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A prospective, multicenter study of cardiac-based seizure detection to activate vagus nerve stimulation

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Abstract
PURPOSE: This study investigates the performance of a cardiac-based seizure detection algorithm (CBSDA) that automatically triggers VNS (NCT01325623). METHODS: Thirty-one patients with drug resistant epilepsy were evaluated in an epilepsy monitoring unit (EMU) to assess algorithm performance and near-term clinical benefit. Long-term efficacy and safety were evaluated with combined open and closed-loop VNS. RESULTS: Sixty-six seizures (n=16 patients) were available from the EMU for analysis. In 37 seizures (n=14 patients) a ≥20% heart rate increase was found and 11 (n=5 patients) were associated with ictal tachycardia (iTC, 55% or 35bpm heart rate increase, minimum of 100bpm). Multiple CBSDA settings achieved a sensitivity of ≥80%. False positives ranged from 0.5 to 7.2/h. 27/66 seizures were stimulated within ±2min of seizure onset. In 10/17 of these seizures, where triggered VNS overlapped with ongoing seizure activity, seizure activity stopped during stimulation. Physician-scored seizure severity (NHS3-scale) showed significant improvement for complex partial seizures (CPS) at EMU discharge and through 12 months (p<0.05). Patient-scored seizure severity (total SSQ score) showed significant improvement at 3 and 6 months. Quality of life (total QOLIE-31-P score) showed significant improvement at 12 months. The responder rate (≥50% reduction in seizure frequency) at 12 months was 29.6% (n=8/27). Safety profiles were comparable to prior VNS trials. CONCLUSIONS: The investigated CBSDA has a high sensitivity and an acceptable specificity for triggering VNS. Despite the moderate effects on seizure frequency, combined open- and closed-loop VNS may provide valuable improvements in seizure severity and QOL in refractory epilepsy patients.
Keywords
Ictal tachycardia, Vagus nerve stimulation, Cardiac based seizure detection, Refractory epilepsy, Quality of life, MINIMALLY IMPORTANT CHANGE, SEVERITY QUESTIONNAIRE, EPILEPSY, SYSTEM, EEG, DURATION, PATIENT

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Chicago
Boon, Paul, Kristl Vonck, Kenou van Rijckevorsel, RIEM EL TAHRY, Christian E Elger, Nandini Mullatti, Andreas Schulze-Bonhage, et al. 2015. “A Prospective, Multicenter Study of Cardiac-based Seizure Detection to Activate Vagus Nerve Stimulation.” Seizure-european Journal of Epilepsy 32: 52–61.
APA
Boon, Paul, Vonck, K., van Rijckevorsel, K., EL TAHRY, R., Elger, C. E., Mullatti, N., Schulze-Bonhage, A., et al. (2015). A prospective, multicenter study of cardiac-based seizure detection to activate vagus nerve stimulation. SEIZURE-EUROPEAN JOURNAL OF EPILEPSY, 32, 52–61.
Vancouver
1.
Boon P, Vonck K, van Rijckevorsel K, EL TAHRY R, Elger CE, Mullatti N, et al. A prospective, multicenter study of cardiac-based seizure detection to activate vagus nerve stimulation. SEIZURE-EUROPEAN JOURNAL OF EPILEPSY. 2015;32:52–61.
MLA
Boon, Paul, Kristl Vonck, Kenou van Rijckevorsel, et al. “A Prospective, Multicenter Study of Cardiac-based Seizure Detection to Activate Vagus Nerve Stimulation.” SEIZURE-EUROPEAN JOURNAL OF EPILEPSY 32 (2015): 52–61. Print.
@article{6985546,
  abstract     = {PURPOSE: This study investigates the performance of a cardiac-based seizure detection algorithm (CBSDA) that automatically triggers VNS (NCT01325623).
METHODS: Thirty-one patients with drug resistant epilepsy were evaluated in an epilepsy monitoring unit (EMU) to assess algorithm performance and near-term clinical benefit. Long-term efficacy and safety were evaluated with combined open and closed-loop VNS.
RESULTS: Sixty-six seizures (n=16 patients) were available from the EMU for analysis. In 37 seizures (n=14 patients) a \ensuremath{\geq}20\% heart rate increase was found and 11 (n=5 patients) were associated with ictal tachycardia (iTC, 55\% or 35bpm heart rate increase, minimum of 100bpm). Multiple CBSDA settings achieved a sensitivity of \ensuremath{\geq}80\%. False positives ranged from 0.5 to 7.2/h. 27/66 seizures were stimulated within {\textpm}2min of seizure onset. In 10/17 of these seizures, where triggered VNS overlapped with ongoing seizure activity, seizure activity stopped during stimulation. Physician-scored seizure severity (NHS3-scale) showed significant improvement for complex partial seizures (CPS) at EMU discharge and through 12 months (p{\textlangle}0.05). Patient-scored seizure severity (total SSQ score) showed significant improvement at 3 and 6 months. Quality of life (total QOLIE-31-P score) showed significant improvement at 12 months. The responder rate (\ensuremath{\geq}50\% reduction in seizure frequency) at 12 months was 29.6\% (n=8/27). Safety profiles were comparable to prior VNS trials.
CONCLUSIONS: The investigated CBSDA has a high sensitivity and an acceptable specificity for triggering VNS. Despite the moderate effects on seizure frequency, combined open- and closed-loop VNS may provide valuable improvements in seizure severity and QOL in refractory epilepsy patients.},
  author       = {Boon, Paul and Vonck, Kristl and van Rijckevorsel, Kenou and EL TAHRY, RIEM and Elger, Christian E and Mullatti, Nandini and Schulze-Bonhage, Andreas and Wagner, Louis and Diehl, Beate and Hamer, Hajo and Reuber, Markus and Kostov, Hrisimir and Legros, Benjamin and Noachtar, Soheyl and Weber, Yvonne G and Coenen, Volker A and Rooijakkers, Herbert and Schijns, Olaf EMG and Selway, Richard and Van Roost, Dirk and Eggleston, Katherine S and Van Grunderbeek, Wim and Jayewardene, Amara K and McGuire, Ryan M},
  issn         = {1059-1311},
  journal      = {SEIZURE-EUROPEAN JOURNAL OF EPILEPSY},
  language     = {eng},
  pages        = {52--61},
  title        = {A prospective, multicenter study of cardiac-based seizure detection to activate vagus nerve stimulation},
  url          = {http://dx.doi.org/10.1016/j.seizure.2015.08.011},
  volume       = {32},
  year         = {2015},
}

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