Authors :
Presenting Author: Evan Nicolai, PhD – LivaNova PLC
Kathryn Nichol, PhD – LivaNova PLC (or a subsidiary)
Ryan Verner, PhD – LivaNova PLC (or a subsidiary)
Gaia Giannicola, PhD – LivaNova PLC (or a subsidiary)
Charles Gordon, PhD – LivaNova PLC (or a subsidiary)
Maxine Dibue, PhD – LivaNova PLC (or a subsidiary)
Alex Moon, PhD – LivaNova PLC
Francesca Beraldi, BS – LivaNova PLC
Rationale:
Approximately 33-50% of people undergoing epilepsy brain surgery fail to achieve seizure freedom. Those who undergo corpus callosotomy may experience a reduction in seizures; yet rarely attain complete seizure freedom and will require antiepileptic medications to manage the remaining seizures. In this analysis, the safety and effectiveness of VNS Therapy™ are evaluated in individuals who have and have not previously undergone brain surgical procedures for epilepsy.
Methods:
CORE-VNS is a comprehensive outcomes study of real-world evidence of VNS Therapy in over 800 people across 16 countries. The study collected multiple outcomes, including seizure frequency for all types of seizures and adverse events at 3, 6, 12, 24, and 36 months. In this analysis, the impact that prior epilepsy brain surgery may have had on the safety profile and change in seizure frequency of the severe seizure types (Focal Impaired Awareness [Motor; FIA-M], Focal Impaired Awareness [Non-Motor; FIA-NM], Focal-to-Bilateral Tonic-Clonic [FBTC], and Generalized Tonic-Clonic [GTC]) is observed. Participants who underwent intracranial monitoring before their initial VNS implant in CORE-VNS were also included in the prior surgery group.
Results: Of the 531 total first implant participants in the CORE-VNS study, 419 reported no previ-ous brain or epilepsy surgery. Lesionectomy, callosotomy, and lobar resection were the 3 most frequently reported therapeutic brain surgeries in the 112 participants with a posi-tive history. After 36 months, participants with surgery prior to VNS implantation experi-enced a median percentage change in frequency of FIA-M by -37.3% (N=39), FIA-NM by -88.8% (N=26), FBTC by -80% (N=27), and GTC by -89% (N=8). The 36-month change in fre-quency of these seizures in the participants without prior surgery was -86.1% (N=121), -100% (N=64), -100% (N=65), and -82% (N=75), respectively. The adverse event (AE) and serious adverse event (SAE) rates related to the implant procedure were similar. People with a history of surgery experienced AE 12.5% and SAE 1.8% and those without experi-enced AE 13.1% and SAE 2.6%.
Conclusions: Adjunctive VNS Therapy™ has consistent safety and effectiveness in participants with and without a history of epilepsy brain surgery.
Funding: The CORE-VNS Study was funded by LivaNova PLC, Houston, TX