A K Wakhloo1, P Lylyk2, J de Vries3, C Taschner4, J Lundquist2, A Biondi5, M Hartmann6, I Szikora7, L Pierot8, N Sakai9, H Imamura9, N Sourour10, I Rennie11, M Skalej12, O Beuing12, A Bonafé13, F Mery14, F Turjman15, P Brouwer16, E Boccardi17, L Valvassori17, S Derakhshani18, M W Litzenberg19, M J Gounis20. 1. From the Division of Neuroimaging and Intervention (A.K.W.), Departments of Radiology, Neurology, and Neurosurgery ajay.wakhloo@umassmemorial.org. 2. Department of Neurosurgery (P.L., J.L.), ENERI, Buenos Aires, Argentina. 3. Department of Neurosurgery (J.d.V.), Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands. 4. Department of Neuroradiology (C.T.), University of Freiburg, Freiburg, Germany. 5. Department of Neuroradiology and Endovascular Therapy (A. Biondi), University of Besançon, Besançon, France. 6. Department of Neuroradiology (M.H.), Helios Hospital, Berlin, Germany. 7. National Institute of Neurosciences (I.S.), Budapest, Hungary. 8. Department of Neuroradiology (L.P.), Hôpital Maison Blanche, University Hospital of Reims, Reims, France. 9. Department of Neurosurgery (N. Sakai, H.I.), Kobe City Medical Center General Hospital, Kobe, Japan. 10. Department of Neuroradiology (N. Sourour), Hôpital Pitié-Salpetrière, Paris, France. 11. Department of Neuroradiology (I.R.), The Royal Hospitals, Belfast, Ireland. 12. Department of Neuroradiology (M.S., O.B.), Universitātsklinikum Magdeburg, Magdeburg, Germany. 13. Department of Neuroradiology (A. Bonafé), Hôpital Guy de Chauillac, Montpellier, France. 14. Department of Neurosurgery (F.M.), Pontificia Universidad Católica de Chile, Santiago, Chile. 15. Department of Neuroradiology (F.T.), Hôpital Neurologique, Lyon, France. 16. Department of Neuroradiology (P.B.), Erasmus University Medical Center, Rotterdam, the Netherlands. 17. Department of Neuroradiology (E.B., L.V.), Niguarda Ca' Granda Hospital, Milan, Italy. 18. Department of Neuroradiology (S.D.), Essex Center for Neurological Sciences, Queen's University Hospital, London, United Kingdom. 19. Stryker Neurovascular (M.W.L.), Fremont, California. 20. New England Center for Stroke Research (M.J.G.), University of Massachusetts Medical School, Worcester, Massachusetts.
Abstract
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.
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.
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