David F. Kallmes 1 , Waleed Brinjikji 1 , Saruhan Cekirge 2 , David Fiorella 3 , Ricardo A. Hanel 4 , Pascal Jabbour 5 , Demetrius Lopes 6 , Pedro Lylyk 7 , Cameron G. McDougall 8 and Adnan Siddiqui 9
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).
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 A disability caused by injury to the brain. Most strokes are caused by loss of blood flow to a portion of the brain (called an ischemic stroke or cerebral infarction) or by injury related to bleeding within the brain tissue (an intracerebral hemorrhage) or into the space around the brain (subarachnoid hemorrhage).. The secondary outcomes were angiographic occlusion rates, which were available for ASPIRe and PUFS only.
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.
Within the blood vessels/vascular system. 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.
ABBREVIATIONS ASPIRe = Aneurysm Study of Pipeline in an Observational Registry; ICA = internal carotid A thick-walled blood vessel carrying blood flow from the heart to any organ of the body, including the brain.; IntrePED = International Retrospective Study of the Pipeline Embolization Device; IQR = interquartile range; PED = Pipeline embolization device; PUFS = Pipeline for Uncoilable or Failed Aneurysms Study.