Purpose: Nonspecific inflammatory reactions characterized by local ten
derness, fever, and flu-like discomfort have been seen in patients und
ergoing endoluminal graft placement in the abdominal aorta or the femo
ral arteries. We undertook a study to assess the clinical and laborato
ry parameters of this inflammation. Methods: Ten patients with femorop
opliteal artery (n = 9) or aortic (n = 1) lesions were treated with En
doPro System 1 stent-grafts made of nitinol alloy and covered with a p
olyester (Dacron) fabric. Eleven patients implanted with a bare nitino
l stent served as the control group. Results: In the stent-graft group
, four patients showed clinical signs of acute inflammation manifested
by fever and local tenderness. Three of these patients suffered throm
bosis of the stent-grafts during the first month of follow-up. Plasma
levels of interleukin-lp and interleukin-6 in all stent-graft patients
were markedly increased 1 day after intervention (7.3 +/- 2.8 versus
90.2 +/- 34.1 pg/mL and 15.6 +/- 5.8 versus 175.5 +/- 66.3 pg/mL, resp
ectively; p < 0.01). This was followed by an increase in fibrinogen (3
.0 +/- 0.2 versus 5.0 +/- 0.2 g/L; p < 0.05) and C-reactive protein (1
4.6 +/- 3.3 versus 77.5 +/- 15.0 mg/L; p < 0.01) at 1 week. No direct
correlation between the inflammatory markers and symptoms could be fou
nd. In vitro analysis showed that individual components of the stent-g
raft did not activate human neutrophils, whereas the intact stent-graf
t itself induced a marked neutrophil activation. Conclusions: The comp
onent of the self-expanding stent-graft responsible for the nonspecifi
c inflammatory reaction was not identified in this study. It is likely
that the stent-graft itself or some as yet unrecognized element of th
e device other than the Dacron fabric or metal alloy may be a potent i
n vivo inducer of cytokine reaction by neutrophils.