title: [Preliminary study of a new heart valve prostheses implanted with minimally invasive techniques: pulsatile-flow testing in vitro].
abstract: The aim of this study was to investigate the pulsatile-flow performance in vitro of a new heart valve prostheses implanted with minimally invasive techniques (HVPMIT). Three HVPMITs were tested valves and another three original biological heart valve prostheses acted as reference valves. The pulsatile-flow parameters (including mean pressure drop, regurgitant percentage of stroke volume, and effective orifice area) were tested in a pulse duplicator according to the methods listed in ISO5840-2005 and GB 12279-2008. The results demonstrated that the regurgitant percentage of stroke volume of tested valves was up to 13%. It was significantly higher than that of the reference valves. This result suggested that paravalvular leakage had occurred in the tested valves. It was found in the further analysis that because HVPMIT was not sewn into the heart tissue when the HVPMIT was implanted in vivo and there was not a sewing ring in the HVPMIT, when tested valves were fixed in the pulse duplicator, some gaps might exist between the stent of HVPMIT and the fix gasket, and the paravalvular leakage could therefore take place through these gaps. This study demonstrated that there are significant differences in the shape, structure, fixation in vivo and clinical operational methods between HVPMIT and original biological heart valve prostheses. It is necessary to establish new test methods which adapt for HVPMIT to evaluate its pulsatile-flow performance according to its own features.
authors.affiliation: Center for Medical Devices Testing, National Institutes for Food and Drug Control, Beijing 100050, China. tang-jinglong@163.com
authors.forename: Jinglong
authors.initials: J
authors.lastname: Tang
authors.forename: Shuo
authors.initials: S
authors.lastname: Wang
authors.forename: Li
authors.initials: L
authors.lastname: Liu
authors.forename: Jian
authors.initials: J
authors.lastname: Wang
authors.forename: Chunren
authors.initials: C
authors.lastname: Wang
mesh_terms: D000818:Animals; D006328:Cardiac Catheterization; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D019060:Minimally Invasive Surgical Procedures / Q000379:methods*; D011474:Prosthesis Design; D011673:Pulsatile Flow