In-vitro thrombogenicity assessment of flow diversion and aneurysm bridging devices

Abstract

Endoluminal devices such as metallic flow diversion (FD) and aneurysm bridging (AB) stents are used for treatment of intracranial aneurysms. Treatments are associated with thrombogenic events mandating the use of dual antiplatelet therapy in all cases. In the current in vitro study, we utilize a slow binding fluorogenic thrombin specific substrate to measure the thrombin generation potential of six devices: four FD devices (Pipeline™ Flex embolization device, Pipeline™ Flex embolization device with Shield Technology™, SILK+, FRED™) and two AB devices (Solitaire™ AB, LEO+). We show that the Pipeline™ Flex embolization device with Shield Technology™ has significantly lower peak thrombin and takes significantly longer time to achieve peak thrombin (time to peak) compared to the other three FD devices (p < 0.05), with statistically similar results to the less thrombogenic AB devices. We conclude that surface modification of endoluminal stents could be an effective method to mitigate thrombogenic complications.

Safety and efficacy of the Derivo Embolization Device for the treatment of ruptured intracranial aneurysms

“…Some second-generation FDDs, such as the Pipeline Flex with Shield technology, exhibit a surface finishing with potentially reduced thrombogenicity 10. However, data on the efficacy and safety of modern FDDs in patients with SAH are scarce 11 12…”

First US experience with Pipeline Flex with Shield Technology using aspirin as antiplatelet monotherapy

“…The experience with PED in this subset of lesions is limited with a few case series reported and ischaemic complications ranging from 0% to 71.4% of cases and mortality rates ranging from 0% to 28.6% 12–18. The inner surface of the PED Shield includes a phosphorylcholine coating, which is abundant on the surface of erythrocytes and attempts to reduce thrombogenicity 19. This technology has been used in implanted vascular devices for more than a decade and Shield Technology refers to a modified version, which creates a chemically bonded coating to the surface of the metallic mesh.…”

Endovascular treatment of blister aneurysms

“…24 In vitro and ex vivo studies have supported this theory by demonstrating reduced thrombin generation and platelet deposition with PED-Shield compared with FDs without phosphorylcholine. 17,20 Importantly, PED-Shield has also been effective clinically. Chiu et al in 2016 used the PED-Shield to treat an intradural VA dissecting aneurysm.…”