Clinical outcomes of closed-loop vagal nerve stimulation in patients with refractory epilepsy

Purpose: The AspireSR (R) is a vagal nerve stimulation (VNS) device that operates as a closed-loop system, delivering an automatic stimulation in response to an ictal heart rate increase that serves as a predictor for an imminent seizure. Our purpose is to assess the outcome of the AspireSR (R) in a patient population managed in a pediatric neurology unit. Methods: The records of patients who underwent transplantation during 2015-2017 and are continuously followed in one pediatric-epilepsy clinic, were retrospectively analyzed. Collected information included demo-graphics, use of antiepileptic drugs and seizure type, frequency and duration before and after VNS implantation. Results: 46 patients ages 5-31 years (mean 15.7 +/- 5.8), mean age at implantation 14 5.8 years, were included. 29 patients (63%) were new insertions and 17 of the patients (37%) underwent a VNS replacement to the AspireSR (R) model. Mean follow-up was 13 +/- 7.5 months (range 2-29 months). The total cohort responder rate (patients with >= 50% reduction in seizure frequency compared to the pre-implantation period) was 60.9%. (62% in the new insertion group; while 59% in the replacement group had additional benefit over their former VNS model, p = 0.981). Epilepsy etiology, age, age at implantation and type of seizures pre-implantation showed no correlation to response-rate. Five patients (10.9%) experienced complete seizure-freedom following implantation (4/5 in the new insertion group). Responses were reported at median follow up of 5 +/- 1.3 months post-implantation. 67.4% experienced shorter seizure duration post-implantation. Conclusion: Our results suggest that the AspireSR (R) device provides an early and meaningful benefit to drug-resistant epilepsy patients, which is relevant for both patients with new insertions and those with replacements of former VNS devices.