Long-term experience in autologous in vitro endothelialization of infrainguinal ePTFE grafts

• Published in: Journal of vascular surgery Vol. 49; no. 2; pp. 352 - 362
• Main Authors: Deutsch, Manfred, MD, Meinhart, Johann, PhD, Zilla, Peter, MD, PhD, Howanietz, Norbert, MD, Gorlitzer, Michael, MD, Froeschl, Alexander, MD, Stuempflen, Andreas, MD, Bezuidenhout, Deon, PhD, Grabenwoeger, Martin, MD
• Format: Journal Article
• Language: English
• Published: United States Mosby, Inc 01.02.2009
• Subjects: Aged; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation - adverse effects; Blood Vessel Prosthesis Implantation - instrumentation; Cell Culture Techniques; Cell Proliferation; Endothelial Cells - transplantation; Feasibility Studies; Female; Fibrin Tissue Adhesive - therapeutic use; Graft Occlusion, Vascular - etiology; Humans; Limb Salvage; Lower Extremity - blood supply; Male; Middle Aged; Peripheral Arterial Disease - pathology; Peripheral Arterial Disease - physiopathology; Peripheral Arterial Disease - surgery; Polytetrafluoroethylene; Prospective Studies; Prosthesis Design; Risk Assessment; Surgery; Time Factors; Tissue Adhesives - therapeutic use; Tissue Scaffolds; Transplantation, Autologous; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency
• ISSN: 0741-5214; 1097-6809
• DOI: 10.1016/j.jvs.2008.08.101

Objective Based on a previous randomized study showing significantly superior patency rates for in vitro endothelialized expanded polytetrafluoroethylene (ePTFE) grafts we investigated whether it was feasible for a nontertiary institution to offer autologous in vitro endothelialization to all elective infrainguinal bypass patients who had no suitable saphenous vein available. Methods Over a period of 15 years, 310 out of 318 consecutive nonacute patients (age 64.7 ± 8.6) received 341 endothelialized ePTFE grafts (308 femoropopliteal: 153 above knee [AK] and 155 below knee [BK] and 33 femorodistal). Autologous endothelial cells were harvested from short segments (3.9 ± 1.1 cm) of subcutaneous veins (80% cephalic, 11% basilic, 2% external jugular, and 7% saphenous) and grown to mass cultures within 18.9 ± 4.5 days before being confluently lined onto fibrin glue-coated ePTFE grafts. The graft diameter was 6 mm (64%) or 7 mm (36%). The overall procedure-related delay for graft implantation was 27.6 + 7.8 days. Growth failure prevented 2.5% of patients from receiving an endothelialized graft. The mean observation period was 9.6 years. Primary patencies were obtained from Kaplan-Meier survivorship functions. Explants for morphological analysis were obtained from eight patients. Results The overall primary patency rate of femoropopliteal grafts was 69% at 5 years (68% [AK] vs 71% [BK]) and 61% at 10 years (59% [AK] vs 64% [BK]). Primary patency of 7 mm vs 6 mm grafts was 78%/62% at 5 years and 71%/55% at 10 years. The difference between the two groups was statistically significant (log rank test P = .023; Breslow test P = .017). Stage I vs II/III patients showed 5-year patencies of 67% vs 73% (N.S.) and 10-year patencies of 61%% vs 53% (N.S.). The primary patency of femorodistal grafts was 52% at 5 years and 36% at 10 years. The limb salvage rate was 94% (fempop) vs 86% (femdistal) at 5 years and 89% vs 71% at 10 years. All retrieved samples showed the presence of an endothelium after 38.9 ± 17.8 months. Conclusion Autologous in vitro endothelialization was shown to be a feasible routine procedure at a nontertiary hospital. Explants confirmed the presence of an endothelium years after implantation while the primary patency in the particularly challenging subgroup of patients without a suitable saphenous vein resembles that of vein grafts.