Eustachian Tube Balloon Dilation: Emerging Practice Patterns for a Novel Procedure

Introduction

Eustachian tube dysfunction (ETD) is one of the most common pathologies that otolaryngologists manage, with a reported prevalence in the general population of about 0.9%.^1-4 A recent systematic review looking at over 9 million visits recorded in the National Ambulatory Medical Care Survey and National Hospital Ambulatory Medical Care Survey between 2005 and 2012 estimated over 2 million visits related to ETD annually in the United States. ⁵ The Eustachian tube connects the middle ear and the nasopharynx to allow for differential aeration to accommodate atmospheric changes in the environment and clearance of secretions. When this anatomical connection fails to properly ventilate the ear, dysfunction occurs, leading to symptoms such as aural fullness, negative pressure within the middle ear space, tinnitus, infections, discomfort, and hearing loss. ⁶

Treatment for ETD has traditionally been managed primarily with medical and surgical therapies. Medical treatment varies widely and commonly involves a combination of topical and systemic corticosteroids and/or antihistamines, which demonstrate marginal evidence for routine use in the literature.^7,8 Traditionally, surgical options were previously limited to primarily pneumatic equalization tube (PET) placement, which itself carries risks for myringosclerosis, chronic perforation, and cholesteatoma. ⁹ Unfortunately, there is a lack of convincing data supporting the efficacy of these mainstay treatment modalities.^2,10

Recently, eustachian tube balloon dilation (ETBD) has been developed and approved by the Food and Drug Administration (FDA) for the treatment of chronic ETD, providing a new tool to address this common pathology. ¹¹ Balloon technology in otolaryngology has been routinely employed for the treatment of chronic rhinosinusitis and subglottic stenosis.^12-14 The ETBD procedure serves to dilate the cartilaginous portion of the Eustachian tube, leading to histopathological changes of the eustachian tube mucosa. ¹⁵ Though the pathophysiology has not been fully elucidated, it is believed that balloon dilation induces a crush injury that spares the basement membrane and when followed by an appropriate recovery period, allows the mucosa and underlying tissues of the cartilaginous eustachian tube to heal in a more favorable and open configuration. ¹⁶

Eustachian tube balloon dilation is a novel procedure that adds to the armamentarium of the otolaryngologist for the treatment of ETD. As more otolaryngologists perform the procedure, we will gain a better understanding of its efficacy and cost-effectiveness. In this cross-sectional, survey-based study, we aim to determine when and how ETBD is being used in practice today and highlight the variations within current practice.

Materials and Methods

A 20-item online survey inquiring about current ETBD practice patterns was constructed by the authors and distributed to all members of the American Rhinologic Society (ARS), American Otological Society (AOS), and American Neurotology Society (ANS). The web link to the survey was serviced through a third-party website (Surveymonkey.com) and provided to these members via their respective online semi-annual mailings in April and May of 2017. The survey remained open for a 3-month period. Institutional Review Board exemption for this study was granted by the Research Determination Committee for Kaiser Permanente Northern California prior to survey activation.

The target group encompassed 1100 ARS members and 633 AOS/ANS members. Demographic information was requested on the survey, including respondents’ geographic location, duration in practice (years), and type of clinical practice (academic university, academic non-university, private multispecialty group, private single-specialty group, private solo). Respondents were classified as new in practice (10 years or less) or established in practice (>10 years). Geographic regions for the survey were defined as follows: New England (Maine, Vermont, New Hampshire, Massachusetts, Connecticut, Rhode Island), Mid-Atlantic (New York, New Jersey, Pennsylvania), Mountain (Wyoming, Idaho, Montana, Nevada, Utah, Colorado, New Mexico, Arizona), North Central (North Dakota, South Dakota, Nebraska, Kansas, Missouri, Iowa, Minnesota, Wisconsin, Illinois, Michigan, Indiana, Ohio), South Central (Texas, Oklahoma, Arkansas, Kentucky, Tennessee, Mississippi, Alabama, Louisiana), Southeast (Maryland, Delaware, West Virginia, Virginia, North Carolina, South Carolina, Georgia, Florida), West Coast (Washington, Oregon, California, Alaska, Hawaii), and Other.

