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Volume 8, Issue 9 (Suppl) J Clin Exp Cardiolog, an open access journal
ISSN: 2155-9880 Euro Cardiology 2017
October 16-18, 2017
October 16-18, 2017 | Budapest, Hungary
20th European Cardiology Conference
J Clin Exp Cardiolog 2017, 8:9(Suppl)
DOI: 10.4172/2155-9880-C1-078
New expandable polyurethane stent valve for transcatheter implantation in children with heart valve
disease; results of physical, hydrodynamic and experimental tests
Miguel A Maluf, Mariana G Massei, Rogerio Orbetelli, Miko Obradovic, Christian Bader, Christoph Klaus, Evandro Drigo, Mauricio R Vaz, André
Gimenes, Fernando Zanoni, Caio Sabino, Jayme Ortiz and Ovandir Bazan
Federal University of São Paulo, Brazil
Introduction: Transcatheter valves manufactured using biological tissue, as the essential structural component, can be induced
to: mechanical degradation after crimping and early calcification in pediatric patients.
Objectives: Manufacture and successful tests of one expandable polyurethane stent valve, may reduce the repeated operations
of valve replacement, during the growing children.
Materials & Methods: I-Physical testing. Prostheses were submitted to universal testing in machine EMIC and a computer
with Tesc software, able to generate graphs of force versus deformation (stretching) II-Hydrodynamic testing. Prostheses with
diameters from 12 to 22 mm, were submitted to pulsatile physiological flow and stress conditions. III-Experimental implants
in sheep.Ten sheep was submitted to prosthesis implant, by trans catheter technique in pulmonary position. In Group A: Four
sheep w/ <20 kg, the stent was expanded up to 18mm and in Group B: Six sheep w/ > 20 kg, expanded up to 22mm.
Results: Physical and Hydrodynamic testing of Polyurethane strip removal of stent valve, before and after undergoing to 30
minutes crimping, showed preservation of properties of resistance and elasticity elongation. In vitro durability was proven
for >15 years. Eight sheep, were submited to 3D echo study, performed in the 6th month of follow-up, showed: there was no
significant transvalvular gradients and trivial regurgitation in 3 cases. Histologic, radiologic and electron microscopic study
of the first prosthesis shows: integrity of structure and free of calcification. Seven survival sheep are well, after 15th months of
follow-up.
Conclusion: Expandable polyurethane stent valve, with special design for implant and expansion in growing children, has
experimental satisfactory hemodynamic performance and durability in vitro and in vivo tests. Calcification and structural
changes were not observed. In the next step, clinical studies are be planned.