Background

Background

Heart valve disease represents a major global health burden.  Currently, replacement of the diseased valve with mechanical or biological substitutes is the gold standard and affects a large group of patients. Moreover, life expectancy is reduced dramatically by 50% in patients who require such heart valve replacement compared to age-matched healthy individuals. Each year over 300,000 heart valves are replaced worldwide. Importantly, still 30-60% of these patients present themselves with prostheses related problems within 10 years post-operatively and often require reoperation within 15 years after receiving an aortic heart valve replacement. Heart valve prosthesis associated complications include thrombo-embolic events requiring lifelong anticoagulation in case of mechanical valves, and limited durability due to calcification and structural failure in case of biological valve substitutes. Non-viability of the currently available prostheses is considered a major issue since this limits the ability to grow, repair or adjust to changes in functional demand within a patient and restricts their application in paediatric patients and grown-ups with congenital heart defects. In order to overcome these prostheses related complications and the subsequent risk for reoperation, minimally invasive solution is required that results in a living valve replacement at the site of destination.