Department of Neurology and Neurological Sciences, Stanford University School of Medicine, Palo Alto, CA, 94304-5979, USA.
Department of Neurology, University of California, Los Angeles, 710 Westwood Plaza, Los Angeles, CA, 90095, USA.
Epilepsy Res. 2021 Jan;169:106532. doi: 10.1016/j.eplepsyres.2020.106532. Epub 2020 Dec 10.
To study the pregnancy outcomes, including obstetric complications and fetal outcomes, in pregnant women with epilepsy (WWE) treated with direct brain-responsive neurostimulation (RNS System).
Retrospective review of obstetric outcomes and fetal outcomes in WWE treated with the RNS System at nine comprehensive epilepsy centers in the United States from 2014-2020. In addition, changes in seizure frequency, anti-seizure medications, and RNS System setting adjustments during pregnancy were investigated.
A total of 10 subjects and 14 pregnancies were identified. The mean age at conception was 30.6 ± 4.3 years old. The mean age at implantation was 29.8 ± 4.4 years old. The mean stimulation charge densities ranged from 1.0 to 3.0 μC/cm during pregnancy. Obstetric complications included recurrent miscarriage (1 patient), cesarean section (3 patients) due to preeclampsia, non-reassuring fetal heart rate tracing or prolonged labor, preterm birth (1 patient), and preeclampsia (1 patient). No still birth, gestational hypertension, gestational diabetes, eclampsia, or maternal mortality were observed. No RNS System-exposed pregnancies had major congenital malformations. One offspring had a minor congenital anomaly of cryptorchidism in a pregnancy complicated with risk factors of advanced maternal age and bicornuate uterus.
The present study is the first report of RNS System-exposed pregnancies in WWE to date. No major congenital malformations were identified. All of the obstetric complications were within the expected range of those in WWE based on previously published data. The sample size of our study is small, so accumulation of additional cases will further help depict the safety profile of treatment with the RNS System during pregnancy.
研究接受直接脑反应神经刺激（RNS 系统）治疗的癫痫（WWE）孕妇的妊娠结局，包括产科并发症和胎儿结局。
对 2014 年至 2020 年期间美国 9 个综合癫痫中心的接受 RNS 系统治疗的 WWE 患者的产科结局和胎儿结局进行回顾性分析。此外，还研究了妊娠期间癫痫发作频率、抗癫痫药物和 RNS 系统设置调整的变化。
共确定了 10 名患者和 14 例妊娠。受孕时的平均年龄为 30.6±4.3 岁。着床时的平均年龄为 29.8±4.4 岁。妊娠期间刺激电荷密度的平均值为 1.0 至 3.0μC/cm。产科并发症包括复发性流产（1 例）、子痫前期（3 例）导致的剖宫产、胎儿心率描记异常或产程延长、早产（1 例）和子痫前期（1 例）。未发生死胎、妊娠高血压、妊娠糖尿病、子痫或孕产妇死亡。未发现 RNS 系统暴露的妊娠存在重大先天畸形。在 1 例妊娠中，由于母体高龄和双角子宫等危险因素，胎儿出现轻微先天性隐睾畸形。
本研究是迄今为止首次报道接受 RNS 系统治疗的 WWE 患者的妊娠情况。未发现重大先天畸形。所有产科并发症均在 WWE 基于先前发表的数据的预期范围内。本研究的样本量较小，因此积累更多病例将有助于进一步描绘妊娠期间接受 RNS 系统治疗的安全性。
