Consent is a fundamental part of our daily working lives. This is something as simple as consent to examine a patient, consent to undertake a procedure as minor as taking blood, through to consent for a major operation. Whatever the reason for obtaining consent, there is clear guidance from the GMC that consent is a process and is decision making in partnership between doctors and patients. As a part of the consent for surgical intervention, we explain risks to patients. These include frequently occurring risks as well as serious or significant risks to the person undergoing the procedure. We can explain the serious risks for an individual operation to our patients, but what if a patient asks to quantify a specific risk? What if this is a procedure that is a relatively recent innovation but is an accepted treatment for a condition?
This month’s editors’ choice looks at the risks associated with balloon dilatation of the eustachian tube. This procedure is becoming more widely available and is part of NICE guidance for treatment. The paper shows that this is a safe procedure overall, but there are potentially severe adverse events associated with undertaking this operation. It provides some insight into what we should discuss with patients as part of their consent process for this operation, but also food for thought about consent in general. As always, thank you to all our reviewers for their valued contributions!
Nazia Munir
Balloon dilation of the eustachian tube (BDET) is now a fairly widely practised procedure to treat both obstructive eustachian tube dysfunction symptoms and glue ear. This study looked at all reported adverse events via the MAUDE database in the USA over a 10-year period. The two main suppliers are Acclarent and Entellus (other providers do exist), and there were three device-related reports, none of which caused any harm to patients. This left 13 patient-related reports, and the most common complication was subcutaneous emphysema. This was of variable severity – of the six patients with this complication, three developed chest involvement, one developed pneumomediastinum, and one needed a chest tube. The lesser complications were managed conservatively as an outpatient, but the more severe cases required admission to a medical ward in three cases, and ITU in one. The most severe adverse event reported was a carotid artery dissection leading to a stroke, which was treated with a stent. The patient made a full recovery with no long-term sequelae. Two patients developed a patulous eustachian tube, one patient reported hearing loss, and another reported tinnitus postoperatively. Whilst it would have been useful to know the number of procedures performed which led to this number of complications, the design of the study precludes this. I think it’s a useful study nonetheless, as it reminds us that the complication of surgical emphysema can be very severe and can require further significant intervention to treat. It’s also important to be reminded of the devastating possibility of a carotid artery dissection which, although rare, is sufficiently serious to warrant discussion of carotid artery injury as one the complications of the procedure.
