Journal
NEUROSURGERY
Volume 80, Issue 1, Pages 40-48Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/neuros/nyw014
Keywords
Cerebral aneurysm; Flow diversion; Pipeline embolization device; PUFS
Categories
Funding
- Chestnut Medical (Irvine, California)
- ev3/Covidien (Irvine, California)
- Chestnut Medical
- eV3/Covidien
- MicroVention
- Sequent
- Micrus
- Benvenue Medical for preclinical studies and clinical trials
- CareFusion
- Codman Shurtleff
- TheraSyn Sensors
- SARIS (Stent-Assisted Recanalization in acute Ischemic Stroke)
- Boston Scientific
- Covidien
- Intratech Medical
- Mynx
- Medina Medical, Inc.
- Blockade Medical, LLC
- Abbott Vascular
- Covidien Medical Advisory Board
- Stryker Neurovascular
- Siemens
- National Institutes of Health
- University at Buffalo (SUNY)
- Hotspur
- Stim-Sox
- Valor Medical
- merican Association of Neurological Surgeons' courses
- Genetech
- SAMMPRIS-NIH
- NFocus
- Cordis
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BACKGROUND: Early and mid-term safety and efficacy of aneurysm treatment with the Pipeline Embolization Device (PED) has been well demonstrated in prior studies. OBJECTIVE: To present 5-yr follow-up for patients treated in the Pipeline for Uncoilable or Failed Aneurysms clinical trial. METHODS: 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. RESULTS: 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 hadmodified Rankin Scale scores <= 2. No delayed neurological deaths or hemorrhagic or ischemic cerebrovascular events were reported beyond 6mo. No recanalization of a previously occluded aneurysm was observed. CONCLUSION: Our 5-yr findings demonstrate that PED is a safe and effective treatment for large and giantwide-necked aneurysms of the intracranial ICA, with high rates of complete occlusion and low rates of delayed adverse events.
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