PTFE or HUV for femoro-popliteal bypass: a multi-centre trial

Despite wide clinical experience the choice between human umbilical vein (HUV) or polytetrafluoroethylene (PTFE) when the saphenous vein is inadequate remains unclear. In a multi-centre trial of 801 femoro-popliteal bypasses, autogenous vein could not be used in 252 (31%), of which 191 were randomised to either HUV or PTFE and started on aspirin 300 mg plus dipyridamole 150 mg (ASA + DPM) twice daily. Graft patency measured objectively by independent trial coordinators was expressed on an "intention to treat" basis by life table and analysed statistically by log rank and confidence intervals (95% CI). Overall, 101 grafts failed and cumulative patency was 53% (45-61%) at 3 years compared with 60% (55-65%) in 549 vein grafts. Prosthetic bypass patency above knee was 65% (55-75%); markedly better than 35% (23-47%) below knee (p less than 0.001) and comparable with 62% (55-69%) in 217 above knee saphenous vein grafts. Most failures occurred early at a rate of 52/1000 patient-months in the first 3 months (43/1000 for vein) falling to 21/1000 by 6 to 12 months and around 10/1000 subsequently. Randomisation produced comparable groups of 87 HUV and 104 PTFE grafts. Cumulative primary patency for HUV was 68, 63 and 57% at 1, 2 and 3 years, respectively compared with 61, 56 and 48% for PTFE with wide confidence intervals for the difference at 3 years (-20 to 38%, p = 0.27).(ABSTRACT TRUNCATED AT 250 WORDS)     

A comparative evaluation of polytetrafluoroethylene, umbilical vein, and saphenous vein bypass grafts for femoral-popliteal above-knee revascularization: a prospective randomized Department of Veterans Affairs cooperative study

PURPOSE: Currently, the choice of a vascular prosthesis for a femoral-popliteal above-knee arterial bypass graft is left to the surgeon's preference, because the available information on comparative evaluations is inconclusive. The Department of Veterans Affairs (VA) Cooperative Study 141 was established to identify whether improved patency exists with different bypass graft materials for patients with femoral-popliteal above-knee bypass grafts. METHODS: Between June 1983 and June 1988, 752 patients at 20 VA medical centers were randomized to receive either an externally supported polytetrafluoroethylene (PTFE; N = 265), human umbilical vein (HUV; N = 261), or saphenous vein (SV; N = 226) for an above-knee femoral-popliteal bypass graft. The indication for the bypass grafting operation was limb salvage in 67.5% of the patients. Patients were observed every 3 months for the first year and every 6 months thereafter. All patients were instructed to take aspirin (650 mg) daily for the duration of the study.Doppler-derived ankle-brachial indices (ABIs) were determined preoperatively and serially postoperatively. A bypass graft was considered to be patent when the Doppler-derived postoperative ABI remained significantly improved (more than 0.15 units higher than their preoperative value) and additional objective information, such as angiograms or operations, did not contradict these observations. Patency failure also included bypass grafts that were removed because of an infection or aneurysmal degeneration. Patency rates were compared by using the Kaplan-Meier life table analysis. RESULTS: The cumulative assisted primary patency rates were statistically similar among the different conduit types at 2 years (SV, 81%; HUV, 70%; PTFE, 69%). After 5 years, above-knee SV bypass grafts had a significantly (P 相似文献   

Heparin-bonded Dacron or polytetrafluorethylene for femoropopliteal bypass: five-year results of a prospective randomized multicenter clinical trial

