Vagus nerve stimulation in pediatric patients: Is it really worthwhile? Vera C. Terra a, ⁎, Luciano L. Furlanetti b , Altacílio Aparecido Nunes c , Ursula Thomé a , Meire Akico Nisyiama a , Américo C. Sakamoto a , Helio R. Machado a a Centro de Cirurgia de Epilepsia (CIREP), Departamento de Neurociências e Ciências do Comportamento, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, SP, Brazil b Division of Stereotactic and Functional Neurosurgery, University Hospital Freiburg, Freiburg im Breisgau, Germany c Departamento de Medicina Social, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo, SP, Brazil abstract article info Article history: Received 12 September 2013 Revised 6 October 2013 Accepted 10 October 2013 Available online xxxx Keywords: Epilepsy Vagal nerve stimulation Pediatric neurosurgery Vagus nerve stimulation (VNS) seems to be effective in the management of selected cases of pharmacoresistant epilepsy in children. This was a case–control prospective study of children with refractory epilepsy submitted to vagal nerve stimulator implantation and a control group with epilepsy treated with antiepileptic drugs. Patients under 18 years of age who underwent clinical or surgical treatment because of pharmacoresistant epilepsy from January 2009 to January 2012 were followed and compared with an age-matched control group at final evaluation. Statistically significant differences were observed considering age at epilepsy onset (VNS group — 1.33 ± 1.45 years; controls — 3.23 ± 3.11; p = 0.0001), abnormal findings in neurological examination (p = 0.01), history of previous ineffective epilepsy surgery (p = 0.03), and baseline seizure frequency (p= 0.0001). At long-term follow-up, 55.4% of the patients in the VNS group had at least 50% reduction of seizure frequency, with 11.1% of the patients presenting 95% reduction on seizure frequency. Also, a decrease in traumas and hospitalization due to seizures and a subjective improvement in mood and alertness were observed. The control group did not show a significant modification in seizure frequency during the study. In this series, VNS patients evolved with a statistically significant reduction of the number of seizures, a decreased morbidity of the seizures, and the number of days in inpatient care. In accordance with the current literature, VNS has been proven to be an effective alternative in the treatment of pediatric patients with drug-resistant epilepsy. © 2013 Elsevier Inc. All rights reserved. 1. Introduction Epilepsy is probably the most prevalent neurological disease that requires ongoing treatment in all age groups and can have significant and even devastating consequences for the patient and his or her family. In infants and young children, epilepsy is even more frequent compared with adults and may be associated with developmental stagnation or regression. If not properly treated, the affected child's outcome for cognitive achievement remains restrained [1]. Despite recent advances in the comprehension of the neuropathology of epilepsy and concerning its clinical management, satisfactory seizure control remains elusive in 30–40% of patients [2]. Although surgical treatment may be appropriate if the epilepsy is severe, medically refractory, and/or caused by a focal epileptogenic lesion, only 10–30% of these patients are appropriate candidates for temporal lobectomy, focal cortical resection, callosotomy, hemispherectomy, subpial transection, or other surgical procedures [3]. Clinical experience with vagal nerve stimulation (VNS) was initiated around twenty years ago with the first human implantation. The Food and Drug Administration (FDA) approved the Cyberonics stimulator in 1997 as an adjunctive therapy for the treatment of pharmacoresistant epilepsy in patients over 12 years of age [3], and since then, most of the studies that aimed to evaluate clinical efficacy were conducted with adults [4–6]. However, recent reports regarding its application in children and adolescents have shown an encouraging experience that supports the application of this tool in young patients [4,6–12]. In the present study, we performed a matched case–control study to explore the outcome of epilepsy in patients submitted to vagal nerve stimulator implantation in a consecutive and prospective study group of 36 children with epilepsy operated on in the same institution. 2. Materials and methods We reviewed all medical records of patients younger than 18 years of age that underwent clinical or surgical treatment due to pharmacoresistant epilepsy, in our university hospital, from January 2009 to January 2012. Data of a subgroup of patients submitted to implantation of a vagal nerve stimulator were analyzed concerning epilepsy classification, previous medical or surgical therapies, adverse events due to VNS, and final outcomes and were compared to an age-matched control group with epilepsy not implanted with a vagal nerve stimulator. Approval of the ethical committee was given to conduct this analysis. All patients were first evaluated in outpatient clinical care and then submitted to Epilepsy & Behavior xxx (2013) xxx–xxx ⁎ Corresponding author at: Centro de Cirurgia de Epilepsia, Departamento de Neurologia, Psiquiatria e Psicologia Médica, Ribeirão Preto CEP 14048-900, Brazil. Fax: +55 16 3633 0760. E-mail address: v.c.terra@gmail.com (V.C. Terra). YEBEH-03639; No. of pages: 5; 4C: 1525-5050/$ – see front matter © 2013 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.yebeh.2013.10.011 Contents lists available at ScienceDirect Epilepsy & Behavior journal homepage: www.elsevier.com/locate/yebeh Please cite this article as: Terra VC, et al, Vagus nerve stimulation in pediatric patients: Is it really worthwhile? Epilepsy Behav (2013), http://dx.doi.org/10.1016/j.yebeh.2013.10.011