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Sudden unexpected death in epilepsy in patients treated with brain-responsive neurostimulation.
Devinsky, Orrin; Friedman, Daniel; Duckrow, Robert B; Fountain, Nathan B; Gwinn, Ryder P; Leiphart, James W; Murro, Anthony M; Van Ness, Paul C.
Afiliación
  • Devinsky O; NYU Langone Medical Center, New York, NY, USA.
  • Friedman D; NYU Langone Medical Center, New York, NY, USA.
  • Duckrow RB; Yale University School of Medicine, New Haven, CT, USA.
  • Fountain NB; University of Virginia, Charlottesville, VA, USA.
  • Gwinn RP; Swedish Neuroscience Institute, Seattle, WA, USA.
  • Leiphart JW; Inova Medical Group, Mclean, VA, USA.
  • Murro AM; Augusta University Medical Center, Augusta, GA, USA.
  • Van Ness PC; Baylor College of Medicine, Houston, TX, USA.
Epilepsia ; 59(3): 555-561, 2018 03.
Article en En | MEDLINE | ID: mdl-29336029
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Encéfalo / Terapia por Estimulación Eléctrica / Muerte Súbita / Epilepsia / Neuroestimuladores Implantables Tipo de estudio: Clinical_trials Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Epilepsia Año: 2018 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
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XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Encéfalo / Terapia por Estimulación Eléctrica / Muerte Súbita / Epilepsia / Neuroestimuladores Implantables Tipo de estudio: Clinical_trials Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Epilepsia Año: 2018 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos