NICE has now issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on vagus nerve stimulation for refractory epilepsy in children.
Vagus nerve stimulation is used in children and adults with epilepsy, particularly complex partial epilepsy that remains incapacitating despite maximal anti-epileptic medication. The technique has also been used in children with medically refractory encephalopathic seizures, idiopathic seizures, primary generalised epilepsy and the Lennox-Gastaut syndrome, which is a young onset epileptic disorder characterised by multiple seizures types and developmental delay.
Epilepsy prevalence is 2% to 5% worldwide (World Health Organisation estimate). About 5% to 30% of people with epilepsy have medically refractory complex partial seizures.
A battery powered pulse generator device is implanted under the skin of the upper left chest. A wire is tunnelled under the skin and connected to the left vagus nerve in the neck (surgery time 45 minutes to 2 hours). Stimulation parameters (pulse width and frequency, current intensity, on/off cycles) are programmed into the pulse generator via a programming wand. Patients or carers may then switch the stimulator on and off by passing a magnet over the generator. The battery lasts 8–12 years and can be replaced under local anaesthetic. A typical treatment regimen might comprise intermittent stimulation for 30 seconds every 5 to 10 minutes throughout the day and night.
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.