OBJECTIVE: Dacron was largely abandoned for femoropopliteal bypass 30 years ago, because better patency rates were achieved with saphenous vein. Despite the range of potential prosthetics, polytetrafluoroethylne (PTFE) clearly predominates in current femoropopliteal practice. We compared heparin-bonded Dacron (HBD) with PTFE in a randomized multicenter clinical trial. METHOD: Over 28 months, 209 patients (179 above-knee disease, 30 below-knee disease) were randomized to receive HBD (n = 106) or PTFE (n = 103) grafts. Aspirin, 300 mg/d, was started before surgery, and was continued if tolerated. RESULTS: At follow-up for a minimum of 5 years (mean, 76 months; range, 60-89 months), 37 patients (17.7%) had died with patent grafts and 121 (58%) grafts were occluded. Primary patency rate, measured with Kaplan-Meier survival analysis, was 46% (95% confidence interval [CI], 35%-57%) at year 5 for HBD, compared with 35% for PTFE (CI, 25%-45%; P < .055). Long-term patency was achieved in only 4 of 78 interventions performed in 55 thrombosed grafts. Secondary patency rate for HBD was 47% (CI, 36%-58%), and for PTFE was 36% (CI, 26%-46%). Risk factors for arterial disease did not significantly influence prosthetic patency. Major limb amputation was necessary in 9 patients with HBD grafts and 20 patients with PTFE grafts (P < .025). Two amputations in the HBD group and 8 amputations in the PTFE group were in patients undergoing bypass surgery to treat claudication only. Limb salvage rate was 86% (CI, 77%-95%) and 74% (CI, 64%-84%), respectively. CONCLUSIONS: Significantly better patency rates were achieved with HBD than with PTFE at 3 years (P < .044), but the difference was no longer statistically significant at 5 years (P < .055). The incidence of major limb amputation, however, was significantly greater (P < .025) in the PTFE group compared with the HBD group at both 3 and 5 years of follow-up.     

Multicenter Randomized Prospective Trial Comparing a Pre-cuffed Polytetrafluoroethylene Graft to a Vein Cuffed Polytetrafluoroethylene Graft for Infragenicular Arterial Bypass

Poor patency of synthetic grafts for infragenicular revascularization has led to use of distal vein patches or cuffs. The aim of this study was to compare the distally widened Distaflo^TM PTFE graft, which mimics a vein cuff, with a PTFE graft with distal vein modification. In this prospective, randomized, multicenter trial we compared use of a precuffed PTFE graft wit that of PTFE grafts with distal vein modification for infragenicular revascularization in patients with critical limb ischemia without saphenous vein. Study end points were primary and secondary patency and limb salvage rates at 2 years. From January 28,1999 to November 1, 2000, 104 patients were enrolled in 10 North American centers. Thirteen were excluded for protocol violation. Ninety-one bypasses were performed in 89 patients with a mean age of 73 years (range 47-90). By randomization, 47 bypasses were done with the precuffed graft and 44 with PTFE graft with vein cuff. Both groups were comparable for comorbidities and operative variables, except for a higher incidence of acute ischemia in the precuffed group (19% vs. 4.5%, p = 0.03). Bypass was a redo procedure in 53% and was performed at the infrapopliteal vessels in 79%. Operative mortality was 2.2% (2/91). Mean follow-up was 14 months (range 1-30). At 1 and 2 years, primary patency was 52% and 49% for the precuffed group and 62% and 44% for the vein cuffed group, respectively (p = 0.53). At 1 year and 2 years, the limb salvage rate was 72% and 65% for the precuffed group and 75% and 62% in the vein cuffed group (p = 0.88). Although numbers are small and follow-up short, this midterm analysis shows similar results for the Distaflo precuffed grafts and PTFE grafts with vein cuff. A precuffed graft is a reasonable alternative conduit for infragenicular reconstruction in the absence of saphenous vein and provides favorable limb salvage.Presented at the Twenty-eighth Annual Meeting of the Peripheral Vascular Surgery Society, Chicago, IL, June 7, 2003.See Appendix 1 for list of Distaflo^TM trial investigators and participating centers.     

Composite sequential grafts in severe ischemia: a comparative study

From October 1978 to June 1983, 64 sequential bypass grafts were performed in 59 patients with limb-threatening ischemia. These patients were classified into three study groups as follows: reversed saphenous vein graft alone (12), composite sequential (proximal polytetrafluoroethylene [PTFE] and distal vein) graft (30), and PTFE graft in entirety (22). Graft patency was confirmed in all cases by serial Doppler ankle pressure measurements or by angiography. Cumulative life-table patency rates were then compared over a period of 27 months. The patency rates for composite sequential grafts using a distal short segment of vein were statistically indistinguishable from those for bypasses performed entirely with saphenous vein. These yielded a patency rate of 80% at 1 and 2 years. In contrast, the 1- and 2-year patency rates of the PTFE sequential grafts were 52% and 47%, respectively (p less than 0.05). Composite sequential bypasses using an otherwise inadequate segment of saphenous vein are a sound alternative revascularization procedure, with a patency rate comparable to that of reversed saphenous vein bypasses.     

