Journal article
Solitaire Flow Restoration Thrombectomy for Acute Ischemic Stroke: Retrospective Multicenter Analysis of Early Postmarket Experience After FDA Approval
Neurosurgery, v 73(1), pp 19-25
Jul 2013
PMID: 23719060
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
BACKGROUND: The promising results of the Solitaire Flow Restoration (FR) With the Intention for Thrombectomy (SWIFT) trial recently led to Food and Drug Administration (FDA) approval of the Solitaire FR stent retriever device for recanalization of cerebral vessels in patients with acute ischemic stroke.
OBJECTIVE: To report the early postmarket experience with this device since its FDA approval in the United States, which has not been previously described.
METHODS: We conducted a retrospective 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.
RESULTS: A 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.
CONCLUSION: Our 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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Details
- Title
- Solitaire Flow Restoration Thrombectomy for Acute Ischemic Stroke: Retrospective Multicenter Analysis of Early Postmarket Experience After FDA Approval
- Creators
- Maxim Mokin - Buffalo State UniversityTravis M. Dumont - University at Buffalo, State University of New YorkErol Veznedaroglu - Capital District Health AuthorityMandy J. Binning - Capital District Health AuthorityKenneth M. Liebman - Capital District Health AuthorityRichard D. Fessler - AscensionChiu Yuen To - AscensionRaymond D. Turner - Medical University of South CarolinaAquilla S. Turk - Medical University of South CarolinaM. Imran Chaudry - Medical University of South CarolinaAdam S. Arthur - The Spine InstituteBenjamin D. Fox - The Spine InstituteRicardo A. Hanel - Jacksonville CollegeRabih G. Tawk - Jacksonville CollegePeter Kan - University of South FloridaJohn R. Gaughen - University of South FloridaGiuseppe Lanzino - Mayo ClinicDemetrius K. Lopes - Rush UniversityMichael Chen - Rush UniversityRoham Moftakhar - Rush UniversityJoshua T. Billingsley - Rush UniversityAndrew J. Ringer - University of CincinnatiKenneth V. Snyder - University at Buffalo, State University of New YorkL. Nelson Hopkins - University at Buffalo, State University of New YorkAdnan H. Siddiqui - University at Buffalo, State University of New YorkElad I. Levy - University at Buffalo, State University of New York
- Publication Details
- Neurosurgery, v 73(1), pp 19-25
- Publisher
- Lippincott Williams & Wilkins
- Number of pages
- 7
- Grant note
- Toshiba ev3/Covidien Vascular Therapies R01NS064592 / NIH; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA Codman Shurtleff Abbott Vascular; Abbott Laboratories
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Neurology; Neurosurgery
- Web of Science ID
- WOS:000330380900015
- Scopus ID
- 2-s2.0-84880570543
- Other Identifier
- 991021917818604721
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Clinical Neurology
- Surgery