Biogenic polymer-based heart valve for congenital cardiac surgery.

Background: Current heart valve prostheses in congenital cardiac surgery (CCS) are unable to grow, remodel, or adapt to a child's evolving physiology, resulting in increased mortality rates due to material-related limitations. The excellent biocompatibility and hemocompatibility of bacterial cellulose (BC) make it a promising alternative. This study aimed to use BC to develop a biogenic polymer-based heart valve and then to assess its hemodynamic performance and long-term durability. Methods: Heart valve leaflets were produced via a standard BC protocol and compressed to a minimal thickness, and their biomechanical properties were evaluated. Using a customized template, BC leaflets were sutured into a 23-mm stent scaffold. Two prototype series with different leaflet designs were tested in a mock circulatory flow loop model with a flow rate of 5 L/minute at 120/80 mm Hg. Long-term durability was assessed for 10 ± 0.5 million cycles at 120/80 mm Hg, followed by retesting. Results: BC valve leaflets exhibited a thickness reduction of 94.01% to 0.3 ± 0.11 mm ( Conclusions: The potential of BC for use in CCS was demonstrated by developing a new biogenic polymer-based valve with excellent hemodynamic performance. These results warrant further investigation and development of this biomaterial.