Why the study?
The study was conducted to evaluate the safety and effectiveness of a novel surgical bovine pericardial valve for aortic and mitral valve replacements.
Does the Cingular bovine pericardial valve provide safe and effective outcomes in patients undergoing surgical aortic or mitral valve replacement?
Does the Cingular bovine pericardial valve provide safe and effective outcomes in patients undergoing surgical aortic or mitral valve replacement?
Answers are grounded in this paper and cite their sources.
The novel Cingular bovine pericardial valve demonstrated excellent safety, low complication rates, and favorable early hemodynamic performance at 1 year for surgical aortic and mitral valve replacement.
ObjectivesTo evaluate the safety and effectiveness of a novel surgical bovine pericardial valve for aortic and mitral valve replacements.MethodsBetween 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.ResultsThe 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 cm2, 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 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.ConclusionsThe 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.
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Chen et al. (2020) studied this question.
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