Development of a patient-specific predictive tool and a regulatory testing machine for transcatheter heart valve replacement

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Cardiovascular disease is the leading cause of death globally and claims more lives than all forms of cancer combined. In Canada, one in every four deaths is from cardiovascular disease. It is the leading cause of burden on healthcare costing the Canadian economy more than $22 billion every year. Valvular disease is one of the most serious cardiovascular problems. Until recently, high-risk patients with valvular disease had no other option than the surgical aortic valve replacement procedure, which has a high mortality rate. Transcatheter valve replacement (TVR) is an emerging minimally invasive device. While many patients experience a significant improvement after TVR intervention, for others the situation worsens significantly. Therefore, there is a crucial need for a predictive tool which has the capability of evaluating TVR intervention scenarios in each patient before the actual intervention to avoid irreversible consequences. Such tool would predict effectiveness of interventions, allowing systematic testing of possible clinical solutions, and thus enable personalization of interventions. Moreover, manufacturers of TVR (and other artificial valves) must validate the design and durability of their devices before releasing them to the market. Despite its importance, there exists no realistic regulatory TVR testing machine. To address these needs, we will develop a platform to be used for two objectives: 1. As a predictive tool for planning clinical interventions: The tool will have the capability testing of effects of TVR intervention scenarios for correcting valvular diseases on the body of each patient body in a patient-specific manner. 2. As a regulatory medical-device testing machine: This machine can serve testing needs of medical-device companies by making it possible to perform many important in vivo evaluation routines in vitro and will significantly reduce the need for animal studies and human trials so it can significantly speed up the device approval process and reduce the time-to-market and cost-to-market for new devices.