Centura Health Physician Group, Neuroscience and Spine, CO, United States.
University of Colorado, Department of Neurology, United States.
Epilepsy Behav. 2022 Apr;129:108653. doi: 10.1016/j.yebeh.2022.108653. Epub 2022 Mar 16.
Clinical trials of a brain-responsive neurostimulator, RNS® System (RNS), excluded patients with a vagus nerve stimulator, VNS® System (VNS). The goal of this study was to evaluate seizure outcomes and safety of concurrent RNS and VNS stimulation in adults with drug-resistant focal-onset seizures.
A retrospective multicenter chart review was performed on all patients with an active VNS and RNS who were treated for a minimum of 6 months with both systems concurrently. Frequency of disabling seizures at baseline before RNS, at 1 year after RNS placement, and at last follow-up were used to calculate the change in seizure frequency after treatment. Data on adverse events and complications related to each device were collected.
Sixty-four patients from 10 epilepsy centers met inclusion criteria. All but one patient received RNS after VNS. The median follow-up time after RNS implantation was 28 months. Analysis of the entire population of patients with active VNS and RNS systems revealed a median reduction in seizure frequency at 1 year post-RNS placement of 43% with a responder rate of 49%, and at last follow-up a 64% median reduction with a 67% responder rate. No negative interactions were reported from the concurrent use of VNS and RNS. Stimulation-related side-effects were reported more frequently in association with VNS (30%) than with RNS (2%).
Our findings suggest that concurrent treatment with VNS and RNS is safe and that the addition of RNS to VNS can further reduce seizure frequency.
脑反应神经刺激器（RNS 系统）的临床试验排除了已接受迷走神经刺激器（VNS 系统）治疗的患者。本研究旨在评估 RNS 和 VNS 联合刺激对药物难治性局灶性发作性癫痫成人的疗效和安全性。
对所有正在使用 VNS 和 RNS 且两种系统联合治疗至少 6 个月的患者进行回顾性多中心病历回顾。采用基线时（RNS 治疗前）、RNS 治疗 1 年后和最后一次随访时的无残疾性癫痫发作频率来计算治疗后癫痫发作频率的变化。收集与每种设备相关的不良事件和并发症的数据。
来自 10 个癫痫中心的 64 名患者符合纳入标准。除 1 例患者外，所有患者均在接受 VNS 治疗后接受 RNS 治疗。RNS 植入后中位随访时间为 28 个月。对同时使用 VNS 和 RNS 系统的所有患者进行分析，结果显示 RNS 治疗 1 年后癫痫发作频率中位数降低 43%，应答率为 49%，最后一次随访时中位数降低 64%，应答率为 67%。同时使用 VNS 和 RNS 未报告有任何负面相互作用。与 RNS（2%）相比，VNS 相关的刺激相关副作用更常见（30%）。
我们的研究结果表明，VNS 和 RNS 同时治疗是安全的，在 VNS 的基础上增加 RNS 可进一步降低癫痫发作频率。
