title: Solitaire Flow Restoration thrombectomy for acute ischemic stroke: retrospective multicenter analysis of early postmarket experience after FDA approval.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Neurosurgery and Radiology, School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York, Buffalo, New York, USA.
authors.forename: Maxim
authors.initials: M
authors.lastname: Mokin
authors.forename: Travis M
authors.initials: TM
authors.lastname: Dumont
authors.forename: Erol
authors.initials: E
authors.lastname: Veznedaroglu
authors.forename: Mandy J
authors.initials: MJ
authors.lastname: Binning
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Liebman
authors.forename: Richard D
authors.initials: RD
authors.lastname: Fessler
authors.forename: Chiu Yuen
authors.initials: CY
authors.lastname: To
authors.forename: Raymond D
authors.initials: RD
authors.lastname: Turner
authors.forename: Aquilla S
authors.initials: AS
authors.lastname: Turk
authors.forename: M Imran
authors.initials: MI
authors.lastname: Chaudry
authors.forename: Adam S
authors.initials: AS
authors.lastname: Arthur
authors.forename: Benjamin D
authors.initials: BD
authors.lastname: Fox
authors.forename: Ricardo A
authors.initials: RA
authors.lastname: Hanel
authors.forename: Rabih G
authors.initials: RG
authors.lastname: Tawk
authors.forename: Peter
authors.initials: P
authors.lastname: Kan
authors.forename: John R
authors.initials: JR
authors.lastname: Gaughen
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Lanzino
authors.forename: Demetrius K
authors.initials: DK
authors.lastname: Lopes
authors.forename: Michael
authors.initials: M
authors.lastname: Chen
authors.forename: Roham
authors.initials: R
authors.lastname: Moftakhar
authors.forename: Joshua T
authors.initials: JT
authors.lastname: Billingsley
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Ringer
authors.forename: Kenneth V
authors.initials: KV
authors.lastname: Snyder
authors.forename: L Nelson
authors.initials: LN
authors.lastname: Hopkins
authors.forename: Adnan H
authors.initials: AH
authors.lastname: Siddiqui
authors.forename: Elad I
authors.initials: EI
authors.lastname: Levy
mesh_terms: D002545:Brain Ischemia / Q000401:mortality* / Q000601:surgery*; D015984:Causality; D015897:Comorbidity; D018795:Device Approval; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D006801:Humans; D008297:Male; D061185:Mechanical Thrombolysis / Q000295:instrumentation* / Q000401:mortality*; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data; D012189:Retrospective Studies; D012307:Risk Factors; D015607:Stents / Q000706:statistics & numerical data*; D020521:Stroke / Q000401:mortality* / Q000601:surgery*; D015996:Survival Rate; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration