Pipeline for uncoilable or failed aneurysms

3-year follow-up results

Tibor Becske, Matthew B. Potts, Maksim Shapiro, David F. Kallmes, Waleed Brinjikji, Isil Saatci, Cameron McDougall, István Szikora, Giuseppe Lanzino, Christopher J. Moran, Henry H. Woo, Demetrius K. Lopes, Aaron L. Berez, Daniel J. Cher, Adnan H. Siddiqui, Elad I. Levy, Felipe C. Albuquerque, David J. Fiorella, Zsolt Berentei, Miklós Marosföi & 2 others Saruhan H. Cekirge, Peter K. Nelson

Research output: Contribution to journalArticle

Abstract

OBJECTIVE The long-term effectiveness of endovascular treatment of large and giant wide-neck aneurysms using traditional endovascular techniques has been disappointing, with high recanalization and re-treatment rates. Flow diversion with the Pipeline Embolization Device (PED) has been recently used as a stand-alone therapy for complex aneurysms, showing significant improvement in effectiveness while demonstrating a similar safety profile to stent-supported coil treatment. However, relatively little is known about its long-term safety and effectiveness. Here the authors report on the 3-year safety and effectiveness of flow diversion with the PED in a prospective cohort of patients with large and giant internal carotid artery aneurysms enrolled in the Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial. METHODS The PUFS trial is a prospective study of 107 patients with 109 aneurysms treated with the PED. Primary effectiveness and safety end points were demonstrated based on independently monitored 180-day clinical and angiographic data. Patients were enrolled in a long-term follow-up protocol including 1-, 3-, and 5-year clinical and imaging follow-up. In this paper, the authors report the midstudy (3-year) effectiveness and safety data. RESULTS At 3 years posttreatment, 74 subjects with 76 aneurysms underwent catheter angiography as required per protocol. Overall, complete angiographic aneurysm occlusion was observed in 71 of these 76 aneurysms (93.4% cure rate). Five aneurysms were re-treated, using either coils or additional PEDs, for failure to occlude, and 3 of these 5 were cured by the 3-year follow-up. Angiographic cure with one or two treatments of Pipeline embolization alone was therefore achieved in 92.1%. No recanalization of a previously completely occluded aneurysm was noted on the 3-year angiograms. There were 3 (2.6%) delayed device- or aneurysm-related serious adverse events, none of which led to permanent neurological sequelae. No major or minor late-onset hemorrhagic or ischemic cerebrovascular events or neurological deaths were observed in the 6-month through 3-year posttreatment period. Among 103 surviving patients, 85 underwent functional outcome assessment in which modified Rankin Scale scores of 0-1 were demonstrated in 80 subjects. CONCLUSIONS Pipeline embolization is safe and effective in the treatment of complex large and giant aneurysms of the intracranial internal carotid artery. Unlike more traditional endovascular treatments, flow diversion results in progressive vascular remodeling that leads to complete aneurysm obliteration over longer-term follow-up without delayed aneurysm recanalization and/or growth.

Original languageEnglish (US)
Pages (from-to)81-88
Number of pages8
JournalJournal of Neurosurgery
Volume127
Issue number1
DOIs
StatePublished - Jul 1 2017
Externally publishedYes

Fingerprint

Aneurysm
Safety
Equipment and Supplies
Internal Carotid Artery
Angiography
Therapeutics
Endovascular Procedures
Intracranial Aneurysm
Stents
Neck
Catheters
Outcome Assessment (Health Care)
Prospective Studies

Keywords

  • Cerebral aneurysm
  • Flow diversion
  • Giant
  • Pipeline Embolization Device
  • Vascular disorders

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

Cite this

Becske, T., Potts, M. B., Shapiro, M., Kallmes, D. F., Brinjikji, W., Saatci, I., ... Nelson, P. K. (2017). Pipeline for uncoilable or failed aneurysms: 3-year follow-up results. Journal of Neurosurgery, 127(1), 81-88. https://doi.org/10.3171/2015.6.JNS15311

Pipeline for uncoilable or failed aneurysms : 3-year follow-up results. / Becske, Tibor; Potts, Matthew B.; Shapiro, Maksim; Kallmes, David F.; Brinjikji, Waleed; Saatci, Isil; McDougall, Cameron; Szikora, István; Lanzino, Giuseppe; Moran, Christopher J.; Woo, Henry H.; Lopes, Demetrius K.; Berez, Aaron L.; Cher, Daniel J.; Siddiqui, Adnan H.; Levy, Elad I.; Albuquerque, Felipe C.; Fiorella, David J.; Berentei, Zsolt; Marosföi, Miklós; Cekirge, Saruhan H.; Nelson, Peter K.

