Coverage Policy Manual
Policy #: 2018007
Category: Surgery
Initiated: February 2018
Last Review: February 2019
  Balloon Dilation of the Eustachian Tube

Description:
The Eustachian tube (ET) connects the middle ear space to the nasopharynx. It is approximately 36 mm long in adults. The ET ventilates the middle ear space to equalize pressure across the tympanic membrane, clears mucociliary secretions, and protects the middle ear from infection and reflux of nasopharyngeal contents (Schilder, 2015). The tube opens during swallowing or yawning.
 
Eustachian tube dysfunction (ETD) occurs when the functional valve of the ET fails to open and/or close properly. This failure may be due to inflammation or anatomic abnormalities. ET dilatory dysfunction (ETDD) is most commonly caused by inflammation including rhinosinusitis and allergic rhinitis. ETDD can cause symptoms such as muffled hearing, ear fullness, tinnitus, and vertigo (Seibert, 2006). Chronic ETDD can lead to hearing loss, otitis media, tympanic membrane perforation, and cholesteatomas.
 
Medical management of ETDD is directed by the underlying etiology: treatment of viral or bacterial rhinosinusitis; systemic decongestants, antihistamines, or nasal steroid sprays for allergic rhinitis; behavioral modifications and/or proton pump inhibitors for laryngopharyngeal reflux; and treatment of mass lesions. Although topical nasal steroids are commonly used for ETDD, triamcinolone acetonide failed to show benefit in patients ages 6 and older presenting with otitis media with effusion and/or negative middle ear pressure in a randomized, placebo-controlled, double-blind trial published in 2011 (Gluth, 2011). Patients who continue to have symptoms following medical management may be treated with surgery. Available surgical management includes myringotomy with placement of tympanostomy tubes or eustachian tuboplasty. There is limited evidence and no randomized controlled trials supporting use of these surgical techniques. Norman et al (2014) reported that eustachian tuboplasty (other than balloon dilation) has been evaluated in 7 case series and was associated with improvement in symptoms in 36% to 92% of patients with low rates (13%-36%) of conversion to type A tympanogram (which is normal). Myringotomy and tympanostomy have been evaluated in 2 case series and were associated with symptom alleviation in a subgroup of patients (Norman, 2014).
 
Balloon dilation is a tuboplasty procedure intended to improve the patency of the cartilaginous eustachian tube. During the procedure, a saline-filled balloon catheter is introduced into the Eustachian tube through the nose using a minimally invasive transnasal endoscopic method. Pressure is maintained for approximately 2 minutes after which the balloon is emptied and removed. The procedure is usually performed under general anesthesia (Poe, 2011; Schroder, 2015).
 
REGULATORY STATUS
In September 2016, the AERA® (Acclarent) was granted a de novo 510(k) classification by the U.S. Food and Drug Administration (FDA) (class II, FDA product code: PNZ). The new classification applies to this device and substantially equivalent devices of this generic type. The AERA® is cleared for dilating the Eustachian tube in patients ages 22 and older with persistent ETD.
In December 2016, the XprESS™ ENT Dilation System (Entellus Medical, Plymouth, MN) was cleared for marketing by FDA through the 510(k) process (K163509). FDA determined that this device was substantially equivalent to existing devices for use in Eustachian tube dysfunction. The predicate devices are XprESS™ Multi-Sinus Dilation System and AERA® Eustachian Tube Balloon Dilation System.
 
Coding:
There is a specific HCPCS code for this service effective 7/1/2017
 
C9745: Nasal endoscopy, surgical; balloon dilation of eustachian tube

Policy/
Coverage:
Effective February 2018
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Balloon dilation of the Eustachian tube for treatment of patients with chronic Eustachian tube dilatory dysfunction does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, balloon dilation of the Eustachian tube for treatment of patients with chronic Eustachian tube dilatory dysfunction is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Rationale:
This evidence review was created in February 2018 with a search of the MEDLINE database through October 16, 2017.
 
Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.
 
To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.
 
