Treatment of Rabbit Elastase-Induced Aneurysm Models by Flow Diverters: Development of Quantifiable Indexes of Device Performance Using Digital Subtraction Angiography

Abstract
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 30 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%.