In: Journal of Neurosurgery, Vol. 127, No. 1, 01.07.2017, p. 81-88.

Research output: Contribution to journalArticle

Becske, T, Potts, MB, Shapiro, M, Kallmes, DF, Brinjikji, W, Saatci, I, McDougall, C, Szikora, I, Lanzino, G, Moran, CJ, Woo, HH, Lopes, DK, Berez, AL, Cher, DJ, Siddiqui, AH, Levy, EI, Albuquerque, FC, Fiorella, DJ, Berentei, Z, Marosföi, M, Cekirge, SH & Nelson, PK 2017, 'Pipeline for uncoilable or failed aneurysms: 3-year follow-up results', Journal of Neurosurgery, vol. 127, no. 1, pp. 81-88. https://doi.org/10.3171/2015.6.JNS15311
Becske T, Potts MB, Shapiro M, Kallmes DF, Brinjikji W, Saatci I et al. Pipeline for uncoilable or failed aneurysms: 3-year follow-up results. Journal of Neurosurgery. 2017 Jul 1;127(1):81-88. https://doi.org/10.3171/2015.6.JNS15311
Becske, Tibor ; Potts, Matthew B. ; Shapiro, Maksim ; Kallmes, David F. ; Brinjikji, Waleed ; Saatci, Isil ; McDougall, Cameron ; Szikora, István ; Lanzino, Giuseppe ; Moran, Christopher J. ; Woo, Henry H. ; Lopes, Demetrius K. ; Berez, Aaron L. ; Cher, Daniel J. ; Siddiqui, Adnan H. ; Levy, Elad I. ; Albuquerque, Felipe C. ; Fiorella, David J. ; Berentei, Zsolt ; Marosföi, Miklós ; Cekirge, Saruhan H. ; Nelson, Peter K. / Pipeline for uncoilable or failed aneurysms : 3-year follow-up results. In: Journal of Neurosurgery. 2017 ; Vol. 127, No. 1. pp. 81-88.
@article{19d731f465b244a99866782dc9930778,
title = "Pipeline for uncoilable or failed aneurysms: 3-year follow-up results",
abstract = "OBJECTIVE The long-term effectiveness of endovascular treatment of large and giant wide-neck aneurysms using traditional endovascular techniques has been disappointing, with high recanalization and re-treatment rates. Flow diversion with the Pipeline Embolization Device (PED) has been recently used as a stand-alone therapy for complex aneurysms, showing significant improvement in effectiveness while demonstrating a similar safety profile to stent-supported coil treatment. However, relatively little is known about its long-term safety and effectiveness. Here the authors report on the 3-year safety and effectiveness of flow diversion with the PED in a prospective cohort of patients with large and giant internal carotid artery aneurysms enrolled in the Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial. METHODS The PUFS trial is a prospective study of 107 patients with 109 aneurysms treated with the PED. Primary effectiveness and safety end points were demonstrated based on independently monitored 180-day clinical and angiographic data. Patients were enrolled in a long-term follow-up protocol including 1-, 3-, and 5-year clinical and imaging follow-up. In this paper, the authors report the midstudy (3-year) effectiveness and safety data. RESULTS At 3 years posttreatment, 74 subjects with 76 aneurysms underwent catheter angiography as required per protocol. Overall, complete angiographic aneurysm occlusion was observed in 71 of these 76 aneurysms (93.4{\%} cure rate). Five aneurysms were re-treated, using either coils or additional PEDs, for failure to occlude, and 3 of these 5 were cured by the 3-year follow-up. Angiographic cure with one or two treatments of Pipeline embolization alone was therefore achieved in 92.1{\%}. No recanalization of a previously completely occluded aneurysm was noted on the 3-year angiograms. There were 3 (2.6{\%}) delayed device- or aneurysm-related serious adverse events, none of which led to permanent neurological sequelae. No major or minor late-onset hemorrhagic or ischemic cerebrovascular events or neurological deaths were observed in the 6-month through 3-year posttreatment period. Among 103 surviving patients, 85 underwent functional outcome assessment in which modified Rankin Scale scores of 0-1 were demonstrated in 80 subjects. CONCLUSIONS Pipeline embolization is safe and effective in the treatment of complex large and giant aneurysms of the intracranial internal carotid artery. Unlike more traditional endovascular treatments, flow diversion results in progressive vascular remodeling that leads to complete aneurysm obliteration over longer-term follow-up without delayed aneurysm recanalization and/or growth.",
keywords = "Cerebral aneurysm, Flow diversion, Giant, Pipeline Embolization Device, Vascular disorders",
author = "Tibor Becske and Potts, {Matthew B.} and Maksim Shapiro and Kallmes, {David F.} and Waleed Brinjikji and Isil Saatci and Cameron McDougall and Istv{\'a}n Szikora and Giuseppe Lanzino and Moran, {Christopher J.} and Woo, {Henry H.} and Lopes, {Demetrius K.} and Berez, {Aaron L.} and Cher, {Daniel J.} and Siddiqui, {Adnan H.} and Levy, {Elad I.} and Albuquerque, {Felipe C.} and Fiorella, {David J.} and Zsolt Berentei and Mikl{\'o}s Marosf{\"o}i and Cekirge, {Saruhan H.} and Nelson, {Peter K.}",
year = "2017",
month = "7",
day = "1",
doi = "10.3171/2015.6.JNS15311",
language = "English (US)",
volume = "127",
pages = "81--88",
journal = "Journal of Neurosurgery",
issn = "0022-3085",
publisher = "American Association of Neurological Surgeons",
number = "1",

