Epilepsy, vagal nerve stimulation by the NCP system, all-cause mortality, and sudden, unexpected, unexplained death
Annegers JF, Coan SP, Hauser WA, and Leestma J (2000) Epilepsy, vagal nerve stimulation by the NCP system, all-cause mortality, and sudden, unexpected, unexplained death. Epilepsia 41:5 549–53
Abstract: PURPOSE: This report concerns the 2-year extension of the study of mortality and sudden, unexpected, unexplained death in epilepsy (SUDEP) in the cohort of patients receiving vagal nerve stimulation by the NCP System for the treatment of epilepsy. METHODS: A cohort of 1,819 individuals was followed 3,176.3 person-years from implantation. The 25 deaths that occurred during NCP System activation were reviewed for SUDEP by a panel. RESULTS: The mortality rates were lower [standardized mortality ratio (SMR = 3.6)] with the extended follow-up compared to the previous finding (SMR = 5.3). The SUDEP rates (4.1 vs. 4.5 per 1,000 person-years) were similar to those in the previous study of this cohort. When the vagal nerve stimulation experience is stratified by duration of use, the rate of SUDEP was 5.5 per 1,000 over the first 2 years, but only 1.7 per 1,000 thereafter. CONCLUSIONS: The mortality and SUDEP rates are similar to those reported from clinical trials of new drugs and cohorts of severe epilepsy. The lower SUDEP rates after 2 years of follow-up are intriguing, but require further investigation.
Keywords: Epilepsy, Mortality, SUDEP, Vagal nerve
Comments and Context
- Reports on the 2 year extension of Annegers et al. More than 1,800 patients were followed after implantation of a vagal nerve stimulator . Rate of SUDEP was 4.1 per 1,000 person-years, slightly lower than at the earlier follow-up time. Death rates were low after removal of the device, likely reflecting the improved epilepsy control that prompted the removal. is study was also sponsored by the device maker.