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

开发用于经导管心脏瓣膜置换术的患者特异性预测工具和监管测试机

• 批准号: 537352-2018
• 负责人: KeshavarzMotamed, Zahra
• 金额: $ 11.2万
• 依托单位: McMaster University
• 依托单位国家: 加拿大
• 项目类别: Collaborative Research and Development Grants
• 财政年份: 2020
• 资助国家: 加拿大
• 起止时间: 2020-01-01 至 2021-12-31
• 项目状态: 已结题
• 来源: https://www.nserc-crsng.gc.ca/ase-oro/Details-Detailles_eng.asp?id=699379
• 关键词: Development; patient; specific; predictive; tool

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.

心血管疾病是全球死亡的主要原因，夺去的生命比所有形式的癌症加起来还要多。在加拿大，每四个死亡中就有一个死于心血管疾病。它是加拿大医疗保健负担的主要原因，每年花费超过220亿美元。瓣膜病是最严重的心血管疾病之一。直到最近，患有瓣膜疾病的高危患者除了手术主动脉瓣置换术之外没有其他选择，这一手术死亡率很高。经导管瓣膜置换术（TVR）是一种新兴的微创手术。虽然许多患者在TVR干预后经历了显著的改善，但对其他患者来说，情况明显恶化。