DISCUSSION
thrombosis, valve thrombosis, death, heart disease, paravalvular leak, rheumatic valve disease, valvar regurgitation, major hemorrhage, bioprosthetic valve, AVR
THROMBOSIS, ENDOCARDITIS, HEART DISEASE, THROMBOEMBOLISM, EDWARDS
According to standards, the ideal sample size is 800 patient-years. A minimum of 400
patient-years are required for each valve position for complete comparisons to
OPCThe results of this clinical retrospective study (BIOPRO) demonstrated safety with a
low early mortality rate (< 30 days after implant) for AVR and a slightly higher
rate for MVR. As a possible explanation, the slightly higher rate of early mortality
rate can be influenced by several factors, mainly multiple valve replacements,
associated procedures, and severe lesions associated with higher subject’s
comorbidities, etcAs far as we observed, the prosthesis did not influence early mortality in the study
population, among causes of death just 1.0% was cardiac-related. Demographic results
demonstrated a high prevalence of several comorbidities, and procedure details
showed a high occurrence of other valve interventions and surgeries associated with
coronary artery bypass grafting. In addition, there is a known high prevalence of
rheumatic valve disease, which is a major cause of heart disease in developing
countriesWhen considered valve-related AE rates for the major safety endpoints
(thromboembolism, valve thrombosis, major hemorrhage, major paravalvular leak, and
endocarditis) were < 2 × OPC for a bioprosthetic valve, there was just one
exception for valve thrombosis rate. However, only one case occurred during the
period of > 30 days up to one year and it is an isolated situation. All data
demonstrated an intrinsic safety of BVP that its intended use for AVR or MVR.In the BIOPRO Trial, analysis of effectiveness is based on NYHA functional
classification and echocardiographic hemodynamic data at one-year follow-up. There
was an improvement in NYHA classification by at least one class for AVR and MVR
patients at one year from baseline. AVR (93.5%) and MVR (95.5%) patients had no
valvar regurgitation at one-year follow-up. In this context, based on hemodynamic
performance, BVP demonstrated acceptable effectiveness considering its intended use
to AVR or MVR, significantly promoting the improvement of hemodynamic performance
and NYHA functional classification compared to baseline values.Furthermore, echocardiographic evaluations were reevaluated by the independent Core
Lab to assess performance of the device in terms of hemodynamic behavior based on
control results of EOAs and mean gradients.The benefit associated with BVP is also supported by results of the actuarial global
survival rate and freedom of AE rate at the end of 12 months. Rate of freedom from
all-cause mortality at one year was 93.9%, and the Kaplan–Meier overall survival
curves indicated that freedom from all-cause mortality was 95.1% for AVR and 92.7%
for MVR.Three other market bioprosthetic heart valves had similar freedom from all-cause
mortality rates — Magna Ease™ – Edwards (90.6%), Trifecta™ – St. Jude
Medical (95.8%), and Avalus™ – Medtronic (96.4%)In addition, the BVP event-free rate was 90.7%; when related to the type of surgery
they were 93.0% (AVR MACCE) and 89.4% (MVR MACCE). In a comparative analysis of late
outcomes between the Trifecta™ and Magna Ease™ biological heart
valves, the freedom from one-year MACCE in the Trifecta™ group was 93.9%, and
in the Magna Ease™ group it was 94.1%