Role of graft oversizing in the fixation strength of barbed endovascular grafts

Abstract

The role of endovascular graft oversizing on risk of distal graft migration following endovascular aneurysm repair for abdominal aortic aneurysm is poorly understood. A controlled in vitro investigation of the role of oversizing in graft-aorta attachment strength for endovascular grafts (EVGs) with barbs was performed. Barbed stent grafts (N = 20) with controlled graft oversizing varying from 4-45% were fabricated while maintaining other design variables unchanged. A flow loop with physiological flow characteristics and a biosynthetic aortic aneurysm phantom (synthetic aneurysm model with a bovine aortic neck) were developed. The stent grafts were deployed into the aortic neck of the bio-synthetic aortic aneurysm phantom under realistic flow conditions. Computed tomography imaging of the graft-aorta complex was used to document attachment characteristics such as graft apposition, number of barbs penetrated, and penetration depth and angle. The strength of graft attachment to the aortic neck was assessed using mechanical pullout testing. Stent grafts were categorized into four groups based on oversizing: 4-10%; 11-20%; 21-30%; and greater than 30% oversizing. Pullout force, a measure of post-deployment fixation strength was not different between 4-10% (6.23 +/- 1.90 N), 11-20% (6.25 +/- 1.84 N) and 20-30% (5.85 +/- 1.89 N) groups, but significantly lower for the group with greater than 30% oversizing (3.67 +/- 1.41 N). Increasing oversizing caused a proportional decrease in the number of barbs penetrating the aortic wall (correlation = -0.83). Of the 14 barbs available in the stent graft, 89% of the barbs (12.5 of 14 on average) penetrated the aortic wall in the 4-10% oversizing group while only 38% (5.25 of 14) did for the greater than 30% group (P < .001). Also, the stent grafts with greater than 30% oversizing showed significantly poorer apposition characteristics such as eccentric compression or folding of the graft perimeter. The number and depth of barb penetration were found to be positively correlated to pullout force. Greater than 30% graft oversizing affects both barb penetration and graft apposition adversely resulting in a low pullout force in this in vitro model. Barbed stent grafts with excessive oversizing are likely to result in poor fixation and increased risk of migration.