The SANTÉ study at 10 years of follow-up: Effectiveness, safety, and sudden unexpected death in epilepsy.
OBJECTIVE
We evaluated the efficacy and safety of deep brain anterior thalamus stimulation after 7 and 10 years, and report the incidence of sudden unexpected death in epilepsy (SUDEP) and overall mortality in adults in the Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy (SANTÉ) study.


METHODS
After the 3-month blinded and 9-month unblinded phases, subjects continued to be assessed during long-term follow-up (LTFU) and later a continued therapy access phase (CAP), to further characterize adverse events and the incidence of SUDEP. Stimulus parameter and medication changes were allowed.


RESULTS
One hundred ten implanted subjects accumulated a total of 938 device-years of experience (69 subjects during the LTFU phase and 61 subjects in the CAP phase). Prior to study closure, 57 active subjects continued therapy at 14 study centers, with follow-up of at least 10 (maximum 14) years. At 7 years, median seizure frequency percent reduction from baseline was 75% (p < .001), with no outcome differences related to prior vagus nerve stimulation or resective surgery. The most severe seizure type, focal to bilateral tonic-clonic, was reduced by 71%. Adding new antiseizure medications did not impact the pattern of seizure reduction over time. There were no unanticipated serious adverse events in the study. The definite-plus-probable SUDEP rate, based on SANTÉ study experience (two deaths in 938 years) and previous pilot studies (0 deaths in 76 years), indicated a rate of 2.0 deaths for 1000 person-years. Overall mortality was 6.9 deaths per 1000 person-years.


SIGNIFICANCE
The long-term efficacy and safety profiles of the deep brain stimulation (DBS) system for epilepsy are favorable and demonstrate stable outcomes. Improvement in frequency of the most severe seizure type may reduce SUDEP risk. The SUDEP rate with DBS (2.0) is comparable to other neuromodulation treatments (i.e., vagus nerve stimulation, responsive neurostimulation) for drug-resistant focal epilepsy.
['Salanova|Vicenta|V|', 'Sperling|Michael R|MR|0000-0003-0708-6006', 'Gross|Robert E|RE|', 'Irwin|Chris P|CP|', 'Vollhaber|Jim A|JA|', 'Giftakis|Jonathon E|JE|0000-0002-4242-3189', 'Fisher|Robert S|RS|', '|||']
D000368:Aged D020643:Anterior Thalamic Nuclei D004311:Double-Blind Method D004599:Electric Stimulation Therapy D004567:Electrodes, Implanted D004830:Epilepsy, Tonic-Clonic D005260:Female D005500:Follow-Up Studies D006801:Humans D015994:Incidence D008279:Magnetic Resonance Imaging D008297:Male D008875:Middle Aged D061214:Patient Safety D012640:Seizures D000080485:Sudden Unexpected Death in Epilepsy D016896:Treatment Outcome D055536:Vagus Nerve Stimulation
sudden unexpected death in epilepsy brain stimulation neuromodulation focal seizures