A Novel Braided Biodegradable
Stent for Use in Congenital Heart Disease: Short-Term Results in Porcine Iliac
Artery.
Abstract
BACKGROUND:
To evaluate the properties and efficacy of a
novel braided biodegradable stent (BBS) consisting of poly (p-dioxanone) (PPDO)
and polycaprolactone (PCL) for usage in children with congenital cardiovascular
diseases.
METHODS:
PCL/PPDO composite filaments were fabricated by
coating PCL layers onto PPDO filaments, which were fused with PPDO
monofilaments to form the BBS. Physical properties of BBSs including elastic
recovery rate, deformation rate and mechanical characteristics with adjunctive
post-dilation were evaluated by radial force-tests. 10 BBS stents and 10
metallic wall stents (WS) as controls were implanted into the common carotid
arteries of 10 pigs and angiography as well as histological examinations were
performed 4 and 8 weeks after implantation.
RESULTS:
An 8 mm BBS with adjunctive post-dilation had
the best morphological retention and dimension stability being similar to an 8
mm WS. Luminal gain percentages of BBS and WS immediately, 4 weeks and 8 weeks
after implantation were 20.44 ± 2.82% and 27.08 ± 0.88%, 12.34 ± 0.18 % and
17.32 ± 8.24%, as well as -1.76 ± 2.45% and -0.98 ± 3.23%. Luminal areas,
internal elastic laminas, neointimal areas, neointimal thicknesses and area
stenosis were not significantly different at 4 weeks and 8 weeks after
implantation. Injury and inflammation were similar in both groups and no
malposition, thrombosis or dissection occurred.
CONCLUSIONS:
BBS with adjunctive post-dilation showed good
physical properties and mechanical stability non inferior to WS. In vivo
evaluations showed that a BBS with post-ballooning had similar short-term
outcomes as a WS. This article is protected by copyright. All rights reserved.
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