The durability test of a novel transcatheter tricuspid valve device

WANG Qiu-ji; XIAO Shuo; ZHONG Li-shan; HUA Lin-bin; ZHANG Chao-long; KE Ying-jie; PANG Shan-wen; HUANG Huan-lei

doi:10.13820/j.cnki.gdyx.20241925

Abstract：Objective This study was designed to test the durability of a novel interventional bovine pericardial tricuspid valve.Methods Bovine pericardial leaflets of three different sizes(19 mm,23 mm,and 29 mm)were used as the test valves,with corresponding sizes of valves produced by Edwards Life Sciences serving as the control group(each size including three test valves and one control valve).The hydrodynamic performance of all test and control valves was preliminarily assessed before testing.Mid-term hydrodynamic assessments were conducted after the valves completed 50 million,100 million,and 150 million cycles.After completing 200 million cycles,final ex vivo fatigue performance as-sessments were conducted.Digital subtraction angiography was used to guide the transcatheter implantation of the tricuspid valves via the right internal jugular vein,and durability was evaluated at 6 months post-operation through transthoracic echocardiography and pathological examination.Results After 200 million fatigue cycles,both the test and control valve leaflets remained intact,with complete opening and closing,and their hydrodynamic performance remained unaffected.The novel transcatheter tricuspid valve passed the fatigue test requirements of the"GB12279-2008 Cardiovascular Im-plants-Artificial Heart Valves"standard,and the hydrodynamic testing met the requirements of the pulsatile flow test specified in the same standard.The in vivo durability test indicated that the valve exhibited good opening and closing func-tions,with no calcification or damage observed at 6 months post-implantation.Conclusion The novel transcatheter tri-cuspid valve demonstrates excellent durability and hydrodynamic properties.