Twelve-year follow up with the Sorin Pericarbon bioprosthesis in the mitral position.

BACKGROUND AND AIMS OF THE STUDY: The aim of this study was to evaluate the long-term follow up of the Pericarbon pericardial bioprosthesis implanted in the mitral position. METHODS: Between January 1985 and January 1991, 78 patients (26 males, 52 females; mean age 56.9 +/- 7.8 years) underwent isolated mitral valve replacement with a Pericarbon valve. All bioprostheses were size 29 mm and implanted by the same surgeon. RESULTS: Total follow up was 663.2 pt-years and it was 97% complete. Early mortality was 1.3% (1/78); two minor cerebral embolisms were observed as early complications. At 12 years the overall survival rate was 85.0 +/- and valve-related survival 93.1 +/- 3.0%; freedom from embolic events was 83.0 +/- 4.5% and from endocarditis 98.7 +/- 1.3%. Freedom from primary tissue failure was 56.8 +/- 6.6%; it was 86.3 +/- 7.5% in patients aged > 60 years and 36.8 +/- 8.2% in younger patients. There were 27 reoperations, 26 for primary tissue failure, one for endocarditis. Comparison between basal and follow up echocardiographic studies showed a significant stenotic deterioration of the bioprosthesis and a negligible incidence of regurgitation. Morphological findings of explanted bioprostheses were characterized by stenotic and diffuse microcalcification, but no tissue tear was observed. CONCLUSIONS: These results confirm that the Pericarbon bioprosthesis is structurally safe and free from the fatigue problems which afflicted the first and second generation of pericardial valves. As with other tissue valves, the rate of calcification is age-dependent, suggesting preferential use of the Pericarbon prosthesis in elderly people.