Carpentier-Edwards standard and supraannular porcine bioprostheses: Comparison of technology

Background. Performance with regard to structural valve deterioration (SVD) with the Carpentier-Edwards standard (CE-S) and supraannular (CE-SAV) (Bax ter Healthcare Corp, Irvine, CA) porcine bioprostheses was evaluated to det ermine whether progress in reduction of structural failure has been achieve d with technological changes. Methods. The CE-S was implanted during 567 aortic valve replacement (AVR) a nd 486 mitral valve replacement (MVR) procedures, and the CE-SAV was implan ted during 1,670 AVR and 1,096 MVR procedures. The failure mode of early st ent dehiscence with the CE-SAV prosthesis, thought to be controlled by manu facturing changes in 1986 and 1987, supported comparison of the CE-SAV with censored cases of stent dehiscence. Stent dehiscence accounted for only 1. 2% (1 of 81) and 14.1% (29 of 205) of AVR and MVR CE-SAV failures, respecti vely. Results. The only difference for AVR for freedom from SVD occurred in the 2 1- to 40-year age group at 15 years and was 68% for the CE-SAV and 31% for the CE-S (p < 0.05). In the 61- to 70-year age group, freedom from SVD at 1 5 years was 76% for the CE-S and 84% for the CE-SAV; for the 71-year or hig her age group, freedom from SVD was 89% and 95%, respectively (p = NS). For MVR freedom from SVD was different only in the 71-year or higher age group and was 90% for the CE-S and 59% for the CE-SAV (p < 0.05). Freedom from S VD was reduced but was similar (p = NS) for the other age groups. For AVR t he actual freedom from SVD at 15 years for the CE-S and CE-SAV was, respect ively, 79% and 72% for the 51- to 60-year age group, 86% and 91% for the 61 - to 70-year age group, and 98% and 98% for the 71-year or higher age group . For MVR, these rates were, respectively, 69% and 75% for the 61- to 70-ye ar age group and 96% and 89% for the 71-year and higher age group. Conclusions. The technologic advancements made in the second-generation CE- SAV bioprosthesis to reduce the incidence of structural failure have not un iformly been successful. The actual freedom from SVD provides evidence for implantation of porcine bioprostheses for AVR in age groups 61 to 70 years and 71 years or higher and for MVR in the age group 71 years or higher. (C) 1999 by The Society of Thoracic Surgeons.