Vicenta Salanova1, Thomas Witt2, Robert Worth2, Thomas R Henry2, Robert E Gross2, Jules M Nazzaro2, Douglas Labar2, Michael R Sperling2, Ashwini Sharan2, Evan Sandok2, Adrian Handforth2, John M Stern2, Steve Chung2, Jaimie M Henderson2, Jacqueline French2, Gordon Baltuch2, William E Rosenfeld2, Paul Garcia2, Nicholas M Barbaro2, Nathan B Fountain2, W Jeffrey Elias2, Robert R Goodman2, John R Pollard2, Alexander I Tröster2, Christopher P Irwin2, Kristin Lambrecht2, Nina Graves2, Robert Fisher2. 1. From Indiana University (V.S., T.W., R.W., N.M.B.), Indianapolis; University of Minnesota (T.R.H.), Minneapolis; Emory University (R.E.G.), Atlanta, GA; University of Kansas (J.M.N.), Kansas City; Weill Cornell (D.L.), New York, NY; Thomas Jefferson University (M.R.S., A.S.), Philadelphia, PA; Marshfield Clinic (E.S.), WI; Veterans Affairs Greater Los Angeles Healthcare System (A.H.); Geffen School of Medicine at UCLA (J.M.S.), Los Angeles, CA; Barrow Neurological Institute (S.C., A.I.T.), Phoenix, AZ; Stanford University (J.M.H., R.F.), CA; NYU Comprehensive Epilepsy Center (J.F.), New York, NY; University of Pennsylvania (G.B., J.R.P.), PA; St. Luke's (W.E.R.), St. Louis, MO; University of California San Francisco (P.G.); University of Virginia School of Medicine (N.B.F., W.J.E.), Charlottesville; Mount Sinai (R.R.G.), New York, NY; and Medtronic, Inc. (C.P.I., K.L., N.G.), Minneapolis, MN. vsalanov@iupui.edu. 2. From Indiana University (V.S., T.W., R.W., N.M.B.), Indianapolis; University of Minnesota (T.R.H.), Minneapolis; Emory University (R.E.G.), Atlanta, GA; University of Kansas (J.M.N.), Kansas City; Weill Cornell (D.L.), New York, NY; Thomas Jefferson University (M.R.S., A.S.), Philadelphia, PA; Marshfield Clinic (E.S.), WI; Veterans Affairs Greater Los Angeles Healthcare System (A.H.); Geffen School of Medicine at UCLA (J.M.S.), Los Angeles, CA; Barrow Neurological Institute (S.C., A.I.T.), Phoenix, AZ; Stanford University (J.M.H., R.F.), CA; NYU Comprehensive Epilepsy Center (J.F.), New York, NY; University of Pennsylvania (G.B., J.R.P.), PA; St. Luke's (W.E.R.), St. Louis, MO; University of California San Francisco (P.G.); University of Virginia School of Medicine (N.B.F., W.J.E.), Charlottesville; Mount Sinai (R.R.G.), New York, NY; and Medtronic, Inc. (C.P.I., K.L., N.G.), Minneapolis, MN.
Abstract
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 investigators' 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.
RCT Entities:
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 investigators' 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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