Background and Purpose-The potential for successful treatment of intracranial aneurysms by flow diversion is gradually being recognized in the clinical setting; however, the devices currently available (stents) are not designed for flow diversion. We evaluate the long-term response of an appropriately designed flow diversion device in producing thrombotic occlusion of experimental aneurysms. Methods-Three different configurations of an original flow diversion device were implanted across thirty elastaseinduced aneurysm models in rabbits. Ten animals per device configuration were followed-up for 3 weeks (nϭ3), 3 months (nϭ3), or 6 months (nϭ4), and tissue explanted postsacrifice was sent for histology. The temporal variation in angiographic contrast intensity within each aneurysm was fitted with a mathematical model to quantify the alteration in local hemodynamics caused by the implanted device. A predictive index, called the washout coefficient, was constructed to estimate long-term aneurysm occlusion probabilities immediately after treatment with any flow diversion device. Results-The device with a porosity of 70% and pore density of 18 pores/mm 2 performed better at occluding aneurysms than devices with 70% porosity, 12 pores/mm 2 and 65% porosity, 14 pores/mm 2 . A value of the washout coefficient less than 30 predicted greater than 97% angiographic aneurysm occlusion over a period of 6 months with a sensitivity of 73% and specificity of 82%. Conclusions-The flow diversion devices effected successful and stable aneurysm occlusion. Pore density, rather than porosity, may be the critical factor modulating efficacy of such devices.
It has been known for more than a decade that intracranial aneurysms can be successfully treated by deploying a porous meshed tube in the parent vessel of the aneurysm. Such devices are currently called flow diverters because they promote intraneurysmal flow stasis and thrombosis by diverting blood flow away from the aneurysm sac. The objective of this study was to use angiographic data to quantify and compare the performance of flow diverters of original design in successfully occluding an experimental aneurysm model. Three different configurations of a novel flow diverter with varying porosities and pore densities were implanted in thirty rabbit elastase-induced aneurysms. Temporal variations in angiographic contrast intensity within the aneurysms were fit to a mathematical model. Optimized model parameters were supplemented by the angiographic percentage aneurysm occlusion and an angiographic measure of device flexibility to derive composite scores of performance. Angiographic quantification further suggested a parameter, which could be employed to estimate long-term aneurysm occlusion probabilities immediately after treatment. Performance scores showed that the device with a porosity of 70% and pore density of 18 pores/mm2 performed better than devices with 65% porosity, 14 pores/mm2 and 70% porosity, 12 pores/mm2 with relative efficacies of 100%, 84%, and 76%, respectively. The pore density of flow diverters, rather than porosity, may thus be a critical factor modulating device efficacy. A value of the prognostic parameter of less than 30 predicted greater than 97% angiographic aneurysm occlusion over six months with a sensitivity of 73% and specificity of 82%.
Endovascular coiling is an acceptable treatment of intracranial aneurysms, yet long term follow-ups suggest that endovascular coiling fails to achieve complete aneurysm occlusions particularly in wide-neck and giant aneurysms. Placing of a stentlike device across the aneurysm neck may be sufficient to occlude the aneurysm by promoting intra-aneurysmal thrombosis; however, conclusive evidence of its efficacy is still lacking. In this study, we investigate in vitro the efficacy of custom designed flow divertors that will be subsequently implanted in a large cohort of animals. The aim of this study is to provide a detailed database against which in vivo results can be analyzed. Six custom designed flow divertors were fabricated and tested in vitro. The design matrix included three different porosities (75%, 70%, and 65%). For each porosity, there were two divertors with one having a nominal pore density double than that of the other. To quantify efficacy, the divertors were implanted in a compliant elastomeric model of an elastase-induced aneurysm model in rabbit and intra-aneurysmal flow changes were evaluated by particle image velocimetry (PIV). PIV results indicate a marked reduction in intra-aneurysmal flow activity after divertor implantation in the innominate artery across the aneurysm neck. The mean hydrodynamic circulation after divertor implantation was reduced to 14% or less of the mean circulation in the control and the mean intra-aneurysmal kinetic energy was reduced to 29% or less of its value in the control. The intra-aneurysmal wall shear rate in this model is low and implantation of the flow divertor did not change the wall shear rate magnitude appreciably. This in vitro experiment evaluates the characteristics of local flow phenomena such as hydrodynamic circulation, kinetic energy, wall shear rate, perforator flow, and changes of these parameters as a result of implantation of stentlike flow divertors in an elastomeric replica of elastase-induced saccular aneurysm model in rabbit. These initial findings offer a database for evaluation of in vivo implantations of such devices in the animal model and help in further development of cerebral aneurysm bypass devices.
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