Six-year prospective multicenter randomized comparison of autologous saphenous vein and expanded polytetrafluoroethylene grafts in infrainguinal arterial reconstructions

Autologous saphenous vein (ASV) and polytetrafluoroethylene (PTFE) grafts were compared in 845 infrainguinal bypass operations, 485 to the popliteal artery and 360 to infrapopliteal arteries. Life-table primary patency rates for randomized PTFE grafts to the popliteal artery paralleled those for randomized ASV grafts to the same level for 2 years and then became significantly different (4-year patency rate of 68% +/- 8% [SE] for ASV vs. 47% +/- 9% for PTFE, p less than 0.025). Four-year patency differences for randomized above-knee grafts were not statistically significant (61% +/- 12% for ASV vs. 38% +/- 13% for PTFE, p greater than 0.25) but were for randomized below-knee grafts (76% +/- 9% for ASV vs. 54% +/- 11% for PTFE, p less than 0.05). Four-year limb salvage rates after bypasses to the popliteal artery to control critical ischemia did not differ for the two types of randomized grafts (75% +/- 10% for ASV vs. 70% +/- 10% for PTFE, p greater than 0.25). Although primary patency rates for randomized and obligatory PTFE grafts to the popliteal artery were significantly different (p less than 0.025), 4-year limb salvage rates were not (70% +/- 10% vs. 68% +/- 20%, p greater than 0.25). Primary patency rates at 4 years for infrapopliteal bypasses with randomized ASV were significantly better than those with randomized PTFE (49% +/- 10% vs. 12% +/- 7%, p less than 0.001). Limb salvage rates at 3 1/2 years for infrapopliteal bypasses with both randomized grafts (57% +/- 10% for ASV and 61% +/- 10% for PTFE) were better than those for obligatory infrapopliteal PTFE grafts (38% +/- 11%, p less than 0.01). These results fail to support the routine preferential use of PTFE grafts for either femoropopliteal or more distal bypasses. However, this graft may be used preferentially in selected poor-risk patients for femoropopliteal bypasses, particularly those that do not cross the knee. Although every effort should be made to use ASV for infrapopliteal bypasses, a PTFE distal bypass is a better option than a primary major amputation.     

Infrainguinal bypass surgery: factors determining late graft patency

The results of 373 infrainguinal bypass grafts, in a single centre, between 1980 and 1988 are reviewed. One hundred and thirty in situ vein (ISV), 47 reversed saphenous vein (RSV), 118 polytetrafluoroethylene (PTFE) and 78 human umbilical vein (HUV) grafts were used. The indications for surgery were disabling claudication in 25 per cent of patients and limb salvage in 75 per cent. In 36 per cent of operations the distal anastomosis was above the knee and in 64 per cent it was below the knee. Overall 5-year patency rates and limb salvage rates respectively were, for ISV (41 and 69 per cent), RSV (62 and 90 per cent), PTFE (31 and 67 per cent) and HUV (29 and 59 per cent). There was no significant difference in patency among these grafts at the above-knee level, but significant differences between vein and prosthetic grafts were evident below the knee (P less than 0.001). Using a proportional hazards model the three factors that consistently correlated with late graft patency were graft type (P less than 0.001), site of distal anastomosis (P less than 0.001) and distal run-off (P less than 0.001). Overall, the results suggest that prosthetic grafts are a suitable alternative to autogenous vein when the distal anastomosis is above the knee, but vein should always be used, if available, below the knee joint.     

PTFE-vein composite grafts for critical limb ischaemia: a valuable alternative to all-autogenous infrageniculate reconstructions.

