Novel transcatheter aortic heart valves exhibiting excellent hemodynamic performance and low-fouling property

Abstract

Transcatheter aortic heart valves (TAHVs) have been widely used for aortic valve replacements, with less trauma and lower clinical risk compared with traditional surgical heart valve replacements. In the present study, composites of poly(ethylene glycol) diacrylate (PEGDA) hydrogels and anisotropic high-shrinkage polyethylene terephthalate/polyamide6 (PET-PA6) fabric (PEGDA/PET-PA6) were fabricated as artificial heart valve leaflets. Dynamic mechanical analyses (DMA) indicated that PEGDA/PET-PA6 composites possessed anisotropic mechanical properties (i.e., storage moduli ∼23.30 ± 1.36 MPa parallel to the aligned fabric fibers and ∼9.68 ± 0.90 MPa perpendicular to the aligned fibers at 1 Hz) that were comparable to aortic valve leaflets. The PEGDA/PET-PA6 composites with smooth surfaces were highly hydrophilic (contact angle ∼41.6° ± 3.8°) and had low-fouling properties without platelet adhesion, suggesting a low risk of thrombogenicity when they interacted with blood. Furthermore, transcatheter aortic heart valves were fabricated using nitinol self-expanding frames and PEGDA/PET-PA6 composites as artificial leaflets, which presented excellent hemodynamic performance with a large orifice area (1.75 cm2) and low regurgitation (3.41%), thus meeting the requirements of ISO 5840-3 standard. Therefore, PEGDA/PET-PA6 composites had suitable mechanical properties, good biocompatibility, and low-fouling properties, indicating that they might be used for TAHVs in the future.