Endovascular placement of stents lined with prosthetic vascular graft
materials offers promise in the treatment of dissections, aneurysms, a
nd atherosclerotic occlusive disease. This study reports the developme
nt of and initial experience with polytetrafluoroethylene (PTFE) graft
-stent devices endoluminally deployed in canines. Each iliac artery in
6 heparinized dogs received a 6-mm-diameter tubular PTFE graft mounte
d on either an 8 mm Palmaz stent (PS) or a metallic-ringed graft attac
hment device (GAD). The graft-stent devices were introduced from the f
emoral artery through a 14 Fr delivery catheter. Positioning and ballo
on expansion of the graft-stent devices were aided by fluoroscopic and
intravascular ultrasound (IVUS) assessment. Animals were studied acut
ely (n = 2) or at weeks 1, 2, 4, or 8 after placement. No interval ant
icoagulation was used. All 6 PTFE-PS devices remained patent. Two of 6
PTFE-GAD devices occluded (at two and four weeks, respectively) owing
to initial inadequate deployment. Nonoccluding thrombus was present i
n an additional 2 PTFE-GAD devices (acute and at one week, respectivel
y) and in 2 PTFE-PS devices (at one week and two weeks, respectively).
Complications included groin hematomas in 2 animals (at one week and
two weeks, respectively) caused by the large traumatic delivery cathet
er. Endoluminal placement of PTFE graft-stent devices is feasible. Acc
urate assessment of deployment by IVUS, reduction of delivery catheter
size, and improved graft-stent design are required.