OBJECTIVES: to analyse the long-term results of primary composite bypass grafts comparing them to PTFE and vein grafts. DESIGN: a retrospective observational study. MATERIALS AND METHODS: between 1980 and 1996, 568 primary infrageniculate bypass procedures were performed; a saphenous-vein graft was used in 428 procedures, a PTFE graft in 44 and a composite PTFE-saphenous-vein graft in 96. Thirty-six composite grafts were below the knee and the remaining 60 extended more distally. Twenty-one bypass grafts from the latter group were sequential. Mean follow-up was 45.6 months. Five-year primary and secondary patency and limb salvage rates were compared by life-table analysis. RESULTS: cumulative 5-year primary patency for composite grafts was 58% and for saphenous-vein grafts 74%, while secondary patency rate was 75% and 82%, respectively (p <0.05). The 5-year limb salvage rate was 80% for composite grafts and 88% for saphenous-vein grafts (p >0.05). The primary and secondary patency and limb salvage rate for PTFE grafts was 24%, 31% and 40%, respectively. CONCLUSION: Composite grafts of PTFE and saphenous vein are significantly superior to PTFE graft alone and should be used in patients who lack sufficient length of saphenous vein.     

Heparin-bonded Dacron or polytetrafluoroethylene for femoropopliteal bypass grafting: a multicenter trial

BACKGROUND: Dacron (polyester fiber) was largely abandoned for femoropopliteal bypass grafts 30 years ago because saphenous vein achieved better patencies. However, in patients taking aspirin, patency in above-knee femoropopliteal bypass grafts has recently been shown to be equivalent to that with saphenous vein. We compared heparin-bonded Dacron (HBD) and polytetrafluoroethylene (PTFE) in a randomized multicenter trial including below-knee popliteal or tibioperoneal trunk bypass graft where the long saphenous vein was absent or inadequate. METHODS: Over 28 months, 209 patients undergoing femoropopliteal bypass grafts (180 above-knee, 29 below-knee) were randomized to HBD (n = 106) or PTFE (n = 103). Each patient was given aspirin (300 mg/d) before surgery, and this continued unless the patient had intolerance to the aspirin. RESULTS: The mean follow-up was 42 months (range, 28-55). Fifteen (7.1%) patients died with patent grafts, and three (1.4%) infected grafts were removed. Patency (measured with Kaplan-Meier survival analysis) at 1, 2, and 3 years for HBD was 70%, 63%, and 55% compared with 56%, 46%, and 42%, respectively, for PTFE (P =.044). A total of 67 secondary interventions were performed on 48 thrombosed grafts; long-term patency was achieved in only three. Risk factors for arterial disease did not significantly influence patency. Amputations have been performed in 23 patients, six after HBD and 17 after PTFE bypass grafts (P =.015). CONCLUSIONS: HBD achieved better patency than PTFE, which carried a high risk of subsequent amputation.     

Upper arm polytetrafluoroethylene grafts for dialysis access. Analysis of two different graft sizes: 6 mm and 6-8 mm

The purpose of this retrospective study was to analyze 2 sizes of expanded polytetrafluoroethylene (PTFE) upper arm grafts for dialysis: 8 millimeters, tapered to 6 mm at the arterial side, and 6 millimeters. All upper arm PTFE grafts (Gore-Tex(R)) were performed between January 1981 and April 1997. Patient characteristics, complication rate, and patency rates were compared for both kind of grafts. Five hundred and seven PTFE grafts were analyzed (183 6-mm grafts and 324 6- to 8-mm grafts). Early failure was found in 5 grafts (2.7%) in 6-mm grafts, and in 5 grafts (1.5%) in 8-mm grafts (not significant). Steal syndrome was found in 1 patient (0.5%) of the 6-mm group, and in 11 (3.4%) of the 8-mm grafts (p=0.085). The rate of late complications requiring surgical repair was 0.56 episode per graft-year in the 6-mm grafts group, and 0.33 in the 8-mm grafts (p<0.001). Primary patency rates of 6-mm grafts were 72%, 33%, and 19% at 1, 3, and 5 years; and secondary patency rates were 86%, 68%, 56%, and 44% at 1, 3, 5, and 6 years, respectively. In the 8-mm grafts group, primary patency rates were 77%, 52%, and 39% at 1, 3, and 5 years; and secondary patency rates were 92%, 84%, 73%, and 66% at 1, 3, 5, and 6 years, respectively. Comparison of patency rates of 6-mm and 8-mm grafts were statistically significant (p<0.001) for both primary and secondary curves. However, secondary survival curves were similar for both kind of grafts in a subpopulation of diabetic patients. The authors conclude that the 8-mm graft, tapered to 6 mm at the arterial side, is a dialysis graft with fewer complications and a better patency rate than grafts of 6 mm placed in the same anatomical position, at least in a population of nondiabetic patients. Steal syndrome was observed in some cases of diabetic and older patients with a large-bore graft. Thus, this kind of prosthesis should be avoided in this population. On the other hand, this is not a prospective, randomized study made with any intention for comparison. Therefore, the aforementioned conclusions must be cautiously considered.     

