Medical Policy
Subject: Balloon Dilation of the Eustachian Tubes
Document #: SURG.00151Publish Date: 04/13/2022
Status: ReviewedLast Review Date: 02/17/2022
Description/Scope

This document addresses the use of balloon dilation of the Eustachian tubes (BDET), also known as balloon dilatation Eustachian tuboplasty. Balloon dilation of the Eustachian tubes is an endoscopic procedure that usually approaches the Eustachian tubes nasally, and using a balloon catheter, expands and stretches the Eustachian tube. It is proposed to relieve chronic ear congestion and middle ear and mastoid infections.

Position Statement

Investigational and Not Medically Necessary:

Balloon dilation of the Eustachian tubes is considered investigational and not medically necessary for all indications.

Rationale

At this time, there are a large number of low quality, small cases series studies addressing the use of the BDET technique (Ashry, 2017; Bast, 2013; Catalano, 2012; Dai, 2016; Gürtler, 2015; Jenckel, 2015; Kim, 2017; Leichtle, 2017; Li, 2019; Luukkainen, 2018; McCoul, 2012; McMurran, 2020; Poe, 2011; Satmis, 2018; Schmitt, 2017; Silvola, 2014; Singh, 2017; Song, 2019; Tisch, 2017; Wanscher, 2014; Williams, 2016; Xiong, 2016; Yin, 2019). These studies, while offering interesting information, provide little in the way of rigorous data evaluating the safety, efficacy, and long-term outcomes of this procedure.

To date, there has been a limited number of randomized controlled trials (RCTs) addressing this issue. Poe and colleagues (2017) reported the results of a study involving 323 subjects (462 ears) with persistent Eustachian tube dilatory dysfunction, refractory to medical management with daily intranasal steroids or a single course of oral steroids. A pool of 81 subjects were involved in a lead-in population which were used to acclimate the investigators to the study procedure. The remaining subjects were randomized in a 2:1 manner to undergo treatment with BDET with concurrent medical management (n=162, with 100 [61.7%] completing study) or continued medical management (n=80, with 71 [88.8%] completing the study). The condition was confirmed by tympanometry, the Eustachian Tube Dysfunction Questionnaire-7 symptom scoring tool (ETDQ-7) and nasal endoscopy. Subjects were allowed to continue concomitant use of other medications to treat sinus or nasal conditions as deemed medically necessary. Follow-up continued to 24 weeks. However, continuation of medical therapy was at the discretion of the investigator after 6 weeks and control subjects were permitted to cross over to the BDET group after 6 weeks and followed through 12 weeks. A majority of subjects in the control arm, while completing the 6-week follow-up, crossed over to the BDET group before the 12-week follow-up (82%, 59/71). At the 6-week follow-up, significantly more BDET group subjects had normal tympanograms (51.8% vs. 13.9%, p<0.0001). At 24 weeks, tympanogram normalization was 62.2% in the BDET group. No comparison to the controls was possible at this time point due to the high number of crossovers. Worsening of tympanograms was noted in 4% of BDET subjects and 5.7% of controls (no p-value provided). Improvement in the ETDQ-7 was significantly greater in the BDET group vs. controls at 6 weeks (56.2% vs. 8.5%, p<0.001). The number of subjects with a positive modified Valsalva maneuver was better in the BDET group vs. controls at 6 weeks (32.8% vs. 3.1%). No device- or procedure-related serious adverse events were reported. This study has several significant limitations, including lack of standardization of concomitant medications, significant loss to follow-up, and significant crossover before the 12-week mark. The results of this trial are questionable given these issues.

Anand and colleagues (2019) published the results of a 52-week continuation of the Poe study detailed above. This trial involved 136 subjects in the BDET group, 73 control subjects, and 74 of the lead-in period subjects. At 52 weeks, the authors reported that the number of BDET-group subjects maintaining normalized tympanograms and normalized ETDQ-7 scores remained unchanged from the 6-week time point (tympanograms: 51.0% vs. 55.5%, ETDQ=7 scores: 57% vs. 63.6%). No device-related adverse events were reported.

In 2015, Schröder reported the results of a large case series study involving 622 subjects aged 7 and older (1076 dilations) who underwent BDET. At 2 months, data was available for 506 subjects (49%). The average Eustachian Tube Score (ETS) improved from 3.15 before the procedure to 5.37 after the procedure (p≤0.001). At 1 year, data was available for 188 (28%) subjects, and the mean ETS improved from 3.13 to 5.75 (p<0.001). Data for 2 years postoperative was reported for 34 subjects (10%) and mean ETS at this time point improved from 2.65 to 6.26 (p≤0.001). Revision surgery was conducted in 10.5% of all balloon dilations (68 subjects), and no adverse events were reported. The large loss to follow-up of this study significantly hampers the value of this data.

