Abstract
OBJECTIVES: To evaluate the safety and effectiveness of a novel surgical bovine pericardial valve for aortic and mitral valve replacements. METHODS: Between March 2016 and October 2017, 197 patients (mean age, 66.9 ± 4.9 years; 40.6% were women) underwent aortic valve replacement and mitral valve replacement and were implanted with the Cingular bovine pericardial valve (Shanghai Cingular Biotech Corporation, Shanghai, China) in a prospective, multicenter, single-arm trial in China. A total of 161 aortic and 49 mitral prostheses were implanted. Patients were followed up to 1 year. The primary end point was the 1-year overall rate of valve-related complications, including thromboembolic event, valve thrombosis, major hemorrhage event, major perivalvular leak, and prosthetic valve endocarditis. RESULTS: The 1-year overall rate of valve-related complications was 0.5% (95% confidence interval, 0.1%-3.7%). The 1-year survival was 96.4%. The mean gradient and effective orifice area for aortic prostheses at 1 year postoperatively were 12.8 ± 4.4 mm Hg and 1.9 ± 0.3 cm(2), respectively. Particularly, the mean gradients and effective orifice area for 19 mm and 21 mm sizes of aortic prostheses at 1 year were 17.0 ± 3.8 mm Hg and 1.6 ± 0.2 cm(2), 13.1 ± 4.0 mm Hg and 1.8 ± 0.1 cm(2), respectively. Patient-prosthesis mismatch occurred in only 1.3% patients for aortic valve implantation at 1 month. No structural valve deterioration and no endocarditis occurred. CONCLUSIONS: The Cingular bovine pericardial valve was safe and effective for surgical aortic and mitral valve replacement. The 1-year rate of valve-related complications was very low. Early hemodynamic performance was excellent even for the small aortic root.