title: Pipeline for uncoilable or failed aneurysms: 3-year follow-up results.
abstract: OBJECTIVE The long-term effectiveness of endovascular treatment of large and giant wide-neck aneurysms using traditional endovascular techniques has been disappointing, with high recanalization and re-treatment rates. Flow diversion with the Pipeline Embolization Device (PED) has been recently used as a stand-alone therapy for complex aneurysms, showing significant improvement in effectiveness while demonstrating a similar safety profile to stent-supported coil treatment. However, relatively little is known about its long-term safety and effectiveness. Here the authors report on the 3-year safety and effectiveness of flow diversion with the PED in a prospective cohort of patients with large and giant internal carotid artery aneurysms enrolled in the Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial. METHODS The PUFS trial is a prospective study of 107 patients with 109 aneurysms treated with the PED. Primary effectiveness and safety end points were demonstrated based on independently monitored 180-day clinical and angiographic data. Patients were enrolled in a long-term follow-up protocol including 1-, 3-, and 5-year clinical and imaging follow-up. In this paper, the authors report the midstudy (3-year) effectiveness and safety data. RESULTS At 3 years posttreatment, 74 subjects with 76 aneurysms underwent catheter angiography as required per protocol. Overall, complete angiographic aneurysm occlusion was observed in 71 of these 76 aneurysms (93.4% cure rate). Five aneurysms were re-treated, using either coils or additional PEDs, for failure to occlude, and 3 of these 5 were cured by the 3-year follow-up. Angiographic cure with one or two treatments of Pipeline embolization alone was therefore achieved in 92.1%. No recanalization of a previously completely occluded aneurysm was noted on the 3-year angiograms. There were 3 (2.6%) delayed device- or aneurysm-related serious adverse events, none of which led to permanent neurological sequelae. No major or minor late-onset hemorrhagic or ischemic cerebrovascular events or neurological deaths were observed in the 6-month through 3-year posttreatment period. Among 103 surviving patients, 85 underwent functional outcome assessment in which modified Rankin Scale scores of 0-1 were demonstrated in 80 subjects. CONCLUSIONS Pipeline embolization is safe and effective in the treatment of complex large and giant aneurysms of the intracranial internal carotid artery. Unlike more traditional endovascular treatments, flow diversion results in progressive vascular remodeling that leads to complete aneurysm obliteration over longer-term follow-up without delayed aneurysm recanalization and/or growth. Clinical trial registration no.: NCT00777088 (clinicaltrials.gov).
authors.affiliation: Departments of 1 Radiology.|Neurology, and.
authors.forename: Tibor
authors.initials: T
authors.lastname: Becske
authors.affiliation: Departments of 1 Radiology.|Neurological Surgery, Neurointerventional Service, NYU School of Medicine, NYU Langone Medical Center, New York, New York.
authors.forename: Matthew B
authors.initials: MB
authors.lastname: Potts
authors.affiliation: Departments of 1 Radiology.|Neurology, and.
authors.forename: Maksim
authors.initials: M
authors.lastname: Shapiro
authors.affiliation: Department of Neurosurgery, Mayo Clinic, Rochester, Minnesota.
authors.forename: David F
authors.initials: DF
authors.lastname: Kallmes
authors.affiliation: Department of Neurosurgery, Mayo Clinic, Rochester, Minnesota.
authors.forename: Waleed
authors.initials: W
authors.lastname: Brinjikji
authors.affiliation: Department of Radiology, Bayindir Hospital, Ankara, Turkey.
authors.forename: Isil
authors.initials: I
authors.lastname: Saatci
authors.affiliation: Department 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 Neurosurgery, Stony Brook Hospital, Stony Brook, New York.
authors.forename: Henry H
authors.initials: HH
authors.lastname: Woo
authors.affiliation: Department of Neurological Surgery, Rush University Medical Center, Chicago, Illinois.
authors.forename: Demetrius K
authors.initials: DK
authors.lastname: Lopes
authors.affiliation: Alembic, LLC, Mountain View.
authors.forename: Aaron L
authors.initials: AL
authors.lastname: Berez
authors.affiliation: Wild Iris Consulting, Palo Alto, California; and.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Cher
authors.affiliation: Departments of Neurological Surgery and Radiology, University of Buffalo, Buffalo, New York.
authors.forename: Adnan H
authors.initials: AH
authors.lastname: Siddiqui
authors.affiliation: Departments of Neurological Surgery and Radiology, University of Buffalo, Buffalo, New York.
authors.forename: Elad I
authors.initials: EI
authors.lastname: Levy
authors.affiliation: Department of Neurological Surgery, Barrow Neurological Institute, Phoenix, Arizona.
authors.forename: Felipe C
authors.initials: FC
authors.lastname: Albuquerque
authors.affiliation: Department of Neurosurgery, Stony Brook Hospital, Stony Brook, New York.
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: Miklós
authors.initials: M
authors.lastname: Marosföi
authors.affiliation: Department of Radiology, Bayindir Hospital, Ankara, Turkey.
authors.forename: Saruhan H
authors.initials: SH
authors.lastname: Cekirge
authors.affiliation: Departments of 1 Radiology.|Neurological Surgery, Neurointerventional Service, NYU School of Medicine, NYU Langone Medical Center, New York, New York.
authors.forename: Peter K
authors.initials: PK
authors.lastname: Nelson
mesh_terms: D002340:Carotid Artery Diseases / Q000150:complications / Q000000981:diagnostic imaging / Q000601:surgery*; D002343:Carotid Artery, Internal; D002533:Cerebral Angiography; D057510:Endovascular Procedures / Q000295:instrumentation*; D005500:Follow-Up Studies; D006801:Humans; D002532:Intracranial Aneurysm / Q000150:complications / Q000000981:diagnostic imaging / Q000601:surgery*; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
keywords: CEC = clinical events committee; CRL = core radiology laboratory; CTA = CT angiography; DSA = digital subtraction angiography; ICA = internal carotid artery; MRA = MR angiography; PED = Pipeline Embolization Device; PITA = Pipeline Embolization Device for the Intracranial Treatment of Aneurysms; PUFS = Pipeline for Uncoilable or Failed Aneurysms; Pipeline Embolization Device; cerebral aneurysm; flow diversion; giant; mRS = modified Rankin Scale; vascular disorders