
University of Bristol
A new polymeric heart valve with a potentially longer life span than current artificial valves could prevent millions of patients with diseased heart valves from requiring life-long blood thinning tablets. Developed by scientists at the University of Bristol and the University of Cambridge, the team's latest in-vitro results suggest that the PoliValve could last for up to 25 years.
More than 1.3 million patients with diseased heart valves need valve replacement therapy globally each year. There are two artificial valves currently available for this, and both have limitations either in durability or biocompatibility. Biological valves are made from fixed pig or cow tissue and have good biocompatibility, meaning patients do not need life-long blood thinning tablets. However, they only last ten to 15 years before failing. While mechanical valves have very good durability, they have poor biocompatibility – patients must take daily blood thinning drugs to prevent life threatening complications due to blood clots.
Professor Geoff Moggridge, Head of the Structured Materials Group at Cambridge's Department of Chemical Engineering and Biotechnology, and Professor Raimondo Ascione, NHS Adult Cardiac Surgeon and Head of the Translational Biomedical Research Centre (TBRC) at the University of Bristol, have spent three years conducting developmental work and extra-vivo and in-vivo testing on the new PoliValve.
The PoliValve is made from a special co-polymer and is designed to resemble the flexibility, biocompatibility and durability of a natural heart valve.
The device combines excellent durability with biocompatibility, addressing the limitations of current biological and mechanical artificial valves. It is made through a simple molding process, reducing manufacture and quality control costs.
Initial testing in animals has been undertaken at Bristol's TBRC facility as a first mandatory in-vivo testing step to ensure safety. Long-term in-vivo testing is already planned and funded as a necessary additional step before bringing this new treatment to patients.
“Patients requiring an artificial heart valve are often faced with the dilemma of choosing between a metallic or tissue valve replacement,” says Professor Sir Nilesh Samani, Medical Director at the British Heart Foundation. “The polymer valve combines the benefits of both. While further testing is needed before this valve can be used in patients, this is a promising development.”
According to ISO standards, a new artificial heart valve must withstand a minimum of 200 million repetitions of opening and closing during bench testing (equivalent of a five-year life span) to be tested in humans. The PoliValve has surpassed this and has exceeded the requirements of ISO standards for hydrodynamic testing as well, showing a functional performance in-vitro comparable to the best-in-class biological valve currently available on the market. The small feasibility pilot study has demonstrated the valve is easy to stitch in with no mechanical failure, no trans-valvular regurgitation, low trans-valvular gradients, and good biocompatibility at histopathology.
The Cambridge-Bristol team hopes to test their valve in patients within the next five years.Get curated news on YOUR industry.
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