Michal Tzadok1, Amit Harush2, Andrea Nissenkorn3, Yaacov Zauberman4, Zeev Feldman4, Bruria Ben-Zeev3. 1. Pediatric Neurology Unit, Edmond and Lili Safra Children's Hospital, The Haim Sheba Medical Center, Ramat Gan Israel; Sackler school of Medicine, Tel Aviv University, Israel. Electronic address: michal.tzadok@sheba.health.gov.il. 2. Sackler school of Medicine, Tel Aviv University, Israel. 3. Pediatric Neurology Unit, Edmond and Lili Safra Children's Hospital, The Haim Sheba Medical Center, Ramat Gan Israel; Sackler school of Medicine, Tel Aviv University, Israel. 4. Department of Neurosurgery, the Haim Sheba Medical Center, Ramat Gan Israel.
Abstract
PURPOSE: The AspireSR® 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® 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 demographics, 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® 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® 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.
PURPOSE: The AspireSR® 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® 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 demographics, 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® 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® device provides an early and meaningful benefit to drug-resistant epilepsypatients, which is relevant for both patients with new insertions and those with replacements of former VNS devices.
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