ETBD practice patterns—training, clinical practice, preoperative evaluation, intraoperative evaluation and technique, and postoperative evaluation—were assessed. To assess training, we inquired about fellowship training and what instruction was provided on the ETBD device. To evaluate clinical practice, we asked about the medical management strategies employed for ETD, when ETBD is indicated, how myringotomy factors in to the decision to proceed with ETBD, the role of ETBD in the pediatric population, and the total number of ETBD cases each respondent had performed to date. Preoperative evaluation was assessed with questions targeting the routine clinical assessment (including Eustachian Tube Dysfunction Questionnaire [ETDQ -7], Sino-Nasal Outcomes Test–22 [SNOT-22], nasal endoscopy, and Valsalva maneuver) and objective testing (audiometry, computed tomography [CT] scans, tubomanometry, and tuboimpedence). To assess intraoperative care, we inquired about anesthesia preference and the use of concurrent myringotomy tubes. Postoperative care was evaluated with questions investigating the use of topical antibiotics, topical steroids, oral antibiotics, oral steroids, and follow-up. For answer choices, always was defined as 100% of the time, often as >70% of the time, sometimes as 30% to 70% of the time, infrequent as <30% of the time, and never as 0% of the time. Respondents were classified as high-volume respondents (>15 cases performed to date), low-volume respondents (⩽15 total cases), or those who have not yet performed any ETBD procedures. Statistical analyses included descriptive statistics, assessing frequencies and bivariate analyses using paired t tests, with threshold for significance set at P < .05.

Results

A total of 157 responses were received from our survey requests between April 2017 and August 2017: 126 (11.4% response rate) from ARS and 31 (4.9% response rate) from AOS/ANS. The majority of responses were from the continental United States (n = 142; 90%); 14 respondents reported practicing internationally, and 1 respondent was from Puerto Rico. By region, the highest response rate was seen from North Central (n = 32; 20.4%), followed by Southeast (n = 31; 19.7%), South Central (n = 25; 15.9%), Mid-Atlantic (n = 24; 15.3%), West Coast (n = 18; 11.5%), New England (n = 9; 5.7%), other (n = 15; 9.6%), and Mountain (n = 3; 1.7%). Most respondents were established in their practice (n = 108; 68.8%), whereas approximately one-third (n = 49; 31.2%) was classified as new in practice. A variety of practice settings were recorded, including 69 (43.9%) academic, 44 (28.0%) pure private practice, and 44 (28.0%) with a combination of private practice with academic affiliation. Among respondents, 44 (28.0%) self-reported as general otolaryngologists, 75 (47.8%) as rhinologists, 33 (21.0%) as otologists, 3 (1.9%) as head and neck oncologists, 1 (0.6%) as a pediatric otolaryngologist, and 1 (0.6%) as a facial plastic and reconstructive surgeon. There were no differences in response rates based on practice setting or subspecialty (P > .05).

At the time of the survey, 72 (50.3%) respondents had not performed ETBD. These responses were excluded from further analysis to concentrate on respondents who had performed the procedure. Of this cohort, 33 (23.1%) had performed 5 or fewer ETBD procedures, 17 (11.9%) between 6 and 15, 8 (5.6%) between 16 and 30, 3 (2.1%) between 31 and 50, and 10 (7.0%) had performed greater than 50 procedures (Figure 1). Specialty breakdown for those who have performed ETBD included 18 (25.4%) general otolaryngologists, 38 (53.5%) rhinologists, and 15 (21.1%) otologists, and 51 (78.1%) had received the recommended manufacturer device training, 13 (18.3%) had received device training as part of residency or fellowship, 17 (23.9%) were trained under another surgeon, and 9 (12.7%) were performing ETBD without any prior training. Additionally, practice settings remained varied among those who had performed ETBD, including 27 (38.0%), 25 (35.2%), and 19 (26.8%) respondents in an academic, private practice, and combination setting, respectively.

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Figure 1.

