Russo Angelo, Hyslop Ann, Gentile Valentina, Boni Antonella, Miller Ian, Chiarello Daniela, Pellino Giuditta, Zenesini Corrado, Martinoni Matteo, Lima Mario, Ragheb John, Cordelli Duccio Maria, Pini Antonella, Jayakar Prasanna, Duchowny Michael
IRCCS Istituto delle Scienze Neurologiche di Bologna, UOC Neuropsichiatria dell'età pediatrica, Bologna, Italy.
Department of Neurology and Comprehensive Epilepsy Program, Brain Institute, Nicklaus Children's Hospital, Miami, Florida, USA.
Epileptic Disord. 2021 Aug 1;23(4):563-571. doi: 10.1684/epd.2021.1299.
We describe a multicenter experience with VNS implantation in pediatric patients with epileptic encephalopathy. Our goal was to assess VNS efficacy and identify potential predictors of favorable outcome. This was a retrospective study. Inclusion criteria were: ≤18 years at the time of VNS implantation and at least one year of follow-up. All patients were non-candidates for excisional procedures. Favorable clinical outcome and effective VNS therapy were defined as seizure reduction >50%. Outcome data were reviewed at one, two, three and five years after VNS implantation. Fisher's exact test, Kaplan-Meier and multiple logistic regression analysis were employed. Twenty-seven patients met inclusion criteria. Responder rate (seizure frequency reduction ≥ 50%) at one-year follow-up was 25.9%, and 15.3% at last follow-up visit. The only variable significantly predicting favorable outcome was time to VNS implantation, with the best outcome achieved when VNS implantation was performed within five years of seizure onset (overall response rate of 83.3% at one year of follow-up and 100% at five years). In total, 63% of patients evidenced improved QOL at last follow-up visit. Only one patient exited the study due to an adverse event at two years from implantation. Early VNS implantation within five years of seizure onset was the only predictor of favorable clinical outcome in pediatric patients with epileptic encephalopathy. Improved QOL and a very low incidence of adverse events were observed.
我们描述了在患有癫痫性脑病的儿科患者中植入迷走神经刺激器(VNS)的多中心经验。我们的目标是评估VNS的疗效,并确定有利结果的潜在预测因素。这是一项回顾性研究。纳入标准为:VNS植入时年龄≤18岁且至少随访一年。所有患者均不适合进行切除手术。良好的临床结果和有效的VNS治疗定义为癫痫发作减少>50%。在VNS植入后1年、2年、3年和5年对结果数据进行回顾。采用Fisher精确检验、Kaplan-Meier法和多元逻辑回归分析。27例患者符合纳入标准。1年随访时的缓解率(癫痫发作频率降低≥50%)为25.9%,末次随访时为15.3%。唯一显著预测良好结果的变量是VNS植入时间,在癫痫发作开始后5年内进行VNS植入时取得的结果最佳(1年随访时的总体缓解率为83.3%,5年时为100%)。在末次随访时,共有63%的患者生活质量得到改善。仅1例患者在植入后2年因不良事件退出研究。癫痫发作开始后5年内早期植入VNS是患有癫痫性脑病的儿科患者良好临床结果的唯一预测因素。观察到生活质量改善且不良事件发生率极低。