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ITALIAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY
Rivista di Chirurgia Vascolare ed Endovascolare
CONTROVERSIES IN VENOUS AND ENDOVENOUS DISEASES
Italian Journal of Vascular and Endovascular Surgery 2014 September;21(3):101-7
A decade of arterial bypass results with the Gore® Propaten® Vascular Graft: long-term clinical results from more than 1000 cases in the multicenter Italian Registry
Pulli R. 1, Dorigo W. 1, Piffaretti G. 2, Castelli P. 2, Griselli F. 3, Dorrucci V. 3, Ferilli F. 4, Ottavi P. 4, De Blasis G. 5, Scalisi L. 5, Monaca V. 6, Battaglia G. 6, Vecchiati E. 7, Casali G. 4, Pratesi C. 1
1 Department of Vascular Surgery, University of Florence, Italy;
2 Department of Vascular Surgery, University of Insubria, Varese, Italy;
3 Unit of Vascular Surgery, Umberto I Hospital, Venice-Mestre, Italy;
4 Unit of Vascular Surgery, Santa Maria Hospital, Terni, Italy;
5 Unit of Vascular Surgery, SS. Filippo e Nicola Hospital, Avezzano, Italy;
6 Unit of Vascular Surgery, V.E. Ferrarotto S. Bambino Hospital, Catania, Italy;
7 Unit of Vascular Surgery, S. Maria Nuova Hospital, Reggio Emilia, Italy
AIM: The aim of this study was to evaluate early and long term results of femoro-popliteal bypasses performed with a bioactive heparin-treated ePTFE graft in patients with peripheral arterial obstructive disease (PAOD) in a multicentric retrospective registry involving seven Italian vascular centres.
METHODS: Over a twelve year period, ending in 2014, a heparin bonded prosthetic graft (Propaten® Gore-Tex®, W.L. Gore & Associates Inc, Flagstaff, AZ) was implanted in 1025 patients undergoing a femoro-popliteal bypasses for PAOD. Among them 210 were performed in the above-the-knee setting, while the remaining 815 were below-the-knee bypasses. Data concerning these interventions were retrospectively collected in a multicenter registry with a dedicated database. Early (<30 days) results were analyzed in terms of graft patency, major amputation rates and mortality. Long-term results were analyzed in terms of primary and secondary graft patency, limb salvage (in patients with critical limb ischemia) and survival.
RESULTS: Thirty-day death rate was 1.2% in the whole group and the rates of perioperative thromboses and amputations were 5% and 2% respectively. Mean duration of follow-up was 33.1 months (SD 26.1); 957 patients (96%) had at least one postoperative clinical and ultrasonographic examination and 585 (60%) reached at least a 2-year follow-up. Cumulative survival rate at 9 years was 50.4% (SE 0.4). Cumulative estimated 5 and 9-year primary patency rates were 49% and 38%, respectively (SE 0.02 and 0.04). Cumulative secondary patency rates at 5 and 9 years were 61.5% and 42%, respectively (SE 0.02 and 0.05). Amputation-free survival rates at the same time interval were 61% and 42%, respectively (SE 0.02 and 0.4).
CONCLUSION: Data from this large, retrospective registry confirmed that the indexed heparin-bonded ePTFE graft provides satisfactory early and long-term results in patients undergoing surgical revascularization for PAOD.