title: Design, Analysis and Testing of a Novel Mitral Valve for Transcatheter Implantation.
abstract: Mitral regurgitation is a common mitral valve dysfunction which may lead to heart failure. Because of the rapid aging of the population, conventional surgical repair and replacement of the pathological valve are often unsuitable for about half of symptomatic patients, who are judged high-risk. Transcatheter valve implantation could represent an effective solution. However, currently available aortic valve devices are inapt for the mitral position. This paper presents the design, development and hydrodynamic assessment of a novel bi-leaflet mitral valve suitable for transcatheter implantation. The device consists of two leaflets and a sealing component made from bovine pericardium, supported by a self-expanding wireframe made from superelastic NiTi alloy. A parametric design procedure based on numerical simulations was implemented to identify design parameters providing acceptable stress levels and maximum coaptation area for the leaflets. The wireframe was designed to host the leaflets and was optimised numerically to minimise the stresses for crimping in an 8 mm sheath for percutaneous delivery. Prototypes were built and their hydrodynamic performances were tested on a cardiac pulse duplicator, in compliance with the ISO5840-3:2013 standard. The numerical results and hydrodynamic tests show the feasibility of the device to be adopted as a transcatheter valve implant for treating mitral regurgitation.
authors.affiliation: UCL Mechanical Engineering, Cardiovascular Engineering Laboratory, University College London, London, WC1E 7JE, UK.
authors.forename: Selim
authors.initials: S
authors.lastname: Bozkurt
authors.affiliation: UCL Mechanical Engineering, Cardiovascular Engineering Laboratory, University College London, London, WC1E 7JE, UK.
authors.forename: Georgia L
authors.initials: GL
authors.lastname: Preston-Maher
authors.affiliation: UCL Mechanical Engineering, Cardiovascular Engineering Laboratory, University College London, London, WC1E 7JE, UK.
authors.forename: Ryo
authors.initials: R
authors.lastname: Torii
authors.affiliation: UCL Mechanical Engineering, Cardiovascular Engineering Laboratory, University College London, London, WC1E 7JE, UK. g.burriesci@ucl.ac.uk.|Ri.MED Foundation, Bioengineering Group, Palermo, Italy. g.burriesci@ucl.ac.uk.
authors.forename: Gaetano
authors.identifier: 0000-0002-9213-3403
authors.initials: G
authors.lastname: Burriesci
mesh_terms: D001783:Blood Flow Velocity; D001794:Blood Pressure; D003198:Computer Simulation; D017076:Computer-Aided Design; D004867:Equipment Design; D019544:Equipment Failure Analysis; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D008943:Mitral Valve / Q000503:physiopathology* / Q000601:surgery*; D008944:Mitral Valve Insufficiency / Q000503:physiopathology* / Q000628:therapy*; D008955:Models, Cardiovascular; D016896:Treatment Outcome
keywords: Bioprosthetic bi-leaflet valve; Heart valve assessment; Heart valve development; Mitral valve; Transcatheter mitral valve implantation (TMVI)