TY - JOUR
T1 - Safety and efficacy of the Pipeline embolization device for treatment of intracranial aneurysms
T2 - A pooled analysis of 3 large studies
AU - Kallmes, David F.
AU - Brinjikji, Waleed
AU - Cekirge, Saruhan
AU - Fiorella, David
AU - Hanel, Ricardo A.
AU - Jabbour, Pascal
AU - Lopes, Demetrius
AU - Lylyk, Pedro
AU - McDougall, Cameron G.
AU - Siddiqui, Adnan
N1 - Funding Information:
Funding for this study was provided by Medtronic. Dr. Kallmes reports receiving consulting fees and support for the present study from Medtronic. He also reports receiving support for non–study-related research of clinical efforts from MicroVention, Codman, NeuroSigma, Sequent Medical, and Surmodics. Dr. Fiorella reports a consultant relationship with Medtronic, Codman, Sequent, MicroVention, and Penumbra. Dr. Hanel reports receiving consulting fees and research funding from Medtronic; a consultant relationship with Codman, Stryker, and MicroVention; and direct stock ownership in Blockade. Dr. Jabbour reports a consultant relationship with Medtronic. Dr. Lopes reports receiving consulting fees and support for non–study-reated clinical or research efforts from Medtronic as well as being a principal investigator for PUFS, IntrePED, ASPIRe, and PREMIER. Dr. McDougall reports a consultant relationship with MicroVention and Covidien/Medtronic. Dr. Siddiqui reports receiving consulting fees from Medtronic and having a consultant relationship with Codman & Shurtleff, Covidien, Guidepoint Global Consulting, Penumbra, Stryker, Pulsar Vascular, MicroVention, Lazarus Effect, Blockade Medical, Reverse Medical, WL Gore & Associates, Three Rivers Medical, Corindus, Amnis Therapeutics, Ltd., and CereVasc, LLC; direct stock ownership in Hotspur, Intratech Medical, StimSox, Valor Medical, Blockade Medical, Lazarus Effect, Pulsar Vascular, Medina Medical, Inc., Three Rivers Medical, Inc., Amnis Therapeutics, Ltd., The Stroke Project, Inc., and Cerevatech Medical; being on national steering commttees for the Penumbra 3D Separator Trial, Covidien SWIFT PRIME Trial, and MicroVention CONFIDENCE and FRED Trials; and being on the advisory board of Codman & Shurtleff, ICAVL, Medina Medical, Inc., Three Rivers Medical, Inc., Amnis Therapeutics, Ltd., The Stroke Project, Inc., CereVasc LLC, and Corindus, Inc.
Publisher Copyright:
© AANS, 2017.
PY - 2017/10
Y1 - 2017/10
N2 - OBJECTIVE The authors performed a pooled analysis of 3 studies-IntrePED (International Retrospective Study of the Pipeline Embolization Device), PUFS (Pipeline for Uncoilable or Failed Aneurysms Study), and ASPIRe (Aneurysm Study of Pipeline in an Observational Registry)-in order to assess angiographic outcomes and clinical safety of the Pipeline embolization device (PED). METHODS IntrePED was a retrospective study, while PUFS and ASPIRe were prospective studies. For each patient included in these studies, the authors collected baseline demographic data, aneurysm characteristics, and procedural details. The primary outcomes for this combined analysis were clinical outcomes, including neurological morbidity and mortality and major ipsilateral intracranial hemorrhage and ischemic stroke. The secondary outcomes were angiographic occlusion rates, which were available for ASPIRe and PUFS only. RESULTS A total of 1092 patients with 1221 aneurysms were included across the 3 studies. The mean aneurysm size was 12.0 ± 7.8 mm and the mean neck size was 6.6 ± 4.8 mm. The major ipsilateral ischemic stroke rate was 3.7% (40/1091). The major ipsilateral intracranial hemorrhage rate was 2.0% (22/1091). The major neurological morbidity rate was 5.7% (62/1091). The neurological mortality rate was 3.3% (36/1091). The combined major morbidity and neurological mortality rate was 7.1% (78/1091). The complete occlusion rates were 75.0% at 180 days (111/148) and 85.5% at 1 year (94/110). The overall aneurysm retreatment rate was 3.0% (33/1091) at a mean follow-up time of 10.2 ± 10.8 months. CONCLUSIONS Endovascular treatment of intracranial aneurysms with the PED is safe and effective. Angiographic occlusion rates progressed with follow-up. Rates of stroke, hemorrhage, morbidity and mortality, and retreatment were low, especially given the fact that the aneurysms treated were generally large and wide necked.
AB - OBJECTIVE The authors performed a pooled analysis of 3 studies-IntrePED (International Retrospective Study of the Pipeline Embolization Device), PUFS (Pipeline for Uncoilable or Failed Aneurysms Study), and ASPIRe (Aneurysm Study of Pipeline in an Observational Registry)-in order to assess angiographic outcomes and clinical safety of the Pipeline embolization device (PED). METHODS IntrePED was a retrospective study, while PUFS and ASPIRe were prospective studies. For each patient included in these studies, the authors collected baseline demographic data, aneurysm characteristics, and procedural details. The primary outcomes for this combined analysis were clinical outcomes, including neurological morbidity and mortality and major ipsilateral intracranial hemorrhage and ischemic stroke. The secondary outcomes were angiographic occlusion rates, which were available for ASPIRe and PUFS only. RESULTS A total of 1092 patients with 1221 aneurysms were included across the 3 studies. The mean aneurysm size was 12.0 ± 7.8 mm and the mean neck size was 6.6 ± 4.8 mm. The major ipsilateral ischemic stroke rate was 3.7% (40/1091). The major ipsilateral intracranial hemorrhage rate was 2.0% (22/1091). The major neurological morbidity rate was 5.7% (62/1091). The neurological mortality rate was 3.3% (36/1091). The combined major morbidity and neurological mortality rate was 7.1% (78/1091). The complete occlusion rates were 75.0% at 180 days (111/148) and 85.5% at 1 year (94/110). The overall aneurysm retreatment rate was 3.0% (33/1091) at a mean follow-up time of 10.2 ± 10.8 months. CONCLUSIONS Endovascular treatment of intracranial aneurysms with the PED is safe and effective. Angiographic occlusion rates progressed with follow-up. Rates of stroke, hemorrhage, morbidity and mortality, and retreatment were low, especially given the fact that the aneurysms treated were generally large and wide necked.
KW - Aneurysm
KW - Endovascular
KW - Interventional neurosurgery
KW - Stroke
KW - Vascular disorders
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U2 - 10.3171/2016.8.JNS16467
DO - 10.3171/2016.8.JNS16467
M3 - Article
C2 - 27791519
AN - SCOPUS:85030571962
SN - 0022-3085
VL - 127
SP - 775
EP - 780
JO - Journal of Neurosurgery
JF - Journal of Neurosurgery
IS - 4
ER -