Medline ® Abstract for Reference 116
of 'Evaluation and management of drug-resistant epilepsy'
116
TI
Long-term efficacy and safety of thalamic stimulation for drug-resistant partial epilepsy.
AU
Salanova V, Witt T, Worth R, Henry TR, Gross RE, Nazzaro JM, Labar D, Sperling MR, Sharan A, Sandok E, Handforth A, Stern JM, Chung S, Henderson JM, French J, Baltuch G, Rosenfeld WE, Garcia P, Barbaro NM, Fountain NB, Elias WJ, Goodman RR, Pollard JR, Tröster AI, Irwin CP, Lambrecht K, Graves N, Fisher R, SANTE Study Group
SO
Neurology. 2015 Mar;84(10):1017-25. Epub 2015 Feb 6.
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.
AD
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.
PMID