Professor of Neurology Monash University, Alfred Hospital and The Royal Melbourne Hospital, Melbourne, Australia Melbourne, Victoria, Australia
Rationale: Vagus Nerve Stimulation (VNS) Therapy® has been an effective treatment for drug-resistant epilepsy for more than 25 years, implanted in over 115,000 patients worldwide. Post-market follow-up suggest continued improvement in patient outcomes with time. Since approval there have been important advances in VNS dosing strategies and device features including responsive stimulation with tachycardia detection that may offer additional clinical benefits. This registry aims to comprehensively document the clinical and psychosocial impact of current VNS Therapy. Methods: Comprehensive Outcomes Registry in Subjects with Epilepsy Treated with VNS Therapy® (CORE-VNS; NCT03529045) is a prospective, multicenter, international observational study. Up to 2,000 consecutive patients implanted with VNS Therapy in approximately 20 countries will be followed up for three to five years. Seizure outcomes measures, such as frequency and severity, post-ictal severity, and duration of seizure-free intervals, will be evaluated. Further, quality of life, sleep quality, antiseizure medication use, rescue drug use, and hospital utilization measures will be collected. Of particular interest will be how VNS Therapy features are utilized in different countries, and how feature use corresponds to safety and efficacy outcomes. Results: Patient recruitment commenced in 2018. Of 558 consented patients, 511 participants were implanted with a VNS Therapy System as of June 11, 2020. Overall, 48.2% were female and the average age at baseline was 26.9 ±16.3 years (range 2-75). One hundred eighty-two participants were younger than 18 years (35.5%), and 107 were 12 years or younger (20.9%). Participants with focal, generalized and combined epilepsy types were 49.4% , 21.9% and 26.4%, respectively. Participants had failed 6.5±3.4 antiseizure medications (range 0-20) prior to VNS Therapy. Most participants had an unknown epilepsy etiology (42.8%), followed by structural etiology (33.0%), genetic etiology (13.7%) and infectious etiology (7.6%). The most frequently reported epilepsy syndromes included Lennox Gastaut Syndrome (n=42), Juvenile Myoclonic Epilepsy (n=10), Tuberous Sclerosis (n=10), Infantile Spasms/West Syndrome (n=9) and Dravet Syndrome (n=9). Updated description of the baseline characteristics will be presented. Conclusions: This registry is the largest prospective VNS study in drug-resistant epilepsy thus far. The results will provide real-world data to guide physicians and their patients, regulators and payers regarding the use of VNS Therapy for this patient population. Funding: Please list any funding that was received in support of this abstract.: None
