3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 7 sources, which was discussed by the committee. The evidence included 2 meta-analyses, 2 reviews, 1 retrospective case series and 2 case reports. It is presented in table 2 of the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The professional experts and the committee considered the key efficacy outcomes to be: frequency and severity of seizures, reduction in antiepileptic medication, reduction in the need for further surgery, and quality of life.
3.3 The professional experts and the committee considered the key safety outcomes to be: damage to adjacent structures, intracranial or cerebral haemorrhage, cranial nerve or neurological deficit, gait disturbance, visual field deficits, cognitive deficit or psychiatric disturbance, and amnestic disorder.
3.4 Patient commentary was sought but none was received.
3.5 The committee noted that, in adults, the procedure has primarily been used to treat temporal lobe epilepsy. In children it has primarily been used for hypothalamic hamartomas.
3.6 The committee was informed that the procedure is much less invasive than open surgery.
3.7 The committee was advised that, in the future, this procedure may be offered as an alternative to drug treatment for epilepsy.
3.8 The committee was pleased to receive consultation comments from patients and their advocates.
3.9 This guidance requires that clinicians doing the procedure make special arrangements for audit. NICE has identified relevant audit criteria and has developed an audit tool (which is for use at local discretion).