Surpass Flow Diverter in the Treatment of Intracranial Aneurysms: A Prospective Multicenter Study

• Published in: American journal of neuroradiology : AJNR Vol. 36; no. 1; pp. 98 - 107
• Main Authors: Wakhloo, A. K., Lylyk, P., de Vries, J., Taschner, C., Lundquist, J., Biondi, A., Hartmann, M., Szikora, I., Pierot, L., Sakai, N., Imamura, H., Sourour, N., Rennie, I., Skalej, M., Beuing, O., Bonafe, A., Mery, F., Turjman, F., Brouwer, P., Boccardi, E., Valvassori, L., Derakhshani, S., Litzenberg, M. W., Gounis, M. J.
• Format: Journal Article
• Language: English
• Published: United States American Society of Neuroradiology 01.01.2015
• Subjects: Aged; Aged, 80 and over; Bioengineering; Blood Vessel Prosthesis; Cerebral Angiography - instrumentation; Embolization, Therapeutic - instrumentation; Evidence-Based Medicine Level 2; Female; Follow-Up Studies; Human health and pathology; Humans; Imaging; Interventional; Intracranial Aneurysm - diagnostic imaging; Intracranial Aneurysm - therapy; Life Sciences; Male; Middle Aged; Neurons and Cognition; Nuclear medicine; Prospective Studies; Treatment Outcome
• ISSN: 0195-6108; 1936-959X; 1936-959X
• DOI: 10.3174/ajnr.A4078

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. 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. 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%. 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.