Systematic literature review comparing clinical utility of heparin-bonded expanded polytetrafluoroethylene graft with autologous saphenous vein graft for the management of below-the-knee peripheral arterial disease.

This systematic literature review compares the clinical outcomes of heparin-bonded expanded polytetrafluoroethylene with autologous saphenous vein in the management of patients undergoing below-the-knee bypass to treat peripheral arterial disease. An electronic literature search was conducted in MEDLINE and Embase to identify comparative studies in patients who underwent below-the-knee surgical bypass. Studies were screened at abstract and full text review using predefined inclusion criteria by two independent reviewers and critically appraised for risk of bias. Meta-analyses were conducted using Review Manager 5 software (Nordic Cochrane Centre). Eight retrospective cohort studies were identified. Meta-analysis of primary patency demonstrated no significant difference between heparin-bonded expanded polytetrafluoroethylene and autologous saphenous vein grafts after 1 (odds ratio: 0.91, 95% confidence interval: [0.52-1.59]; P = .74), 2 (1.12 [0.60-2.10]; P = .77), 3 (0.62 [0.26-1.48]; P = .28), and 4 years (0.70 [0.36-1.39]; P = .31). Similarly, for secondary patency, no significant difference was detected at 1 (0.62 [0.33-1.15]; P = .13), 2 (0.83 [0.32-2.13]; P = .69), 3 (0.60 [0.27-1.32]; P = .20), and 4 years (0.66 [0.32-1.36]; P = .26). There was no significant difference between autologous veins and heparin-bonded expanded polytetrafluoroethylene for limb salvage and mortality at all time points. A sensitivity analysis to compare outflow vessels was conducted in only tibial bypass and identified no differences. All analyses were considered at high-risk bias because of heterogeneity in study populations and attrition in follow-up. This meta-analysis demonstrates similar outcomes between autologous saphenous vein and heparin-bonded expanded polytetrafluoroethylene for patency, limb salvage, and mortality through 4 years. The use of heparin-bonded expanded polytetrafluoroethylene synthetic grafts is a satisfactory option to prevent amputation, particularly when autologous saphenous vein grafts are not available. Controlled clinical studies are needed to further inform future decision-making and economic modeling related to the choice of conduit for below-the-knee graft construction.

Dexter DJ ，O'Neill F ，Neville RF 《-》

A multicenter comparison between autologous saphenous vein and heparin-bonded expanded polytetrafluoroethylene (ePTFE) graft in the treatment of critical limb ischemia in diabetics.

The aim of this study was to evaluate early and follow-up results of below-knee bypasses performed using a bioactive heparin-treated expanded polytetrafluoroethylene (ePTFE) graft in diabetic patients with critical limb ischemia (CLI) in a multicenter 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 centers in the same period of time. Over an 8-year period, ending in 2009, a heparin-bonded prosthetic graft (Propaten Gore-Tex; W. L. Gore & Associates Inc, Flagstaff, Ariz) was implanted in 180 diabetic patients undergoing below-knee revascularization for CLI in seven Italian hospitals (group 1). In the same period in these seven centers, 133 below-knee bypasses with ipsilateral ASV in diabetics with CLI were performed (group 2). 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. The interventions consisted of below-knee bypasses in 132 cases in group 1 (73%) and in 45 cases in group 2 (33%; P < .001); 48 patients in group 1 (27%) and 88 patients in group 2 (67%; P < .001) had distal tibial anastomosis. Patients in group 1 had more frequently adjunctive procedures performed at distal anastomotic sites to improve run-off status. Postoperative and long-term medical treatment consisted of single antiplatelet therapy in 93 cases (52%) in group 1 and in 64 cases (48%, P = ns) in group 2, of double antiplatelet therapy in 18 cases (10%) in group 1 and in four cases (3%; P = .05) in group 2 and of oral anticoagulants in 69 patients in group 1 (38%) and in 65 (49%; P = .02) in group 2. Mean duration of follow-up was 28.3 ± 21.4 months; 308 patients (98%) had at least one postoperative clinical and ultrasonographic examination and 228 (72%) reached at least a 1-year follow-up. Estimated 48-month survival rates were 76.6% in group 1 and 72.7% in group 2 (P = > .9, log-rank 0.08). Primary patency rate at 48 months was significantly better in group 2 (63.5%) than in group 1 (46.3%; P = .03, log-rank 4.1). Assisted primary patency rates at 48 months were 47.3% (SE 0.05) in group 1 and 69% (SE 0.05) in group 2 (P = .01, log-rank 6.3). The rates of secondary patency at 48 months were 57.5% in group 1 and 69.6% in group 2 (P = .1, log-rank 2.3); the corresponding values in terms of limb salvage and amputation free-survival rates were 75.4% and 82.4% (P = .3, log-rank 1), and 59.9% and 64.4% (P = .3, log-rank 0.9), respectively. Data from this large, retrospective registry confirmed that the indexed heparin-bonded ePTFE graft provides satisfactory early and midterm results in diabetic patients undergoing surgical treatment of CLI. While autologous saphenous vein maintains its superiority in terms of primary patency, secondary patency rates are not statistically different, even in the presence of a trend for improved secondary patency with vein graft; and also limb salvage rates are comparable.

