETBD under LA between October 2019 and July 2024 by a single surgeon at our tertiary centre. Data were collected on demographics, indications, pre-operative examination and investigations. Pre-operative ETDQ-7 questionnaires were completed, as well as at each follow-up appointment.
Adult patients attending clinic with persistent symptoms of either unilateral or bilateral obstructive ETD who had failed a trial of medical management with intra-nasal corticosteroid spray and ET auto-insufflation were offered ETBD. Obstructive ETD was differentiated from possible patulous ETD by the absence of autophony in the clinical history. Persistent ETD was defined by refractory symptoms despite three months or more of medical therapy and an ETDQ-7 mean score greater than or equal to 2.14. Chronic ETD is defined as a duration greater than or equal to three months in the 2015 expert consensus statement by Schilder et al.Reference Schilder, Bhutta, Butler, Holy, Levine and Kvaerner5, and is a criterion for identifying patients suitable for ETBD in the 2019 Delphi consensus statementReference Tucci, McCoul, Rosenfeld, Tunkel, Batra and Chandrasekhar13. While there is some discrepancy in the literature as to what truly defines obstructive ETDReference Schilder, Bhutta, Butler, Holy, Levine and Kvaerner5, Reference Froehlich, Le, Nguyen, McRackan, Rizk and Meyer8, Reference Tucci, McCoul, Rosenfeld, Tunkel, Batra and Chandrasekhar13, the ETDQ-7 is a widely used validated score that has been demonstrated to have highly sensitive and specific discriminant validity at a cut-off mean score greater than or equal to 2.14. Other relative indications considered were baro-challenge-induced ETD and conductive hearing loss no longer amenable to ventilation tube insertion.
All suitable patients are offered ETBD under LA unless they had a significant septal deviation affecting access, or they expressed a preference to have the procedure under GA.
Statistical analysis was conducted using Excel (Microsoft, Redmond, Washington, USA). Total and mean ETDQ-7 scores at baseline and follow-up were compared using a paired Student’s t-test. A p-value of < 0.05 was considered statistically significant.
Local anaesthetic protocol
Eustachian tube balloon dilatation is performed under LA in our dedicated Interventional Clinic, utilising a procedure room within the out-patient department. The operation is performed by a single surgeon assisted by a nurse specialist. To perform the procedure effectively with minimal discomfort, anaesthesia must be achieved from the inferior border of the middle turbinate and below. Our protocol involves first spraying the nasal cavity with 2.5 ml of 5 per cent lignocaine with 0.5 per cent phenylephrine. Following this, adrenaline (1 mg/ml, 1:1000) soaked ribbon gauze is placed into the posterior nasal cavity bilaterally. A Merocel nasal pack (Medtronic Xomed Inc, Minneapolis, Minnesota, USA) is inserted bilaterally, anterior to the ribbon gauze, and soaked in 0.5 per cent bupivacaine with 1:200,000 adrenaline. The patient is then moved to the waiting room and asked to sit with their head tilted backwards for 20 minutes. The posteriorly placed ribbon gauze acts as a conduit to leach the bupivacaine and adrenaline to the posterior nasal cavity, leading to a greater degree of anaesthesia and decongestion in this region. After 20 minutes, the pack and ribbon gauze are removed, and the posterior septum and inferior root of the middle turbinate are infiltrated with 2.2 ml of 2 per cent lignocaine with 1:80,000 adrenaline using a spinal needle. The ET itself is not directly anaesthetised. The patient is positioned upright at a 45-degree angle, and a 0-degree 4 mm rigid nasendoscope is used with an Endoscopy Stack System (Karl Storz SE, Tuttlingen, Germany) to visualise the ET orifice. The Stryker XprESS ENT dilatation system14 (Stryker, Kalamazoo, Michigan, USA) is used with a size 6.0 x 20 mm balloon for primary procedures and a size 7.0 x 20 mm for revisions. This model was selected over others available, as it is a single-hand-use device with a thin profile that does not interfere with the simultaneous use of the endoscope in the nares. Once positioned in the ET, the balloon is inflated by the assistant to 12 atmospheres for 2 minutes per side.
Results and analysis
Thirty-one patients underwent 40 (31 primary, 9 revision) ETBD procedures between October 2019 and July 2024. Pre-operative findings are summarised in Table 1. Most operations were bilateral (62.5%) and performed for obstructive ETD (87.1%). Average baseline ETDQ-7 score was 29.4 (SD 9.4) with a mean score of 4.2 (SD 1.4). Median duration of follow-up was 89 days (42–1455).
Eustachian Tube Balloon Dilatation Patient Characteristics
Sensorineural hearing loss (SNHL); Conductive hearing loss (CHL); Eustachian tube dysfunction (ETD); Fibreoptic nasendoscopy (FNE); Eustachian Tube Dysfunction Questionnaire (ETDQ-7); Pure tone audiometry (PTA); Eustachian tube (ET); Standard deviation (SD)
Primary procedures for obstructive ETD
Twenty-seven patients underwent ETBD for obstructive ETD. Twenty patients had short-term follow-up ETDQ-7 scores, five of whom had both short-term and long-term follow-up ETDQ-7 scores. Seven patients only had long-term follow-up ETDQ-7 scores available.
