Sequential cohort study of Dacron patch closure following carotid endarterectomy

BACKGROUND: Carotid endarterectomy reduces the risk of stroke and death in patients with severe carotid artery stenosis. This study examined whether the technique used to close the arteriotomy influenced the rate of perioperative transient ischaemic attack (TIA), stroke or death. METHODS: A cohort of 236 patients undergoing carotid endarterectomy at a single centre was studied; 117 patients had primary closure of the arteriotomy and 119 patients in a sequential series had closure with a Dacron patch. A standard endarterectomy with completion intraoperative duplex imaging and digital subtraction angiography was used throughout. RESULTS: Patch closure was associated with a significant reduction in the 30-day combined death, stroke and TIA rate: 10.3 per cent for primary closure versus 2.5 per cent for patch closure (P = 0.017). The risk of any cerebral event (stroke or TIA) was also significantly reduced (7.7 versus 1.7 per cent; P = 0.033). Residual stenosis on completion angiography was more common after primary closure (24.6 versus 7.4 per cent; P = 0.003). CONCLUSION: Dacron patch closure had a higher technical success rate on completion imaging and was associated with a significant reduction in the risk of perioperative stroke, TIA and death.     

Carotid endarterectomy with a polyurethane patch versus primary closure: a prospective randomized study

INTRODUCTION: 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. PATIENTS AND METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.     

Does routine patch angioplasty after carotid endarterectomy lessen the risk of perioperative stroke?

From 1964 through 1991 we performed primary closure of the arteriotomy in 1173 patients and patch angioplasty in 506 patients after carotid endarterectomy. The decision to patch was made at the surgeon's discretion. In general a patch was used for small arteries. In the primary closure group 32 patients (2.7%) had a perioperative stroke and in the patch angioplasty group 17 (3.4%) had a stroke. The difference (2.7% vs. 3.4%) was not significant (p<0.5275, Fisher's exact two-tailed test). A total of 240 arteries were closed with a vein patch and 11 (4.6%) of these patients had a stroke; 266 were closed with a synthetic patch (Dacron, 211; polytetrafluoroethylene, 55) and six of the patients had a stroke (2.3%). The difference in stroke rate between the vein and synthetic patch groups (4.6% vs. 2.3%) was not significant (p<0.2159). Patch angioplasty cannot be shown to reduce the incidence of perioperative stroke. Late carotid patency was not studied. This study supports a policy of selective patch angioplasty based on arterial size rather than patching all carotid arteries. When a patch is used, we prefer filamentous Dacron as the patch material.Presented at the Eleventh Annual Meeting of the Southern California Vascular Surgical Society, Dana Point, Calif., September 18–20, 1992.     

Randomized trial of vein versus dacron patching during carotid endarterectomy: long-term results

BACKGROUND AND PURPOSE: Overviews of randomized patch trials by the Cochrane Collaboration suggest that a policy of routine patching is preferable to routine primary closure. However, there is no systematic evidence that patch type, whether prosthetic or vein, influences outcome after carotid endarterectomy (CEA). METHODS: Two hundred seventy-three patients were randomized to vein or thin-walled Dacron patch (Hemashield Finesse) closure of the arteriotomy after 276 CEA procedures. Patients were reviewed clinically and with duplex ultrasound scanning at 1, 6, 12, 24, and 36 months or until death. No patients were lost to follow-up. Cumulative statistical analyses are presented for the 264 patients (269 CEAs) who actually received a randomized treatment allocation. RESULTS: Cumulative freedom from death or ipsilateral stroke at 3 years (including operative events) was 93.0% in the Dacron patch group and 95.5% in the vein group P =.42). Cumulative freedom from death or any stroke was 91.5% after Dacron patch closure and 93.9% after vein closure (P =.46). Cumulative freedom from recurrent stenosis greater than 70% or occlusion at 3 years was 92.9% for patients randomized to the Dacron patch group and 98.4% for patients randomized to the vein group (P =.03). At 3 years the incidence of stroke in the carotid territory not operated on was 1.0% in 93 patients with no contralateral internal carotid artery disease at randomization, and increased to 1.3% in 78 patients with 1% to 69% stenosis, and 2.0% in 51 patients with contralateral 70% to 99% stenosis. No late strokes occurred distal to 42 occluded contralateral internal carotid arteries. CONCLUSIONS: Patch type has no influence on early operative risk, no association with enhanced patterns of thrombogenicity in the early postoperative period, and no influence on risk for ipsilateral or any stroke at 3 years. Dacron patches were, however, associated with a significantly higher incidence of recurrent stenosis at 3 years, with most occurring within 6 to 12 months of surgery. However, the higher incidence of recurrent stenosis was not associated with a parallel increase in late stroke, and in this study a program of serial ultrasound surveillance could not have prevented one ipsilateral stroke.     

