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.
Highlights
Mitral regurgitation is one of the major mitral valve pathologies leading to heart failure.[27]
Structural failure typically occurs due to excessive stresses, with the locations of structural failure in explanted bioprosthetic heart valves often associated with the peak regions of maximum principal stress.[9]
To healthy native mitral valve,[58] leaflets were designed with a conical shape, reducing their cross section linearly form the inlet to the outlet
Summary
Mitral regurgitation is one of the major mitral valve pathologies leading to heart failure.[27]. Primary anatomical changes affecting the mitral valve leaflets, or left ventricular remodelling which may lead to dislocation of papillary muscles.[15] mild and moderate mitral regurgitation may be tolerated and do not require surgical intervention, patients with severe symptomatic mitral regurgitation have a very low survival rate in absence of interventions[40] which restore the coaptation of the mitral valve leaflets,[11] or replace the mitral valve with a prosthetic device.[30]. While non-randomised reports suggest that repairing techniques have significantly lower mortality rates,[54] randomised studies indicate no significant difference in the mortality rates[3] between replacement and repair[20] in ischemic related mitral regurgitation. Surgical repair remains the best option for the treatment of degenerative mitral regurgitation.[19,20]
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