Background And Aim Of The Study: A multicenter study was designed to evaluate the Pericarbon pericardial bioprosthesis for up 10 years after implantation in the aortic position.
Methods: Between January 1986 and November 1996, 321 patients (mean age 75.8 +/- 7.3 years) received 325 Pericarbon pericardial valves in the aortic position. Four patients underwent redo surgery and each received a second Pericarbon prosthesis. Associated cardiac procedures in 80 patients were mainly coronary bypass (n = 66). Follow up extended up to 10 years (cumulative follow up of 931.0 patient-years; mean follow up 3.1 +/- 2.2 years).
Results: There were 19 late deaths, with seven valve-related. Twelve patients suffered an embolic complication (transient cerebral attack in four, peripheral in six and induction of a myocardial infarction in two). Of these complications, five occurred within 30 days of surgery and seven beyond the first year. Ten patients were reoperated on, six for primary tissue failure, two for prosthetic endocarditis and two for paraprosthetic leak. Primary failure was due in all cases to leaflet mineralization. No primary tear of the leaflet was reported. Actuarial freedom after 10 years from primary tissue failure was 83.9 +/- 7.4% and from major embolic events 97.6 +/- 1.0%. Freedom from valve-related mortality at 10 years was 92.1 +/- 4.9%.
Conclusions: These results indicate that, over a period of up to 10 years, the Pericarbon pericardial bioprosthesis compares favorably with other replacement valves.
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