Efficacy and safety following two or more years of vagus nerve stimulation (VNS Therapy) in pediatric patients with drug‐resistant epilepsy enrolled in a Russian VNS Registry
Abstract Introduction Following approval in 2009 of vagus nerve stimulation (VNS Therapy) for drug‐resistant epilepsy (DRE) in the Russian Federation, this is the first multicenter study across Russia to evaluate the safety and efficacy of adjunctive VNS Therapy. Methods The retrospective, observati...
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| Format: | Article |
| Language: | English |
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Wiley
2023-07-01
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| Series: | Brain and Behavior |
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| Online Access: | https://doi.org/10.1002/brb3.3076 |
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| author | Anna A. Feygina Yana N. Koshelyaevskaya Maxine Dibué Kira V. Voronkova Mikhail N. Klochkov Nadezhda Y. Koroleva Stanislav S. Ivanov Ekaterina S. Bolshakova Elza F. Fatykhova |
| author_facet | Anna A. Feygina Yana N. Koshelyaevskaya Maxine Dibué Kira V. Voronkova Mikhail N. Klochkov Nadezhda Y. Koroleva Stanislav S. Ivanov Ekaterina S. Bolshakova Elza F. Fatykhova |
| author_sort | Anna A. Feygina |
| collection | DOAJ |
| description | Abstract Introduction Following approval in 2009 of vagus nerve stimulation (VNS Therapy) for drug‐resistant epilepsy (DRE) in the Russian Federation, this is the first multicenter study across Russia to evaluate the safety and efficacy of adjunctive VNS Therapy. Methods The retrospective, observational registry included 58 pediatric patients with DRE (5–17 years old at implantation) who had ≥2 years of VNS. To ensure a robust evaluation process, changes in seizure frequency were evaluated for all seizure types as well as “most disabling” seizures (defined as seizures accompanied by falls, physical trauma, and/or incontinence in the absence of preventative measures). Results With 2 years of VNS Therapy, 37 of 49 patients (76%) experiencing the most disabling epileptic seizures had a >50% decrease in frequency of such seizures, and 16 (33%) reported no longer experiencing the “most disabling” seizure type. In addition, based on the McHugh Outcome scale, VNS Therapy had a positive outcome on both frequency and severity of all epileptic seizure types, with a >50% decrease in frequency of all epileptic seizure types noted in 37 of 58 patients (64%), and 31% of patients had a Class I outcome, including 11 patients (19%) who achieved seizure freedom. VNS Therapy also had a positive effect on the frequency of status epilepticus: 13 patients (22%) had status epilepticus prior to implantation with a mean rate of 9.4 ± 17.7 events per year (range, 0–52), and after VNS Therapy, only one patient continued to experience status epilepticus (at 1 event per 4–6 months). VNS Therapy had an acceptable safety profile and no adverse events leading to VNS discontinuation were reported. Conclusions The results demonstrate that VNS Therapy is being safely and effectively applied to pediatric patients in the Russian healthcare system. |
| first_indexed | 2024-03-13T00:05:13Z |
| format | Article |
| id | doaj.art-d0d2d0c3ecfb4074a74127019e4b5d7d |
| institution | Directory Open Access Journal |
| issn | 2162-3279 |
| language | English |
| last_indexed | 2024-03-13T00:05:13Z |
| publishDate | 2023-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | Brain and Behavior |
| spelling | doaj.art-d0d2d0c3ecfb4074a74127019e4b5d7d2023-07-13T04:43:16ZengWileyBrain and Behavior2162-32792023-07-01137n/an/a10.1002/brb3.3076Efficacy and safety following two or more years of vagus nerve stimulation (VNS Therapy) in pediatric patients with drug‐resistant epilepsy enrolled in a Russian VNS RegistryAnna A. Feygina0Yana N. Koshelyaevskaya1Maxine Dibué2Kira V. Voronkova3Mikhail N. Klochkov4Nadezhda Y. Koroleva5Stanislav S. Ivanov6Ekaterina S. Bolshakova7Elza F. Fatykhova8Medical Affairs International, Neuromodulation LivaNova PLC London UKDepartment of Biostatistics Regional United System of Medical Informatization, LLC Moscow RussiaMedical Affairs International, Neuromodulation LivaNova PLC London UKFaculty of Additional Professional Education Pirogov Russian National Research Medical University Moscow RussiaNeurology Department