Eur J Paediatr Neurol. 2012 Jan 17. [Epub ahead of print]

Clinical outcomes, quality of life, and costs associated with implantation of vagus nerve stimulation therapy in pediatric patients with drug-resistant epilepsy.

Helmers SL, Duh MS, Guérin A, Sarda SP, Samuelson TM, Bunker MT, Olin BD, Jackson SD, Faught E.

Source

Emory University School of Medicine, Atlanta, GA, United States.

Abstract

BACKGROUND:

VNS (Vagus Nerve Stimulation Therapy) is approved in the USA to treat refractory epilepsy as adjunctive to antiepileptic drugs (AEDs) in patients ≥12 years with complex partial seizures.

AIMS:

To evaluate clinical outcomes, quality-adjusted life years (QALY), and costs associated with VNS in pediatric patients with drug-resistant epilepsy in a real-world setting.

METHODS:

A retrospective analysis was conducted using Medicaid data (USA). Patients had ≥1 neurologist visits with epilepsy diagnosis (ICD-9 345.xx, 780.3x), ≥1 procedure claims for VNS implantation, ≥1 AEDs, ≥6-months of Pre- and Post-VNS continuous enrollment. Pre-VNS period was 6-months and Post-VNS period extended from implantation until device removal, death, Medicaid disenrollment, or study end (up to 3 years). Incidence rate ratios (IRR) and costs ($2010) were estimated. QALYs were estimated using number of seizure-related events.

RESULTS:

For patients 1-11 years old (N = 238), hospitalizations and emergency room visits were reduced Post-VNS vs. Pre-VNS (adjusted IRR = 0.73 [95% CI: 0.61-0.88] and 0.74 [95% CI: 0.65-0.83], respectively). Average total healthcare costs were lower Post-VNS vs. Pre-VNS ($18,437 vs. $18,839 quarterly [adjusted p = 0.052]). For patients 12-17 years old (N = 207), hospitalizations and status epilepticus events were reduced Post-VNS vs. Pre-VNS (adjusted IRR = 0.43 [95% CI: 0.34-0.54] and 0.25 [95% CI: 0.16-0.39], respectively). Average total healthcare costs were lower Post-VNS vs. Pre-VNS period ($14,546 vs. $19,695 quarterly [adjusted p = 0.002]). Lifetime QALY gain after VNS was 5.96 (patients 1-11 years) and 4.82 years (patients 12-17 years).

CONCLUSIONS:

VNS in pediatric patients is associated with decreased resource use and epilepsy-related events, cost savings, and QALY gain.
Copyright © 2012 European Paediatric Neurology Society. Published by Elsevier Ltd. All rights reserved.

PMID:

22261080

[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/22261080

Epileptic Disord. 2011 Dec;13(4):382-8.

Vagus nerve stimulation: effectiveness and tolerability in 64 paediatric patients with refractory epilepsies.

Cersósimo RO, Bartuluchi M, Fortini S, Soraru A, Pomata H, Caraballo RH.

Source

Neurology Department.

Abstract

Aim. We discuss the effectiveness, tolerability, and safety of vagus nerve stimulation (VNS) as adjunctive therapy in 64 paediatric patients with refractory epilepsies. Materials and methods. Sixty-four patients (34 male and 30 female) implanted with VNS for refractory epilepsy were analysed. Electroclinical features were compatible with Lennox-Gastaut syndrome in 46 patients, focal epilepsies in 10 patients, Dravet syndrome in three patients, epilepsy with myoclonic-astatic seizures in three patients, and West syndrome in two. The NeuroCybernetic Prosthesis (NCP) system (Cyberonics, Webster, TX, USA) was employed and the following stimulation parameters were used: output current of 1 to 2.5mA, signal frequency of 30Hz, signal pulse width of 500μs, and signal "on" and "off" times of 30 seconds and 5 minutes, respectively. Results. Of 46 patients with LGS, 30 cases showed a significant improvement in seizure control, with a reduction in seizure frequency of at least 50%. Ten patients with focal epilepsy, three patients with myoclonic-astatic seizures, two patients with Dravet, and two patients with West showed a significant improvement in seizure control, with a reduction in seizure frequency of at least 50%. A good clinical response was evident early and efficacy progressively improved with the duration of treatment up to 36 months. In a significant number of patients, reduced seizure severity and shorter recovery time and hospital stay were also observed. VNS was well tolerated in all patients. Conclusion. VNS is an effective and well-tolerated treatment for paediatric patients with refractory epilepsies, improving quality of life and neuropsychological performance.

PMID:

22258042

[PubMed - in process]

http://www.ncbi.nlm.nih.gov/pubmed/22258042