Abstract
Intracranial aneurysms (IAs) are defined as a focal dilation or pathological bulge in the arterial walls, which can grow and rupture, generating catastrophic outcomes in patients (4). Because most unruptured IAs are asymptomatic, their diagnosis is mostly incidental. Currently, there are various therapeutic approaches, however, endovascular management has positioned itself as the management of choice in most cases of ruptured and non-ruptured IA since it has shown less morbidity, fewer hospital stays, and shorter recovery times for patients (5). There are various endovascular devices on the market for the management of IAs, such as flow-diverting stents and intrasaccular devices such as the Woven EndoBridge (WEB), which aim to form intrasaccular thrombosis of the IA (30). The extensive morphological diversity of IAs among patients means that the selection of the intrinsic characteristics of the endovascular device is a complex task that requires high precision. For the above, simulation software are being developed to facilitate this process for health professionals, which has been shown to improve performance, and reduce the presence of errors and surgical time (3).The validation of medical software consists of confirming with objective evidence that the software complies with its intended uses and consistently satisfies the needs of the user. This process is necessary so that the medical device can be implemented and approved by regulatory entities such as the FDA and the European Commission (37). However, the validation processes of medical software are little or not codified, which does not allow us to objectively judge its applicability and effectiveness. The first objective of this thesis was to describe the validation process used to implement a virtual simulation software in the endovascular treatment of intracranial aneurysms (Sim&SizeTM) and its impact on variables associated with its use such as surgical time, size, and the number of endovascular devices. and potential risks. The second objective of this thesis consists of a first phase in which the validation process of the potential use of 3D printed models of intracranial aneurysms to simulate and select the most appropriate endovascular device is described, evaluating its accuracy in the 3D angiography of the patient and the correspondence between operators. In the second phase, a heterogeneous model was developed by Alain Berod et. al was used to evaluate the computational fluid dynamics (CFD) and the structural mechanics of patients with bifurcation IA treated with the WEB device. Some haemodynamic parameters and indexes of the IA before and after WEB simulation were measured and their relation to complete occlusion was evaluated. The relationships between the geometrical defined parameters of the IA and its relation to the implanted device were also evaluated in order to determine the predictive factors before implantation that favor the chances of the long-term success of the endovascular procedure.