| Objective:To investigate Long-term efficacy and safety of vagus nerve stimulation in children with intractable epilepsy.Methods:Six children with refractory epilepsy treated with implantable vagus nerve stimulation system from December 2017 to February 2018 of our hospital from December 2017 to February 2018 were selected.The clinical data were followed up and analyzed.The epileptic seizures before and after operation at 6,24,30,36,42 and 48 months were recorded.The seizure frequency and improved Engel classification were used as the evaluation indexes to evaluate the effectiveness.Gesell Scale(GDS)was used to evaluate the changes of cognitive function at 6,24,30,36,42 and 48 months after operation.Seizure severity scale(NHS3)was used to evaluate the changes of seizure severity at 24,30,36,42 and 48 months after operation.ABAS-Ⅱ adaptive behavior scale,ABC abnormal behavior scale and Achenbach Child Behavior Checklist(CBCL)were used to evaluate the improvement of social life ability and abnormal behavior at 24,30,36,42 and 48 months after operation.All assessment scales were compared between groups by independent sample t test,P<0.05 was statistically significant.ECG was monitored 24h,30h,36h,42h and 48h after operation,and adverse events were recorded.GraphPad software was used to analyze the relationship between VNS stimulation current and seizure frequency.Results:(1)Clinical data:Six cases were male,the minimum age of onset was 2 days,the maximum age of onset was 2 years and 9 months,the average age of onset was 1 year,the minimum age of VNS surgery was 3 years,the maximum age was 5 years and 4 months,the average age of surgery was 4 years and 6 months.Among the 6 cases,2 cases were West syndrome,1 case was Dravet syndrome,1 case was nodular sclerosis,2 cases could not be classified,and 6 cases had various forms of epilepsy.Of the 6 cases,4 had MRI abnormalities:1 had nodular sclerosis,2 had softening lesions,1 had hippocampal atrophy and 3 had brain atrophy.The EEG of 6 cases showed interphase multi-discharge.(2)Validity evaluation:The mean seizure frequency before operation was 149.6±129.68 times/month,and the seizure frequency after 6,24,30,36,42 and 48 months of follow-up after VNS was 73.4 ± 79.55,27.58±89.84,42.2±89.84,43.08 ±83.91,41.92 ± 83.44 and 39.33±79.55 times/month,respectively.The modified Engel classification after 48 months of operation:2 cases were grade Ⅰ(seizure free),1 case was grade Ⅱ,2 cases were grade Ⅲ,and 1 case was grade Ⅳ.48 months after operation,EEG showed that 4 cases of epilepsy discharge decreased,no significant change.Evaluation of severity of seizures:NHS3 scale was used to evaluate the severity of seizures 24,30,36,42 and 48 months after VNS operation,which were all reduced compared with those before operation.(3)Cognitive and social behavior assessment:Gesell scale evaluation was completed in 6 patients before and 6,24,30,36,42 and 48 months after operation.Independent sample t test showed that there was no significant difference in the results of each functional area of Gesell scale before operation(adaptability,big exercise,fine exercise,language,and personal social interaction)compared with 6,24,30,36,42,and 48 months after operation(P>0.05).There was no significant difference in ABAS-Ⅱ score(conceptual skills,social skills,practical skills and comprehensive ability)between 24 months after operation and different time points(30,36,42 and 48 months after operation)(P>0.05).The comprehensive ability score of 6 children was 67 points(diagnostic autism),1 case was 53-67 points(suspected autism),and 1 case was 67 points.The ABC score showed a downward trend in general.The independent sample t test showed that there was no significant difference between 24 months after operation and 30,36 and 42 months after operation(P>0.05),and there was difference between 24 months after operation and 48 months after operation(P<0.05).6 cases of CBCL scales rated social skills<30 and behavioral problems<70 at 24,30,36,42 and 48 months postoperatively,and independent sample t-tests showed no significant differences in social skills at 24 months compared with 30,36,42 and 48 months postoperatively(P>0.05)).In terms of behavioral problems,there was no significant difference between 24 months and 30,36,42 months after operation(P>0.05),and there was difference between 48 months after operation(P<0.05).(4)Safety assessment of VNS surgery:24-hour ECG monitoring of 1 case of occasional ventricular premature beat,1 case of occasional atrial premature beat,long-term follow-up were no permanent adverse reactions.(5)VNS stimulation current and seizure frequency:The stimulation current corresponding to the lowest seizure frequency was 1.9-2.0mA,1.0mA,1.5mA,1.1mA,1.0mA,0.5mA in 6cases,of which 5 cases were high parameter current(≥1mA).Conclusions:1.VNS is long-term effective and safe in the treatment of refractory epilepsy in children,can reduce the frequency and severity of seizures,and has a long-term cumulative effect.2.VNS may improve comorbidities such as autism and abnormal behavior.3.High parameter current is more likely to effectively control seizures. |
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