Table 6.
SD-TEVGs evaluated in large animals in arterial bypass using end-to-end (ETE) anastomosis (with antithrombotic therapy).
| Study Group | Model | Graft | Modification | Outcome | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| D (mm) | L (cm) | Animal | Implantation site | Anastomosis | Antithro-mbotic therapy | Graft type | Material | Chemical Modification | Biological modification = Recellularization | Luminal cell type | Medial cell type | Mechanical modification = Precondition | Follow-up (day) | Patency | Graft Failure | |
| Arts 2002 [62] Transduction 3 weeks |
4 | 5 | Dog | Carotid artery | ETE | Yes | Synthetic | ePTFE | None | Autologous | Fat-derived microvascular endothelial cells | None | No | 21 | 100% | No failure |
| Arts 2002 [62] 1 month |
4 | 5 | Dog | Carotid artery | ETE | Yes | Synthetic | ePTFE | None | Autologous | Fat-derived microvascular endothelial cells | None | No | 30 | 83% | Thrombus |
| Arts 2002 [62] 1 month control |
4 | 5 | Dog | Carotid artery | ETE | Yes | Synthetic | ePTFE | None | None | None | None | No | 30 | 83% | Thrombus |
| Arts 2002 [62] 12 months |
4 | 5 | Dog | Carotid artery | ETE | Yes | Synthetic | ePTFE | None | Autologous | Fat-derived microvascular endothelial cells | None | No | 365 | 100% | No failure |
| Arts 2002 [62] 12 months control |
4 | 5 | Dog | Carotid artery | ETE | Yes | Synthetic | ePTFE | None | None | None | None | No | 365 | 0 | Organised thrombus |
| Chue 2004 [63] no mesh |
3.75 | 6 | Dog | Femoral artery | ETE | Yes | Autologous cells on autologous ECM | IBTA (from peritoneal and pleural cavities, based on Polyethylene or C-flex) | None | None | None | None | No | 90–195 | 83% | Organized thrombus |
| Chue 2004 [63] PGA mesh |
3.75 | 6 | Dog | Femoral artery | ETE | Yes | Autologous cells on autologous ECM and synthetic graft | IBTA with biodegradable PGA mesh (from peritoneal and pleural cavities, based on Polyethylene) | None | None | None | None | No | 90–195 | 75% | Organized thrombus |
| Chue 2004 [63] polypropylene mesh |
3.75 | 6 | Dog | Femoral artery | ETE | Yes | Autologous cells on autologous ECM and synthetic graft | IBTA with nonbiodegradable polypropylene mesh (from peritoneal and pleural cavities, based on Polyethylene) | None | None | None | None | No | 90–195 | 0 | Organized thrombus |
| Ju 2017 [64] Acellular control |
4.75 | 5 | Sheep | Carotid artery | ETE | Yes | Synthetic and natural | Bilayered blending of PCL and calf type I collagen | None | None | None | None | No | 10 | 0 | Thrombus |
| Ju 2017 [64] EC + SMC + flow |
4.75 | 5 | Sheep | Carotid artery | ETE | Yes | Autologous cell on synthetic and natural graft | Bilayered blending of PCL and calf type I collagen | None | Autologous | PB-EC | Artery-SMCs | Yes | 180 | 100% | No failure |
| Kaushal 2001 [65] 130 days |
4 | 4.5 | Sheep | Carotid artery | ETE | Yes | Autologous cells on xenograft | Decellularized porcine iliac blood artery | None | Autologous | PB-EC | None | Yes | 130 | 100% | No failure |
| Kaushal 2001 [65] Acellular control | 4 | 4.5 | Sheep | Carotid artery | ETE | Yes | Xenogeneic | Decellularized porcine iliac blood artery | None | None | None | None | No | 15 | 25% | Thrombus |
| L’Heureux 1998 [66] w/o EC |
3 | 5 | Dog | Femoral artery | ETE (interpreted from figure) | Yes, immunosuppression | Xenogeneic | Dehydrated Human vascular SMC and fibroblasts cells sheet | None | None | None | None | No | 7 | 50% | Thrombus |
| Ma 2017 [67] DAFP + EC |
4 (outer diameter) | 6 | Dog | Carotid artery | ETE | Yes | Autologous cells on xenograft | Decellularized aortae of fetal pigs | None | Autologous | Vein-EC | None | Yes | 180 | 100% | No failure |
| Mrowczynski 2014 [68] ePTFE control |
4 | 5 | Pig | Carotid artery | ETE | Yes | Synthetic | ePTFE | None | None | None | None | No | 28 | 67% | NR |
| Mrowczynski 2014 [68] PCL |
4 | 5 | Pig | Carotid artery | ETE | Yes | Synthetic | PCL | None | None | None | None | No | 28 | 78% | Thrombus from prosthetic kink |
| Neff 2011 [69] dsTEBV (EC + SMC) |
5 | 6 | Sheep | Carotid artery or femoral artery | ETE | Yes | Autologous cells on xenograft | Decellularized porcine carotid arterial segments | None | Autologous | PB-EC | Artery-SMC | Yes | 120 | 100% | No failure |
| Neff 2011 [69] ecTEBV (EC) |