Eustachian tube balloon dilation case numbers by practitioner for respondents who had performed eustachian tube balloon dilation at the time of the survey.

Medical therapies employed by respondents were solicited in 4 questions. The common medical therapies included nasal corticosteroids (97.0%), oral corticosteroids (41.8%), nasal antihistamines (37.3%), oral antihistamines (34.3%), nasal decongestants (34.3%), proton pump inhibitors (31.3%), oral decongestants (28.4%), and leukotriene antagonist (17.9%). Respondents’ indications included performing ETBD on all ETD patients who failed medical management (64.5%), ETD patients with 1 ear tube placement failure (26.9%), and ETD patients with 2 or more ear tube placement failures (38.8%) (Figure 2). Only 2 respondents (3.0%) reported considering ETBD for all patients with ETD. Most respondents (80.3%) only performed ETBD in the adult population older than 18 years of age. Approximately one-quarter (24.2%) would perform revision ETBD in a patient who had already had a previous dilation.

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Figure 2.

Indications for eustachian tube balloon dilation as reported by respondents who perform this procedure.

Respondents were queried about routine preoperative management in 3 questions. Preoperative evaluation included nasal endoscopy (86.6%), pressure equalization maneuver (ie, Valsalva maneuver, Toynbee maneuver, or Politzer insufflation) (70.2%), SNOT-22 questionnaire (32.8%), and ETDQ-7 (43.3%). Nearly all respondents (95.5%) obtained a preoperative audiogram with tympanometry, while only 56.7% obtained a preoperative CT scan. Rarely did respondents obtain Eustachian tubomanometry (6.0%) or tuboimpedence studies (4.5%) prior to ETBD (Figure 3).

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Figure 3.

Preoperative workup performed by practitioners of eustachian tube balloon dilation. Respondents were allowed to choose more than 1 option. All respondents chose at least 1 modality.

Intraoperative strategies were assessed in 3 questions. Most respondents (57.6%) reported always performing ETBD under general anesthesia, while 10.6% usually or always performed the procedure under local anesthesia. Respondents’ practices with concurrent myringotomy tube placement were evaluated: 9.1% always placed an ear tube at the time of ETBD, 39.4% never placed a tube in the same setting, and 51.5% placed a tube if there were significant retractions of the tympanic membrane or a history of recurrent otitis media (Figure 4).

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Figure 4.

When to perform myringotomy. Respondents were asked when they would consider performing myringotomy with placement of ear tube in the same setting as Eustachian tube balloon dilation.

Respondents were asked about their postoperative practice patterns in 4 questions. None of the respondents stated that they always gave topical steroid and/or antibiotics after ETBD, whereas 2 (3.1%) reported that they have given these medications often, 9 (14.0%) sometimes, 15 (23.4%) infrequently, and 38 (59.4%) respondents reported not giving topical steroid and/or antibiotics after ETBD. One respondent (1.6%) reported always giving postoperative oral antibiotics, 3 (4.7%) often giving postoperative antibiotics, 6 (9.4%) sometimes, 9 (14.0%) infrequently, and 45 (70.3%) never. Two (3.1%) reported always giving postoperative oral steroids after ETBD, 6 (9.4%) often, 4 (6.25%) sometimes, 14 (21.9%) infrequently, and 38 (59.4%) never (Figure 5). All respondents recommended follow-up with ETDB patients, but the duration of follow-up varied from less than 1 month (9.4%) to between 1 and 3 months (26.6%), between 4 and 6 months (20.3%), and greater than 6 months (43.8%).

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Figure 5.

Percentage of respondents who routinely prescribe postoperative topical antibiotic or steroid drops, oral antibiotics, or oral steroids.

The overall attitude toward this novel procedure was assessed: 53.1% of respondents had a positive view, 42.2% were undecided, and 4.7% disliked ETBD and would not recommend it. In terms of coding the procedure, 70.4% of respondents listed ETBD as 69799–Unlisted procedure, middle ear. Additional coding practices included coding with 31231–Nasal endoscopy, diagnostic (21.1%); 31295/31296/31297–Nasal/sinus endoscopy, surgical; with balloon dilation (19.7%); 92511–Nasopharyngoscopy with endoscope (11.3%); and 31237–Nasal/sinus endoscopy, surgical, with biopsy, polypectomy or debridement (2.8%).