Decreased recurrent carotid stenosis by routine patching and intraoperative scanning

Our objective was to review the results of carotid endarterectomies (CEAs) with Dacron patch angioplasty and intraoperative color-flow duplex scanning (CFS). In a 3-year period, patients who underwent CEA with Dacron patch angioplasty and intraoperative CFS were studied. We excluded patients who had primary closure, vein patch, and redo endarterectomy. Serial CFS was obtained first in the early postoperative period (one day to 3 weeks), then at 6 months, and then yearly. Intraoperative CFS abnormalities were classified as major, requiring immediate revision, or minor, which were observed. The diagnosis of recurrent stenosis by US was based on the detection of an increased peak systolic frequency (>8000 MHz) or velocity (>250 cm/second) in the internal carotid artery. There were 212 CEAs performed in 200 patients (128 men and 84 women) included in this study. Three patients (1.4%) awoke with a stroke, two (0.94%) had transient ischemic attacks, and three (1.4%) developed transient hypoglossal nerve paresis. Intraoperative CFS showed a major defect that required an immediate revision in six patients (2.8%). Minor abnormalities were detected in another 41 patients (19.3%), but no revision was necessary. In follow-up three patients were identified with a severe recurrent carotid stenosis (>80%) and they underwent redo CEA. This rate of recurrence (1.4%) is significantly lower than the rate we had previously reported in a larger study (82 of 1209, 6.8%; P = 0.003). We conclude that the combined use of Dacron patch angioplasty and intraoperative CFS after CEA is associated with a low perioperative morbidity and a low incidence of recurrent stenosis in the first 2 years after operation.     

Patch closure improves results with carotid endarterectomy

The type of closure after a carotid endarterectomy, primary closure versus patch angioplasty, is controversial. Most authorities agree that in a small carotid artery (相似文献   

The natural history of early recurrent carotid artery stenosis.

BACKGROUND: Early recurrent carotid stenosis, defined as greater than 50% stenosis within 2 years of a carotid endarterectomy (CEA), occurs in 4% to 19% of patients. These lesions are secondary to myointimal hyperplasia (MH). The natural history of these lesions has been examined prospectively, but the appropriate management of these lesions has not been clearly defined. The vascular surgery service at Madigan Army Medical Center (MAMC) has prospectively collected a cohort of patients with recurrent high-grade carotid stenoses following CEA to determine their natural history and define the ideal therapeutic approach for those lesions. METHODS: Patients undergoing CEA between January 1, 1993, and January 1, 1997, at a single tertiary care institution were followed prospectively with postoperative carotid duplexes at 3-month intervals for the first year and then every 6 months for a year and then annually thereafter. Data were collected regarding patient demographics, type of carotid closure, neurologic morbidity, and death. These results were compared with accepted rates in the literature. Discrete variables were tested for significance by chi-square analysis and Fisher's exact test. A P value less than or equal to 0.05 was considered significant. RESULTS: One hundred and seventy-four (174) patients with 181 operative sites were evaluated. Fourteen patients with 17 sites (9%) had recurrent stenosis. Twelve patients with 14 sites (7%) had stenoses of 50% to 79%. All were asymptomatic. Two patients with 3 sites (2%) had stenoses greater than 80%. Two sites were managed operatively because of neurologic symptoms or preocclusive nature and one remains asymptomatic and stable on serial duplex imaging. All lesions were present at 6 months and those in the 50% to 79% category did not progress in follow-up. Recurrent carotid stenosis occurred to a significantly higher degree in women (women 11 of 60 18.3% versus men 6 of 114 5.3%; P = 0.25), primary closure versus patch angioplasty (primary 6 of 22 27.3% versus patch 11 of 159 6.9%; P = 0.01), and dacron versus polytetrafluoroethylene (PTFE) patch angioplasty (dacron 7 of 36 19.4% versus PTFE 2 of 100 2.0%; P = 0.02). CONCLUSION: Early recurrent stenosis (50% to 79%) is a benign lesion. Patch angioplasty is preferred over primary closure. Dacron patches had a significantly higher rate of recurrent stenosis when compared with PTFE patches. Women undergoing CEA are more prone to recurrent stenosis. Postoperative duplex at 3 and 6 months will identify recurrent carotid stenosis (given a normal duplex prior to discharge following CEA). Moderate high-grade (50% to 79%) stenoses are benign. High-grade (80% to 99%) stenoses require individual management.     

