Retrospective Multicenter Study of Solitaire FR for Revascularization in the Treatment of Acute Ischemic Stroke

The purpose of this study was to evaluate safety and efficacy of the Solitaire FR device in the treatment of patients with acute ischemic stroke secondary to large artery occlusion. We conducted a retrospective study of consecutive patients presenting with acute ischemic stroke treated with Solitair...

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Veröffentlicht in:Stroke (1970) 2012-10, Vol.43 (10), p.2699-2705
Hauptverfasser: Dávalos, Antoni, Pereira, Vitor Mendes, Chapot, René, Bonafé, Alain, Andersson, Tommy, Gralla, Jan
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container_end_page 2705
container_issue 10
container_start_page 2699
container_title Stroke (1970)
container_volume 43
creator Dávalos, Antoni
Pereira, Vitor Mendes
Chapot, René
Bonafé, Alain
Andersson, Tommy
Gralla, Jan
description The purpose of this study was to evaluate safety and efficacy of the Solitaire FR device in the treatment of patients with acute ischemic stroke secondary to large artery occlusion. We conducted a retrospective study of consecutive patients presenting with acute ischemic stroke treated with Solitaire FR as the first-line device to restore blood flow in 6 experienced European centers. This study was entirely funded and supported by Coviden Neurovascular. An independent Corelab determined modified Thrombolysis in Cerebral Infarction scores on the preprocedure and postprocedure angiograms. Complete revascularization was defined as modified Thrombolysis in Cerebral Infarction 2b or 3 post-Solitaire FR device use. Symptomatic intracranial hemorrhage was defined as parenchymal hemorrhage Type 2 associated with a decline of ≥ 4 points in the National Institutes of Health Stroke Scale score within 24 hours or causing death. Favorable functional outcome was considered as modified Rankin Scale score ≤ 2 at Day 90. We studied 141 patients (mean age, 66 years; median National Institutes of Health Stroke Scale, 18); 74 patients received intravenous tissue-type plasminogen activator before endovascular treatment. Complete revascularization was achieved in 120 of 142 occlusion sites (85%) and good outcome in 77 of 141 (55%) patients. Good outcome was more frequent in patients treated with intravenous tissue-type plasminogen activator than in those without (66% versus 42%; P
doi_str_mv 10.1161/STROKEAHA.112.663328
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We conducted a retrospective study of consecutive patients presenting with acute ischemic stroke treated with Solitaire FR as the first-line device to restore blood flow in 6 experienced European centers. This study was entirely funded and supported by Coviden Neurovascular. An independent Corelab determined modified Thrombolysis in Cerebral Infarction scores on the preprocedure and postprocedure angiograms. Complete revascularization was defined as modified Thrombolysis in Cerebral Infarction 2b or 3 post-Solitaire FR device use. Symptomatic intracranial hemorrhage was defined as parenchymal hemorrhage Type 2 associated with a decline of ≥ 4 points in the National Institutes of Health Stroke Scale score within 24 hours or causing death. Favorable functional outcome was considered as modified Rankin Scale score ≤ 2 at Day 90. We studied 141 patients (mean age, 66 years; median National Institutes of Health Stroke Scale, 18); 74 patients received intravenous tissue-type plasminogen activator before endovascular treatment. Complete revascularization was achieved in 120 of 142 occlusion sites (85%) and good outcome in 77 of 141 (55%) patients. Good outcome was more frequent in patients treated with intravenous tissue-type plasminogen activator than in those without (66% versus 42%; P&lt;0.01). Symptomatic intracranial hemorrhage was reported in 5 patients (4%) and 29 of 141 (20%) patients died or were lost during follow-up (3 cases). This retrospective study with centralized evaluation shows that the use of Solitaire FR is safe and achieves good revascularization rates and functional outcomes in patients with acute ischemic stroke and large artery occlusion.</description><identifier>ISSN: 0039-2499</identifier><identifier>EISSN: 1524-4628</identifier><identifier>DOI: 10.1161/STROKEAHA.112.663328</identifier><identifier>PMID: 22851547</identifier><identifier>CODEN: SJCCA7</identifier><language>eng</language><publisher>Hagerstown, MD: American Heart Association, Inc</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Biological and medical sciences ; Brain - blood supply ; Cardiovascular system ; Cerebral Revascularization - instrumentation ; Cerebral Revascularization - methods ; Cerebrovascular Disorders - drug therapy ; Equipment and Supplies - adverse effects ; Europe ; Female ; Follow-Up Studies ; Humans ; Male ; Medical sciences ; Middle Aged ; Neurology ; Pharmacology. Drug treatments ; Regional Blood Flow - physiology ; Retrospective Studies ; Stents - adverse effects ; Stroke - physiopathology ; Stroke - therapy ; Thrombectomy - instrumentation ; Thrombolytic Therapy - methods ; Tissue Plasminogen Activator - therapeutic use ; Treatment Outcome ; Vascular diseases and vascular malformations of the nervous system ; Vasodilator agents. 