PERICARBON PERICARDIAL VALVE PROSTHESIS - MIDTERM RESULTS OF THE AORTIC-VALVE REPLACEMENT

This clinical study was undertaken to verify the encouraging results o f experimental studies regarding a new pericardial bioprosthesis. From May 1989 to November 1993, 204 patients underwent an aortic valve rep lacement with the Pericarbon(R) (Sorin Biomedica Cardio S.p.A., Salugg ia, Italy) prosthesis. A follow-up was 100% complete and extended to 6 5 months (total 408 patient-years, average 2.0 +/- 1.4 years). Mean ag e at the operation was 75.1 +/- 5.5 years and 96% were in NYHA clinica l stage III or IV. There were 86 men and 118 women; 73 patients had an isolated aortic valve disease, 131 had a concomitant cardiosurgical p rocedure (coronary artery bypass grafting in 106 patients). The operat ive mortality (30-day mortality) rate was 11.8% (24/204). There were 2 4 late deaths (5.9 +/- 1.2% patient-year). The actuarial probability o f survival was 68 +/- 5% at 5 years. Four patients died of valve-relat ed causes (one thromboembolic complication, two endocarditis, one anti coagulant-related hemorrhage). Actuarial rate of freedom from valve-re lated 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% p atient-year) and one reoperation (0.2% patient-year). After 5 years fr eedom from thromboembolic events was 83 +/- 7%, from anticoagulant-rel ated hemorrhage 96 +/- 2%, from endocarditis 97 +/- 2%, and from reope ration 99 +/- 1%. Echocardiographic study performed in 30 patients sho wed a paraprosthetic leak in four patients, a central leak in two, and cusp thickening in another three. The clinical data showed that the P ericarbon prosthesis has valve-related morbidity. The echocardiographi c 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.