Preview

Epilepsy and paroxysmal conditions

Advanced search

Efficacy and safety of using vagus nerve stimulation in patients with pharmacoresistant epilepsy in the Russian Federation: a multi-center retrospective observational program

https://doi.org/10.17749/2077-8333/epi.par.con.2021.089

Full Text:

Abstract

Objective: to assess efficacy and safety of vagus nerve stimulation (VNS) in patients with pharmacoresistant epilepsy.

Material and methods. A multi-center retrospective observational program was applied in patients with pharmacoresistant epilepsy by using vagus nerve stimulation for at least 2 years. There were enrolled 151 subjects, patient age on stimulator implantation varied from 5 to 65 years (24.4±13.1 years). Among them, subjects under 18 or at least 18 years of age comprised 58 (38.4%) and 93 (61.6%), respectively. Changes in rate and severity of major group epileptic seizures (highly disabling type) 24 months after VNS-therapy vs. baseline state as well as during 3-, 6-, 9-, 12-month follow-up were compared. There were assessed stimulator-related effects on VNS-therapy as well as patient quality of life 2 years after therapy. The dynamics of the frequency of all types of epileptic seizures was evaluated according to McHugh Outcome scale.

Results. Mean epilepsy duration on stimulator implantation was 170.9±126.8 months, with maximum up to 666 months (55 years). Number of patients with dominant (disabling) seizures on implantation procedure comprised 136 (90.1%). Decline in dominant epileptic seizure rate by 50–99% was recorded in 91 patients (66.9%) 24 months after VNStherapy. Among such subjects were 41 patients (30.15%) featured with disabling seizures including 24 fully seizure free subjects (17.65%). Decreased rate of all group epileptic seizures by more than 50% (responders) was found in 52.9% cases, including subjects under 18 and adults in 63.9% and as few as 46.3% (p<0.05), respectively. While assessing dynamic rate for all groups of epileptic seizures applied with VNS-therapy by using McHugh Outcome scale it was found that class I (lowered seizure rate by 80–100%) was observed in 44 cases (29.1%), including 18 patients under 18 (31%) and 26 subjects above 18 (28%) (insignificant difference). Mean dominant group epileptic seizure rate was also significantly decreased in both age groups from 20 down to 5.7 per month. Severity of epileptic seizures and postseizure condition upon VNS-therapy was decreased in 38.6% and 43.9% patients 24 months after therapy and on final follow-up visit, respectively (more than 24 months after implantation). No serious adverse events as well as adverse effects resulting in therapy cancel were noted. Conclusion. Vagus nerve stimulation is an effective and safe auxiliary treatment method for therapy of pharmacoresistant epilepsy both in children and adults.><0.05) , respectively. While assessing dynamic rate for all groups of epileptic seizures applied with VNS-therapy by using McHugh Outcome scale it was found that class I (lowered seizure rate by 80–100%) was observed in 44 cases (29.1%), including 18 patients under 18 (31%) and 26 subjects above 18 (28%) (insignificant difference). Mean dominant group epileptic seizure rate was also significantly decreased in both age groups from 20 down to 5.7 per month. Severity of epileptic seizures and postseizure condition upon VNS-therapy was decreased in 38.6% and 43.9% patients 24 months after therapy and on final follow-up visit, respectively (more than 24 months after implantation). No serious adverse events as well as adverse effects resulting in therapy cancel were noted.

Conclusion. Vagus nerve stimulation is an effective and safe auxiliary treatment method for therapy of pharmacoresistant epilepsy both in children and adults.

About the Authors

K. V. Voronkova
Pirogov Russian National Research Medical University
Russian Federation

Kira V. Voronkova – Dr. Med. Sc., Professor, Faculty of Additional Professional Education

RSCI SPIN-code: 1636-7627

16 Pervaya Leonov Str., Moscow 129226



M. N. Klochkov
Bekhterev National Medical Research Center for Psychiatry and Neurology
Russian Federation

Mikhail N. Klochkov – Neurologist

3 Bekhterev Str., Saint Petersburg 192019



N. Yu. Koroleva
Bekhtereva Institute of the Human Brain, Russian Academy of Sciences
Russian Federation

Nadezhda Yu. Koroleva – MD, PhD, Head of Center for Epileptology, Neurology and video-EEG monitoring

