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Vagus nerve stimulation for drug-resistant epilepsy: a European long-term study up to 24 months in 347 children

(2014) EPILEPSIA. 55(10). p.1576-1584
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The integrative neuroscience of behavioral control (Neuroscience)
Abstract
Objective: To gain insight into the long-term impact of vagus nerve stimulation (with VNS Therapy) in children with drug-resistant epilepsy, we conducted the largest retrospective multicenter study to date over an extended follow-up period of up to 24months. Methods: The primary objective was to assess change in seizure frequency of the predominant seizure type (defined as the most disabling seizure) following VNS device implantation. Treating physicians collected data from patient records from baseline to 6, 12, and 24months of follow-up. Results: The analysis population included 347children (aged 6months to 17.9years at the time of implant). At 6, 12, and 24months after implantation, 32.5%, 37.6%, and 43.8%, respectively, of patients had 50%reduction in baseline seizure frequency of the predominant seizure type. The responder rate was higher in a subgroup of patients who had no change in antiepileptic drugs (AEDs) during the study. Favorable results were also evident for all secondary outcome measures including changes in seizure duration, ictal severity, postictal severity, quality of life, clinical global impression of improvement, and safety. Post hoc analyses demonstrated a statistically significant correlation between VNS total charge delivered per day and an increase in response rate. VNS Therapy is indicated as adjunctive therapy in children with focal, structural epilepsies, who for any reason are not good candidates for surgical treatment following the trial of two or more AEDs. Children with predominantly generalized seizures from genetic, structural epilepsies, like Dravet syndrome or Lennox-Gastaut syndrome, could also benefit from VNS Therapy. Significance: The results demonstrate that adjunctive VNS Therapy in children with drug-resistant epilepsy reduces seizure frequency and is well tolerated over a 2-year follow-up period. No new safety issues were identified. A post hoc analysis revealed a dose-response correlation for VNS in patients with epilepsy.
Keywords
NEUROLOGY, IMPLANTATION, PHASE-III, THERAPY, SUBCOMMITTEE, AMERICAN ACADEMY, CLINICAL ARTICLE, REFRACTORY EPILEPSY, Clinical trial, Epilepsy, Pediatrics, Quality of life, Vagus nerve stimulation, RANDOMIZED CONTROLLED-TRIAL, PARTIAL-ONSET SEIZURES

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Citation

Please use this url to cite or link to this publication:

MLA
Orosz, Iren et al. “Vagus Nerve Stimulation for Drug-resistant Epilepsy: a European Long-term Study up to 24 Months in 347 Children.” EPILEPSIA 55.10 (2014): 1576–1584. Print.
APA
Orosz, I., McCormick, D., Zamponi, N., Varadkar, S., Feucht, M., Parain, D., Griens, R., et al. (2014). Vagus nerve stimulation for drug-resistant epilepsy: a European long-term study up to 24 months in 347 children. EPILEPSIA, 55(10), 1576–1584.
Chicago author-date
Orosz, Iren, David McCormick, Nelia Zamponi, Sophia Varadkar, Martha Feucht, Dominique Parain, Roger Griens, et al. 2014. “Vagus Nerve Stimulation for Drug-resistant Epilepsy: a European Long-term Study up to 24 Months in 347 Children.” Epilepsia 55 (10): 1576–1584.
Chicago author-date (all authors)
Orosz, Iren, David McCormick, Nelia Zamponi, Sophia Varadkar, Martha Feucht, Dominique Parain, Roger Griens, Louis Vallée, Paul Boon, Christopher Rittey, Amara K Jayewardene, Mark Bunker, Alexis Arzimanoglou, and Lieven Lagae. 2014. “Vagus Nerve Stimulation for Drug-resistant Epilepsy: a European Long-term Study up to 24 Months in 347 Children.” Epilepsia 55 (10): 1576–1584.
Vancouver
1.
Orosz I, McCormick D, Zamponi N, Varadkar S, Feucht M, Parain D, et al. Vagus nerve stimulation for drug-resistant epilepsy: a European long-term study up to 24 months in 347 children. EPILEPSIA. 2014;55(10):1576–84.
IEEE
[1]
I. Orosz et al., “Vagus nerve stimulation for drug-resistant epilepsy: a European long-term study up to 24 months in 347 children,” EPILEPSIA, vol. 55, no. 10, pp. 1576–1584, 2014.
@article{5908208,
  abstract     = {Objective: To gain insight into the long-term impact of vagus nerve stimulation (with VNS Therapy) in children with drug-resistant epilepsy, we conducted the largest retrospective multicenter study to date over an extended follow-up period of up to 24months. 
Methods: The primary objective was to assess change in seizure frequency of the predominant seizure type (defined as the most disabling seizure) following VNS device implantation. Treating physicians collected data from patient records from baseline to 6, 12, and 24months of follow-up. 
Results: The analysis population included 347children (aged 6months to 17.9years at the time of implant). At 6, 12, and 24months after implantation, 32.5%, 37.6%, and 43.8%, respectively, of patients had 50%reduction in baseline seizure frequency of the predominant seizure type. The responder rate was higher in a subgroup of patients who had no change in antiepileptic drugs (AEDs) during the study. Favorable results were also evident for all secondary outcome measures including changes in seizure duration, ictal severity, postictal severity, quality of life, clinical global impression of improvement, and safety. Post hoc analyses demonstrated a statistically significant correlation between VNS total charge delivered per day and an increase in response rate. VNS Therapy is indicated as adjunctive therapy in children with focal, structural epilepsies, who for any reason are not good candidates for surgical treatment following the trial of two or more AEDs. Children with predominantly generalized seizures from genetic, structural epilepsies, like Dravet syndrome or Lennox-Gastaut syndrome, could also benefit from VNS Therapy. 
Significance: The results demonstrate that adjunctive VNS Therapy in children with drug-resistant epilepsy reduces seizure frequency and is well tolerated over a 2-year follow-up period. No new safety issues were identified. A post hoc analysis revealed a dose-response correlation for VNS in patients with epilepsy.},
  author       = {Orosz, Iren and McCormick, David and Zamponi, Nelia and Varadkar, Sophia and Feucht, Martha and Parain, Dominique and Griens, Roger and Vallée, Louis and Boon, Paul and Rittey, Christopher and Jayewardene, Amara K and Bunker, Mark and Arzimanoglou, Alexis and Lagae, Lieven},
  issn         = {0013-9580},
  journal      = {EPILEPSIA},
  keywords     = {NEUROLOGY,IMPLANTATION,PHASE-III,THERAPY,SUBCOMMITTEE,AMERICAN ACADEMY,CLINICAL ARTICLE,REFRACTORY EPILEPSY,Clinical trial,Epilepsy,Pediatrics,Quality of life,Vagus nerve stimulation,RANDOMIZED CONTROLLED-TRIAL,PARTIAL-ONSET SEIZURES},
  language     = {eng},
  number       = {10},
  pages        = {1576--1584},
  title        = {Vagus nerve stimulation for drug-resistant epilepsy: a European long-term study up to 24 months in 347 children},
  url          = {http://dx.doi.org/10.1111/epi.12762},
  volume       = {55},
  year         = {2014},
}

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