RESUMO
BACKGROUND: The Labcor TBLP Supra™ prosthesis is a second-generation tissue valve that has evolved from the Labcor TBLP™ prosthesis, first introduced in 1984. The Supra prosthesis is a triple-composite porcine valve, with no specific anticalcification treatment being used in its production other than standard tissue fixation with 0.4% glutaraldehyde. To date, more than 100,000 Supra valves have been implanted, mainly in South America. Despite this remarkably high number of implants, only marginal data exist concerning durability and safety issues. Hence, the study aim was to analyze short-term and intermediate outcomes relating to the clinical and hemodynamic performance of the Supra valve, as well as complication rates METHODS: A follow up study was initiated to evaluate outcomes and durability of the Labcor Supra prosthesis. Between September 2004 and October 2010, a total of 331 patients (mean age 75.8 ± 7.2 years; mean logistic EuroSCORE 8.5 ± 2.3%) underwent aortic valve replacement using the Supra porcine bioprosthesis. RESULTS: The 30-day mortality rate was 4.8% (n = 16). The overall actuarial five-year survival was 72.3 ± 4.9%, and eight-year survival was 60.4 ± 5.6%. Actuarial freedom from reoperation was 96.3 ± 2.4% after five years, and 92.5 ± 3.5% after eight years. Actuarial freedom from structural valve deterioration (SVD) was 99.7 ± 0.3% at five years, and 97.2 ± 0.8% at eight years; actuarial freedom from thromboembolism was 97.5 ± 1.0% and 95.7 ± 1.6% at these times. Actuarial freedom from event rates for endocarditis were 99.5 ± 0.3% and 96.8 ± 0.6%, and 96.1 ± 0.9% and 93.0 ± 1.4% for reoperation CONCLUSIONS: No evidence was found of increased rates of SVD. All parameters studied were comparable to those examined for other second-generation porcine prostheses. Further long-term follow up investigations are required however, for the final judgment of this prosthesis.