Bekhterev National Medical Research Center for Psychiatry and Neurology Saint Petersburg RussiaHead of Center for Epileptology, Neurology, and Video‐EEG monitoring, Bekhtereva Institute of the Human Brain Russian Academy of Sciences Saint Petersburg RussiaNeurosurgery Department Republican Children's Clinical Hospital Republic of Bashkortostan RussiaNeurology Department Voyno‐Yasenetskiy Scientific and Practical Center of Specialized Medical Care for Children Moscow RussiaNeurosurgery Department Republican Clinical Hospital Kazan RussiaAbstract Introduction Following approval in 2009 of vagus nerve stimulation (VNS Therapy) for drug‐resistant epilepsy (DRE) in the Russian Federation, this is the first multicenter study across Russia to evaluate the safety and efficacy of adjunctive VNS Therapy. Methods The retrospective, observational registry included 58 pediatric patients with DRE (5–17 years old at implantation) who had ≥2 years of VNS. To ensure a robust evaluation process, changes in seizure frequency were evaluated for all seizure types as well as “most disabling” seizures (defined as seizures accompanied by falls, physical trauma, and/or incontinence in the absence of preventative measures). Results With 2 years of VNS Therapy, 37 of 49 patients (76%) experiencing the most disabling epileptic seizures had a >50% decrease in frequency of such seizures, and 16 (33%) reported no longer experiencing the “most disabling” seizure type. In addition, based on the McHugh Outcome scale, VNS Therapy had a positive outcome on both frequency and severity of all epileptic seizure types, with a >50% decrease in frequency of all epileptic seizure types noted in 37 of 58 patients (64%), and 31% of patients had a Class I outcome, including 11 patients (19%) who achieved seizure freedom. VNS Therapy also had a positive effect on the frequency of status epilepticus: 13 patients (22%) had status epilepticus prior to implantation with a mean rate of 9.4 ± 17.7 events per year (range, 0–52), and after VNS Therapy, only one patient continued to experience status epilepticus (at 1 event per 4–6 months). VNS Therapy had an acceptable safety profile and no adverse events leading to VNS discontinuation were reported. Conclusions The results demonstrate that VNS Therapy is being safely and effectively applied to pediatric patients in the Russian healthcare system.https://doi.org/10.1002/brb3.3076drug‐resistant epilepsypediatric patientsRussiaseizure frequencyvagus nerve stimulationVNS Therapy |
| spellingShingle | Anna A. Feygina Yana N. Koshelyaevskaya Maxine Dibué Kira V. Voronkova Mikhail N. Klochkov Nadezhda Y. Koroleva Stanislav S. Ivanov Ekaterina S. Bolshakova Elza F. Fatykhova Efficacy and safety following two or more years of vagus nerve stimulation (VNS Therapy) in pediatric patients with drug‐resistant epilepsy enrolled in a Russian VNS Registry Brain and Behavior drug‐resistant epilepsy pediatric patients Russia seizure frequency vagus nerve stimulation VNS Therapy |
| title | Efficacy and safety following two or more years of vagus nerve stimulation (VNS Therapy) in pediatric patients with drug‐resistant epilepsy enrolled in a Russian VNS Registry |
| title_full | Efficacy and safety following two or more years of vagus nerve stimulation (VNS Therapy) in pediatric patients with drug‐resistant epilepsy enrolled in a Russian VNS Registry |
| title_fullStr | Efficacy and safety following two or more years of vagus nerve stimulation (VNS Therapy) in pediatric patients with drug‐resistant epilepsy enrolled in a Russian VNS Registry |
| title_full_unstemmed | Efficacy and safety following two or more years of vagus nerve stimulation (VNS Therapy) in pediatric patients with drug‐resistant epilepsy enrolled in a Russian VNS Registry |
| title_short | Efficacy and safety following two or more years of vagus nerve stimulation (VNS Therapy) in pediatric patients with drug‐resistant epilepsy enrolled in a Russian VNS Registry |
| title_sort | efficacy and safety following two or more years of vagus nerve stimulation vns therapy in pediatric patients with drug resistant epilepsy enrolled in a russian vns registry |
| topic | drug‐resistant epilepsy pediatric patients Russia seizure frequency vagus nerve stimulation VNS Therapy |
| url | https://doi.org/10.1002/brb3.3076 |
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