The midterm (6 years) clinical results of the Carpenter-Edwards supra-annular bioprosthesis]

We present here the clinical results with a second-generation porcine bioprosthesis, the Carpentier-Edwards supra-annular valve (CESA). Two-hundred and twenty-two CESA bioprostheses were implanted in 189 patients during a four-year period (from 1984 to 1987), either as an isolated procedure or associated to mitral or tricuspid repair. The mid-term clinical results have been evaluated after a mean follow-up of 3.4 years, being 96% complete. There were 16 in-hospital deaths (8.4%) and 6 late, potentially valve-related, cardiac deaths (1.1% patients/year). Overall, 86.7 +/- 2% of the patients were free from cardiac death at 6 years (95.1 +/- 2% of the patients surviving the operative period). Linearized rates of valve related complications were the following: 1.4% patients/year for thromboembolism (including valve thrombosis), 0.5% patients/year for treatment-related hemorrhage and 0.7% patients/year for endocarditis. We did not found any case of either intrinsic or extrinsic valve failure, unrelated to infection of thrombosis. Two patients were reoperated, one because of valve thrombosis and the other due to prosthetic valve endocarditis (reoperation rate of 0.3% patients/year). When lethal and nonlethal valve-related complications (including in-hospital deaths) were considered all together, 75.8 +/- 8.4% of the patients remained alive and free of morbid events at 6 years. When patients were grouped according to the valve replaced (aortic, mitral and multiple), best results were found with patients submitted to isolated aortic valve replacement. We conclude that the CESA bioprosthesis has an excellent mid-term clinical performance. However, longer follow-up is necessary to know if improvement in valve design and manufacturing results in increased valve durability.