Authors: Pedram Malekenia
FDA approval for VNS implantation is limited to patients over 4 years of age with medically refractory partial onset seizures. In young children with severe generalized epilepsy, however, VNS implantation is therefore off-label. The objective of this study was to retrospectively explore the feasibility, safety, and efficacy of VNS procedures in children under 6 with medically refractory generalized epilepsy.Methods: This was a retrospective observational cohort study of a group of patients under 6 years of age with generalized, medically resistant epilepsy (MRE) who underwent VNS implantation between 2010-2020. Inclusion criteria encompassed: failure of more than 2 anti-seizure drugs (ASDs) alone or in combination, neurologist referral for VNS, informed consent with knowledge of “off-label” status in young children and >1year of follow up. Outcome measures included seizure reduction rate of 50% or greater and post-operative morbidity defined nominally. Statistical analysis was conducted with JMP 14.0.
Forty-five patients were included; 5 patients < 3 years old, and 40 patients 3-6 years old. There were no intraoperative complications. By one year follow up 11% (n=5) had experienced perioperative complications ranging from 2 wound infections, mild cough, hyperactivity, hoarseness and one patient with persistent surgical site pain.
Greater than 50% seizure reduction was observed in 36.4% (n=4) of patients < 4years old at 6 months, 1, 2 and 5 year follow up. In the 4–6-year-old cohort, this was observed in 32.4% (n=11) at 6 months, 41.1% (n=14) at 1 year, 38.2% (n=13) at 2 years and 41.1% (n=14) at 5 years.
VNS implantation for patients under 6 years old with generalized onset MRE has not been FDA approved. This retrospective study establishes feasibility, illustrates an acceptable safety profile in this age group and demonstrates efficacy comparable to that reported in older patients.