The Clinical Issue
Around 42% of infant mortality in the world is related to congenital heart defects (CHD). Congenital cardiac abnormalities are the most frequent congenital abnormalities (8-12/1000 births). According to the European study EUROCAT, the prevalence of CHD in Europe is 8/1000.
More than one third of these CHDs (such as Tetralogy of Fallot, Pulmonary atresia or Truncus arteriosus) and some surgical procedures (such as the Ross procedure) require the reconstruction of the right ventricular outflow tract (RVOT). Current clinical approaches for such a reconstruction involve the use of inert materials without any growth potential and which require multiple reoperations with a risk of mortality (1 to 6%) and morbidity (haemorrhagic syndrome, cerebral vascular accident, damage to the coronary arteries, cardiac rhythm alterations and infection).
Presently all the patients who have had surgery for a congenital heart defect involving the RVOT with implantation of a tube during childhood, will need at least one (and sometimes up to 5!) revision surgery in their life because of failure of the implanted conduit.
The need for a living and growing valved tube for these children is obvious.