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Salanova, Vicenta; Witt, Thomas; Worth, Robert; Henry, Thomas R; Gross, Robert E; Nazzaro, Jules M; Labar, Douglas; Sperling, Michael R; Sharan, Ashwini; Sandok, Evan; Handforth, Adrian; Stern, John M; Chung, Steve; Henderson, Jaimie M; French, Jacqueline; Baltuch, Gordon; Rosenfeld, William E; Garcia, Paul; Barbaro, Nicholas M; Fountain, Nathan B; Elias, W Jeffrey; Goodman, Robert R; Pollard, John R; Tröster, Alexander I; Irwin, Christopher P; Lambrecht, Kristin; Graves, Nina; Fisher, Robert
Neurology, 2015-March-10, 2015-Mar-10, 2015-03-10, 20150310, Letnik: 84, Številka: 10Journal Article
OBJECTIVE:To report long-term efficacy and safety results of the SANTE trial investigating deep brain stimulation of the anterior nucleus of the thalamus (ANT) for treatment of localization-related epilepsy. METHODS:This long-term follow-up is a continuation of a previously reported trial of 5- vs 0-V ANT stimulation. Long-term follow-up began 13 months after device implantation with stimulation parameters adjusted at the investigatorsʼ discretion. Seizure frequency was determined using daily seizure diaries. RESULTS:The median percent seizure reduction from baseline at 1 year was 41%, and 69% at 5 years. The responder rate (≥50% reduction in seizure frequency) at 1 year was 43%, and 68% at 5 years. In the 5 years of follow-up, 16% of subjects were seizure-free for at least 6 months. There were no reported unanticipated adverse device effects or symptomatic intracranial hemorrhages. The Liverpool Seizure Severity Scale and 31-item Quality of Life in Epilepsy measure showed statistically significant improvement over baseline by 1 year and at 5 years (p < 0.001). CONCLUSION:Long-term follow-up of ANT deep brain stimulation showed sustained efficacy and safety in a treatment-resistant population. CLASSIFICATION OF EVIDENCE:This long-term follow-up provides Class IV evidence that for patients with drug-resistant partial epilepsy, anterior thalamic stimulation is associated with a 69% reduction in seizure frequency and a 34% serious device-related adverse event rate at 5 years.
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