Medium long-term follow-up outcomes of BalMedic® bovine pericardial bioprosthetic valve in the mitral position

Abstract

Background: In China, where Rheumatic heart disease is still prevalent, two thirds of valve replacements are in mitral position. Before a valve replacement operation is conducted, most patients have reached Class III/IV heart function under the New York Heart Association (NYHA) classification system. As the background to this disease is quite different to that of degenerated cases, which are more prevalent in Western countries, the development of an artificial heart valve that is suitable for local patients is very significant for China. In this medium long-term clinical follow-up study, a data analysis was conducted of domestic heart valve production for mitral replacement. Methods: A total of 288 patients who underwent mitral valve replacements from 2005 to 2015 at 2 cardiac surgery centres (i.e., The Affiliated Hospital of Qingdao University, and The First People's Hospital of Yulin) were evaluated. All implanted bioprostheses were BalMedic® bovine pericardial bioprosthetic valves, which had been granted marketing approval by the China Food and Drug Administration (CFDA) in 2003. Double valve cases that involved both aortic and mitral replacements were not included in the study. On average, patients were aged 54.5±10.8 (range, 11 to 77 years) before the procedure. The mean follow-up period was 7.2±2.6 years. The study examined the overall survival (OS) curve, and different age group results. To gain further insights into the functions of the valves, the OS curve and the age group results for the reoperation-free and structural valve deterioration (SVD)-free rates are also presented. Results: The 10-year OS rate was 65.6%, the 10-year reoperation-free rate was 76.3%, and the 10-year SVD-free rate was 58.0%. In relation to the age group results, younger patients had higher survival rates, while older patients had higher reoperation-free rates and SVD-free rates. Conclusions: In relation to the medium long-term clinical follow-up results, the durability performance of the BalMedic® bovine pericardial valve in the mitral position was satisfactory, especially among patients whose heart function was worse than that of Western sufferers. Survival rate, reoperation-free rate and SVD-free rate were used for the comprehensive analysis.