22. European Stroke Conference 36 Acute stroke: new treatment concepts A Treatment for Undifferentiated Stroke: The VitalFlow Stimulator M.K. Borsody1, E. Schwenner2, A. Garcia3, R. Lara4, I. Gonzalez5, F. Moldonado6, A. Iwamura7, J. Steel8, F. Castro Prado9, E. Sacristan Rock10 MD-5 GmbH, Leipzig, GERMANY1, MD-5 GmbH, Leipzig, GERMANY2, Universidad Autono-ma Metropolitana, Mexico City, MEXICO3, Universidad Autonoma Metropolitana, Mexico City, MEXICO4, Universidad Autonoma Metropolitana, Mexico City, MEXICO5, Universidad Autonoma Metropolitana, Mexico City, MEXICO6, Sutter Research Institute, Sacramento, USA7, Sutter Re-search Institute, Sacramento, USA8, Hospital Central Norte de Azcapotzalco, Mexico City, MEXI-CO9, Universidad Autonoma Metropolitana, Mexico City, BACKGROUND: The VitalFlow stimulator is a non-invasive medical device that increases blood flow to the brain (cerebral blood flow CBF) by stimulating the facial nerve. The VitalFlow is be-ing developed to be simple to use, effective in ischemic stroke, and safe in ischemic and hemorrhag-ic stroke. Our preliminary experiments support these concepts. METHODS: A prototype VitalFlow stimulator was applied to anesthetized dogs and sheep. Normal animal experiments assessed CBF using laser Doppler flowmetry and cerebral arteries with angiog-raphy. In stroke experiments, CBF was measured using contract perfusion protocols and hematoma size was measured using T1 and T2 protocols on a 3T MRI. Ischemic stroke was caused by injec-tion of autologous blood clots into the internal carotid artery (ICA) and embolization of the clot into the middle cerebral artery (MCA). Hemorrhagic stroke was caused by stereotaxic rupture of the in-tracranial 296 © 2013 S. Karger AG, Basel Scientific Programme ICA. RESULTS: The VitalFlow prototype did not cause adverse effects during stimulation nor lasting ef-fects in normal animals after recovery from anesthesia. Optimal stimulation parameters and device positioning for increasing CBF were determined in normal animals. In ischemic stroke experiments, VitalFlow stimulation administered 30-90 minutes after MCA occlusion in animals with confirmed CBF deficits restored 80% of the lost CBF (n=9). No restoration of CBF was observed without Vi-talFlow stimulation (n=6). Surprisingly, in hemorrhagic stroke animals (n=3) with stable intracra-nial hematomas, no hematoma enlargement was observed after VitalFlow stimulation; in fact, CBF was not increased in this condition, suggesting self-regulation of the facial nerve response. CONCLUSIONS: Our preliminary results support the development concepts for the VitalFlow. We intend to develop the VitalFlow as an emergency treatment for ischemic stroke that can be applied to stroke patients prior to diagnostic evaluation. 37 Acute stroke: new treatment concepts Conceptual Evolution in Thrombectomy? The Penumbra Separator 3D with Lesional Aspira-tion in Acute Stroke Treatment A. Mpotsaris1, C. Loehr2, M. Oelerich3, W. Weber4 Karolinska University Hospital, Stockholm, SWEDEN1, Klinikum Vest, Recklinghausen, GER-MANY2, Klinikum Vest, Recklinghausen, GERMANY3, Klinikum Vest, Recklinghausen, GERMA-NY4 Background and Purpose— IV rtPA therapy has limited effectiveness in the revascularization of large artery occlusions in acute stroke.We describe our experience with the self-expanding, fully re-trievable Penumbra Separator 3D device in acute stroke from large vessel occlusion. Materials and Methods—Prospective, single-center study of 20 patients with an acute ischemic stroke secondary to a large artery occlusion within 9 hours from symptom onset. The occlusion sites were middle cerebral artery in 9 patients, internal carotid artery terminus in 8 patients, and basilar artery in 3 patients. Thrombectomy was performed in 18 patients who had previously received IV rtPA, and of these, 2 patients had prior failed treatment with the Solitaire stent. One patient had prior failed treatment with the Revive stent. All patients were followed clinically for 90 days post-procedure. Results—Successful revascularization defined by Thrombolysis in Cerebral Infarction grade 2a to 3 was achieved in 18 of 20 (90%) treated vessels. The median time from symptom onset to revascu-larization was 4.4 (interquartile range 3.8 – 5.6) hours. No procedural complications occurred, and no symptomatic intracranial hemorrhage was observed. Three (15%) patients died. At 90 days, 50% of patients showed good functional outcome (modified Rankin Scale score ≤2) and 60% of patients showed composite good outcomes (mRS score ≤2, having a score equivalent to the pre-stroke mRS score if the pre-stroke mRS was higher than 2, or NIHSS score improvement of 10 or greater). Con-clusion— Early results suggest that the Separator 3D, which uniquely combines a clot retriever with lesional aspiration, may enable safe and effective revascularization.
Karger_ESC London_2013
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