Pericarbon pericardial valve prosthesis: midterm results of the aortic valve replacement.

Abstract

This clinical study was undertaken to verify the encouraging results of experimental studies regarding a new pericardial bioprosthesis. From May 1989 to November 1993, 204 patients underwent an aortic valve replacement with the Pericarbon (Sorin Biomedica Cardio S.p.A., Saluggia, Italy) prosthesis. A follow-up was 100% complete and extended to 65 months (total 408 patient-years, average 2.0+/-1.4 years). Mean age at the operation was 75.1+/-5.5 years and 96% were in NYHA clinical stage III or IV. There were 86 men and 118 women; 73 patients had an isolated aortic valve disease, 131 had a concomitant cardiosurgical procedure (coronary artery bypass grafting in 106 patients). The operative mortality (30-day mortality) rate was 11.8% (24/204). There were 24 late deaths (5.9+/-1.2% patient-year). The actuarial probability of survival was 68+/-5% at 5 years. Four patients died of valve-related causes (one thromboembolic complication, two endocarditis, one anticoagulant-related hemorrhage). Actuarial rate of freedom from valve-related death was 95+/-3% at 5 years. Valve-related morbidity included seven thromboembolic episodes (1.7% patient-year), four anticoagulant-related complications (0.9% patient-year), three endocarditis (0.7% patient-year) and one reoperation (0.2% patient-year). After 5 years freedom from thromboembolic events was 83+/-7%, from anticoagulant-related hemorrhage 96+/-2%, from endocarditis 97+/-2%, and from reoperation 99+/-1%. Echocardiographic study performed in 30 patients showed a paraprosthetic leak in four patients, a central leak in two, and cusp thickening in another three. The clinical data showed that the Pericarbon prosthesis has valve-related morbidity. The echocardiographic results suggest that the prosthesis can undergo a pathologic process during the first 5 years after implantation. This makes it necessary to continue the follow-up and include the larger number of patients in the echocardiographic investigation.