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

Abstract: 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 was 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 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 of 6.92 months on average was observed with a Standard Error of 0.24 months in the aneurysm population surveyed. Time-To-Occlusion 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 V&V of treatment simulation in more extensive, multi-centre and randomized databases is required.