Long-Term Follow-up of 6–8 mm Brachioaxillary Polytetrafluorethylene Grafts for Hemodialysis

Abstract: Eight millimeter expanded polytetrafluoroeth-ylene (e-PTFE) grafts, tapered to 6 mm at the arterial site, are used by our group in the upper arm in order to avoid midgraft stenosis observed with other graft sizes. Long-term results (1–12 years) on 157 6–8 mm brachioaxillary e-PTFE grafts (Gore-Tex) are analyzed. Early failure was found in 4 grafts (2.5%). The rate of late complications was 0.37 episodes per graft-year. Steal syndrome, found in 4 cases (2.5%), was successfully treated in 3 cases by graft banding. Neither midgraft nor arterial anastomotic stenosis was observed in the 63 grafts requiring surgical thrombectomy or fistulography. The primary patency rates were 73%, 53%, and 41% at 1, 3, and 5 years, respectively. The secondary patency rates were 91%, 80%, and 72% at 1, 3, and 5 years, respectively. Comparison between both curves by the log rank test was significant (p < 0.001) expressing the efficiency of rescue surgery. We conclude that a 6–8 mm graft can be successfully used for dialysis in the brachioaxillary position     

Randomized comparison of 6-mm straight grafts versus 6- to 8-mm tapered grafts for brachial-axillary dialysis access

OBJECTIVE: This report presents the results of a prospective randomized study that compared 2 grafts of different diameter: 6 mm, and 8 mm tapered to 6 mm at the arterial site, placed in the upper arm for hemodialysis in a selected population of patients younger than 71 years without diabetes. METHODS: Seventy consecutive patients younger than 71 years without diabetes who required an upper arm graft between January 1997 and January 2002 and without previous access in the same limb were randomly allocated to receive either a 6-mm graft or 6- to 8-mm graft. Graft flow was measured every 3 months with the Doppler dilution technique. When access flow was less than 600 mL/min, fistulography was performed, and any stenosis was surgically treated with venous outflow replacement. Thrombectomy and associated stenosis treatment in the same stage was performed in all cases immediately after detection of thrombosis. Complication rate, and primary, assisted primary, and secondary patency rates were compared between the two groups with the Student t test and life table analysis. RESULTS: Mean access flow was 975 mL/min for 6-mm grafts (range, 600-1500 mL/min; 95% confidence interval [CI], 889-1070), and for 6- to 8-mm grafts was 1397 mL/min (range, 1122-2700 mL/min; 95% CI, 1122-1672). This difference was significant (P <.01). Complication rate was 0.45 episodes per graft-year in 6-mm grafts, and 0.19 episodes per graft-year in 6- to 8-mm grafts (P <.01). At 1, 2, and 3 years, primary patency rates were 62%, 58%, and 44%, respectively, for 6-mm grafts, and 85%, 78%, and 73% for 6- to 8-mm grafts; log-rank comparison between curves was P =.0259. At 1, 2, and 3 years, secondary patency rates were 85%, 85%, and 85%, respectively, for 6-mm grafts, and 90%, 90%, and 90% for 6- to 8-mm grafts; log-rank comparison between curves was not significant, at P =.0603. At 1, 2, and 3 years, assisted primary patency rates were 84%, 79%, and 76%, respectively, for 6-mm grafts, and 90% for 6- to 8-mm grafts; log-rank comparison was P =.0414. CONCLUSIONS: The results of this study show an advantage in terms of primary and assisted primary patency rates, and complication rate for upper arm grafts with diameter 6 mm to 8 mm over grafts with 6-mm diameter in a patient population younger than 70 years without diabetes. The finding of a similar secondary patency rate in both groups is probably due to the surveillance program with sequential measurement of access flow and prompt surgical treatment of stenosis. However, we needed twice the number of rescue procedures in 6-mm grafts to achieve a similar patency rate as with large-bore grafts. These study results must be carefully evaluated, taking into consideration the small number of patients and the selected patient population.     

