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Pericarbon Pericardial Valve Prosthesis: Midterm Results of the Aortic Valve Replacement

Thomas W. Dubiel

Hans-Erik Hansson

Johan Landelius

Sven-Olov Nyström

Jan W. Borowiec, MD, PhD

Department of Thoracic and Cardiovascular Surgery University Hospital 751 85 Uppsala, Sweden

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 complica tion, 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 reop eration 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 echocardio graphic 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.

Angiology, Vol. 49, No. 1, 1-11 (1998)
DOI: 10.1177/000331979804900101


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