Outcome of the FUSION vascular graft for above-knee femoropopliteal bypass.

Although endovascular procedures have become popular for the treatment of patients with femoropopliteal occlusive disease, open surgical bypass is still required in a significant proportion of patients. Saphenous vein is the conduit of choice, but prosthetic bypass grafts are often necessary. The Peripheral Bypass Grafting: Prospective Evaluation of FUSION Vascular Graft for Above Knee Targets (PERFECTION) trial was performed to assess the clinical outcome of the FUSION vascular graft (Maquet Cardiovascular, Wayne, NJ), a novel bilayer prosthetic graft with an external expanded polytetrafluoroethylene inner layer and an outer knit polyester layer. Eligible study patients included those requiring prosthetic femoral-to-above-knee popliteal bypass for claudication, rest pain, or localized tissue loss without wet gangrene. During a 30-month period ending in March 2012, 117 patients were enrolled in the PERFECTION trial and underwent bypass with FUSION vascular grafts at 10 European investigational sites. Patients were followed up with duplex ultrasound imaging and ankle-brachial indices performed at 30 days, 6 months, and 12 months. The primary efficacy end point was 12-month primary patency of the study graft, assessable in 102 patients. Safety end points included all-cause mortality, major adverse events, amputation, and graft reinterventions. The 67 male (57.3%) and 50 female (42.7%) patients averaged 67.8 ± 8.9 years in age and were implanted with 6-mm (25 [21.4%]), 7-mm (26 [22.2%]), or 8-mm (66 [56.4%]) FUSION grafts. The 30-day primary graft patency was 95.3%, with five graft occlusions in the perioperative period. The 12-month primary rate was 85.6%, and the secondary patency rate was 93.2%. Ankle-brachial indices increased from a mean of 0.53 ± 0.20 preoperatively to 0.97 ± 0.16 at 30 days and 0.91 ± 0.22 at 12 months. There were no major amputations through 12 months of follow-up, 15 patients (12.8%) had graft reinterventions, one patient (0.9%) developed a graft infection, and five patients (4.3%) died of unrelated causes. The findings of the prospective, multicenter PERFECTION study confirm clinical utility of the FUSION vascular graft through 12 months of follow-up. Patency rates equal or exceed those reported with other nonbioactive vascular grafts. These observations suggest that the FUSION graft is a useful alterative to standard expanded polytetrafluoroethylene grafts and should be considered as an option in patients requiring prosthetic femoral-to-above-knee popliteal arterial reconstruction.

Assadian A ，Eckstein HH ，Peripheral Bypass Grafting: Prospective Evaluation of FUSION Vascular Graft for Above Knee Targets (PERFECTION) Study Group 《-》

Randomized controlled trial comparing the safety and efficacy between the FUSION BIOLINE heparin-coated vascular graft and the standard expanded polytetrafluoroethylene graft for femoropopliteal bypass.

