title: Early postmarket experience after US Food and Drug Administration approval with the Trevo device for thrombectomy for acute ischemic stroke.
abstract: BACKGROUND
  TREVO 2 showed the Trevo stent retriever to be more successful for revascularization than Merci for acute stroke intervention in patients treated within 8 hours of symptom onset. These results led to US Food and Drug Administration approval of Trevo.
  
  
  OBJECTIVE
  To report the first postmarket experience with Trevo since US Food and Drug Administration approval at a single high-volume comprehensive stroke center in the United States.
  
  
  METHODS
  A retrospective analysis of prospectively collected data was conducted in patients who underwent intervention for ischemic stroke with the Trevo device. Trevo was used alone or in conjunction with other intra-arterial devices. Two groups of patients were identified: those with symptom onset within (group 1) and those with symptom onset beyond (group 2) 8 hours. Recanalization, outcome, symptomatic intracranial hemorrhage, and in-hospital and 90-day mortality were assessed.
  
  
  RESULTS
  Fifty-two patients were identified, 27 in group 1 and 25 in group 2. Thrombolysis in Cerebral Infarction grade 2 to 3 revascularization was achieved in 93% of group 1 and 84% of group 2 patients. In-hospital mortality and symptomatic intracranial hemorrhage rates were 3.8% and 12% for groups 1 and 2, respectively. Ninety-day mortality was 15% and 24% for groups 1 and 2, respectively. In groups 1 and 2, 48% and 42% of patients, respectively, had good outcomes (modified Rankin Scale score, 0-2), and 50% in both groups of patients achieved Thrombolysis in Cerebral Infarction grade 3 revascularization. Group 2 had longer revascularization times and required adjuvant devices more frequently.
  
  
  CONCLUSIONS
  Our postmarket experience shows that in highly selected patients Trevo is safe and effective, even beyond 8 hours, despite longer procedure times and the need for adjuvant devices.
authors.affiliation: Capital Health, Capital Institute for Neurosciences, Trenton and Pennington, New Jersey.
authors.forename: Mandy J
authors.initials: MJ
authors.lastname: Binning
authors.forename: Joseph G
authors.initials: JG
authors.lastname: Adel
authors.forename: Christina R
authors.initials: CR
authors.lastname: Maxwell
authors.forename: Kenneth
authors.initials: K
authors.lastname: Liebman
authors.forename: Zakaria
authors.initials: Z
authors.lastname: Hakma
authors.forename: Cynthia
authors.initials: C
authors.lastname: Diaz
authors.forename: Rosemary
authors.initials: R
authors.lastname: Silva
authors.forename: Erol
authors.initials: E
authors.lastname: Veznedaroglu
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002545:Brain Ischemia / Q000601:surgery; D002548:Cerebral Revascularization / Q000295:instrumentation*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D015607:Stents; D020521:Stroke / Q000601:surgery*; D017131:Thrombectomy / Q000295:instrumentation*; D061665:Time-to-Treatment; D014481:United States; D014486:United States Food and Drug Administration