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ITALIAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY
A Journal on Vascular and Endovascular Surgery
Italian Journal of Vascular and Endovascular Surgery 2005 September;12(3):75-81
Lower limb below-knee revascularization with a new bioactive prosthetic graft. A case-control study
Dorigo W., Pulli R., Alessi Innocenti A., Di Carlo F., Mikhalyaeva O., Chiti E., Bellandi S., Di Vito Francesco M., Pratesi C.
Department of Vascular Surgery University of Florence, Florence, Italy
Aim. The aim of this study was to retrospectively evaluate immediate and mid-term results of below-knee bypasses performed with a new bioactive heparin-treated ePTFE graft, compared with results obtained with autologous vein and standard ePTFE in a case-control study.
Methods. From March 2002 to December 2004 in 24 patients (group 1) undergoing below-knee revascularization without suitable autologous vein a new bioactive prosthetic graft was used consisting of an ePTFE prosthetic graft with covalent end-point attachment of heparin to graft surface. Control groups were randomly obtained from our historical database and consisted of 25 patients who underwent below-knee revascularization with in situ autologous saphenous vein (group 2) and of 21 patients who had standard ePTFE graft below knee revascularization (group 3), treated in the same period of group 1. Early and long results in terms of mortality, primary patency and limb salvage rates were evaluated.
Results. There were no significative differences among the 3 groups in terms of sex, age, common risk factors for atherosclerosis, indications for surgical intervention and run-off vessels’ status. Our standard protocol for intra- and postoperative drug therapy was used in all the patients. Early graft thrombosis occurred in 5 patients (20%) in group 1, in 3 patients (12%) in group 2 and in 10 patients (47%) in group 3 (P=0.002 for group 1 versus group 3). In the perioperative period 5 major amputations occurred (2 in group 1, 1 in group 2 and 2 in group 3), without significant differences among the 3 groups. Mean duration of follow-up was 19 months (SD 11.2); estimated 18-months primary patency was 53% in group 1, 75% in group 2 and 40% in group 3, with a trend towards significant better primary patency in modified ePTFE than in standard ePTFE (P=0.07). Limb salvage at 18 months was significantly better in group 2 than in group 1 and in group 3; again, there was trend towards significant better limb salvage in modified ePTFE than in standard ePTFE (P=0.08).
Conclusion. In our experience, the use of a modified ePTFE graft with covalent end-point linkage of heparin molecules on graft surface seems to significantly reduce the rate of early graft thrombosis compared with standard synthetic materials and provides also slightly better mid-term results, making it a possible graft of choice in the absence of suitable autologous veins.