Lower Limb Revascularization with a New Bioactive Prosthetic Graft: Early and Late Results

Abstract

The aim of the study was to evaluate the immediate and long-term results of femoropopliteal bypasses performed with a new bioactive heparin-treated expanded polytetrafluoroethylene (ePTFE) graft in a single-center experience. From March 2002 to April 2006, 51 patients underwent lower limb revascularization with a new bioactive ePTFE prosthetic graft with covalent endpoint attachment of heparin to the graft surface. Data concerning preoperative assessment, intraoperative strategy, drug administration, and follow-up surveillance program were prospectively collected in a dedicated database; early results were analyzed in terms of graft patency, amputation rate, and deaths. Follow-up consisted of clinical and duplex scan examination at 1, 6, and 12 months and yearly thereafter. Midterm results in terms of primary and secondary patency, limb salvage, and survival were analyzed. Patients were predominantly male (35 patients, 71%), with a mean age of 71 years (SD ¼ 9.05). Indications for surgical revascularization were critical limb ischemia in 36 patients and severe intermittent claudication in 15 patients. Interventions were performed for occlusion of a native vessel in 35 cases, whereas 12 patients had late thrombosis of a femoropopliteal bypass; the remaining four patients were operated on for an occluded popliteal artery aneurysm. Intervention consisted of below-knee bypass in 34 patients, while the other 17 had an above-knee revascularization. No perioperative deaths occurred. Cumulative 30-day graft patency was 88%, with an amputation rate of 4% (two cases). Results were similar in above-and below-knee revascularizatons. Mean duration of follow-up was 18 months (SD ¼ 7). Cumulative estimated 24-month survival and primary patency rates were 97% and 80.2%, respectively; the corresponding limb salvage rate was 85.7%. Long-term results did not significantly differ in above-and below-knee revascularizatons. In our experience, the use of a modified ePTFE graft with covalent end-point linkage of heparin molecules on the graft surface provides good early and midterm results, with low rates of graft thrombosis and amputation.

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

“…5 Results from our multicenter registry confirmed earlier results in terms of excellent safety, with a negligible rate of perioperative bleeding requiring surgical revision, graft patency, and amputation rates. 6,7,[15][16][17] We did not find any differences in terms of early graft failure between aboveknee and below-knee revascularizations, although there was a trend toward better perioperative limb salvage rates in above-knee interventions. As described previously, 18 we noticed a significantly higher percentage of early graft thromboses and amputations in patients undergoing redo procedures and in patients with preoperative poor runoff status.…”

“…5 Some clinical studies subsequently demonstrated promising results in terms of early and midterm results. 6,7 The aim of this study was to evaluate early and midterm results of above-knee and below-knee bypasses performed with this bioactive heparin-treated expanded polytetrafluoroethylene (ePTFE) graft in patients with critical limb ischemia in a multicentric retrospective registry involving seven Italian vascular centers.…”

Heparin-bonded ePTFE grafts compared with vein grafts in femoropopliteal and femorocrural bypasses: 1- and 2-year results

“…Five previous clinical studies of the use of these prostheses in lower-limb bypasses have been reported. [6][7][8][9][10] One of these studies was, like ours, a retrospective, nonrandomized comparison of the performance of heparinbonded ePTFE grafts (n ϭ 37) and ASV grafts (n ϭ 37) in infragenicular FP bypass procedures. 8 In that investigation, by Battaglia et al, 8 there were no significant preoperative differences between the two graft groups in demographic characteristics, risk factors, concomitant disease, or number of patients with severe vascular disease.…”

“…Although no randomized controlled studies of the heparinbonded ePTFE grafts have been reported, favorable outcomes have been achieved with these prostheses in several series. [6][7][8][9][10][11] Results in BK applications have been especially encouraging.…”

The Role of Infrainguinal Bypass Surgery in the Endovascular Era

“…11) In Italy, a multicentric graft-based registry on the use of heparin-bonded ePTFE grafts has been working since 2002. Seven centers are involved, with the aim to assess the early and long-term results of this graft.…”