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

OBJECTIVE

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.