Background and purpose A majority of previously published studies on treatment of intracranial aneurysms with the Pipeline Embolization Device (PED) are small single institution case series and may not be generalizable to the overall patient population. The International Retrospective Study of the Pipeline Embolization Device (IntrePED), Pipeline for Uncoilable or Failed Aneurysms Study (PUFS) and Aneurysm Study of Pipeline In an Observational Registry (ASPIRe) studies represent large, multicenter studies that followed pre-defined study protocols in order to fully characterize the safety and efficacy of the PED. In this study, we present a pooled analysis of patients included in these studies in order to assess both angiographic outcomes and clinical safety of the PED.
Materials and methods All centers included in these three studies acquired IRB or EC approval. IntrePED was a retrospective registry, PUFS was a prospective study and ASPIRe was a prospective registry. For each patient included in these studies we collected the following baseline information: demographic characteristics, aneurysm size and location, and aneurysm neck size. The number of PEDs used and mean treatment time were also collected. Aneurysm occlusion data were available from PUFS and ASPIRE at 180 days and 1 year and from PUFS at 3 and 5 years. All angiographic images were evaluated by an independent core lab. Major complication data were available in all three studies and included major ipsilateral ischemic stroke, major ipsilateral intracranial hemorrhage, major morbidity, neurological mortality, combined major morbidity and neurological mortality, and all-cause mortality.
Results A total of 1092 patients with 1221 aneurysms were included across the three studies. Mean aneurysm size was 12.0 ± 7.8 mm. Mean aneurysm neck size was 6.6 ± 4.8 mm. Multiple PEDs were used in 37% of patients (452/1218). Mean procedure time was 106 ± 553 min. The rate of major ipsilateral ischemic stroke was 3.7% (40/1091). Major ipsilateral intracranial hemorrhage rate was 2.2% (24/1091). Major morbidity was 5.9% (64/1091). Neurological mortality rate was 3.3% (36/1091). Combined major morbidity and neurological mortality rate was 7.3% (80/1091). All cause mortality rate was 4.0% (44/1091). Angiographic complete occlusion rates were 79% at 180 days (112/141) and 86% at 1 year (95/111).
Conclusions Endovascular treatment of intracranial aneurysms with the PED is both safe and effective. Angiographic occlusion rates progressed with follow-up with complete angiographic occlusion rates of approximately 79% at 180 days increasing to 86% at 1 year. Rates of stroke, hemorrhage, morbidity and mortality are low, especially given the fact that the aneurysms treated were generally large and wide-necked.
Disclosures D. Kallmes: 1; C; Covidien. W. Brinjikji: None. P. Nelson: None. G. Lanzino: 2; C; Covidien. F. Albuquerque: None. I. Szikora: None. D. Lopes: None. R. Hanel: None. J. Delgado Almandoz: None. P. Lylyk: None. S. Cekirge: None. E. Levy: 1; C; Covidien. P. Jabbour: 2; C; Covidien. H. Woo: None. C. McDougall: None. T. Beckse: None.
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