Saphenous vein versus PTFE for above-knee femoropopliteal bypass. A review of the literature.

The autogenous saphenous vein is considered the best bypass graft material for arterial bypasses below the inguinal ligament. However, a synthetic graft or prosthesis is considered an acceptable alternative, especially when the distal anastomosis is situated above the knee. Some studies even suggest that patency rates for vein and synthetic grafts are comparable, whereas others indicate that a vein graft is superior to a prosthetic graft, even above the knee. To test the hypothesis that both vein grafts and synthetic prostheses are equally beneficial in the above-knee position, we performed a systematic review of available studies comparing the patency of saphenous vein and polytetrafluoroethylene (PTFE) as bypass material. English and German medical literature from 1966 to 2002 was searched using Medline, and 25 articles meeting our inclusion and exclusion criteria were selected. The patency of venous bypasses was superior to that of PTFE bypasses at all time intervals studied. After 2 years, the primary patency rate of venous bypasses was 81% as compared to 67% for PTFE bypasses, and after 5 years it was 69 and 49%, respectively. After 5 years, the secondary patency of PTFE bypasses reached 60%. When only randomized trials were considered, venous bypasses were again superior to PTFE bypasses at all intervals studied. After 2 years, the primary patency rate of venous and PTFE bypasses was 80 and 69%, respectively, and after 5 years it was 74 and 39%, respectively. Since both randomized and retrospective studies comparing venous with PTFE bypasses showed that vein grafts were 'better' than PTFE prostheses, the null hypothesis that there is no difference between the two types of graft material was rejected (p=0.008). We conclude from this systematic review that if a saphenous vein is available, a venous bypass should be chosen at all times, even if patients have an anticipated short life expectancy (<2 years). If the saphenous vein is absent or not suitable for bypass grafting, PTFE is a good alternative as bypass material.     

Patency Rates and Complications of Exxcel Yarn-Wrapped Polytetrafluoroethylene Grafts Versus Gore-Tex Stretch Polytetrafluoroethylene Grafts: A Prospective Study

Purpose. Polytetrafluoroethylene (PTFE) has long been used for hemodialysis access when there is no suitable superficial vein. We conducted a prospective randomized study to compare two PTFE grafts; the stretch Gore-tex graft and the Exxcel graft.Methods. Between May 2000 and February 2001, PTFE grafts were implanted for hemodialysis access in the upper extremities of 94 consecutive patients with end-stage renal disease. Graft selection was randomized, with patients receiving either a Gore-tex or an Exxcel graft. All grafts were monitored for signs of thrombosis or other complications. Graft survival was analyzed using a life-table analysis and the log-rank test was applied to compare graft patency.Results. The primary patency rates 1 and 2 years after implantation were 51% and 36% for the Exxcel grafts, and 71% and 45% for the Gore-tex grafts, respectively. The difference between the two groups was not significant at any time. The incidence of complications needing further surgical management was 8.2% in the Exxcel group and 6.7% in the Gore-tex group, without a significant difference.Conclusion. Exxcel grafts or Gore-tex stretch grafts can be used for dialysis access with similar expected outcomes for up to 2 years, despite the differences in their outer surface design. The yarn-wrapped design does not appear to enhance the graft patency and we found no remarkable difference.     

