Benefits of carotid patching: a randomized study. Is venous patch grafting after carotid endarterectomy able to reduce the rate of restenosis? Prospective randomized pilot study with stratification. Long-term follow-up for recurrent stenosis: a prospective randomized study of expanded polytetrafluoroethylene patch angioplasty versus primary closure after carotid endarterectomy. Comparison of saphenous vein patch, polytetrafluoroethylene patch, and direct arteriotomy closure after carotid endarterectomy. Part I. Perioperative results. Saphenous vein patch versus primary closure for carotid endarterectomy: long-term assessment of a randomized prospective study. Carotid endarterectomy with a polyurethane patch versus primary closure: a prospective randomized study. Randomized controlled trial of patch angioplasty for carotid endarterectomy. The Joint Vascular Research Group. Prospective randomized trial of carotid endarterectomy with primary closure and patch angioplasty with saphenous vein, jugular vein, and polytetrafluoroethylene: perioperative (30-day) results. A randomized trial of synthetic patch versus direct primary closure in carotid endarterectomy.
Advocates of carotid artery patching claim a reduced incidence of recurrent stenosis after endarterectomy. A prospective study was undertaken to determine its value with random selection between primary closure and saphenous vein patching. A consecutive series of 129 carotid endarterectomies was evaluated by duplex scanning at 3, 6, and 12 months after operation. Intravenous digital subtraction angiography (DSA) was performed in the first postoperative days for control of the surgical technique and after 1 year to serve as a reference for the duplex scanning. Sixty-two patients were selected to have primary closure and 67 were chosen for the patching technique. Both groups were identical with regard to risk factors (mean age 63 years, 74% were men, 57% had hypertension, 41% had coronary disease, 37% had peripheral arterial disease, and 9% had diabetes mellitus), side of operation (55% left), symptoms (18% were asymptomatic), and postoperative DSA (81% were normal, 17% had residual lesions, and 2% had occlusions). A complete 1-year follow-up was obtained in 105 cases (81%); duplex scanning showed recurrent stenosis of more than 50% in 12 cases (11%). This was significantly higher after primary closure (10 of 48 patients = 21%) compared with patch closure (2 of 57 = 3.5%; p = 0.006) and also in women (6 of 25 = 24%) compared with men (6 of 80 = 7.5%; p = 0.03). Recurrent stenosis was present in 6 of 11 women with primary closure (55%), 4 of 37 men with primary closure (11%), 2 of 43 men with patching (5%), and none of 14 women with patch closure (0%).(ABSTRACT TRUNCATED AT 250 WORDS) Many studies have already demonstrated that the restenosis rate after carotid endarterectomy is greater as expected since ultrasound examination has become a routine procedure after endarterectomy. The purpose of our randomized study is to compare the rates of restenosis with two methods of carotid endarterectomy--direct suturing and autologous vein grafting. Sofar restenosis are found after endarterectomy and direct suturing. Different possible causes for restenosis are discussed. We hope to inform soon if patching with the autologous vein is the best method in order to prevent early restenosis after CEA. To determine the effect of primary closure (PC) versus expanded polytetrafluoroethylene patch graft angioplasty (PGA) on the incidence of recurrent stenosis (> 50% lumen diameter narrowing) after carotid endarterectomy (CEA), 87 patients undergoing 100 consecutive CEA were prospectively randomized into two groups.
                Forty-four patients underwent 51 PC, and 43 patients underwent 49 PGA. All patients were evaluated after operation by duplex scanning at 1.5, 12, 24, and 36 months. There were no significant differences in the demographic characteristics or operative indications for CEA between the two patient groups. Complete follow-up was achieved in 86% (75/87) of the patients during the 36-month surveillance period.
