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.
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
Piffaretti, G.;CASTELLI, PATRIZIO;
2014-01-01
Abstract
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.
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