@article{d60b63505a884201ab4813478af2d095,
title = "Long-Term clinical and angiographic outcomes following pipeline embolization device treatment of complex internal carotid artery aneurysms: Five-year results of the pipeline for uncoilable or failed aneurysms trial",
abstract = "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 had modified Rankin Scale scores ≤2. No delayed neurological deaths or hemorrhagic or ischemic cerebrovascular events were reported beyond 6 mo. 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 giant wide-necked aneurysms of the intracranial ICA, with high rates of complete occlusion and low rates of delayed adverse events.",
keywords = "Cerebral aneurysm, Flow diversion, PUFS, Pipeline embolization device",
author = "Tibor Becske and Waleed Brinjikji and Potts, {Matthew B.} and Kallmes, {David F.} and Maksim Shapiro and Moran, {Christopher J.} and Levy, {Elad I.} and McDougall, {Cameron G.} and Istv{\'a}n Szikora and Giuseppe Lanzino and Woo, {Henry H.} and Lopes, {Demetrius K.} and Siddiqui, {Adnan H.} and Albuquerque, {Felipe C.} and Fiorella, {David J.} and Isil Saatci and Cekirge, {Saruhan H.} and Berez, {Aaron L.} and Cher, {Daniel J.} and Zsolt Berentei and Mikl{\'o}s Marosfoi and Nelson, {Peter K.}",
note = "Funding Information: This study was funded by Chestnut Medical and ev3/Covidien (Irvine, California). The PUFS trial was supported and funded by Chestnut Medical and eV3/Covidien. Dr Becske is a consultant/proctor in the use of the PED for Covidien. Dr Kallmes{\textquoteright} institution received a grant from Chestnut Medical and ev3/Covidien for funding of a clinical trial; support for travel to meetings for the study or other purposes from MictroVention; consultancy fees not related to this study from Medtronic and ev3/ Covidien; financial support for grants or pending grants from ev3/Covidien, MicroVention, Sequent, Micrus, and Benvenue Medical for preclinical studies and clinical trials; development funds for educational presentations from ev3/Covidien and CareFusion; and travel/accommodations/meeting expenses unrelated to this study from MicroVention and ev3/Covidien; and he received royalties from the University of Virginia Patent Foundation. Dr Shapiro is a consultant/proctor in the use of the PED for Covidien. Dr Moran is a chief medical officer for Covidien, and he received fees from ev3/Covidien for lectures and for development of educational presentations. Serves as a consultant for and receives honoraria from Medtronic NV. Dr Levy is a board member of Codman & Shurtleff; received consultancy fees from Codman & Shurtleff, ev3/Covidien, and TheraSyn Sensors; is a consultant for Pulsar; serves on the Acute Ischemic Stroke Clinical Advisory Board for Stryker; provided expert testimony for Medical Legal Review; has grants or grants pending from SARIS (Stent-Assisted Recanalization in acute Ischemic Stroke), Codman & Shurtleff, ev3/Covidien, and Boston Scientific; received honoraria and lecture fees from Boston Scientific and Covidien; received funds from stocks or stock options from Intratech Medical, Mynx, Medina Medical, Inc., and Blockade Medical, LLC; is National PI for Covidien{\textquoteright}s SWIFT Prime Trials; and received fees for carotid stent training from Abbott Vascular. Dr McDougall received consultancy fees from the Covidien Medical Advisory Board. Dr Szikora and his institution received consulting fees or honoraria from Chestnut Medical, and he received consultancy fees from Stryker Neurovascular and ev3/Covidien and speaker{\textquoteright}s and service fees for being on speakers{\textquoteright} bureaus of Stryker Neurovascular and ev3/Covidien. Dr Lanzino{\textquoteright}s institution received consulting fees or honoraria from ev3/Covidien and support for travel to meetings for the study or other purposes from ev3/Covidien for presentation to a FDA panel; his institution received an unrestricted educational grant from ev3/Covidien. Dr Woo{\textquoteright}s institution received funds for grants or for pending grants from Siemens and from MicroVention; he received royalties paid by Codman & Shurtleff for an acute stroke device after acquisition of Revasc and travel/accommodations/meeting expenses unrelated to this study from Siemens; and he is the President/CFO of Vascular Simulations. Dr Lopes is a consultant for Covidien and Stryker; shareholder/ownership in Penumbra, Chestnut Medical, and Blockade Medical; advisory board for Siemens and Medtronic from whom he has also received research grants and for whom he has been a consultant; principal investigator for Liberty Trial (Penumbra). Dr Siddiqui received financial compensation from Codman & Shurtleff for serving on its advisory board and from Codman & Shurtleff, Concentric Medical, ev3/Covidien, Guide Point Global Consulting, and Penumbra for consultancy; he has grants or grants pending from the National Institutes of Health and the University at Buffalo (SUNY); he received fees for lectures and for serving on speakers bureaus from Codman & Shurtleff and Genetech; he received funds for stock/stock options from Hotspur, Intratech Medical, Stim-Sox, and Valor Medical; his institution received funds for travel/accommodations/meeting expenses unrelated to this study from the 44th Neuroendovascular Complication Meeting and Asia Pacific Stroke Conference; he received honoraria from Abbott Vascular, American Association of Neurological Surgeons{\textquoteright} courses, and Genetech; and he has a nonfinancial relationship with Penumbra and serves on the National Steering Committee for 3D Separator Trial. Dr Fiorella received grant support from SAMMPRIS-NIH and consultancy fees from Codman & Shurtleff, ev3/Covidien, NFocus, and Cordis; has grants or grants pending from Siemens, MicroVention; serves as a consultant for Medtronic; and holds stocks or stock options from Vascular Simulators. Dr Saatci{\textquoteright}s institution received fees for participation in review activities from Chestnut Medical, and she received consultancy fees from ev3/Covidien. Dr Cekirge{\textquoteright}s institution received financial compensation for review activities from Chestnut Medical, and he received consultancy fees from ev3/Covidien (Medtronic), MicroVention, and Sequent. Dr Berez was an employee of Chestnut Medical and ev3/Covidien and received patent royalties from Covidien; he has stock/stock options in Chestnut Medical and Covidien, and is a founder and employee of Chestnut; he received travel/accommodations/meeting expenses unrelated to this study from Chestnut Medical and ev3/Covidien; and he is the founder and CEO of Chestnut Medical, the company that developed the PED, and is the inventor named on the relevant patents. Dr Cher was an employee of Chestnut Medical and ev3/Covidien during the data collection phase of this study, is currently a consultant for Covidien/Medtronic, and he had stock/stock options in Chestnut Medical and Covidien. Dr Nelson is a consultant/proctor in the use of the PED for Covidien/Medtronic. The other authors have no personal, financial, or Publisher Copyright: Copyright {\textcopyright} 2016 by the Congress of Neurological Surgeons.",
year = "2017",
month = jan,
day = "1",
doi = "10.1093/neuros/nyw014",
language = "English (US)",
volume = "80",
pages = "40--48",
journal = "Neurosurgery",
issn = "0148-396X",
publisher = "Lippincott Williams and Wilkins",
number = "1",
}