SELECTION OF POLYMER FOR STENT-GRAFT COATING IN TERMS OF BIOCOMPATIBILITY AND BIODEGRADATION CHARACTERISTICS

Highlights

Coated stents or stent-grafts are widely used in endovascular surgery to close arterial perforations, dissections and aneurysms, as well as in stenting of arteries with loose atherosclerotic plaques in order to reduce the risk of emboli and strokes. The material of stent coating is of great importance in the prevention of early thrombosis and restenosis of stent grafts. Biodegradable polymers have an advantage over non-biodegradable polymers because they do not remain in the patient's tissues for a long period of time and do not cause chronic inflammation. The study of the dynamics and biodegradation characteristics of polymer coating can provide information about its suitability and safety in the stent graft.

Annotation 

Aim. To screen potentially suitable polymers for stent-graft coating with the following assessment of biocompatibility and biodegradation dynamics in an in vivo experiment.

Methods. The coating was applied on the stent by electrospinning from a solution of polymers: Polycaprolactone (PCL); polydioxanone (PDO); polylactide-co-caprolactone (P(LA/CL)) with lactide: caprolactone ratio – 70:30; polylactide-co-glycolide (PLGA) with lactide: glycolide ratio – 50:50. Chloroform (CHCl3) and 1,1,1,1,3,3,3,3,3-hexafluoro-2-propanol (HFP) were used as a solvent. Gore-Tex polymer membrane made of polytetrafluoroethylene (ePTFE) was used as control. In order to evaluate biocompatibility and biodegradation dynamics in vivo, the studied polymeric samples were implanted subcutaneously in male Wistar rats for periods of 7 and 14 days, 1, 2, 3 and 6 months. After explantation all samples were studied histologically.

Results. 14 days after implantation a moderate inflammatory reaction developed on all polymer specimens. The PTFE material was separated from the surrounding tissues by a thin ordered fibrous capsule, confirming its satisfactory biocompatible properties. The porous structure of PCL membranes was filled by fibroblasts and the specimens were tightly integrated into the surrounding tissues. P(LA/CL) degrades with the formation of large fragments. The composite polymer P(LA/CL)/PDO degraded to form small fragments that are tightly integrated with the fibrous capsule. PLGA membranes showed high rates of degradation - membrane fragments were detected 3 months after implantation, after 6 months the samples were completely degraded.

Conclusion. The results of biocompatibility and biodegradation assessment in vivo indicate that the most promising polymers for stent-graft creation are PCL, PLGA and composite polymer P(LA/CL)/PDO. In order to finalize the choice of polymer, it is necessary to conduct further studies to assess the biocompatibility and degradation of polymer coating during implantation of stent-grafts into the arterial bed of large laboratory animals.

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