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Solitaire Flow Restoration Thrombectomy for Acute Ischemic Stroke: Retrospective Multicenter Analysis of Early Postmarket Experience After FDA Approval

Mokin, Maxim MD, PhD*; Dumont, Travis M. MD*; Veznedaroglu, Erol MD; Binning, Mandy J. MD; Liebman, Kenneth M. MD; Fessler, Richard D. II MD§; To, Chiu Yuen DO§; Turner, Raymond D. IV MD; Turk, Aquilla S. DO; Chaudry, M. Imran MD; Arthur, Adam S. MD, MPH; Fox, Benjamin D. MD; Hanel, Ricardo A. MD, PhD#; Tawk, Rabih G. MD#; Kan, Peter MD, MPH**; Gaughen, John R. Jr MD**; Lanzino, Giuseppe MD‡‡; Lopes, Demetrius K. MD§§; Chen, Michael MD§§; Moftakhar, Roham MD§§; Billingsley, Joshua T. MD§§; Ringer, Andrew J. MD¶¶; Snyder, Kenneth V. MD, PhD*; Hopkins, L. Nelson MD*; Siddiqui, Adnan H. MD, PhD*; Levy, Elad I. MD*

doi: 10.1227/01.neu.0000429859.96652.57
Research-Human-Clinical Studies: Editor's Choice
Editor's Choice

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.

ABBREVIATIONS: ASPECTS, Alberta Stroke Program Early CT score

ECASS, European-Australasian Acute Stroke Study

FDA, Food and Drug Administration

ICH, intracranial hemorrhage

IV, intravenous

mRS, modified Rankin Scale

NIHSS, National Institutes of Health Stroke Scale Score

sICH, symptomatic intracranial hemorrhage

SWIFT, Solitaire FR With the Intention for Thrombectomy

TIMI, Thrombolysis in Myocardial Infarction

tPA, tissue plasminogen activator

*Departments of Neurosurgery and Radiology, School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York, Buffalo, New York;

Capital Health, Trenton, New Jersey;

§St. John Providence Health System, Detroit, Michigan;

Departments of Neurosurgery and Radiology, Medical University of South Carolina, Charleston, South Carolina;

Semmes-Murphey Neurologic and Spine Institute, Memphis, Tennessee;

#Department of Neurosurgery, Mayo Clinic, Jacksonville, Florida;

**University of South Florida, Departments of Neurosurgery and Neuroradiology, Tampa, Florida;

‡‡Department of Neurosurgery, Mayo Clinic, Rochester, Minnesota;

§§Department of Neurosurgery, Rush University Medical Center, Chicago, Illinois; and

¶¶Department of Neurosurgery, Mayfield Clinic, University of Cincinnati, Cincinnati, Ohio

Correspondence: Elad I. Levy, MD, FACS, FAHA, University at Buffalo Neurosurgery, 100 High Street, Suite B4, Buffalo NY 14203. E-mail: elevy@ubns.com.

Received October 23, 2012

Accepted February 19, 2013

Copyright © by the Congress of Neurological Surgeons