title: Safety and efficacy of the Pipeline embolization device for treatment of intracranial aneurysms: a pooled analysis of 3 large studies.
abstract: 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.
authors: Department of Radiology, Mayo Clinic, Rochester, Minnesota.
authors: David F
authors: DF
authors: Kallmes
authors: Department of Radiology, Mayo Clinic, Rochester, Minnesota.
authors: Waleed
authors: W
authors: Brinjikji
authors: Koru Hospital and Bayindir Hospitals, Ankara, Turkey; and.
authors: Saruhan
authors: S
authors: Cekirge
authors: Department of Neurosurgery, Cerebrovascular Center, Stony Brook University Medical Center, Stony Brook.
authors: David
authors: D
authors: Fiorella
authors: Stroke and Cerebrovascular Surgery, Lyerly Neurosurgery/Baptist Neurological Institute, Jacksonville, Florida.
authors: Ricardo A
authors: RA
authors: Hanel
authors: Department of Neurosurgery, Thomas Jefferson University, Philadelphia, Pennsylvania.
authors: Pascal
authors: P
authors: Jabbour
authors: Department of Neurological Surgery, Rush University Medical Center, Chicago, Illinois.
authors: Demetrius
authors: D
authors: Lopes
authors: Department of Neurosurgery, ENERI-Clinica La Sagrada Familia, Buenos Aires, Argentina.
authors: Pedro
authors: P
authors: Lylyk
authors: Department of Endovascular Neurosurgery, Barrow Neurological Institute, Phoenix, Arizona.
authors: Cameron G
authors: CG
authors: McDougall
authors: Department of Neurosurgery, University at Buffalo Neurosurgery, Buffalo, New York.
authors: Adnan
authors: A
authors: Siddiqui
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D004621:Embolization, Therapeutic / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D006801:Humans; D002532:Intracranial Aneurysm / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
keywords: ASPIRe = Aneurysm Study of Pipeline in an Observational Registry; ICA = internal carotid artery; IQR = interquartile range; IntrePED = International Retrospective Study of the Pipeline Embolization Device; PED = Pipeline embolization device; PUFS = Pipeline for Uncoilable or Failed Aneurysms Study; aneurysm; endovascular; interventional neurosurgery; stroke; vascular disorders