RSCI SPIN-code: 7016-9057

9 Academician Pavlov Str., Saint Petersburg 197376



S. S. Ivanov
Republican Children’s Clinical Hospital
Russian Federation

Stanislav S. Ivanov – Neurosurgeon

98 Stepan Kuvykin Str., Ufa 450106, Republic of Bashkortostan



A. B. Dmitriev
Federal Neurosurgical Center
Russian Federation

Aleksandr B. Dmitriev – MD, PhD, Head of Department of Functional Neurosurgery

RSCI SPIN-code: 2075-4940

132/1 Nemirovich-Danchenko Str., Novosibirsk 630087



E. S. Bolshakova
Voyno-Yasenetskiy Scientific and Practical Center of Specialized Medical Care for Children
Russian Federation

Ekaterina S. Bolshakova – Neurologist

38 Aviators Str., Moscow 119620



E. F. Fatykhova
Republican Clinical Hospital
Russian Federation

Elza F. Fatykhova – MD, PhD, Neurosurgeon

138 Orenburgskiy Trakt, Kazan 420064, Republic of Tatarstan



A. A. Usoltseva
Krasnoyarsk State Medical University
Russian Federation

Anna A. Usoltseva – Laboratory Assistant, Chair of Medical Genetics and Clinical Neurophysiology, Institute of Postgraduate Education

WoS ResearcherID: AAM-9334-2021; Scopus Author ID: 57210425243; RSCI SPIN-code: 9163-0862

1 Partizan Zheleznyak Str., Krasnoyarsk 660022



D. V. Dmitrenko
Krasnoyarsk State Medical University
Russian Federation

Diana V. Dmitrenko – Dr. Med. Sc., Chief of Chair of Medical Genetics and Clinical Neurophysiology, Institute of Postgraduate Education; Head of Neurological Center for Epileptology, Neurogenetics and Brain Research, University Clinic; Head of Laboratory of Medical Genetics

WoS ResearcherID: H-7787-2016; Scopus Author ID: 55413907300; RSCI SPIN-code: 9180-6623

1 Partizan Zheleznyak Str., Krasnoyarsk 660022



A. A. Feygina
Sorin Group Rus, LLC
Russian Federation

Anna A. Feygina – MD, PhD, Clinical Manager for Neuromodulation in Russia and Belarus

30 Marshal Proshlyakov Str., Moscow 123458



Ya. N. Koshelyaevskaya
Regional United System of Medical Informatization, LLC
Russian Federation

Yana N. Koshelyaevskaya – Biostatistician

Scopus Author ID: 57189088749; RSCI SPIN-code: 8660-0502

1 bld. 1 Volokolamskoye Shosse, Moscow 125080



References

1. Kwan P., Brodie M.J. Early identification of refractory epilepsy. N Engl J Med. 2000; 342 (5): 314–9. https://doi.org/10.1056/NEJM200002033420503.

2. Chen Z., Brodie M.J., Liew D., Kwan P. Treatment outcomes in patients with newly diagnosed epilepsy treated with established and new antiepileptic drugs: a 30-year longitudinal cohort study. JAMA Neurol. 2018; 75 (3): 279–86. https://doi.org/10.1001/jamaneurol.2017.3949.

3. Englot D.J., Chang E.F. Rates and predictors of seizure freedom in resective epilepsy surgery: an update. Neurosurg Rev. 2014; 37 (3): 389–404. https://doi.org/10.1007/s10143-014-0527-9.

4. Englot D.J., Raygor K.P., Molinaro A.M., et al. Factors associated with failed focal neocortical epilepsy surgery. Neurosurgery. 2014; 75 (6): 648–56. https://doi.org/10.1227/NEU.0000000000000530.

5. Ayvazyan S.O., Shiryaev Yu.S. Modern treatment of drug-resistant epilepsy, available in Russian. Epilepsia i paroksizmalʹnye sostoania / Epilepsy and Paroxysmal Conditions. 2016; 8 (1): 22–8 (in Russ.). https://doi.org/10.17749/2077-8333.2016.8.1.022-028.

6. Englot D.J. A modern epilepsy surgery treatment algorithm: incorporating traditional and emerging technologies. Epilepsy Behav. 2018; 80: 68–74. https://doi.org/10.1016/j.yebeh.2017.12.041.

7. Lipatova L.V., Skoromets T.A., Gromov S.A., et al. Experience of using vagus nerve stimulation to treat drug resistant epilepsy. Neurology, Neuropsychiatry, Psychosomatics. 2014; 6 (1S): 18–21 (in Russ.). https://doi.org/10.14412/2074-2711-2014-1S-18-21.

