Surpass flow diverter in the treatment of intracranial aneurysms

A prospective multicenter study

Ajay K. Wakhloo, P. Lylyk, J. De Vries, C. Taschner, J. Lundquist, A. Biondi, M. Hartmann, I. Szikora, L. Pierot, N. Sakai, H. Imamura, N. Sourour, I. Rennie, M. Skalej, O. Beuing, A. Bonafé, F. Mery, F. Turjman, P. Brouwer, E. Boccardi & 4 others L. Valvassori, S. Derakhshani, M. W. Litzenberg, M. J. Gounis

Research output: Contribution to journalArticle

65 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)98-107
Number of pages10
JournalAmerican Journal of Neuroradiology
Volume36
Issue number1
DOIs
Publication statusPublished - Jan 1 2015

Fingerprint

Intracranial Aneurysm
Multicenter Studies
Prospective Studies
Nervous System
Aneurysm
Stroke
Therapeutics
Safety
Morbidity
Cranial Nerves
Stents
Angiography
Neck
Hemorrhage
Equipment and Supplies
Mortality

ASJC Scopus subject areas

  • Clinical Neurology
  • Radiology Nuclear Medicine and imaging

Cite this

Wakhloo, A. K., Lylyk, P., De Vries, J., Taschner, C., Lundquist, J., Biondi, A., ... Gounis, M. J. (2015). Surpass flow diverter in the treatment of intracranial aneurysms: A prospective multicenter study. American Journal of Neuroradiology, 36(1), 98-107. https://doi.org/10.3174/ajnr.A4078

Surpass flow diverter in the treatment of intracranial aneurysms : A prospective multicenter study. / Wakhloo, Ajay 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.; Bonafé, A.; Mery, F.; Turjman, F.; Brouwer, P.; Boccardi, E.; Valvassori, L.; Derakhshani, S.; Litzenberg, M. W.; Gounis, M. J.

In: American Journal of Neuroradiology, Vol. 36, No. 1, 01.01.2015, p. 98-107.

Research output: Contribution to journalArticle

Wakhloo, AK, 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, Bonafé, A, Mery, F, Turjman, F, Brouwer, P, Boccardi, E, Valvassori, L, Derakhshani, S, Litzenberg, MW & Gounis, MJ 2015, 'Surpass flow diverter in the treatment of intracranial aneurysms: A prospective multicenter study', American Journal of Neuroradiology, vol. 36, no. 1, pp. 98-107. https://doi.org/10.3174/ajnr.A4078
Wakhloo, Ajay 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. ; Bonafé, A. ; Mery, F. ; Turjman, F. ; Brouwer, P. ; Boccardi, E. ; Valvassori, L. ; Derakhshani, S. ; Litzenberg, M. W. ; Gounis, M. J. / Surpass flow diverter in the treatment of intracranial aneurysms : A prospective multicenter study. In: American Journal of Neuroradiology. 2015 ; Vol. 36, No. 1. pp. 98-107.
@article{eea71810f4e1460dbc359c4bcda8a797,
title = "Surpass flow diverter in the treatment of intracranial aneurysms: A prospective multicenter study",
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.",
author = "Wakhloo, {Ajay K.} and P. Lylyk and {De Vries}, J. and C. Taschner and J. Lundquist and A. Biondi and M. Hartmann and I. Szikora and L. Pierot and N. Sakai and H. Imamura and N. Sourour and I. Rennie and M. Skalej and O. Beuing and A. Bonaf{\'e} and F. Mery and F. Turjman and P. Brouwer and E. Boccardi and L. Valvassori and S. Derakhshani and Litzenberg, {M. W.} and Gounis, {M. J.}",
year = "2015",
month = "1",
day = "1",
doi = "10.3174/ajnr.A4078",
language = "English",
volume = "36",
pages = "98--107",
journal = "American Journal of Neuroradiology",
issn = "0195-6108",
publisher = "American Society of Neuroradiology",
number = "1",

}

TY - JOUR

T1 - Surpass flow diverter in the treatment of intracranial aneurysms

T2 - A prospective multicenter study

AU - Wakhloo, Ajay K.

AU - Lylyk, P.

AU - De Vries, J.

AU - Taschner, C.

AU - Lundquist, J.

AU - Biondi, A.

AU - Hartmann, M.

AU - Szikora, I.

AU - Pierot, L.

AU - Sakai, N.

AU - Imamura, H.

AU - Sourour, N.

AU - Rennie, I.

AU - Skalej, M.

AU - Beuing, O.

AU - Bonafé, A.

AU - Mery, F.

AU - Turjman, F.

AU - Brouwer, P.

AU - Boccardi, E.

AU - Valvassori, L.

AU - Derakhshani, S.

AU - Litzenberg, M. W.

AU - Gounis, M. J.

PY - 2015/1/1

Y1 - 2015/1/1

N2 - 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.

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.

UR - http://www.scopus.com/inward/record.url?scp=84920982553&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84920982553&partnerID=8YFLogxK

U2 - 10.3174/ajnr.A4078

DO - 10.3174/ajnr.A4078

M3 - Article

VL - 36

SP - 98

EP - 107

JO - American Journal of Neuroradiology

JF - American Journal of Neuroradiology

SN - 0195-6108

IS - 1

ER -