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We conducted a retrospective study of consecutive patients presenting with acute ischemic stroke treated with Solitaire FR as the first-line device to restore blood flow in 6 experienced European centers. This study was entirely funded and supported by Coviden Neurovascular. An independent Corelab determined modified Thrombolysis in Cerebral Infarction scores on the preprocedure and postprocedure angiograms. Complete revascularization was defined as modified Thrombolysis in Cerebral Infarction 2b or 3 post-Solitaire FR device use. Symptomatic intracranial hemorrhage was defined as parenchymal hemorrhage Type 2 associated with a decline of ≥ 4 points in the National Institutes of Health Stroke Scale score within 24 hours or causing death. Favorable functional outcome was considered as modified Rankin Scale score ≤ 2 at Day 90. We studied 141 patients (mean age, 66 years; median National Institutes of Health Stroke Scale, 18); 74 patients received intravenous tissue-type plasminogen activator before endovascular treatment. Complete revascularization was achieved in 120 of 142 occlusion sites (85%) and good outcome in 77 of 141 (55%) patients. Good outcome was more frequent in patients treated with intravenous tissue-type plasminogen activator than in those without (66% versus 42%; P&lt;0.01). Symptomatic intracranial hemorrhage was reported in 5 patients (4%) and 29 of 141 (20%) patients died or were lost during follow-up (3 cases). This retrospective study with centralized evaluation shows that the use of Solitaire FR is safe and achieves good revascularization rates and functional outcomes in patients with acute ischemic stroke and large artery occlusion.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Biological and medical sciences</subject><subject>Brain - blood supply</subject><subject>Cardiovascular system</subject><subject>Cerebral Revascularization - instrumentation</subject><subject>Cerebral Revascularization - methods</subject><subject>Cerebrovascular Disorders - drug therapy</subject><subject>Equipment and Supplies - adverse effects</subject><subject>Europe</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neurology</subject><subject>Pharmacology. Drug treatments</subject><subject>Regional Blood Flow - physiology</subject><subject>Retrospective Studies</subject><subject>Stents - adverse effects</subject><subject>Stroke - physiopathology</subject><subject>Stroke - therapy</subject><subject>Thrombectomy - instrumentation</subject><subject>Thrombolytic Therapy - methods</subject><subject>Tissue Plasminogen Activator - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Vascular diseases and vascular malformations of the nervous system</subject><subject>Vasodilator agents. 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We conducted a retrospective study of consecutive patients presenting with acute ischemic stroke treated with Solitaire FR as the first-line device to restore blood flow in 6 experienced European centers. This study was entirely funded and supported by Coviden Neurovascular. An independent Corelab determined modified Thrombolysis in Cerebral Infarction scores on the preprocedure and postprocedure angiograms. Complete revascularization was defined as modified Thrombolysis in Cerebral Infarction 2b or 3 post-Solitaire FR device use. Symptomatic intracranial hemorrhage was defined as parenchymal hemorrhage Type 2 associated with a decline of ≥ 4 points in the National Institutes of Health Stroke Scale score within 24 hours or causing death. Favorable functional outcome was considered as modified Rankin Scale score ≤ 2 at Day 90. We studied 141 patients (mean age, 66 years; median National Institutes of Health Stroke Scale, 18); 74 patients received intravenous tissue-type plasminogen activator before endovascular treatment. Complete revascularization was achieved in 120 of 142 occlusion sites (85%) and good outcome in 77 of 141 (55%) patients. Good outcome was more frequent in patients treated with intravenous tissue-type plasminogen activator than in those without (66% versus 42%; P&lt;0.01). Symptomatic intracranial hemorrhage was reported in 5 patients (4%) and 29 of 141 (20%) patients died or were lost during follow-up (3 cases). 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subjects Adult
Aged
Aged, 80 and over
Biological and medical sciences
Brain - blood supply
Cardiovascular system
Cerebral Revascularization - instrumentation
Cerebral Revascularization - methods
Cerebrovascular Disorders - drug therapy
Equipment and Supplies - adverse effects
Europe
Female
Follow-Up Studies
Humans
Male
Medical sciences
Middle Aged
Neurology
Pharmacology. Drug treatments
Regional Blood Flow - physiology
Retrospective Studies
Stents - adverse effects
Stroke - physiopathology
Stroke - therapy
Thrombectomy - instrumentation
Thrombolytic Therapy - methods
Tissue Plasminogen Activator - therapeutic use
Treatment Outcome
Vascular diseases and vascular malformations of the nervous system
Vasodilator agents. Cerebral vasodilators
title Retrospective Multicenter Study of Solitaire FR for Revascularization in the Treatment of Acute Ischemic Stroke
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