PURPOSE: The purpose of this study is in vitro and in vivo experimental eva
luation of a square stent-based vascular occlusion device for large vessels
,
MATERIALS AND METHODS: Square stent-based large vessel occluders (LVO) 5 mm
-50 mm in size were constructed from stainless-steel square stents covered
by porcine small intestine submucosa (SIS), The LVOs with two back-side bar
bs were delivered through a guiding catheter, The LVOs with two back-side b
arbs and two frontal barbs were front-loaded and delivered coaxially, A pus
her with a retention mechanism at its end was used for deployment, In vitro
testing for competency was performed with use of a flow model with pressur
e increases, In an experimental pilot study in seven pigs and five dogs, 16
LVOs were placed into the aorta (n = 4), common iliac artery (n = 2), pulm
onary artery (n = 4), and medial sacral artery (n = 6), Four animals receiv
ed two LVOs in different locations, Angiography was performed before and af
ter placement of each LVO, Animals were followed for as long as 3 months wi
th use of angiography and were then killed for gross and histologic evaluat
ion,
RESULTS: In vitro LVOs with two and four barbs were easily collapsed and pu
shed through or front-loaded into guiding catheters (6-F for a 5-mm occlude
r, 10-F for a 50-mm occluder). A 20-mm LVO adapted to tubular structures 10
-15 mm in diameter, forming polygons 17-18.5 mm in length, In the flow mode
l, LVOs endured pressure increases to 300 mm Hg, In vivo, the LVOs self-exp
anded and adapted to the vessel without migration in all cases, The locking
pusher allowed precise LVO placement and engagement of its barbs into the
vessel wall before complete deployment, preventing dislodgment by blood flo
w, Complete arterial occlusion occurred within 10-20 minutes and arteries r
emained occluded until the animal was killed in all cases, After 2 months,
histologic evaluation revealed replacement of SIS by host tissue and its re
modeling with variable fibrocytes, fibroblasts, and some inflammatory cells
, Complete endothelialization was seen on both sides of the LVO,
CONCLUSION: The SIS LVO is effective and reliable for acute and chronic occ
lusion in a high flow model in an experimental animal.