Evaluation of 4-mm to 7-mm versus 6-mm prosthetic brachial-antecubital forearm loop access for hemodialysis: results of a randomized multicenter clinical trial

OBJECTIVE: Prosthetic arteriovenous fistulas for hemodialysis vascular access have a high incidence rate of thrombotic occlusions that result in graft failure. This randomized multicenter study was performed to assess the patency rates and the effect of 4-mm to 7-mm grafts on the development of stenoses. METHODS: A total of 109 patients who needed vascular access for hemodialysis were randomized to receive either 6-mm (n = 57) or 4-mm to 7-mm prosthetic brachial-antecubital forearm loop accesses (polytetrafluoroethylene). Duplex scanning, with measurement of blood flow and peak systolic velocity and detection of stenoses (>50%), was performed at 1, 6, and 12 months after surgery. Clinical data were obtained in a prospective manner and primary, assisted primary, and secondary patency rates were calculated with the Kaplan-Meier life-table analysis. Statistical analysis was performed with the independent samples t test and chi(2) test. RESULTS: At 1 year, patency rates were similar for both 4-mm to 7-mm and 6-mm prostheses (primary, 46% versus 43%; assisted primary, 62% versus 58%; secondary, 87% versus 91%). The incidence rate of thrombotic occlusion was comparable for both groups (0.74/patient-year versus 0.88/patient-year; P >.05). Mean graft flow at 1, 6, and 12 months was 1416 versus 1415 mL/min, 1345 versus 1319 mL/min, and 1595 versus 1265 mL/min (P >.05) for 4-mm to 7-mm and 6-mm grafts, respectively. Also, no differences in peak systolic velocities in any part of the grafts were observed. The percentage of stenoses detected was equal in both groups at 1 year after surgery (27% versus 20%; P >.05). CONCLUSION: A 4-mm to 7-mm tapered prosthetic brachial-antecubital forearm loop access did not reduce the incidence rates of stenoses and thrombotic occlusions compared with a 6-mm prosthetic conduit. Moreover, no differences in patency rates were observed. Therefore, we believe that the 4-mm to 7-mm graft should not be used routinely for hemodialysis vascular access.     

Collagen- versus gelatine-coated Dacron versus stretch PTFE bifurcation grafts for aortoiliac occlusive disease: long-term results of a prospective,randomized multicenter trial

BACKGROUND: In this prospective randomized multicenter trial, knitted gelatine-coated Dacron, knitted collagen-coated Dacron, and stretch polytetrafluoroethylene (PTFE) aortic bifurcation grafts were compared for their long-term results. METHODS: Between 1991 and 1998, 149 patients undergoing elective revascularization for aortoiliac occlusive disease were prospectively randomized at 3 tertiary referral centers of vascular surgery. The patients received either gelatine-coated Dacron (GEL-D) grafts (n = 52), collagen-coated Dacron (COL-D) grafts (n = 49), or stretch PTFE grafts (n = 48). RESULTS: No intraoperative deaths were recorded. The 30-day mortality was 4%. The mean follow-up time was 97 months. Primary patency rates were 77% for GEL-D, 78% for COL-D, and 79% for PTFE at 8 years. The differences were not different (P >.8). Secondary corrected 8-year patency rates were also not significantly different (P >.5): 91% for GEL-D, 96% for COL-Dm and 90% for PTFE. Five Dacron and 1 PTFE grafts were affected by infections. CONCLUSIONS: Bifurcation grafts for revascularization of aortoiliac occlusive disease using these 3 materials were comparable in terms of primary and secondary patency and long-term complication rates.     

Six year experience with expanded polytetrafluoroethylene arterial grafts for limb salvage

