LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, has announced the full 36-month results of the CORE-VNS study. The journal Neuromodulation: Technology at the Neural Interface published the findings. The study is the first long-term effectiveness evaluation of contemporary VNS Therapy™ devices in people with Drug-Resistant Epilepsy (DRE). The article, “CORE-VNS Seizure and Non-Seizure 36 Month Outcomes in People with Drug-resistant Epilepsy,” covers the full international CORE-VNS cohort. As a result, it offers one of the most extensive evaluations of long-term VNS Therapy outcomes in DRE.
Researchers ran the study across 61 sites in 16 countries. It showed favorable long-term outcomes for adjunctive VNS Therapy in both children and adults with DRE. Notably, significant benefits appeared as early as three months after implantation. Those benefits then lasted through 36 months of follow-up.
“This study provides compelling, real-world evidence supporting the long-term effectiveness and safety of modern VNS Therapy for people living with drug-resistant epilepsy,” said Arjune Sen, Professor of Global Epilepsy at The University of Oxford, Consultant Neurologist at Oxford University Hospitals NHS Foundation Trust, and coordinating investigator for the CORE-VNS study. “We observed meaningful clinical benefits as early as three months after implantation, and those benefits endured throughout the study period. Beyond reducing seizure frequency, the study demonstrated improvements in healthcare utilization and reductions in seizure severity. The CORE-VNS findings underscore the important role VNS Therapy can play in the long-term management of drug-resistant epilepsy and highlight the importance of timely referral to comprehensive epilepsy centers for evaluation once drug resistance has been established.”
Strong Seizure Reduction Across 36 Months
Among participants with 36-month follow-up data, median seizure frequency fell by 76% from baseline. In the same group, 64% achieved at least a 50% reduction in seizures. Nearly half of them saw reductions of 80% or more. Moreover, the benefits reached beyond seizure counts. Participants also reported improvements in rescue medication use, healthcare resource utilization, seizure severity, and quality of life. Specifically, at 36 months:
- 16% (64/392; 95% confidence interval [CI] 13.3%–19.7%) achieved complete seizure freedom
- 28% (108/392; 95% CI 23.9%–31.5%) had a 100% reduction in the seizure types present at baseline
- 45% (174/391) reported improved quality of life
- 73% reduction in seizure-related hospitalizations compared to baseline
Importantly, investigators found that the therapeutic benefit stayed durable throughout follow-up. More participants moved into higher response categories over time. Seizure freedom also rose steadily during the study. In addition, most responders either maintained or improved their outcomes at later visits. Regression to lower response categories was uncommon.
Experts Highlight Long-Term Effectiveness of VNS Therapy
The published analysis included 531 participants who received their first VNS Therapy implant. They came from the broader study, which enrolled more than 800 people in total. Of these, 426 completed 36 months of follow-up, an 80% retention rate. Furthermore, the data showed significant reductions in seizure severity and post-ictal severity across all seizure types. Investigators identified no new safety concerns.
“The findings published in Neuromodulation demonstrate not only a 76% median reduction in seizure frequency at three years but also meaningful benefits across multiple measures important to patients, caregivers, and healthcare systems,” said Stephanie Bolton, President, Global Epilepsy at LivaNova. “Most encouragingly, the study showed that benefits from VNS Therapy emerged early and continued to improve over time, reinforcing its important role in the long-term management of Drug-Resistant Epilepsy.”
Lower Healthcare Use and the Need for Early Referral
The study also recorded substantial drops in healthcare resource utilization. For example, participants reporting seizure-related emergency department visits fell from 32% at baseline to 15% at 36 months. Likewise, seizure-related hospitalizations declined from 27% to 7%, a 73% reduction.
Epilepsy is a disorder that affects over 50 million people worldwide. Anti-seizure medications will not prevent about one-third of them from developing DRE. Current practice guidelines call for referral to specialized epilepsy centers when drug resistance is established. Nevertheless, many patients continue to experience long delays before being evaluated for advanced treatment options. Overall, the CORE-VNS results make a strong case for earlier referral and long-term neuromodulation care.
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News Source: Businesswire.com
