Prospective randomized trial of ACUSEAL (Gore-Tex) vs Finesse (Hemashield) patching during carotid endarterectomy: long-term outcome

BACKGROUND: Several studies have reported that carotid endarterectomy with patch angioplasty is superior to primary closure. Conventional polytetrafluoroethylene (Gore-Tex, W. L. Gore & Associates, Flagstaff, Ariz) patching has been shown to have results similar to autogenous saphenous vein patching; however, it requires a longer hemostasis time. This study examined the long-term clinical outcome and incidence of restenosis after carotid endarterectomy using the new ACUSEAL (Gore-Tex) patching vs Hemashield Finesse (Boston Scientific Corp, Natick, Mass) patching. METHODS: The study randomized 200 patients (1:1) undergoing carotid endarterectomy to 100 with ACUSEAL patching and 100 with Hemashield-Finesse patching. All patients underwent immediate and 1-month postoperative duplex ultrasound studies, which were repeated at 6-month intervals. Kaplan-Meier analysis was used to estimate the freedom from stroke, stroke-free survival, and the risk of restenosis for both groups. RESULTS: The demographic and clinical characteristics, the mean operative diameter of the internal carotid artery, and the length of the arteriotomy were similar in both groups. The mean hemostasis time was 5.1 for the ACUSEAL patching vs 3.7 minutes for Finesse patching (P = .01); however, the mean operative times were similar for both groups (P = .61). The incidence of ipsilateral stroke was 2% for ACUSEAL patching (both early perioperative strokes) vs 3% for Finesse patching (2 early and 1 late stroke) at a mean follow-up of 21 months. The respective cumulative stroke-free rates at 1, 2, and 3 years were 98%, 98%, and 98% for ACUSEAL patching vs 97%, 97%, and 97% for Finesse patching (P = .7). The respective cumulative stroke-free survival rates at 1, 2, and 3 years were 97%, 92%, and 88% for ACUSEAL patching vs 96%, 96%, and 91% for Finesse patching (P = .6). The respective freedom from > or =70% carotid restenosis at 1, 2, and 3 years was 98%, 96%, and 89% for ACUSEAL patching vs 92%, 85%, and 79% for Finesse patching (P = .04). CONCLUSIONS: Carotid endarterectomy with ACUSEAL patching and Finesse patching had similar stroke-free rates and stroke-free survival rates. The mean hemostasis time for the ACUSEAL patch was 1.4 minutes longer than that for the Finesse patch; however, the Finesse patch had higher restenosis rates than the ACUSEAL patch.     

Prospective randomized study of carotid endarterectomy with polytetrafluoroethylene versus collagen-impregnated Dacron (Hemashield) patching: perioperative (30-day) results.

PURPOSE: Several studies have reported that carotid endarterectomy (CEA) with patch angioplasty has results that are superior to primary closure. Polytetrafluoroethylene (PTFE) patching has been shown to have results comparable with autogenous vein patching; however, it requires a prolonged hemostasis time. Therefore, many surgeons are using collagen-impregnated Dacron patching (Hemashield [HP]). This study is the first prospective randomized trial comparing CEA with PTFE patching versus HP patching. METHODS: Two hundred CEAs were randomized into two groups, 100 PTFE and 100 HP patching. All patients underwent immediate postoperative and 1-month postoperative color duplex ultrasound scanning studies. Demographic and clinical characteristics were similar in both groups, including the mean operative diameter of the internal carotid artery. RESULTS: The perioperative stroke rates were 0% for PTFE, versus 7% for HP (4 major and 3 minor strokes, P =.02). The combined perioperative stroke and transient ischemic attack rates were 3% for PTFE, versus 12% for HP (P =.047). The operative mortality rate for PTFE was 0%, versus 2% for HP (P =.477). Five perioperative carotid thromboses were noted in patients undergoing HP patching, versus none in patients undergoing PTFE patching (P =.07). After 1 month of follow-up, 2% of patients in the PTFE group had a 50% or more restenosis, versus 12% of patients in the HP group (P =.013). The mean operative time for PTFE patching was 119 minutes, versus 113 minutes for HP patching (P =.081). The mean hemostasis time was significantly higher for PTFE patching than for HP patching, 14.4 versus 3.4 minutes (P <.001). CONCLUSION: CEA with HP patching had a higher incidence of perioperative strokes, carotid thrombosis, and 50% or more early restenosis than CEA with PTFE patching. However, the mean hemostasis time was higher for PTFE patching than for HP patching.     

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.     