We have used 822 polytetrafluoroethylene (PTFE) grafts in arterial reconstructions for limb salvage over the last 6 years at Montefiore Medical Center-Albert Einstein College of Medicine, Four hundred and twenty-seven femoropopliteal reconstructions with PTFE had a 6 year cumulative life table patency rate of 55% with follow-up of 76 grafts for more than 3 years and 28 grafts for more than 4 years. Seventy-nine bypasses to the isolated popliteal segment had a 6 year cumulative patency rate of 72%. There were 207 bypasses performed to the tibial, peroneal or dorsalis pedis arteries. Life table patency rates were 55% at 1 year, 40% at 2 years and 37% at 4 years. Ninety-two PTFE femorofemoral and 62 axillofemoral bypasses had 5 1/2 year cumulative life table patency rates of 83% and 75%, respectively. Axillopopliteal PTFE bypasses can salvage otherwise doomed limbs. Thirty-four such grafts had 74% 1 year and 45% 5 year patency rates. The overall infection rate in all 822 PTFE grafts was only 0.5%. Thus, PTFE is a promising vascular prosthetic material which facilitates otherwise difficult or impossible limb salvage procedures.     

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.     

Long-term complication and patency rates of Vectra and IMPRA Carboflo vascular access grafts with aggressive monitoring, surveillance and endovascular management

The purpose of this study is to compare infection, pseudoaneurysm formation and patency rates during long-term follow-up of polyurethane and polytetrafluoroethylene (PTFE) vascular access grafts maintained with contemporary endovascular methods. During a 34-month period, 239 polyurethane and 125 carbon-impregnated PTFE vascular access grafts were placed in 324 consecutive patients. Thirty-six patients (9.9%) developed a pseudoaneurysm (anastomotic, n = 6 or at the needle-stick site, n = 30). An additional 19 patients (5.2%) required graft excision for infection. Three-year graft infection and pseudoaneurysm formation (at needle-stick site) rates were similar in polyurethane and PTFE grafts (11% versus 8%, P = 0.61, and 17% versus 23%, P = 0.72, respectively). Three-year secondary patency was better in polyurethane than PTFE grafts (69% versus 57%, respectively, P = 0.012). Straight upper arm polyurethane grafts had the best secondary patency (P = 0.001). Contemporary long-term secondary patency of vascular access grafts is satisfactory. Further follow-up is necessary to compare late infection and pseudoaneurysm formation rates.     

Polytetrafluoroethylene versus human umbilical vein in above-knee femoropopliteal bypass: six-year results of a randomized clinical trial.

In a prospective, randomized trial 6 mm polytetrafluoroethylene (PTFE) and 6 mm human umbilical vein (HUV) were compared in above-knee femoropopliteal bypass grafting. In claudicants a prosthetic graft was used intentionally, in limb-salvage cases only when autologous vein was insufficient. Ninety-six extremities were randomized (49 PTFE and 47 HUV). Operative indication was disabling claudication in 77 and limb salvage in 19 extremities. The two groups were comparable as to preoperative risk factors and operative and postoperative treatment. Median follow-up was 76 months (range 47 to 91 months), during which 23 patients died of nonrelated causes with functioning grafts. Thirty-eight grafts failed (33 because of occlusion and five for other reasons). At 6 years the primary patency rate was 38.7% in the PTFE group and 71.4% in the HUV group (p < 0.001). Corresponding rates for secondary patency at 6 years were 51.4% and 76.4% (p < 0.005).     

Axillopopliteal bypass for limb salvage.

Forty-one axillopopliteal bypass grafts have been placed in 30 patients for limb salvage in the past 12 years. The mean patient age was 65.6 years; 8 were women; 19 smoked; and six had diabetes. Sixteen grafts were straight axillopopliteal bypass grafts, and 25 were sequential axillopopliteal bypass grafts. Cumulative life-table primary patency rates at 1, 2, and 3 years were 70%, 56%, and 43%, respectively; secondary patency rates were 73%, 57%, and 50%, respectively. Corresponding limb salvage rates were 86%, 69%, and 69%, respectively. Ringed polytetrafluoroethylene (PTFE) graft patency at 3 years was 61% versus 40% for unsupported PTFE grafts (p = 0.35). Ringed PTFE axillofemoral grafts with sequential femoropopliteal saphenous vein grafts had a 3-year patency of 67%. Graft patency was restored in 25% of occluded grafts by thrombectomy and in 80% of occluded grafts by thrombectomy with graft revision (p = 0.21). Cumulative 3-year patient survival was 48%. The 30-day operative mortality rate was 20%; patients operated on for graft infection had a 30-day operative mortality rate of 36%. The data support the use of axillopopliteal bypass for limb salvage when standard revascularization techniques are contraindicated. Long-term patency is enhanced by use of externally supported PTFE and sequential femoropopliteal saphenous vein.     