                The perioperative permanent neurologic morbidity in the PC and PGA groups was noted to be 4% and 2%, respectively (PC = 2/51 vs PGA = 1/49, p = 0.58). Three additional reversible cerebral ischemic events occurred in the postoperative period (PC = 2/51 vs PGA = 1/49, p = 0.58). Other morbidity included immediate postoperative hemorrhage requiring reexploration (1/51) in the PC group and an infected expanded polytetrafluoroethylene patch requiring removal and replacement with autogenous vein (1/49). Long-term follow-up detected a single patient with significant bilateral restenoses of his primarily closed carotid arteries. None of the patients in the PGA group had restenoses (PC = 2/51 vs 0/49, p = 0.50). In addition, no postoperative dilation of the common or internal carotid arteries or perioperative death was observed.
                In patients undergoing CEA, these data demonstrate no significant difference in the perioperative morbidity or mortality between PC and PGA. Use of the patch did not engender patients to patch rupture or aneurysmal degeneration as previously described with vein patch angioplasty procedures. This series supports effective use of either technique to achieve minimal rates of restenosis. To evaluate the perioperative outcomes and the immediate increases in size after patch closure, 140 carotid endarterectomies were randomized into one of three groups: direct no-patch closure, saphenous vein patch closure, and polytetrafluoroethylene patch closure. Seven patients (4.4%) experienced signs of cerebral ischemia in the immediate postoperative period. In three cases this was transient and reversible. In the other four reexploration was undertaken and carotid thrombosis was corrected by thrombectomy. The condition of one of these patients deteriorated to a permanent stroke, whereas the other patients made a complete recovery. Neurologic complications were more frequent in the no-patch group, but the differences between the groups were not significant. The incidence of perioperative internal carotid stenosis, aneurysmal dilatation, and other morphologic abnormalities was assessed in 131 intravenous digital subtraction angiograms taken before the patient was discharged from the hospital. Eight (17.0%) of the endarterectomies in the no-patch group were narrowed by 30% to 50% diameter stenosis, whereas none of the patched arteries had more than 30% stenosis. In contrast, dilatation of the common or internal carotid artery to more than twice the measured diameter was absent in non-patched arteries but was present in seven (17.0%) saphenous patch closures and four (9.23%) polytetrafluoroethylene patch closures. We conclude that patch closure after carotid endarterectomy is less likely to cause stenosis in the perioperative period. Poly-tetrafluoroethylene patches resist dilatation better than do saphenous vein patches and are less likely to become aneurysmal. This study examines the long-term results of a randomized prospective study comparing primary versus saphenous vein patch (VP) closure after carotid endarterectomy (CEA).
                One-hundred thirty-six patients undergoing 163 CEAs over a 46-month period were prospectively randomized to VP, or primary closure. Patients with internal carotid artery diameters less than 5 mm and those requiring complex CEAs underwent obligatory vein patch (OVP). Patients were monitored with duplex scanning every 3 months for 1 year and every 6 months thereafter. All patients received aspirin.
                There were three perioperative strokes (one in the primary group, two in the OVP group) and no perioperative deaths. Two perioperative revisions were performed within 30 days of the original CEA for residual disease. During a mean follow-up of 59 +/- 4 months, nine ipsilateral neurologic events have occurred, including two strokes and seven transient ischemic attacks. Sixteen patients had duplex evidence of recurrent stenosis, and one was associated with a stroke 36 months after CEA. Recurrence rates were similar in all groups (cumulative recurrence at 5 years: primary 7.8%, VP 14.3%, OVP 5.3%). Of the 136 patients (163 procedures), 72 (53%) (88 procedures) are alive and well, 16 (11.7%) (19 procedures) have been lost to follow-up, and 48 patients (35.3%) (56 procedures) have died. The cumulative stroke-free survival rate at 84 months was 71% for VP, 74% for OVP, and 60% for the primary group.
                These results demonstrate that CEA is a durable procedure. The use of VP closure did not produce superior long-term results compared with the use of primary closure in this select group of patients. The use of synthetic patch angioplasty during carotid endarterectomy (CEA) has been advocated to reduce restenosis, stroke, and death, but the type of material used is still being debated. This study compared rate of restenosis, neurologic events, and perioperative death in patients undergoing CEA with primary closure versus polyester urethane patch closure.
