BACKGROUND AND PURPOSE: The recently introduced Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is the third generation of Pipeline flow-diverter devices. It has a new stent-surface modification, which reduces thrombogenicity. We aimed to evaluate clinical and radiographic (safety and efficacy) outcomes of the Pipeline Shield. MATERIALS AND METHODS: The 30-day and 1-year mortality and morbidity rates and the 6- and 18-month radiographic aneurysm occlusion outcomes for procedures performed between March 2016 and January 2018 were analyzed. 3D-TOF-MRA was used for follow-up. RESULTS: Forty-four attempted Pipeline Shield procedures were performed for 41 patients with 44 target aneurysms (total of 52 aneurysms treated). A total of 88.5% of devices were inserted in the anterior circulation, and 11.5%, in the posterior circulation; 49/52 (94.2%) aneurysms were saccular; and 1/52 (1.9%) was fusiform. One (1.9%) aneurysm was an iatrogenic pseudoaneurysm, and 1 (1.9%) was a dissecting aneurysm. Seventy-one percent (35/49) of the saccular aneurysms were wide-neck (neck, >4 mm), 34.6% (18/52) were large (≥10 mm), and 3.8% (2/52) were giant (≥25 mm). The mean aneurysm sac maximal diameter was 9.0 mm, and the mean neck width was 5.0 mm. The cumulative mortality and morbidity rates were 2.3% and 6.8% at 1 year, respectively. The adequate occlusion rate was 78.8% at 6 months and 90.3% at 18 months. CONCLUSIONS: In this pragmatic and non-industry-sponsored study, the occlusion rates and safety outcomes were similar to those seen in previously published studies with flow-diverter devices and earlier generation Pipeline Embolization Devices.

The reliability of relaxation time measures in synthetic magnetic resonance images (MRIs) of homemade phantoms were validated, and the diagnostic suitability of synthetic imaging was compared to that of conventional MRIs for detecting ischemic lesions. Phantoms filled with aqueous cupric-sulfate (CuSO₄) were designed to mimic spin-lattice (T₁) and spin-spin (T₂) relaxation properties and were used to compare their accuracies and stabilities between synthetic and conventional scans of various brain tissues. To validate the accuracy of synthetic imaging in ischemic stroke diagnoses, the synthetic and clinical scans of 18 patients with ischemic stroke were compared, and the quantitative contrast-to-noise ratios (CNRs) were measured, using the Friedman test to determine significance in differences. Results using the phantoms showed no significant differences in the interday and intersession synthetic quantitative T₁ and T₂ values. However, between synthetic and referenced T₁ and T₂ values, differences were larger for longer relaxation times, showing that image intensities in synthetic scans are relatively inaccurate in the cerebrospinal fluid (CSF). Similarly, CNRs in CSF regions of stroke patients were significantly different on synthetic T₂-weighted and T₂-fluid-attenuated inversion recovery images. In contrast, differences in stroke lesions were insignificant between the two. Therefore, interday and intersession synthetic T₁ and T₂ values are highly reliable, and discrepancies in synthetic T₁ and T₂ relaxation times and image contrasts in CSF regions do not affect stroke lesion diagnoses. Additionally, quantitative relaxation times from synthetic images allow better estimations of ischemic stroke onset time, consequently increasing confidence in synthetic MRIs as diagnostic tools for ischemic stroke.