LONG-TERM RESULTS WITH THE SORIN PERICARBON VALVE IN THE AORTIC POSITION - A MULTICENTER STUDY

Background and aim of the study: A multicenter study was designed to e valuate the Pericarbon(TM) pericardial bioprosthesis for up 10 years a fter implantation in the aortic position. Methods: Between January 198 6 and November 1996, 321 patients (mean age 75.8 +/- 7.3 years) receiv ed 325 Pericarbon pericardial valves in the aortic position. Four pati ents underwent redo surgery and each received a second Pericarbon pros thesis. Associated cardiac procedures in 80 patients were mainly coron ary bypass (n = 66). Follow up extended up to 10 years (cumulative fol low up of 931.0 patient-years; mean follow up 3.1 +/- 2.2 years). Resu lts: There were 19 late deaths, with seven valve-related. Twelve patie nts suffered an embolic complication (transient cerebral attack in fou r, peripheral in six and induction of a myocardial infarction in two). Of these complications, five occurred within 30 days of surgery and s even beyond the first year. Ten patients were reoperated on, six for p rimary tissue failure, two for prosthetic endocarditis and two for par aprosthetic leak. Primary failure was due in all cases to leaflet mine ralization. No primary tear of the leaflet was reported. Actuarial fre edom 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 mo rtality at 10 years was 92.1 +/- 4.9%. Conclusions: These results indi cate that, over a period of up to 10 years, the Pericarbon pericardial bioprosthesis compares favorably with other replacement valves.