Prospective study of carotid endarterectomy with modified polytetrafluoroethylene (ACUSEAL) patching: early and late results

OBJECTIVE: Carotid endarterectomies (CEAs) with standard polytetrafluoroethylene (PTFE) patching have been shown to have results comparable with those of autogenous vein patching; however, prolonged bleeding through needle holes in PTFE is a commonly recognized problem. This is the first study of CEA using a new hemostatic modified PTFE patch (GORE-TEX) analyzing the early and late outcomes. METHODS: Two hundred consecutive CEAs were entered into this protocol. All patients had an immediate postoperative carotid duplex ultrasound scan that was repeated at 1 month and every 6 to 12 months thereafter. A Kaplan-Meier analysis was used to estimate the stroke-free survival and the risk of restenosis. The mean follow-up was 21 months (range, 1 to 48 months). RESULTS: The perioperative stroke rate was 1.5% (1% ipsilateral and 0.5% contralateral, two minor strokes and one major stroke) with no perioperative mortality or perioperative carotid thrombosis. The incidence of perioperative transient ischemic attacks was 3.5% (2.5% ipsilateral and 1% contralateral). The mean hemostasis time after completion of the patching was 3 minutes, in contrast to 14 minutes for conventional PTFE (in a previous study). The rates of freedom from ipsilateral strokes at 1, 2, 3, and 4 years were 99%, 99%, 99%, and 99%, respectively. The cumulative stroke-free survival rates at 1, 2, 3, and 4 years were 98%, 96%, 93%, and 93%, respectively. The rates of freedom from > or =70% restenosis at 1, 2, 3, and 4 years were 97%, 97%, 94%, and 94%, respectively. CONCLUSIONS: CEAs with a new modified PTFE patch are safe, have low perioperative stroke rates, are durable, and have an acceptable hemostasis time.     

Prospective randomized trial of carotid endarterectomy with primary closure and patch angioplasty with saphenous vein, jugular vein, and polytetrafluoroethylene: Perioperative (30-day) results

Purpose: 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.Methods: 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.Results: 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 (PC vs all patching, p = 0.008; PC vs PTFE-PC, p = 0.0017; PC vs SVP, p = 0.028). In contrast, early postoperative dilation of the internal carotid artery to more than twice the measured diameter was not significantly higher in patched arteries than in PC arteries. The mean operative and hemostasis times were significantly longer for patching than for PC.Conclusions: Patch closure is less likely than PC to cause perioperative CVA, RIND, and early internal carotid artery stenosis. (J Vasc Surg 1996;24;998-1007.)     

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.     

Systematic review of randomized controlled trials of patch angioplasty versus primary closure and different types of patch materials during carotid endarterectomy

BACKGROUND: Patch angioplasty during carotid endarterectomy (CEA) may reduce the risk for perioperative or late carotid artery recurrent stenosis and subsequent ischemic stroke. We performed a systematic review of randomized controlled trials to assess the effect of routine or selective carotid patch angioplasty compared with CEA with primary closure, and the effect of different materials used for carotid patch angioplasty. METHODS: Randomized trials were included if they compared carotid patch angioplasty with primary closure in any patients undergoing CEA or use of one type of carotid patch with another. RESULTS: Thirteen eligible randomized trials were identified. Seven trials involving 1281 operations compared primary closure with routine patch closure, and 8 trials with 1480 operations compared different patch materials (2 studies compared both). Patch angioplasty was associated with a reduction in risk for stroke of any type (P = .004), ipsilateral stroke (P = .001), and stroke or death during both the perioperative period (P = .007) and long-term follow-up (P = .004). Patching was also associated with reduced risk for perioperative arterial occlusion (P = .0001) and decreased recurrent stenosis during long-term follow-up (P < .0001). Seven trials that compared different patch types showed no difference in the risk for stroke, death, or arterial recurrent stenosis either perioperatively or at 1-year follow-up. One study of 180 patients (200 arteries) compared collagen-impregnated Dacron (Hemashield) patches with polytetrafluoroethylene patches. There was a significant increase in risk for stroke (P = .02), combined stroke and transient ischemic attack (P = .03), and recurrent stenosis (P = .01) at 30 days, and an increased risk for late recurrent stenosis greater than 50% (P < .001) associated with Dacron compared with polytetrafluoroethylene. CONCLUSIONS: Carotid patch angioplasty decreases the risk for perioperative death or stroke, and long-term risk for ipsilateral ischemic stroke. More data are required to establish differences between various patch materials.     