BALLOON DILATION FOR EUSTACHIAN TUBE DYSFUNCTION
The evidence for balloon dilation for Eustachian Tube Dysfunction (ETD) consists of case series, systematic reviews of these case series, and a 2017 RCT. Huisman et al provided pooled results while Hwang et al provided qualitative summaries only (Huisman, 2018; Hwang, 2016). Most selected case series provided follow-up of less than a year. One series with 78 patients had a mean of 12 months of follow-up and another with 37 patients had a mean of 18 months of follow-up. All case series reported that patients experienced improvement when comparing symptoms before and after balloon dilation. The selected studies differed with respect to other treatments for ETD used before and after balloon dilation. In Huisman (2017), revisions due to failure of the first ET balloon dilation procedure were reported in 3 of the 15 studies (n=714 patients); 122 revisions were reported.
 
Randomized Controlled Trials
One 2017 published RCT (n-323) has compared balloon dilation of the Eustachian tube (BDET) with ET balloon catheter (ETBC) plus medical management vs medical management alone (Poe, 2017). The balloon catheter used in the trial was a custom-designed ET balloon catheter (Acclarent). The RCT results are also described in the AERA (Acclarent) de novo summary from the Food and Drug Administration (FDA, 2015).  A second RCT (NCT02391584) was described in a single paragraph in the XprESS device 510(k) FDA summary (FDA, 2017). However, the results have not been published and the information provided is not sufficient for evaluation.
 
Eligible patients in Poe et al had persistent patient-reported symptoms of ETD (ETDQ-7; mean item score, ≥2.1) and abnormal tympanometry (type B or type C), and failed medical management including either a minimum of 4 weeks of daily use of any intranasal steroid spray or a minimum of one course of an oral steroid (Poe, 2017). Each investigator was required to perform 3 successful ETBC procedures in nonrandomized “lead-in” patients who were then followed for durability and safety outcomes. Randomization and analyses were performed at the person-level whether or not the patient had unilateral or bilateral ETD. The primary efficacy outcome (normalization of tympanometry) was assessed by both site investigators and a blinded, independent evaluator; discrepancies were resolved by a second independent evaluator. For bilaterally treated patients, both ears had to be rated as normalized for that patient to be considered normalized for the primary outcome. Patients completed follow-up visits at 2, 6, 12, 24, and 52 weeks but data from the 52-week visit have not been reported. Patients in the medical management arm were allowed to receive BDET after the 6-week visit. Trial enrollment was stopped early after the second preplanned look when the prespecified O’Brien-Fleming stopping boundary for the primary outcome was crossed.
 
At baseline, the mean ETDQ-7 score was 4.7, 43% of patients had allergic rhinitis, and 61% of patients had at least 1 prior ear tube surgery. By the second interim analysis, 162 patients had been assigned to ETBC and 141 were included in analysis; 80 been assigned to medical management and 72 were included in analysis. Patients were included in analysis if they received the study treatment for which they were randomized and had 6-week follow-up data. Approximately 52% of ETBC patients experienced tympanogram normalization at 6 weeks compared with 14% of medical management patients (p<0.001). The publication reported that sensitivity analysis was performed to test the robustness of results for the impact of missing data in the analysis cohort vs an intention-to-treat cohort but the method of sensitivity analyses was not described. It was noted that there was a significant treatment by site interaction. Two sites had a higher percentage of tympanogram normalization for MM subjects than for ETBC subjects while the remaining sites had higher normalization for ETBC. The pre-specified secondary efficacy outcome (percentage with minimal clinically important difference change of 0.5 points on ETDQ-7) was not reported in the publication but was reported in the FDA summary. The minimal clinically important difference change in ETDQ-7 scores was observed for 91% of ETBC patients at 6 weeks compared with 45% of medical management patients (p not reported). Fifty-six percent of ETBC patients had an ETDQ-7 mean item score of less than 2.1 at 6 weeks compared with about 9% of medical management patients (p<0.001).
 
Comparative analyses were not possible after 6 weeks because 82% of medical management patients elected to ETBC after 6 weeks. Durability of the effect is supported by analysis of tympanogram normalization in 170 patients with week 24 data (98 randomized to ETBC and 74 from the lead-in); 62% of those randomized to ETBC and 58% of lead-in patients demonstrated tympanogram normalization at 24 weeks. Data from 52 weeks have not been reported.
 
