Saphenous vein patch versus polytetrafluoroethylene patch after carotid endarterectomy. Heparin-bonded Dacron or polytetrafluorethylene for femoropopliteal bypass: five-year results of a prospective randomized multicenter clinical trial. Dacron or PTFE for above-knee femoropopliteal bypass. a multicenter randomised study. Prospective randomized study on bilateral above-knee femoropopliteal revascularization: Polytetrafluoroethylene graft versus reversed saphenous vein. Randomized trial of vein versus Dacron patching during carotid endarterectomy: influence of patch type on postoperative embolization. Prospective randomized trial of carotid endarterectomy with primary closure and patch angioplasty with saphenous vein, jugular vein, and polytetrafluoroethylene: perioperative (30-day) results. Dacron vs. polytetrafluoroethylene grafts for femoropopliteal bypass: a prospective randomised multicentre trial. Multicenter randomized prospective trial comparing a pre-cuffed polytetrafluoroethylene graft to a vein cuffed polytetrafluoroethylene graft for infragenicular arterial bypass. Prospective randomized trial of ACUSEAL (Gore-Tex) versus Hemashield-Finesse patching during carotid endarterectomy: early results. A prospective, randomized study of saphenous vein patching versus synthetic patching during carotid endarterectomy.
Although carotid patch angioplasty has been performed on a selective or routine basis in all large series of carotid endarterectomy, the choice of patch material still remains in question. The objective of this study has been a prospective randomized evaluation of the relative risks and benefits of saphenous vein patch versus PTFE patch material for carotid endarterectomy. During a 4-year period, 84 patients undergoing 95 carotid endarterectomies were randomized into two groups: 45 venous patch (n = 40) and 50 PTFE patch (n = 44). All operations were carried out under general anesthesia and systematic placement of a shunt. The patients were evaluated at 1, 3, 6 months and every year with doppler, periorbitary photoplethysmography, intravenous digital subtraction angiography, and neurologic assessment (mean follow-up 29 +/- 1 month). Operative time among patients having PTFE patch was significantly longer (p < 0.05) than among those having saphenous vein patch, due to bleeding from suture holes. Perioperatively, no neurologic complications or deaths were observed in venous patch patients, however there was a permanent stroke and one death from arterial wall disruption in the PTFE patch group. The incidence of aneurysmal dilatation in the saphenous vein patch group (15.5%) was higher than for the PTFE patch group (2%). On late follow-up, no deaths, carotid thrombosis or patch rupture were observed in either group. Recurrent stenosis occurred in 2 cases having PTFE patch. One reoperation for recurrence was required. In addition, one patient with PTFE patch angioplasty developed an infected false aneurysm at 7 months.(ABSTRACT TRUNCATED AT 250 WORDS) 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.
                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.
                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.
                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. To compare polytetrafluorethylene (PTFE) and polyester grafts (Dacron) for above knee femoropopliteal bypass.
                Multicenter randomised clinical trial.
                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.
                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).
                This trial confirms that Dacron is at least as durable as PTFE for above-knee bypass procedures, and might even be superior. Some controversy exists as to whether polytetrafluoroethylene (PTFE) is equivalent to reversed saphenous vein (SV) as bypass graft material for above-knee femoropopliteal revascularization. We compared the 5-year patency rate with reversed SV and PTFE grafts in patients with claudication who underwent bilateral above-knee femoropopliteal revascularization.
                Between January 1994 and December 1997, 51 patients (102 limbs) with bilateral disabling claudication due to superficial femoral artery occlusion underwent above-knee femoropopliteal bypass grafting, with SV in one limb and PTFE graft in the other limb. Patients were randomly selected for sequential surgical treatment with either SV-PTFE or PTFE-SV. Kaplan-Meier analysis was used to estimate patency rate, and various factors were analyzed to ascertain any association with revascularization failure.
                There was no perioperative (30 day) limb loss or death, but five late deaths (late survival rate, 90%). Mean follow-up was 59 months. In the SV group, three bypass grafts failed, requiring repeat operation in only one patient. In the PTFE group, eight bypass grafts failed, leading to five repeat operations. There was no statistically significant difference in primary "assisted" patency rate for the two grafts: 100%, 98%, and 94% for SV grafts, and 96%, 84%, and 84% for PTFE grafts (P =.09), after 1, 3, and 5 years, respectively.
