One-year outcome with a bovine pericardial valve

Abstract Objectives To evaluate the safety and effectiveness of a novel surgical bovine pericardial valve for aortic and mitral valve replacements (AVR and MVR). Methods Between March 2016 and October 2017, 197 patients (mean age, 66.9 ± 4.9 years; 40.6% were female) underwent AVR and MVR implanted with the Cingular bovine pericardial valve in a prospective, multi-center, 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 endpoint was the 1-year overall rate of valve-related complications, including thromboembolic event, valve thrombosis, major haemorrhage event, major perivalvular leak, and prosthetic valve endocarditis. Results The 1-year overall rate of valve-related complications was 0.5% (95% CI: 0.1% - 3.7%). The 1-year survival was 96.4%. The mean gradient and effective orifice area (EOA) for aortic prostheses at 1 year postoperatively were 12.8 ± 4.4 mm Hg and 1.9 ± 0.3 cm2, respectively. Particularly, the mean gradients and EOA 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 cm2, 13.1 ± 4.0 mm Hg and 1.8 ± 0.1 cm2, 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 AVR and MVR. The 1-year rate of valve-related complications was very low. Early hemodynamic performance was excellent even for the small aortic root.