title: Early postmarket results after treatment of intracranial aneurysms with the pipeline embolization device: a U.S. multicenter experience.
abstract: BACKGROUND
  The pipeline embolization device (PED) is the latest technology available for intracranial aneurysm treatment.
  
  
  OBJECTIVE
  To report early postmarket results with the PED.
  
  
  METHODS
  This study was a prospective registry of patients treated with PEDs at 7 American neurosurgical centers subsequent to Food and Drug Administration approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and periprocedural events. Follow-up data included degree of aneurysm occlusion and delayed (> 30 days after the procedure) complications.
  
  
  RESULTS
  Sixty-two PED procedures were performed to treat 58 aneurysms in 56 patients. Thirty-seven of the aneurysms (64%) treated were located from the cavernous to the superior hypophyseal artery segment of the internal carotid artery; 22% were distal to that segment, and 14% were in the vertebrobasilar system. A total of 123 PEDs were deployed with an average of 2 implanted per aneurysm treated. Six devices were incompletely deployed; in these cases, rescue balloon angioplasty was required. Six periprocedural (during the procedure/within 30 days after the procedure) thromboembolic events occurred, of which 5 were in patients with vertebrobasilar aneurysms. There were 4 fatal postprocedural hemorrhages (from 2 giant basilar trunk and 2 large ophthalmic artery aneurysms). The major complication rate (permanent disability/death resulting from perioperative/delayed complication) was 8.5%. Among 19 patients with 3-month follow-up angiography, 68% (13 patients) had complete aneurysm occlusion. Two patients presented with delayed flow-limiting in-stent stenosis that was successfully treated with angioplasty.
  
  
  CONCLUSIONS
  Unlike conventional coil embolization, aneurysm occlusion with PED is not immediate. Early complications include both thromboembolic and hemorrhagic events and appear to be significantly more frequent in association with treatment of vertebrobasilar aneurysms.
authors.affiliation: Department of Neurosurgery and Toshiba Stroke and Vascular Research Center, University at Buffalo, State University of New York, Buffalo, New York 14203, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Kan
authors.forename: Adnan H
authors.initials: AH
authors.lastname: Siddiqui
authors.forename: Erol
authors.initials: E
authors.lastname: Veznedaroglu
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Liebman
authors.forename: Mandy J
authors.initials: MJ
authors.lastname: Binning
authors.forename: Travis M
authors.initials: TM
authors.lastname: Dumont
authors.forename: Christopher S
authors.initials: CS
authors.lastname: Ogilvy
authors.forename: John R
authors.initials: JR
authors.lastname: Gaughen
authors.forename: J
authors.initials: J
authors.lastname: Mocco
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Velat
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Ringer
authors.forename: Babu G
authors.initials: BG
authors.lastname: Welch
authors.forename: Michael B
authors.initials: MB
authors.lastname: Horowitz
authors.forename: Kenneth V
authors.initials: KV
authors.lastname: Snyder
authors.forename: L Nelson
authors.initials: LN
authors.lastname: Hopkins
authors.forename: Elad I
authors.initials: EI
authors.lastname: Levy
mesh_terms: D000368:Aged; D001241:Aspirin / Q000627:therapeutic use; D001807:Blood Vessel Prosthesis; D004621:Embolization, Therapeutic / Q000295:instrumentation* / Q000379:methods*; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D005500:Follow-Up Studies; D006801:Humans; D002532:Intracranial Aneurysm / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011358:Product Surveillance, Postmarketing; D012189:Retrospective Studies; D016896:Treatment Outcome; D014481:United States
chemical_list: D005343:Fibrinolytic Agents; D001241:Aspirin