Many risks and challenges must still be addressed and explored before tissue engineered heart valves can fully be clinically implemented:
* Contamination – Particular source materials can foster a microbiological environment that is conducive to the susceptibility of viruses and infectious diseases. Anytime an external scaffold is implanted within the human body, contamination, while inevitable, can be diminished through the enforcement of sterile technique.
* Scaffold Interactions - There are many risks associated with the interactions between cells and the implanted scaffold as specific biocompatibility requirements are still largely unknown with current research. The response to these interactions are also highly individualistic, dependent on the specific patient's biological environment; therefore, animal models researched prior may not accurately portray outcomes in the human body. Due to the highly interactive nature between the scaffold and surrounding tissue, properties such as biodegradability, biocompatibility, and immunogenicity must all be carefully considered as they are key factors in the performance of the final product.
* Structural complexity – Heart valves with their heterogeneous structure are very complex and dynamic, thus posing a challenge for tissue engineered valves to mimic. The new valves must have high durability while also meeting the anatomical shape and mechanical functions of the native valve.