Five-year outcomes of surgical aortic valve replacement with a novel bovine pericardial bioprosthesis

Abstract

Abstract OBJECTIVES The short-term performance of the Cingular bovine pericardial aortic valve was proven. This study evaluated its 5-year safety and haemodynamic outcomes. METHODS It enrolled 148 patients who underwent surgical aortic valve replacement with the Cingular bovine pericardial aortic valve between March 2016 and October 2017 in 5 clinical centres in China. Safety and haemodynamic outcomes were followed up to 5 years. The incidence of all-cause mortality, structural valve deterioration and reintervention was estimated by Kaplan–Meier analysis. RESULTS The mean age of patients was 67.7 [standard deviation (SD) 5.1] years, and 36.5% of patients were female. The mean follow-up was 5.3 (SD 1.2) years. Five-year freedom from all-cause mortality, structural valve deterioration and all-cause reintervention were 91.2%, 100% and 99.3%, respectively. At 5 years, the mean gradient and effective orifice area of all sizes combined were 14.0 (SD 5.5) mmHg and 1.9 (SD 0.3) cm2, respectively. For 19- and 21-mm sizes of aortic prostheses, the mean gradients and effective orifice area at 5 years were 17.5 (SD 7.0) mmHg and 1.6 (SD 0.2) cm2 and 13.7 (SD 6.7) mmHg and 1.8 (SD 0.3) cm2, respectively. The incidence of moderate or severe patient–prosthesis mismatch was 4.1% and 0.0% patients at 5 years, respectively. CONCLUSIONS The 5-year safety and haemodynamic outcomes of Cingular bovine pericardial aortic valve are encouraging. Longer-term follow-up is warranted to assess its true durability.