                In a prospective randomized study, we compared patch angioplasty with polyester urethane (Vascular-patch, B. Braun Medical AG, Tuttlingen, Germany) to primary closure between February 1999 and March 2002 in 404 operations. Early (30-day) stroke and mortality rate, long-term restenosis, and neurologic events were compared in the two groups during 2.5 to 5 years of follow-up (median follow-up, 2 years).
                Primary closure was used in 216 operations, and patch angioplasty was used in 206. Clamping time was significantly shorter in the primary closure group ( P < .001). Perioperative mortality and neurologic events were similar in both groups (1.9% vs 3.9%, P = .21, odds ratio [OR], 2.1; 95% confidence interval [CI], 0.56 to 9.85). The rate of residual stenosis (> or =50%) at 0 or 3-month follow-up was significantly lower in the patch group (2 operations, 1.1%) compared with the primary closure group (17 operations, 8.9%) ( P = .001, OR, 0.114; 95% CI, 0.026 to 0.5). Multivariable logistic regression showed that only primacy closure was found to influence residual stenosis. Restenosis of 70% was significantly less in the patch angioplasty group (2.2% vs 8.6%) ( P = . 01, hazard ratio, 0.246; 95% CI, 0.08 to 0.75). No correlation was found between restenosis and gender, preoperative symptoms, or risk factors.
                Patch angioplasty with polyester urethane significantly reduced the restenosis rate ( P = . 01) compared with primary closure. Even though clamping time was longer, patching was not associated with more perioperative complications. A randomized controlled trial was performed to evaluate patch angioplasty for patients undergoing carotid endarterectomy. There were 213 patient episodes affecting 148 men and 65 women, with 109 allocated to patch angioplasty. Following surgery six patients suffered transient ischaemic attacks but these did not delay discharge from hospital. Six individuals (four patched operations, two not patched) required re-exploration for postoperative haemorrhage and eight (two patched procedures, six not) had potentially serious neurological problems after operation. Of these eight patients, four (none receiving patch angioplasty) underwent re-exploration and in each case a clot was removed and a patch inserted; three of the four made a good long-term recovery. The other four patients suffered completed strokes from which one died. Two further patients (one patched procedure, one not) died after operation from myocardial events, giving an overall 30-day stroke or mortality rate of 2.8 per cent. Objective follow-up assessment with duplex scanning at 1 year was completed by 94.8 per cent of patients; significantly more vessel restenoses and occlusions were observed in those not receiving patches (P < 0.01). Patch angioplasty reduces the number of immediate postoperative complications, and significantly lowers vessel restenosis and occlusion rates at 1 year after operation. 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 define whether or not direct microscopic closure with or without the use of a vascular patch is advantageous in terms of clinical outcome and late vessel occlusion rates after microsurgical carotid endarterectomy.
                Three hundred thirty-eight elective carotid endarterectomies in 315 patients were randomized to direct arteriotomy or closure with a polyester collagen-coated vascular patch. Ten procedures did not follow the randomization process because of technical difficulties and were excluded. Vessel patency (duplex ultrasound) and outcome were assessed during and immediately after surgery and at 4 and 12 months after surgery.
                Four-month ultrasound assessment (n = 321) identified five occluded vessels: two in the patch group (n = 149) and three in the direct closure group (n = 172). Six patients in the patch group had died or were significantly disabled at 4 months, compared with five in the direct closure group. At the 12-month assessment (n = 313), eight vessels had occluded: five from the patched group (n = 146) and three from the direct closure group (n = 167). Eight patients in the patch group had died or were significantly disabled, compared with four in the direct closure group. No statistically significant difference between the two groups in terms of vessel occlusion, morbidity, or mortality was seen (P > 0.1).
                No difference in vessel patency and clinical outcome has been identified after microscopic patch angioplasty and direct arteriotomy repair. The authors conclude that there is no benefit from the routine use of patch angioplasty in microscopic carotid endarterectomy.
Limited evidence suggests that carotid patch angioplasty may reduce the risk of perioperative arterial occlusion and restenosis. It would appear to reduce the risk of ipsilateral stroke and there is a non significant trend towards a reduction in perioperative any stroke rate and all-cause case fatality.