Department of Neurology, Indiana University, Indianapolis, Indiana, USA.
Department of Neurology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Epilepsia. 2021 Jun;62(6):1306-1317. doi: 10.1111/epi.16895. Epub 2021 Apr 8.
We evaluated the efficacy and safety of deep brain anterior thalamus stimulation after 7 and 10 years, and report the incidence of sudden unexpected death in epilepsy (SUDEP) and overall mortality in adults in the Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy (SANTÉ) study.
After the 3-month blinded and 9-month unblinded phases, subjects continued to be assessed during long-term follow-up (LTFU) and later a continued therapy access phase (CAP), to further characterize adverse events and the incidence of SUDEP. Stimulus parameter and medication changes were allowed.
One hundred ten implanted subjects accumulated a total of 938 device-years of experience (69 subjects during the LTFU phase and 61 subjects in the CAP phase). Prior to study closure, 57 active subjects continued therapy at 14 study centers, with follow-up of at least 10 (maximum 14) years. At 7 years, median seizure frequency percent reduction from baseline was 75% (p < .001), with no outcome differences related to prior vagus nerve stimulation or resective surgery. The most severe seizure type, focal to bilateral tonic-clonic, was reduced by 71%. Adding new antiseizure medications did not impact the pattern of seizure reduction over time. There were no unanticipated serious adverse events in the study. The definite-plus-probable SUDEP rate, based on SANTÉ study experience (two deaths in 938 years) and previous pilot studies (0 deaths in 76 years), indicated a rate of 2.0 deaths for 1000 person-years. Overall mortality was 6.9 deaths per 1000 person-years.
The long-term efficacy and safety profiles of the deep brain stimulation (DBS) system for epilepsy are favorable and demonstrate stable outcomes. Improvement in frequency of the most severe seizure type may reduce SUDEP risk. The SUDEP rate with DBS (2.0) is comparable to other neuromodulation treatments (i.e., vagus nerve stimulation, responsive neurostimulation) for drug-resistant focal epilepsy.
我们评估了深部脑前丘脑刺激 7 年和 10 年后的疗效和安全性，并报告了 Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy（SANTÉ）研究中成年人癫痫性意外猝死（SUDEP）和总死亡率的发生率。
在 3 个月的盲法和 9 个月的非盲法阶段之后，受试者继续在长期随访（LTFU）期间进行评估，随后进入持续治疗访问阶段（CAP），以进一步描述不良事件和 SUDEP 的发生率。允许刺激参数和药物变化。
110 名植入患者总共积累了 938 个设备年的经验（69 名患者在 LTFU 阶段，61 名患者在 CAP 阶段）。在研究关闭之前，57 名活跃患者在 14 个研究中心继续接受治疗，随访时间至少为 10 年（最长 14 年）。7 年后，与基线相比，中位数癫痫发作频率百分比降低了 75%（p<0.001），且与先前的迷走神经刺激或切除术无结果差异。最严重的癫痫发作类型，局灶性双侧强直阵挛，降低了 71%。添加新的抗癫痫药物不会影响随时间推移的癫痫发作减少模式。研究中没有未预料到的严重不良事件。基于 SANTÉ 研究经验（在 938 年中有 2 例死亡）和以前的试点研究（在 76 年中有 0 例死亡），确定的 plus 可能的 SUDEP 发生率为每 1000 人年 2.0 例死亡。总死亡率为每 1000 人年 6.9 例死亡。
深部脑刺激（DBS）系统治疗癫痫的长期疗效和安全性良好，且结果稳定。最严重的癫痫发作类型频率的改善可能会降低 SUDEP 的风险。DBS（2.0）的 SUDEP 发生率与其他神经调节治疗（即迷走神经刺激、反应性神经刺激）治疗耐药性局灶性癫痫的发生率相当。
