Does prosthetic covering of nitinol stents alter healing characteristics or hemodynamics?

Abstract

To evaluate placement of polyester (Dacron) coverings on nitinol stents implanted in the canine aorta to determine the effect on cross-sectional lumen area, development of intimal hyperplasia, device endothelialization, and flow hemodynamics. Ten polyester-covered and 10 uncovered nitinol stents (60-mm length, 10- or 12-mm diameter) were deployed percutaneously in the normal infrarenal aorta of 20 adult mongrel dogs using random assignment. Angiography, intravascular ultrasound (IVUS), and duplex ultrasound performed at device deployment and before explantation at 6 weeks were used to measure aorta/device diameter and cross-sectional area. Pressure-perfusion-fixed aortic segments were compared for surface endothelialization (CD31 staining) and for thickness of neointimal formation. All 20 endoluminal devices were accurately positioned in the infrarenal aorta without early or delayed evidence of device thrombosis, significant lumen narrowing, or device deformity. IVUS and duplex scanning identified no anatomical stenosis in either the covered or the bare devices by duplex ultrasound; peak systolic velocity measurements were similar (106+/-25 cm/s in the covered stent versus 96+/-25 cm/s for bare stents, p > 0.05). Mean neointimal thickness was significantly greater (p < 0.005) in the covered (326+/-145 microm) compared with the bare (219+/-62 microm) stents. Intima-to-media height ratios were greater in the covered stents (3.0+/-1.1 compared with 1.1+/-0.2, p < 0.003). Mean surface area endothelialization in the proximal, middle, and distal sections of each device was similar (p > 0.05) in covered (59%, 56%, and 69%) and bare (59%, 65%, and 53%) stents. Deployment and balloon dilation of a covered nitinol stent in a nondiseased canine aorta increased neointimal development compared with an uncovered stent, but overall lumen cross-sectional area was preserved. No differences in device patency, intradevice thrombus formation, flow hemodynamics, or luminal endothelialization were demonstrated, despite a thicker intradevice neointima induced by the polyester covering.