Collect data on the safety and clinical performance of the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis
Multicenter, observational, retrospective, non-comparative, non-randomized study to determine the safety and clinical performance of the Bovine Pericardium Valvular Bioprosthesis in patients who required replacement of their native or bioprosthetic valve (aortic or mitral), according to ISO 14155 and ISO 5840.
Study Type
OBSERVATIONAL
Enrollment
913
Heart Valve Replacement
Hospital Ana Nery - HAN/SESAB
Salvador, Estado de Bahia, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA
Porto Alegre, Rio Grande do Sul, Brazil
InCor - Instituto do Coração do Hospital das Clínicas da FMUSP
São Paulo, São Paulo, Brazil
Clinical success
Valve implantation without occurrences and without serious adverse events until hospital discharge.
Time frame: Until discharge from the index hospitalization (an average of 7 days is expected).
Composite event
Defined as death, stroke, and/or reintervention after 1 year of follow-up.
Time frame: 01 year
Extracorporeal circulation time AND Aortic clamping time (minutes)
Time frame: during the procedure
Intensive care unit (ICU) time (days)
Time frame: Until discharge from the index hospitalization (an average of 2 days is expected)
Length of in-hospital stay (days)
Time frame: Until discharge from the index hospitalization (an average of 7 days is expected).
New York Heart Association (NYHA) dunctional class at 5 years post-implant compared to baseline
The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Class II. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases.
Time frame: at discharge, 30 days, 6 months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Valve related adverse events
structural valve deterioration, non-structural dysfunction, valve thrombosis, embolism, bleeding event, or operated valve endocarditis; death related to reintervention on the operated valve; or sudden, unexplained death
Time frame: at discharge, 30 days, 6 months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Early rates AND late linearized rates AND actuarial rates of valve-related adverse events
thromboembolism, valve thrombosis, all bleeds, major bleeds, paravalvular leaks, severe paravalvular leaks, endocarditis, non-structural dysfunction, structural valve deterioration (rupture and calcification)
Time frame: at discharge, 30 days, 6 months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Subject's average peak systolic gradient (mmHg) measurements at 5 years post-implant
Time frame: 5 years post-implant
Subject's average mean systolic gradient (mmHg) measurements at 5 years post-implant.
Time frame: 5 years post-implant
Subject's average effective orifice area measurements at 5 years post-implant
Time frame: 5 years post-implant
Subject's average effective orifice area index (EOAI) measurements at 5 years post-implant
Time frame: 5 years post-implant
Subject's average performance index measurements at 5 years post-implant
Time frame: 5 years post-implant
Subject's average cardiac output measurements at 5 years post-implant
Time frame: 5 years post-implant
Subject's amount of aortic valvular regurgitation at 5 years post-implant
Time frame: 5 years post-implant
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