Document Detail

In-vivo assessment of a novel polymer (SIBS) trileaflet heart valve.
MedLine Citation:
PMID:  20845899     Owner:  NLM     Status:  MEDLINE    
BACKGROUND AND AIM OF THE STUDY: A novel trileaflet polymer valve, which is a composite design of a biostable and biocompatible polymer poly(styrene-block-isobutylene-block-styrene) (SIBS) with an embedded reinforcement polyethylene terephthalate (PET) fabric, is being developed with the intention of providing a valve that has low thrombogenicity, high durability and favorable hemodynamic performance. The study aim was to investigate the biocompatibility and performance of this SIBS valve prototype under physiological loading conditions similar to humans, using a large-animal model. METHODS: Four SIBS valves (two with surface modification using dimyristoyl phosphatidylcholine, DMPC), and two commercial Magna tissue valves, were implanted into sheep. Hemodynamic and blood chemistry measurements were performed periodically during the postoperative period. The explanted SIBS valves were extensively evaluated using macroscopic, histological, radiographical and scanning electron microscopy/energy-dispersive spectroscopy analysis. RESULTS: Three animals, one with the DMPC-coated SIBS valve, and two with the Magna valves, reached the end of the study in satisfactory clinical condition, and were euthanized after 20 weeks. The other three animals (two with SIBS valves, one with a DMPC-coated SIBS valve) died at 6, 6.5, and 10 weeks due either to material failure or myocardial infarction. The explanted valves exhibited stent deformation and cracks on the leaflets, which exposed the underlying PET fabric and resulted in severe blood and tissue reactions. Extrinsic calcification was identified on the leaflets, and was associated with the regions of surface cracks. CONCLUSION: The SIBS valve failed in animal testing because of material failure and calcification. The physical properties of SIBS must be improved in order to provide the structural integrity required for long-term in-vivo use in the form of a heart valve.
Qiang Wang; Anthony J McGoron; Richard Bianco; Yasushi Kato; Leonard Pinchuk; Richard T Schoephoerster
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Publication Detail:
Type:  Evaluation Studies; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Journal of heart valve disease     Volume:  19     ISSN:  0966-8519     ISO Abbreviation:  J. Heart Valve Dis.     Publication Date:  2010 Jul 
Date Detail:
Created Date:  2010-09-17     Completed Date:  2010-10-05     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9312096     Medline TA:  J Heart Valve Dis     Country:  England    
Other Details:
Languages:  eng     Pagination:  499-505     Citation Subset:  IM    
Department of Biomedical Engineering, Florida International University, Miami, USA.
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MeSH Terms
Aortic Valve / surgery*,  ultrasonography
Biocompatible Materials*
Equipment Failure Analysis
Feasibility Studies
Heart Valve Prosthesis*
Heart Valve Prosthesis Implantation / adverse effects,  instrumentation*
Materials Testing
Microscopy, Electron, Scanning
Models, Animal
Polyethylene Terephthalates
Prosthesis Design
Prosthesis Failure
Surface Properties
Time Factors
Grant Support
Reg. No./Substance:
0/Biocompatible Materials; 0/Polyethylene Terephthalates; 0/Styrenes; 0/poly(styrene-b-isobutylene-b-styrene); 13699-48-4/Dimyristoylphosphatidylcholine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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