Abstract
Flow diverters (FDs) for the endovascular treatment of intracranial aneurysms are effective for sidewall aneurysms, but their use at a bifurcation is problematic because FDs only partially cover the aneurysm neck and impede flow into a daughter branch; they are thus not employed routinely in this anatomy. eCLIPs was developed as a non-tubular implant to completely cover the neck of an aneurysm and serve as a coil retention device necessary for the adequate treatment of wide-neck bifurcation aneurysms. eCLIPs has shown some flow diversion effects in bifurcation anatomy but not equal to those exhibited by clinically accepted flow diverters in sidewall anatomy. A new generation of eCLIPs implant, the eCLIPs bifurcation flow diverter (eBFD), with higher metal coverage, was developed to achieve a similar flow diversion as a Pipeline Embolization Device (PED), a prototypical FD. Particle image velocimetry was used to capture the fluid dynamics and velocity reduction within silicone aneurysm replicas. A circulatory mimicking loop was developed to circulate the flow through the silicone models. All generations of eCLIPs implants had some flow-diverting effect, with increasing metal coverage density of the implant proportionately increasing the flow diversion effect. The eBFD, with a metal density of 35%, showed greater flow diversion than PED, with 30% metal density, for bifurcation anatomy. The eBFD showed similar reduction of flow in a bifurcation anatomy to PED in a sidewall, both sufficient to permit early thrombosis of the aneurysm. Thus, the eBFD can potentially provide sufficient flow diversion for the treatment of bifurcation aneurysms to avoid adjunctive coiling.
Highlights
A brain aneurysm is a localized enlargement of an intracranial artery, usually due to damaged smooth muscle cells and elastin in the arterial layers [1] but often exacerbated by localized perturbation of blood flow
The current study employed a steady flow for analysis, but this model should not mitigate the value of the results shown since different studies have shown that steady flow provides a strong indication of fundamental hemodynamic trends that are present under both steady and pulsatile conditions in the aneurysm [36,37]
Conclusions eCLIPs has undergone three iterations for the treatment of intracranial bifurcation aneurysms, the first never achieving clinical uptake due to the delivery impediments associated with its balloon-expandable stainless steel design
Summary
A brain aneurysm is a localized enlargement of an intracranial artery, usually due to damaged smooth muscle cells and elastin in the arterial layers [1] but often exacerbated by localized perturbation of blood flow. The Brain Aneurysm Foundation reported that the worldwide annual mortality due to intracranial aneurysms is 500,000, with approximately 50% of these patients being younger than 50 years old [2]. Common treatments for intracranial aneurysms include embolic coiling and stent-assisted coiling, but these are associated with frequent recurrence, especially for wide-neck aneurysms [3,4]. Stent-assisted coiling prevents coil protrusion into the parent artery lumen, a particular problem with wide-neck aneurysms, and reduces the recurrence risk [5]. Intra-aneurysmal coils act by initiating and propagating thrombus that cause the aneurysm to heal by thrombotic occlusion.
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