Validating Fatigue Safety Factor Calculation Methods for Cardiovascular Stents

Evaluating risk of fatigue fractures in cardiovascular implants via nonclinical testing is essential to provide an indication of their durability. This is generally accomplished by experimental accelerated durability testing and often complemented with computational simulations to calculate fatigue safety factors (FSFs). While many methods exist to calculate FSFs, none have been validated against experimental data. The current study presents three methods for calculating FSFs and compares them to experimental fracture outcomes under axial fatigue loading, using cobalt-chromium test specimens designed to represent cardiovascular stents. FSFs were generated by calculating mean and alternating stresses using a simple scalar method, a tensor method which determines principal values based on averages and differences of the stress tensors, and a modified tensor method which accounts for stress rotations. The results indicate that the tensor method and the modified tensor method consistently predicted fracture or survival to 107 cycles for specimens subjected to experimental axial fatigue. In contrast, for one axial deformation condition, the scalar method incorrectly predicted survival even though fractures were observed in experiments. These results demonstrate limitations of the scalar method and potential inaccuracies. A separate computational analysis of torsional fatigue was also completed to illustrate differences between the tensor method and the modified tensor method. Because of its ability to account for changes in principal directions across the fatigue cycle, the modified tensor method offers a general computational method that can be applied for improved predictions for fatigue safety regardless of loading conditions.