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Neurosurgery. 2017 Jan 1;80(1):40-48. doi: 10.1093/neuros/nyw014.

Long-Term Clinical and Angiographic Outcomes Following Pipeline Embolization Device Treatment of Complex Internal Carotid Artery Aneurysms: Five-Year Results of the Pipeline for Uncoilable or Failed Aneurysms Trial.

Author information

1
Rochester General Hospital, Rochester, New York.
2
Mayo Clinic, Rochester, Minn-esota.
3
Northwestern University Feinberg School of Medicine, Chicago, Illinois.
4
New York University Langone Medical Center, New York, New York.
5
Washington University School of Medicine, St. Louis, Missouri.
6
University of Buffalo, Buffalo, New York.
7
Barrow Neurological Institute, Phoenix, Arizona.
8
National Institute of Neurosurgery, Budapest, Hungary.
9
Brook Hospital, Stony Brook, New York.
10
Rush University Medical Center, Chicago, Illinois.
11
Bayindir Hospital, Ankara, Turkey.
12
Alembic, LLC, Mountain View, California.
13
Wild Iris Consulting, Palo Alto, California.

Abstract

BACKGROUND:

Early and mid-term safety and efficacy of aneurysm treatment with the Pipeline Embolization Device (PED) has been well demonstrated in prior studies.

OBJECTIVE:

To present 5-yr follow-up for patients treated in the Pipeline for Uncoilable or Failed Aneurysms clinical trial.

METHODS:

In our prospective, multicenter trial, 109 complex internal carotid artery (ICA) aneurysms in 107 subjects were treated with the PED. Patients were followed per a standardized protocol at 180 d and 1, 3, and 5 yr. Aneurysm occlusion, in-stent stenosis, modified Rankin Scale scores, and complications were recorded.

RESULTS:

The primary endpoint of complete aneurysm occlusion at 180 d (73.6%) was previously reported. Aneurysm occlusion for those patients with angiographic follow-up progressively increased over time to 86.8% (79/91), 93.4% (71/76), and 95.2% (60/63) at 1, 3, and 5 yr, respectively. Six aneurysms (5.7%) were retreated. New serious device-related events at 1, 3, and 5 yr were noted in 1% (1/96), 3.5% (3/85), and 0% (0/81) of subjects. There were 4 (3.7%) reported deaths in our trial. Seventy-eight (96.3%) of 81 patients with 5-yr clinical follow-up had modified Rankin Scale scores ≤2. No delayed neurological deaths or hemorrhagic or ischemic cerebrovascular events were reported beyond 6 mo. No recanalization of a previously occluded aneurysm was observed.

CONCLUSION:

Our 5-yr findings demonstrate that PED is a safe and effective treatment for large and giant wide-necked aneurysms of the intracranial ICA, with high rates of complete occlusion and low rates of delayed adverse events.

KEYWORDS:

Cerebral aneurysm; Flow diversion; PUFS; Pipeline embolization device

PMID:
28362885
DOI:
10.1093/neuros/nyw014
[Indexed for MEDLINE]

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