Evaluation of Paravalvular Leakage in Novel Mechanical Heart Valve

We developed a new mechanical heart valve prototype with a unique mechanism for attachment to cardiac tissue. The development of novel prosthetic heart valve systems requires careful assessment of paravalvular leaks — leakage of fluid that takes place between the valve and the cardiac tissue it is attached to. Traditional methods of testing paravalvular leaks in flow chambers are not ideal for novel devices and may underestimate its true extent. In this paper we developed a novel method of quantifying paravalvular leaks involving the use of 3D printed prototype heart valves and cadaveric bovine hearts, and compared the results with those from commercially available Medtronic ATS mechanical bileaflet valves. The average leak in our final prototype heart valves were found to be 0.13 ml/sec, compared to 0.33 ml/sec in the ATS valve.