Authors :
Presenting Author: James Wheless, BScPharm, MD, FAAP, FACP, FAAN, FAES, FCNS – University of Tennessee Health Science Center and Le Bonheur Children's Hospital
Muhammad Zafar, MD – Duke University School of Medicine
Gholam Motamedi, MD – Georgetown University Medical Center
Gaia Giannicola, PhD – LivaNova PLC (or a subsidiary)
Fawzi Babtain, MBBS – King Faisal Specialist Hospital and Research Center -Jeddah
Saleh Salim Baeesa, MD, FRCSC – King Faisal Specialist Hospital and Research Centre
Menaka Fry, MD – National Hospital for Neurology and Neurosurgery, Queen Square
Riëm El Tahry, MD, PhD – Institute of Neurosciences, UCLouvain, Brussels, Belgium
Gudrun Groeppel, MD – Johannes Kepler University
Terence O’Brien, MD – Monash University
Paul Lyons, MD PhD – Winchester Neurological Consultants
Kore Liow, MD – Hawaii Pacific Neuroscience, University of Hawaii at Mānoa
Ryan Verner, PhD – LivaNova PLC (or a subsidiary)
Kathryn Nicol, PhD – LivaNova PLC
Francesca Beraldi, BS – LivaNova PLC
Charles Gordon, PhD – LivaNova PLC (or a subsidiary)
Danielle Urry, MD – LivaNova PLC
Arjune Sen, PhD – Oxford NIHR Biomedical Research Centre, John Radcliffe Hospital
Rationale: Vagus nerve stimulation (VNS) has been approved in the USA for use in pediatric patients with drug-resistant epilepsy (DRE)
>12 years of age since 2015 and >4 years of age since 2017. Prospective, real-world evidence across this population has been limited despite knowledge of the benefits of early and robust seizure control in this age group. The CORE-VNS represents the first large cohort of prospectively gathered pediatric data on the effectiveness of VNS Therapy™ for DRE.
Methods: Participants were included in a multicenter, multinational observational study - CORE-VNS (NCT03529045) with over 800 people across 16 countries. This study collected data on seizure and non-seizure outcomes following treatment with VNS Therapy™. Participants 4-< 18 (children) and adults
>18-65 years of age who received their first VNS Therapy™ were selected for this analysis. Seizure frequency reduction of defined most disabling seizures and patient-described outcome measures (quality of life and quality of sleep) were collected at baseline and at 3, 6, 12, 24, and 36 months.
Results: Of the total 531 first implant participants in the study, 213 children and 282 adults met the criteria for this analysis. While all seizure types are reported, certain seizure types were more commonly described in this analysis as most disabling (focal impaired aware motor (FIA-M), focal impaired aware non-motor (FIA-NM), focal to bilateral tonic-clonic (FBTC), and generalized tonic-clonic seizures (GTC)). Seizure frequency reduction was reported in all seizure types across age groups early (3-month visit) in the study. At the 36-month follow-up, children had a median seizure reduction of 86.7% FIA-M, 100% FIA-NM, 100% FBTC, and 75.2% GTC. In comparison, adults had median seizure reductions of 77.8% FIA-M, 72.3% FIA-NM, 91.7% FBTC, and 100% GTC for the same time point. At 36 months, 80.3% of children and 81.5% of adults reported their quality of life as very good/pretty good/good and bad. The most commonly reported (~5%) adverse events in children were cough and dysphonia.
Conclusions:
Adjunctive VNS Therapy™ reduced the most severe types of seizures in children early after implantation, with sustained effectiveness and improved quality of life at 36 months. Funding: LivaNova PLC, Houston, TX, USA