Discussion

This study is the first to investigate emerging patterns and trends in how ETBD is being used by practitioners in various practices throughout the US since FDA approval in September of 2016. Eustachian tube balloon dilation is in its infancy, and it is unclear how this technology will affect management of ETD patients. Our study assessed a variety of parameters surrounding ETBD to highlight current trends. Given the nature of ETD, we targeted specific specialty societies that were likely to perform this procedure: ARS, AOS, and ANS. The response rate of 9.1% is in keeping with previous survey studies.^17-19 There were no differences in the response rates between specialist groups, and we expect greater acceptance and use among general otolaryngologists as ETBD becomes more commonly employed.

Indications for ETBD vary widely given the broad definition of ETD, which presents a problem when considering clinical practice and objective research. ²⁰ In our study, we attempted to ascertain what indications are being used for ETBD in practice. Among respondents, 64.5% reported that they consider ETBD after failure of medical management. In our study, nearly all respondents (97.0%) reported using a trial of topical nasal steroid medication for the treatment of ETD, though the use of additional medical treatment modalities ranged from about 41.8% to 17.9%. Failure of ETD resolution after myringotomy with placement of an ear tube was a less popular indication for ETBD among respondents. The lack of specific and systematic indications for ETBD remains a subject for further research.

There is also a plethora of outcome measures used in the literature to assess efficacy of ETBD. Direct otoscopic visualization of the tympanic membrane, pneumatic otoscopy, ability to perform Valsalva and Toynbee maneuvers, tubomanometry, as well as the Eustachian tube score, which provides an objective measurement of Eustachian tube function using a weighted combination of the aforementioned outcomes on a scale from 0 to 14, have all been used.^21,22 Schröder et al ²³ reported improvement in tube scores from 3.13 (±2.47 SD) to 5.75 (±2.76 SD) after 1 year and 2.65 (±2.89 SD) to 6.26 (±3.07 SD) after 2 years. ²³ A recent meta-analysis by Hwang et al ²⁰ reported favorable outcomes after ETBD in which 7 studies assessed improvement in Valsalva or Toynbee maneuver from 20 (8%) preoperatively to 177 (72%) out of 245 ears following ETBD. Six studies^24-29 used tympanograms as their outcome metric and found that in preoperative ears, 7 out of 141 ears (5%) had a type A tympanogram, as compared to 86 out of 141 ears (61%) postoperatively. One study used quality of life measures, which showed a reduction in both ETDQ-7 and SNOT-22 pre- vs 6 month postoperative scores of 4.5 to 2.8 (p <0.001) and 51.4 to 30 (p= 0.001), respectively. Huisman et al also performed a meta-analysis of 15 studies assessing outcomes of Valsalva, otoscopy, tympanometry, and Eustachian tube score. ³⁰ Five studies (Ockermann, Reineke, Upile, Ebmeyer and Sudhoff, 2012)^24,28,29,31 found an improvement in Valsalva success after ETBD after a total of 153 procedures (Relative Risk [RR] = 0.13; 95% CI, 0.04-0.38; P = .0002). Six studies (Kivekas, Chao and Faquin, 2015)^{25,26,28,31,32} included otoscopy data with 166 procedures indicating a decline in abnormal tympanic membranes after ETBD (RR = 0.38; 95% CI, 0.07-2.05; P = .26); 9 studies (Kivekas, Chao and Faquin, 2015)^{24-26,28,29,31-33}, which included 255 total procedures with postoperative data for tympanometry, indicated a decline in the inability to dilute the Eustachian tubes (RR = 0.47; 95% CI, 0.32-0.70, P = .0002). Lastly, 3 studies ³⁴ (Ockermann, Reineke, Upile, Ebmeyer and Sudhoff, 2012) ³¹ and 670 total procedures showed a mean improvement in Eustachian tube score of 3.94 (95% CI, 2.60-5.27; P < .00001).

