Evaluation of a hybrid small caliber vascular graft in a rabbit model.

Objective: A hybrid small-caliber artificial vascular graft based on bilayer porcine small intestinal submucosa (SIS) with curdlan and dipyridamole mixture film serving as the so-called sandwich filler was developed for biological performance evaluation. We evaluated the performance of the graft and filler. Methods: SIS was coated with heparin by 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide. Curdlan acted as the carrier of dipyridamole. Three types of graft tubes (2 mm internal diameter and 20 mm in length) were manufactured: bilayer SIS with 10% curdlan thorn 10% dipyridamole mixture film (SCD), bilayer SIS with 10% curdlan film (SC), and monolayer SIS (S). The remodeling characteristics of the grafts were evaluated by implanting them as bypass in rabbit carotid arteries for 2 and 3 months. Each group contained 16 rabbits, and 16 nonsurgical rabbits served as the control group. Results: Eight rabbits of each group, including the graft occluded group, were killed at 2 months and the others were killed at 3 months. Follow-up showed that all 8 grafts in SCD group were patent at 2 months. Six of 16 grafts in the SC group and 5 of 16 grafts in the S group were occluded at 2 months. One of 8 SCD grafts were occluded at 3 months and the patent showed a confluent endothelium without intimal hyperplasia. The neointima layer was composed of circumferentially aligned vascular smooth muscle cells. At 3 months, SC and S group grafts showed incomplete endothelialization and varying degrees of mural thrombus, accompanied by occlusion in the SC group (3 of 8) and S group (2 of 8). Conclusions: The novel hybrid small caliber artificial vascular graft exhibited an improvement in revascularization resulting in high patency rate.