}

TY - JOUR

T1 - Pipeline for uncoilable or failed aneurysms

T2 - 3-year follow-up results

AU - Becske, Tibor

AU - Potts, Matthew B.

AU - Shapiro, Maksim

AU - Kallmes, David F.

AU - Brinjikji, Waleed

AU - Saatci, Isil

AU - McDougall, Cameron

AU - Szikora, István

AU - Lanzino, Giuseppe

AU - Moran, Christopher J.

AU - Woo, Henry H.

AU - Lopes, Demetrius K.

AU - Berez, Aaron L.

AU - Cher, Daniel J.

AU - Siddiqui, Adnan H.

AU - Levy, Elad I.

AU - Albuquerque, Felipe C.

AU - Fiorella, David J.

AU - Berentei, Zsolt

AU - Marosföi, Miklós

AU - Cekirge, Saruhan H.

AU - Nelson, Peter K.

PY - 2017/7/1

Y1 - 2017/7/1

N2 - OBJECTIVE The long-term effectiveness of endovascular treatment of large and giant wide-neck aneurysms using traditional endovascular techniques has been disappointing, with high recanalization and re-treatment rates. Flow diversion with the Pipeline Embolization Device (PED) has been recently used as a stand-alone therapy for complex aneurysms, showing significant improvement in effectiveness while demonstrating a similar safety profile to stent-supported coil treatment. However, relatively little is known about its long-term safety and effectiveness. Here the authors report on the 3-year safety and effectiveness of flow diversion with the PED in a prospective cohort of patients with large and giant internal carotid artery aneurysms enrolled in the Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial. METHODS The PUFS trial is a prospective study of 107 patients with 109 aneurysms treated with the PED. Primary effectiveness and safety end points were demonstrated based on independently monitored 180-day clinical and angiographic data. Patients were enrolled in a long-term follow-up protocol including 1-, 3-, and 5-year clinical and imaging follow-up. In this paper, the authors report the midstudy (3-year) effectiveness and safety data. RESULTS At 3 years posttreatment, 74 subjects with 76 aneurysms underwent catheter angiography as required per protocol. Overall, complete angiographic aneurysm occlusion was observed in 71 of these 76 aneurysms (93.4% cure rate). Five aneurysms were re-treated, using either coils or additional PEDs, for failure to occlude, and 3 of these 5 were cured by the 3-year follow-up. Angiographic cure with one or two treatments of Pipeline embolization alone was therefore achieved in 92.1%. No recanalization of a previously completely occluded aneurysm was noted on the 3-year angiograms. There were 3 (2.6%) delayed device- or aneurysm-related serious adverse events, none of which led to permanent neurological sequelae. No major or minor late-onset hemorrhagic or ischemic cerebrovascular events or neurological deaths were observed in the 6-month through 3-year posttreatment period. Among 103 surviving patients, 85 underwent functional outcome assessment in which modified Rankin Scale scores of 0-1 were demonstrated in 80 subjects. CONCLUSIONS Pipeline embolization is safe and effective in the treatment of complex large and giant aneurysms of the intracranial internal carotid artery. Unlike more traditional endovascular treatments, flow diversion results in progressive vascular remodeling that leads to complete aneurysm obliteration over longer-term follow-up without delayed aneurysm recanalization and/or growth.

