Simulation of intra-saccular devices for pre-operative device size selection: Method and validation for sizing and porosity simulation.

Intra-saccular devices (ID) are novel braided devices used for complex intracranial aneurysms treatment. Treatment success is associated with correct device size selection. A technique that predicts the ID size within the aneurysm before intervention will provide a powerful computational tool to aid the interventionist during device selection. We present a method to calculate the device's final height, radial expansion and porosity within the patient's anatomy, which allows assessing different device sizes before treatment takes place. The proposed sizing technique was tested in-vitro and in real patient's geometries obtained from 3DRA angiographic images of 8 unruptured aneurysms previously treated with IDs. The obtained simulated height was compared to the real height, with a mean error of less than 0.28 mm (±0.44). The porosity calculation method was tested in-vitro with an error of 0.02 (±0.022). The results of both sizing and porosity experiments resemble well measures from real patients. This methodology could be used before treatment to provide the interventionist with additional information that allows selecting the device that best fits the patient's aneurysm to be treated.

Cerebral Aneurysm Occlusion at 12-Month Follow-Up After Flow-Diverter Treatment: Statistical Modeling for V&V With Real-World Data.

Background: Flow-Diverter (FD) porosity has been pointed as a critical factor in the occlusion of cerebral aneurysms after treatment. Objective: Verification and Validation of computational models in terms of predictive capacity, relating FD porosity and occlusion after cerebral aneurysms treatment. Methods: Sixty-four aneurysms, with pre-treatment and follow-up images, were considered. Patient demographics and aneurysm morphological information were collected. The computational simulation provided by ANKYRAS provided FD porosity, expansion, and mesh angle. FD occlusion was assessed and recorded from follow-up images. Multiple regression Logit and analysis of covariance (ANCOVA) models were used to model the data with both categorical and continuous models. Results: Occlusion of the aneurysm after 12 months was affected by aneurysm morphology but not by FD mesh morphology. A Time-To-Occlusion (TTO) of 6.92 months on average was observed with an SE of 0.24 months in the aneurysm population surveyed. TTO was estimated with statistical significance from the resulting model for the data examined and was capable of explaining 92% of the data variation. Conclusions: Porosity was found to have the most correction power when assessing TTO, proving its importance in the process of aneurysm occlusion. Still, further Verification and Validation (V&V) of treatment simulation in more extensive, multi-center, and randomized databases is required.