Optimal grafting methods for the small abdominal aorta

Aortobifemoral bypass procedures were performed on 42 patients with the hypoplastic aortoiliac syndrome over an eight year period. During the first five years, 22 patients had either a 13 X 6.5 mm or a 14 X 7 mm knitted Dacron graft and served as historic controls for a second group of 20 others who had 14 X 7 mm grafts of expanded polytetrafluoroethylene (PTFE), during the last three years of the study. Although the two groups were neither concurrent nor randomized, they were nonetheless well matched with regard to age, sex, risk factors, indications for operations, distribution and severity of distal occlusive disease, and type of distal anastomosis. There was only one early graft limb occlusion in the PTFE group after a median follow-up of 14 months, compared to nine occlusions and one amputation in the Dacron group after a median follow-up of 26.2 months. The cumulative patency of the PTFE grafts was 95% at four years compared to only 52% for Dacron (p = 0.11). If the single postoperative occlusion which occurred in each group is excluded, then the difference in patency rates bordered on statistical significance (p = 0.06). Inclusion of the profunda femoris orifice in the distal anastomosis was also found to be an important factor contributing to long-term patency which approached statistical significance (p = 0.075). The configuration of the proximal aortic anastomosis (end to end vs. end to side), or the concomitant use of lumbar sympathectomy or the postoperative infusion of Dextran did not have a statistically significant influence on patency.(ABSTRACT TRUNCATED AT 250 WORDS)     

Fluoropolymer coated Dacron or polytetrafluoroethylene for femoropopliteal bypass grafting: a multicentre trial

Background: This trial was designed to compare graft patency between expanded polytetrafluoroethylene (PTFE) and fluoro­polymer coated Dacron for femoropopliteal bypass in patients in whom saphenous vein was unavailable. Methods: A multicentre prospective trial randomized 129 patients (74 men, 55 women) who underwent femoropopliteal bypass using either a PTFE or fluoropolymer coated Dacron graft. The indication for operation was disabling claudication in 68 (52.7%) and critical limb ischaemia in 61 (47.3%) patients. Distal anastomosis was above the knee in 76 (58.9%) and below the knee in 53 (41.1%) patients. Results: Primary patency at 6, 12 and 24 months was 71%, 56% and 47% for PTFE and 50%, 36% and 36% for fluoropolymer coated Dacron (P = 0.002), respectively. Secondary patency at 6, 12 and 24 months was 77%, 60% and 48% for PTFE and 66%, 49% and 46% for fluoropolymer coated Dacron (P = 0.13), respectively. The superior primary patency of PTFE over fluoropolymer coated Dacron was most evident in patients with poor prognostic indicators for graft survival: critical limb ischaemia (P = 0.001); below‐knee anastomosis (P = 0.01); and smaller (6 mm) diameter grafts (P = 0.002). Graft thrombosis developed in the first month in 22 of 61 (36%) patients receiving fluoropolymer coated grafts compared to six of 68 (8.8%) patients receiving PTFE, which accounts for the difference in primary patency. Successful thrombectomy in 10 of the 22 fluoropolymer coated grafts resulted in similar secondary patency. Conclusion: Polytetrafluoroethylene has superior primary patency and similar secondary patency to fluoropolymer coated Dacron. These results support the preferential use of PTFE in patients with critical limb ischaemia, especially when a below‐knee distal anastomosis and smaller diameter graft is required.     

