Fanglin Lu1, Fan Qiao2, Yanmeng Lv2, Zhao An2, Xiaohong Liu2, Peng Cao3, Zhigang Song4, Zhiyun Xu5. 1. Department of Cardiovascular Surgery, Changhai Hospital, The Second Military Medical University, Shanghai, China. Electronic address: lufanglin@smmu.edu.cn. 2. Department of Cardiovascular Surgery, Changhai Hospital, The Second Military Medical University, Shanghai, China. 3. Jenscare Biotechnology, Co. Ltd., Ningbo, China. 4. Department of Cardiovascular Surgery, Changhai Hospital, The Second Military Medical University, Shanghai, China. Electronic address: zhgsong@smmu.edu.cn. 5. Department of Cardiovascular Surgery, Changhai Hospital, The Second Military Medical University, Shanghai, China. Electronic address: zhiyunx@smmu.edu.cn.
Abstract
BACKGROUND: Interventional treatments of tricuspid regurgitation have been emerging as minimally invasive alternatives. Among those reported transcatheter tricuspid devices, the radial force between the device and native tricuspid annulus is the common principle to be employed for device immobilization. However, this immobilization mechanism may potentially lead to adverse consequences. We developed a radial force-independent stent valve device for implantation at native tricuspid annular site without inducing stress on either myocardial tissue or the bioprosthesis. METHODS: We designed a radial force-independent LuX-Valve as a transcatheter bioprosthesis, comprising a stent valve and a delivery system. The device employs a combination of a right ventricle anchoring component, two leaflet-grasping clips, and an atrial disc as a mechanical integrity to immobilize the stent valve device in secure at the native tricuspid annulus. We evaluated the feasibility and safety of implantation of this device in a goat model. RESULTS: We successfully implanted LuX-Valves at the tricuspid position through the right atrium in 17 goats. Procedures in 16 cases were safe. Time for the operator to implant the device until immobilization in secure ranged from 3.5 to 10 min. No significant paravalvular leakage was detected by echocardiography during follow-up, up to 180 days. Histopathology showed no evidence of stent fracture and myocardial injury. CONCLUSION: The results indicated that radial force-independent LuX-Valve was safe and practicable for tricuspid valve implantation with satisfactory prosthetic function.
BACKGROUND: Interventional treatments of tricuspid regurgitation have been emerging as minimally invasive alternatives. Among those reported transcatheter tricuspid devices, the radial force between the device and native tricuspid annulus is the common principle to be employed for device immobilization. However, this immobilization mechanism may potentially lead to adverse consequences. We developed a radial force-independent stent valve device for implantation at native tricuspid annular site without inducing stress on either myocardial tissue or the bioprosthesis. METHODS: We designed a radial force-independent LuX-Valve as a transcatheter bioprosthesis, comprising a stent valve and a delivery system. The device employs a combination of a right ventricle anchoring component, two leaflet-grasping clips, and an atrial disc as a mechanical integrity to immobilize the stent valve device in secure at the native tricuspid annulus. We evaluated the feasibility and safety of implantation of this device in a goat model. RESULTS: We successfully implanted LuX-Valves at the tricuspid position through the right atrium in 17 goats. Procedures in 16 cases were safe. Time for the operator to implant the device until immobilization in secure ranged from 3.5 to 10 min. No significant paravalvular leakage was detected by echocardiography during follow-up, up to 180 days. Histopathology showed no evidence of stent fracture and myocardial injury. CONCLUSION: The results indicated that radial force-independent LuX-Valve was safe and practicable for tricuspid valve implantation with satisfactory prosthetic function.