Dalchow and others (2016) reported the results of a prospective case series study involving 202 subjects (342 dilations). The authors used a “tube score” consisting of the type of tympanogram and the R value of the tubomanometry to evaluate pre- and postoperative tube function. All subjects underwent follow-up with postoperative assessments at 1 month (n=175, 86.6%), 3 months (n=92, 45.5%), 9 months (n=29, 14.4%) and 12 months (n=19, 9.4%). The mean pre-treatment tube score was 2.23 ± 1.147 and was reported to have significantly improved to 2.68 ± 1.011 at 1 year (no p-value provided). As with the prior reported studies, the loss to follow-up of this trial hampers its utility in assessing the efficacy of this procedure.

In 2017 Skevas published the results of a meta-analysis assessing cervicofacial and mediastinal emphysema involving 3670 procedures in 2272 subjects treated with BDET at four centers across Europe. The ages ranged from 2 to 83 years. Postoperative emphysema developed in 7 subjects, limited to parotid region cheek and soft and hard palate. Another 3 developed emphysema of the soft tissues associated with pneumomediastinum. The overall complication rate involving pneumomediastinum was reported as 0.27%.

Si and others (2017) conducted a double-blind RCT involving 120 subjects with adhesive otitis media (adOM) who were assigned to one of four groups: 1) conservative therapy, 2) BDET, 3) cartilage tympanoplasty, or 4) combined BDET and cartilage tympanoplasty. There were 30 subjects in each group and the follow-up period was 2 years. No significant differences between the tympanoplasty alone and combined groups were noted. Both the tympanoplasty alone and combined groups had significant improvements in air-bone gap compared to controls (p<0.1), but no differences were found between these two groups. All three surgical groups had significant improvements in the Tinnitus Handicap Inventory vs. the control group (p<0.05). At both 1 and 2 years, the combined group had significant improvements vs. tympanoplasty alone (p<0.05). Results from the Chronic Otitis Media Outcome Score-15 (COMOT-15) indicated significant improvements in all surgical groups (p<0.05). The combined group had significantly higher scores vs. tympanoplasty alone (p<0.05). Eustachian tube scores (ETS) improved in both the BDET-only and combined groups vs. controls and vs. tympanoplasty alone (p<0.05 for both). No improvement in the tympanoplasty-alone group vs. controls was reported. Two subjects in the BDET-alone group reported patulous Eustachian tube post-operatively.

Meyer (2019) reported the results of a prospective RCT involving 60 subjects with Eustachian tube dysfunction undergoing treatment with either balloon dilation (n=31) or medical therapy (n=29). Subjects were followed for 1 year, but after 6 weeks, control participants had the option to undergo balloon dilation if symptoms persisted. Twenty-three control group subjects underwent balloon dilation treatment and continued through the remainder of the 12-month trial, resulting in 49 total subjects completing the trial. No adverse events were reported in either group. Among subjects with abnormal baseline assessments, improvements in tympanogram type (pā€Š<ā€Š0.006) and tympanic membrane position (pā€Š<ā€Š0.001) were significantly better for the balloon dilation group than for the control group. The authors reported that technical success was 100% (91 successful dilations/91 attempts) and most procedures (72%) were completed in the office under local anesthesia. Improvements in the ETDQ-7 scores were maintained through 12 months after balloon dilation. This study included multiple methodological flaws, including no attempt to blind the participants as to which treatment they received, allowing crossover at 6 weeks, and including a small subject pool. Additional investigation is warranted with larger, more robust trials.

Cutler (2019) published the results of a follow-up study of the experimental arm of the trial reported by Meyer et al. in 2019. Out of the 49 subjects completing the initial 12-month study, 47 were included in this follow-up study. Of the total study population, 93.6% were of Caucasian ethnicity. The mean follow-up for all participants was 29.4 months (range 18-42 months). Overall, ETDQ-7 scores were significantly reduced from a mean of 4.5 at baseline to 2.0 at last measured timepoint (p<0.0001). Additionally, each individual component of the ETDQ-7 tool was likewise significantly improved (p<0.0001 for all). Only 1 subject underwent repeat dilation procedure concurrently with FESS for rhinosinusitis. The ability to clear the ears with the Valsalva maneuver increased from 28.3% to 73.9% (p<0.0001). Type A tympanograms also increased from 70% to 86.3% (p=0.005). In subjects with abnormal middle ear assessments at baseline, tympanic membrane position was normalized in 76% (p<0.0001), Valsalva maneuver response was positive (p<0.0001), and normalization of tympanograms occurred in 62.5% (p<0.001). These results, which equate to a long-term cohort study, indicate significant improvements with the use of Eustachian tube dilation. However, the small size of the study, limited diversity, lack of blinding, and other methodological flaws weaken the generalizability of these results.

