Comparison of Outcomes and Safety of the Brain-Responsive Neurostimulator in Adults with Medically Intractable Focal Onset Seizures at a Single Epilepsy Center Versus Multi-Center Phase IV Study
Abstract number :
3.309
Submission category :
9. Surgery / 9A. Adult
Year :
2021
Submission ID :
1826000
Source :
www.aesnet.org
Presentation date :
12/6/2021 12:00:00 PM
Published date :
Nov 22, 2021, 06:51 AM
Authors :
Angela Wabulya, MB ChB - University of North Carolina at Chapel Hill; Eldad Hadar - University of North Carolina at Chapel Hill; Linh Ngo - University of North Carolina at Chapel Hill; Tejinder Singh - University of North Carolina at Chapel Hill; Shabina Sheikh - University of North Carolina at Chapel Hill; Atif Sheikh - University of North Carolina at Chapel Hill; Hae Won Shin - University of New Mexico
Rationale: About 30% to 40% of patients with epilepsy are refractory to medications. In 2014, the RNS System was approved for adults with medically refractory focal onset seizures arising from 1 or 2 seizure foci. Studies have shown that the benefit of the RNS system improved over time. Over nine years in a multi-center study, the median percent seizure reduction was 75%, the responder rate was 73%, with more than 66% of patients had a >90% reduction in seizures. Our center has been using this device since 2015. Our objective was to evaluate safety and efficacy of brain-responsive neuro-stimulation in adults with medically intractable focal onset seizures at a single epilepsy center over a 5-year period and compare outcomes with those reported in a large multicenter study conducted over a 9-year period as reported by Nair et al 2020.
Methods: This is a retrospective review inpatient with intractable epilepsy who had The RNS System implanted at a single level IV epilepsy center. Patients had to have at least six months of data after activation of the RNS device. Evaluation of Efficacy was assessed as median percent change in seizure frequency and as responder rate (rate of a >50% seizure frequency reduction frequency), and safety was assessed as spontaneously reported adverse effects.
Results: Of the 40 patients implanted, 21 had data analyzed at six months of data. The responder rate was 78%, 44% had a >90% reduction in seizure frequency, while 35% were seizure-free over a period ranging from 10 to 55 months. Complications included infection in 3 of 40 implanted patients, all of whom the device was explanted; however, there were no stimulation-related adverse severe effects.
Conclusions: Findings in this single epilepsy center were comparable to those reported at multi-center study with a responder rate of 78% in addition to 35% being seizure-free. The device was safe, with only three infections reported. Findings show replicability of outcomes reported in a multi-center study. They should encourage health care providers regarding the efficacy and safety of the brain-responsive neuro-stimulation in adults with medically intractable focal onset seizures from 1 or 2 seizure foci.
Funding: Please list any funding that was received in support of this abstract.: None.
Surgery