Biogenic polymer-based heart valve for congenital cardiac surgery

Area of Science:

• Biomaterials Science
• Cardiovascular Engineering
• Regenerative Medicine

Background:

• Current heart valve prostheses for congenital cardiac surgery (CCS) fail to grow or adapt to pediatric physiology, leading to high mortality.
• Material limitations in existing prostheses necessitate the development of advanced alternatives.
• Bacterial cellulose (BC) offers excellent biocompatibility and hemocompatibility, making it a suitable candidate for novel heart valve development.

Purpose of the Study:

• To develop a biogenic polymer-based heart valve using bacterial cellulose (BC).
• To evaluate the hemodynamic performance of the novel BC heart valve.
• To assess the long-term durability of the BC heart valve in a simulated physiological environment.

Main Methods:

• BC leaflets were produced and compressed to minimal thickness, with biomechanical properties evaluated.
• BC leaflets were sutured into a 23-mm stent scaffold, creating two prototype series with distinct leaflet designs.
• Hemodynamic performance was tested in a mock circulatory loop, and long-term durability was assessed over 10 million cycles.

Main Results:

• BC valve leaflets achieved significant thickness reduction (94.01%) while maintaining 100% durability at 500 mm Hg.
• The valves demonstrated acceptable hemodynamic performance with a mean transvalvular pressure drop (MTP) of 8.32 ± 1.23 mm Hg and mean regurgitation fraction (REG) of 10.22 ± 4.42%.
• Series 2 valves showed improved performance, with intact leaflets after long-term durability testing and favorable MTP, REG, and effective orifice area (EOA) values.

Conclusions:

• A novel biogenic polymer-based heart valve utilizing BC was successfully developed.
• The BC heart valve demonstrated promising hemodynamic performance and durability for congenital cardiac surgery applications.
• Further investigation and development of BC as a biomaterial for pediatric heart valves are warranted.