Format

Send to

Choose Destination
Epilepsia. 2018 Mar;59(3):555-561. doi: 10.1111/epi.13998. Epub 2018 Jan 16.

Sudden unexpected death in epilepsy in patients treated with brain-responsive neurostimulation.

Author information

1
NYU Langone Medical Center, New York, NY, USA.
2
Yale University School of Medicine, New Haven, CT, USA.
3
University of Virginia, Charlottesville, VA, USA.
4
Swedish Neuroscience Institute, Seattle, WA, USA.
5
Inova Medical Group, Mclean, VA, USA.
6
Augusta University Medical Center, Augusta, GA, USA.
7
Baylor College of Medicine, Houston, TX, USA.

Abstract

OBJECTIVE:

To study the incidence and clinical features of sudden unexpected death in epilepsy (SUDEP) in patients treated with direct brain-responsive stimulation with the RNS System.

METHODS:

All deaths in patients treated in clinical trials (N = 256) or following U.S. Food and Drug Administration (FDA) approval (N = 451) through May 5, 2016, were adjudicated for SUDEP.

RESULTS:

There were 14 deaths among 707 patients (2208 postimplantation years), including 2 possible, 1 probable, and 4 definite SUDEP events. The rate of probable or definite SUDEP was 2.0/1000 (95% confidence interval [CI] 0.7-5.2) over 2036 patient stimulation years and 2.3/1000 (95% CI 0.9-5.4) over 2208 patient implant years. Stored electrocorticograms around the time of death were available for 4 patients with probable/definite SUDEP and revealed the following: frequent epileptiform activity ending abruptly (n = 2), no epileptiform activity or seizures (n = 1), and an electrographic and witnessed seizure with cessation of postictal electrocorticography (ECoG) activity associated with apnea and pulselessness (n = 1).

SIGNIFICANCE:

The SUDEP rate of 2.0/1000 patient stimulation years among patients treated with the RNS System is favorable relative to treatment-resistant epilepsy patients randomized to the placebo arm of add-on drug studies or with seizures after resective surgery. Our findings support that treatments that reduce seizures reduce SUDEP risk and that not all SUDEPs follow seizures.

KEYWORDS:

brain stimulation; closed-loop; neuromodulation; partial seizures; sudden unexpected death in epilepsy

Comment in

PMID:
29336029
DOI:
10.1111/epi.13998
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Wiley
Loading ...
Support Center