8. Odintsova G.V., Mamatkhanov М.R., Lebedev К.E., et al. Vagus nerve stimulation in the treatment of pharmacoresistant epilepsy in children. Russian Neurosurgical Journal Named After Professor Polenov. 2016; 8 (S): 192 (in Russ.).

9. Pylaeva O.A., Chadaev V.A., Bobylova M.Yu., Mukhin K.Yu. Efficiency of vagus nerve stimulation in epilepsy (literature review and case report). Russian Journal of Child Neurology. 2019; 14 (2): 7–17 (in Russ.). https://doi.org/10.17650/2073-8803-2019-14-2-7-17.

10. Klochkov M.N., Katyshev S.A., Vtorov A.V., et al. Vagus Nerve Stimulator implantation in a pregnant woman with drug resistant epilepsy. Epilepsia i paroksizmalʹnye sostoania / Epilepsy and Paroxysmal Conditions. 2019; 11 (4): 388–94 (in Russ.). https://doi.org/10.17749/2077-8333.2019.11.4.388-394.

11. McHugh J.C., Singh H.W., Phillips J., et al. Outcome measurement after vagal nerve stimulation therapy: proposal of a new classification. Epilepsia. 2007; 48 (2): 375–8. https://doi. org/10.1111/j.1528-1167.2006.00931.x.

12. O’Donoghue M.F., Duncan J.S., Sander J.W. The National Hospital Seizure Severity Scale: a further development of the Chalfont Seizure Severity Scale. Epilepsia. 1996; 37 (6): 563–71. https://doi.org/10.1111/j.1528-1157.1996.tb00610.x.

13. Engel J., Van Ness P., Rasmussen T., Ojemann L. Outcome with respect to epileptic seizures. In: Engel J. (Ed.) Surgical treatment of the epilepsies. 2nd ed. New York: Raven Press; 1993: 609–21.

14. González H.F.J., Yengo-Kahn A., Englot D.J. Vagus nerve stimulation for the treatment of epilepsy. Neurosurg Clin N Am. 2019; 30 (2): 219–30. https://doi.org/10.1016/j.nec.2018.12.005.

15. Tsai J.D., Fan P.C., Lee W.T., et al. Vagus nerve stimulation in pediatric patients with failed epilepsy surgery. Acta Neurol Belg. 2020 Mar 4. Epub 2020 Mar 4. https://doi.org/10.1007/s13760-020-01303-8.

16. Ben-Menachem E., Manon-Espaillat R., Ristanovic R., et al. Vagus nerve stimulation for treatment of partial seizures: 1. A controlled study of effect on seizures. First International Vagus Nerve Stimulation Study Group. Epilepsia. 1994; 35 (3): 616–26. https://doi.org/10.1111/j.1528-1157.1994.tb02482.x.

17. Handforth A., DeGiorgio C.M., Schachter S.C., et al. Vagus nerve stimulation therapy for partial-onset seizures: a randomized activecontrol trial. Neurology. 1998; 51 (1): 48–55. https://doi.org/10.1212/wnl.51.1.48.

18. Amar A.P., Heck C.N., Levy M.L., et al. An institutional experience with cervical vagus nerve trunk stimulation for medically refractory epilepsy: rationale, technique, and outcome. Neurosurgery. 1998; 43 (6): 1265–76. https://doi.org/10.1097/00006123-199812000-00001.

19. Englot D.J., Chang E.F., Auguste K.I. Efficacy of vagus nerve stimulation for epilepsy by patient age, epilepsy duration, and seizure type. Neurosurg Clin N Am. 2011; 22 (4): 443–8. https://doi.org/10.1016/j.nec.2011.07.002.

20. Englot D.J., Chang E.F., Auguste K.I. Vagus nerve stimulation for epilepsy: a meta-analysis of efficacy and predictors of response. J Neurosurg. 2011; 115 (6): 1248–55. https://doi.org/10.3171/2011.7.JNS11977.

21. DeGiorgio C., Heck C., Bunch S., et al. Vagus nerve stimulation for epilepsy: randomized comparison of three stimulation paradigms. Neurology. 2005; 65 (2): 317–9. https://doi.org/10.1212/01.wnl.0000168899.11598.00.

22. Englot D.J., Rolston J.D., Wright C.W., et al. Rates and predictors of seizure freedom with vagus nerve stimulation for intractable epilepsy. Neurosurgery. 2016; 79 (3): 345–53. https://doi.org/10.1227/NEU.0000000000001165.

23. Behr C., Goltzene M.A., Kosmalski G., et al. Epidemiology of epilepsy. Rev Neurol (Paris). 2016; 172 (1): 27–36. https://doi.org/10.1016/j.neurol.2015.11.003.

