Walter Dorigo1, Raffaele Pulli1, Patrizio Castelli2, Vittorio Dorrucci3, Fiore Ferilli4, Giovanni De Blasis5, Vincenzo Monaca6, Enrico Vecchiati7, Richard Neville8, Carlo Pratesi1
1Vascular Surgery, University of Florence, Florence, Italy; 2University of Insubria, Varese, Italy; 3Umberto I Hospital, Venice-Mestre, Italy; 4Santa Maria Hospital, Terni, Italy; 5SS. Filippo e Nicola Hospital, Avezzano, Italy; 6V.E. Ferrarotto S. Bambino Hospital, Catania, Italy; 7S. Maria Nuova Hospital, Reggio Emilia, Italy; 8George Washington University, Washington DC.
OBJECTIVES: To compare early and follow-up results of below-knee bypasses performed with a bioactive heparin-treated ePTFE graft and with autologous saphenous vein (ASV) in patients with critical limb ischemia in a multicentric retrospective registry involving eight Italian and American vascular centers.
METHODS: Over a nine-year period, ending in 2010, a heparin-bonded prosthetic graft (Propaten Gore-Tex®, W.L. Gore & Associates Inc, Flagstaff, AZ) was implanted in 461 patients undergoing below-knee revascularization for critical limb ischemia in seven Italian and one American hospitals (HePTFE group). In the same period of time in these eight centers 376 below-knee bypasses with ipsilateral ASV in patients with critical limb ischemia were performed (ASV group).
Early (<30 days) results were analyzed in terms of graft patency, major amputation rates and mortality. Follow-up results were analyzed in terms of primary and secondary graft patency, limb salvage and survival.
RESULTS: Early graft thrombosis occurred in 52 patients (33 in HePTFE group and 19 in ASV group); there were 26 early major amputations (19 in HePTFE group and 7 in ASV group), with 30-day major amputation rates of 3.9% and 1.9%, respectively (p=0.09).
Mean duration of follow-up was 27.1±22.4 months. Primary patency rate at 48 months was significantly better in ASV group (61.8%) than in HePTFE group (38.5%; p<0.001, log rank 19.1). The rates of secondary patency at 48 months were 51.9% in HePTFE group and 65.9% in ASV group (p=0.02, log rank 52); the corresponding values in terms of limb salvage and amputation free-survival rates were 74.4% and 78.9% (p=0.3, log rank 0.9), and 52.9% and 54% (p=0.6, log rank 0.2), respectively.
CONCLUSIONS: Heparin-bonded ePTFE graft provides satisfactory early and mid-term results in patients undergoing surgical treatment of critical limb ischemia. While autologous saphenous vein maintains its superiority in terms of primary and secondary patency, limb salvage rates are comparable.
AUTHOR DISCLOSURES: P. Castelli, Nothing to disclose; G. De Blasis, Nothing to disclose; W. Dorigo, Nothing to disclose; V. Dorrucci, Nothing to disclose; F. Ferilli, Nothing to disclose; V. Monaca, Nothing to disclose; R. Neville, Nothing to disclose; C. Pratesi, Nothing to disclose; R. Pulli, Nothing to disclose; E. Vecchiati, Nothing to disclose.
Posted April 2012