Background and aims of the study: Between 1st January 1988 and 30th June 1996, a total of 165 patients (115 males, 50 females; mean age 66.8 years) underwent isolated aortic valve replacement with Carpentier-Edwards supra-annular porcine bioprostheses in our unit. Our clinical experience with this device is reported.
Methods: In this retrospective study, mortality and complications observed in these patients were analyzed. Complications appearing with a non-biased time-course were expressed by means of linearized rates. Actuarial analysis was performed using the Kaplan-Meier method.
Results: Cumulative follow up was 551.2 patient-years, with a mean follow up of 3.5 years per patient. The hospital mortality rate was 6.7%. Linearized rates (events per 100 patient-years) and actuarial probabilities of freedom from the different complications at 8.5 years follow up, respectively, were: late mortality, 4.5 and 58.6%; valve-related mortality, 1.1 and 82.6%; thromboembolism, 1.3 and 92.7%; prosthetic endocarditis, 0.5 and 97.4%; non-structural dysfunction, 0.5 and 94.7%; structural deterioration, 0.5 and 91.6%; reoperation, 0.5 and 94.2%. Actuarial freedom from any valve-related mortality or morbidity at 8.5 years was estimated at 66.3%.
Conclusions: The Carpentier-Edwards supra-annular bioprosthesis, when implanted in the aortic position, presents a low rate of valve-related complications at this length of follow up. However, the limited life expectancy of our patients undergoing aortic valve replacement with bioprostheses (usually elderly subjects) may overshadow the potential good performance of this device.