Carotid patch angioplasty: immediate and long-term results

To determine the benefit of carotid patch angioplasty, a retrospective study of 1000 consecutive carotid endarterectomies was done. Based on the type of carotid endarterectomy closure, patients were divided into four groups: 250 had primary closure, 250 had expanded polytetrafluoroethylene patch, 250 had Dacron patch, and 250 had saphenous vein patch. On the basis of operative technique or type of carotid artery closure, no statistical difference was found in the incidence of postoperative stroke (p greater than 0.25): primary closure 1.6% (4), expanded polytetrafluoroethylene 2.0% (5), Dacron patch 1.6% (4), and saphenous vein patch (0). Postoperative carotid patency was determined by B-mode ultrasonography, and 717 patients were evaluated in follow-up extending to 6 years (mean 37.8 months). Based on the method of carotid endarterectomy closure, no significant difference (p greater than 0.25) was found in the incidence of significant restenosis (greater than 50% diameter reduction): primary closure 4.0% (7), expanded polytetrafluoroethylene 4.0% (6), Dacron 5.4% (9), and saphenous vein 1.0% (2). Significant restenosis was most frequent in habitual smokers (93%, 25/28) and females (78%, 22/28) despite the method of carotid endarterectomy closure. No statistical difference was found in the incidence of late ipsilateral stroke either (p greater than 0.25): primary closure 2.9% (5), expanded polytetrafluoroethylene 2% (3), Dacron 5% (3), and saphenous vein 0%. These results indicate that the incidence of postoperative stroke, regardless of method of arterial closure, was not statistically different. The method of carotid closure did not appear to affect the occurrence of late ipsilateral stroke or restenosis; however, patch angioplasty with saphenous vein appears appropriate in habitual smokers, and likely in patients with small internal carotid arteries.     

Carotid artery Dacron patch graft angioplasty: a ten-year experience

Of 394 carotid endarterectomies performed during a 10-year period, 36 (9%) included Dacron patch graft angioplasties. Patch graft angioplasties were used selectively in patients because they had undergone previous carotid endarterectomy or had small-caliber vessels. There were no postoperative infections, occlusions, emboli, stroke, or pseudoaneurysms. In addition, no clinically detectable recurrent stenoses developed in this high-risk group of patients. Twenty-four of the 27 patients available for follow-up were screened for asymptomatic stenoses with spectral analysis and B-mode imaging; there was no sign of hemodynamically significant recurrent stenosis in this group. These encouraging results support the continued selective use of Dacron patch graft angioplasty in carotid surgery.     

Prospective controlled study of carotid endarterectomy with hemashield patch: is it thrombogenic?

The use of patch angioplasty after carotid endarterectomy (CEA) has been shown to have superior results to CEA with primary closure. Polytetrafluoroethylene (PTFE) patches have been shown to have comparable results to autogenous vein patching; however, PTFE has the disadvantage of prolonged hemostasis time. Therefore, many surgeons are using collagen-impregnated Dacron patches (Hemashield[HP]). We believe this is the first prospective controlled study of the use of HP in carotid endarterectomy. This study included 144 consecutive patients who had 151 CEAs with HP. Postoperative duplex ultrasounds were done at 1 month and every 6 months thereafter. The mean follow-up was 12 months (range: 1-30 months). Indications for CEA included symptomatic (64%) and asymptomatic (36%) stenoses. The overall incidence of ipsilateral stroke was 5% (4% perioperative), with a combined TIA and stroke rate of 12%. Incidence of > or =50% recurrent stenosis was 21% (7% symptomatic TIA/stroke) and > or =80% recurrent stenosis was 9%. Kaplan-Meier analysis showed that at 1 year and 2.5 years freedom from > or =50% recurrent stenosis was 78% and 57%, respectively, freedom from > or =80% recurrent stenosis was 92% and 77%, respectively, and a stroke-free survival rate of 94% and 72%, respectively. Women had a 22% and men a 14% recurrent stenosis rate (p=0.04). There was no correlation between other specific risk factors and recurrent stenosis except for hypertension (33% vs 12%, p=0.003). The authors concluded that CEA with HP had a higher incidence of recurrent stenosis (21%), and a higher perioperative stroke rate (4%) after a mean follow-up of 12 months than previously reported using PTFE or saphenous vein patching (2% and 9% recurrent stenosis rates, respectively, and 1% and 0% perioperative stroke rates, respectively after a mean follow-up of 30 months). This raises the question as to whether this patch is thrombogenic in this location. Therefore, a randomized controlled trial comparing this patch with other patches (PTFE or vein) is warranted.     

