CORE-VNS Study Full Cohort at 36 Months Demonstrates Significant Reduction in Severe Disabling Seizures
Abstract number :
1.322
Submission category :
4. Clinical Epilepsy / 4C. Clinical Treatments
Year :
2025
Submission ID :
984
Source :
www.aesnet.org
Presentation date :
12/6/2025 12:00:00 AM
Published date :
Authors :
Presenting Author: Arjune Sen, MD PhD – University of Oxford
Patrick Kwan, BMedSci, BM, BChir, FRACP, PhD, FAHMS – Monash Institute of Medical Engineering, Monash Univeristy
James Valeriano, MD – Allegheny Health Network
Muhammad Zafar, MD – Duke University School of Medicine
Karen C. Keough, MD – Austin Dell Children’s Medical Center, 7940 Shoal Creek Blvd
Ricky Lee, MD – Ascension Via Christi Hospital
Riëm El Tahry, MD, PhD – Institute of Neurosciences, UCLouvain, Brussels, Belgium
Jane Boggs, MD – Wake Forest University
Firas Fahoum, MD – Faculty of Medical & Health Sciences, Tel Aviv University; Neurological Institute, Tel Aviv Sourasky Medical Center
Rhys Thomas, MD PhD – Newcastle University
Terrence J. O'Brien, MB, BS, MD, FRACP, FRCPE, FAHMS, FAES – Monash University, Melbourne, VIC, Australia
Gaia Giannicola, PhD – LivaNova PLC (or a subsidiary)
Charles Gordon, PhD – LivaNova PLC (or a subsidiary)
Kathryn Nichol, PhD – LivaNova PLC (or a subsidiary)
Maxine Dibue, PhD – LivaNova PLC (or a subsidiary)
Massimiliano Boffini, PhD – LivaNova PLC
Francesca Beraldi, BS – LivaNova PLC
Rationale: VNS Therapy™ has been approved for use in people with drug-resistant epilepsy (DRE) since 1997. The CORE-VNS is a comprehensive outcomes study of real-world evidence in VNS Therapy, including over 800 people across 16 countries. It also represents the first large cohort of prospectively gathered data on the effectiveness of responsive VNS Therapy for DRE. In this analysis, we describe how VNS Therapy reduces the frequency of severe seizures that result in loss of consciousness in people receiving their first neuromodulation device.
Methods: Participants enrolled in the prospective, multicenter, multinational observational CORE-VNS (NCT03529045) study could receive their first VNS Therapy device or enroll when seeking battery replacement. The study recorded seizure frequency changes using the 2017 ILAE classification scheme for each seizure type as well as seizure and non-seizure outcomes and safety. Participants were asked to identify their most disabling seizure type at each visit and report on the severity of that seizure type (which may have changed throughout the study). In this analysis, severe seizures that result in loss-of-consciousness are analyzed: Focal Impaired Awareness Motor and Non-motor (FIA-M, FIA-NM), Focal-to-Bilateral Tonic-Clonic (FBTC), and Generalized Tonic-Clonic (GTC).
Results: CORE-VNS included 555 people with DRE for initial implantation with VNS Therapy. Of this population, 531 proceeded to implantation, 526 had at least one post-implantation follow-up visit, and 426 completed the study with at least 36 months of follow-up. Participants with highly debilitating seizures that result in loss of consciousness experienced meaningful seizure frequency reductions. At 36 months, VNS Therapy, median change in FIA-M seizures was -80.1% (95%CI: -90, -66.7), FIA-NM seizures was -94.4% (95%CI: -100, -77.3), FBTC seizures was -95.0% (95%CI: -100, -72.7), and GTC seizures was -84.0% (95%CI: -100, -66.7). The median monthly frequency of GTC seizures decreased from 4.0 (95%CI: 2.3, 6.7) at baseline to 1.00 (95%CI: 0.0, 1.7) at 36 months. Post-ictal severity for the patient’s self-reported “most disabling seizure” also decreased. Finally, participants tended to report less use of rescue medication, the emergency department, and seizure-related hospitalization in the follow-up, suggesting that reductions in seizure frequency have meaningful impacts on overall disease burden. For all participants, n=92/794 (11.6%) reported an adverse event that was causally, possibly, or probably related to VNS Therapy. Commonly reported adverse events were consistent with the safety profile of VNS Therapy and included dysphonia, dyspnea, and cough.
Conclusions: VNS Therapy reduces the frequency of severe disabling seizures with loss of consciousness, resulting in a reduced risk of serious health sequelae.
Funding: This study was sponsored by LivaNova PLC.
Clinical Epilepsy