title: Results from an Italian multicentric registry comparing heparin-bonded ePTFE graft and autologous saphenous vein in below-knee femoro-popliteal bypasses.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Vascular Surgery, University of Florence, Florence, Italy. dorigow@unifi.it
authors.forename: W
authors.initials: W
authors.lastname: Dorigo
authors.forename: R
authors.initials: R
authors.lastname: Pulli
authors.forename: G
authors.initials: G
authors.lastname: Piffaretti
authors.forename: P
authors.initials: P
authors.lastname: Castelli
authors.forename: F
authors.initials: F
authors.lastname: Griselli
authors.forename: V
authors.initials: V
authors.lastname: Dorrucci
authors.forename: F
authors.initials: F
authors.lastname: Ferilli
authors.forename: P
authors.initials: P
authors.lastname: Ottavi
authors.forename: G
authors.initials: G
authors.lastname: De Blasis
authors.forename: L
authors.initials: L
authors.lastname: Scalisi
authors.forename: V
authors.initials: V
authors.lastname: Monaca
authors.forename: G
authors.initials: G
authors.lastname: Battaglia
authors.forename: E
authors.initials: E
authors.lastname: Vecchiati
authors.forename: G
authors.initials: G
authors.lastname: Casali
authors.forename: C
authors.initials: C
authors.lastname: Pratesi
mesh_terms: D000368:Aged; D000792:Angiography; D000925:Anticoagulants / Q000494:pharmacology; D001157:Arterial Occlusive Diseases / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D020099:Coated Materials, Biocompatible; D005260:Female; D005263:Femoral Artery / Q000503:physiopathology / Q000601:surgery*; D005500:Follow-Up Studies; D006493:Heparin / Q000494:pharmacology*; D006801:Humans; D007558:Italy; D008297:Male; D011138:Polytetrafluoroethylene; D011150:Popliteal Artery / Q000601:surgery*; D011474:Prosthesis Design; D012008:Recurrence; D012042:Registries; D012189:Retrospective Studies; D012501:Saphenous Vein / Q000637:transplantation*; D013997:Time Factors; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014654:Vascular Patency
chemical_list: D000925:Anticoagulants; D020099:Coated Materials, Biocompatible; D011138:Polytetrafluoroethylene; D006493:Heparin