The Use of Balloon Eustachian Tuboplasty in Patients with Eustachian Tube Dysfunction: A Retrospective Pilot Usage Experience

Abstract

Chronic eustachian tube dysfunction is a condition that affects a large number of adults every year. While many cases can be managed pharmacologically, there is a significant portion that does not respond to medical treatment alone. Invasive methods from the aural side like grommet or tympanic tube insertion have complications associated with it and often cannot address the underlying condition of the nasopharyngeal side of the eustachian tube. Balloon eustachian tuboplasty (BET) is a minimally invasive intervention that has been used successfully in countries like Germany and USA in the past decade. This paper presents the experience of a new clinical user of BET in India by retrospectively looking at the outcomes of the first 10 patients on which the procedure was performed. A marketed product EustaCare was used for the cases. There was a 90% procedural success rate within 4 weeks with one patient showing no improvement in symptoms even after 8 weeks. There were no adverse events associated with the procedure nor technical issues with the product. The product is easy to learn and use. Further study is needed to draw any conclusions on long term safety and efficacy, though historical records and preliminary results for this procedure described in this paper seem promising.

Electronic supplementary material

The online version of this article (10.1007/s12070-020-01822-z) contains supplementary material, which is available to authorized users.

Introduction

While India specific data on eustachian tube dysfunction (ETD), global data suggests that the Eustachian tube dysfunction affects at least 1% of adults [1, 2]. In India, that would amount to 13–14 million patients, suffering from acute or chronic Eustachian tube dysfunction. This is based on an estimation from 2011 Census data and baseline population growth rate [3]. Traditional treatment options available in India include pharmacological agents, mechanical devices and nasal surgery. However, these interventions are ineffective in 25–35% of patients [1, 4].

Balloon eustachian tuboplasty (BET) is a minimally invasive intervention for chronic ETD that is just being introduced in India but is reasonably well established in the USA and Europe. It aims to improve tube compliance and middle-ear ventilation through mechanical dilation of the cartilaginous Eustachian tube. This dilation is believed to trigger histopathological changes to the mucosa that may alter the inflammatory process [3]. However, Eustachian tube balloon dilation is a relatively new procedure, and the operative technique needs further studies to confirm its efficacy and complications. This paper captures the experience of 10 patients who underwent standalone BET as a treatment for their unresolved BET. The study covers the indications, safety, short term efficacy from follow up.

Materials and Methods

This was a retrospective study where the charts of patients who underwent BET in a 6-month period (January through June 2019) were included. The objective of this study was to assess the safety, usability and short-term efficacy of EustaCare, an indigenous BET product, in a clinical setting at a Tertiary Care Centre. The EustaCare system included a disposable balloon dilator, a reusable angled guide and an off the shelf pressurized inflation device.

The pre-procedure protocol involves autoclaving the guide followed by insertion of the sterile balloon into it. The balloon is connected to the inflation device that has been filled with 10–15 ml of saline and voided of air.

The guide is inserted into the natural nasal orifice and directed towards the paranasal opening of the Eustachian tube. The balloon is then guided into the ET up to the boney isthmus followed by inflating it to 10 atmospheres (bar) pressure. The pressurized balloon is held in place for 30–120 s. After deflating the balloon, it is retracted back into the guide and the system removed from the nose. Excess secretions can be suctioned at this point and packs or gauze used to clean the opening. The entire procedure is done under direct endoscopic visualization and can be done under local or general anesthesia.

Patients above the age of 18, who were not pregnant and who had not responded to medical management for at least 6 weeks were considered for BET. The patients who underwent the procedure did not have any contraindications like requiring other surgeries, having clotting disorders or any concurrent severe condition that would make them unsuitable for sedation and anesthesia.

The assessment parameters common for patients included:

• Clinical symptoms

• ETDQ-7 scores

• Tympanometry (for non-perforations)

• Tympanic membrane examination

Each patient was followed up with for 4 weeks or until symptom resolution (whichever came first). Further patients were asked to come in if recurrence, adverse event or resolution happened at any time in the following weeks.

Informed consent for the procedure was obtained from all patients, which included permission to use data for research purposes. The hospital approved the use of the device prior to use on any patients. EustaCare is a marketed device, and this was not an investigational prospective study.

Results

In total, 10 patients were included in the study. The average age of the cohort was 32 years. 8 of the 10 patients were male (80%), and 2 were female (20%).

