Development and evaluation of a novel artificial catheter-deliverable prosthetic heart valve and method for in vitro testing.

Background: This work presents a novel artificial prosthetic heart valve designed to be catheter or percutaneously deliverable, and a method for in vitro testing of the device. The device is intended to create superior characteristics in comparison to tissue-based percutaneous valves.

Methods: The percutaneous heart valve (PhV) was constructed from state-of-the-art polymers, metals and fabrics. It was tested hydrodynamically using a modified left heart simulator (Lhs) and statically using a tensile testing device.

Results: The PhV exhibited a mean transvalvular pressure gradient of less than 15 mmhg and a mean regurgitant fraction of less than 5 percent. It also demonstrated a resistance to migration of up to 6 N and a resistance to crushing of up to 25 N at a diameter of 19 mm. The PhV was crimpable to less than 24 F and was delivered into the operating Lhs via a 24 F catheter.

Conclusion: An artificial PhV was designed and optimized, and an in vitro methodology was developed for testing the valve. The artificial PhV compared favorably to existing tissue-based PhVs. The in vitro test methods proved to be reliable and reproducible. The PhV design proved the feasibility of an artificial alternative to tissue based PhVs, which in their traditional open-heart implantable form are known to have limited in vivo durability.