Aneurysm Study of Pipeline in an Observational Registry (ASPIRe).
OBJECTIVE
Few prospective studies exist evaluating the safety and efficacy of the Pipeline Embolization Device (PED) in the treatment of intracranial aneurysms. The Aneurysm Study of Pipeline In an observational Registry (ASPIRe) study prospectively analyzed rates of complete aneurysm occlusion and neurologic adverse events following PED treatment of intracranial aneurysms.


METHODS
We performed a multicenter study prospectively evaluating patients with unruptured intracranial aneurysms treated with PED. Primary outcomes included (1) spontaneous rupture of the Pipeline-treated aneurysm; (2) spontaneous nonaneurysmal intracranial hemorrhage (ICH); (3) acute ischemic stroke; (4) parent artery stenosis, and (5) permanent cranial neuropathy. Secondary endpoints were (1) treatment success and (2) morbidity and mortality at the 6-month follow-up. Vascular imaging was evaluated at an independent core laboratory.


RESULTS
One hundred and ninety-one patients with 207 treated aneurysms were included in this registry. The mean aneurysm size was 14.5 ± 6.9 mm, and the median imaging follow-up was 7.8 months. Twenty-four aneurysms (11.6%) were small, 162 (78.3%) were large and 21 (10.1%) were giant. The median clinical follow-up time was 6.2 months. The neurological morbidity rate was 6.8% (13/191), and the neurological mortality rate was 1.6% (3/191). The combined neurological morbidity/mortality rate was 6.8% (13/191). The most common adverse events were ischemic stroke (4.7%, 9/191) and spontaneous ICH (3.7%, 7/191). The complete occlusion rate at the last follow-up was 74.8% (77/103).


CONCLUSIONS
Our prospective postmarket study confirms that PED treatment of aneurysms in a heterogeneous patient population is safe with low rates of neurological morbidity and mortality. Patients with angiographic follow-up had complete occlusion rates of 75% at 8 months.
Department of Radiology, Mayo Clinic, Rochester, Minn., USA.
David F
DF
Kallmes
Department of Radiology, Mayo Clinic, Rochester, Minn., USA.
Waleed
W
Brinjikji
Department of Neuroradiology, Niguarda Ca' Granda Hospital of Milan, Milan, Italy.
Edoardo
E
Boccardi
Department of Radiology, Istituto Neurologico Carlo Besta, Milan, Italy.
Elisa
E
Ciceri
Department of Radiology, Houston Methodist Hospital, Houston, Tex., USA.
Orlando
O
Diaz
Department of Neurosurgery, Mayo Clinic, Jacksonville, Fla., USA.
Rabih
R
Tawk
Departments of Neurosurgery at Stony Brook University, Stony Brook, N.Y., USA.
Henry
H
Woo
Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pa., USA.
Pascal
P
Jabbour
Departments of Neurosurgery, Phoenix, Ariz., USA.
Felipe
F
Albuquerque
Neurointerventional Services, Department of Interventional Neuroradiology, Alfried Krupp Hospital, Essen, Germany.
Rene
R
Chapot
Department of Radiology, CHU Montpellier, Montpellier, France.
Alain
A
Bonafe
Department of Neurosurgery, Norton Neuroscience Institute, Norton Healthcare, Louisville, Ky., USA.
Shervin R
SR
Dashti
Department of Radiology, Neuroscience Institute, Abbott Northwestern Hospital, Minneapolis, Minn., USA.
Josser E
JE
Delgado Almandoz
Neurointerventional Services, Baptist Health Lexington, Lexington, Ky., USA.
Curtis
C
Given
Division of Neurosurgery, Royal University Hospital, University of Saskatchewan, Saskatoon, Sask., Canada.
Michael E
ME
Kelly
Department of Radiology, Washington University School of Medicine, St. Louis, Mo., USA.
DeWitte T
DT
Cross
Department of Neuroradiology, David Geffen School of Medicine at UCLA, Los Angeles, Calif., USA.
Gary
G
Duckwiler
Neurointerventional Associates, P.A., St. Petersburg, Fla., USA.
Nasser
N
Razack
Department of Neurological Surgery, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
Ciaran J
CJ
Powers
Department of Radiology, Klinikum Stuttgart, Stuttgart, Germany.
Sebastian
S
Fischer
Department of Neurological Surgery, Rush University Medical Center, Chicago, Ill., USA.
Demetrius
D
Lopes
Department of Neurosurgery, University of Alabama, Birmingham, Ala., USA.
Mark R
MR
Harrigan
Swedish Medical Center/RIA Neurovascular, Englewood, Colo., USA.
Daniel
D
Huddle
Department of Neurosurgery, Medical University of South Carolina, Charleston, S.C., USA.
Raymond
R
Turner
Department of Neurology, Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wis., USA.
Osama O
OO
Zaidat
Department of Interventional Radiology, Ghent University Hospital, Gent, Belgium.
Luc
L
Defreyne
Division of Neuroradiology, Joint Department of Medical Imaging and Division of Neurosurgery, Department of Surgery, University Health Network and Departments of Medical Imaging and Surgery, University of Toronto, Toronto, Ont., Canada.
Vitor Mendes
VM
Pereira
Department of Radiology, Koru Hospital and Bayindir Hospitals, Ankara, Turkey.
Saruhan
S
Cekirge
Cerebrovascular Center, Stony Brook University Medical Center, Stony Brook, N.Y., USA.
David
D
Fiorella
Stroke and Cerebrovascular Surgery, Lyerly Neurosurgery/Baptist Neurological Institute, Jacksonville, Fla., USA.
Ricardo A
RA
Hanel
Department of Neurosurgery, Clinica La Sagrada Familia, ENERI, Buenos Aires, Argentina.
Pedro
P
Lylyk
Endovascular Neurosurgery, Barrow Neurological Institute, Phoenix, Ariz., USA.
Cameron
C
McDougall
Department of Neurosurgery, University at Buffalo Neurosurgery, Buffalo, N.Y., Phoenix, Ariz., USA.
Adnan
A
Siddiqui
Department of Neurointerventional Services, National Institute of Clinical Neurosciences, Budapest, Hungary.
Istvan
I
Szikora
Department of Neurosurgery, University at Buffalo Neurosurgery, Buffalo, N.Y., Phoenix, Ariz., USA.
Elad
E
Levy
Flow diverter; Intracranial aneurysm; Neurological morbidity and mortality