A Versatile Engineering Platform for the Fabrication of Prosthetic Venous Valves Using Electrospinning

Area of Science:

• Biomaterials Engineering
• Vascular Surgery
• Regenerative Medicine

Background:

• Chronic venous insufficiency affects millions due to valvular incompetence.
• Existing prosthetic venous valves (PVVs) have been unsuccessful due to thrombosis and leaflet thickening from cell overgrowth.
• A new approach is needed to create functional and durable PVVs.

Purpose of the Study:

• To develop a fabrication platform for percutaneous PVVs that overcomes limitations of previous designs.
• To create PVVs that prevent thrombosis and leaflet thickening.
• To demonstrate the versatility of the platform for various cardiovascular applications.

Main Methods:

• Developed a fabrication platform embedding stent struts in electrospun fibers to create leaflets.
• Utilized dual electrospinning with materials like thermoplastic polyurethane (TPU) and elastin-like recombinamers (ELRs).
• Fabricated bicuspid PVVs and tested tricuspid pediatric heart valves in vitro and according to ISO 8540 standards.

Main Results:

• The electrospun matrix separates leaflets from cells and struts from blood, preventing hyperplastic overgrowth.
• ELR/TPU constructs showed minimal platelet adhesion, no hemolysis, and supported endothelialization in vitro.
• Functional evaluation confirmed excellent hydrodynamic performance; pediatric heart valves met ISO 8540 standards.

Conclusions:

• The novel electrospinning platform enables the fabrication of functional PVVs with improved hemocompatibility and hemodyamics.
• This platform offers a versatile solution for venous valve replacement and other cardiovascular device applications.
• The technology shows promise for addressing unmet needs in treating chronic venous insufficiency and pediatric heart conditions.