Responsive neurostimulation (RNS) appears to reduce the risk of sudden unexpected death in epilepsy (SUDEP), according to research published online ahead of print January 16 in Epilepsia. The results provide evidence that treatments that reduce seizures decrease the risk of SUDEP, according to the authors. The data also indicate that not every SUDEP follows a seizure.
Orrin Devinsky, MD, Director of the Comprehensive Epilepsy Center at New York University Langone Medical Center, and colleagues examined data for all deaths in patients with epilepsy who received RNS in clinical trials or following FDA approval through May 5, 2016, and adjudicated them for SUDEP. In all, 256 patients received treatment during trials, and 451 received treatment after FDA approval.
Orrin Devinsky, MD
The investigators observed 14 deaths, including two possible, one probable, and four definite cases of SUDEP. The rate of probable or definite SUDEP was 2.0/1,000 over 2,036 patient stimulation years and 2.3/1,000 over 2,208 patient implant years. The age-adjusted standardized mortality ratio for definite and probable SUDEP was 0.75.
“The SUDEP rate of 2.0/1,000 patient stimulation years among patients undergoing treatment with RNS is favorable relative to patients [with treatment-resistant epilepsy] randomized to the placebo arm of add-on drug studies (SUDEP rate of 6.1/1,000 patient years), patients who were referred for epilepsy surgery but did not receive epilepsy surgery (SUDEP rate of 6.3/1,000 patient years), and patients with recurrent seizures after epilepsy surgery (SUDEP rate 6.3/1,000 patient years),” said the authors. “Future explorations can examine whether certain seizure patterns are particularly associated with SUDEP.”
Devinsky O, Friedman D, Duckrow RB, et al. Sudden unexpected death in epilepsy in patients treated with brain-responsive neurostimulation. Epilepsia.2018 Jan 16 [Epub ahead of print].