Abstract

Background: The pipeline embolization device (PED) is the most widely utilized flow diverter. Although the PED was initially designed to treat large and complex aneurysms of the internal carotid artery, its use has now extended to several other indications. Data on the safety and long-term outcomes remain, however, limited. Objective: To assess the long-term safety and efficacy of the PED in the largest reported single-center series to date. Methods: This is an analysis of a prospectively maintained database at a single-institution. Patients included in the analysis were consecutively treated at Jefferson Hospital for Neuroscience between 2011 and 2017. P2Y12 assays were used. Complications reported both in the perioperative period and through follow-up. Aneurysm occlusion was classified as complete (100%), near-complete (95-99%), or incomplete (<95%). Results: A total of 585 patients were included in the study. Mean aneurysm size was 8.5±6.3mm. Aneurysm morphology was saccular in 87.5% and fusiform/dissecting in 11.1%. The mean number of PEDs deployed per aneurysm was 1.2±0.5, decreasing significantly from 1.4±0.7 in 2011-2012 to 1.1±0.3 in 2016-2017 (p<0.001). Additional coiling was performed in 6.5% of patients. Hemorrhage occurred in 3.2% of patients, thromboembolism in 1.2%, device migration in 1.2%, in-pipeline stenosis in 7.3%, and neurological mortality in 1.7%. At a mean angiographic/imaging follow-up of 24.8±19.4 months, complete or near-complete occlusion was seen in 88.5%. Significant predictors of incomplete aneurysm occlusion were older age (OR 1.04, p<0.001), prior treatment of aneurysm (p=0.014, OR 1.93), fusiform shape (OR 2.3, p=0.032) and increasing aneurysm size (OR 1.039, p=0.023). Adjunctive coiling or use of multiple stents was not associated with improved occlusion or decreased complication rates. Conclusions: At a high-volume center with experienced operators, treatment with the PED was associated with durable aneurysm occlusion and a low risk of complication. The results support the extension of the indications of flow diversion. Several predictors of outcomes were identified and these should be discussed with patients when considering flow diversion.

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