Short-term follow-up
Twenty patients had a baseline pre-operative ETDQ-7 score and a six-week post-operative ETDQ-7 score (Table 2). At follow-up, there was a statistically significant decrease in the average total ETDQ-7 score of -6.75 (SD 8.85) points (t(19) = 3.41, p = 0.0029). There was also a statistically significant decrease in the mean ETDQ-7 score of -0.96 (SD 1.26) points (t(19) = 3.41, p = 0.0029).
Follow-up of Primary Procedures
* p < 0.05
Eustachian Tube Dysfunction Questionnaire (ETDQ-7); Standard deviation (SD)
Long-term follow-up
Twelve patients had a baseline pre-operative ETDQ-7 score and either a three-month, six-month or twelve month or more follow-up post-operative ETDQ-7 score (Table 2). At follow-up, there was a statically significant decrease in the average total ETDQ-7 score of -7.58 (SD 10.88) points (t(11) = 2.41, p = 0.034). There was also a statistically significant decrease in the mean ETDQ-7 score of -1.08 (SD 1.55) points (t(11) = 2.41, p = 0.034).
Primary procedures for other indications
Baro-challenge-induced ETD
Three patients underwent ETBD for baro-challenge-induced ETD. One patient had a unilateral procedure, and two had bilateral procedures. At six-week and three-month follow-up, all three reported subjective improvement with reduced baro-challenge-induced symptoms when flying or scuba diving.
Conductive hearing loss no longer amenable to ventilation tube insertion
One patient underwent unilateral ETBD for right-sided conductive hearing loss (CHL) that was long-standing for eight years, and had not improved despite two previous grommet insertions and one previous T-tube insertion. Pre-operatively, they had a retracted tympanic membrane, a Type B tympanogram and mild-to-moderate CHL. At post-operative follow-up, the examination and audiology findings were unchanged.
Revision procedures
Eight patients with obstructive ETD underwent nine revision procedures (Table 3); for seven patients, the primary procedure was performed under LA, while for one patient it was performed under GA. The median time between the primary and revision procedures was 140 days (56–196). Indications for revision included no improvement, only temporary improvement before recurrence or bilateral symptoms with only unilateral improvement after the primary ETBD. The average ETDQ-7 score at diagnosis was 20.38 (SD 3.78) with a mean score of 2.9 (SD 0.55). Six patients had pre-operative and post-operative ETDQ-7 scores recorded (Table 4). At follow-up, there was a decrease in the average total ETDQ-7 score of -3.50 (SD 5.43) and the mean score of -0.50 (SD 0.78), but neither of these results reached statistical significance.
Revision Eustachian Tube Balloon Dilatation Patient Characteristics
Sensorineural hearing loss (SNHL); Conductive hearing loss (CHL); Fibreoptic Nasendoscopy (FNE); Eustachian Tube Dysfunction Questionnaire (ETDQ-7); Pure tone audiometry (PTA); Eustachian tube (ET); Standard deviation (SD)
Follow-up of Revision Eustachian Tube Balloon Dilatation Procedures
Eustachian Tube Dysfunction Questionnaire (ETDQ-7); Standard deviation (SD)
Adverse events
No adverse events were reported. All patients tolerated the procedure at the manufacturer-recommended insufflation pressure and duration. No patients required post-operative analgesia.
Discussion
We present the results of a prospective case-series analysis of 31 patients who underwent 40 ETBD procedures. This represents the largest reported case series in the literature of ETBD procedures performed in the out-patient setting solely under LA, without sedation. Average age was 43.3 years, and 58.1 per cent were male, reflecting the typical demographic described in the literatureReference Froehlich, Le, Nguyen, McRackan, Rizk and Meyer15, Reference Ungar, Demir Bajin, Dahm, Lin, Chen and Le16. At short-term follow-up, there was a significant decrease in the total ETDQ-7 score of -6.75 and the mean ETDQ-7 score of -0.96 points (p = 0.0029). These results were maintained at longer-term follow-up, with a significant decrease in the total ETDQ-7 score of -7.58 and the mean ETDQ-7 score of -1.08 points (p = 0.034). These findings are in line with results previously reported in the literature, with a recent meta-analysis of 12 studies demonstrating a decrease in the mean ETDQ-7 score of 2.13 points at 6 weeks and 2.22 points at long-term follow-upReference Froehlich, Le, Nguyen, McRackan, Rizk and Meyer8.
