A single-center 14-year follow-up study of the BalMedic(®) bovine pericardial bioprosthetic valve

BACKGROUND: The causes of valvular disease in China are complex, with a broad age distribution. For patients with early mechanical valve replacement, the quality of life is affected by postoperative anticoagulation-related complications. Since 2005, we have used bioprosthetic valves to provide more options for patients. In this study, we retrospectively analyzed the 14-year follow-up data of patients undergoing BalMedic bovine pericardial bioprosthetic valve replacement (manufacturer: Beijing Balance Medical Tech Co., Ltd.) to evaluate its intermediate- to long-term clinical effectiveness. METHODS: From 2005 to 2014, 336 BalMedic pericardial bioprosthesis valves were implanted in 299 patients (mean age 53.5 years, 59.86% female) at The First People’s Hospital of Yulin. Among followed up 290 discharged patients, 284 underwent aortic valve replacement and mitral valve replacement (AVR group, MVR group) for further grouping analysis, 6 underwent tricuspid valve replacement (TVR). The mean follow-up was 7.7±2.5 years (5 to 14), for a total of 2,196 valve-years, 98.28% of the patients completed follow-up. RESULTS: The perioperative mortality was 3% (9/299). After discharge, 68 patients (23.4%, 68/290) died, and 36 (12.4% 36/290) underwent the second valve replacement. The overall 5- and 10-year survival rates were 89.95% and 72.53%, respectively. For patients undergoing AVR alone, the overall 10-year survival rates were 80.64%, the reoperation-free rates were 92.94%, and the SVD-free rates were 90.95%. For patients undergoing MVR and double valve replacement (DVR group), the 10-year survival rates were 67.21% and 82.90%, the reoperation-free rates were 72.26% and 73.33%, the SVD-free rates were 58.90% and 53.80%, respectively. Subgroup analysis by age showed no significant intergroup difference in overall survival but a significant intergroup difference in reoperation-free and SVD-free rates (P<0.05). CONCLUSIONS: With a similar 10-year overall survival rate as its foreign counterparts, BalMedic bovine pericardial bioprosthesis is reliable choice for both aortic valve and mitral valve. In patients undergoing AVR, the BalMedic valve is superior to the similar foreign counterparts in overall survival, reoperation-free survival, and SVD-free rates. While in MVR or DVR, Chinese patients are younger because of different etiology, postoperative outcomes show non-inferior to those from the foreign counterparts.