                The overall results of this randomized study show that SV and PTFE grafts have a statistically comparable patency rate when used above the knee in patients with claudication. Use of SV, however, leads to fewer occlusions and repeat operations. A recent overview indicated that although routine patching is safer than routine primary closure after carotid endarterectomy (CEA), there is no systematic evidence that patch type influences outcome. However, most surgeons still believe that prosthetic patches are probably more thrombogenic than vein patches. This study tested the hypothesis that there was no difference in thrombogenicity between the different patch types.
                A total of 274 patients undergoing 276 CEAs were randomized to either Dacron-patch closure (n = 137) or vein-patch closure (n = 139). All patients with an accessible cranial window were monitored for 3 hours postoperatively with transcranial Doppler scanning (TCD). The number of emboli and rate of embolization were quantified with the requirement for selective dextran therapy to control high rates of postoperative embolization. All patients were assessed postoperatively and again at 30 days by a neurologist, and all patients underwent a duplex examination at 30 days.
                The 30-day death/any stroke rate was 2.2% for patients in the Dacron-patch group and 3.6% for patients in the vein-patch group (P =.72). Patients in the Dacron-patch group had a higher incidence of postoperative emboli (median, 5; interquartile range, 0-10.5) than patients in the vein-patch group (median, 3; interquartile range, 1-17; P =.028). However, the incidence of detecting more than 50 emboli was virtually identical, and patch type had no effect on the incidence of high-rate, sustained embolization that required dextran therapy (5.3% for Dacron, 3.7% for vein). No patient had a carotid thrombosis at 30 days.
                Sustained, high-rate embolization, previously shown to be highly predictive of progression to carotid thrombosis, appears to be patient dependent, rather than related to patch type. The early outcomes of carotid endarterectomy (CEA) with primary closure (PC) versus vein patch closure (saphenous vein [SVP] and jugular vein [JVP]) and polytetrafluoroethylene patch closure (PTFE-PC) were compared.
                Three hundred ninety-nine CEAs were randomized into the following groups: 135 PC, 134 PTFE-PC, and 130 vein patch closure (SVP alternating with JVP). Surviving patients underwent a carotid color duplex ultrasonographic scan 1 month after surgery. Demographic characteristics were similar in all groups.
                The incidence of perioperative cerebrovascular accidents (CVAs) was 4.4% for PC, 0.8% for PTFE-PC, and 0% for vein patch closure (PC vs vein patch, p = 0.0165; PC vs all patching [vein and PTFE], p = 0.007). The perioperative CVA and reversible ischemic neurologic deficit (RIND) combined rates for all patching were superior to PC (1.5% vs 5.2%; p = 0.04). These combined rates were also superior for vein patch closure when compared with PC (0.8% vs 5.2%; p = 0.037). The mean diameter of the internal carotid artery was similar in patients who had perioperative neurologic deficits and those who did not. After 1 month of follow-up, 11.9% of the PC arteries were narrowed 50% or more in contrast to 2.3% for PTFE-PC, 3.1% for SVP, and 10.3% for JVP. To compare the patency of PTFE (Polytetrafluoroethylene) and unsealed knitted Dacron femoro-popliteal bypasses.
                Multi-centre prospective randomised trial.
                Of 203 patients randomised, 194 were included in the final analysis (103 Dacron grafts and 91 PTFE grafts). The median follow-up was 36 months (range: 6-72 months); the distal anastomosis was above-knee in 141 and below-knee in 53 cases. Univariate comparisons of patency were made by the Kaplan-Meier method, multivariate calculations on the effects of covariables by a Cox regression analysis.
                There was no difference regarding primary and secondary patency or limb salvage between Dacron and PTFE. The primary 3-year patency for Dacron grafts was 64% (95% confidence interval [C.I.] 55-74%) and for PTFE grafts 61% (C.I. 49-72%). The corresponding 3-year secondary patency was 81% (C.I. 73-89%) and 75% (C.I. 65-86%) respectively, the limb salvage rate 90% (C.I. 84-96%) and 91% (C.I. 84-97%). Upon multivariate analysis below-knee anastomosis was the principal independent predictor of primary graft failure (risk ratio 1.7 [C.I. 1.05-2.8]), impaired secondary patency was associated with infragenicular bypass (risk ratio 3.3 [C.I. 1.8-6.3]) and distal gangrene (risk ratio [C.I. 1.01-3.8]p=0.048), major amputation was independently predicted by below-knee bypass, tissue necrosis, and poor run-off index.
