Abstracts

Rationale: Recent estimates of the US population and the prevalence of epilepsy indicated that approximately one-half million women with epilepsy are of childbearing age. The effect of pregnancy on seizure frequency is uncertain but previous studies have reported that 34% of the pregnancies had increased seizure frequency. In addition, the treatment of epilepsy during pregnancy is particularly challenging in that the potential adverse effects of antiepileptic drugs on the fetus need to be balanced against the maternal and fetal risks associated with uncontrolled seizures. With the rapid development of new stimulation devices such as vagus nerve stimulation (VNS), responsive neurostimulation (RNS) and deep brain stimulation (DBS) in the past 10 years, further interest has been shown about their influence of seizure control during pregnancy for epilepsy patients. Since FDA approval, over 1600 refractory epilepsy patients have been implanted with the RNS system. With the unique advantage of intracranial recording at the seizure focus through RNS system, it will ultimately allow us to understand better the interictal discharges and ictal events with objective ECOG data prior, during and after the pregnancy. However, very little information is known about the influence of RNS on pregnancy and fetal outcomes. Methods: This is a retrospective multicenter cohort study. Each center identifies cases from 2009-2019 who meet the inclusion criteria as follows: (1) female patients who are implanted with RNS; (2) epilepsy patients who also experienced pregnancy. Clinical information regarding epilepsy factors, anti-seizure medication, RNS settings and adjustment, and seizure frequencies prior, during and after the pregnancy were analyzed. In addition, pregnancy outcomes were assessed including OB complications, delivery methods, fetal death and major congenital malformation. Results: Total seven cases met the inclusion criteria among seven different institutions and are included in the current study. One out of these seven patients experienced 4 miscarriages while on treatment of various combination including RNS, as well as levetiracetam and/or lamotrigine. This patient subsequently had two live births, one of the children had undescended testes. Otherwise, no other OB complications, fetal loss, nor major congenital malformation occurred in this cohort. Currently the study is undergoing data analysis. Conclusions: This observational study for the first time provides preliminary information about the utilization and safety of RNS treatment for epilepsy female patients at childbearing age. Funding: No funding