AB - OBJECTIVE The long-term effectiveness of endovascular treatment of large and giant wide-neck aneurysms using traditional endovascular techniques has been disappointing, with high recanalization and re-treatment rates. Flow diversion with the Pipeline Embolization Device (PED) has been recently used as a stand-alone therapy for complex aneurysms, showing significant improvement in effectiveness while demonstrating a similar safety profile to stent-supported coil treatment. However, relatively little is known about its long-term safety and effectiveness. Here the authors report on the 3-year safety and effectiveness of flow diversion with the PED in a prospective cohort of patients with large and giant internal carotid artery aneurysms enrolled in the Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial. METHODS The PUFS trial is a prospective study of 107 patients with 109 aneurysms treated with the PED. Primary effectiveness and safety end points were demonstrated based on independently monitored 180-day clinical and angiographic data. Patients were enrolled in a long-term follow-up protocol including 1-, 3-, and 5-year clinical and imaging follow-up. In this paper, the authors report the midstudy (3-year) effectiveness and safety data. RESULTS At 3 years posttreatment, 74 subjects with 76 aneurysms underwent catheter angiography as required per protocol. Overall, complete angiographic aneurysm occlusion was observed in 71 of these 76 aneurysms (93.4% cure rate). Five aneurysms were re-treated, using either coils or additional PEDs, for failure to occlude, and 3 of these 5 were cured by the 3-year follow-up. Angiographic cure with one or two treatments of Pipeline embolization alone was therefore achieved in 92.1%. No recanalization of a previously completely occluded aneurysm was noted on the 3-year angiograms. There were 3 (2.6%) delayed device- or aneurysm-related serious adverse events, none of which led to permanent neurological sequelae. No major or minor late-onset hemorrhagic or ischemic cerebrovascular events or neurological deaths were observed in the 6-month through 3-year posttreatment period. Among 103 surviving patients, 85 underwent functional outcome assessment in which modified Rankin Scale scores of 0-1 were demonstrated in 80 subjects. CONCLUSIONS Pipeline embolization is safe and effective in the treatment of complex large and giant aneurysms of the intracranial internal carotid artery. Unlike more traditional endovascular treatments, flow diversion results in progressive vascular remodeling that leads to complete aneurysm obliteration over longer-term follow-up without delayed aneurysm recanalization and/or growth.

KW - Cerebral aneurysm

KW - Flow diversion

KW - Giant

KW - Pipeline Embolization Device

KW - Vascular disorders

UR - http://www.scopus.com/inward/record.url?scp=85021711135&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85021711135&partnerID=8YFLogxK

U2 - 10.3171/2015.6.JNS15311

DO - 10.3171/2015.6.JNS15311

M3 - Article

VL - 127

SP - 81

EP - 88

JO - Journal of Neurosurgery

JF - Journal of Neurosurgery

SN - 0022-3085

IS - 1

ER -