The Pipeline Embolization Device for the Intracranial Treatment of Aneurysms Trial (free pdf)
The Pipeline Embolization Device for the Intracranial Treatment of Aneurysms Trial
P.K. Nelsona, P. Lylykb, I. Szikorac, S.G. Wetzeld, I. Wankee and D. Fiorellaf
aFrom the Neurointerventional Service (P.K.N.), Departments of Radiology and Neurosurgery, NYU Langone Medical Center, New York, New York
bDepartment of Neurosurgery (P.L.), Eneri Instituto Medico, Buenos Aires, Argentina
cDepartment of Neuroradiology (I.S.), National Institute of Neurosurgery, Budapest, Hungary
dDepartment of Neuroradiology (S.G.W.), Institute of Radiology, University Hospital Basel, Basel, Switzerland
eDepartment of Neuroradiology (I.W.), University Hospital of Essen, Essen, Germany
fDepartment of Neurosurgery (D.F.), Stony Brook University Medical Center, Stony Brook, New York.
Please address correspondence to: David Fiorella, MD, PhD, Department of Neurosurgery, Cerebrovascular Center, State University of New York at Stony Brook, Stony Brook University Hospital, Health Sciences Center 080, Stony Brook, NY, e-mail: dfiorella
BACKGROUND AND PURPOSE: Endoluminal reconstruction with flow diverting devices representsa novel constructive technique for the treatment of cerebralaneurysms. We present the results of the first prospective multicentertrial of a flow-diverting construct for the treatment of intracranialaneurysms.
MATERIALS AND METHODS: Patients with unruptured aneurysms that were wide-necked (>4mm), had unfavorable dome/neck ratios (<1.5), or had failedprevious therapy were enrolled in the PITA trial between Januaryand May 2007 at 4 (3 European and 1 South American) centers.Aneurysms were treated with the PED with or without adjunctivecoil embolization. All patients underwent clinical evaluationat 30 and 180 days and conventional angiography 180 days aftertreatment. Angiographic results were adjudicated by an experiencedneuroradiologist at a nonparticipating site.
RESULTS: Thirty-one patients with 31 intracranial aneurysms (6 men; 42–76years of age; average age, 54.6 years) were treated during thestudy period. Twenty-eight aneurysms arose from the ICA (5 cavernous,15 parophthalmic, 4 superior hypophyseal, and 4 posterior communicatingsegments), 1 from the MCA, 1 from the vertebral artery, and1 from the vertebrobasilar junction. Mean aneurysm size was11.5 mm, and mean neck size was 5.8 mm. Twelve (38.7%) aneurysmshad failed (or recurred after) a previous endovascular treatment.PED placement was technically successful in 30 of 31 patients(96.8%). Most aneurysms were treated with either 1 (n = 18)or 2 (n = 11) PEDs. Fifteen aneurysms (48.4%) were treated witha PED alone, while 16 were treated with both PED and embolizationcoils. Two patients experienced major periprocedural stroke.Follow-up angiography demonstrated complete aneurysm occlusionin 28 (93.3%) of the 30 patients who underwent angiographicfollow-up. No significant in-construct stenosis (50%) was identifiedat follow-up angiography.
CONCLUSIONS: Intracranial aneurysm treatment with the PED is technicallyfeasible and can be achieved with a safety profile analogousto that reported for stent-supported coil embolization. PEDtreatment elicited a very high rate (93%) of complete angiographicocclusion at 6 months in a population of the most challenginganatomic subtypes of cerebral aneurysms.
Abbreviations: IA, intracranial aneurysm • ICA, internal carotid artery • ID, internal diameter • LICA, left ICA • MCA, middle cerebral artery • PED, Pipeline Embolization Device • PICA, posterior inferior cerebellar artery • PITA, Pipeline for the Intracranial Treatment of Aneurysms • SES, self-expanding stent
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