Paul Lyons1, James Wheless2, Ryan Verner3, Jose Ferreira4, Kore Liow5, James Valeriano6, Gholam K Motamedi7
1Winchester Neurological Consultants, 2UTHSC-Pediatric Neurology, 3LivaNova PLC, 4Pediatric Epilepsy & Neurology Specialists, 5University of Hawaii, John Burns School of Medicine, 6Allegheny Neurological Associates, 7Georgetown
Objective:
Evaluate RWE of VNS in those with Lennox-Gastaut Syndrome (LGS).
Background:
While VNS is used to manage symptoms of LGS, reported efficacy has centered on retrospective reviews and the population prevalence of LGS at individual centers has limited the availability of prospective data.
Design/Methods:
Patients enrolled into a prospective, multicenter, multinational observational registry (CORE-VNS, NCT03529045). This registry aims to collect up to 36 months of data on seizure and non-seizure outcomes following treatment with VNS and includes patients receiving an initial VNS implant as well as those undergoing battery replacement. Participants identified as having a recorded diagnosis of LGS, and those receiving initial VNS implants were identified for analysis. Baseline seizure frequency data, quality of life, and quality of sleep were collected at baseline and 3, 6, 12, 24, and 36 months. For this interim analysis, 12-month outcomes are compared to baseline.
Results:
Fifty-six (56) participants (median age = 12.44 years) received an initial implant to manage LGS symptoms (30.4% European, 28.6% from the Americas, and 26.8% Western Pacific), most with severe cognitive impairment (71.4%). Patients failed to respond to a median of 6 ASMs, and 83.9% had not undergone epilepsy surgery. After 12 months of VNS, 62.3% responded to therapy (≥50% reduction in seizure frequency, all seizures) and 54.7% had experienced a ≥80% reduction in seizure frequency. The overall median seizure frequency reduction at 12 months was 56.7%, the median reduction in focal seizures was 71.3%, and the median reduction in generalized seizures was 49.0%. Most subjects reported improvement in quality of life at 12 months (54.17%). Overall sleep quality was not improved or worsened. Only 16.1% reported at least 1 treatment-emergent AE (cough, dysphonia, oropharyngeal and/or neck pain).
Conclusions:
RWE with VNS supports its use as an effective treatment that can improve the quality of life for patients living with LGS.