Introduction Over 182,000 American patients receive SAVR annually. By 2026, this number is expected to hit 240,000. SAVR patients must choose between two undesirable options; mechanical or tissue valves. Mechanical valves require regular anticoagulation to prevent fatal thrombosis, whereas tissue valves are relatively short-lived. Additive manufacturing promises a solution, with the ability to create complex structures rapidly and accurately with a variety of materials. The purpose of this study is to evaluate the feasibility of utilizing additive manufacturing in developing an aortic valve prosthesis.
Methods Three prototypes were constructed, each further deviating from historical aortic valve designs. Trileaflet valve was made with an Elegoo Mars 3 and Resione elastic resin. It was designed in TinkerCAD and sliced with Chitubox. Form Wash and Cure were used for washing and curing. A mock circulatory loop was used for ISE (Insufficiency or Stenosis Equivalent) evaluation and ISE data was further analyzed with CircAdapt. The blood utilized in the mock circulatory loop contained mock RBCs, which were microscopically evaluated for damage in biocompatibility evaluation.
Results Trileaflet valve had an ISE of insufficiency = 8% stenosis = 0%. It showed normal trends in blood pressure and cardiac output when evaluated by CircAdapt at different heart rates and displayed a normal dip in blood pressure after 95 BPM. However, diastolic pressure was slightly low. When blood was being evaluated, hemolysis rate = 3.5% using a hemocytometer, which was within target value. The valve had almost optimal performance in terms of hemodynamics and stenosis but could be improved in terms of ISE.
Conclusions The trileaflet valve's natural design is TAVR-compatible, ideal for high-risk patients. A print time of 12 minutes allows for rapid and dynamic production. Reported hemodynamics are superior to current valve designs and valves are easily customizable. Results are promising but more research is required.