While we had pre-and post-operative data for only six patients who underwent revision procedures, we found there was a decrease in the total and mean ETDQ-7 scores, although this was not statistically significant. In the current literature, no reliable predictors of outcome following ETBD are availableReference Sheppard, Beckmann, Caversaccio and Anschuetz17. There are very few published studies reporting outcomes following revision procedures, and the benefit after a prior ineffective ETBD is unclearReference Tucci, McCoul, Rosenfeld, Tunkel, Batra and Chandrasekhar13. A recent retrospective study of 10 patients who underwent repeat ETBD actually reported an average increase in the ETDQ-7 score of 6.7 per cent, indicating worsening of symptomsReference Keschner, Garg, Loch and Luk18. In our centre, we offer a single revision ETBD to patients who tolerated the procedure without issue but derived no improvement, only temporary improvement or only unilateral improvement with bilateral ETD. For revision procedures, we would consider using a larger size 7.0 x 20 mm balloon.
There is currently no consensus on the diagnostic or outcome measures to use for baro-challenge-induced ETD, and patients may have a normal examination and ETDQ-7 score at ambient pressureReference Schilder, Bhutta, Butler, Holy, Levine and Kvaerner5. However, there is evidence that patients with a history of recurrent symptoms on baro-challenge may improve with ETBDReference Møller, Berthelsen and Svahn19, Reference Raymond, Shih, Elvis, Nguyen, Brennan and Meyer20. A 2022 systematic review found that 84.3 per cent of patients reported an improvement in symptoms after ETBD, and 79.1 per cent were able to return to activities that involved baro-challengeReference Raymond, Shih, Elvis, Nguyen, Brennan and Meyer20. A recent large case series by Møller et al. also demonstrated a significant improvement in ETDQ-7 and Visual Analogue Scale scores during pressurisation after ETBDReference Møller, Berthelsen and Svahn19. Three patients in our case series underwent ETBD for baro-challenge-induced ETD. All reported subjective improvement in symptoms during activities of scuba diving or flying.
The benefit of ETBD in patients with chronic ear disease or previous ear surgery has not been determined, and there is a paucity of studies looking at prior ear disease as a predictor of outcomeReference Tucci, McCoul, Rosenfeld, Tunkel, Batra and Chandrasekhar13. In our case series, one patient underwent ETBD for long-standing CHL who had previously had multiple ventilation tube insertions. Dilatation led to no improvement in hearing, tympanogram or ETDQ-7 score. While we do offer ETBD to appropriate patients who have had prior ear surgery, we are conservative regarding expectations for improvement and counsel patients accordingly.
All patients who underwent ETBD under LA tolerated the procedure successfully with no compromise of insufflation pressure or duration. In addition, all patients who underwent a primary procedure under LA and subsequently required a revision opted for this to also be under LA. There are several benefits to performing ETBD under LA. While the LA techniques described in the literature vary, the protocols frequently describe combining them with awake sedationReference Dean21, Reference Toivonen, Dean, Kawai and Poe22. Our LA protocol was specifically designed to avoid the need for sedation. This enables ETBD to be conducted in an out-patient setting without pre-operative assessment, intra-operative or post-operative monitoring, or an anaesthetist. This is significantly more convenient for our patients, who attend the clinic for approximately 2 hours in total. They avoid a GA and any post-anaesthetic side effects and can return to usual activities that day without an escort. We can also offer them ETBD in a timelier manner. Our waiting list for ETBD under LA in our Interventional Clinic is currently two months, whereas our admitted patient pathway waiting list can be more than a year. We receive a payment tariff for each procedure, and the only fixed costs incurred are those for the equipment required. By performing them under LA, we avoid the cost of using the operating theatre, which is estimated to be £2,200 per 4-hour session. We can perform up to 6 LA balloon dilatations per clinic session, which equates to a potential saving of £367/patient. No additional staffing costs are incurred as the out-patient clinic is already running at that time. There are also wider benefits to efficiency, as the theatre time can then be utilised by our department for other cases.
The rate of adverse events following ETBD in the literature is 3 per centReference Ramakrishnan, D’Souza and Kadambi23, with the majority being minor and self-resolving. No adverse events were reported during our study period.
A limitation of our study was that, while it was prospective, there was a degree of incomplete documentation of ETDQ-7 scores at both short-term and long-term follow-up time points after some of the primary procedures and after a small number of the revision procedures. We also did not have pre-operative and post-operative tympanograms or patient-reported outcome measures relating to intra-operative or post-operative pain scores during the procedures available for analysis.
Conclusions
This study demonstrates that primary ETBD under LA for both obstructive ETD and baro-challenge-induced ETD can lead to a significant improvement in patient-reported symptoms. Following a specific LA protocol, ETBD can be performed successfully in the out-patient setting with no compromise to insufflation pressure or duration and no increased risk of adverse events. This benefits patients in terms of convenience and immediate return to activity, and offers significant cost and efficiency savings for a department.
Financial support
The research received no specific grant from any funding agency, commercial or not-for-profit sectors.
Competing interests
The authors declare none.
Ethical statement and informed consent
The study was conducted in accordance with the Declaration of Helsinki. Following UK Medical Research Council guidance, ethical approval was not required for this study.
Appendix 1.
Eustachian Tube Dysfunction Questionnaire (ETDQ-7)
Do you get these symptoms in one ear only or both ears?
Left ear only Right ear only Both ears
Total score: ÷7 = Mean item score
