TRANSLINK proposes a prospective clinical and biological observational study of an international multicentre cohort of patients (over 3000 BHV recipients and matched controls) recruited in three large EU centres of cardiac surgery. The objectives, centred on the analysis of the TRANSLINK cohort, are the following:
- To characterize the nature and the magnitude of humoral anti-BHV immune response and determine the coparticipation of the natural cellular immune response following BHV implantation.
- To correlate the magnitude and quality of the anti-BHV immune response with the BHV function and clinical outcome.
- To explore, beside the possible detrimental effects of the immune response the BHV, the potential side-effect on the BHV recipients themselves (susceptibility to bacterial infection, vascular inflammation)
- Finally, the project will lead to the development of novel preventive and therapeutic strategies to combat BHV related adverse immune reactions. In particular, TRANSLINK will enable the production of a novel generation of immune-resistant BHV that lack expression of putative immunodominant epitope, responsible for premature graft failure. In addition, TRANSLINK will enable the generation of novel specifically-designed molecules with binding capacity to protect the implant and, possibly, BHV recipients from immune-mediated damage.