Based on the implementation of a clinical study that will entail the enrolment of a retrospective and prospective cohort of over 2,000 BHV recipients and control patients from 4 large EU cardiac surgery groups, the TRANSLINK project aims primarily to establish the possible role of recipients’ anti-BHV immune response as a major cause to mid- to-long term clinical dysfunction.
Precise molecular analysis of pre-implantation BHV sugar moieties will be performed. Possible indirect side-effects on BHV endocarditis and host vessels’ inflammation are secondary end points. Serial and trans-sectional blood samples will be dispatched to a battery of highly specialised partner groups for testing anti-Gal, -Neu5Gc and -hyaluronic acid antibodies using both validated and newly-designed screening tools, glycan array patterns, and macrophages/NK responses.
Phase A : Diagnostic
Objective: to assess the differential immune response in patients with or without SVD (given the low rate of SVD) a matched cases-controls study allows a powerful statistical analysis avoiding main confounding factors for a first discovery of a SVD-specific immune response. Results will be validated in prospective Phase B. The following graph shows the enrollment of the diagnostic study:
Phase B1: Prevalent patients
This cohort is specifically designed to study the kinetics of the immune response before and after implantation of an aortic BHV. Eight of the most frequently implanted BHV worldwide will be assessed. The first graph shows the enrollment of control patients, the second graph shows the enrollment of incident patients.
Phase B2: Incident patients
Due to the low incidence of SVD during the first 4 post-operative years, a second cohort will be constituted by patients undergone biological aortic valve replacement at least 5 years before. The objective of this second cohort is to cover a period of time where risk of SVD occurrence is potentially high. The first graph shows the enrollment of control patients, the second graph shows the enrollment of incident patients.