Closure of the arteriotomy after carotid endarterectomy: patch type is related to intraoperative microemboli and restenosis rate

OBJECTIVE: Patch closure after carotid endarterectomy (CEA) improves clinical outcome compared with primary closure. Whether there are differences in outcome between various patch materials is still not clear. The objective of this retrospective study was to investigate whether a relationship exists between the patch type and the number of microemboli as registered during CEA by transcranial Doppler imaging, the clinical outcome (transient ischemic attack and cerebrovascular accident), and the occurrence of restenosis. METHODS: We included 319 patients who underwent CEA. Intraoperative microembolus registration was performed in 205 procedures. Microembolization was recorded during four different periods: dissection, shunting, clamp release, and wound closure. The decision to perform primary closure or to use a patch for the closure of the arteriotomy was made by the surgeon, and Dacron patches were used when venous material was insufficient. Cerebral events were recorded within the first month after CEA, and duplex scanning was performed at 3 months (n = 319) and 1 year (n = 166) after CEA. A diameter reduction of more than 70% was defined as restenosis. RESULTS: Primary, venous, and Dacron patch closures were performed in 83 (26.0%), 171 (53.6%), and 65 (20.4%) patients, respectively. Primary closure was significantly related to sex (Dacron patch, 35 men and 30 women; venous patch, 108 men and 63 women; primary closure, 72 men and 11 women; P < .001). The occurrence of microemboli during wound closure was also related to sex (women, 2.5 +/- 0.6; men, 1.0 +/- 0.2; P = .01). Additionally, during clamp release, Dacron patches were associated with significantly more microemboli than venous patches (11.1 +/- 3.4 vs 4.0 +/- 0.9; P < .01), and this difference was also noted during wound closure (3.1 +/- 0.9 vs 1.4 +/- 0.4; P < .05). Transient ischemic attacks and minor strokes after CEA occurred in 5 (2.4%) of 205 and 6 (2.9%) of 205 procedures, respectively, and the degree of microembolization during dissection was related to adverse cerebral events (P = .003). In contrast, the type of closure was not related to immediate clinical adverse events. However, primary closure and Dacron patches were associated with an increase in the restenosis rate compared with venous patches: after 400 days, the restenosis rate for Primary closure was 11%, Dacron patch 16%, and venous patch 7% (P = .05; Kaplan-Meier estimates). CONCLUSIONS: Microemboli are more prevalent during clamp releases and wound closure when Dacron patches are used. Additionally, the observed differences in embolization noted by patch type were mainly evident in women. However, the use of Dacron patches was not related to immediate ischemic cerebral events but was associated with a higher restenosis rate compared with venous patch closure. This suggests that venous patch closure may be preferred for CEA.     

Prospective randomized trial of ACUSEAL (Gore-Tex) versus Hemashield-Finesse patching during carotid endarterectomy: early results

BACKGROUND/PURPOSE: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.     

