Long-term evaluation of anterior thalamic deep brain stimulation for epilepsy in the European MORE registry

IF 6.6 1区医学 Q1 CLINICAL NEUROLOGY Epilepsia Pub Date : 2024-06-05 DOI:10.1111/epi.18003

Elisabeth Kaufmann, Jukka Peltola, Albert J. Colon, Kai Lehtimäki, Milan Majtanik, Jürgen K. Mai, Beata Bóné, Carla Bentes, Volker Coenen, Antonio Gil-Nagel, Antonio J. Goncalves-Ferreira, Philippe Ryvlin, Rod Taylor, Thomas C. Brionne, Frans Gielen, Shannon Song, Paul Boon, the MORE study group

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Abstract

Objective

Short-term outcomes of deep brain stimulation of the anterior nucleus of the thalamus (ANT-DBS) were reported for people with drug-resistant focal epilepsy (PwE). Because long-term data are still scarce, the Medtronic Registry for Epilepsy (MORE) evaluated clinical routine application of ANT-DBS.

Methods

In this multicenter registry, PwE with ANT-DBS were followed up for safety, efficacy, and battery longevity. Follow-up ended after 5 years or upon study closure. Clinical characteristics and stimulation settings were compared between PwE with no benefit, improvers, and responders, that is, PwE with average monthly seizure frequency reduction rates of ≥50%.

Results

Of 170 eligible PwE, 104, 62, and 49 completed the 3-, 4-, and 5-year follow-up, respectively. Most discontinuations (68%) were due to planned study closure as follow-up beyond 2 years was optional. The 5-year follow-up cohort had a median seizure frequency reduction from 16 per month at baseline to 7.9 per month at 5-year follow-up (p < .001), with most-pronounced effects on focal-to-bilateral tonic–clonic seizures (n = 15, 77% reduction, p = .008). At last follow-up (median 3.5 years), 41% (69/170) of PwE were responders. Unifocal epilepsy (p = .035) and a negative history of epilepsy surgery (p = .002) were associated with larger average monthly seizure frequency reductions. Stimulation settings did not differ between response groups. In 179 implanted PwE, DBS-related adverse events (AEs, n = 225) and serious AEs (n = 75) included deterioration in epilepsy or seizure frequency/severity/type (33; 14 serious), memory/cognitive impairment (29; 3 serious), and depression (13; 4 serious). Five deaths occurred (none were ANT-DBS related). Most AEs (76.3%) manifested within the first 2 years after implantation. Activa PC depletion (n = 37) occurred on average after 45 months.

Significance

MORE provides further evidence for the long-term application of ANT-DBS in clinical routine practice. Although clinical benefits increased over time, side effects occurred mainly during the first 2 years. Identified outcome modifiers can help inform PwE selection and management.

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欧洲 MORE 登记处对丘脑前部深部脑刺激治疗癫痫的长期评估。

目的：有报道称，对耐药局灶性癫痫（PwE）患者进行丘脑前核深部脑刺激（ANT-DBS）可取得短期疗效。由于长期数据仍然匮乏，美敦力癫痫注册中心（Medtronic Registry for Epilepsy，MORE）对ANT-DBS的临床常规应用进行了评估：在这项多中心登记中，对使用 ANT-DBS 的 PwE 进行了安全性、有效性和电池寿命随访。随访在 5 年后或研究结束时结束。对无获益者、改善者和应答者（即平均每月癫痫发作频率减少率≥50%）之间的临床特征和刺激设置进行了比较：在 170 名符合条件的患者中，分别有 104 人、62 人和 49 人完成了为期 3 年、4 年和 5 年的随访。由于 2 年后的随访是可选的，因此大多数中止随访（68%）的原因是计划终止研究。5 年随访组群的癫痫发作频率中位数从基线时的每月 16 次降至 5 年随访时的每月 7.9 次（p 意义重大：MORE为ANT-DBS在临床常规实践中的长期应用提供了进一步的证据。虽然临床获益随着时间的推移而增加，但副作用主要发生在头两年。确定的结果调节因素有助于为患者的选择和管理提供依据。

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来源期刊

Epilepsia 医学-临床神经学

CiteScore

10.90

自引率

10.70%

发文量

319

审稿时长

2-4 weeks

期刊介绍： Epilepsia is the leading, authoritative source for innovative clinical and basic science research for all aspects of epilepsy and seizures. In addition, Epilepsia publishes critical reviews, opinion pieces, and guidelines that foster understanding and aim to improve the diagnosis and treatment of people with seizures and epilepsy.