title: Long-Term Clinical and Angiographic Outcomes Following Pipeline Embolization Device Treatment of Complex Internal Carotid Artery Aneurysms: Five-Year Results of the Pipeline for Uncoilable or Failed Aneurysms Trial.
abstract: Early and mid-term safety and efficacy of aneurysm treatment with the Pipeline Embolization Device (PED) has been well demonstrated in prior studies.
  
  
  
  To present 5-yr follow-up for patients treated in the Pipeline for Uncoilable or Failed Aneurysms clinical trial.
  
  
  
  In our prospective, multicenter trial, 109 complex internal carotid artery (ICA) aneurysms in 107 subjects were treated with the PED. Patients were followed per a standardized protocol at 180 d and 1, 3, and 5 yr. Aneurysm occlusion, in-stent stenosis, modified Rankin Scale scores, and complications were recorded.
  
  
  
  The primary endpoint of complete aneurysm occlusion at 180 d (73.6%) was previously reported. Aneurysm occlusion for those patients with angiographic follow-up progressively increased over time to 86.8% (79/91), 93.4% (71/76), and 95.2% (60/63) at 1, 3, and 5 yr, respectively. Six aneurysms (5.7%) were retreated. New serious device-related events at 1, 3, and 5 yr were noted in 1% (1/96), 3.5% (3/85), and 0% (0/81) of subjects. There were 4 (3.7%) reported deaths in our trial. Seventy-eight (96.3%) of 81 patients with 5-yr clinical follow-up had modified Rankin Scale scores ≤2. No delayed neurological deaths or hemorrhagic or ischemic cerebrovascular events were reported beyond 6 mo. No recanalization of a previously occluded aneurysm was observed.
  
  
  
  Our 5-yr findings demonstrate that PED is a safe and effective treatment for large and giant wide-necked aneurysms of the intracranial ICA, with high rates of complete occlusion and low rates of delayed adverse events.
authors.affiliation: Rochester General Hospital, Rochester, New York.
authors.forename: Tibor
authors.initials: T
authors.lastname: Becske
authors.affiliation: Mayo Clinic, Rochester, Minn-esota.
authors.forename: Waleed
authors.initials: W
authors.lastname: Brinjikji
authors.affiliation: Northwestern University Feinberg School of Medicine, Chicago, Illinois.
authors.forename: Matthew B
authors.initials: MB
authors.lastname: Potts
authors.affiliation: Mayo Clinic, Rochester, Minn-esota.
authors.forename: David F
authors.initials: DF
authors.lastname: Kallmes
authors.affiliation: New York University Langone Medical Center, New York, New York.
authors.forename: Maksim
authors.initials: M
authors.lastname: Shapiro
authors.affiliation: Washington University School of Medicine, St. Louis, Missouri.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Moran
authors.affiliation: University of Buffalo, Buffalo, New York.
authors.forename: Elad I
authors.initials: EI
authors.lastname: Levy
authors.affiliation: Barrow Neurological Institute, Phoenix, Arizona.
authors.forename: Cameron G
authors.initials: CG
authors.lastname: McDougall
authors.affiliation: National Institute of Neurosurgery, Budapest, Hungary.
authors.forename: István
authors.initials: I
authors.lastname: Szikora
authors.affiliation: Mayo Clinic, Rochester, Minn-esota.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Lanzino
authors.affiliation: Brook Hospital, Stony Brook, New York.
authors.forename: Henry H
authors.initials: HH
authors.lastname: Woo
authors.affiliation: Rush University Medical Center, Chicago, Illinois.
authors.forename: Demetrius K
authors.initials: DK
authors.lastname: Lopes
authors.affiliation: University of Buffalo, Buffalo, New York.
authors.forename: Adnan H
authors.initials: AH
authors.lastname: Siddiqui
authors.affiliation: Barrow Neurological Institute, Phoenix, Arizona.
authors.forename: Felipe C
authors.initials: FC
authors.lastname: Albuquerque
authors.affiliation: Brook Hospital, Stony Brook, New York.
authors.forename: David J
authors.initials: DJ
authors.lastname: Fiorella
authors.affiliation: Bayindir Hospital, Ankara, Turkey.
authors.forename: Isil
authors.initials: I
authors.lastname: Saatci
authors.affiliation: Bayindir Hospital, Ankara, Turkey.
authors.forename: Saruhan H
authors.initials: SH
authors.lastname: Cekirge
authors.affiliation: Alembic, LLC, Mountain View, California.
authors.forename: Aaron L
authors.initials: AL
authors.lastname: Berez
authors.affiliation: Wild Iris Consulting, Palo Alto, California.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Cher
authors.affiliation: National Institute of Neurosurgery, Budapest, Hungary.
authors.forename: Zsolt
authors.initials: Z
authors.lastname: Berentei
authors.affiliation: National Institute of Neurosurgery, Budapest, Hungary.
authors.forename: Miklós
authors.initials: M
authors.lastname: Marosfoi
authors.affiliation: New York University Langone Medical Center, New York, New York.
authors.forename: Peter K
authors.initials: PK
authors.lastname: Nelson
mesh_terms: D000328:Adult; D000368:Aged; D002340:Carotid Artery Diseases / Q000000981:diagnostic imaging / Q000628:therapy*; D002343:Carotid Artery, Internal; D002533:Cerebral Angiography; D004621:Embolization, Therapeutic / Q000295:instrumentation*; D005260:Female; D006801:Humans; D002532:Intracranial Aneurysm / Q000000981:diagnostic imaging / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome
keywords: Cerebral aneurysm; Flow diversion; PUFS; Pipeline embolization device