A novel polymeric heart valve with potentially greater benefits than current artificial valves has been developed by UK scientists.
The latest animal model and laboratory results of the valve, which could be tested in patients within five years, have been published in Biomaterials Science.
Researchers developed and tested at International Organisation for Standardisation (ISO) standards a novel prosthetic heart valve (PoliValve) manufactured by injection moulding.
The unique feature of this polymeric valve is that it is made of a self-assembling polymer with a microstructure conferring mechanical anisotropy analogous to that of natural valve tissue.
This anisotropy has been optimised by computational modelling and can be controlled by well-defined processing, notably injection position, temperature and rate.
In-vivo short-term feasibility testing in sheep confirmed preliminary safety, functionality and biocompatibility. In the study, the valve was shown to be easy to stitch in and had no signs of mechanical failure at one hour to 24 hours after surgery, and no anticoagulation was needed.
The results support progression to a long-term efficacy trial, the researchers said.
Replacement heart valves are subject to ISO standards, which stipulates that they must last 200 million heartbeats – about five years. In the study, the PoliValve demonstrated durability in accelerated in-vitro tests up to 1.2 billion cycles, equivalent to 30 patient years.
A long-term trial testing the safety of the polymeric valve versus a best in class tissue valve is already underway.
It is hoped the polymeric valve will overcome the limitations of the two currently available types of artificial replacement valves. People fitted with a mechanical valve must take lifelong anticoagulation drugs, whereas tissue valves are not as durable and usually need replacing later in life.
The research has been supported by the British Heart Foundation.
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