{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T01:15:17Z","timestamp":1792804517876,"version":"4.5.0"},"reference-count":16,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2018,1,16]],"date-time":"2018-01-16T00:00:00Z","timestamp":1516060800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2018,3]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To study the incidence and clinical features of <jats:styled-content style=\"fixed-case\">sudden unexpected death in epilepsy (SUDEP<\/jats:styled-content>) in patients treated with direct brain\u2010responsive stimulation with the <jats:styled-content style=\"fixed-case\">RNS<\/jats:styled-content> System.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>All deaths in patients treated in clinical trials (N = 256) or following <jats:styled-content style=\"fixed-case\">U.S. Food and Drug Administration (FDA)<\/jats:styled-content> approval (N = 451) through May 5, 2016, were adjudicated for <jats:styled-content style=\"fixed-case\">SUDEP<\/jats:styled-content>.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>There were 14 deaths among 707 patients (2208 postimplantation years), including 2 possible, 1 probable, and 4 definite <jats:styled-content style=\"fixed-case\">SUDEP<\/jats:styled-content> events. The rate of probable or definite <jats:styled-content style=\"fixed-case\">SUDEP<\/jats:styled-content> was 2.0\/1000 (95% <jats:styled-content style=\"fixed-case\">confidence interval [CI<\/jats:styled-content>] 0.7\u20105.2) over 2036 patient stimulation years and 2.3\/1000 (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 0.9\u20105.4) over 2208 patient implant years. Stored electrocorticograms around the time of death were available for 4 patients with probable\/definite <jats:styled-content style=\"fixed-case\">SUDEP<\/jats:styled-content> 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).<\/jats:p><\/jats:sec><jats:sec><jats:title>Significance<\/jats:title><jats:p>The <jats:styled-content style=\"fixed-case\">SUDEP<\/jats:styled-content> rate of 2.0\/1000 patient stimulation years among patients treated with the <jats:styled-content style=\"fixed-case\">RNS<\/jats:styled-content> System is favorable relative to treatment\u2010resistant epilepsy patients randomized to the placebo arm of add\u2010on drug studies or with seizures after resective surgery. Our findings support that treatments that reduce seizures reduce <jats:styled-content style=\"fixed-case\">SUDEP<\/jats:styled-content> risk and that not all <jats:styled-content style=\"fixed-case\">SUDEP<\/jats:styled-content>s follow seizures.<\/jats:p><\/jats:sec>","DOI":"10.1111\/epi.13998","type":"journal-article","created":{"date-parts":[[2018,1,16]],"date-time":"2018-01-16T05:26:39Z","timestamp":1516080399000},"page":"555-561","source":"Crossref","is-referenced-by-count":67,"title":["Sudden unexpected death in epilepsy in patients treated with brain\u2010responsive neurostimulation"],"prefix":"10.1111","volume":"59","author":[{"given":"Orrin","family":"Devinsky","sequence":"first","affiliation":[{"name":"NYU Langone Medical Center New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Friedman","sequence":"additional","affiliation":[{"name":"NYU Langone Medical Center New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert B","family":"Duckrow","sequence":"additional","affiliation":[{"name":"Yale University School of Medicine New Haven CT USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathan B","family":"Fountain","sequence":"additional","affiliation":[{"name":"University of Virginia Charlottesville VA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryder P","family":"Gwinn","sequence":"additional","affiliation":[{"name":"Swedish Neuroscience Institute Seattle WA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James W","family":"Leiphart","sequence":"additional","affiliation":[{"name":"Inova Medical Group Mclean VA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony M","family":"Murro","sequence":"additional","affiliation":[{"name":"Augusta University Medical Center Augusta GA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul C","family":"Van Ness","sequence":"additional","affiliation":[{"name":"Baylor College of Medicine Houston TX USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,1,16]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(11)70193-4"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(16)30158-2"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(13)70214-X"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.12180"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000002253"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0000000000001280"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.12534"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1157.1997.tb06137.x"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.13419"},{"key":"e_1_2_8_11_1","unstructured":"Death rates by 10\u2010year age groups: United States and each state 2007: Worktable 23R.https:\/\/www.cdc.gov\/nchs\/data\/dvs\/mortfinal2007_worktable23r.pdf. 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