Chen (2020) reported the results of a retrospective non-randomized controlled trial involving 50 subjects with otitis media with effusion who had received myringotomy and tympanostomy tube placement in conjunction with Eustachian tube dilation (n=25) vs. those who received myringotomy and tympanostomy tube placement only (n=25). The method of selecting which subjects to study was not explained. Adenoidectomy was conducted in subjects found to have adenoid hypertrophy (n=16 in the balloon group and n=17 in the control group). The authors reported a statistically significant difference in air-bone gap between the two groups at 18 months, with mean differences of the balloon group lower (about 4 dB HL) vs. the control group (p=0.05). At 18 months the cure rate was 76.1 % for the balloon group vs. 60.9% in the controls (p=0.116), and total effective rates were 93.5% and 89.1%, respectively (p=0.71). No serious adverse events or complications were reported. While significant improvements in air-bone gap measurements at 18 months were reported, differences in cure rate and total effective rates were not. While these results are not totally supportive of the use of Eustachian tube dilation, the study methodology has serious flaws that weaken the strength of the findings, including its small size, potential selection bias, retrospective design, and lack of randomization and blinding.

In 2021, Toivonen and colleagues published results of a study to determine the safety and efficacy of BDET in children. The study involved 26 subjects (46 Eustachian tubes) whose ages ranged from 7 to 17 years and underwent BDET. The study indicated all subjects underwent adjunctive procedures at the time of BDET. Authors noted significant improvement in middle ear function following BDET. Tympanograms improved to type A in 50% at 6 months, 59% at 12 months, and 85% at 36 months. Mean scores of mucosal inflammation declined from 3.2 (±0.6) preoperatively to 2.5 (±0.7) at 6 months and 1.7 (±0.6) at 36 months postoperatively. They concluded BDET appears to be a safe and effective alternative treatment when conventional therapy fails. The authors noted a limitation in their study. The inclusion of adjunctive procedures created a possibility that the benefit credited to BDET may have happen from the other procedure.

In 2019, the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) published a consensus statement regarding the use of BDET (Tucci, 2019). This document was the result of a Delphi survey method involving a panel of selected representatives from a variety of medical specialty societies. They provide a list of 28 statements that reached consensus, including the following:

2.   BDET is contraindicated for patients diagnosed as having a patulous ETD.
6.   The benefit of repeat BDET after a prior ineffective BDET has not been determined.
13. BDET is appropriate in patients with obstructive ETD who have failed medical therapy for identified treatable causes.
15. Medical management of known pathology that could affect nasal or ET function is appropriate to perform prior to BDET.
16. Patients with a history of recurrent barochallenge, defined as uncomfortable pressure in the ear upon exposure to ambient pressure changes that cannot be easily relieved, may improve following BDET.
20. Potential risks of BDET that are relevant to patient counseling include bleeding, scarring, infection, development of patulous ETD, and/or the need for additional procedures.
22. A dehiscent carotid artery identified on imaging is a contraindication to use of a device without a depth marker that demarcates insertion into the cartilaginous eustachian tube.
24. BDET is an alternative to tympanostomy tube placement for obstructive ETD.

While this document may reflect the consensus opinion of medical experts, it is not annotated or supported by references to published evidence.

At this time there is insufficient evidence to support the safety and efficacy of BDET for the treatment of conditions related to Eustachian tube dysfunction. The available studies are either too small or have significant methodological flaws to provide reliable and generalizable results. Additional investigation is warranted.

Background/Overview

According to several recent review articles (Hwang, 2016; Llewellyn, 2014), Eustachian tube dysfunction impacts approximately 1% of adults, although a much higher prevalence is suspected possibly due to under reporting by individuals suffering from the condition. It is unclear how many individuals undergo surgical treatment.

