An improved methodology for investigating the parameters influencing migration resistance of abdominal aortic stent-grafts.

PURPOSE: To develop an improved methodology for investigating the parameters influencing stent-graft migration, with particular focus on the limitations of existing methods.

METHODS

A physiological silicone rubber abdominal aortic aneurysm (AAA) model for fixation studies was manufactured based on an idealized AAA geometry: the model had a 24-mm neck, a 50-mm aneurysm, 12-mm-diameter legs, a 60 degrees bifurcation angle, and 2-mm-thick walls. The models were authenticated in neck fixation experiments. The displacement force required to migrate stent-grafts in physiological pulsatile flow was tested dynamically in water at 37 degrees C. A commercially available longitudinally rigid stent-graft (AneuRx) and a homemade device with little longitudinal rigidity were studied in a number of different configurations to investigate the effect of neck fixation length and systolic pressure on displacement force.

RESULTS

The AneuRx (6.95+/-0.49 to 8.52+/-0.5 N) performed significantly better than the homemade device (2.57+/-0.11 to 4.62+/-0.25 N) in pulsatile flow. The opposite was true in the neck fixation tests because the longitudinal stiffness of the AneuRx was not accounted for. Increasing pressure or decreasing fixation length compromised the fixation of the homemade device. This relationship was not as clear for the AneuRx because decreasing proximal fixation resulted in an increase in iliac fixation, which could assist fixation in this device.

CONCLUSION

Assessing the migration resistance of stent-grafts based solely on proximal fixation discriminates against devices that are longitudinally stiff. Current in vivo models may give inaccurate displacement forces due to the high degree of oversizing in these studies. A novel in vitro approach, accounting for longitudinal rigidity and realistic graft oversizing, was developed to determine the resistance of aortic stent-grafts to migration in the period immediately after device implantation.