A prospective, multicenter study of cardiac-based seizure detection to activate vagus nerve stimulation
- Author
- Paul Boon (UGent) , Kristl Vonck (UGent) , Kenou van Rijckevorsel, RIEM EL TAHRY (UGent) , Christian E Elger, Nandini Mullatti, Andreas Schulze-Bonhage, Louis Wagner, Beate Diehl, Hajo Hamer, Markus Reuber, Hrisimir Kostov, Benjamin Legros, Soheyl Noachtar, Yvonne G Weber, Volker A Coenen, Herbert Rooijakkers, Olaf EMG Schijns, Richard Selway, Dirk Van Roost (UGent) , Katherine S Eggleston, Wim Van Grunderbeek, Amara K Jayewardene and Ryan M McGuire
- Organization
- 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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Please use this url to cite or link to this publication: http://hdl.handle.net/1854/LU-6985546
- MLA
- Boon, Paul, et al. “A Prospective, Multicenter Study of Cardiac-Based Seizure Detection to Activate Vagus Nerve Stimulation.” SEIZURE-EUROPEAN JOURNAL OF EPILEPSY, vol. 32, 2015, pp. 52–61, doi:10.1016/j.seizure.2015.08.011.
- APA
- Boon, P., Vonck, K., van Rijckevorsel, K., EL TAHRY, R., Elger, C. E., Mullatti, N., … McGuire, R. M. (2015). A prospective, multicenter study of cardiac-based seizure detection to activate vagus nerve stimulation. SEIZURE-EUROPEAN JOURNAL OF EPILEPSY, 32, 52–61. https://doi.org/10.1016/j.seizure.2015.08.011
- Chicago author-date
- 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. https://doi.org/10.1016/j.seizure.2015.08.011.
- Chicago author-date (all authors)
- Boon, Paul, Kristl Vonck, Kenou van Rijckevorsel, RIEM EL TAHRY, Christian E Elger, Nandini Mullatti, Andreas Schulze-Bonhage, Louis Wagner, Beate Diehl, Hajo Hamer, Markus Reuber, Hrisimir Kostov, Benjamin Legros, Soheyl Noachtar, Yvonne G Weber, Volker A Coenen, Herbert Rooijakkers, Olaf EMG Schijns, Richard Selway, Dirk Van Roost, Katherine S Eggleston, Wim Van Grunderbeek, Amara K Jayewardene, and Ryan M McGuire. 2015. “A Prospective, Multicenter Study of Cardiac-Based Seizure Detection to Activate Vagus Nerve Stimulation.” SEIZURE-EUROPEAN JOURNAL OF EPILEPSY 32: 52–61. doi:10.1016/j.seizure.2015.08.011.
- 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.
- IEEE
- [1]P. Boon et al., “A prospective, multicenter study of cardiac-based seizure detection to activate vagus nerve stimulation,” SEIZURE-EUROPEAN JOURNAL OF EPILEPSY, vol. 32, pp. 52–61, 2015.
@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 ≥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.}}, 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}}, 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}}, language = {{eng}}, pages = {{52--61}}, title = {{A prospective, multicenter study of cardiac-based seizure detection to activate vagus nerve stimulation}}, url = {{http://doi.org/10.1016/j.seizure.2015.08.011}}, volume = {{32}}, year = {{2015}}, }
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