CORE-VNS: A Prospective Outcomes Registry of People With Drug-resistant Epilepsy Treated With Vagus Nerve Stimulation Therapy - Full Cohort Demographics
Abstract number :
2.406
Submission category :
4. Clinical Epilepsy / 4C. Clinical Treatments
Year :
2021
Submission ID :
1886459
Source :
www.aesnet.org
Presentation date :
12/5/2021 12:00:00 PM
Published date :
Nov 22, 2021, 06:56 AM
Authors :
Massimiliano Boffini, PhD - LivaNova; Patrick Kwan, MD, PhD – Professor, Department of Neuroscience, The Royal Melbourne Hospital; Firas Fahoum, MD, Ph.D – Tel Aviv Sourasky Medical Center and Tel Aviv University, Tel Aviv, Israel; Riëm El Tahry, MD, Ph.D – Cliniques Universitaires Saint-Luc UCL, Brussels, Belgium; Terence O'Brien, MD – The Alfred Hospital and Monash University, Melbourne, Australia; Karen Keough, MD – Child Neurology Consultants of Austin, Austin, TX, United States; Jane Boggs, MD – Wake Forest University, Winston-Salem, United States; Hadassa Goldberg-Stern, MD – Schneider Children’s Medical Center, Petah Tiqva, Israel; Ryan Verner, Ph.D – LivaNova PLC, London, United Kingdom; Lisa Lee, Ms – LivaNova PLC, London, United Kingdom; Gaia Giannicola, Ph.D – LivaNova PLC, London, United Kingdom; Wim Van Grunderbeek, Mr – LivaNova PLC, London, United Kingdom; Arjune Sen, MD, Ph.D – Oxford NIHR Biomedical Research Centre, John Radcliffe Hospital, Oxford, United Kingdom
Rationale: Vagus Nerve Stimulation (VNS) Therapy® has been used for more than 25 years to effectively treat people with drug-resistant epilepsy. In 2014 the responsive VNS devices, capable of delivering extra-stimulation when cardiac biomarkers of seizures are detected, were introduced. In more recent years other features have been added to VNS generators. The Comprehensive Outcomes Registry in Subjects with Epilepsy Treated with VNS Therapy® (CORE-VNS; NCT03529045) aims to document the clinical and psychosocial impact of VNS Therapy, including the most recent models of VNS generator. Here, we report the baseline characteristics of the people enrolled in the registry.
Methods: CORE-VNS is a prospective, multicenter, global observational study. Recruitment was open from 2018 to June 2021. People who received VNS Therapy were recruited from 61 sites in 15 countries. Participants are being followed up for up to 60 months after VNS implantation. We collected baseline information including age, duration of epilepsy before VNS implantation (for first implantations), epilepsy type, etiology, and specific syndromes. History of treatments including previous epilepsy surgery and number of antiseizure medications (ASM) failed were also recorded. During follow up visits at 3, 6, 12, 24, 48, 36 and 60 months we assess clinical outcomes including seizure frequency, maximum seizure-free duration, seizure and post-ictal severity, quality of life, quality of sleep, use of ASM and rescue medications, as well as healthcare utilization including seizure related emergency department visits and hospitalizations.
Results: A total of 822 individuals (49.1% female) were enrolled and 792 of them were successfully implanted with a VNS Therapy System; 540 (65.7%) of them had their first implantation and 252 (30.7%) a re-implantation. 729 people (88.6%) were implanted with a responsive VNS generator and 335 (40.8%) with the most recent model which has additional features. Median age at recruitment was 24.0 years (range 1-75), with 309 (37.6%) younger than 18 years, and 176 (21.4%) below 12 years. 50.0% of the subjects have focal epilepsy, 20.4% generalized epilepsy, 27.4% combined epilepsy types. All participants have drug-resistant epilepsy (failure of two or more antiseizure medications) prior to VNS Therapy, with a median number of failed ASM of 6.0 (range 2-20), and 145 (17.6%) subjects had previous epilepsy surgery. Most (41.7%) of those recruited had unknown etiology for their epilepsy, followed by structural (33.1%), genetic (15.9%) and infectious (6.3%) etiologies. The most frequently reported epilepsy syndromes were Lennox Gastaut syndrome (n=97), tuberous sclerosis (n=30), infantile spasms/West syndrome (n=18), juvenile myoclonic epilepsy (n=15), and Dravet syndrome (n=14).
Conclusions: CORE-VNS is the largest prospective outcomes study of VNS Therapy for drug-resistant epilepsy thus far. The number and variety of participants included in the registry allow the analysis of real-world data on the efficacy and safety of the most recent VNS generators. The findings can guide physicians, people with epilepsy, regulators and payers regarding the use of VNS Therapy for this population.
Funding: Please list any funding that was received in support of this abstract.: LivaNova was the study sponsor.
Clinical Epilepsy