RT Journal Article
SR Electronic
T1 Surpass Flow Diverter in the Treatment of Intracranial Aneurysms: A Prospective Multicenter Study
JF American Journal of Neuroradiology
JO Am. J. Neuroradiol.
FD American Society of Neuroradiology
DO 10.3174/ajnr.A4078
A1 A.K. Wakhloo
A1 P. Lylyk
A1 J. de Vries
A1 C. Taschner
A1 J. Lundquist
A1 A. Biondi
A1 M. Hartmann
A1 I. Szikora
A1 L. Pierot
A1 N. Sakai
A1 H. Imamura
A1 N. Sourour
A1 I. Rennie
A1 M. Skalej
A1 O. Beuing
A1 A. Bonafé
A1 F. Mery
A1 F. Turjman
A1 P. Brouwer
A1 E. Boccardi
A1 L. Valvassori
A1 S. Derakhshani
A1 M.W. Litzenberg
A1 M.J. Gounis
YR 2014
UL http://www.ajnr.org/content/early/2014/08/14/ajnr.A4078.abstract
AB BACKGROUND AND PURPOSE: Incomplete occlusion and recanalization of large and wide-neck brain aneurysms treated by endovascular therapy remains a challenge. We present preliminary clinical and angiographic results of an experimentally optimized Surpass flow diverter for treatment of intracranial aneurysms in a prospective, multicenter, nonrandomized, single-arm study. MATERIALS AND METHODS: At 24 centers, 165 patients with 190 intracranial aneurysms of the anterior and posterior circulations were enrolled. The primary efficacy end point was the percentage of intracranial aneurysms with 100% occlusion on 6-month DSA. The primary safety end point was neurologic death and any stroke through a minimum follow-up of 6 months. RESULTS: Successful flow-diverter delivery was achieved in 161 patients with 186 aneurysms (98%); the mean number of devices used per aneurysm was 1.05. Clinical follow-up (median, 6 months) of 150 patients (93.2%), showed that the primary safety end point occurred in 18 subjects. Permanent neurologic morbidity and mortality were 6% and 2.7%, respectively. Morbidity occurred in 4% and 7.4% of patients treated for aneurysms of the anterior and posterior circulation, respectively. Neurologic death during follow-up was observed in 1.6% and 7.4% of patients with treated intracranial aneurysms of the anterior and posterior circulation, respectively. Ischemic stroke at ≤30 days, SAH at ≤7 days, and intraparenchymal hemorrhage at ≤7 days were encountered in 3.7%, 2.5%, and 2.5% of subjects, respectively. No disabling ischemic strokes at >30 days or SAH at >7 days occurred. New or worsening cranial nerve deficit was observed in 2.7%. Follow-up angiography available in 158 (86.8%) intracranial aneurysms showed 100% occlusion in 75%. CONCLUSIONS: Clinical outcomes of the Surpass flow diverter in the treatment of intracranial aneurysms show a safety profile that is comparable with that of stent-assisted coil embolization. Angiographic results showed a high rate of intracranial aneurysm occlusion. Abbreviations EVTendovascular treatmentFDflow diverterPUFSPipeline Embolization Device for Uncoilable or Failed Aneurysms