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Mitroflow pericardial bioprosthesis: clinical performance to ten years
J L Pomar1, W R Jamieson, L C Pelletier
1Universitat de Barcelona, Spain.
The Annals of Thoracic Surgery
|August 1, 1995
Summary
The Mitroflow pericardial bioprosthesis shows 10-year clinical performance, with 58% survival and 45% freedom from structural valve deterioration. Valve position impacts deterioration rates, with aortic valve replacement performing best.
Area of Science:
- Cardiovascular Surgery
- Biomaterials Science
- Clinical Performance Assessment
Background:
- The Mitroflow pericardial bioprosthesis is a second-generation device.
- Long-term clinical performance data is crucial for evaluating bioprosthetic heart valves.
Purpose of the Study:
- To assess the 10-year clinical performance of the Mitroflow pericardial bioprosthesis.
- To evaluate patient survival and freedom from structural valve deterioration (SVD) and thromboembolism (TE).
Main Methods:
- A retrospective analysis of 445 patients who underwent valve replacement with the Mitroflow bioprosthesis between 1982 and 1992.
- Follow-up data was collected for a total of 1,524 patient-years.
- Outcomes analyzed included early and late mortality, patient survival, freedom from SVD, and freedom from TE.
Main Results:
- Overall patient survival at 10 years was 58% ± 5%.
- Freedom from structural valve deterioration (SVD) at 10 years was 45% ± 7%, with significant differences by valve position (AVR 80%, MVR 58%, MR 38%).
- Freedom from thromboembolism (TE) at 10 years was 87% ± 2% and not significantly different by valve position.
Conclusions:
- The Mitroflow pericardial bioprosthesis demonstrates moderate long-term durability, with significant variations in SVD rates depending on valve position.
- Aortic valve replacement cases showed better SVD-free survival compared to mitral and multiple valve replacements.
- The prosthesis offers acceptable freedom from thromboembolism over a 10-year period.