Objective: To evaluate the evidence since the 1999 assessment regarding efficacy and safety of vagus nerve stimulation (VNS) for epilepsy, currently approved as adjunctive therapy for partial-onset seizures in patients .12 years.
Methods:We reviewed the literature and identified relevant published studies. We classified these studies according to the American Academy of Neurology evidence-based methodology.Results: VNS is associated with a .50% seizure reduction in 55% (95% confidence interval [CI] 50%-59%) of 470 children with partial or generalized epilepsy (13 Class III studies). VNS is associated with a .50% seizure reduction in 55% (95% CI 46%-64%) of 113 patients with Lennox-Gastaut syndrome (LGS) (4 Class III studies). VNS is associated with an increase in $50% seizure frequency reduction rates of ;7% from 1 to 5 years postimplantation (2 Class III studies). VNS is associated with a significant improvement in standard mood scales in 31 adults with epilepsy (2 Class III studies). Infection risk at the VNS implantation site in children is increased relative to that in adults (odds ratio 3.4, 95% CI 1.0-11.2). VNS is possibly effective for seizures (both partial and generalized) in children, for LGS-associated seizures, and for mood problems in adults with epilepsy. VNS may have improved efficacy over time.Recommendations: VNS may be considered for seizures in children, for LGS-associated seizures, and for improving mood in adults with epilepsy (Level C). VNS may be considered to have improved efficacy over time (Level C). Children should be carefully monitored for site infection after VNS implantation. Neurology In 1997, the US Food and Drug Administration (FDA) approved vagus nerve stimulation (VNS) as adjunctive therapy for reducing the frequency of seizures in patients .12 years of age with partialonset seizures refractory to antiepileptic medications.1 A 1999 American Academy of Neurology (AAN) technology assessment concluded that VNS is indicated for patients .12 years with medically intractable partial seizures who are not candidates for potentially curative surgical resections such as lesionectomies or mesial temporal lobectomies. The authors also recommended that patients undergo a thorough epilepsy evaluation to rule out nonepileptic conditions or treatable symptomatic epilepsies before implantation of a vagus nerve stimulator. At that time, evidence was insufficient to recommend VNS for epilepsy in young children or for seizures associated with Lennox-Gastaut syndrome (LGS). Since the 1999 AAN assessment, the FDA has approved VNS for the adjunctive long-term treatment of chronic or recurrent depression in patients .18 years who are experiencing a major depressive episode and have not had an adequate response to 4 or more adequate antidepressant treatments.1 Moreover, there are new reports of long-term efficacy and VNS use in pediatric epilepsy and other seizure types and syndromes. We evaluated this evidence using the AAN guideline methodology.