Summary:Purpose: To determine rates of all-cause mortality and of sudden, unexpected, unexplained deaths in epilepsy (SUDEP) in a cohort of individuals treated with the Neuro Cybernetic Prosthesis (NCP) System for intractable epilepsy, and; to contrast the NCP experience with other epilepsy cohorts.Methods: A cohort of 791 individuals were followed for 1,335 person-years from implantation. Of the total cohort, 120 individuals had their NCP System devices deactivated. The 15 deaths which occurred during NCP System activation were reviewed for SUDEP by a panel. There were three additional deaths and 242.5 person-years of monitoring after deactivation.Results: The standardized mortality ratios for NCP System were 5.3, 95% confidence interval (CI) 3.0-8.7; and for the time period after device deactivation, 4.4,95% CI 0.9-12.8. Six of the deaths during stimulation were considered definite or probable SUDEP and two as possible SUDEP. Seven were not considered to be SUDEP. The incidence of definite/probable SUDEP was 4.5 per 1,000 person-years and 6.0 per 1,000 person-years for definite/probable/possible SUDEP.Conclusions: The mortality rates and standardized mortality ratios are comparable with studies of young adults with intractable epilepsy who were not treated with NCP System. These SUDEP rates are not significantly different from those reported in the recent studies of lamotrigine (LTG), gabapentin (GBP), and tiagabine (TGB). The higher rates of SUDEP in the NCP System cohort, as compared with recent drug trials, presumably is explained by the selection of relatively higher-risk patients for the NCP System device. Key Words: EpilepsyMortality-SUDEP-Vagal nerve.Individuals with epilepsy have long been known to have increased mortality rates. A number of factors account for these higher rates, including (a) accidents during seizures, especially drowning; (b) the causes of epilepsy, such as brain tumors and cerebrovascular disease; and (c) an increase in unexplained deaths (1). An apparent high incidence of unexpected death has been observed in recent clinical trials of adjunctive drugs for epilepsy (2-4). Cases of SUDEP were found in the early experiences of clinical trials and open-label use of lamotrigine (LTG), gabapentin (GBP), tiagabine (TGB), and the Neuro-Cybernetic Prosthesis (NCP) System. These deaths tended to occur in relatively young (1 5-44 years of age) individuals who were otherwise in reasonable states of health. The deaths usually occurred in benign circumstances; most often the individual was found dead in bed. Many of the deaths were accompanied by