Dorigo W, Pulli R, Piffaretti G, Castelli P, Griselli F, Dorrucci V, Ferilli F, Ottavi P, De Blasis G, Scalisi L, Monaca V, Battaglia G, Vecchiati E, Casali G, Pratesi C
Department of Vascular Surgery, University of Florence, Florence, Italy.
J Cardiovasc Surg (Torino). 2012 Apr;53(2):187-94.
The aim of this study was to evaluate early and follow-up results of below-knee 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 centers and to compare them with those obtained in patients operated on with autologous saphenous vein (ASV) in the same centres in the same period of time.
Over a nine-year period, ending in 2010, a heparin bonded prosthetic graft (Propaten Gore-Tex, W.L. Gore & Associates Inc, Flagstaff, AZ, USA) was implanted in 556 patients undergoing below-knee revascularization for PAOD (HePTFE group). In the same period of time 394 below-knee bypasses with ipsilateral ASV were performed (ASV group). 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. Follow-up results were analyzed in terms of primary and secondary graft patency, limb salvage and survival.
Among patients of HePTFE group, 413 had critical limb ischemia (74%); the corresponding figure for ASV group was 84% (332 interventions, P<0.001). Eighty-nine patients in HePTFE group (16%) and 207 patients in ASV group (52.5%; P<0.001) had distal tibial anastomosis. Patients in HePTFE group had more frequently adjunctive procedures performed at distal anastomotic sites in order to improve run-off status. Thirty-day death rate was 1.9% in HePTFE group and 0.5% in ASV group (P=0.08). The rates of perioperative thromboses and amputations were 6% and 3.5% in HePTFE group, and 5% and 1.7% in ASV group, without significant differences between the two groups. Mean duration of follow-up was 28.5±22.1 months; 921 patients (97%) had at least one postoperative clinical and ultrasonographic control. Estimated 48-month survival rates were 81% in HePTFE group and 74% in ASV group (P=0.7, log rank 0.1). Primary patency rate at 48 months was significantly better in ASV group (61%) than in HePTFE group (44.5%; P=0.004, log rank 8.1). The rates of secondary patency at 48 months were 57% in HePTFE group and 67.5% in ASV group (P=0.1, log rank 1.9); the corresponding values in terms of limb salvage in patients with critical limb ischemia were 77% and 79.5% (P=0.3, log rank 0.9), respectively.
Data from this large, retrospective registry confirmed that the indexed heparin-bonded ePTFE graft provides satisfactory early and mid-term results in patients undergoing surgical below-knee revascularization. While autologous saphenous vein maintains its superiority in terms of primary patency, secondary patency and limb salvage rates are comparable.
本研究旨在评估在一个涉及七个意大利血管中心的多中心回顾性登记研究中，采用生物活性肝素处理的ePTFE移植物进行膝下旁路手术的患者的早期和随访结果，并将其与同期在同一中心接受自体大隐静脉（ASV）手术的患者的结果进行比较。
在截至2010年的九年期间，将肝素结合人工血管移植物（Propaten Gore-Tex，美国亚利桑那州弗拉格斯塔夫的W.L. Gore & Associates公司）植入556例因外周动脉阻塞性疾病（PAOD）接受膝下血管重建术的患者（肝素处理的ePTFE组）。同期进行了394例采用同侧ASV的膝下旁路手术（ASV组）。有关这些干预措施的数据通过一个专用数据库在多中心登记研究中进行回顾性收集。早期（<30天）结果从移植物通畅率、大截肢率和死亡率方面进行分析。随访结果从移植物的初级和次级通畅率、肢体挽救率和生存率方面进行分析。
在肝素处理的ePTFE组患者中，413例患有严重肢体缺血（74%）；ASV组的相应数字为84%（332例干预，P<0.001）。肝素处理的ePTFE组有89例患者（16%），ASV组有207例患者（52.5%；P<0.001）进行了胫前远端吻合。肝素处理的ePTFE组患者为改善流出道状态，更频繁地在远端吻合部位进行辅助手术。肝素处理ePTFE组的30天死亡率为1.9%，ASV组为0.5%（P=0.08）。肝素处理的ePTFE组围手术期血栓形成率和截肢率分别为6%和3.5%；ASV组分别为5%和1.7%，两组之间无显著差异。平均随访时间为28.5±22.1个月；921例患者（97%）至少进行了一次术后临床和超声检查。肝素处理的ePTFE组48个月的估计生存率为81%，ASV组为74%（P=0.7，对数秩检验0.1）。48个月时ASV组的初级通畅率（61%）显著优于肝素处理的ePTFE组（44.5%；P=0.004，对数秩检验8.1）。48个月时肝素处理的ePTFE组的次级通畅率为57%，ASV组为67.5%（P=0.1，对数秩检验1.9）；严重肢体缺血患者在肢体挽救方面的相应数值分别为77%和79.5%（P=0.3，对数秩检验0.9）。
来自这个大型回顾性登记研究的数据证实，索引肝素结合的ePTFE移植物在接受膝下手术血管重建的患者中提供了令人满意的早期和中期结果。虽然自体大隐静脉在初级通畅率方面保持其优势，但次级通畅率和肢体挽救率相当。