5 | 6 | Sheep | Carotid artery or femoral artery | ETE | Yes | Autologous cells on xenograft | Decellularized porcine carotid arterial segments | None | Autologous | PB-EC | None | Yes | 120 | 100% | No failure |
| Nemcova 2001 [70] Acellular xenograft |
4 | 5 | Dog | Femoral artery | ETE | Yes | Xenogeneic | Acellular porcine small intestinal submucosa | Type I bovine collagen | None | None | None | No | 63 | 89% | Wall thickening |
| Rothuizen 2016 [71] Tissue capsule |
4.2 | 4 | Pig | Carotid artery | ETE | Yes | Autologous ECM and synthetic graft | IBTA (from subcutaneous, based on PEOT/PBT) | None | None | None | None | No | 28 | 88% | Peri-anastomotic intimal hyperplasia |
| Turner 2006 [72] Collagen coating |
4.5 | 4.5 | Goat | Carotid artery | ETE | Yes | Allogeneic cells on synthetic graft | PU | Alpha-2(VIII) collagen | Allogeneic | Artery-ECs | None | No | 1 | 100% | No failure |
| Turner 2006 [72] Fibronectin coating |
4.5 | 4.5 | Goat | Carotid artery | ETE | Yes | Allogeneic cells on synthetic graft | PU | Fibronectin | Allogeneic | Artery-ECs | None | No | 1 | 100% | No failure |
| Turner 2006 [72] Uncoated control |
4.5 | 4.5 | Goat | Carotid artery | ETE | Yes | Allogeneic cells on synthetic graft | PU | None | Allogeneic | Artery-ECs | None | No | 1 | 0 | Occlusive red thrombus developed from distal white thrombus |
| Wang 2019 [73] IBTA 2 months |
3.9 | 6 | Pig | Carotid artery | ETE | Yes | Autologous ECM | Decellularized IBTA (from subcutaneous, based on PTFE) | Heparin | None | None | None | No | 60 | 67% | Anastomotic stenosis resulting thrombus |
| Weber 2017 [44] DAT, 9 months |
4.5 | 10 | Sheep | Carotid artery | ETE | Yes | Microbiological Derived | Bacterial nanocellulose | None | None | None | None | No | 270 | 67% | Thrombus formation next to the proximal anastomosis |
| Weber 2017 [44] Smooth + DAT, 2 months |
4.5 | 10 | Sheep | Carotid artery | ETE | Yes | Microbiological derived | Bacterial nanocellulose | None | None | None | None | No | 60 | 80% | NR |
| Wulff 2017 [74] SSHS-coated ePTFE |
3.5 | 20 | Sheep | Carotid artery | Interposition | Yes | Synthetic | ePTFE | Semisynthetic heparan sulphate-like on SEPS layer | None | None | None | No | 140 | 25% | Anastomotic neointimal hyperplasia originating from the genuine vessel + delamination SEPS delaminated from the ePTFE graft |
| Wulff 2017 [74] Uncoated ePTFE control |
3.5 | 20 | Sheep | Carotid artery | Interposition | Yes | Synthetic | ePTFE | None | None | None | None | No | 140 | 13% | Anastomotic neointimal hyperplasia originating from the genuine vessel |
| Zhou 2009 [75] DS control |
3 | 4.5 | Dog | Carotid artery | ETE | Yes | Allogeneic | Decellularized canine carotid arteries | None | None | None | None | No | 180 | 47% | Thrombus |
| Zhou 2009 [75] VHDS graft |
3 | 4.5 | Dog | Carotid artery | ETE | Yes | Allogeneic | Decellularized canine carotid arteries | Heparin and VEGF | None | None | None | No | 180 | 93% | Thrombus |
| Zhou 2012 [76] Acellular control (DV) |
3 | 4.5 | Dog | Carotid artery | ETE | Yes | Allogeneic | Decellularized canine carotid arteries | None | None | None | None | No | 90 | 60% | Thrombus |
| Zhou 2012 [76] Heparin + EPC |
3 | 4.5 | Dog | Carotid artery | ETE | Yes | Autologous cells on allograft | Decellularized canine carotid arteries | Heparin | Autologous | PB-EC | None | Yes | 90 | 95% | Thrombus |
| Zhou 2014 [77] Acellular control |
3 | 4.5 | Dog | Carotid arteries | ETE | Yes | Synthetic and natural graft | CS/PCL | None | None | None | None | No | 90 | 17% | Thrombus |
| Zhou 2014 [77] CS/PCL + OEC |
3 | 4.5 | Dog | Carotid artery | ETE | Yes | Autologous cells on synthetic and natural graft | CS/PCL | None | Autologous | PB-EC | None | Yes | 90 | 83% | Thrombus |
ETE: end-to-end anastomosis; ECM: extracellular matrix; PTFE: polytetrafluoroethylene; ePTFE: expanded polytetrafluoroethylene; IBTA: in-body tissue architecture; C-flex: styrene-ethylenebutylene modified block co-polymer with silicone oil; PGA: polyglycolic acid; PCL: polycaprolactone; PEOT/PBT: poly (ethylene oxide terephthalate) epoly (butylene terephthalate); SMC: smooth muscle cell; PU: polyurethane; CS/PCL: Chitosan/poly(e-caprolactone); SEPS: styrene ethylene propylene styrene co-polymer; VEGF: vascular endothelial growth factor; PB-EC: peripheral blood-endothelial cell; and EC: endothelial cell.