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Fisics-Incor bovine pericardial bioprostheses: 15 year results
P M Pomerantzeff1, C M Brandao, P Cauduro
1Heart Institute, Hospital das Clínicas, Medical School, University of São Paulo, São Paulo, Brazil.
The Heart Surgery Forum
|March 29, 2001
Summary
The Fisics-Incor bovine pericardial bioprosthesis demonstrated satisfactory outcomes in patients undergoing valve replacement surgery. Long-term survival and functional class improvements were observed, indicating its effectiveness.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
- Medical Device Evaluation
Background:
- A study evaluated 2,607 Fisics-Incor bovine pericardial bioprostheses implanted between 1982 and 1995.
- The patient cohort included 2,259 individuals with a mean age of 47.2 years, predominantly male (55%).
- A significant proportion (45.7%) had a history of rheumatic fever.
Purpose of the Study:
- To assess the long-term efficacy and safety of the Fisics-Incor bovine pericardial bioprosthesis.
- To evaluate clinical outcomes, including survival rates and functional status, following valve replacement procedures.
Main Methods:
- The study involved various valve replacement procedures: 1,073 aortic, 1,085 mitral, 27 tricuspid, and 195 mitral-aortic replacements.
- Combined procedures, such as tricuspid valve repair and coronary artery bypass grafting, were performed in 32.9% of patients.
- Data were collected and analyzed over a 14-year period.
Main Results:
- Hospital mortality was 8.6%, with variations across valve types (aortic: 4.7%, mitral: 8.6%, double-valve: 12.8%).
- Long-term complication rates per patient-year included calcification (1.1%), thromboembolism (0.2%), rupture (0.9%), leak (0.1%), and endocarditis (0.5%).
- Fifteen-year actuarial survival was 56.7%, with significant improvements in New York Heart Association functional class for 80.6% of patients post-operatively.
Conclusions:
- The Fisics-Incor bovine pericardial bioprostheses yielded satisfactory results in the studied patient population.
- The bioprosthesis demonstrated acceptable long-term performance and contributed to improved patient functional status.
