One-year outcome with a bovine pericardial valveCentral MessagePerspective
Jinmiao Chen, MD, PhD,
Chen He, MD,
Minzhi Lv, MD,
Yingqiang Guo, MD,
Liang Tao, MD,
Tao Hong, MD, PhD,
Chunsheng Wang, MD,
Xinmin Zhou, MD,
Tianxiang Gu, MD,
Lai Wei, MD, PhD,
Jiahui Fu, MPH,
Yao Wang, MD,
Yu Shi, MD
Affiliations
Jinmiao Chen, MD, PhD
Department of Cardiac Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Heart Valve, Shanghai, China
Chen He, MD
Department of Cardiac Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Heart Valve, Shanghai, China
Minzhi Lv, MD
Department of Biostatistics, Zhongshan Hospital, Fudan University, Shanghai, China
Yingqiang Guo, MD
Department of Cardiac Surgery, West China Hospital, Sichuan University, Sichuan Province, China
Liang Tao, MD
Department of Cardiac Surgery, Wuhan Asia Heart Hospital, Hubei Province, China
Tao Hong, MD, PhD
Department of Cardiac Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Heart Valve, Shanghai, China; Address for reprints: Tao Hong, MD, PhD, and Chunsheng Wang, MD, Department of Cardiac Surgery, Zhongshan Hospital, Fudan University, 180 Fenglin Rd, Shanghai 200032, China.
Chunsheng Wang, MD
Department of Cardiac Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Heart Valve, Shanghai, China; Address for reprints: Tao Hong, MD, PhD, and Chunsheng Wang, MD, Department of Cardiac Surgery, Zhongshan Hospital, Fudan University, 180 Fenglin Rd, Shanghai 200032, China.
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 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. 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.