Collagen versus gelatin-coated Dacron versus stretch polytetrafluoroethylene in abdominal aortic bifurcation graft surgery: results of a seven-year prospective, randomized multicenter trial

BACKGROUND: A prospective randomized multicenter trial was performed to compare knitted gelatin-coated Dacron bifurcation grafts, knitted collagen-coated Dacron grafts, and stretch polytetrafluoroethylene (PTFE) grafts. METHODS: Between 1991 and 1998, 315 elective patients were randomized by age, gender, diabetes, runoff, indication (aneurysm, aortoiliac occlusive disease), and nicotine consumption at 3 centers of vascular surgery in Austria. The patients received gelatin-coated Dacron (GEL-D) grafts (n = 109), collagen-coated Dacron (COL-D) grafts (n = 100), or stretch PTFE grafts (n = 106). RESULTS: No intraoperative deaths occurred. The 30-day mortality was 3%. No difference was found between the 3 graft materials in long-term patency. The primary 5-year patency rates were 92% for GEL-D, 89% for COL-D, and 91% for stretch PTFE (P =.6001). The secondary 5-year patency rates also differed: 97% for GEL-D, 100% for COL-D, and 97% for stretch PTFE (P =.2062). Early occlusions were observed overall in 3% and late occlusions in 5% of patients. When both Dacron grafts were compared collectively with stretch PTFE, a difference was found in infection rate: Dacron 3% (6/209) versus PTFE 0% (0/106); P <.03. CONCLUSIONS: The bifurcation grafts of all 3 materials were comparable in primary and secondary patency rates, incidence of false aneurysms, and rate of perioperative complications. Graft infections were confined to the 2 Dacron grafts and did not occur in stretch PTFE grafts.     

Long-term Outcomes of Brachiobasilic Transposition Fistula for Haemodialysis

OBJECTIVES: The transposed basilic vein to brachial artery arteriovenous fistula provides secondary vascular access for haemodialysis. The long-term results of such fistula are assessed in this retrospective series. MATERIAL AND METHODS: Over a 5-year period 75 brachiobasilic transposition fistulae were performed in 74 patients. There was a median follow up of 14 months. RESULTS: Primary patency was achieved in 69 (92%) of the fistulae, and secondary patency in 74 (99%) of the fistulae. Successful interventions included angioplasties in four, and saphenous vein interposition in one, whilst three patients had failed thrombectomies. Dialysis was performed using 69 (92%) of the fistulae while 6 (8%) were never used. Of the 75 fistulae 47 (63%) were patent at follow up. Cumulative secondary patency was 66% at 1 year, 52% at 2 years, and 43% at 3 years. Complications developed in 41 (55%), and included thrombosis, infection, stenosis, arm oedema, bleeding, steal syndrome and microaneurysm formation. CONCLUSIONS: Brachiobasilic transposition fistulae have good long-term patency rates. The complication rate, although high, is lower than that reported for PTFE grafts. Brachiobasilic fistulae should be used in preference to PTFE grafts for secondary access.     

Reverse tapered vs. straight PTFE (Gore-Tex) grafts in dogs

Reversed Autogenous Saphenous Vein (RASV) remains the material of choice in infrainguinal arterial bypass. A characteristic of RASV not seen in other grafts is its reverse tapered (RT) configuration. The purpose of this study was to investigate this geometric configuration. Straight 6 mm PTFE (gore-tex) grafts (SG) and 4-7 mm reverse tapered PTFE (gore-tex) grafts (RTG) were both implanted in the aorto-iliac position in 16 mongrel dogs. Specimens of surviving dogs were examined by the usual methods. In terms of absolute patency, 9 of 14 RTG (64%) and 5 of 14 SG (36%) P = 0.05, anastomotic thrombus formation 6 of 14 (43%) RTG vs. 10 of 14 (71%) SG P = 0.05 and in midgraft thrombus deposition P = 0.025 the RTG performed significantly better than the SG. In light of these results and other considerations, the reverse tapered configuration merits clinical investigation with other materials and in other species.     