The first patient was tried under LA but converted to IV sedation due to lack of cooperation. All patients after that were treated under the same anesthesia condition. All procedures were standalone BET procedures with no other ear or nose procedure happening during the duration of the study.

There were no technical issues with the product and no serious adverse events. A minor ooze of blood was seen in some cases which resolved itself without need for intervention. Some patients complained of some pain following the procedure which also resolved itself without need for intervention. Patients were followed for 8 weeks (checks every week) for symptom resolution. No follow up ETDQ-7 scoring was done. Tympanometry was done for all patients without perforations but showed no abnormality. Tympanometry did not show any significant change before and after the procedure. Table 1 summarizes the results.

Table 1.

Overview of BET cases

Sr. no	Gender	Age	Tympanic membrane	Side/s treated	Initial ETDQ-7 score	Time for resolution
1	Male	55	Normal	Left	49	< 2 weeks (10 days)
2	Male	30	Normal	Bilateral	33	2 weeks
3	Male	60	Central Perforation	Left	21	3 weeks
4	Male	59	Normal	Left	34	2 weeks
5	Female	49	Normal	Bilateral	21	No resolution even at 8 weeks
6	Male	70	Central Perforation	Right	33	3 weeks
7	Male	65	Normal	Bilateral	35	2 weeks
8	Female	55	Normal	Bilateral	35	2 weeks
9	Male	30	Normal	Bilateral	33	2 weeks
10	Male	60	Normal	Left		2 weeks

There was a 90% procedural success rate within 4 weeks with one patient showing no improvement in symptoms even after 8 weeks. Cases were done between January and May 2019. As of September 15th 2019, there has been no recurrence in any of the 9 patients that had symptom resolution. The average time for confirmed resolution was 15 days with most patients reporting an immediate improvement of symptoms after the procedure.

Table 2 shows the significant clinical symptoms that were assessed as part of diagnosing chronic ETD and confirming resolution.

Table 2.

Clinical symptoms for ETD patients

Sr. no	Ear block	Tinnitus	Pain	Discharge
1	Yes	Yes	No	No
2	Yes	Yes	Yes	No
3	Yes	No	Yes	Yes
4	No	Yes	No	No
5	Yes	Yes	No	No
6	Yes	No	Yes	Yes
7	Yes	Yes	Yes	No
8	Yes	Yes	No	No
9	No	Yes	Yes	No
10	Yes	No	Yes	No

Discussion

Chronic Eustachian tube dysfunction that does not respond to medication affects a large number of people each year. Balloon Eustachian tuboplasty seems to be gaining acceptance as a safe and effective procedure. BET has proven effective in 90% of patients in this case series within four weeks of the procedure.

Published literature of various types of ETD showed an improvement in short-term and long-term follow-up [5]. Follow up in previously published studies ranged from immediately post-op to up to 5 years. Thus, it can be considered a reasonably effective procedure and a suitable intervention for adult patients suffering ETD and not responding to medication.

The procedure can be done under any anesthesia that the patient will tolerate and takes less than 5 min per Eustachian Tube. There is no specific pre-op and post-op care required beyond what would be prescribed to patients undergoing nasal surgery.

The EustaCare device is easy to use and provides sufficient visual and tactile feedback during the procedure. It can be used single-handedly with another person required for the inflation step.

The study is limited as a retrospective review as it lacks follow up ETDQ-7 score data and clear, quantifiable improvements. The limited number of subjects also prevents the drawing of any conclusions beyond reporting the results from the clinical experience of one doctor. However, success at this early stage is a positive indication for the procedure.

Conclusion and Way Forward

More extensive prospective studies with longer follow up, and more subjects are needed to make definitive conclusions and better understand the indications for the procedure and long-term efficacy.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Funding

This is not a sponsored study.

Compliance with Ethical Standards

Conflict of interest

One author, Pooja Kadambi is employed by the company that makes the product used in this study. However, she did not have anything to do with device usage or data collection, thus there is no conflict of interest.

Ethical Approval

This study was conducted as an independent retrospective study. This does constitute as human subject research to the extent that the treating physician and author Dr. Narendran Ramakrishnan had access to patient records. The second author only had access to de-identified patient data.

Informed Consent

Informed consent was gathered from all patients undergoing the procedure including consent to use data towards scientific research and publications.