Systematic Literature Review Comparing Clinical Utility Of Heparin-bonded Expanded Polytetrafluoroethylene Graft To Autologous Saphenous Vein Graft For Management Of Lower Limb Peripheral Arterial Disease
David J. Dexter, MD1, Frank O-Neill, PhD2, Richard Neville, MD3.
1Eastern Virginia Medical School, Norfolk, VA, USA, 2W.L. Gore & Associates, Flagstaff, AZ, USA, 3INOVA Health System, Falls Church, VA, USA.
OBJECTIVES: This systematic literature review compares clinical results of heparin-bonded expanded polytetrafluoroethylene with that of autologous saphenous vein as a conduit for patients undergoing below-the-knee bypass to treat peripheral arterial disease of the lower extremity. METHODS:A literature search was conducted using MEDLINE and EMBASE databases, to identify comparative studies in in patients undergoing below-the-knee surgical bypass. Studies were screened at both abstract and full text levels and reviewed to meet inclusion criteria by two independent reviewers. All studies were assessed for quality and risk of bias. Meta-analyses were conducted to combine data from the studies using Review Manager 5 software (Nordic Cochrane Centre, Copenhagen, Denmark).
RESULTS: Eight retrospective cohort studies published between 2009 and 2018 that compared heparin-bonded expanded polytetrafluoroethylene and autologous saphenous vein grafts were identified. Meta-analysis demonstrated comparable primary patency for heparin-bonded expanded polytetrafluoroethylene and autologous saphenous vein grafts after 1 year (0.94 [0.48-1.82, p =0.85]), 2 years (1.12[0.52-2.43], p=0.77) and 3 years (0.62 [0.26-1.48, p=0.28], but significantly favored autologous saphenous vein grafts at 4 years (0.51[0.33-,0.78,p<0.01]). In regards to secondary patency, no significant difference was detected at 1 year (0.62[0.33-1.15, p=0.13) and 3 years (0.60 [0.27-1.32, p=0.20) respectively, while 4 year outcomes suggested a benefit of autologous saphenous vein (0.65 [0.50-0.83, p>0.01).However, there was considerable heterogeneity in the studies and a lack of large controlled studies.CONCLUSIONS: This metanalysis of available clinical trials suggests comparable patency between heparin-bonded expanded polytetrafluoroethylene and autologous saphenous vein grafts for 3 years postoperatively. At the four year interval, autologous vein conduit may have a patency advantage. However, those studies that reported autologous saphenous vein grafts to have improved patency beyond three years demonstrated a risk of trial bias. In these studies, heparin-bonded synthetic grafts were used to prevent amputation when autologous saphenous vein was not available indicating a possible disparity in study groups.. Well conducted and controlled clinical studies are needed to further inform future decision-making and economic modelling related to the choice of conduit for below‑the‑knee bypass graft construction.
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