All FDA-approved devices are indicated for use in the adult population, though our study results show that 20% of surgeons will perform ETBD on children younger than 18 years of age.^11,36 The few studies of ETBD among children overseas has had promising results. Maier et al ³⁷ performed a retrospective analysis of 66 children who underwent ETBD in Germany. His group found no complications, with clinical improvement in over 80% of patients. ³⁷ Further study is needed before recommending ETBD in the pediatric population.

Complications appear to beuncommon without any adverse events pertaining to injury of the internal carotid artery or patulous Eustachian tube yet reported in the literature for routine use of ETBD. There currently exists a discrepancy regarding when providers will obtain a preoperative CT to rule out internal carotid artery (ICA) dehiscence and current manufacturer guidelines. The Acclarent Aera was the only approved device within the US for ETBD at the time of the survey. Acclarent specifically recommends that all patients undergo a preoperative screening for ICA dehiscence as part of their inclusion criteria before ETBD. ³⁵ Conversely, Entellis XprESS includes a screening only as part of the potential preoperative workup. ³⁸ Our study found that 56.7% of respondents routinely obtain a CT scan in their patients. Abdel-Aziz et al ³⁹ performed a retrospective analysis of almost 300 patients undergoing ETBD and found a prevalence of ICA dehiscence of 6.3%. They also noted zero adverse events in those patients who underwent balloon dilation with an ipsilateral dehiscent ICA. ³⁹ Furthermore, no study to date has demonstrated injury to the internal carotid artery after ETBD.^{9,15,22-24,39-41} Additional cost-benefit analysis on CT scans and ICA dehiscence would be helpful to define the role preoperative CT in ETBD. Eustachian tube balloon dilation surgeons should consider the implicit radiation exposure, low predictive value, and lack of serious adverse events to date when deciding on whether a preoperative CT scan is needed.

Other adverse events were reported by Schröder et al, ⁴⁰ including a case of minor epistaxis after ETBD. There have also been 2 reports of self-limited subcutaneous emphysema.^9,41 Additional reported complications include otitis media, mucosal lacerations, radiculopathy secondary to operative positioning, mild rhinitis, and temporary increased tinnitus.^23,24,26

This cross-sectional survey may have introduced recall bias as clinicians were asked to provide information on their prior practice patterns. One limitation for this study is our response rate. Though low, we believe an adequate response rate was still achieved. Nevertheless, we likely missed a subset of our target population of clinicians performing ETBD who are not members of the survey web link to the ARS and AOS/ANS societies. Admittedly, some otolaryngologists may belong to more than one of these societies, though we do not have access to these data. Responses from providers who had not yet performed ETBD at the time of the survey were retroactively filtered out of our analysis. An additional limitation of our study is that this survey was administered prior to the advent of alternative FDA-approved devices for ETBD. After the survey period, there have been additional devices manufactured for ETBD, including Acclarent Aera Eustachian Tube Balloon Dilation System (Acclarent Inc, Irvine, California, USA), Entellis XprESS ENT Dilation System (Entellus Medical Inc, Plymouth, Minnesota, USA), and Bielefeld balloon catheter by Spiggle & Theis (Spiggle & Theis, Medizintechnik GmbH Overath, Germany; only available in Europe). It is unlikely that varying devices produce differing patient outcomes, though no randomized control trials are yet available to confirm this. Operator comfort and familiarity is likely to be the largest contributing factor in success of one device over another.

Conclusion

Eustachian tube balloon dilation is a novel surgical technique recently approved by the FDA for use in the US for treatment of chronic ETD. We performed a practice pattern survey to ascertain how this technique is currently being used in the US. As this procedure gains more traction with practicing otolaryngologists, its role will continue to be better defined, including the indications for use, role of preoperative CT screening, timing of ETBD after failure of medical management, and role for ETBD in the pediatric population. Further high-level studies on ETBD will help direct evidence-based recommendations and guide practice patterns for the treatment of ETD. The introduction of alternative devices and specific reimbursement codes will continue to evolve this exciting niche practice.