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

2012 ◽  
Vol 16 (5) ◽  
pp. 449-458 ◽  
Author(s):  
Sandra L. Helmers ◽  
Mei Sheng Duh ◽  
Annie Guérin ◽  
Sujata P. Sarda ◽  
Thomas M. Samuelson ◽  
...  
Author(s):  
Carlo Efisio Marras ◽  
Gabriella Colicchio ◽  
Luca De Palma ◽  
Alessandro De Benedictis ◽  
Giancarlo Di Gennaro ◽  
...  

Background: Vagus nerve stimulation (VNS) is a palliative treatment for medical intractable epileptic syndromes not eligible for resective surgery. Health technology assessment (HTA) represents a modern approach to the analysis of technologies used for healthcare. The purpose of this study is to assess the clinical, organizational, financial, and economic impact of VNS therapy in drug-resistant epilepsies and to establish the congruity between costs incurred and health service reimbursement. Methods: The present study used an HTA approach. It is based on an extensive detailed bibliographic search on databases (Medline, Pubmed, Embase and Cochrane, sites of scientific societies and institutional sites). The HTA study includes the following issues: (a) social impact and costs of the disease; (b) VNS eligibility and clinical results; (c) quality of life (QoL) after VNS therapy; (d) economic impact and productivity regained after VNS; and (e) costs of VNS. Results: Literature data indicate VNS as an effective treatment with a potential positive impact on social aspects and on quality of life. The diagnosis-related group (DRG) financing, both on national and regional levels, does not cover the cost of the medical device. There was an evident insufficient coverage of the DRG compared to the full cost of implanting the device. Conclusions: VNS is a palliative treatment for reducing seizure frequency and intensity. Despite its economic cost, VNS should improve patients’ quality of life and reduce care needs.


2020 ◽  
Vol 8 (3) ◽  
pp. 138-148
Author(s):  
Xiaoya Qin

Vagus nerve stimulation (VNS) is a neuromodulation therapy increasingly used for treating drug-resistant epilepsy. However, it remains to be determined which patients are best suited for the treatment, and it is difficult to predict the therapeutic effect before the implantation. Mutations in some genes could lead to epilepsy. Here we report two cases of pediatric patients with drug-resistant epilepsy treated by VNS therapy: Patient 1 with ARX mutation achieved good outcomes; Patient 2 with the CDKL5 mutation did not show improvement. Additionally, the therapeutic impact of VNS on brain networks was investigated, hoping to provide some empirical evidence for a better understanding of the mechanism of VNS treatment.


2021 ◽  
Vol 3 (2) ◽  
pp. e000218
Author(s):  
Arjune Sen ◽  
Ryan Verner ◽  
James P Valeriano ◽  
Ricky Lee ◽  
Muhammad Zafar ◽  
...  

IntroductionThe Vagus Nerve Stimulation Therapy System (VNS Therapy) is an adjunctive neuromodulatory therapy that can be efficacious in reducing the frequency and severity of seizures in people with drug-resistant epilepsy (DRE). CORE-VNS aims to examine the long-term safety and clinical outcomes of VNS in people with DRE.Methods and analysisThe CORE-VNS study is an international, multicentre, prospective, observational, all-comers, post-market registry. People with DRE receiving VNS Therapy for the first time as well as people being reimplanted with VNS Therapy are eligible. Participants have a baseline visit (prior to device implant). They will be followed for a minimum of 36 months and a maximum of 60 months after implant. Analysis endpoints include seizure frequency (average number of events per month), seizure severity (individual-rated categorical outcome including very mild, mild, moderate, severe or very severe) as well as non-seizure outcomes such as adverse events, use of antiseizure medications, use of other non-pharmacological therapies, quality of life, validated measures of quality of sleep (Pittsburgh Sleep Quality Index or Children’s Sleep Habit Questionnaire) and healthcare resource utilisation. While the CORE-VNS registry was not expressly designed to test hypotheses, subgroup analyses and exploratory analysis that require hypothesis testing will be conducted across propensity score matched treatment groups, where possible based on sampling.Ethics and disseminationThe CORE-VNS registry has already enrolled 823 participants from 61 centres across 15 countries. Once complete, CORE-VNS will represent one of the largest real-world clinical data sets to allow a more comprehensive understanding of the management of DRE with adjunctive VNS. Manuscripts derived from this database will shed important new light on the characteristics of people receiving VNS Therapy; the practical use of VNS across different countries, and factors influencing long-term response.Trail registration numberNCT03529045.


Author(s):  
JF Tellez-Zenteno ◽  
L Hernandez-Ronquillo ◽  
J Arcand ◽  
A Vitali ◽  
K Watherhouse

Vagus Nerve Stimulation (VNS) therapy has been widely recognized as an alternative for the treatment of drug resistant epilepsy (DRE), although modification of AEDs during VNS treatment could explain improvement in patients. We retrospectively assessed the efficacy of VNS in 30 adult epileptic patients treated with > 6 months follow-up. The criteria for implantation were the following: a) not candidate for resective epilepsy surgery, b) DRE, c) impairment of quality of life, d) no other option of treatment. We assessed socio-demographics, seizure etiology, seizure classification and AEDs used during treatment with VNS. We assessed adverse effects and efficacy. Responder rate was defined as >50 seizure improvement from baseline, Thirty patients (females-18, males-12; age 35.1+13.3) were included. After 6 months, 12 months, 24 months and 36 months, the response rate was as follows: 13/30(43%), 13/27 (48%), 9/22(41%) and 16/8 (50%), none of them were seizure free. Changes of AEDs were done in 57% of patients at 6 months, 43% at 12, 43% at 24, 43% at 24 months. Other outcomes will be discussed. Our study shows that VNS is an effective therapy although significant changes in medications were done along the therapy, therefore the real effect of VNS could be controversial


Author(s):  
C. Martorell-Llobregat ◽  
P. González-López ◽  
E. Luna ◽  
M. Asensio-Asensio ◽  
R. Jadraque-Rodríguez ◽  
...  

2019 ◽  
Vol 20 (3) ◽  
pp. 189-198 ◽  
Author(s):  
Laura Pérez-Carbonell ◽  
Howard Faulkner ◽  
Sean Higgins ◽  
Michalis Koutroumanidis ◽  
Guy Leschziner

Vagus nerve stimulation (VNS) is a neuromodulatory therapeutic option for drug-resistant epilepsy. In randomised controlled trials, VNS implantation has resulted in over 50% reduction in seizure frequency in 26%–40% of patients within 1 year. Long-term uncontrolled studies suggest better responses to VNS over time; however, the assessment of other potential predictive factors has led to contradictory results. Although initially designed for managing focal seizures, its use has been extended to other forms of drug-resistant epilepsy. In this review, we discuss the evidence supporting the use of VNS, its impact on seizure frequency and quality of life, and common adverse effects of this therapy. We also include practical guidance for the approach to and the management of patients with VNS in situ.


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