Redo carotid surgery: An analysis of materials and configurations used in carotid reoperations and their influence on perioperative stroke and subsequent recurrent stenosis

Objective: The ideal method of arterial reconstruction in operations for recurrent carotid disease after prior endarterectomy is unknown. The goal of this study was to review a series of carotid reoperations and to determine whether the surgical technique influenced the rate of perioperative stroke, late stroke, or secondary restenosis. Methods: A retrospective review was conducted of 82 carotid reoperations performed on 74 patients at our institution. Results: The patient population included 39 men (52.7%) and 35 women (47.3%), with a mean age of 67.5 years. The indications for redo surgery included transient ischemic attack or amaurosis fugax in 35.3% of the patients, stroke in 6.1%, and asymptomatic restenosis (>80%) in 58.5%. Patch angioplasty with or without redo endarterectomy was used in 47 cases (57.3%), with saphenous vein in 26 (31.7%), Dacron in 15 (18.3%), and polytetrafluoroethylene in 6 (7.3%). Interposition grafting was used in 35 cases (42.7%), with saphenous vein in 9 (11.0%), Dacron in 10 (12.2%), and polytetrafluoroethylene in 16 (19.5%). The perioperative complications included three strokes (3.7%). There was a trend toward increased perioperative neurologic complications with interposition grafting when compared with patch angioplasty (8.6% vs 2.1%), although this did not reach statistical significance. Long-term clinical follow-up was obtained in all cases with a mean duration of 35 months, with follow-up duplex scanning performed in 89.2%. The late failures of redo surgery included four significant secondary restenoses and five total occlusions. There was a trend towards improved long-term results with interposition grafting as opposed to patch angioplasty. However, the cases in which reconstruction was performed with a vein had a significantly higher rate of late failures (stroke, secondary recurrent stenosis, or occlusion) than those in which reconstruction was performed with any prosthetic material (26.7% vs 2.3%; P = .002 by Fisher exact test). Conclusion: The use of autologous material for redo carotid surgery in any configuration appears to significantly increase the rate of subsequent recurrent stenosis or total occlusion of the operated artery. The reason for this finding is unclear but may be related to both host and technical factors. Prosthetic material may be more durable in the long-term for redo carotid surgery. Interposition grafting for redo carotid surgery may increase the perioperative neurologic complication rate to some degree; however, this was not statistically significant in this series. Interposition grafting may be a more durable solution in long-term follow-up than redo endarterectomy and patch angioplasty. A longer follow-up period will be needed to confirm this conclusion. (J Vasc Surg 1999;29:72-81.)     

Reoperations for carotid artery stenosis: role of primary and secondary reconstructions

PURPOSE: This is an analysis of the role of primary and secondary carotid artery reconstructions and systemic risk factors on the incidence and timing of reoperations and their perioperative and late outcomes. METHODS: This is a retrospective analysis of prospectively stored data. Between 1981 and 1999, 69 secondary carotid artery procedures were performed on 66 patients (3 were bilateral). Of these, 29 operations and patients came from my series of 1514 primary carotid endarterectomies (CEAs). Overall, secondary operations were performed on 37 women (1 bilateral) and 29 men (2 bilateral) with a mean age of 68 years. Indications for reoperation were transient ischemic attack in 27%, stroke in 12%, global ischemia in 9%, and asymptomatic > or = 70% recurrent stenosis in 52%. Secondary reconstruction was by saphenous vein patching in 57% (n = 39), Dacron patching in 29% (n = 20), polytetrafluoroethylene patch in 1% (n = 1), and interposition bypass graft in 13% (n = 9). The main outcome measures included restenosis, re-restenosis, and perioperative and late stroke and death. RESULTS: Reoperations were more frequent after originally primarily closed CEA (6.2%) than after patched CEA (1.6%, P =.01). Reoperations after Dacron-patched CEA occurred at a mean of 16 months compared with a mean of 84 months for vein-patched CEA (P <.001). Male sex and history of smoking have a slightly adverse but not statistically significant effect on the incidence and time of reoperation. Restenosis in the distal common carotid artery requiring reoperation had a near-linear rate of occurrence, whereas that in the internal carotid artery segment was bimodal with a higher incidence in the first 3 years and after 7 years. There were no (0%) 30-day perioperative deaths. There were two (2.9%) 30-day strokes (1 major, 1 minor). Over a mean follow-up of 50 months (range, 1-180), the Kaplan-Meier cumulative survival was 74% at 5 years and 54% at 10 years. This is significantly higher than late death after primary CEA independent of age. The cumulative freedom from stroke rate was 90% at 5 years and 86% at 10 years. After secondary procedures re-recurrent stenosis > or = 25% occurred in 25% (n = 17), > or = 50% in 13% (n = 9), and > or = 70% in 4% (n = 3). There was no statistically significant difference in stroke or re-restenosis rates between vein-patched, Dacron-patched, and bypassed reoperations, although re-recurrence tended to occur earlier after Dacron-patched than vein-patched procedures. Analysis of pooled literature data and the results of this study for stroke and re-restenosis outcomes by type secondary reconstruction (patch versus bypass graft) and by material (vein versus synthetic) give a balanced picture of near equality for each. Vein- and Dacron-patched arteries have similar outcomes, whereas polytetrafluoroethylene appears to be superior to vein and Dacron for interposition bypass graft. CONCLUSIONS: Secondary carotid artery operations are more frequent after primarily closed CEA than patched CEA. Perioperative mortality and stroke rates for reoperations are within the acceptable window of primary CEA. The incidence of late death after reoperations is higher than after primary CEA. The perioperative stroke, late stroke, and re-restenosis outcomes of vein- and Dacron-patched secondary operations are similar, as are those for patched and bypassed carotid arteries.     

