Medical Policy

 

Subject: Balloon Dilation of the Eustachian Tubes
Document #: SURG.00151 Publish Date:    04/25/2018
Status: New Last Review Date:    03/22/2018

Description/Scope

This document addresses the use of balloon dilation of the Eustachian tubes, 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 this technique (Bast, 2013; Catalano, 2012; Dai, 2016; Gürtler, 2015; Jenckel, 2015; Kim, 2017; Leichtle, 2017; Luukkainen, 2018; McCoul, 2012; Poe, 2011; Satmis, 2018; Schmitt, 2017; Silvola, 2014; Singh, 2017; Tisch, 2017; Wanscher, 2014; Williams, 2016; Xiong, 2016).  These studies, while offering interesting information, provide little in the way of rigorous data evaluating the safety, efficacy, and long-term outcomes of balloon dilation of the Eustachian tubes.

To date, there has only been one randomized controlled trial (RCT) addressing this issue.  Poe and colleagues (2017) reported the results of a study involving 242 subjects (351 ears) with persistent Eustachian tube dilatory dysfunction, refractory to medical management with daily intranasal steroids or a single course of oral steroids.  Subjects were randomized in a 2:1 manner to undergo treatment with balloon dilation (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 typanomanometry, 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 balloon 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 balloon group before the 12-week follow-up (82%, 59/71).  At the 6-week follow-up, significantly more balloon group subjects had normal tympanograms (51.8% vs. 13.9%, p<0.0001).  At 24 weeks, tympanogram normalization was 62.2% in the balloon 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 balloon subjects and 5.7% of controls (no p-value provided).  Improvement in the ETDQ-7 was significantly greater in the balloon 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 balloon 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.

In 2015, Schröder reported the results of a large case series study involving 622 subjects aged 7 and older (1076 dilations) who underwent balloon dilation of the Eustachian tubes.  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, n=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 3,670 procedures in 2,272 subjects treated with balloon dilation of the Eustachian tubes 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%.

At this time there is insufficient evidence to support the safety and efficacy of balloon dilation devices 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, 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.

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

 

30999

Unlisted procedure, nose [when specified as nasal endoscopy with balloon dilation of eustachian tube]

69799

Unlisted procedure, middle ear [when specified as balloon dilation of eustachian tube, any approach]

 

 

HCPCS

 

C9745

Nasal endoscopy, surgical; balloon dilation of eustachian tube

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. 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.
  2. Catalano PJ, Jonnalagadda S, Yu VM. Balloon catheter dilatation of Eustachian tube: a preliminary study. Otol Neurotol. 2012; 3(9):1549-1552.
  3. 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.
  4. 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.
  5. Gürtler N, Husner A, Flurin H. Balloon dilation of the Eustachian tube: early outcome analysis. Otol Neurotol. 2015; 36(3):437-443.
  6. Hwang SY, Kok S, Walton J. Balloon dilation for eustachian tube dysfunction: systematic review. J Laryngol Otol. 2016; 130 Suppl 4:S2-S6.
  7. 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.
  8. 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.
  9. Leichtle A, Hollfelder D, Wollenberg B, Bruchhage KL. Balloon Eustachian Tuboplasty in children. Eur Arch Otorhinolaryngol. 2017; 274(6):2411-2419.
  10. 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.
  11. 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.
  12. McCoul ED, Anand VK. Eustachian tube balloon dilation surgery. Int Forum Allergy Rhinol. 2012; 2(3):191-198.
  13. Ockermann T, Reineke U, Upile T, et al. Balloon dilatation eustachian tuboplasty: a clinical study. Laryngoscope. 2010; 120(7):1411-1416.
  14. Poe D, Anand V, Dean M, et al. Balloon dilation of the eustachian tube for dilatory dysfunction: arandomized controlled trial. Laryngoscope. 2017 Sep 20. [Epub ahead of print]
  15. Poe DS, Silvola J, Pyykkö I. Balloon dilation of the cartilaginous eustachian tube. Otolaryngol Head Neck Surg. 2011; 144(4):563-569.
  16. 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.
  17. Schmitt D, Akkari M, Mura T, et al. Medium-term assessment of Eustachian tube function after balloon dilation. Eur Ann Otorhinolaryngol Head Neck Dis. 2017 Dec 27. [Epub ahead of print]
  18. Schröder S, Lehmann M, Ebmeyer J, et al. Balloon ustachian tuboplasty: a retrospective cohort study. Clin Otolaryngol. 2015; 40(6):629-638.
  19. 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.
  20. 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.
  21. 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.
  22. 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.
  23. Wanscher JH, Svane-Knudsen V. Promising results after balloon dilatation of the Eustachian tube for obstructive dysfunction. Dan Med J. 2014; 61(4):A4818.
  24. 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.
  25. 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.
Index

Eustachian tube dilation
Eustachian tuboplasty

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Document History
Status Date Action

New

03/22/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. Initial document development.