Midterm results from a multicenter registry on the treatment of infrainguinal critical limb ischemia using a heparin-bonded ePTFE graft

Objectives: To report midterm results of infrainguinal bypasses performed with a heparin-bonded expanded polytetrafluoroethylene (ePTFE) graft in patients presenting with critical limb ischemia. Methods: Over a 7-year period ending in 2008, 425 patients presenting with critical limb ischemia underwent infrainguinal revascularization using a heparin-bonded ePTFE graft in seven Italian vascular centers. Preoperative, intraoperative, and follow-up data were collected in a multicenter registry. Patients were predominantly male (79%) with a mean age of 73.5 years. Mean preoperative ankle brachial index (ABI) was 0.35 and 192 of the patients (45%) were diabetic. Intervention consisted of a femoral to below-knee bypass in 324 patients (76%), whereas the remaining 101 patients had a femoral to above-knee bypass. In patients with below-knee bypass, distal target vessels were the popliteal artery in 238 cases, the tibioperoneal trunk in 38 cases, and a tibial vessel in the remaining 48 cases (anterior tibial artery in 20 cases, posterior tibial artery in 23 cases, and peroneal artery in 5). Follow-up consisted of clinical and duplex scanning examinations within 3 months from the intervention and yearly thereafter. Early (< 30 day) results were analyzed in terms of deaths, graft thromboses, and amputations with univariate and multivariate (stepwise logistic regression) analysis. Follow-up results were evaluated in terms of primary and secondary graft patency, limb salvage, and survival rate with univariate and multivariate (Cox regression) analysis. Results: Thirteen perioperative deaths occurred (3.1%). Thirty-day primary graft patency was 92.5% and limb salvage was 95.8%. Follow-up was available in 98% of patients with a median duration of 25.5 months (SD, 17.6; range, 1-72). Cumulative estimated 36-month primary and secondary patency, limb salvage, and survival rates were 61%, 70%, 83%, and 83%, respectively. At univariate analysis, the factors associated with poorer limb salvage rates during follow-up were the presence of ischemic ulcers or gangrene (log-rank, 8.4; P = .004; 95% confidence interval [CI] 1.2-3.5; odds ratio [OR], 2.1), the presence of only one patent tibial vessel (log-rank, 41.3; P < .001; 95% CI, 3.1-10.8, OR, 5.8), redo surgery (log-rank, 12.4; P < .001; 95% CI, 1.4-4; OR, 2.4) and the postoperative treatment with antiplatelet therapy in comparison to oral anticoagulants (log-rank, 5.1; P = .02; 95% CI, 1.0-3.4; OR, 1.8). At multivariate analysis redo surgery (P = .02; 95% CI, 1.1-3.1; OR, 1.8), poor runoff score (P < .001; 95% CI, 2.5-9.1; OR, 4.7) and preoperative clinical status (P = .02; 95% CI, 1.1-3.1; OR, 1.8) were independently associated with decreased limb salvage rates. Conclusion: The use of a heparin-bonded ePTFE graft provides good early and midterm results, with low rates of late amputations. Primary and secondary patency made this graft an excellent alternative to autologous saphenous vein when it is absent, unsuitable, or of poor quality.