Novel polymeric heart valve for global heart valve disease

Cardiovascular disease remains the leading cause of global deaths and a major contributor to disability. This includes aortic valve stenosis (AS), affecting 9 million people worldwide and mitral regurgitation (MR), affecting 24 million people worldwide. In the UK, mortality in patients with untreated severe AS is estimated to be as high as 50% and 97% at 2- and 5- years, presenting a diagnosis crisis in an aging population. In middle- and low- income countries, rheumatic heart disease remains the most prevalent cause in young adults. Valve replacement with a prosthesis remains the most effective treatment against AS, presenting a lifesaving procedure. However, complications include calcification, durability and a need for lifelong anti-coagulant therapy. Polymer heart valves can bridge the durability of mechanical heart valves with the haemocompatibility of biological valves and at a fraction of the cost. Yet, despite advances in polymer science, there has been little change in leaflet design and very few have reached clinical translation.

The Wheatley Heart Valve (WHV) is a novel patented polymer valve comprised of a series of contiguous circles designed to facilitate helical blood flow through the aorta. This minimises bending stresses and generates a sinus washout of blood, alleviating the risks from thrombosis. Moreover, it can be manufactured from a flat sheet, expanding the possibilities for adaptations such as surface treatments and leaflet reinforcements. Early computational fluid models confirm the unique curvature of the WHV facilitates helical blood flow downstream of the valve.

Through a multi-disciplinary team consisting of clinicians, biomedical engineers, mathematicians, physicists and manufacturing experts, this research sets out to validate and optimise the design of this technology. By integrating the complex relationships between blood-surface properties, haemodynamics, leaflet design and advanced manufacturing techniques, this approach will advance the WHV closer to clinical translation.

Acknowledgements We are grateful to Tenovus Scotland Strathclyde for supporting this project.