Despite improvements in endovascular therapy for lower extremity arterial disease, open surgical revascularization is still required when the disease is extensive. Although autogenous vein is the conduit of choice for open femoropopliteal bypass, prosthetic grafts can be an acceptable alternative when adequate vein is not available. The FUSION BIOLINE heparin-coated vascular graft (Maquet Endovascular, Wayne, NJ) was developed to improve the patency rate associated with standard prosthetic grafts. The current study, the FINEST Trial (Comparison of Safety and Primary Patency Between the FUSION BIOLINE Heparin-Coated Vascular Graft and EXXCEL Soft ePTFE), was designed to assess the clinical outcome of heparin-coated and standard vascular grafts in a prospective, randomized, controlled, multicenter trial. During a 25-month period ending in June 2012, 209 eligible patients scheduled to undergo elective prosthetic femoral to above-knee or below-knee popliteal bypass were randomized to receive a standard expanded polytetrafluoroethylene (ePTFE) graft or the heparin-coated FUSION BIOLINE vascular graft. Among 203 patients in the efficacy analysis, claudication was the presenting symptom in 147 (72.4%), and the site of the distal anastomosis was at the above-knee level in 174 (85.7%). Grafts were assessed by duplex ultrasound imaging and ankle-brachial indices performed postoperatively at discharge and at 30 days, 6 months, and 12 months. The primary efficacy end point was primary patency of the study graft. The primary safety end point was the composite of major adverse events and periprocedural death. Secondary end points included the time to hemostasis of bleeding at the anastomotic suture hole and primary assisted and secondary patency. The primary patency rates at 6 months were 86.4% for the FUSION BIOLINE heparin-coated vascular graft group compared with 70.0% for the standard ePTFE group, a difference of 16.4% (95% confidence interval, 2.7%-29.9%; P = .006), and the respective rates at 12 months were 76.5% and 67.0% (95% confidence interval, -4.8% to 23.0%; P = .05). The mean time to hemostasis of bleeding at the suture hole was 3.5 minutes in the FUSION BIOLINE group and 11.0 minutes in the standard ePTFE group (P < .0001). Major adverse events were significantly lower in the FUSION BIOLINE group, occurring in 17.1%, compared with 30.7% in the standard ePTFE group (P = .033), principally a result of a lower rate of major graft reinterventions through 12 months in the FUSION BIOLINE group (16.2% vs 30.7%). Data from this randomized multicenter study demonstrated improved midterm patency, less bleeding at the suture hole, and lower major adverse events with the FUSION BIOLINE heparin-coated vascular graft compared with standard ePTFE grafts. Although the ultimate long-term benefit of the graft cannot be ascertained with the data currently available, the utility of the FUSION BIOLINE vascular graft appears promising.

Lumsden AB ，Morrissey NJ ，Comparison of Safety and Primary Patency Between the FUSION BIOLINE Heparin-Coated Vascular Graft and EXXCEL Soft ePTFE (FINEST) Trial Co-investigators 《-》

A meta-analysis to compare Dacron versus polytetrafluroethylene grafts for above-knee femoropopliteal artery bypass.

Surgical revascularization for lower limb ischemia remains an important component for optimization of quality of life and symptoms in patients with peripheral arterial disease. In the absence of a vein graft, prosthetic alternatives are considered. The objective of this meta-analysis was to establish which prosthetic graft, Dacron or polytetrafluroethylene (PTFE), has the better long-term patency in patients undergoing an above-knee femoropopliteal arterial bypass. This meta-analysis was performed by use of Cochrane and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. An electronic search of all relevant databases was performed from 1990 to 2013 with the Medical Subject Headings "Dacron," "polytetrafluroethylene," "PTFE," "above knee," "femoropopliteal," and "bypass" combined with the Boolean operator "AND." The inclusion criteria were randomized controlled trials, use of Dacron vs PTFE prosthetic conduits, and completion of an above-knee femoropopliteal arterial bypass involving adult patients older than 18 years presenting with disabling claudication, rest pain or tissue loss, occlusion of the superficial femoral artery, and reconstitution of the above-knee popliteal artery. Whenever studies included above- and below-knee data, only the above-knee arterial bypass data were extracted and analyzed. Graft patency rates were calculated with RevMan 5.1 software provided by the Cochrane Collaboration. Ninety-one publications were reviewed. After exclusion of duplicate, nonrandomized, and alternative bypass surgery studies, eight randomized controlled trials were identified and included in the meta-analysis. Two of the included trials represented follow-up evaluation of two previous studies, and for the purpose of this analysis, the initial and follow-up studies were subsequently evaluated as one trial. In this meta-analysis, 1192 patients were assessed, including 601 Dacron and 591 PTFE above-knee lower limb arterial bypasses. Primary patency was calculated from all included studies. However, only four studies provided data to evaluate secondary patency. Mean age reported was 66 years. Although all studies described cardiovascular comorbidities and risk factors including myocardial ischemia, diabetes, hypertension, and smoking, exact patient numbers were not consistently provided. Included studies evaluated grafts from 5 to 8 mm. Although primary and secondary patency rates at 12 months were not significantly different (relative risk [RR], 0.78; P = .08, and RR, 0.84; P = .52), 24-, 36-, and 60-month primary patency rates were significantly better with Dacron compared with PTFE grafts (RR, 0.79; P = .003; RR, 0.80; P = .03; RR, 0.85; P = .02). Statistical analysis also supported higher secondary patency rates for Dacron at 24 months (RR, 0.75; P = .02) and 60 months (RR, 0.76-0.77; P = .03-.27). Although primary patency was similar between grafts (28% vs 28%; P = .12), secondary patencies were better with Dacron at 10 years (49% vs 35%; P = .01). Antiplatelet and anticoagulation protocols varied between the trials. There was no difference in amputation, overall morbidity, or mortality rates between the two surgical graft populations. Current evidence suggests that Dacron prosthetic grafts are superior to PTFE grafts in above-knee femoropopliteal arterial bypass procedures. Further randomized trials targeting standardization of confounding variables, particularly graft size and best medical therapy, are warranted.