Long-term follow-up for recurrent stenosis: A prospective randomized study of expanded polytetrafluoroethylene patch angioplasty versus primary closure after carotid endarterectomy

Purpose: 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.Methods: 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.Results: 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.Conclusions: 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. (J VASC SURG 1994;19:198-205.)     

Restenosis after carotid endarterectomy in patients with paired vein and Dacron patch reconstruction

This is an analysis of restenosis after bilateral carotid endarterectomy (CEA) with saphenous vein patch reconstruction on one side and Dacron patch reconstruction on the other. The possibility that differences in reconstruction geometry between vein and Dacron patched sides effected restenosis outcomes was evaluated as was the value of serial common carotid wall thickness measurements in predicting restenosis. Between 1990 and 1997, 33 bilateral CEA were performed within one year on 22 men and 11 women using a greater saphenous vein patch on one side and a knitted Dacron patch on the other. Interoperative post-CEA geometry was measured. Follow-up was by duplex scans that included wall thickness measurements in the endarterectomized common carotid bulb. Over a mean follow-up of 43 months 10 (30%) Dacron patched and one (3%) vein patched CEA developed > or = 25% restenosis (p = 0.001), seven (21%) Dacron patched and no vein patched CEA developed > or = 50% restenosis (p = 0.01) and four (12%) Dacron patched and no vein patched CEA developed > or = 70% restenosis (p = 0.11). The Kaplan-Meier cumulative > or = 25% restenosis rates for Dacron and vein patched CEA were 22% and 0% at 2 years and 41% and 5% at 5 years respectively (p = 0.002). The cumulative > or = 50% restenosis rates for Dacron and vein patched CEA were 16% and 0% at 2 years and 34% and 0% at 5 years respectively (p = 0.003). The cumulative > or = 70% restenosis rates for Dacron and vein patched CEA were 8% and 0% at 2 years and 20% and 0% at 5 years respectively (p = 0.02). For both patients with and without recurrent stenosis the mean within patient between sides differences of the diameters of the internal carotid, internal carotid bulb, common carotid bulb, and common carotid arteries and the lengths of the internal carotid and total patch segments were not significantly different and all were less than 5%. Common carotid bulb wall thickness measured at the time of identification of the nine unilateral Dacron patched CEA restenosis was 1.5 +/-0.5 mm compared to 1.4 +/-0.4 mm (m +/-1 SD) for the contralateral vein patched CEA (p = 0.45 by paired t test). Dacron patched CEA have a significantly higher incidence of mild, moderate and severe restenosis than do saphenous vein patched CEA independent of systemic risk factors. The within patient equality of Dacron and vein patched carotid reconstruction geometry in patients with unilateral restenosis indicates that patch material is the major local risk factor, not adverse hemodynamics produced by variance in geometry. Common carotid bulb wall thickness measurements after CEA are not predictors or indicators of recurrent stenosis.     

