Neuroophthalmological outcomes associated with use of the Pipeline Embolization Device: analysis of the PUFS trial results

Daniel H. Sahlein Departments of Neurology,
Radiology,

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Mohammad Fouladvand Departments of Neurology,
Ophthalmology, and

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Tibor Becske Departments of Neurology,
Radiology,

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Isil Saatci Department of Interventional Neuroradiology, Koru Hospitals, Ankara;

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Cameron G. McDougall Division 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 Neurological Surgery, Stony Brook University, Stony Brook;

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

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Aaron L. Berez Alembic LLC, Mountain View, California

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

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Adnan H. Siddiqui Department of Neurosurgery, University at Buffalo, Buffalo, New York;

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Elad I. Levy Department of Neurosurgery, University at Buffalo, Buffalo, New York;

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

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David J. Fiorella Department of Neurological Surgery, Stony Brook University, Stony Brook;

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Zsolt Berentei National Institute of Neurosciences, Budapest, Hungary;

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Miklos Marosfoi National Institute of Neurosciences, Budapest, Hungary;

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Saruhan H. Cekirge Department of Interventional Neuroradiology, Bayindir Hospitals, Ankara/Istanbul, Turkey;

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

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Peter K. Nelson Radiology,
Neurosurgery, New York University Langone Medical Center, New York;

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OBJECT

Neuroophthalmological morbidity is commonly associated with large and giant cavernous and supraclinoid internal carotid artery (ICA) aneurysms. The authors sought to evaluate the neuroophthalmological outcomes after treatment of these aneurysms with the Pipeline Embolization Device (PED).

METHODS

The Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial was an international, multicenter prospective trial evaluating the safety and efficacy of the PED. All patients underwent complete neuroophthalmological examinations both before the PED procedure and at a 6-month follow-up. All examinations were performed for the purpose of this study and according to study criteria.

RESULTS

In total, 108 patients were treated in the PUFS trial, 98 of whom had complete neuroophthalmological follow-up. Of the patients with complete follow-up, 39 (40%) presented with a neuroophthalmological baseline deficit that was presumed to be attributable to the aneurysm, and patients with these baseline deficits had significantly larger aneurysms. In 25 of these patients (64%), the baseline deficit showed at least some improvement 6 months after PED treatment, whereas in 1 patient (2.6%), the deficits only worsened. In 5 patients (5%), new deficits had developed at the 6-month follow-up, while in another 6 patients (6%), deficits that were not originally assumed to be related to the aneurysm had improved by that time. A history of diabetes was associated with failure of the baseline deficits to improve after the treatment. The aneurysm maximum diameter was significantly larger in patients with a new deficit or a worse baseline deficit at 6 months postprocedure.

CONCLUSIONS

Patients treated with the PED for large and giant ICA aneurysms had excellent neuroophthalmological outcomes 6 months after the procedure, with deficits improving in most of the patients, very few deficits worsening, and few new deficits developing.

ABBREVIATIONS

APD = afferent pupillary defect; CN = cranial nerve; ICA = internal carotid artery; PED = Pipeline Embolization Device; PUFS = Pipeline for Uncoilable or Failed Aneurysms; VA = visual acuity; VF = visual field.
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