par Boon, Paul
;Hamer, Hajo;Reuber, Markus;Kostov, Hrisimir;Legros, Benjamin
;Noachtar, Soheyl;Weber, Yvonne Y.G.;Coenen, Volker Arnd;Rooijakkers, Herbert;Schijns, Olaf E M G O.E.M.G.;Selway, Richard;Vonck, Kristl;Van Roost, Dirk;Eggleston, Katherine K.S.;Van Grunderbeek, Wim;Jayewardene, Amara A.K.;McGuire, Ryan R.M.;Van Rijckevorsel, Kenou;Tahry, Riem El;Elger, Christian Erich E C.E.;Mullatti, Nandini;Schulze-Bonhage, Andreas;Wagner, Louis;Diehl, Beate
Référence Seizure, 32, page (52-61)
Publication Publié, 2015-11


Référence Seizure, 32, page (52-61)
Publication Publié, 2015-11
Article révisé par les pairs
Résumé : | 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 35 bpm heart rate increase, minimum of 100 bpm). Multiple CBSDA settings achieved a sensitivity of ≥80%. False positives ranged from 0.5 to 7.2/h. 27/66 seizures were stimulated within ±2 min 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. |