Experimental Validation of SAPIEN^TM Transcatheter Heart Valve Finite Element Analysis Models

The Edwards SAPIEN^TM transcatheter heart valve is designed for heart-valve replacement in patients with severe aortic stenosis without open-heart surgery. Physiological finite element analysis (FEA) has been performed to provide an assessment of the fracture and fatigue resistance of the device during deployment and operation. Experimental validation is an essential step in establishing the credibility of computational modeling and simulation [1,2]. The present study validates FEA frame models by comparing the crimping behavior of the FEA models with the results of crimping experiments. FEA models for the Edwards SAPIEN^TM transcatheter-heart-valve frames were created to assess the structural integrity and durability of the frame, in conjunction with a number of accelerated reliability tests. When a SAPIEN^TM valve is prepared for delivery, the valve is reduced in diameter onto a delivery catheter using a radial force fixture called a “crimper”. During crimping, the frame deforms...