Prospective randomized trial of carotid endarterectomy with primary closure and patch angioplasty with saphenous vein,jugular vein,and polytetrafluoroethylene: Long-term follow-up

Purpose: This study examines the long-term clinical outcome and the incidence of recurrent stenosis (≥50%) after carotid endarterectomy (CEA) with primary closure (PC) versus vein patch closure (VPC), saphenous (SVP), and jugular vein (JVP) and polytetrafluoroethylene patch closure (PTFE-P). Methods: A total of 399 CEAs were randomized into the following groups: 135 PC, 134 PTFE-P, and 130 VPC (SVP alternating with JVP). Postoperative duplex ultrasound scans were performed at 1, 6, and 12 months and every year thereafter. The mean follow-up was 30 months with a range of 1 to 62 months, and demographic characteristics were similar in all groups. Kaplan-Meier analysis was used to estimate the risk of restenosis and the stroke-free survival. Results: The incidence of ipsilateral stroke was 5% (seven of 135) for PC, 1% (one of 134) for PTFE-P, and 0% for VPC (PC vs VPC, p = 0.008; PC vs PTFE-P, p = 0.034). Seven strokes occurred in the perioperative period. All three groups had similar mortality rates. The cumulative stroke-free survival rate at 48 months was 82% for PC, 84% for PTFE-P, and 88% for VPC (p < 0.01 for PC vs PTFE-P or VPC). PC had a higher incidence of recurrent stenosis and occlusion (34%) than PTFE-P (2%) and VPC (9%) (SVP 9%, JVP 8%) (p < 0.001). PTFE-P had a lower recurrent stenosis rate than VPC (p < 0.045). Restenoses necessitating a redo CEA were also higher for PC (11%) than for PTFE-P (1%) and VPC (2%) (p < 0.001). Women with PC had a higher recurrent stenosis rate than men (46% vs 23%, p = 0.008). Kaplan-Meier analysis showed that freedom from recurrent stenosis at 48 months was 47% for PC, 84% for VPC, and 96% for PTFE-P (p < 0.001). The SVP and JVP results were comparable. The mean operative diameter of the internal carotid artery was similar in patients with or without restenosis. Significantly more late internal carotid artery dilatations occurred in the VPC group compared with the PC group. Conclusions: Patch closure (VPC or PTFE-P) is less likely than PC to cause perioperative stroke. Patching was also superior in lowering the incidence of late recurrent stenoses, especially in women. (J Vasc Surg 1998;27:222-34.)     

A fifteen-year experience with carotid endarterectomy after a formal operative protocol requiring highly frequent patch angioplasty

PURPOSE: The early and late outcomes of carotid endarterectomy (CEA) following a rigid protocol of patch angioplasty or occasionally interposition bypass grafting, when the arteriotomy required to obtain a complete internal carotid end point extended distal to the bulb segment, and primary closure, when it was limited to the bulb, were studied. METHODS: From November 1983 to August 1998, 1360 consecutive primary CEAs were performed on 1133 patients (621 men, 512 women), with a mean age of 67 years. Of these patients, 3.8% (51) had primary closure, 66.4% (903) had greater saphenous vein patch angioplasty, 28.4% (386) had synthetic (359 Dacron, 27 polytetrafluoroethylene) patch angioplasty, and 1.4% (20) had vein interposition bypass grafting procedures. Indications were transient ischemic attack in 34.7% of patients (472), stroke in 16.6% of patients (226), nonlateralizing symptoms in 10.9% of patients (148), and asymptomatic stenosis 70% or greater in 37.8% of patients (514). The mean follow-up period was 4.6 years. RESULTS: The 30-day mortality rate was 1.0% (13 patients; 11 cardiac-related deaths, 2 strokes). The 30-day stroke rate was 1.3% (18 patients; 13 ipsilateral strokes, 5 major, 8 minor). The combined 30-day stroke and death rate was 2.1%. Four of the strokes (1 death) were caused by the hyperperfusion syndrome. The 30-day ipsilateral major stroke or mortality rate was 1.2% (16 patients). The 30-day rate of ipsilateral major stroke or death from stroke was 0.4% (5 patients). There were two synthetic and one vein patch internal carotid occlusions in 30 days. Synthetic-patched CEAs were predicted by means of Cox proportional hazards analysis to have higher risk ratios than saphenous vein-patched CEAs for early and late stroke (1. 3; 95% CI, 1.7 to 1.0; P =.04), for 50% or greater restenosis (2.4; 95% CI, 3.4 to 1.6; P <.001), and for 70% or greater restenosis (2. 5; 95% CI, 3.6 to 1.7; P <.001). The cumulative mortality rate (Kaplan-Meier) was 13% at 5 years and 31% at 10 years. The cumulative stroke rate was 7% at 5 years and 14% at 10 years. The 50% or greater restenosis rate was higher in women than in men at 5 years (9% versus 5%; P =.02, Wilcoxon), but tended to equalize later. The 50% or greater restenosis rate was higher in synthetic-patched CEAs than in saphenous vein-patched CEAs (12% versus 1% at 1 year; 17% versus 3% at 4 years; and 24% versus 10% at 8 years; P <.001 by means of log-rank and Wilcoxon). Restenosis after 5 years was more frequently located in the distal common carotid artery (13 of 20 cases). Late reoperations were more frequent and occurred earlier in synthetic-patched CEAs (eight cases at a mean of 1.6 years) than vein-patched CEAs (14 cases at a mean of 6.9 years; P =.01). No strokes and one restenosis of 50% or greater occurred in the 51 primarily closed CEAs. CONCLUSION: Patch angioplasty reconstruction of CEAs with arteriotomies that extend distal to the carotid bulb gives excellent early and long-term outcomes. Saphenous vein-patched CEAs are superior to synthetic patched CEAs for stroke and restenosis prevention. Primary closure is safe and durable when complete end points and arteriotomies are within the carotid bulb.     