As noted above, BDET is an endoscopic procedure that usually approaches the Eustachian tubes nasally, and using a balloon catheter, expands and stretches the Eustachian tube. It is proposed to relieve chronic ear congestion and middle ear and mastoid infections.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
For the procedure codes listed below, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT

 

69705

Nasopharyngoscopy, surgical, with dilation of eustachian tube (ie, balloon dilation); unilateral

69706

Nasopharyngoscopy, surgical, with dilation of eustachian tube (ie, balloon dilation); bilateral

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Anand V, Poe D, Dean M, et al. Balloon dilation of the Eustachian tube: 12-month follow-up of the randomized controlled trial treatment group. Otolaryngol Head Neck Surg. 2019; 160(4):687-694.
  2. Ashry Y, Kawai K, Poe D. Utility of adjunctive procedures with balloon dilation of the Eustachian tube. Laryngoscope Investig Otolaryngol. 2017; 2(6):337-343.
  3. Bast F, Frank A, Schrom T. Balloon dilatation of the Eustachian tube: postoperative validation of patient satisfaction. ORL J Otorhinolaryngol Relat Spec. 2013; 75(6):361-365.
  4. Catalano PJ, Jonnalagadda S, Yu VM. Balloon catheter dilatation of Eustachian tube: a preliminary study. Otol Neurotol. 2012; 3(9):1549-1552.
  5. Chen S, Zhao M, Zheng W, et al. Myringotomy and tube insertion combined with balloon Eustachian tuboplasty for the treatment of otitis media with effusion in children. Eur Arch Otorhinolaryngol. 2020; 277(5):1281-1287.
  6. Cutler JL, Meyer TA, Nguyen SA, et al. Long-term outcomes of balloon dilation for persistent Eustachian tube dysfunction. Otol Neurotol. 2019; 40(10):1322-1325.
  7. Dai S, Guan GF, Jia J, et al. Clinical evaluation of balloon dilation eustachian tuboplasty surgery in adult otitis media with effusion. Acta Otolaryngol. 2016; 136(8):764-767.
  8. Dalchow CV, Loewenthal M, Kappo N, et al. First results of Endonasal dilatation of the Eustachian tube (EET) in patients with chronic obstructive tube dysfunction. Eur Arch Otorhinolaryngol. 2016; 273(3):607-613.
  9. Gürtler N, Husner A, Flurin H. Balloon dilation of the Eustachian tube: early outcome analysis. Otol Neurotol. 2015; 36(3):437-443.
  10. Hwang SY, Kok S, Walton J. Balloon dilation for eustachian tube dysfunction: systematic review. J Laryngol Otol. 2016; 130 Suppl 4:S2-S6.
  11. Jenckel F, Kappo N, Gliese A, et al. Endonasal dilatation of the Eustachian tube (EET) in children: feasibility and the role of tubomanometry (Estève) in outcomes measurement. Eur Arch Otorhinolaryngol. 2015; 272(12):3677-3683.
  12. Kim KY, Tsauo J, Song HY, et al. Fluoroscopy-guided balloon dilation in patients with Eustachian tube dysfunction. Eur Radiol. 2017; 8; 28(3):910-919.
  13. Leichtle A, Hollfelder D, Wollenberg B, Bruchhage KL. Balloon Eustachian Tuboplasty in children. Eur Arch Otorhinolaryngol. 2017; 274(6):2411-2419.
  14. Li YQ, Chen YB, Yin GD, Zeng XL. Effect of balloon dilation eustachian tuboplasty combined with tympanic tube insertion in the treatment of chronic recurrent secretory otitis media. Eur Arch Otorhinolaryngol. 2019; 276(10):2715-2720.
  15. Llewellyn A, Norman G, Harden M, et al. Interventions for adult Eustachian tube dysfunction: a systematic review. Health Technol Assess. 2014; 18(46):1-180, v-vi.
  16. Luukkainen V, Vnencak M, Aarnisalo AA, et al. Patient satisfaction in the long-term effects of Eustachian tube balloon dilation is encouraging. Acta Otolarynol. 2018; 138(2):122-127.
  17. McCoul ED, Anand VK. Eustachian tube balloon dilation surgery. Int Forum Allergy Rhinol. 2012; 2(3):191-198.
  18. McMurran AEL, Hogg GE, Gordon S, et al. Balloon Eustachian tuboplasty for Eustachian tube dysfunction: report of long-term outcomes in a UK population. J Laryngol Otol. 2020; 134(1):34-40.
  19. Meyer T, O'Malley EM, Schlosser RJ, et al. A randomized controlled trial of balloon dilation as a treatment for persistent Eustachian tube dysfunction with 1-year follow-up. Otol Neurotol, 2018; 39(7):894-902.
