Authors :
Presenting Author: Gaia Giannicola, PhD – LivaNova PLC (or a subsidiary)
Andrea Oliveira, MD – Fundacao Felice Rosso, Hospital Felicio Rocho
Riëm El Tahry, MD, PhD – Institute of Neurosciences, UCLouvain, Brussels, Belgium
Michal Tzadok, MD – Faculty of Medical & Health Sciences, Tel Aviv University, Edmond and Lily Safra Children's Hospital, Sheba Medical Center
Firas Fahoum, MD – Faculty of Medical & Health Sciences, Tel Aviv University; Neurological Institute, Tel Aviv Sourasky Medical Center
Terence O’Brien, MD – Monash University
Kasia Sieradzan, MD – Southmead Hospital (North Bristol NHS Trust)
Gholam Motamedi, MD – Georgetown University Medical Center
Arjune Sen, PhD – Oxford NIHR Biomedical Research Centre, John Radcliffe Hospital
Patrick Kwan, PhD, FRCP – The Alfred Hospital, Monash University
Maxine Dibue, PhD – LivaNova PLC (or a subsidiary)
Ryan Verner, PhD – LivaNova PLC (or a subsidiary)
Charles Gordon, PhD – LivaNova PLC (or a subsidiary)
Kathryn Nichol, PhD – LivaNova PLC (or a subsidiary)
Rationale:
The patient journey from epilepsy diagnosis to VNS Therapy can be highly variable. Exposure to surgical therapies for drug-resistant epilepsy (DRE) can be delayed due to access to a surgical center, fear of surgical risks, or physician/patient/family preference for pharmaceutical management. This analysis seeks to study the impact of VNS Therapy on individuals with drug-resistant epilepsy (DRE), focusing on varying durations between epilepsy diagnosis and device implantation, and the influence of this time on outcomes.
Methods:
People with DRE enrolled in the CORE-VNS (NCT03529045) study were categorized and grouped by time between epilepsy diagnosis and initial implant with VNS Therapy: early, < 5 years; intermediate, 5 to < 10 years; or late, > 10 years. Clinical outcomes were assessed across seizure-related (frequency) and non-seizure domains (Quality of Life) at 3, 6, 12, 24, and 36 months post-implantation.Results:
Of participants who received their initial VNS Therapy implant in CORE-VNS, 115 were implanted early, while 140 and 274 were implanted in the intermediate and late groups, respectively. Participants implanted later were much more likely to be adults (83.6%) compared to the early (15.7%) or intermediate (30.0%) groups. This appeared to have no impact on baseline ASM count. Participants implanted later had lower baseline seizure frequency overall (median seizures per month 10.7 late vs 28.7 early and 21.7 intermediate). Participants implanted earlier tended to have greater seizure frequency reduction than those implanted later: median percentage change from baseline in seizure frequency at 36 months for the early group was -88.2% (95% CI -100% to -76.5%) versus -71.4% (95% CI -81.6% to -55.0%) in the late group. 40.2% of participants implanted early achieved a 100% reduction in seizure frequency at 36 months, compared to 22.6% in the late implant group. Participants implanted later were less likely to report improved Quality of Life (late 38.2% vs early 49.4% and intermediate 52.8%). Living longer with DRE may reduce the perceived or actual benefits on quality of life. Conclusions:
Greater seizure reduction following VNS Therapy may be associated with earlier use following epilepsy diagnosis, provided the patient is otherwise indicated for implantation.Funding: LivaNova PLC