The SANTe study at 10 years of follow-up: Effectiveness, safety, and sudden unexpected death in epilepsy
The SANTe study at 10 years of follow-up: Effectiveness, safety, and sudden unexpected death in epilepsy
复制标题
DOI：
10.1111/epi.16895
复制
发表时间：
2021-04-08
期刊：
影响因子：
5.6
通讯作者：
Fisher, Robert S.
中科院分区：
文献类型：
--
作者：
Salanova, Vicenta;Sperling, Michael R.;Fisher, Robert S.
目的 我们评估了 7 和 10 年后深部脑前丘脑刺激的有效性和安全性，并报告了丘脑前核刺激治疗癫痫 (SANTe) 研究中成人癫痫突然意外死亡 (SUDEP) 的发生率和总体死亡率。方法经过 3 个月的盲法和 9 个月的非盲法阶段后，在长期随访 (LTFU) 和随后的继续治疗中继续对受试者进行评估进入阶段（CAP），以进一步描述不良事件和 SUDEP 的发生率。允许改变刺激参数和药物。 结果 100 名植入受试者总共积累了 938 设备年的经验（LTFU 阶段有 69 名受试者，CAP 阶段有 61 名受试者）。在研究结束之前，57 名活跃受试者在 14 个研究中心继续接受治疗，并随访至少 10 年（最多 14 年）。 7 年时，中位癫痫发作频率较基线降低了 75% (p < .001)，与之前的迷走神经刺激或切除手术没有相关的结果差异。最严重的癫痫发作类型（局灶性至双侧强直阵挛）减少了 71%。随着时间的推移，添加新的抗癫痫药物并不会影响癫痫发作减少的模式。研究中没有出现意外的严重不良事件。根据 SANTe 研究经验（938 年中有 2 例死亡）和之前的试点研究（76 年内有 0 例死亡），确定加可能的 SUDEP 率表明 1000 人年的死亡率为 2.0。总体死亡率为每 1000 人年 6.9 人死亡。 意义 深部脑刺激 (DBS) 系统治疗癫痫的长期疗效和安全性良好，并显示出稳定的结果。改善最严重癫痫发作类型的频率可能会降低 SUDEP 风险。 DBS 的 SUDEP 率 (2.0) 与治疗耐药性局灶性癫痫的其他神经调节治疗（即迷走神经刺激、反应性神经刺激）相当。
Objective 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 (SANTe) study.Methods 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.Results 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 SANTe 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.Significance 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.