Value and limitations of secondary femoropopliteal bypasses with polytetrafluoroethylene

Secondary femoropopliteal bypasses with polytetrafluoroethylene (PTFE) grafts are widely regarded to be of questionable value. This has prompted some to abandon all attempts at secondary revascularization with PTFE and others to recommend that primary femoropopliteal bypasses be performed preferentially with PTFE grafts so that vein may be used for secondary procedures. Because we questioned both of these views, we reviewed all femoropopliteal bypasses done at our institution in the past 12 years and identified 73 secondary PTFE femoropopliteal procedures performed after a failed ipsilateral infrainguinal bypass (69 failed femoropopliteal; 4 failed femorodistal). Seventy (96%) secondary bypasses were performed for limb salvage and 3 (4%) for severe disabling claudication. Insertion of grafts to the popliteal artery was above the knee in 26 (36%) and below the knee in 47 (64%). Primary life-table graft patency at 4 years was only 38%. Forty-eight reinterventions in 34 limbs were required to restore or maintain graft patency in thrombosed or failing grafts. For thrombosed grafts, 20 interventions consisted of 9 simple thrombectomies and 11 thrombectomies with additional revision procedures (5 distal or proximal extensions, 6 patch angioplasties). Twenty-eight lesions threatening graft patency were treated by percutaneous transluminal angioplasty in 3, proximal or distal extensions in 20, and patch angioplasty in 5. As a result of these reinterventions, the overall secondary patency rate was 55% at 4 years, and the limb salvage rate was 74% at 4 years. Although aggressive follow-up and reintervention may be required, the use of secondary PTFE conduits in the femoropopliteal position is a viable option in patients undergoing limb salvage procedures who are at high risk.(ABSTRACT TRUNCATED AT 250 WORDS)     

Rat epigastric pedicle model: a clinically relevant evaluation of 1-mm PTFE grafts

Twenty-eight Sprague-Dawley rats had 1.0-mm polytetrafluoroethylene (PTFE) interposition grafts placed in their femoral artery that supplied a 3.0 X 3.0 cm epigastric pedicle flap. The model is the first to evaluate 1.0-mm PTFE under rigorous, clinically simulating conditions. Anastomoses employed a new, continuous telescoping suture technique. Grafts were selected for histological and electron microscopic evaluation, which confirmed the development of a cellular neointimal lining. Viability of the flap model had a 90% correlation with graft patency. Overall graft patency was 50%. Patency was documented in some specimens harvested at 200 days. The flap model is a good indicator of graft patency. PTFE grafts of 1.0-mm internal diameter are not yet equivalent to autologous veins. Future refinements, particularly aseptic technique, are expected to result in even higher patency rates.     

Femoropopliteal bypass for claudication: Vein vs. PTFE

The vascular graft of choice for femoropopliteal bypass in patients with intolerable claudication is controversial. We retrospectively reviewed our experience with 239 patients suffering from claudication secondary to superficial femoral artery obstruction. Femoropopliteal reconstruction was performed with saphenous vein to the below-knee popliteal artery in 66 patients (BK-vein). Polytetrafluoroethylene (PTFE) was used in 128 patients as a bypass graft to the above-knee popliteal artery (AK-PTFE) and 45 patients had a PTFE graft to the below-knee popliteal artery (BK-PTFE). All patients were enrolled in a postoperative graft surveillance program with graft revision when appropriate. There was one perioperative death (0.4%). Primary patency at 5 years for AK-PTFE, BK-PTFE, and BK-vein was 58.0%, 55.0%, and 60.3%, respectively, and was not significantly different among the graft groups. Graft revision for failed/failing grafts resulted in 5-year secondary patency rates of 79.2% (AK-PTFE), 73.3% (BK-PTFE), and 74.4% (BK-vein). These secondary patency rates were not statistically different. Eventual conversion to a vein graft in patients initially treated with PTFE maximized patency in the femoropopliteal segment with 5-year patency rates of 84.6% and 93.0% for the AK-PTFE and BK-PTFE graft groups, respectively. Major leg amputation was necessary during the entire course of the study in eight (3.3%) patients. We conclude that long-term patency rates for femoropoliteal bypass in patients with intolerable claudication are similar for PTFE and autologous saphenous vein grafts.Presented at the Twentieth Annual Meeting of the Peripheral Vascular Surgery Society, New Orleans, La., June 10, 1995.     

