Study Population
Nine hundred and three patients with native valve or prosthetic aortic and/or
mitral replacement were included in the BIOPRO Trial analysis group. The
patients who have received biological heart valves were followed up to one year
after the procedure, meeting the requirements of the ISO guidance. All operated
patients available for follow-up underwent routine clinical examinations such as
echocardiography and blood biochemistry.This study followed “real life” practices for surgical valve replacement and
standard of care at participating sites. Inclusion and exclusion criteria are
described in S2. The inclusion criteria were based on the European Society of
Cardiology/European Association for Cardio-Thoracic Surgery Guidelines to
extrapolate the results to the European Union population