Abstracts

Rationale: Implanted devices can be a viable treatment option for the one-third of epilepsy patients who do not respond to anti-seizure medications (ASM). Decisions on who may qualify as a candidate for surgery are multifactorial. Here we report data collected from the Human Epilepsy Project 2 (HEP2). This observational study enrolled subjects with medication-resistant focal epilepsy. We report overall utilization of implanted devices and factors associated implantation in this cohort.

Methods: Subjects between age 16 and 35 were recruited from 13 epilepsy centers across the United states who were diagnosed with focal epilepsy, and previously failed 4 previous trials with ASMs, with at least 2 due to failure of seizure control. Subjects were excluded from the study if they had completed a pre-surgical evaluation and/or intended to pursue resective surgery in the near term. Subjects were also excluded if they had undergone resective surgery or placement with DBS/RNS/VNS within the prior 12 months. Information obtained at the initial visit included baseline data on demographics, seizure history, history of neurological insult, medical history, family history of epilepsy, EEG and MRI results, and all treatment information including previously implanted devices.

Results: Of the 154 subjects in the study, only 49 (31.8%) had implanted devices (see Table 1). Devices included: VNS, (n=26, 17%), RNS, (n=18, 12%), and DBS (n=4, 3%). There were no significant differences among subjects with and without implants across age, education level, ethnicity or gender. However, implantation rates differed by identified race (see Table 2). Devices were implanted in 33.9% of the 103 subjects who identified as white, and 28.5% of the 7 who identified as Asian, compared to only 5.8% of the 17 subjects who identified as Black and none of the 5 subjects who identified as multiracial. (p=.01 for difference between Black and all other races).

Conclusions: In this treatment resistant population, only a small percentage of patients utilized an implanted device, though all are candidates. This data does not differentiate patients who are not offered a device vs. those who are offered a device and refuse it. It is critical to identify barriers to viable treatment options in patients with refractory epilepsy. The HEP2 data suggests Black patients are less likely to have an implanted device. More work will need to be done to study how race and other factors may impact implantation candidacy evaluations and patient decision-making.

Funding: Please list any funding that was received in support of this abstract.: This study has received funding from UCB, Neurelis, and SK Life Sciences.