BACKGROUND AND PURPOSE: This study was designed to investigate the safety and efficacy of the Onyx liquid embolic system in treating a selected population of patients with intracranial aneurysms that presented difficulties for surgical or endovascular alternatives. METHODS: A prospective observational study was conducted in 20 European centers enrolling a consecutive series of 119 patients with 123 aneurysms judged suitable for Onyx treatment. The series consists of findings collected in 97 of 119 patients with 100 of 123 aneurysms, because one center declined to provide data to the study sponsor or allow outside audit. Clinical and angiographic outcomes were recorded at discharge, 3 months, and 12 months. All adverse events and re-treatments were recorded. Seventy-nine aneurysms were large or giant. RESULTS: Twelve-month follow-up angiography findings were available for 71 aneurysms. This angiographic follow-up showed complete occlusion in 56 (79%) aneurysms, subtotal occlusion in nine (13%), and incomplete occlusion in six (8%). Procedure- or device-related permanent neurologic morbidity at final follow-up was present in eight of 97 patients. Seven patients died: two deaths were procedure related; one, disease related; and four, unrelated causes. Seventy-five of the 82 patients alive and with follow-up at 12 months were at Rankin 2 or better status. Delayed occlusion of the parent vessel occurred in nine patients; delayed occlusion was asymptomatic in five and resulted in permanent neurologic deficit in two. CONCLUSION: In selected patients with aneurysms that are unsuitable for coil treatment or in whom previous treatment has failed to occlude the aneurysm, Onyx treatment offers an endovascular alternative. Aneurysm occlusion rates are superior to reported rates of coil occlusion, and treatment morbidity is comparable to that of published prospective data on endovascular results for this subgroup of patients.
BACKGROUND AND PURPOSE: This study was designed to investigate the safety and efficacy of the Onyx liquid embolic system in treating a selected population of patients with intracranial aneurysms that presented difficulties for surgical or endovascular alternatives. METHODS: A prospective observational study was conducted in 20 European centers enrolling a consecutive series of 119 patients with 123 aneurysms judged suitable for Onyx treatment. The series consists of findings collected in 97 of 119 patients with 100 of 123 aneurysms, because one center declined to provide data to the study sponsor or allow outside audit. Clinical and angiographic outcomes were recorded at discharge, 3 months, and 12 months. All adverse events and re-treatments were recorded. Seventy-nine aneurysms were large or giant. RESULTS: Twelve-month follow-up angiography findings were available for 71 aneurysms. This angiographic follow-up showed complete occlusion in 56 (79%) aneurysms, subtotal occlusion in nine (13%), and incomplete occlusion in six (8%). Procedure- or device-related permanent neurologic morbidity at final follow-up was present in eight of 97 patients. Seven patients died: two deaths were procedure related; one, disease related; and four, unrelated causes. Seventy-five of the 82 patients alive and with follow-up at 12 months were at Rankin 2 or better status. Delayed occlusion of the parent vessel occurred in nine patients; delayed occlusion was asymptomatic in five and resulted in permanent neurologic deficit in two. CONCLUSION: In selected patients with aneurysms that are unsuitable for coil treatment or in whom previous treatment has failed to occlude the aneurysm, Onyx treatment offers an endovascular alternative. Aneurysm occlusion rates are superior to reported rates of coil occlusion, and treatment morbidity is comparable to that of published prospective data on endovascular results for this subgroup of patients.
Authors: Andrew Molyneux; Richard Kerr; Irene Stratton; Peter Sandercock; Mike Clarke; Julia Shrimpton; Rury Holman Journal: Lancet Date: 2002-10-26 Impact factor: 79.321
Authors: David O Wiebers; J P Whisnant; J Huston; I Meissner; R D Brown; D G Piepgras; G S Forbes; K Thielen; D Nichols; W M O'Fallon; J Peacock; L Jaeger; N F Kassell; G L Kongable-Beckman; J C Torner Journal: Lancet Date: 2003-07-12 Impact factor: 79.321
Authors: Y Murayama; F Viñuela; A Ulhoa; Y Akiba; G R Duckwiler; Y P Gobin; H V Vinters; R J Greff Journal: Neurosurgery Date: 1998-11 Impact factor: 4.654
Authors: Yuichi Murayama; Yih Lin Nien; Gary Duckwiler; Y Pierre Gobin; Reza Jahan; John Frazee; Neil Martin; Fernando Viñuela Journal: J Neurosurg Date: 2003-05 Impact factor: 5.115
Authors: H Saruhan Cekirge; Isil Saatci; M Halil Ozturk; Barbaros Cil; Anil Arat; Michel Mawad; Fikret Ergungor; Deniz Belen; Uygur Er; Sami Turk; Murat Bavbek; Zeki Sekerci; Ethem Beskonakli; Osman E Ozcan; Tuncalp Ozgen Journal: Neuroradiology Date: 2006-01-04 Impact factor: 2.804