Authors : Miguel A. Maluf; Mariana G. Massei, Chem; André Gimenes ; Fernando Zanoni ; Ovandir Bazan; Elida Obaldia; Orlando Auciello
Volume/Issue : Volume 6 - 2021, Issue 3 - March
Google Scholar : http://bitly.ws/9nMw
Scribd : https://bit.ly/3skGd04
Patients with pediatric prostheses suffer
from mismatch and early calcification, which causes a
high number of reoperations
Methods: Expandable Polyurethane Stent Valve – EPSV,
is composed by a flexible polyurethane (PU) leaflets is
grown on the top of an expandable cobalt-chrome alloy
stent, including the formation of three leaflets. Physical,
Hydrodynamic, Animal studies, were performed
following: ISO 5840-3,2015.
Results: Physical tests. Result of study of surface
scanning of pre and post crimp stent, showed no
structural modification of the PU. Hydrodynamic test
showed a pressure gradient oscillation between 5 to
20mm, in basal or stress condition respectively.
Experimental studies. Sheep were subjected to 3D echoDoppler study, in 6th
follow-up months, which showed
satisfactory hemodynamic performance, with low
transvalvular gradient (M = 6.60 mm Hg).
Ultrastructural Study: Six stents were explanted after 20
days to 21 months of follow-up to Ultrastructural
analysis. All of which revealed no presence of calcium
growth and prostheses structure was intact.
Conclusions: Association between: stent - design and PUleaflets, allowed acceptable hemodynamic performance,
regardless of the stent valve diameter. The resistance of
polyurethane to crimping and the lack of calcification of
leaflets, are advantages that will allow greater durability
of the prosthesis. This new concept of synthetic
expandable stent valve could be a viable option in
growing patients
Keywords : Stent, Valve, Pulmonary, Synthetic, Catheter