Rychlik IJ ，Davey P ，Murphy J ，O'Donnell ME ... -  《-》

Four-year randomized prospective comparison of percutaneous ePTFE/nitinol self-expanding stent graft versus prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery occlusive disease.

McQuade K ，Gable D ，Pearl G ，Theune B ，Black S ... -  《-》

Heparin-bonded expanded polytetrafluoroethylene femoropopliteal bypass grafts outperform expanded polytetrafluoroethylene grafts without heparin in a long-term comparison.

Expanded polytetrafluoroethylene (ePTFE) grafts have become an acceptable prosthetic alternative to autologous vein for infrainguinal arterial reconstructions. Recently, heparin bonding to the graft's luminal surface has been used as an adjunctive method of improving graft patency. We retrospectively evaluated a prospective experience with heparin-bonded ePTFE (HePTFE) vs the results of a prior experience with standard ePTFE (SePTFE) to compare patency rates in above-knee (AK) and below-knee (BK) femoropopliteal bypass through the 5-year follow-up. Prosthetic femoropopliteal bypasses performed by our four-surgeon group were constructed using 6-mm SePTFE grafts before August 2007. Subsequently, all such bypasses were constructed using 6-mm HePTFE (Propaten graft; W. L. Gore & Associates, Flagstaff, Ariz). The surgical technique used in all cases throughout the study was similar irrespective of surgeon or graft material. Loss of primary patency was defined by graft thrombosis; duplex scan confirmed graft failure. Descriptive estimation of patency rates was carried out using standard Kaplan-Meier methods. Cox proportional hazards regression was used to analyze relationships between predictors and time to loss of patency. There were 192 AK (87 Propaten, 105 SePTFE) and 60 BK (42 Propaten, 18 SePTFE) grafts. Overall primary patency for Propaten was statistically better than SePTFE at years 1 (93.6% vs 84.2%), 2 (79.7% vs 73.8%), 3 (79.7% vs 69.5%), 4 (74.5% vs 59.9%) and 5 (74.5% vs 56.2%; log-rank test, P = .036). Five-year primary patency was superior for Propaten AK grafts (85.2% vs 59.3%; log-rank test, P = .028) and for Propaten BK grafts (59.6% vs 0.0/undeterminable; log-rank test, P = .016). Variables significantly associated with loss of patency for Propaten and SePTFE were claudication (hazard ratio [HR], 0.41), age (HR, 0.95), isolated popliteal artery (HR, 3.1-4.4), and ankle-brachial index after the procedure (HR, 0.10). Controlling for conduit effect, clopidogrel use did not significantly affect patency (P = .076). No grafts were associated with heparin-induced thrombocytopenia. These data show that the Propaten HePTFE graft offered significantly better long-term patency over the SePTFE graft, suggesting Propaten as the prosthetic graft of choice for bypasses to the femoropopliteal artery when autologous vein is unavailable or inappropriate.

Samson RH ，Morales R ，Showalter DP ，Lepore MR Jr ，Nair DG ... -  《-》