Balloon Dilation: a Minimally-Invasive Alternative to Grommets

Posted on 5 February 2018

Balloon Dilation Eustachian Tuboplasty (BET) is a minimally invasive interventional method to treat chronic obstructive Eustachian Tube Dysfunction in carefully-selected patients (Eustachian Tube Dysfunction, 2nd Edition Holger Sudhoff et al, UniMed 2017). It offers a valid and permanent alternative to repeat grommets in both adults and children. An ENT surgeon at Mediclinic Constantiaberg, Dr Michael Molyneaux, explains further.

Eustachian Tube Dysfunction (ETD) is one of the most common problems seen in ENT clinics with a prevalence of at least 1%. ETD is diagnosed by looking at symptoms and signs associated with pressure dysregulation in the ear such as a persistent blocked ear, acute otitis media, otitis media effusion, eardrum retractions or adhesions and chronic middle ear infections as well as the inability to equalise pressure in the ear when experiencing changes in air pressure (flying, diving or swimming). This can then lead to severe ear pain and even burst eardrums. Diagnosis involves suggestive symptoms and signs on history (with the completion of a questionnaire) and examination in combination with special investigations to evaluate the Eustachian tube function and middle ear function.

Balloon Dilation Eustachian Tuboplasty (BET) is not reserved only for adults with Eustachian tube dysfunction or who have had multiple sets of grommets. It is also indicated in children over the age of two (ideally four) with Eustachian tube dysfunction who have failed medical management and had at least two sets of grommets as well.

Balloon Dilation Eustachian Tuboplasty for Adults

‘Adult candidates for the surgery may have been diagnosed with a Eustachian Tube Dysfunction at an early age or developed problems at a later stage. A suggestive history would include multiple sets of grommets as a child and even as an adult, an inability to equalise (the Valsalva maneuver), pain or pressure in the ears during flying or diving which does not relieve with equalisation attempts, chronic middle ear infections or chronic fluid retention (middle ear effusion) in the ears and hearing loss due to middle ear dysfunction,’ says Dr Molyneaux.

His first adult patient, a 26-year-old male presented with fluid build up in his middle ears, hearing loss and retracted eardrums. He had had 11 sets of grommets during his life and was also using long-term nasal medication. As his hearing loss was impeding his work and he did not want another set of grommets, he sought a permanent solution that would allow him to equalise the pressure in his ears with ease and improve his hearing. Dr Molyneaux performed a balloon dilation. Three days later the patient could equalise his middle-ear pressures and a year-and-a-half later he has not needed to have grommets inserted and no longer suffers from hearing loss.

BET for children

‘Children who are candidates for the surgery have had at least two sets of grommets and their nasal problems addressed such as removal of their adenoids/tonsils or their allergies managed by medication (adenoidal tissue and inflammation may affect the Eustachian Tube function and any allergic condition in the nasal cavity can cause chronic inflammation rendering the tube non-functional). If they still have continual fluid build up, an inability to equalise or recurrent middle ear infections and they are older than at least two years of age, they are good candidates,’ he says.

Dr Molyneaux’s first child patient, a girl of six, had four sets of grommets and also had her adenoids removed during one of the earlier procedures. Despite being on nasal medication, she had constant pain in her ears and was suffering from hearing loss, both of which impacted her performance at school. Her mother was looking for alternatives to another set of grommets especially as grommets only function temporarily.

‘We did a Eustachian Tube Balloon Dilation in September 2016. The patient subsequently stopped experiencing pain, didn’t need another set of grommets and her hearing had improved on the hearing test to within normal limits,’ explains Dr Molyneaux.

Preoperative evaluation

‘The most important factor for success with this procedure is patient selection. This would involve a thorough evaluation to diagnose Eustachian Tube Dysfunction and once this is confirmed, ensure the patient is fit for the procedure. This evaluation typically involves:

  • Completion of a Eustachian tube dysfunction questionnaire
  • Measuring the pressure in the middle ears and movement in the eardrum, which would confirm a non-functional Eustachian tube (Tympanometry)
  • Physical examination of the ears with a microscope while the patient performs equalisation attempts looking for movement on the eardrum
  • Evaluating the nasal cavity and openings of the Eustachian tube through the nose with nasal endoscopy
  • Performing a hearing test

The surgery

‘The day-case procedure is done in theatre using a rigid endoscope and a balloon dilator. In simplest terms, we go through the nose, find the Eustachian tube opening, and then advance the balloon into the Eustachian tube. We then inflate it to 10 bar and leave it in place for 2 minutes before deflating and removing the device. While this is a high pressure, when a patient equalises they create up to 5 times more pressure in the Eustachian tube,’ says Dr Molyneaux.

‘Patients are evaluated for two hours in the ward after the procedure and if no problems are incurred the patient is discharged home. Some patients may have some discomfort in the area of the Eustachian tube immediately after the procedure which is resolved by a mild anti-inflammatory.’

Contraindications

Surgeons cannot perform the surgery in patients with:

  • Sinus-related conditions that are not yet treated
  • Skull-based fractures: the carotid artery is right next to the Eustachian tube, however, it’s covered with bone. If you have a fracture of this protective bone, there may be a risk of making contact during surgery. However, an injury of the carotid artery has never happened.
  • Congenital syndromes such as Down Syndrome, cleft palates (tube are narrowed and muscular function is abnormal) or midfacial congenital abnormalities because their anatomy is altered and surgeons risk harming other structures.

‘With the balloon dilation, you are widening the cartilaginous area, while these patients may be presenting with skeletal or muscular abnormalities that underpin the issue. Surgical options for these patients can extend to long-term ventilation tubes (T-tubes), grommets or other surgeries where appropriate,’ says Dr Molyneaux.

In addition, patients with ruptured eardrums will be required to wait six weeks for the natural healing process. Patients with long-standing Eustachian Tube Dysfunction and several holes or ruptures in their ears have an inherent weakness that puts them at risk of eardrum retraction from a build-up of negative pressure (cholesteatoma). Therefore it is advisable to consider the balloon dilation even after a burst eardrum.

Risks

‘The risks are negligible with previous reports of complications due to early forceful equalisation attempts immediately after the procedure. This is avoided by delaying equalisation manoeuvres and straining for three days. As this procedure is performed under general anaesthetic, the patient would need to be evaluated for any anaesthetic risk. However, performing this procedure under procedural sedation might be a viable option in the future,’ explains Dr Molyneaux.

In children, both grommets and balloon dilation require a general anaesthetic and thus Eustachian balloon dilation has no additional risk. The procedure is safely performed in children from 2 years of age without any reported complications. The benefit of this procedure is that the eardrum is not damaged and that repeat procedures may not always be necessary unlike grommet insertion. It affords the child, and adult, the potential to equalise and avoid long term middle ear disease.

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