24. Klinkenberg S., Aalbers M.W., Vles J.S., et al. Vagus nerve stimulation in children with intractable epilepsy: a randomized controlled trial. Dev Med Child Neurol. 2012; 54 (9): 855–61. https://doi.org/10.1111/j.1469-8749.2012.04305.x.

25. Scherrmann J., Hoppe C., Kral T., et al. Vagus nerve stimulation: clinical experience in a large patient series. J Clin Neurophysiol. 2001; 18 (5): 408–14. https://doi.org/10.1097/00004691-200109000-00004.

26. Elliott R.E., Morsi A., Kalhorn S.P. Vagus nerve stimulation in 436 consecutive patients with treatment-resistant epilepsy: long-term outcomes and predictors of response. Epilepsy Behav. 2011; 20 (1): 57–63. https://doi.org/10.1016/j.yebeh.2010.10.017.

27. Wasade V.S., Schultz L., Mohanarangan K., et al. Long-term seizure and psychosocial outcomes of vagus nerve stimulation for intractable epilepsy. Epilepsy Behav. 2015; 53: 31–6. https://doi.org/10.1016/j.yebeh.2015.09.031.

28. Wang H.J., Tan G., Zhu L.N., et al. Predictors of seizure reduction outcome after vagus nerve stimulation in drug-resistant epilepsy. Seizure. 2019; 66: 53–60. https://doi.org/10.1016/j.seizure.2019.02.010.

29. Spanaki M.V., Allen L.S., Mueller W.M., Morris G.L. Vagus nerve stimulation therapy: 5-year or greater outcome at a university-based epilepsy center. Seizure. 2004; 13 (8): 587–90. https://doi.org/10.1016/j.seizure.2004.01.009.

30. Panebianco M., Rigby A., Weston J., Marson A.G. Vagus nerve stimulation for partial seizures. Cochrane Database Syst Rev. 2015; 2015 (4): CD002896. https://doi.org/10.1002/14651858.CD002896.pub2.

31. George M.S., Aston-Jones G. Noninvasive techniques for probing neurocircuitry and treating illness: vagus nerve stimulation (VNS), transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). Neuropsychopharmacology. 2010; 35 (1): 301–16. https://doi.org/10.1038/npp.2009.87.

32. Revesz D., Rydenhag B., Ben-Menachem E. Complications and safety of vagus nerve stimulation: 25 years of experience at a single center. J Neurosurg Pediatr. 2016; 18 (1): 97–104. https://doi.org/10.3171/2016.1.PEDS15534.

33. Iriarte J., Urrestarazu E., Alegre M., et al. Late-onset periodic asystolia during vagus nerve stimulation. Epilepsia. 2009; 50 (4): 928–32. https://doi.org/10.1111/j.1528-1167.2008.01918.x.

34. Marzec M., Edwards J., Sagher O., et al. Effects of vagus nerve stimulation on sleep-related breathing in epilepsy patients. Epilepsia. 2003; 44 (7): 930–5. https://doi.org/10.1046/j.1528-1157.2003.56202.x.

35. Morris G.L., Gloss D., Buchhalter J., et al. Evidence-based guideline update: vagus nerve stimulation for the treatment of epilepsy: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2013; 81 (16): 1453–9. https://doi.org/10.1212/WNL.0b013e3182a393d1.

36. Areshkina I.G., Dmitrenko D.V., Shnayder N.A., Narodova E.A. Efficacy and safety of vagal nerve stimulation in patients with pharmacoresistant epilepsy. Epilepsia i paroksizmalʹnye sostoania / Epilepsy and Paroxysmal Conditions. 2019; 11 (1): 27–36 (in Russ.). https://doi.org/10.17749/2077-8333.2019.11.1.27-36.


For citation:


Voronkova K.V., Klochkov M.N., Koroleva N.Yu., Ivanov S.S., Dmitriev A.B., Bolshakova E.S., Fatykhova E.F., Usoltseva A.A., Dmitrenko D.V., Feygina A.A., Koshelyaevskaya Ya.N. Efficacy and safety of using vagus nerve stimulation in patients with pharmacoresistant epilepsy in the Russian Federation: a multi-center retrospective observational program. Epilepsy and paroxysmal conditions. 2021;13(2):106-122. (In Russ.) https://doi.org/10.17749/2077-8333/epi.par.con.2021.089

Views: 133


ISSN 2077-8333 (Print)
ISSN 2311-4088 (Online)