There is much interest and debate at ENT conferences and within current literature about the role of balloon dilatation techniques for Eustachian tube dysfunction (ETD), a condition which we still only have limited understanding of, and which can be challenging to treat. This follow-up up study of a previously published prospective multicentre RCT has small numbers but uses an increasingly well recognised outcome measure, the seven-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7) score, as well as tympanogram, tympanic membrane position, and Valsalva manoeuvre. It is pertinent to note however that it is authored by a team in the US sponsored by Entellus, who manufacture the balloon apparatus.
Forty-seven patients had extended follow-up for a mean of 29.4 months (18-42 months) following balloon dilatation for ETD and were found to have a statistically significant mean change from baseline in the overall ETDQ-7 score (4.5+/-0.8 at baseline to 2.0+/-1.0 at last follow-up).
Revision dilation rate was 2%. They identified that in patients who had an abnormal middle ear finding at baseline, 76.0% had normalised tympanic membrane position ( p<0.0001), 62.5% had normalisation of tympanogram type ( p<0.001), and 66.7% had positive Valsalva manoeuvres ( p<0.0001). This study found that participant satisfaction was high at 83.0%. There are certainly limitations of this study, most notably that patients were not blinded to their treatment, and there were no controls beyond the initial six weeks. The ETDQ-7 score in combination with clinical examination and tympanogram has been used in several studies now monitoring outcomes after ETD procedures and allows results to be compared between studies. The ETDQ-7 is particularly useful in measuring treatment outcomes as many patients with ETD symptoms have no clinically abnormal findings. The evidence of this study is that in this small patient cohort there was sustained improvement in patient’s symptoms beyond two years after balloon tuboplasty.