Carotid endarterectomy with patch closure versus carotid eversion endarterectomy and reimplantation: a prospective randomized study

BACKGROUND: Although carotid eversion endarterectomy (CEE) has obtained consensus providing excellent early and late results, conventional carotid endarterectomy (CEA) with or without patching continues to be considered the gold standard surgical procedure. The few studies published to date comparing CEE with CEA in a small series of patients have failed to show substantial advantages of one technique over the other, and further randomized comparative studies are still required. The purpose of this study was to compare the outcome of CEA with routine patch closure (CEAP) with that of CEE and reimplantation (CEER) of the internal carotid artery in the common carotid artery. METHODS: Three hundred thirty-six primary CEAs performed in 310 patients were randomized into 2 groups, 167 CEAPs and 169 CEERs. Surviving patients underwent duplex ultrasound scan control at 30 days, 6 months, 12 months, and every postoperative year thereafter. The mean follow-up was 34 months (range, 1 to 69 months). Demographic characteristics, risk factors, associated diseases, and indications for surgery were comparable in the 2 groups. RESULTS: Although the rate of intraoperative electroencephalogram changes was comparable in the 2 groups, the incidence of shunting was statistically higher in the CEAP group (28.1% vs 1.2%, P < .00001). The carotid cross-clamping time was significantly lower in the CEER group (P = .01). Although all deaths were in the CEAP group, the overall perioperative death and stroke-related death rates were comparable in the 2 groups. The perioperative stroke rate was statistically higher in the CEAP group (2.9% vs 0%, P = .03). Although the recurrent stenosis rate was comparable in the 2 groups (1.2% vs 0%), the CEAP group had a statistically higher rate of combined recurrent stenoses and occlusions (4.9% vs 0%, P = .003). The late mortality rate was similar in both groups. CONCLUSIONS: Although the outcome of CEAP in this series is consistent with that of the main reported trials, the CEER procedure is less likely than CEAP to cause perioperative stroke and death and seems superior in reducing the incidence of recurrent stenosis and late occlusive events.     

Clinical and technical factors influencing recurrent carotid stenosis and occlusion after endarterectomy

Carotid endarterectomy was performed in 152 patients during a 27-month period. The first 82 patients had primary closure of the arteriotomy, whereas the subsequent 70 patients underwent closure with Dacron patch angioplasty. Duplex scanning was undertaken postoperatively in 102 of these patients with a mean follow-up period of 17 months. Perioperative thrombosis occurred in two patients (1.3%), late postoperative recurrent stenosis in 14 patients (13.7%), and late postoperative occlusion in three patients (2.9%). Of the various factors investigated for their correlation with late recurrent stenosis or occlusion, only three were significant: the female sex (recurrent stenosis in 29% vs. 8%, p less than 0.05), a small (less than 4 mm) internal carotid artery (37% vs. 12%, p less than 0.05), and failure to close the arteriotomy with a patch (29% vs. 6%, p less than 0.05). The development of recurrent carotid lesions appeared independent of smoking history, antiplatelet therapy, use of a shunt, or extent of carotid plaque. These data suggest that patients with small internal carotid arteries, specifically female patients, are at greater risk for recurrent carotid stenosis. Patch angioplasty may decrease this risk and should be considered in these patients.