  20. Ockermann T, Reineke U, Upile T, et al. Balloon dilatation eustachian tuboplasty: a clinical study. Laryngoscope. 2010; 120(7):1411-1416.
  21. Poe D, Anand V, Dean M, et al. Balloon dilation of the eustachian tube for dilatory dysfunction: a randomized controlled trial. Laryngoscope. 2018, 128(5):1200-1206.
  22. Poe DS, Silvola J, Pyykkö I. Balloon dilation of the cartilaginous eustachian tube. Otolaryngol Head Neck Surg. 2011; 144(4):563-569.
  23. Satmis MC, van der Torn M. Balloon dilatation of the Eustachian tube in adult patients with chronic dilatory tube dysfunction: a retrospective cohort study. Eur Arch Otorhinolarygnol. 2018; 275(2):395-400.
  24. Schmitt D, Akkari M, Mura T, et al. Medium-term assessment of Eustachian tube function after balloon dilation. Eur Ann Otorhinolaryngol Head Neck Dis. 2018; 135(2):105-110.
  25. Schröder S, Lehmann M, Ebmeyer J, et al. Balloon ustachian tuboplasty: a retrospective cohort study. Clin Otolaryngol. 2015; 40(6):629-638.
  26. Si Y, Chen Y, Xu G, et al. Cartilage tympanoplasty combined with eustachian tube balloon dilatation in the treatment of adhesive otitis media. Laryngoscope. 2019; 129(6):1462-1467.
  27. Silvola J, Kivekäs I, Poe DS. Balloon dilation of the cartilaginous portion of the Eustachian tube. Otolaryngol Head Neck Surg. 2014; 151(1):125-130.
  28. Singh T, Taneja V, Kulendra K, et al. Balloon Eustachian tuboplasty treatment of longstanding Eustachian tube dysfunction. J Laryngol Otol. 2017; 131(7):614-619.
  29. Skevas T, Dalchow CV, Euteneuer S, et al. Cervicofacial and mediastinal emphysema after balloon Eustachian tuboplasty (BET): a retrospective multicenter analysis. Eur Arch Otorhinolaryngol. 2018; 275(1):81-87.
  30. Song HY, Park HJ, Kang WS, et al. Fluoroscopic balloon dilation using a flexible guide wire to treat obstructive eustachian tube dysfunction. J Vasc Interv Radiol. 2019; 30(10):1562-1566.
  31. Tisch M, Meier H, Sudhoff H. Balloon dilation of the Eustachian tube; clinical experience in the management of 126 children. Acta Otolaryngol Italica. 2017; 37(6):509-512.
  32. Toivonen J, Kawai K, Gurberg J, Poe D. Balloon dilation for obstructive eustachian tube dysfunction in children. Otol Neurotol. 2021 Apr 1;42(4):566-572.
  33. Wanscher JH, Svane-Knudsen V. Promising results after balloon dilatation of the Eustachian tube for obstructive dysfunction. Dan Med J. 2014; 61(4):A4818.
  34. Williams B, Taylor BA, Clifton N, Bance M. Balloon dilation of the Eustachian tube: a tympanometric outcomes analysis. J Otolaryngol Head Neck Surg. 2016; 45:13.
  35. Xiong H, Liang M, Zhang Z, et al. Efficacy of balloon dilation in the treatment of symptomatic Eustachian tube dysfunction: one year follow-up study. Am J Otolaryngol. 2016; 37(2):99-102.
  36. Yin G, Tan J, Li P. Balloon dilation of Eustachian tube combined with tympanostomy tube insertion and middle ear pressure equalization therapy for recurrent secretory otitis media. J Otol. 2019; 14(3):101-105.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Tucci DL, McCoul ED, Rosenfeld RM, et al. Clinical consensus statement: balloon dilation of the Eustachian tube. Otolaryngol Head Neck Surg. 2019; 161(1):6-17.
Index

Eustachian tube dilation
Eustachian tuboplasty

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Reviewed

02/17/2022

Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Rationale and References sections.

Reviewed

02/11/2021

MPTAC review. Updated Rationale and References sections. Updated Coding section to remove NOC codes no longer applicable.

 

12/16/2020

Updated Coding section with 01/01/2021 CPT and HCPCS changes; added 69705, 69706,.code C9745 deleted 12/31/2020.

Reviewed

02/20/2020

MPTAC review. Updated Rationale and References sections

Reviewed

03/21/2019

MPTAC review. Updated Rationale and References sections

New

03/22/2018

MPTAC review. Initial document development.


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