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Pipeline for uncoilable or failed aneurysms: 3-year follow-up results

Tibor Becske Departments of Radiology,
Neurology, and

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Matthew B. Potts Departments of Radiology,
Neurological Surgery, Neurointerventional Service, NYU School of Medicine, NYU Langone Medical Center, New York, New York;

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Maksim Shapiro Departments of Radiology,
Neurology, and

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David F. Kallmes Department of Neurosurgery, Mayo Clinic, Rochester, Minnesota;

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Waleed Brinjikji Department of Neurosurgery, Mayo Clinic, Rochester, Minnesota;

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Isil Saatci Department of Radiology, Bayindir Hospital, Ankara, Turkey;

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Cameron G. McDougall Department of Neurological Surgery, Barrow Neurological Institute, Phoenix, Arizona;

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István Szikora National Institute of Neurosciences, Budapest, Hungary;

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Giuseppe Lanzino Department of Neurosurgery, Mayo Clinic, Rochester, Minnesota;

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Christopher J. Moran Division of Interventional Neuroradiology, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, Missouri;

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Henry H. Woo Department of Neurosurgery, Stony Brook Hospital, Stony Brook, New York;

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Demetrius K. Lopes Department of Neurological Surgery, Rush University Medical Center, Chicago, Illinois;

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Aaron L. Berez Alembic, LLC, Mountain View;

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Daniel J. Cher Wild Iris Consulting, Palo Alto, California; and

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Adnan H. Siddiqui Departments of Neurological Surgery and Radiology, University of Buffalo, Buffalo, New York

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Elad I. Levy Departments of Neurological Surgery and Radiology, University of Buffalo, Buffalo, New York

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Felipe C. Albuquerque Department of Neurological Surgery, Barrow Neurological Institute, Phoenix, Arizona;

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David J. Fiorella Department of Neurosurgery, Stony Brook Hospital, Stony Brook, New York;

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Zsolt Berentei National Institute of Neurosciences, Budapest, Hungary;

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Miklós Marosföi National Institute of Neurosciences, Budapest, Hungary;

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Saruhan H. Cekirge Department of Radiology, Bayindir Hospital, Ankara, Turkey;

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Peter K. Nelson Departments of Radiology,
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Publication Date:
14 Oct 2016
Page Range:
81–88
Volume/Issue:
Volume 127: Issue 1
DOI link:
https://doi.org/10.3171/2015.6.JNS15311
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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.

Clinical trial registration no.: NCT00777088 (clinicaltrials.gov)

ABBREVIATIONS

CEC = clinical events committee; CRL = core radiology laboratory; CTA = CT angiography; DSA = digital subtraction angiography; ICA = internal carotid artery; MRA = MR angiography; mRS = modified Rankin Scale; PED = Pipeline Embolization Device; PITA = Pipeline Embolization Device for the Intracranial Treatment of Aneurysms; PUFS = Pipeline for Uncoilable or Failed Aneurysms.
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Contributor Notes

Correspondence Tibor Becske, NYU School of Medicine, NYU Langone Medical Center, 660 First Ave., 7th Fl., New York, NY 10016. email: tibor.becske@nyumc.org

INCLUDE WHEN CITING Published online October 14, 2016; DOI: 10.3171/2015.6.JNS15311.

Disclosures Dr. Saatci reports being a consultant for Covidien, from which he has also received clinical or research support for the study described (includes equipment or material). Dr. McDougall reports being a consultant for MicroVention and eV3. Dr. Szikora reports being a consultant for Covidien, Stryker Neurovascular, Sequent Medical, Codman Neurovascular. Dr. Lanzino reports being a consultant for Covidien. Dr. Moran reports being a consultant for Medtronic Neurovascular. Dr. Woo reports having ownership in Vascular Simulations LLC; being a consultant for MicroVention Inc.; and receiving royalties for intellectual properties from Codman and Shurtleff. Dr. Cher reports being a consultant for Covidien. Dr. Siddiqui reports financial interests in StimSox, Valor Medical, Neuro Technology Investors, Cardinal, Medina Medical Systems, Buffalo Technology Partners, Inc., and International Medical Distribution Partners. He is a consultant to (paid per project or per hour) Codman, Medtronic, GuidePoint Global Consulting, Penumbra, Stryker, MicroVention, W.L. Gore & Associates, Three Rivers Medical, Inc., Corindus, Inc., Amnis Therapeutics, Ltd., CereVasc, LLC, Pulsar Vascular, The Stroke Project, Inc., Cerebrotech Medical Systems, Inc., Rapid Medical, Lazarus (acquired by Medtronic), Medina Medical (acquired by Medtronic), Reverse Medical (acquired by Medtronic), Covidien (acquired by Medtronic), Neuravi, Silk Road Medical, and Rebound Medical. He is the primary investigator or on national steering committees for Penumbra, 3D Separator Trial; Covidien (Now Medtronic), SWIFT PRIME and SWIFT DIRECT Trials; MicroVention, FRED Trial; MicroVention, CONFIDENCE Study; LARGE Trial; POSITIVE Trial; Penumbra, COMPASS Trial; and Penumbra, INVEST Trial. He is a board member of the Intersocietal Accreditation Committee. Dr. Albuquerque is a consultant for eV3/Covidien. Dr. Marosfoi reports being a consultant for Covidien, MicroVention, and Sequent. Dr. Berez reports holding stock in Medtronic. Dr. Nelson reports being a consultant for Covidien.

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