Abstract Details

Title VNS in Lennox-Gastaut Syndrome: Real-world Experience from CORE-VNS

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 1-014

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.

Objective

Evaluate RWE of VNS in those with Lennox-Gastaut Syndrome (LGS).

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.

Authors/Disclosures
Paul Lyons, MD (Winchester Neurological Consultants) PRESENTER	Dr. Lyons has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for UCB. Dr. Lyons has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Jazz Pharmaceuticals .
James W. Wheless, MD, FAAP, FAAN (UTHSC-Pediatric Neurology)	Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Supernus. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aquestive. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Greenwich. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurelis. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for LivaNova. Dr. Wheless has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Eisai. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Supernus. Dr. Wheless has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Greenwich. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BioMarin. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Zogenix. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neurelius.
Ryan Verner	Ryan Verner has received personal compensation for serving as an employee of LivaNova USA Inc. Ryan Verner has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sella Therapies. Ryan Verner has stock in LivaNova PLC.
Jose A. Ferreira, MD (Pediatric Epilepsy and Neurology Specialists)	No disclosure on file
Kore K. Liow, MD, FACP (University of Hawaii, John Burns School of Medicine)	The institution of Dr. Liow has received research support from UCB. The institution of Dr. Liow has received research support from Livanova. The institution of Dr. Liow has received research support from Biogen. The institution of Dr. Liow has received research support from Novartis. The institution of Dr. Liow has received research support from Eisai. The institution of Dr. Liow has received research support from Engage Therapeutics. The institution of Dr. Liow has received research support from SK Lifescience. The institution of Dr. Liow has received research support from Cerevel. The institution of Dr. Liow has received research support from Xenon. The institution of Dr. Liow has received research support from NeuroDerm. The institution of Dr. Liow has received research support from Avanir. The institution of Dr. Liow has received research support from Annovis. The institution of Dr. Liow has received research support from Acadia. The institution of Dr. Liow has received research support from Prothena. The institution of Dr. Liow has received research support from SAGE. The institution of Dr. Liow has received research support from Annovis. The institution of Dr. Liow has received research support from Cyclerion.
James P. Valeriano, MD (Allegheny Neurological Associates)	Dr. Valeriano has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for ucb. Dr. Valeriano has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for neurilis.
Gholam K. Motamedi, MD (Georgetown Univ Hosp/ Dept of Neuro)	Dr. Motamedi has nothing to disclose.