A Suller-Marti,1,2 M Keezer,3 R Verner,4 M Veilleux,5 K Myers,6 J Burneo,1,7 G Giannicola,4
P Roncon,8 M Dibue,8 E Shamshiri4
1 Schulich School of Medicine and Dentistry, Western University, Department of Clinical
Neurological Sciences, London, Canada
2 Schulich School of Medicine and Dentistry, Western University, Department of Pediatrics, London, Canada
3 School of Public Health, Université de Montréal, Montreal, Department of Neurosciences, Quebec, Canada,
4 LivaNova PLC (or a subsidiary), Houston, TX
5 Montreal Neurological Institute and Hospital, Department of Neurology and Neurosurgery, Montreal, Canada
6 McGill University Medical Center, Research Institute, Quebec, Canada
7 Schulich School of Medicine and Dentistry, Department of Epidemiology and Biostatistics, Ontario, Canada,
8 LivaNova PLC (or a subsidiary), London, United Kingdom
Purpose: Evaluate long-term outcomes of VNS in patients with generalized tonic-clonic
seizures (GTCs).
Method: Patients were enrolled in the prospective, multicenter CORE-VNS study
(NCT03529045). Those with primary GTCs were included, while individuals with focal
seizures or Lennox-Gastaut Syndrome were excluded. A 3-month retrospective baseline
period documented seizure frequency and patient-reported outcomes before VNS
implantation. Participants were followed for up to 36 months post-implant. For analysis,
patients were categorized by time from diagnosis: within 5 years or more than 5 years.
Seizure diaries and adverse events were collected at 3, 6, 12, 24, and 36 months.
Results: Fifty-nine (N=59) participants received a VNS implant: 12 within 5 years of
diagnosis and 47 after 5 years. Those implanted earlier were younger (median 9.7 vs. 25.9
years). Patients had failed a median of six antiseizure medications. At 36 months, the GTC
responder rate (≥50% seizure reduction) was 70% (N=28, 95% CI: 56%–81.7%), with a
median seizure frequency change (MSFC) of -83.2% (95% CI: -100% to -53.3%). Those
implanted earlier had a higher responder rate (83.3% vs. 67.7%) and MSFC (-94.3% vs. –
76.4%). Quality of life improved in 27% (N=10). Adverse events occurred in 35.6% (N=21),
with the most common being dysphonia (11.9%, N=7), dyspnea (6.8%, N=4), implant site
pain (5.1%, N=3), and cough, oropharyngeal pain, or infection (3.4%, N=2 each).
Conclusion: Adjunctive VNS was well tolerated and reduced GTC frequency, with a 70%
responder rate and MSFC of -94.3% at 36 months. Outcomes were favorable regardless of
time since diagnosis, reflecting modern VNS use in GTCs.