Dorigo W ，Pulli R ，Castelli P ，Dorrucci V ，Ferilli F ，De Blasis G ，Monaca V ，Vecchiati E ，Pratesi C ，Propaten Italian Registry Group ... -  《-》

Comparison of propaten heparin-bonded vascular graft with distal anastomotic patch versus autogenous saphenous vein graft in tibial artery bypass.

Kaisar J ，Chen A ，Cheung M ，Kfoury E ，Bechara CF ，Lin PH ... -  《-》

A Systematic Review and Meta-Analysis of Heparin-Bonded Expanded Polytetrafluoroethylene Grafts for Below-The-Knee Femoral Bypass Surgery.

Heparin-bonded expanded polytetrafluoroethylene (hb-ePTFE) synthetic grafts are an alternative to autologous vein grafts (AVG) for surgical bypass interventions in lower limb peripheral arterial disease (LLPAD). However, the clinical benefits of hb-ePTFE grafts have not been reviewed systematically for patients undergoing below-the-knee (BK) surgical bypass. This study aimed to meta-analyze available data on the utility of hb-ePTFE in patients undergoing BK surgical bypass. Medline, Embase, and Cochrane databases were searched, restricted to material in English with no date restriction. In addition, proceedings from relevant congresses were screened going back 2 years. The search was performed in December 2021. Eligible studies included prospective or retrospective comparative studies or prospective single-arm cohorts with an hb-ePTFE arm. Methodological quality was assessed with the ROBINS-I criteria. Outcomes included primary patency, amputation/limb salvage, and overall survival. Clinical outcomes were expressed as event rates. Studies were compared using meta-analysis to generate a standardized mean event rate for each outcome, with its 95% confidence interval (95% CI), using a random-effects model. Following deduplication, 10,263 records were identified and 261 were assessed as full texts. No prospective comparative studies were identified. The level of evidence was uniformly low. Seventeen publications describing data from 9 individual patient cohorts met the inclusion criteria. These cohorts included a total of 1,452 patients undergoing BK surgical bypass with hb-ePTFE. The primary patency rate was 78.9% [95% CI: 72.2-85.7%] at 1 year, 68.2% [95% CI: 62.8-73.6%] at 2 years, decreasing to 48.0% [95% CI: 27.3-68.7%] at 5 years. The secondary patency rate was 84.8% [95% CI: 77.0-92.5%] at 1 year and 68.9% [95% CI: 43.0-94.9%] at 3 years; the 1-year limb salvage rate was 88.3% [95% CI: 79.6-97.1%] at 1 year and 79.0% [95% CI: 56.7-100%] at 3 years. In patients undergoing BK bypass surgery, hb-ePTFE synthetic grafts, compared to uncoated grafts, perform well for patency and limb salvage. However, the quality of the evidence is low, and well-performed randomized clinical trials are needed to inform clinical decision-making on the choice of synthetic graft.

Gouëffic Y ，Piffaretti G ，Iqbal K ，Dorweiler B ，Hyhlik-Dürr A ... -  《-》

A comparison of femorocrural bypasses performed with modified heparin-bonded expanded polytetrafluorethylene grafts and those with great saphenous vein grafts to treat critical limb ischemia.

Gessaroli M ，Tarantini S ，Leone M ，Fabbri E ，Panzini I ... -  《-》