Key result
The Innovia polymer valve demonstrated a fivefold lower platelet activation rate compared with the Carpentier-Edwards Perimount Magna bioprosthetic valve in vitro (p=0.005).
Why the study?
Does the Innovia polymer valve reduce platelet activation rates compared to the Carpentier-Edwards Perimount Magna Aortic Bioprosthetic Valve in an in vitro LVAD model?
Does the Innovia polymer valve reduce platelet activation rates compared to the Carpentier-Edwards Perimount Magna Aortic Bioprosthetic Valve in an in vitro LVAD model?
Effect estimate: fivefold lower (PAS assay)
p-value: p=0.005
The Innovia polymer valve demonstrated significantly lower thrombogenic potential compared to a commercial bioprosthetic valve in an in vitro model, encouraging further development for heart valve prostheses.
Supports polymer valve development for lower thrombogenicity in LVADs; hypothesis-generating and requires in vivo validation before any clinical consideration.
Trileaflet polymeric prosthetic aortic valves (AVs) produce hemodynamic characteristics akin to the natural AV and may be most suitable for applications such as transcatheter implantation and mechanical circulatory support (MCS) devices. Their success has not yet been realized due to problems of calcification, durability, and thrombosis. We address the latter by comparing the platelet activation rates (PARs) of an improved polymer valve design (Innovia LLC) made from poly(styrene-block-isobutylene-block-styrene) (SIBS) with the commercially available Carpentier-Edwards Perimount Magna Aortic Bioprosthetic Valve. We used our modified prothrombinase platelet activity state (PAS) assay and flow cytometry methods to measure platelet activation of a pair of 19 mm valves mounted inside a pulsatile Berlin left ventricular assist device (LVAD). The PAR of the polymer valve measured with the PAS assay was fivefold lower than that of the tissue valve (p = 0.005) and fourfold lower with flow cytometry measurements (p = 0.007). In vitro hydrodynamic tests showed clinically similar performance of the Innovia and Magna valves. These results demonstrate a significant improvement in thrombogenic performance of the polymer valve compared with our previous study of the former valve design and encourage further development of SIBS for use in heart valve prostheses.
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Claiborne et al. (2010) studied this question. Innovia polymer valve made from poly(styrene-block-isobutylene-block-styrene) (SIBS) vs. Carpentier-Edwards Perimount Magna Aortic Bioprosthetic Valve was evaluated on Platelet activation rates (PARs) measured with PAS assay and flow cytometry (fivefold lower (PAS assay), p=0.005). The Innovia polymer valve demonstrated a fivefold lower platelet activation rate compared with the Carpentier-Edwards Perimount Magna bioprosthetic valve in vitro (p=0.005).
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