Flow waveform assessment of polytetrafluoroethylene grafts for reconstruction of lower extremity arteries. A preliminary report

On the basis of our findings that the outcome of reconstructive surgery for lower limbs could well be predicted by flow waveform analysis, we reviewed femoropopliteal arterial bypass operations involving the use of polytetrafluoroethylene (PTFE) grafts for 35 patients. Of 38 grafts, 26 were PTFE alone, and 12 were PTFE/vein composite grafts. Neither ankle pressure index nor angiographic distal runoff was of predictive value as a prognostic indicator. The cumulative patency rate, calculated by the life-table method, revealed the usefulness of flow waveform analysis for prediction of the outcome of PTFE grafts. In type 0 or I flow, the patency rate was 94% at 1 and 2 years and 79% at 3 years. In contrast, in type II flow, the patency rate was 74% at 1 year, 66% at 2 years, and 49% at 3 years, with a statistical significance at 2 and 3 years (p less than 0.05). Comparison of the result of PTFE grafts with that of PTFE/vein composite grafts showed superior results of composite grafts at 3 years after implantation (42% vs. 83%, p less than 0.05). These findings indicate that flow waveform analysis is useful for prediction of the outcome of PTFE grafts and that PTFE/vein composite grafts should probably be used, particularly in cases of abnormal blood flow.     

Effects of a venous cuff at the venous anastomosis of polytetrafluoroethylene grafts for hemodialysis vascular access

INTRODUCTION AND METHODS: The most frequent complication of polytetrafluoroethylene (PTFE) arteriovenous grafts for hemodialysis is thrombotic occlusion due to stenosis caused by intimal hyperplasia. This complication is also known for peripheral bypass grafts. Because the use of a venous cuff at the distal anastomosis improves the patency of peripheral bypass grafts, we considered that it might also improve the patency of PTFE arteriovenous grafts. Therefore, a randomized multicenter trial was carried out to study the effect of a venous cuff at the venous anastomosis of PTFE arteriovenous grafts on the development of stenoses and the patency rates. RESULTS: Of the 120 included patients, 59 were randomized for a venous cuff. The incidence of thrombotic occlusion was lower in the cuff group (0.68 per patient-year) than in the no-cuff group (0. 88 per patient-year; P =.0007). However, the primary and secondary patency rates were comparable. The cuff group tended to have fewer stenoses at the venous and arterial anastomoses when examined with duplex scan. Graft failure was higher in patients with an initial anastomosing vein diameter smaller than 4 mm (7 of 18 [39%]) than in those with a vein diameter of 4 mm or larger (16 of 88 [18%]; P =. 052). Local edema, skin atrophy, and obesity yielded a higher risk on graft failure (23% vs 11%). CONCLUSION: A venous cuff at the venous anastomosis of PTFE arteriovenous grafts for hemodialysis reduced the incidence of thrombotic occlusions; stenosis at the venous anastomosis was reduced. However, this did not result in a better patency rate. Therefore, the venous cuff should not be used routinely. Initial vein diameter and local problems (edema, obesity, or skin atrophy) appear to be the most important risk factors for graft failure.     

Femoropopliteal bypass revisited: an analysis of 138 cases

Femoropopliteal bypass is utilized for infrainguinal arterial reconstruction in parents with claudication, rest pain, non-healing ulcers and gangrene. Reported patency and limb salvage rates have varied considerably and controversy exists concerning conduit choice. The purpose of this study was to reveiw the authors' results with femoropoplital bypass to determine factors which may influence outcome in a contemporary series of patients. Between 1986 and 1991, 138 femoropopliteal bypasses were performed in 120 patients. Mean follow-up was 28 (range 1–66) months. Autogenous vein was used in 59% and polytetrafluoroethylene (PTFE) in the remainder. Above-knee anastomoses were performed in 34% and below-knee in 66%. The secondary patency for autogenous vein grafts (95% at 4 years) was significantly better than for PTFE grafts (69% at 4 years; p<0.01). Secondary patency for below-knee autogenous vein grafts also was better than that for below-knee PTFE grafts (95% versus 50% at 4 years; P < 0.02). Limb salavage rates were worse for below-knee PTFE grafts than all other groups (P < 0.01). Eight of 15 failed above-knee PTFE grafts were salvaged with belowknee autogenous vein grafts and did well. In the present series, autogenous vein femoropopliteal grafts demonstrated better overall patency and limb salvage. Below-knee PTFE bypasses should be reserved for limb salvage cases in patients without adequate autogenous conduits. Failed PTFE grafts can be salvaged by autogenous bypasses, yet an advantage to this approach was not seen.     