Adverse events were only briefly described in the publication but are more fully described in the Food and Drug Administration summary (FDA, 2015). Two-hundred ninety-nine patients who were treated with ETBC were included in the safety analysis (80 lead-in patients, 149 patients randomized ETBC, 70 patients randomized to medical management who received ETBC). There were 16 nonserious device or procedure-related adverse events in 13 patients most commonly, epistaxis and ETD. Two patients had 3 potentially device-related adverse events: mucosal tear, worsened ETD, and conductive hearing loss. The potentially device- or procedure-related adverse events were mild or moderate in severity and resolved without sequelae. Five serious adverse events were reported (4 events in the BDET group, 1 event in the MM group); all were thought to be unrelated to device, procedure, or medications.
 
Although several medical and surgical treatments are used for ETD, none has strong evidence demonstrating effectiveness. Balloon dilation of the Eustachian tube has been evaluated in case series, systematic reviews of case series, and a published RCT. Most assessed case series provided follow-up of less than a year and all showed short-term improvement comparing symptoms before and after balloon dilation. The number of revisions needed due to failure of the initial ET balloon dilation procedure was reported in 3 case series (n=714 patients); 122 revisions were reported. In the published RCT, balloon dilation plus medical management was compared with medical management alone, with comparative data available at 6 weeks of follow-up. The trial was stopped early due to significant benefit of the balloon dilation compared with medical management at the second preplanned analysis. A greater proportion in the balloon dilation group demonstrated tympanogram normalization (52%) compared with the medical management group (14%) at 6 weeks and reported reduction in symptoms at 6 weeks on a validated questionnaire (ETDQ). The tympanogram outcome was assessed by blinded evaluation but the symptom scores were patient-reported and patients were not blinded (ie, there was no sham procedure); therefore, results could have been biased. Hearing outcomes were not reported. Intention-to-treat analyses were not shown, but a sensitivity analysis showing robustness of the results to missing data was reportedly performed. There was variability in the treatment effect as 2 (of 21) sites did not show benefit for balloon dilation, which the investigators suggested could have been due to device and procedural learning curve of the study staff or problems with protocol compliance. The rate of adverse events was low and none of the serious adverse events was thought to be related to the device or procedure. The trial was designed to follow patients for 52 weeks but long term data have not yet been reported. Durability of effect, rates of reoperation or revisions, and safety data over the first year are needed.
 
SUMMARY OF EVIDENCE
For individuals who have chronic Eustachian tube dilatory dysfunction despite medical management who receive balloon dilation of the Eustachian tube, the evidence includes case series, systematic reviews of case series, and a randomized controlled trial. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. The criteria for diagnosing Eustachian tube dilatory dysfunction (ETDD) are not standardized. Several medical and surgical treatments are used for ETDD but there is limited evidence for available treatments. Most case series assessed herein provided follow-up of less than a year and all showed short-term improvement comparing symptoms before and after balloon dilation. The number of revision procedures required due to failure of the first Eustachian tube balloon dilation procedure was reported in 3 case series (n=714 patients); 122 revisions were reported. In the published RCT evaluating balloon dilation of the Eustachian tube, patients were eligible if they reported persistent ETDD symptoms as measured on the 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7), a tool to assess symptoms, and had abnormal tympanometry. A greater proportion of patients in the balloon dilation group demonstrated tympanogram normalization (52%) compared with the medical management group (14%) at 6 weeks and reported reduction in symptoms at 6 weeks on the ETDQ-7. Durability of effect at 24 weeks was demonstrated in a subset of patients. The rate of adverse events was low and none of the serious adverse events were thought to be related to the device or procedure. The 52-week follow-up data have not been reported. Durability of effect, rates of reoperation or revisions, and safety data over the first year are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.
 
