RNS-It Never Gets Old

Objective: This commentary aims to prospectively evaluate safety and efficacy of brain-responsive neurostimulation in adults with medically intractable focal onset seizures (FOS) over 9 years. Methods: Adults treated with brain-responsive neurostimulation in 2-year feasibility or randomized controlled trials were enrolled in a long-term prospective open label trial (LTT) to assess safety, efficacy, and quality of life (QOL) over an additional 7 years. Safety was assessed as adverse events (AEs), efficacy as median percent change in seizure frequency and responder rate, and QOL with the Quality of Life in Epilepsy (QOLIE-89) Inventory. Results: Of 256 patients treated in the initial trials, 230 participated in the LTT. At 9 years, the median percent reduction in seizure frequency was 75% (P < 0.0001, Wilcoxon signed rank), the responder rate was 73%, and 35% had a >= 90% reduction in seizure frequency. We found that 18.4% (47 of 256) experienced >= 1 year of seizure freedom, with 62% (29 of 47) seizure-free at the last folnlow-up and an average seizure-free period of 3.2 years (range: 1.04-9.6 years). Overall QOL and epilepsy-targeted and cognitive domains of QOLIE-89 remained significantly improved (P < 0.05). There were no serious AEs related to stimulation, and the sudden unexplained death in epilepsy (SUDEP) rate was significantly lower than predefined comparators (P < 0.05, 1-tailed.2). Conclusions: Adjunctive brain-responsive neurostimulation provides significant and sustained reductions in the frequency of FOS with improved QOL. Stimulation was well tolerated, implantation-related AEs were typical of other neurostimulation devices, and SUDEP rates were low.