Epilepsy, vagal nerve stimulation by the NCP system, mortality, and sudden, unexpected, unexplained death.
OBJECTIVE
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.
Annegers
J F
JF
The University of Texas Health Science Center Houston, School of Public Health, 77225, USA.
Coan
S P
SP
Hauser
W A
WA
Leestma
J
J
Duffell
W
W
Tarver
B
B
D000328:Adult; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use; D002423:Cause of Death; D002986:Clinical Trials as Topic; D015331:Cohort Studies; D016001:Confidence Intervals; D003645:Death, Sudden / Q000453:epidemiology*; D004599:Electric Stimulation Therapy / Q000295:instrumentation / Q000379:methods*; D004827:Epilepsy / Q000401:mortality* / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D012307:Risk Factors; D014630:Vagus Nerve / Q000502:physiology*
D000927:Anticonvulsants