Translating CORE-VNS Study Outcomes Into Epilepsy Care

Maxine Dibue (00:00):

My name is Maxine Dibue, and I've been with LivaNova for 10 years, where I'm the medical director for VNS for the international region. This AES is especially exciting for us, because finally we're presenting results from our Core VNS study. It's a study that we've been working on for the past 8 years across 16 countries and 61 sites. It's a study that survived the COVID-19 pandemic, and so we're really proud to present results that capture all the faces of epilepsy that we see with vagus nerve stimulation. Core VNS is a real-world observational study. It was conducted across 5 continents, 16 different countries, and essentially it was an “all-comer study”. Anyone affected by drug-resistant epilepsy that got a vagus nerve stimulator was eligible for this study, so it really allowed us to capture all the different phases of epilepsy.

(00:56):

I think one of the things that really stood out to us, and we think is a major contribution to epilepsy research and especially the neuromodulation part of that, is the impact of VNS therapy on individual seizure types. This has been discussed and debated for as long as VNS therapy has been used in drug-resistant epilepsy, so that's actually more than 30 years. Core VNS allows us to really look at the differences in how seizure types are impacted in severity and frequency by VNS therapy. It's really striking how we see that tonic-clonic seizures are showing an especially pronounced effect in core VNS. We think this is really just not just meaningful, from a scientific point of view, obviously, to have that differentiation, but also really impactful for patient outcomes.

(01:52):

I think one of the most important elements is that we're not just looking at the seizure frequency and seizure severity. We're looking at the “so what?" How does this impact the patients? When we see this really pronounced reduction in tonic-clonic seizures, we're also able to look at what that changes for patients. We see a very significant reduction in the use of rescue medication. We see a very significant reduction in the episodes of status epilepticus, the episodes and the patients who are affected by status epilepticus, and we see very significant reductions in epilepsy-related hospitalizations and ER visits. I personally think that Core VNS will point us in the right direction to focus future VNS research. I think Core VNS has helped us to identify seizure types that respond to VNS, but we want to go a step further, right?

(02:51):

We want to be able to have really accurate predictions of how a patient will respond to VNS in terms of seizure frequency, severity, comorbidities, mood, and so on. I think Core VNS will help us focus on how to achieve that type of prediction and estimation in the future to deliver really, truly personalized neuromodulation. Core VNS is the most comprehensive real-world study on VNS, and it is a contemporary study. That's important, because VNS therapy has undergone incremental improvements over the past 30 years, so it was really critical for us to evaluate the impact that VNS has now in the modern epilepsy landscape, in combination with all modern anti-epileptic drugs, with all the diagnostic processes and technologies that we have available, and also across this global landscape. I think that is really central to the value we can derive out of Core VNS, that ultimately we hope will help us improve patient outcomes.s