PRACTICE GUIDELINES AND POSITION STATEMENTS
National Institute for Health and Care Excellence
In 2011, the National Institute for Health and Care Excellence published guidance on balloon dilation of the Eustachian tube (NICE, 2011). The guidance stated: “Current evidence on the efficacy and safety of balloon dilatation of the Eustachian tube is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research, which should address the efficacy of the procedure in the short and longer term, and also document safety outcomes..”
 
U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS
Not applicable.
 
ONGOING AND UNPUBLISHED CLINICAL TRIALS
Some currently unpublished trials that might influence this review are summarized below.
 
NCT02391584     XprESS Eustachian Tube Dilation Study                                        
                                 Planned Enrollment: 70  
                         Expected completion date: Sep 2017 (ongoing)  
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2019. No new literature was identified that would prompt a change in the coverage statement.                                                                                                                        

CPT/HCPCS:
C9745Nasal endoscopy, surgical; balloon dilation of eustachian tube

References: Food and Drug Administration.(2015) De Novo Classification Request For Acclarent Aera™ Eustachian Tube Balloon Dilation System. 2015; https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN150056.pdf. Accessed January 2, 2018.

Food and Drug Administration.(2017) 510(k) Summary: XprESS ENT Dilation System. 2017; https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163509.pdf. Accessed January 2, 2018.

Gluth MB, McDonald DR, Weaver AL, et al(2011) Management of eustachian tube dysfunction with nasal steroid spray: a prospective, randomized, placebo-controlled trial. Arch Otolaryngol Head Neck Surg. May 2011;137(5):449-455. PMID 21576556

Huisman JML, Verdam FJ, Stegeman I, et al.(2018) Treatment of Eustachian tube dysfunction with balloon dilation: A systematic review. Laryngoscope. Jan 2018;128(1):237-247. PMID 28799657

Hwang SY, Kok S, Walton J.(2016) Balloon dilation for eustachian tube dysfunction: systematic review. J Laryngol Otol. Jul 2016;130 Suppl 4:S2-6. PMID 27488333

Katz J.(2002) Handbook of Clinical Audiology. 5th ed. Baltimore: Lippincott Williams & Wilkins; 2002.

Llewellyn A, Norman G, Harden M, et al.(2014) Interventions for adult Eustachian tube dysfunction: a systematic review. Health Technol Assess. Jul 2014;18(46):1-180, v-vi. PMID 25029951

McCoul ED, Anand VK, Christos PJ.(2012) Validating the clinical assessment of eustachian tube dysfunction: The Eustachian Tube Dysfunction Questionnaire (ETDQ-7). Laryngoscope. May 2012;122(5):1137-1141. PMID 22374681

National Institute for Health and Care Excellence.(2011) Balloon Dilation of the Eustachian tube [IPG 409]. 2011; https://www.nice.org.uk/guidance/ipg409/chapter/1-Guidance. Accessed October 28, 2017.

Norman G, Llewellyn A, Harden M, et al.(2014) Systematic review of the limited evidence base for treatments of Eustachian tube dysfunction: a health technology assessment. Clin Otolaryngol. Feb 2014;39(1):6-21. PMID 24438176

Poe D, Anand V, Dean M, et al.(2017) Balloon dilation of the eustachian tube for dilatory dysfunction: A randomized controlled trial. Laryngoscope. Sep 20 2017. PMID 28940574

Poe DS, Hanna BM.(2011) Balloon dilation of the cartilaginous portion of the eustachian tube: initial safety and feasibility analysis in a cadaver model. Am J Otolaryngol. Mar-Apr 2011;32(2):115-123. PMID 20392533

Schilder AG, Bhutta MF, Butler CC, et al.(2015) Eustachian tube dysfunction: consensus statement on definition, types, clinical presentation and diagnosis. Clin Otolaryngol. Oct 2015;40(5):407-411. PMID 26347263

Schroder S, Lehmann M, Ebmeyer J, et al.(2015) Balloon Eustachian tuboplasty: a retrospective cohort study. Clin Otolaryngol. Dec 2015;40(6):629-638. PMID 25867023

Seibert JW, Danner CJ.(2006) Eustachian tube function and the middle ear. Otolaryngol Clin North Am. Dec 2006;39(6):1221-1235. PMID 17097443


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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