Cardiac Valve Replacement and Related Interventions

Recent progress in biomaterials for heart valve replacement: Structure, function, and biomimetic design

“…The transvalvular pressure of the valve needs to be low enough; (3) There should be no or little regurgitation phenomenon when valve is close (low regurgitation fraction(RF)); (4) The artificial heart valve needs to eliminate drawbacks of the existing prostheses, e.g. calcific degeneration and blood coagulation; (5)The implanted valve needs to have a good biocompatibility so that it would not destroy the normal blood components or be rejected by the immune system; (6) The implanted heart valve as well as its tent should not cause any damage to the vascular wall or endothelium; (7) The stability of aortic root (including ventricular-arterial junction (VAJ), sinuses of Valsalva, STJ, aortic annulus) and valve is essential to keep the hemodynamic environment stable and thus reduce the chance of fatigue damage. 68 Therefore, the prosthesis needs to be able to customized to fit different patient's aortic root; (8) The implanting process of the prosthesis needs to be convenient for surgeon; (9) The morphology and structure could totally recover without any fatal damage after collapse when used in transcatheter heart valve implant; (10) The cost of the prosthesis should be affordable for general people.…”

“…1 Besides, more than 100,000 heart valve surgeries are performed each year in the United States and over 300,000 operations are performed worldwide, with most of them are replacement of the mitral or aortic valves. 5 Based on simulation, the number of elderly patients with calcific aortic stenosis is projected to more than double by 2050 in both the United States and Europe. 1 Therefore, the demand for heart valve replacement will rapidly increase, and the development of ideal heart valve prosthesis is in great demand at the same time.…”

Preclinical Assessment of Cardiac Valve Substitutes: Current Status and Considerations for Engineered Tissue Heart Valves

“…Minimizing extraneous factors allows focus on the experimental device (and the reciprocal responses of the animal) as the sole independent variables. Analysis of explanted devices must be performed by a well-qualified pathological team who has broad relevant experience with the assessment of explanted heart valve substitutes in both humans and in the animal model utilized (50). A non-GLP phase data and conclusions should be submitted to the sponsor with recommendations relative to redesign.…”