Methods
valve disease, valve thrombosis, BIOPRO, major hemorrhage, Death
ADVERSE EVENTS, EVENT, ENDOCARDITIS, THROMBOEMBOLISM
The BIOPRO Trial is an observational, retrospective, non-comparative,
non-randomized, and multicenter study. We collected data from 903 patients
with symptomatic, moderate, or severe valve disease who underwent BVP
implants in the timeframe from 2013 to 2020 at three Brazilian institutions.
Death, valve-related adverse events (AEs), functional recovery, and
hemodynamic performance were evaluated at the hospital, at discharge, and
six months and one year later. Primary analysis compared late (> 30 days
after implant) linearized rates of valve-related AEs, such as
thromboembolism, valve thrombosis, major hemorrhage, major paravalvular
leak, and endocarditis, following objective performance criteria (OPC).
Analysis was performed to include at least 400 valve-years for each valve
position (aortic and mitral) for complete comparisons to OPC. Kaplan-Meier
survival and major adverse cardiovascular and cerebrovascular event analyses
were also performed.