Epilepsy, vagal nerve stimulation by the NCP system, mortality, and sudden, unexpected, unexplained death
Annegers JF, Coan SP, Hauser WA, Leestma J, Duffell W, and Tarver B (1998) Epilepsy, vagal nerve stimulation by the NCP system, mortality, and sudden, unexpected, unexplained death. Epilepsia 39:2 206–12.
Abstract: 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.
Keywords: Epilepsy, Mortality, SUDEP, Vagal nerve
- Incidence of sudden death was evaluated among a patient cohort receiving vagal nerve stimulation. No significant affect of the device on risk was evident. 791 patients were in the study group. SUDEP incidence was 4.5 per 1,000 person-years in this cohort of patients with refractory epilepsy. Introduction includes helpful meta-analysis with valuable discussion on the changing rate of sudden death in both epilepsy and control populations over the lifespan, with apparent equalization of rates (no increased risk of sudden death for epilepsy patients) by around age 75. The study also provides informative history on initial resistance to the notion of SUDEP from those who believed any increased mortality among epilepsy patients was due to the causes of the epilepsy (e.g., trauma) rather than to epilepsy per se; this view lost support when a series of trials for new AEDs suggested that epilepsy can increase risk directly. The study was partially supported by the device manufacturer.