Division of Pediatric Neurosurgery, Cohen Children's Medical Center, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Health, New Hyde Park, NY, USA.
Division of Pediatric Neurology, Cohen Children's Medical Center, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell Health, New Hyde Park, NY, USA.
Childs Nerv Syst. 2022 Mar;38(3):547-556. doi: 10.1007/s00381-021-05416-0. Epub 2021 Nov 27.
Vagus nerve stimulators (VNS) have emerged as an effective treatment modality for pediatric patients suffering from intractable, drug-resistant epilepsy. Newer devices, AspireSR™ Model 106 and the SenTiva™ Model 1000 (VNS TherapyⓇ, LivaNova™), contain an "auto-stimulation" feature that detects ictal tachycardia and transmits pulsations to attenuate seizures. However, the exact benefits of auto-stimulation compared to its risks still merit further exploration. This study evaluates the utility of these specific devices in a heterogeneous population of pediatric and young adult patients with intractable epilepsy.
This is a retrospective chart review of 55 patients who underwent either VNS insertion with or without an auto-stimulation-enabled VNS device at a single level four epilepsy center. Seizure frequency, seizure subtype, side effects, and change in anti-seizure medication load both before and after VNS implantations were collected from patient self-reporting at the time of VNS insertion and 12 months following implantation. Information regarding output current, auto-stimulation current, duty cycling, and auto-stimulation threshold of the device was obtained from documented VNS interrogation for patients with auto-stimulation-enabled VNS devices.
Patients with auto-stimulation-enabled VNS devices had a mean 56.0% (SD = 0.414) seizure frequency reduction 12 months post-VNS insertion, while patients without auto-stimulation-enabled VNS devices had a mean 41.6% (SD = 0.456) seizure frequency reduction during the same interval. The mean seizure frequency reduction 12 months post-VNS insertion for patients with a SenTiva™ 1000 model was 66.0% (SD = 0.426). For patients with auto-stimulation-enabled VNS devices, post-treatment seizure reduction was significantly correlated with daily auto-stimulation activation (R = 0.432, p = 0.025).
This study supports the clinical safety and utility of auto-stimulation-enabled VNS models, specifically the SenTiva™ 1000, in treating pediatric patients with intractable epilepsy of various subtypes and etiologies. Further research is needed to evaluate the sustained impact of auto-stimulation on long-term outcomes (≥ 2 years follow-up post-VNS).
迷走神经刺激器（VNS）已成为治疗患有难治性、耐药性癫痫的儿科患者的有效治疗方法。较新的设备，AspireSR 模型 106 和 SenTiva 模型 1000（VNS Therapy Ⓡ，LivaNova ⁇ ），包含一个“自动刺激”功能，可以检测到发作性心动过速并传输脉冲以减轻癫痫发作。然而，与风险相比，自动刺激的确切益处仍值得进一步探索。本研究评估了这些特定设备在患有难治性癫痫的儿科和年轻成年患者的异质人群中的效用。
这是一项回顾性图表研究，共纳入了 55 名患者，他们在一家四级癫痫中心接受了 VNS 植入术，其中一些患者使用了具有自动刺激功能的 VNS 设备。在 VNS 植入术时和植入术后 12 个月，通过患者自我报告收集了癫痫发作频率、癫痫发作类型、副作用以及抗癫痫药物负荷的变化。对于具有自动刺激功能的 VNS 设备的患者，从记录的 VNS 询问中获得了设备的输出电流、自动刺激电流、占空比和自动刺激阈值的信息。
具有自动刺激功能的 VNS 设备的患者在 VNS 植入后 12 个月的平均癫痫发作频率降低了 56.0%（SD ⁇ = 0.414），而没有自动刺激功能的 VNS 设备的患者在同一时间段内的平均癫痫发作频率降低了 41.6%（SD ⁇ = 0.456）。植入 VNS 后 12 个月，使用 SenTiva ⁇ 1000 模型的患者的平均癫痫发作频率降低了 66.0%（SD ⁇ = 0.426）。对于具有自动刺激功能的 VNS 设备的患者，治疗后癫痫发作减少与每日自动刺激激活显著相关（R ⁇ = 0.432，p ⁇ = 0.025）。
这项研究支持自动刺激功能的 VNS 模型，特别是 SenTiva ⁇ 1000，在治疗各种类型和病因的难治性癫痫儿科患者中的临床安全性和实用性。需要进一步研究来评估自动刺激对长期结果（VNS 后至少 2 年的随访）的持续影响。
