Long-term Outcomes in Patients with Generalized Tonic-clonic Seizures Following VNS Therapy: Interim CORE-VNS 36 Months
Abstract number :
2.25
Submission category :
4. Clinical Epilepsy / 4C. Clinical Treatments
Year :
2024
Submission ID :
908
Source :
www.aesnet.org
Presentation date :
12/8/2024 12:00:00 AM
Published date :
Authors :
Presenting Author: Ana Suller-Marti, MD, PhD – Schulich School of Medicine and Dentistry Western University London Health Sciences Center
Mark Keezer, MD PhD – Centre hospitalier univesitaire de Montréal (CHUM)
Ryan Verner, PhD – LivaNova PLC (or a subsidiary)
Andrea Andrade, MD – Children's Health Research Institute
Martin Veilleux, MD – Department of Neurology and Neurosurgery, Montreal Neurological Institute and Hospital, Montreal, Quebec, Canada
Kenneth Myers, MD, PhD, FRCPC – Research Institute of the McGill University Health Centre
Jorge Burneo, MD, MSPH, FAAN, FAES, FRCPC – Western University, London Ontario Canada
Gaia Giannicola, PhD – LivaNova PLC
Paola Roncon, MS – LivaNova PLC (or a subsidiary)
Rationale: Generalized tonic-clonic seizures (GTCs) are substantially devastating with considerable health risks, including sudden unforeseen death. Use of device-based therapies, such as vagus nerve stimulation (VNS) is common for patients resistant to antiseizure medications (ASMs), and important for those for whom surgery is undesirable or not feasible. We have examined the long-term outcomes of VNS in patients with GTCs.
Methods: Patients were enrolled into a prospective, multicenter observational registry called CORE-VNS (NCT03529045). Participants with primary GTCs were selected for analysis. Participants with focal seizures at baseline or GS in the context of Lennox-Gastaut Syndrome were excluded. Selected study participants completed a 3-month retrospective baseline period, where seizure diaries and other patient-reported outcomes measures were collected before VNS implantation. After the VNS implant, participants were followed for up to 36 months. For purposes of analysis, study participants meeting criteria were further analyzed depending on time from diagnosis: within 5 years and greater than 5 years. At 3, 6, 12, 24, and 36 months, seizure diary information and adverse events were collected.
Results: A total of 59 participants met the study criteria and received an initial VNS implant. Twelve (12) were implanted within 5 years of their epilepsy diagnosis, and 47 were implanted more than 5 years after their epilepsy diagnosis. Those implanted earlier tended to be younger (9.7 vs 25.9 years old, median). Participants failed many preceding ASMs (6 median, range 2 to 20) and there was no difference between the early and late implant groups. For the reporting cohort (N=40), the GTC responder rate (≥50% reduction from baseline) at 36 months was 70% (N=28) (95% CI: 56 % to 81.7%) and the median seizure frequency change (MSFC) was -83.2% (95% CI: -100% to –53.3%). Those with GTCs implanted earlier were more likely to be responders at 36 months (83.3% vs 67.7%) and had a higher MSFC (-94.3% vs -76.4%). Study participants noted an improved quality of life (total 27% (n=10), implanted within 5 years of diagnosis 25.0% (N=1) and implanted greater than 5 years from diagnosis 27.3% (N=9)). Based on participants reporting at the time of abstract submission, 35.6% (N=21) of participants experienced at least one adverse event. The most frequent treatment-emergent adverse events associated with VNS stimulation were dysphonia (11.9%, N=7), dyspnea (6.8%, N=4), implant site pain (5.1%, N=3); and cough, oropharyngeal pain, and implant site infection (3.4%, N=2).
Conclusions: In this prospective study, adjunctive VNS was relatively well-tolerated and reduced the frequency of GTCs with a responder rate of 70% and MSFC of -94.3% at 36 months. Response rates and MSFC, regardless of time since epilepsy diagnosis, are representative of the modern experience with VNS when used in those with GTCs.
Funding: The CORE-VNS study was funded by LivaNova, PLC
Clinical Epilepsy