Semi-Quantitative Method of Assessing the Thrombogenicity of Biomaterials Intended for Long-Term Blood Contact.

Biomaterials used in cardiosurgical implants and artificial valves that have long-term contact with blood pose a great challenge for researchers due to the induction of thrombogenicity. So far, the assessment of the thrombogenicity of biomaterials has been performed with the use of highly subjective descriptive methods, which has made it impossible to compare the results of various experiments. The aim of this paper was to present a new semi-quantitative method of thrombogenicity assessment based on scanning electron microscope (SEM) images of an adhered biological material deposited on the surfaces of prepared samples. The following biomaterials were used to develop the proposed method: Bionate 55D polyurethane, polyether-ether ketone, Ti6Al7Nb alloy, sintered yttria-stabilized zirconium oxide (ZrO 2 + Y 2 O 3 ), collagen-coated glass, and bacterial cellulose. The samples were prepared by incubating the biomaterials with platelet-rich plasma. In order to quantify the thrombogenic properties of the biomaterials, a TR parameter based on the fractal dimension was applied. The obtained results confirmed that the use of the fractal dimension enables the quantitative assessment of thrombogenicity and the proper qualification of samples in line with an expert's judgment. The polyurethanes showed the best thrombogenic properties of the tested samples: Bionate 55D ( TR = 0.051) and PET-DLA 65% (average TR = 0.711). The ceramics showed the worst thrombogenic properties ( TR = 1.846). All the tested materials were much less thrombogenic than the positive control ( TR = 5.639).