Nine-year prospective efficacy and safety of brain-responsive neurostimulation for focal epilepsy

被引：288

作者：

Nair, Dileep R. ^{[1
]}

Laxer, Kenneth D. ^{[2
]}

Weber, Peter B. ^{[2
]}

Murro, Anthony M. ^{[3
]}

Park, Yong D. ^{[3
]}

Barkley, Gregory L. ^{[4
]}

Smith, Brien J. ^{[5
]}

Gwinn, Ryder P. ^{[6
]}

Doherty, Michael J. ^{[6
]}

Noe, Katherine H. ^{[7
]}

Zimmerman, Richard S. ^{[7
]}

Bergey, Gregory K. ^{[8
]}

Anderson, William S. ^{[8
]}

Heck, Christianne ^{[9
]}

Liu, Charles Y. ^{[9
]}

Lee, Ricky W. ^{[10
]}

Sadler, Toni ^{[10
]}

Duckrow, Robert B. ^{[11
]}

Hirsch, Lawrence J. ^{[11
]}

Wharen, Robert E., Jr. ^{[12
]}

Tatum, William ^{[12
]}

Srinivasan, Shraddha ^{[13
]}

McKhann, Guy M. ^{[13
]}

Agostini, Mark A. ^{[14
]}

Alexopoulos, Andreas V. ^{[1
]}

Jobst, Barbara C. ^{[15
]}

Roberts, David W. ^{[15
]}

Salanova, Vicenta ^{[16
]}

Witt, Thomas C. ^{[16
]}

Cash, Sydney S. ^{[17
]}

Cole, Andrew J. ^{[17
]}

Worrell, Gregory A. ^{[18
]}

Lundstrom, Brian N. ^{[18
]}

Edwards, Jonathan C. ^{[19
]}

Halford, Jonathan J. ^{[19
]}

Spencer, David C. ^{[20
]}

Ernst, Lia ^{[20
]}

Skidmore, Christopher T. ^{[21
]}

Sperling, Michael R. ^{[21
]}

Miller, Ian ^{[22
]}

Geller, Eric B. ^{[23
]}

Berg, Michel J. ^{[24
]}

Fessler, A. James ^{[24
]}

Rutecki, Paul ^{[25
]}

Goldman, Alica M. ^{[26
]}

Mizrahi, Eli M. ^{[26
]}

Gross, Robert E. ^{[27
]}

Shields, Donald C. ^{[28
]}

Schwartz, Theodore H. ^{[29
]}

Labar, Douglas R. ^{[29
]}

机构：

[1] Cleveland Clin Fdn, 9500 Euclid Ave, Cleveland, OH 44195 USA

[2] Calif Pacific Med Ctr, San Francisco, CA USA

[3] Augusta Univ, Augusta, GA USA

[4] Henry Ford Hosp, Detroit, MI 48202 USA

[5] Ohio Hlth Neurosci, Columbus, OH USA

[6] Swedish Neurosci Inst, Seattle, WA USA

[7] Mayo Clin Arizona, Scottsdale, AZ USA

[8] Johns Hopkins Med, Baltimore, MD USA

[9] USC, Keck Sch Med, Los Angeles, CA USA

[10] Via Christi Epilepsy Ctr, Wichita, KS USA

[11] Yale Univ, Sch Med, New Haven, CT USA

[12] Mayo Clin Florida, Jacksonville, FL USA

[13] Columbia Univ, Med Ctr, New York, NY USA

[14] Univ Texas Southwestern Med Ctr Dallas, Dallas, TX 75390 USA

[15] Geisel Sch Med Dartmouth, Hanover, NH USA

[16] Indiana Univ Sch Med, Indianapolis, IN 46202 USA

[17] Massachusetts Gen Hosp, Boston, MA 02114 USA

[18] Mayo Clin Minnesota, Rochester, MN USA

[19] Med Univ South Carolina, Charleston, SC 29425 USA

[20] Oregon Hlth & Sci Univ, Portland, OR 97201 USA

[21] Thomas Jefferson Univ, Philadelphia, PA 19107 USA

[22] Nicklaus Childrens Hosp, Miami, FL USA

[23] St Barnabas Hosp, Livingston, NJ USA

[24] Univ Rochester, Med Ctr, Rochester, NY 14642 USA

[25] Univ Wisconsin Hosp & Clin, Madison, WI 53792 USA

[26] Baylor Coll Med, Houston, TX 77030 USA

[27] Emory Univ, Sch Med, Atlanta, GA USA

[28] George Washington Univ, Sch Med & Hlth Sci, Washington, DC 20052 USA

[29] Weill Cornell Med Coll, New York, NY USA

[30] Univ Virginia, Sch Med, Charlottesville, VA 22908 USA

[31] Louisiana State Univ, Hlth Sci Ctr, New Orleans, LA USA

[32] Univ Florida, Gainesville, FL USA

[33] Wake Forest Univ Hlth Sci, Winston Salem, NC USA

[34] NeuroPace Inc, Mountain View, CA 94043 USA

[35] Stanford Univ, Palo Alto, CA 94304 USA

来源：

NEUROLOGY | 2020年 / 95卷 / 09期

关键词：

SUDDEN UNEXPECTED DEATH; QUALITY-OF-LIFE; LOCALIZED NEOCORTICAL RESECTIONS; VAGUS NERVE-STIMULATION; TEMPORAL-LOBE; LONG-TERM; STANDARDS-SUBCOMMITTEE; CORTICAL STIMULATION; PRACTICE PARAMETER; SURGERY;

D O I：

10.1212/WNL.0000000000010154

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Objective To prospectively evaluate safety and efficacy of brain-responsive neurostimulation in adults with medically intractable focal onset seizures (FOS) over 9 years. Methods Adults treated with brain-responsive neurostimulation in 2-year feasibility or randomized controlled trials were enrolled in a long-term prospective open label trial (LTT) to assess safety, efficacy, and quality of life (QOL) over an additional 7 years. Safety was assessed as adverse events (AEs), efficacy as median percent change in seizure frequency and responder rate, and QOL with the Quality of Life in Epilepsy (QOLIE-89) inventory. Results Of 256 patients treated in the initial trials, 230 participated in the LTT. At 9 years, the median percent reduction in seizure frequency was 75% (p < 0.0001, Wilcoxon signed rank), responder rate was 73%, and 35% had a >= 90% reduction in seizure frequency. We found that 18.4% (47 of 256) experienced >= 1 year of seizure freedom, with 62% (29 of 47) seizure-free at the last follow-up and an average seizure-free period of 3.2 years (range 1.04-9.6 years). Overall QOL and epilepsy-targeted and cognitive domains of QOLIE-89 remained significantly improved (p < 0.05). There were no serious AEs related to stimulation, and the sudden unexplained death in epilepsy (SUDEP) rate was significantly lower than predefined comparators (p < 0.05, 1-tailed chi(2)). Conclusions Adjunctive brain-responsive neurostimulation provides significant and sustained reductions in the frequency of FOS with improved QOL. Stimulation was well tolerated; implantation-related AEs were typical of other neurostimulation devices; and SUDEP rates were low. ClinicalTrials.gov identifier NCT00572195. Classification of evidence This study provides Class IV evidence that brain-responsive neurostimulation significantly reduces focal seizures with acceptable safety over 9 years.

引用

页码：E1244 / E1256

页数：13

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