title: Neuroophthalmological outcomes associated with use of the Pipeline Embolization Device: analysis of the PUFS trial results.
abstract: OBJECTIVE
  Neuroophthalmological morbidity is commonly associated with large and giant cavernous and supraclinoid internal carotid artery (ICA) aneurysms. The authors sought to evaluate the neuroophthalmological outcomes after treatment of these aneurysms with the Pipeline Embolization Device (PED).
  
  
  METHODS
  The Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial was an international, multicenter prospective trial evaluating the safety and efficacy of the PED. All patients underwent complete neuroophthalmological examinations both before the PED procedure and at a 6-month follow-up. All examinations were performed for the purpose of this study and according to study criteria.
  
  
  RESULTS
  In total, 108 patients were treated in the PUFS trial, 98 of whom had complete neuroophthalmological follow-up. Of the patients with complete follow-up, 39 (40%) presented with a neuroophthalmological baseline deficit that was presumed to be attributable to the aneurysm, and patients with these baseline deficits had significantly larger aneurysms. In 25 of these patients (64%), the baseline deficit showed at least some improvement 6 months after PED treatment, whereas in 1 patient (2.6%), the deficits only worsened. In 5 patients (5%), new deficits had developed at the 6-month follow-up, while in another 6 patients (6%), deficits that were not originally assumed to be related to the aneurysm had improved by that time. A history of diabetes was associated with failure of the baseline deficits to improve after the treatment. The aneurysm maximum diameter was significantly larger in patients with a new deficit or a worse baseline deficit at 6 months postprocedure.
  
  
  CONCLUSIONS
  Patients treated with the PED for large and giant ICA aneurysms had excellent neuroophthalmological outcomes 6 months after the procedure, with deficits improving in most of the patients, very few deficits worsening, and few new deficits developing.
authors.affiliation: Departments of 1 Neurology.|Radiology.
authors.forename: Daniel H
authors.initials: DH
authors.lastname: Sahlein
authors.affiliation: Departments of 1 Neurology.|Ophthalmology, and.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Fouladvand
authors.affiliation: Departments of 1 Neurology.|Radiology.
authors.forename: Tibor
authors.initials: T
authors.lastname: Becske
authors.affiliation: Department of Interventional Neuroradiology, Koru Hospitals, Ankara;
authors.forename: Isil
authors.initials: I
authors.lastname: Saatci
authors.affiliation: Division of Neurological Surgery, Barrow Neurological Institute, Phoenix, Arizona;
authors.forename: Cameron G
authors.initials: CG
authors.lastname: McDougall
authors.affiliation: National Institute of Neurosciences, Budapest, Hungary;
authors.forename: István
authors.initials: I
authors.lastname: Szikora
authors.affiliation: Department of Neurosurgery, Mayo Clinic, Rochester, Minnesota;
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Lanzino
authors.affiliation: Division of Interventional Neuroradiology, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, Missouri;
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Moran
authors.affiliation: Department of Neurological Surgery, Stony Brook University, Stony Brook;
authors.forename: Henry H
authors.initials: HH
authors.lastname: Woo
authors.affiliation: Department of Neurological Surgery, Rush University, Chicago, Illinois;
authors.forename: Demetrius K
authors.initials: DK
authors.lastname: Lopes
authors.affiliation: Alembic LLC, Mountain View, California.
authors.forename: Aaron L
authors.initials: AL
authors.lastname: Berez
authors.affiliation: Wild Iris Consulting LLC, Palo Alto; and.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Cher
authors.affiliation: Department of Neurosurgery, University at Buffalo, Buffalo, New York;
authors.forename: Adnan H
authors.initials: AH
authors.lastname: Siddiqui
authors.affiliation: Department of Neurosurgery, University at Buffalo, Buffalo, New York;
authors.forename: Elad I
authors.initials: EI
authors.lastname: Levy
authors.affiliation: Division of Neurological Surgery, Barrow Neurological Institute, Phoenix, Arizona;
authors.forename: Felipe C
authors.initials: FC
authors.lastname: Albuquerque
authors.affiliation: Department of Neurological Surgery, Stony Brook University, Stony Brook;
authors.forename: David J
authors.initials: DJ
authors.lastname: Fiorella
authors.affiliation: National Institute of Neurosciences, Budapest, Hungary;
authors.forename: Zsolt
authors.initials: Z
authors.lastname: Berentei
authors.affiliation: National Institute of Neurosciences, Budapest, Hungary;
authors.forename: Miklos
authors.initials: M
authors.lastname: Marosfoi
authors.affiliation: Department of Interventional Neuroradiology, Bayindir Hospitals, Ankara/Istanbul, Turkey;
authors.forename: Saruhan H
authors.initials: SH
authors.lastname: Cekirge
authors.affiliation: Department of Neurosurgery, Mayo Clinic, Rochester, Minnesota;
authors.forename: David F
authors.initials: DF
authors.lastname: Kallmes
authors.affiliation: Radiology.|Neurosurgery, New York University Langone Medical Center, New York;
authors.forename: Peter K
authors.initials: PK
authors.lastname: Nelson
mesh_terms: D002343:Carotid Artery, Internal; D004621:Embolization, Therapeutic / Q000295:instrumentation*; D005260:Female; D006801:Humans; D002532:Intracranial Aneurysm / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009901:Optic Nerve Diseases / Q000209:etiology* / Q000517:prevention & control*; D011446:Prospective Studies; D016896:Treatment Outcome
keywords: APD = afferent pupillary defect; CN = cranial nerve; ICA = internal carotid artery; PED = Pipeline Embolization Device; PUFS = Pipeline for Uncoilable or Failed Aneurysms; Pipeline Embolization Device; VA = visual acuity; VF = visual field; aneurysm; aneurysm embolization; flow diversion; neuroophthalmology; vascular disorders