An in silico trials platform for the evaluation of effect of the arterial anatomy configuration on stent implantation.

The introduction of Bioresorbable Vascular Scaffolds (BVS) has revolutionized the treatment of atherosclerosis. InSilc is an in silico clinical trial (ISCT) platform in a Cloud-based environment used for the design, development and evaluation of BVS. Advanced multi-disciplinary and multiscale models are integrated in the platform towards predicting the short/acute and medium/long term scaffold performance. In this study, InSilc platform is employed in a use case scenario and demonstrates how the whole in silico pipeline allows the interpretation of the effect of the arterial anatomy configuration on stent implantation.

Simulated versus physical bench tests: The economic evaluation of the InSilc platform for designing, developing, and assessing vascular scaffolds.

BACKGROUND: In silico medicine allows for pre-clinical and clinical simulated assessment of medical technologies and the building of patient-specific models to support medical decisions and forecast personal health status. While there is increasing trust in the potential central role of in silico medicine, there is a need to recognize its degree of reliability and evaluate its economic impact. An in silico platform has been developed within a Horizon 2020-funded project (In-Silc) for simulations functional to designing, developing, and assessing drug-eluting bioresorbable vascular scaffolds.The main purpose of this study was to compare the costs of 2 alternative strategies: the adoption of In-Silc platform versus the performance of only physical bench tests. METHODS: A case study was provided by a medical device company. The values of the model parameters were principally set by the project partners, with use of interviews and semi-structured questionnaires, and, when not available, through literature searches or derived by statistical techniques. An economic model was built to represent the 2 scenarios. RESULTS: The InSilc strategy is superior to the adoption of physical bench tests only. Ceteris paribus, the costs are 424,355€ for the former versus 857,811€ for the latter. CONCLUSIONS: In silico medicine tools can decrease the cost of the research and development of medical devices such as bioresorbable vascular scaffolds. Further studies are needed to explore the impact of such solutions on the innovation capacity of companies and the consequent potential advantages for target patients and the healthcare system.

In vitro and in silico testing of partially and fully bioresorbable vascular scaffold.

Coronary artery disease (CAD), one of the leading causes of death globally, occurs due to the growth of atherosclerotic plaques in the coronary arteries, causing lesions which restrict the flow of blood to the myocardium. Percutaneous transluminal coronary angioplasty (PTCA), including balloon angioplasty and coronary stent deployment is a standard clinical invasive treatment for CAD. Coronary stents are delivered using a balloon catheter inserted across the lesion. The balloon is inflated to a nominal pressure, opening the occluded artery, deploying the stent and improving the flow of blood to the myocardium. All stent manufacturers have to perform standard in vitro mechanical testing under different physiological conditions. In this study, partially and fully bioresorbable vascular scaffolds (BVS) from Boston Scientific Limited have been examined in vitro and in silico for three different test methods: inflation, radial compression and crush resistance. We formulated a material model for poly-L-lactic acid (PLLA) and implemented it into our in-house software tool. A comparison of the different experimental results is presented in the form of graphs showing displacement-force curves, diameter - load curves or diameter - pressure curves. There is a strong correlation between simulation and real experiments with a coefficient of determination (R2) > 0.99 and a correlation coefficient (R) > 0.99. This preliminary study has shown that in-silico tests can mimic the applicable ISO standards for mechanical in vitro stent testing, providing the opportunity to use data generated using in-silico testing to partially or fully replacing the mechanical testing required for regulatory submission.

Design and implementation of in silico clinical trial for Bioresorbable Vascular Scaffolds.

In the recent years, Bioresorbable Vascular Scaffolds (BVS) for the treatment of atherosclerosis have been introduced. InSilc is a cloud based in silico clinical trial (ISCT) platform for drug-eluting BVS. The platform integrates multidisciplinary and multiscale models predicting the BVS performance. In this study, we present a use case scenario and demonstrate the functioning of the individual modules and of the whole pipeline and the ability to predict BVS short, medium, long-term outcomes.