Background and aim of the study: The study aim was to evaluate the durability of the new Mitroflow 12A pericardial bioprosthesis and to assess ventricular mass regression after aortic valve replacement (AVR) in patients with small valves.
Methods: A total of 326 Mitroflow 12A pericardial bioprostheses was implanted without any other associated valve procedure. The mean patient age was 73.5 +/- 6.1 years; 252 patients (78.0%) were in NYHA class III/IV. Small valves (19 and 21 mm) were implanted in 212 patients (65.6%). The total follow up period was 837.1 patient-years (pt-yr). A subset of 61 patients with preoperative stenosis was selected and submitted to conventional echo-Doppler assessment at a mean period of 11.1 months after surgery.
Results: Hospital mortality was 8.6%. At eight years of follow up, survival was 57.1%. Freedom from structural valve deterioration (SVD) was 86.5% per pt-yr. Mean gradients were significantly reduced postoperatively for each valve size (to 18 +/- 8 mmHg for 19-mm valves and 12 +/- 4 mmHg for 25-mm valves). The effective orifice area (EOA) was also increased significantly for all valve sizes (to 1.1 +/- 0.1 cm2 for 19-mm valves and 1.8 +/- 0.2 cm2 for 25-mm valves). The left ventricular mass index (LVMI) decreased significantly, from 177 +/- 29 to 136 +/- 22 g/m2 for the 19-mm valve, and from 200 +/- 42 to 132 +/- 22 g/m2 for the 25-mm valve. The EOA index (EOAI) showed mismatch for the 19- and 21-mm valves (0.74 and 0.82 cm2/m2, respectively). The diagrammatic calculation between LVMI and relative wall thickness after surgery showed that 29.7% of patients achieved a normal pattern of remodeling (including 19- and 21-mm valves), despite various degrees of mismatch.
Conclusion: The new Mitroflow 12A pericardial bioprosthesis showed an absence of mechanical failure after an eight-year follow up, with a satisfactory rate of SVD. Significant reductions in LVMI and improved ventricular geometry were observed, despite the small valve sizes implanted.