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   

Frequency of postoperative carotid duplex surveillance and type of closure: results from a randomized trial

BACKGROUND/PURPOSE: In several nonrandomized studies investigators have reported on the value of postoperative carotid duplex surveillance (PCDS) with mixed results; however the type of closure was not analyzed in these studies. In this study we analyze the frequency and timing of postoperative carotid duplex ultrasound scanning according to the type of closure from a randomized carotid endarterectomy (CEA) trial comparing primary closure (PC) versus patching. PATIENT POPULATION AND METHODS: We randomized 399 CEAs into 135 PCs, 134 polytetrafluoroethylene (PTFE) patch closures, and 130 vein patch closures (VPCs) with a mean follow-up of 47 months. PCDS was done at 1, 6, and 12 months and every year thereafter (a mean of 4.0 studies per artery). Kaplan-Meier analysis was used to estimate the rate of > or = 80% restenosis over time and the time frame of progression from < 50%, to 50%-79% and > or = 80% stenosis. RESULTS: Restenoses of > or =80% developed in 24 (21%) arteries with PC and nine (4%) with patching. Kaplan-Meier estimate of freedom of > or = 80% restenosis at 1, 2, 3, 4, and 5 years was 92%, 83%, 80%, 76%, and 68% for PC, respectively, and 100%, 99%, 98%, 98%, and 91% for patching, respectively, (P <.01). Of 56 arteries with 20% to 50% restenosis, two of 28 patch closures and 10 of 28 PCs progressed to 50% to < 80% restenosis (P =.02); none of the patch closures and six of 28 PCs progressed to > or =80% (P =.03). In PCs, the median time to progression from <50% to 50%-79%, < 50% to > or =80%, and 50%-79% to > or = 80% was 42, 46, and 7 months, respectively. Of the 24 arteries with > or =80% restenosis in PC, 10 were symptomatic. Thus, assuming th symptomatic restenosis would have undergone duplex scan examinations regardless, there were 14 asymptomatic arteries (12%) that could have been detected only with PCDS (estimated cost, $139, 200), and those patients would have been candidates for redo CEA. Of the 9 arteries (3 PTFE closures and 6 VPCs) with > or =80% restenosis with patch closures, 6 asymptomatic (4 VPCs and 2 PTFE closures) arteries (3%) could have been detected with PCDS. In patients with normal duplex scan findings at the first 6 months, only four (2%) of 222 patched arteries (two asymptomatic) developed > or = 80% restenosis versus five (38%) of 13 in patients with abnormal duplex scan examination findings (P<.001). CONCLUSIONS: PCDS is beneficial in patients with PC, but is less beneficial in patients with patch closure. PCDS examinations at 6 months and at 1- to 2-year intervals for several years after PC are adequate. For patients with patching, a 6-month postoperative duplex scan examination with normal results is adequate.     

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.     

Determinants of carotid endarterectomy anatomic durability: effects of serum lipids and lipid-lowering drugs

OBJECTIVES: Carotid endarterectomy (CEA) remains the gold standard for treatment of carotid stenosis. With inevitable comparisons of catheter-based therapy to all aspects of CEA, this study of a large contemporary series was undertaken to evaluate the determinants of anatomic durability of CEA. METHODS: During the interval (1989 through 1999), 2,127 primary, isolated CEAs with selective patching (50.2%) were performed in 1,853 patients (61.8% male, 36.1% symptomatic). End points included patient longevity and perioperative morbidity as well as evidence of CEA anatomic durability as defined by duplex evaluation: CEA restenosis (moderate, >50%, or greater recurrent stenosis), which included CEA anatomic failure (severe, >70%, restenosis/carotid occlusion). The incidence of CEA recurrent stenosis was temporally assessed early (<2 years) and late (>2 years) after operation. Clinical and surgical variables potentially associated with the study endpoints were analyzed by univariate and multivariate methods. RESULTS: The perioperative stroke and death rate was 1.4% and the 2-year and 10-year survival was 88.1% and 44.9%, respectively. Anatomic failure after CEA developed in 3.9% at 2 years and in 8.5% at 5 years; only 3.2% of CEA patients underwent reoperation during a mean follow-up of 73.4 months. Early (<2 years) analysis revealed 12.2% restenosis, whereas late (>2 years) results identified 9.8% progression of carotid stenosis and a 5.8% rate of anatomic failure. Multivariate analysis determined elevated creatinine (odds ratio [OR], 1.719, P < .001) and female gender (OR, 1.564; P < .02) correlated with early restenosis. Surgical patch closure and lipid-lowering drugs were protective for both early restenosis, with ORs of 0.543 (P < .0.001) and 0.601 (P < .007) and early anatomic failure ORs of 0.469 (P < .02) and 0.517 (P < .03), respectively. Although only elevated serum cholesterol (OR, 1.009; P < .03) correlated with late anatomic failure, only lipid-lowering drugs were protective for both late freedom from progression of disease (OR, 0.202; P < .0002) or late CEA anatomic failure (OR, 0.128; P < .0003). CONCLUSIONS: The association of female gender and elevated cholesterol with recurrent carotid stenosis is confirmed, elevated creatinine is introduced as a risk factor, and surgical patch repair is protective for early CEA recurrent carotid stenosis. The unique findings of the significant, beneficial effects of lipid-lowering drugs on both early and late CEA anatomic durability and patient survival indicate that such therapy should be instituted in most patients after CEA.     