                PTFE and Dacron are equally suitable for femoro-popliteal 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 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. Several studies have reported that carotid endarterectomy (CEA) with patch angioplasty produces superior results compared with primary closure. Conventional polytetrafluoroethylene (PTFE) patching has been shown to have results comparable to autogenous vein patching; however, it requires a prolonged hemostasis time. Therefore, many surgeons use collagen-impregnated Dacron patching (Hemashield [HP]). Recently, we reported a satisfactory hemostasis time using the new hemostatic PTFE patch (ACUSEAL by Gore). This study is the first prospective randomized trial comparing the ACUSEAL patch with the HP Finesse patch.
                200 CEAs were 1:1 randomized into two patch closure groups (ACUSEAL or Finesse). All patients underwent immediate and 1 month postoperative duplex ultrasound studies. Demographic and clinical characteristics were similar in both groups, including the mean operative diameter of the internal carotid artery and length of arteriotomy.
                The overall perioperative ipsilateral stroke rate was 2% (2% ACUSEAL, 2% Finesse; P = 1.0). The perioperative ipsilateral TIA rates were 0% for the ACUSEAL and 2% for the Finesse patch (P = .5). The combined perioperative neurological event (TIA + stroke) rates were 2% for ACUSEAL and 4% for the Finesse (P = .68). The early >or=50% restenosis rate was 0% for ACUSEAL vs 4% for Finesse patching. Two perioperative carotid thromboses were noted with Finesse patching vs none with ACUSEAL patching (P = .50). The combined early morbidity rate (TIA, stroke, and >or=50% restenosis or thrombosis) was 2% for the ACUSEAL patch vs 8% for the Finesse patch (P = .10). The mean hemostasis time for the ACUSEAL and Finesse patches was 5.1 vs 3.7 minutes (P = .01), however, the mean operative times were similar for both groups (P = .61).
                The perioperative neurological events and overall short-term morbidity associated with CEA when using ACUSEAL or Finesse patches were similar. Both patches have short hemostasis times. The objective of this study was the determination of whether the choice of either autogenous saphenous vein (ASV) or synthetic material for patch angioplasty significantly influences the results after carotid endarterectomy (CEA).
                With Institutional Review Board approval, 195 patients (145 men and 50 women; mean age, 69 years) who underwent 207 CEAs were prospectively randomized to arteriotomy closure with ASV or synthetic patches from July 1996 to January 2000. One hundred and one patients (52%) were randomized to the ASV cohort, and 94 (48%) were randomized to the synthetic cohort. Aside from a slight gender imbalance (70% versus 79% male in the ASV versus the synthetic group), there were no clinically important differences in baseline demographic variables, risk factors, or surgical indications between the ASV and synthetic groups.
                With all 207 randomized procedures on an intent-to-treat basis, there were two early (<30 days) postoperative deaths (1%). There were three perioperative strokes in the ASV cohort (3.0%) and two in the synthetic cohort (2.1%; P =.99). Two of these early strokes occurred in a subset of nine patients who received neither patch material, all after randomization but before CEA. Two patients in each group had late strokes. The cumulative freedom from stroke rate at 1 year (ASV, 94%; synthetic, 95%) was virtually identical for both cohorts. With the 125 patients who had at least one postoperative duplex scan, the incidence rate of recurrent (>or=60%) carotid stenosis was 4.8% (three of 62) for the ASV group and 6.3% (four of 63) for the synthetic group (P =.99).
                No significant differences in the stroke, mortality, or restenosis rates were shown between the ASV and the synthetic cohorts. While conceding the power limitations inherent in this study, we conclude that CEA may be safely performed with similar early results with ASV or synthetic patches.
The number of outcome events is too small to allow reliable conclusions to be drawn and more trial data are required to establish whether any differences do exist. Nevertheless, there is some evidence that other synthetic (e.g. PTFE) patches may be superior to collagen impregnated Dacron grafts in terms of perioperative stroke rates and restenosis. Pseudoaneurysm formation may be more common after use of a vein patch compared with a synthetic patch.