Carpentier-Edwards bioprosthesis: a 7-year follow-up in 361 patients.

Three hundred sixty-one patients undergoing heart valve replacement with Carpentier-Edwards bioprostheses (CE) were evaluated: 169 patients underwent replacement of the mitral valve (MVR), 124 of the aortic valve (AVR), one of the tricuspid valve (TVR) and 67 of 2 or more valves (mVR). A total of 420 CEs were implanted. Overall operative mortality was 4.7% (7.1 for MVR, 1.6 for AVR, 4.5 for mVR). Early complications included hemorrhage (5 cases), thromboembolism (one case), paraprosthetic leak (one case). Actuarial survival rates at 5 years were computed for overall deaths, cardiac deaths and prosthetic deaths. In the 3 subgroups these 3 rates were respectively 78.7 +/- 5.6%, 82.9 +/- 5.4%, 96.4 +/- 1.6% for MVR, 88.9 +/- 3.3%, 94.2 +/- 2.3%, 98.7 +/- 1.3% for AVR, and 82.3 +/- 5.9%, 88.3 +/- 5.1%, 98.5 +/- 1.5% for mVR. Actuarial freedom from prosthetic complications at 7 years was 59.6 +/- 7.5%, 78.1 +/- 4.1% and 61.9 +/- 8.0% for MVR, AVR and mVR patients. Thromboembolism-free rates were 87.2 +/- 3.9% and 99.2 +/- 0.8% for MVR and AVR, while the thromboembolic linearized rate was 2.8% per patient-year and instantaneous risk of thromboembolism was 4.1% at one and instantaneous risk of thromboembolism was 4.1% at one year for MVR. Anticoagulant-related hemorrhage linearized occurrence was 1.0%, 1.2% and 0.8% per patient-year among the 3 subgroups. Prosthetic endocarditis occurred in 12 patients with a linearized rate of 1.1% per patient-year. Eleven of these patients were treated successfully. Three episodes of primary tissue failure were recorded (0.2% linearized rate per year, instantaneous risk 3.5% at the sixth year).(ABSTRACT TRUNCATED AT 250 WORDS)