• Neurosurgery · Feb 2013

    Solitaire FR Thrombectomy for Acute Ischemic Stroke: Retrospective Multicenter Analysis of Early Postmarket Experience after FDA Approval.

    • Maxim Mokin, Travis M Dumont, Erol Veznedaroglu, Mandy J Binning, Kenneth M Liebman, Richard D Fessler, Chiu Yuen To, Raymond D Turner, Aquilla S Turk, M Imran Chaudry, Adam S Arthur, Benjamin D Fox, Ricardo A Hanel, Rabih G Tawk, Peter Kan, John R Gaughen, Giuseppe Lanzino, Demetrius K Lopes, Michael Chen, Roham Moftakhar, Joshua T Billingsley, Andrew J Ringer, Kenneth V Snyder, L Nelson Hopkins, Adnan H Siddiqui, and Elad I Levy.
    • 1Departments of Neurosurgery and Radiology, School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York, Buffalo, NY 2Capital Health, Trenton, NJ 3St. John Providence Health System, Detroit, MI 4Departments of Neurosurgery and Radiology, Medical University of South Carolina, Charleston, SC 5Semmes-Murphey Neurologic and Spine Institute, Memphis, TN 6Department of Neurosurgery, Mayo Clinic, Jacksonville, FL 7University of South Florida, Department of Neurosurgery and Neuroradiology, Tampa, FL 8Department of Neurosurgery, Mayo Clinic, Rochester, MN 9Department of Neurosurgery, Rush University Medical Center, Chicago, IL 10Department of Neurosurgery, Mayfield Clinic, University of Cincinnati, Cincinnati, OH.
    • Neurosurgery. 2013 Feb 25.

    BackgroundThe promising results of the Solitaire Flow Restoration (FR) With the Intention for Thrombectomy (SWIFT) trial recently led toFood and Drug Administration (FDA) approval of theSolitaire FR stent retriever device for recanalization of cerebral vessels in patients with acute ischemic stroke. ObjectiveTo report the early postmarket experience with this device since its FDA approval in the United States, which has not been previously described. MethodsWe conducted aretrospective analysis of consecutive acute ischemic strokes cases treated between March 2012 and July 2012 at 10 United States centers where the Solitaire FR was used as a single device or in conjunction with other intraarterial endovascular approaches. ResultsA total of 101 patients were identified (mean age, 64.7 years; mean admission National Institutes of Health Stroke Scale [NIHSS] score, 17.6). Intravenous thrombolysis was administered in 39% of cases; other endovascular techniques were utilized in conjunction with the Solitaire FR in 52%. Successful recanalization (Thrombolysis in Myocardial Infarction 2/3) was achieved in 88%. The rate of symptomatic intracranial hemorrhage within the first 24 hours was 15%. In-hospital mortality was 26%. At 30 days, 38% of patients had favorable functional outcome (modified Rankin scale score ≤2).Severity of NIHSS score on admission was a strong predictor of poor outcome. ConclusionOur study shows that a variety of other endovascular approaches are used in conjunction with Solitaire FR in actual practice in the United States.Early postmarket results suggest that Solitaire FR is an effective tool for endovascular treatment of acute ischemic stroke.

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