Department of Neurosurgery and Gamma Knife Radiosurgery, IRCCS San Raffaele Scientific Institute, Vita-Salute University, Milan, Italy.
Department of Neurology, Mayo Clinic, Rochester, Minnesota, USA.
Neurosurgery. 2021 Sep 15;89(4):686-694. doi: 10.1093/neuros/nyab253.
The Food and Drug Administration approved the deep brain stimulation of the anterior nucleus of the thalamus (ANT-DBS) as an adjunctive therapy for drug-resistant epilepsy (DRE) in the United States in 2018. The DBS Therapy for Epilepsy Post-Approval Study is further evaluating the safety and effectiveness of ANT-DBS among different patients' groups. For this study, devices for vagus nerve stimulation (VNS) must be removed prior to enrolment.
To investigate the outcomes of concomitant ANT-DBS and VNS treatment for DRE.
A retrospective analysis was performed for 33 patients who underwent ANT-DBS using previous VNS to define distinct subgroups: standard ANT-DBS (9 subjects), ANT-DBS with functional VNS (12 subjects), and ANT-DBS with the VNS implantable pulse generator explanted or turned off at the time of the DBS (12 subjects). Effectiveness and safety data were analyzed across the whole population and among subgroups.
A mean decrease in seizure frequency of 55% was observed after a mean follow-up of 25.5 mo. Approximately 67% of patients experienced ≥50% reduction in seizure frequency. Seizure reduction percentage was not significantly different among groups. Approximately 50% of subjects with no appreciable improvement and 75% of those who showed benefit after VNS (including improvement in seizure frequency, seizure severity, and seizure duration or quality of life) achieved a seizure reduction ≥50% after ANT-DBS surgery. There were no complications related to concomitant VNS and ANT-DBS.
ANT-DBS for DRE provides excellent results despite previous and ongoing VNS therapy. Removal of VNS does not appear to be necessary before ANT-DBS.
美国食品和药物管理局于 2018 年批准丘脑前核深部脑刺激（ANT-DBS）作为耐药性癫痫（DRE）的辅助治疗方法。DBS 治疗癫痫后批准研究进一步评估了不同患者群体中 ANT-DBS 的安全性和有效性。为此研究，在入组前必须移除迷走神经刺激（VNS）设备。
研究同时进行 ANT-DBS 和 VNS 治疗 DRE 的结果。
对 33 名使用先前 VNS 进行 ANT-DBS 的患者进行回顾性分析，以定义不同的亚组：标准 ANT-DBS（9 例）、具有功能 VNS 的 ANT-DBS（12 例）和在 DBS 时植入脉冲发生器已取出或关闭的 VNS 的 ANT-DBS（12 例）。对整个人群和亚组进行有效性和安全性数据的分析。
在平均随访 25.5 个月后，观察到平均癫痫发作频率降低 55%。约 67%的患者癫痫发作频率降低≥50%。各组之间的癫痫发作减少百分比无显著差异。大约 50%的无明显改善的患者和 75%的 VNS 后受益的患者（包括癫痫发作频率、癫痫严重程度、癫痫发作持续时间或生活质量的改善）在接受 ANT-DBS 手术后达到≥50%的癫痫发作减少。同时进行 VNS 和 ANT-DBS 没有出现相关并发症。
尽管之前和正在进行 VNS 治疗，ANT-DBS 治疗 DRE 仍能取得优异的效果。在进行 ANT-DBS 之前，似乎没有必要移除 VNS。