Seven-year follow-up of expanded polytetrafluoroethylene (PTFE) femoropopliteal bypass grafts.

Expanded polytetrafluoroethylene (PTFE) grafts have proven to be an acceptable short-term alternative for femoropopliteal reconstruction in those patients without suitable autologous saphenous vein. One hundred and twenty-seven femoropopliteal arterial bypass operations utilizing PTFE grafts were performed in 105 patients. Seven-year follow-up is now available for 20 grafts, 6-year follow-up for 47 grafts, and 5-year follow-up for 62 grafts. Graft occlusion was determined by angiography, Doppler assessment, loss of previously palpable pulses, or return of symptoms. Thirty nonocclusive graft losses were due to death, infection, aneurysm, amputation, or proximal occlusive disease. Overall cumulative patency rate, according to occlusive criteria alone and calculated by the life-table method, was 74% at 6 months, 63% at 1 year, 48% at 3 years, 40% at 5 years, and 35% at 7 years. Excluding early bypass failures (less than 1 year patency), 75% of grafts were patent at 3 years, 63% at 5 years, and 55% patent 7 years following operation. Diabetes mellitus was associated with a significantly lower patency rate. Patency rates were not adversely affected by graft diameter, distal popliteal anastomotic site, number of patent runoff vessels, preoperative symptoms, or prior arterial reconstruction. In patients without suitable autologous saphenous vein, the PTFE graft has proven to be a durable and dependable long-term alternative for femoropopliteal reconstruction.     

Saphenous vein or PTFE for femoropopliteal bypass. A prospective randomized trial.

To evaluate the patency of PTFE (Gore-tex) as a femoropopliteal bypass, a prospective randomized trial was performed between PTFE and saphenous vein. Forty-nine consecutive patients with intermittent claudication, rest pain, or tissue loss due to an occlusion of the superficial femoral artery entered the study. Randomization between PTFE and saphenous vein was performed at the time of operation after assessment of the quality of the latter. The two groups did not differ significantly regarding stage of peripheral ischemia, outflow tract, or localization of the distal anastomosis. The patency rate 6 weeks after operation was 92% for each group. After a mean follow-up of 54 months, the patency rate for the PTFE group was 37% and 70% for the saphenous vein group (p less than 0.001). In the PTFE group, there were eight major amputations. No amputations were performed in the saphenous vein group. It is concluded from this study that the saphenous vein is by far superior to PTFE as a femoropopliteal bypass.     

Is the preferential use of polytetrafluoroethylene grafts for femoropopliteal bypass justified?

The objective of this review is to analyze the long-term results of femoropopliteal bypass done preferentially with polytetrafluoroethylene (PTFE) grafts in patients who presumably had saphenous vein available. The results are analyzed according to preoperative variables in an attempt to determine those instances in which PTFE grafts may be preferred for the first reconstruction and to identify those patients who benefited from vein preservation. From 1979 to 1985, 146 femoropopliteal bypass operations were performed in 120 patients with 6 mm PTFE grafts used preferentially. The results with follow-up at 5 years are analyzed by actuarial methods. The patency rate at hospital discharge was 100%. The overall primary patency rate at 5 years was 57%. Reconstructions above the knee (101) and below the knee (45) had significantly different 5-year patency rates (63% vs 44%, p less than 0.03). Sixty-two reconstructions done to alleviate disabling claudication had a 5-year primary patency rate of 69% and no amputations. Eighty-one reconstructions were done to treat critical ischemia with a 5-year patency rate of 49% and a 5-year foot salvage rate of 73%. When secondary operations were required to treat graft failures, the 4-year cumulative patency rate of the secondary reconstruction was 18% when performed with a prosthetic graft, in contrast to 70% when performed with the spared saphenous vein. We conclude that femoropopliteal reconstruction with PTFE grafts is a reasonable alternative for older patients with disabling claudication. Patients with critical ischemia will likely benefit from preservation of the vein with initial femoropopliteal reconstruction done with PTFE. Staged infrainguinal revascularization for foot salvage may improve present results. In this regard the sequence PTFE-then-vein carries a higher predicted patency rate than the sequence vein-then-PTFE.