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.     

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.     

Dacron or PTFE for above-knee femoropopliteal bypass. a multicenter randomised study.

OBJECTIVES: To compare polytetrafluorethylene (PTFE) and polyester grafts (Dacron) for above knee femoropopliteal bypass. DESIGN: Multicenter randomised clinical trial. MATERIAL AND METHODS: 427 patients were randomised between 6mm Dacron (Uni-Graft, B. Braun Melsungen AG, 34212 Melsungen, Germany) and PTFE (Goretex, W. L. Gore & Ass. Inc., Newark DE 19711, USA) above-knee femoropopliteal bypass grafts within 13 centres in Denmark (n=261), Norway (n=113) & Finland (n=53) between 1993 and 1998. Fourteen (3%) patients were excluded, leaving 413 patients with 208 Dacron and 205 PTFE grafts for analysis. Age, gender, indication (claudication: 65%), run-off (2 or 3 vessels: 76%), diabetes (17%) and hypertension (31%) as well as cerebrovascular (9%) and cardiac (33%) risks were evenly distributed. Patients were followed postoperatively at 1, 12 and 24 months. Patency assessment was based on ankle-brachial pressures or imaging in case of doubt. RESULTS: The two-year primary patency rates for Dacron and PTFE were 70% and 57% (p=0.02), whereas the secondary patency rates were 76% and 65% (p=0.04), respectively. Primary patency at two years was significantly influenced by the number of patent crural vessels (two or three 67%, one 50%, p=0.01). Amputations at two years, major in 4% and minor in 3%, 30-days mortality and complications (wound infections: 3% and other wound complications: 13%) occurred equally frequent in both groups. At two years, patients treated for critical limb ischemia had a major amputation more often than patients operated on for intermittent claudication, 10 and 3 respectively (p=0.003), and had higher mortality rates, 20% and 8% respectively (p=0.001). CONCLUSION: This trial confirms that Dacron is at least as durable as PTFE for above-knee bypass procedures, and might even be superior.     

The multiple sequential distal bypass graft: seven-year follow-up

Thirty-nine infrainguinal bypass grafts with multiple sequential distal anastomoses were performed on 35 patients ranging in age from 32 to 79 years (mean 65.8 years) with severe femoropopliteal occlusive disease. Thirty-eight procedures were performed for limb salvage indications. Distal anastomoses were performed to the popliteal-anterior tibial arteries in seven procedures, the popliteal-posterior tibial arteries in six, the popliteal-peroneal arteries in six, the anterior tibial-peroneal arteries in eight, the posterior tibial-peroneal arteries in 10, and the posterior tibial-anterior tibial arteries in two. Saphenous vein was the graft material in 31 procedures (in situ in two), polytetrafluoroethylene (PTFE) in four, and saphenous vein-PTFE composite in four. The mean Doppler ankle-arm index was 0.38 +/- 0.14 preoperatively and 0.89 +/- 0.13 postoperatively. The early (30-day) graft patency rate was 93%. With life-table analysis, the long-term primary patency rate was 70% at 1 year, 61% at 3 years, and 52% at 7 years for saphenous vein grafts; the secondary patency rate was 65% at 7 years for saphenous vein grafts. The secondary patency rate for PTFE and PTFE-vein composite grafts was 75% at 1 year, 50% at 3 years, and 17% at 5 years. Cumulative life-table limb salvage rates were 91% at 1 year, 85% at 5 years, and 61% at 7 years. The multiple sequential distal bypass graft is durable and highly efficacious in achieving limb salvage.     

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.