TRANSLINK: Defining the Role of Xeno-directed and Immune Events (SVD) in Patients Receiving Animal-derived Bioprosthetic Heart Valves

Inclusion Criteria

• •To be enrolled, the following criteria have to be fulfilled:
• •\*Phase A: Diagnostic Study
• •Patient age: 18 to 85 years old at the time of surgery
• •Echographic signs of SVD (Mean trans-valvular gradient ≥ 30 mm Hg AND Effective Orifice Area ≤ 1 cm2 worsen over time OR Aortic Insufficiency \> grade 2/4)
• •Single aortic valve replacement +/- associated to CABG, Bental, Mitral or Tricuspid repair, aortic surgery, Radiofrequency.
• •First cardiac surgery (no multiple cardiac surgeries)
• •No immunosuppressive regimen any time within the 6 months prior surgery.
• •\- No use of other allo or xenogenic tissue than aortic valve prosthesis during cardiac surgery
• •Patient has been informed of the nature of the study, agrees to its provisions and has signed the informed consent form prior to any study related procedure
• •Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational site
• •Non-SVD patients (control-patients):
• •Patients will be defined as patients operated on with an aortic BHV without echographic signs of SVD and matched for: Age at surgery (±2 years), type of BHV and follow-up time (± 6 months).
• •Patient has been informed of the nature of the study, agrees to its provisions and has signed the informed consent form prior to any study related procedure
• •Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational site
• •To increase the statistical power (which cannot be calculated according to the novelty of the project), two controls will be matches with each SVD-Case.
• •\*Phase B: Prospective Study
• •B1: Cohort of prevalent patients
• •Patient age: 18 - 85 years old at the time of surgery
• •Patient scheduled for single aortic valve replacement with a BHV (surgical or percutaneous valve) +/- associated to CABG, Bental, Mitral or Tricuspid repair, aortic surgery, Radiofrequency.
• •First cardiac surgery (no multiple cardiac surgeries)
• •No immunosuppressive regimen any time within the 6 months prior surgery and no immunosuppressive regimen after surgery.
• •No use of other allo or xenogenic tissue than aortic valve prosthesis during cardiac surgery
• •Patient is affiliated to the Social Security or equivalent system
• •Patient has been informed of the nature of the study, agrees to its provisions and has signed the informed consent form prior to any study related procedure
• •Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational site Eight of the most frequently implanted BHV worldwide will be assessed: 1 surgical porcine valve: Mosaic (Medtronic); 4 surgical bovine pericardium valves: Perimount-Carpentier (Edwards), Magna ease (Edwards), Trifecta (St. Jude Medical) and the Mitroflow PRT valve (Sorin); 1 surgical equine valve: 3F-valve or Enable (Medtronic) and 2 percutaneous pericardium valves (TAVI): Corevalve (porcine pericardium - Medtronic) and Sapien valve (bovine pericardium - Edwards).
• •Fifty patients per type of BHV will be included. When 50 patients were included in one of the eight groups, we will stop the inclusions in this group.
• •Additionally, a control group of heart operated patients without biological valve will be included in the study (patients operated on with a mechanical valve (n=50) or for CABG without BHV (n=50).
• •Control group (CABG or aortic mechanical valve)
• •Patient age: \>65 years old for CABG and 18-85 years old for mechanical valve replacement
• •Patient operated on coronary artery bypass (for CABG group)
• •Patient with valve aortic replacement following aortic valve stenosis (for mechanical valve group)
• •No immunosuppressive regimen any time within the 6 months prior surgery and no immunosuppressive regimen after surgery.
• •No use of other allo or xenogenic tissue than aortic valve prosthesis during cardiac surgery.
• •B2: Cohort of incident patients
• •Patient age: 18 to 85 years old (at the time of surgery) who underwent a single isolated aortic valve replacement with a BHV +/- associated to CABG, Bental, Mitral or Tricuspid repair, aortic surgery, Radiofrequency. more than 5 years ago.
• •First cardiac surgery (no multiple cardiac surgeries)
• •No immunosuppressive regimen any time within the 6 months before inclusion and no immunosuppressive regimen after inclusion.
• •Patient is affiliated to the Social Security or equivalent system
• •Patient has been informed of the nature of the study, agrees to its provisions and has signed the informed consent form prior to any study related procedure
• •Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational site
• •As control, patients who underwent isolated CABG (n=50) or aortic mechanical valve replacement more than 5 years ago (n=50) will be enrolled.
• •Control group (CABG or aortic mechanical valve)
• •Patient age (at the time of surgery): \> 65 years old for CABG and 18-85 years old for mechanical valve replacement
• •Patient operated on coronary artery bypass (for CABG group) more than 5 years ago
• •Patient with valve aortic replacement following aortic valve stenosis (for mechanical valve group) more than 5 years ago
• •No immunosuppressive regimen any time within the 6 months prior inclusion and no immunosuppressive regimen after inclusion.
• •No use of other allo or xenogenic tissue than aortic valve prosthesis during cardiac surgery