Danish ENT surgeon DR MARTIN NUE MØLLER discusses use of the procedure as a treatment for chronic otitis media in children.
Eustachian tube balloon dilation can be a first line tool in the treatment of chronic otitis media in children. We are undertaking a multi-national clinically controlled, randomised, patient blinded, prospective trial of this therapy.
The cumulative incidence of otitis media with effusion in Denmark for children younger than seven years is 61%, making the disease one of the most common in Danish children.
Denmark also has one of the world’s highest prevalence’s of ventilation tube (grommet) treatment, which is as high as 26% of chronic otitis media (COME) patients. Almost 16% of all Danish children under seven are treated with ventilation tubes at least once and some materials suggest this is as high as 25%.
Up to half of children treated with ventilation tubes fail to recover from COME and are treated with a second ventilation tube within the first two years of treatment. In Denmark with a population of only 5.9 million people, more than 18,000 children are treated with ventilation tubes every year.
It is commonly accepted that the main reason for the disease is Eustachian tube dysfunction.
Children under seven have different anatomy of the Eustachian tube, with a more horizontal angle of the tube which causes slightly impaired ability to open due to the less efficient pull from the pharyngeal muscles.
Also, an enlarged tuba-tonsil (local inflammatory burden of the posterior lip of the Eustachian tube orifice) contributes to dysfunction. The latter is a very common phenomenon in children under seven and has the same characteristics as adenoids, both functional and histological.
The principal result of balloon dilation of the Eustachian tube appears to be a reduction of inflammatory epithelial changes and submucosal inflammatory infiltrate of the tuba tonsil. The effect is much like that seen after adenoid removal. However, Eustachian tube dilation is not included in any part of the treatment of COME in Denmark. It is used in first and second line treatment in countries such as Germany and the USA.
Several studies have shown that balloon dilation of the Eustachian tube in children may be effective in treating COME and perhaps be better than grommets.
Primary and secondary endpoints
If included in our study, patients with verified COME will have bilateral grommets and only balloon dilation of one ear. Patients will be their own control. We will evaluate the effectiveness of Eustachian tube dilation in those older than two and younger than seven through the need of a second grommet later when the first is extruded (failure to treatment).
The secondary endpoint will be assessment of the prevalence of adenoids higher than Cassano grade 2 in children with COME aged two to seven years. These patients will be excluded from the study after verification by nasal endoscopy under full anesthesia.
Potential benefits
The socioeconomic burden from COME in children is huge. Patients and parents often have multiple assessments and consultations with ENT practitioners, as well as high sick-leave, loss of sleep at night, recurrent acute otitis media, delayed speech development and failure to thrive.
There is no relevant medication for patients under four, but betamethasone may be used for children aged four to seven with questionable effect and compliance. Grommets is a symptomatic treatment and introduces risks such as 3% tympanic membrane perforation, risk of infections, clogging, hearing deterioration and some literature even suggests secondary cholesteatoma. Further, 50% will need a second grommet and full anesthesia.
Balloon dilation seeks to treat the cause of the disease and, if proven effective in the first line study, it may prevent the need for a second grommet for 50% of patients. If we succeed in showing benefit from this study, a second study is warranted and should be planned as a direct comparison between grommets and balloon dilation in a randomised, clinical study.
A Queensland Children’s Hospital Department of Otolaryngology systematic review and meta-analysis of outcomes after balloon dilation of the Eustachian tube in children was published in the Australian Journal of Otolaryngology on 15 March 2024.
Reviewers said there was hesitancy in performing it in children due to their shorter and more horizontal Eustachian tube.
The review concluded balloon dilation of the Eustachian tube was ”a safe and potentially effective procedure for the treatment of obstructive Eustachian tube dysfunction” but prospective cohort studies and randomised controlled trials were needed before it could be recommended as evidence-based management.
The potential impact from our study is massive and could affect millions of children world-wide, from a socioeconomic perspective and a paediatric healthcare perspective.
About the Author: Dr Martin Nue Møller is a Danish ENT surgeon and founder of Venteus surgical devices for otorhinolaryngology, head and neck surgery.
