Long-term Results of a Heparin-bonded Expanded Polytetrafluoroethylene Grafts for Above-the-knee Femoropopliteal Bypasses: A Japanese Prospective Multicenter Registry

Propaten (WL Gore & Associates, Flagstaff, AZ) is a bioactive heparin-bonded expanded polytetrafluoroethylene graft widely used for bypass surgery; however, its long-term results are yet to be established. In this study, we evaluated the long-term results of Propaten for above-the-knee femoropopliteal bypasses (AKFPB) using a Japanese prospective multicenter registry. In this prospective single-arm multicenter registry, 120 limbs (113 patients) underwent AKFPB for superficial femoral artery (SFA) lesion in 20 Japanese institutions between July 2014 and October 2017. We evaluated the long-term results by estimating primary patency (PP), secondary patency (SP), freedom from target lesion revascularization (TLR), and freedom from death at 6 years using the Kaplan-Meier method. Factors associated with the risk for the loss of PP were investigated using the Cox proportional hazards regression model. Baseline characteristics of 120 limbs are summarized in Table. Mean lesion length was 26.2 ± 5.7 cm, chronic limb-threatening ischemia was present in 45 limbs (37.5%), and only 35 limbs (29.2%) had all three runoff vessels patent. Technical success was achieved in all cases, and 49 limbs (40.8%) had concomitant additional procedure, mainly endovascular treatment (EVT), and cuffed distal anastomosis was employed in 93 limbs (77.5%). There were eight perioperative complications (6.7%), however, mean ankle brachial index (ABI) improved from 0.45 ± 0.27 to 0.96 ± 0.14, and improvement in Rutherford classification (RC) was achieved in 98 limbs (81.7%) at 30 days. Clinical improvement was sustained at the latest follow-up as mean ABI was 0.87 ± 0.23, and improvement in RC was achieved in 105 limbs (87.5%). PP, freedom from TLR, SP, and freedom from death at 6 years were 66.1% ± 4.9%, 72.4% ± 4.5%, 85.6% ± 3.6%, and 62.9% ± 4.8%, respectively (Fig 1). As for the factors associated with the risk for the loss of PP, prior coronary disease (unadjusted hazard ratio [HR], 2.57; 95% confidence interval [CI], 1.09-4.36; P = .006), hemodialysis (unadjusted HR, 2.62; 95% CI, 1.19-5.57; P = .02), three runoff vessels patent (unadjusted HR, 0.48; 95% CI, 0.22-1.06; P = .07), and cuffed distal anastomosis (unadjusted HR, 0.51; 95% CI, 0.25-1.07; P = .08) were selected for the multivariate analysis from the result of univariate analysis; however, only prior coronary disease remained significant (adjusted HR, 2.18; 95% CI, 1.09-4.36; P = .03). Long-term sustained clinical improvement and acceptable SP was achieved for AKFPB using Propaten. When good venous conduit is unavailable, AKFPB using Propaten is a reasonable revascularization option for complex SFA lesions, especially when EVT is inappropriate.TablePatients’ demographics and characteristicsVariableN = 120 limbsAge, years72.7 ± 8.1Male sex81 (67.5%)Body mass index, kg/m222.5 ± 3.8Rutherford classification 230 (25.0%) 345 (37.5%) 413 (10.8%) 531 (25.8%) 61 (0.8%)Ankle brachial index0.45 ± 0.27Number of runoff vessels 01 (0.8) 143 (35.8) 241 (34.2) 335 (29.2)TASC II classifications A0 (0.0) B6 (5.0) C20 (16.7) D94 (78.3)Lesion length, cm26.2 ± 5.7Outflow popliteal artery diameter, mm4.9 ± 1.1Key comorbidities and medical history Smoking, current31 (25.8%) Smoking, former67 (55.8%) Prior superficial femoral artery treatment32 (26.7%) Arterial hypertension91 (75.8%) Diabetes mellitus63 (52.5%) Dyslipidemia57 (47.5%) Chronic kidney disease (eGFR <60 mL/min)69 (57.5%) Hemodialysis17 (14.2%) Prior coronary disease38 (31.7%) Prior cerebrovascular disease24 (20.8%) Serum albumin <3.0 g/dL24 (20.8%)eGFR, Estimated glomular filtration rate.Categorical variables are presented as number (%), and continuous variables are presented as mean ± standard deviation. Open table in a new tab