The complete follow-up of a 7-year prospective open-label long-term treatment study of a responsive neurostimulation system was presented . Patients treated with this type of treatment experienced sustained reductions in seizures. In a third of patients, this reduction was 90% or greater during the last 3 months.
Participants of the long-term treatment study were 230 out of 256 patients who were treated in a 2-year randomised, double-blinded controlled pivotal study (n=191), or a prior 2-year feasibility study (n=65). Mean age was 34 years; mean epilepsy duration 19.6 years; mean number of anti-epileptic drugs used 2.9; median seizure frequency 10.2 per month. The median percent reduction reached 75% at the end of year 9 (n=168). In addition, 30% of subjects experienced at least one seizure-free period of 6 months or more; 19% experienced a seizure-free period of 12 months or more. The median percent reduction in seizures was 67.2%. Infection risk was 3.7% per procedure; all but 1 infection was soft tissue only. There were 16 deaths, 9 due to possible or definite ‘sudden unexpected death in epilepsy’. The authors concluded that these outcomes support the long-term effectiveness and safety of this treatment of medically intractable focal seizures.
1. Nair D, et al. AAN 2019, S36.005.
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