Efficacy, safety, and predictors of vagus nerve stimulation in children with drug-resistant epilepsy: A single-center prospective study.

OBJECTIVE

To evaluate the safety and effectiveness of vagus nerve stimulation (VNS) in treating drug-refractory epilepsy (DRE) in children and to identify key predictive factors influencing its efficacy.

METHODS

This was a prospective, single-center study conducted from October 2016 to July 2020. A total of 54 children treated with VNS were followed for 24 months. The effectiveness and safety of VNS were assessed at 2, 6, 12, 18, and 24 months. Kaplan-Meier univariate survival analysis and Cox regression analysis were used to identify predictors of treatment response.

RESULTS

At 2, 6, 12, 18, and 24 months, the effectiveness of VNS (defined as a ≥50 % reduction in seizure frequency) was 29.6 %, 20.4 %, 39.6 %, 76.0 % and 75.0 %, respectively. Seizure freedom rates were 0 %, 0 %, 3.8 %, 8.0 % and 10.4 %, respectively. The effectiveness rate for patients with Lennox-Gastaut syndrome at 24 months was 67.7 %. Significant improvements were also observed in neurodevelopmental scores and quality of life (p < 0.05). Cox regression identified absence seizures and abnormal neuroimaging (CT/MRI) as independent negative predictors of VNS response at 18 and 24 months. Adverse events were transient and tolerable, with 5 (9.3 %) cases of transient hoarseness, 3 (5.6 %) of cough, 3 (5.6 %) of decreased appetite, 2 (3.7 %) of skin irritation, 2 (3.7 %) of localized skin infection, and 1 (1.8 %) of menstrual cycle disturbance.

CONCLUSION

VNS is an effective and safe long-term therapy for pediatric DRE, with cumulative benefits over time. The presence of absence seizures and abnormal neuroimaging findings were key predictors of a less favorable response, which may inform clinical decision-making regarding patient selection. Caution is advised when initiating VNS therapy in children with DRE exhibiting these characteristics.