Abstract
Background:We have designed a reinforced drug-loaded vascular graft composed of polycaprolactone (PCL) and polydioxanone (PDO) via a combination of electrospinning/3D printing approaches. To evaluate its potential for clinical application, we compared the in vivo blood compatibility and performance of PCL/PDO + 10%DY grafts doped with an antithrombotic drug (dipyridamole) with a commercial expanded polytetrafluoroethylene (e-PTFE) graft in a porcine model.Methods:A total of 10 pigs (weight: 25–35 kg) were used in this study. We made a new 5-mm graft with PCL/PDO composite nanofiber via the electrospinning technique. We simultaneously implanted a commercially available e-PTFE graft (n = 5) and our PCL/PDO + 10%DY graft (n = 5) into the carotid arteries of the pigs. No anticoagulant/antiplatelet agent was administered during the follow-up period, and ultrasonography was performed weekly to confirm the patency of the two grafts in vivo. Four weeks later, we explanted and compared the performance of the two grafts by histological analysis and scanning electron microscopy (SEM).Results:No complications, such as sweating on the graft or significant bleeding from the needle hole site, were seen in the PCL/PDO + 10%DY graft immediately after implantation. Serial ultrasonographic examination and immunohistochemical analysis demonstrated that PCL/PDO + 10%DY grafts showed normal physiological blood flow and minimal lumen reduction, and pulsed synchronously with the native artery at 4 weeks after implantation. However, all e-PTFE grafts occluded within the study period. The luminal surface of the PCL/PDO + 10%DY graft in the transitional zone was fully covered with endothelial cells as observed by SEM.Conclusion:The PCL/PDO + 10%DY graft was well tolerated, and no adverse tissue reaction was observed in porcine carotid models during the short-term follow-up. Colonization of the graft by host endothelial and smooth muscle cells coupled with substantial extracellular matrix production marked the regenerative capability. Thus, this material may be an ideal substitute for vascular reconstruction and bypass surgeries. Long-term observations will be necessary to determine the anti-thrombotic and remodeling potential of this device.
Highlights
Vascular atherosclerosis is among the leading causes of numerous diseases, which in most cases result in death [1]
To evaluate its potential for clinical application, we compared the in vivo blood compatibility and performance of polycaprolactone and polydioxanone (PCL/PDO) ? 10%DY grafts doped with an antithrombotic drug with a commercial expanded polytetrafluoroethylene (e-PTFE) graft in a porcine model
No plasma leakage was seen in the PCL/ PDO ? 10%DY grafts, but obvious plasma leakage was seen in several e-PTFE grafts (Supplementary Video 1)
Summary
Vascular atherosclerosis is among the leading causes of numerous diseases, which in most cases result in death [1]. The application of these conduits for blood vessel replacement in the coronary arteries and lower extremities, where the diameters are \ 6 mm, is often challenging, and they eventually fail This has led to a great deal of bioengineering research to develop efficient alternatives [6]. We simultaneously implanted a commercially available e-PTFE graft (n = 5) and our PCL/PDO ? Colonization of the graft by host endothelial and smooth muscle cells coupled with substantial extracellular matrix production marked the regenerative capability. This material may be an ideal substitute for vascular reconstruction and bypass surgeries. Long-term observations will be necessary to determine the anti-thrombotic and remodeling potential of this device
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