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.     

A personal experience with coronary artery bypass grafting, carotid patching, and other factors influencing the outcome of carotid endarterectomy

OBJECTIVE: This study was conducted to investigate the influence of coronary artery bypass grafting (CABG), carotid patching, and other factors on the outcome of all carotid endarterectomies (CEAs) performed by a single surgeon at a tertiary referral center. METHODS: The series includes 2262 CEAs (335 bilateral) in 1521 men and 741 women (33%) with median ages of 66 and 68 years, respectively. Surgical indications were asymptomatic stenosis for 1503 procedures (66%), retinal ischemia or cerebral transient ischemic attacks each for 271 (12%), and prior stroke for 217 (9.6%). CEA was done as an isolated operation in 1959 patients and was performed in conjunction with simultaneous CABG in 303 (13%). Primary arteriotomy closure was used for 783 CEAs (35%), vein patching for 1232 (54%), and synthetic patching for 247 (11%). Outcome event rates were assessed by logistic regression analysis, proportional hazards models, and Kaplan-Meier estimations. RESULTS: Postoperative mortality (odds ratio [OR], 3.5; 95% confidence interval [CI], 1.7 to 7.5; P = .001), stroke (OR, 3.2; 95% CI, 1.6 to 6.4; P = .001), and combined stroke and mortality rates (OR, 3.4; 95% CI, 2.0 to 5.8; P < .001) were significantly higher for simultaneous CEA/CABG than for isolated CEA. Ipsilateral postoperative stroke rates were similar (2.6% vs 1.7%, P = .41) in both settings. Vein patching had a lower risk for ipsilateral stroke (OR, 0.42; 95% CI, 0.21 to 0.86; P = .015) than primary closure, but was not significantly different from synthetic patching (P = .10). The documented incidence of postoperative carotid thrombosis was 1.5% with primary closure, 0.6% with vein patching, and 2.0% with synthetic patching (P = .088). Overall Kaplan-Meier survival was 92% at 1 year, 71% at 5 years, 41% at 10 years, and 20% at 15 years, but long-term mortality rates were higher after simultaneous CEA/CABG (hazard ratio, 1.3; 95% CI, 1.1 to 1.5; P = .002) than after CEA alone. Late strokes or retinal infarctions have been reported after 97 (5.0%) of the 1923 operations for which follow-up was available, 51 (2.3%) of which were ipsilateral to CEA. The incidence of > or = 60% recurrent stenosis was independently influenced by carotid patching (OR, 0.61; 95% CI, 0.40 to 0.92; P = .019) but not by the choice of patch material (P = .11). CONCLUSIONS: These results substantiate the common observation that patients who require simultaneous CEA/CABG have a higher risk for adverse outcomes than patients who undergo isolated CEA. Carotid patching provided significant benefit with respect to the risks for ipsilateral postoperative stroke and > or = 60% recurrent stenosis.     

Intraoperative duplex ultrasonography as an adjunct to technical excellence in 100 consecutive carotid endarterectomies

PURPOSE: To evaluate the relationship of intraoperative duplex ultrasonography (duplex) results to neurologic outcomes and restenosis among patients undergoing carotid endarterectomy (CEA). METHODS: One hundred consecutive CEAs were performed at a military medical center over 28 months. Prospectively acquired demographics, duplex results, revisions, and surgical outcomes were reviewed. RESULTS: Thirty-four percent (34 of 100) of sites were abnormal by completion duplex. Of these, 70% (24 of 34) were B-mode flap type defects located in the common carotid artery (CCA), internal carotid artery (ICA), or external carotid artery (ECA). Twenty-one percent of the defects (7 of 34) were technically unacceptable and immediately revised. Subsequently, 3 perioperative neurologic events occurred, 2 strokes and 1 transient ischemic attack (TIA), all among patients with an identified but unrepaired defect involving the ICA or CCA. This association of unrepaired defect with early stroke or TIA was significant (P = 0.02). No significant association (P >0.05) between unrepaired defects and late ipsilateral stroke or TIA or restenosis was identified. CONCLUSIONS: Intraoperative duplex scanning is a useful adjunct to CEA that can identify correctable mechanical problems. Residual elevated velocities or B-mode flaps 2 mm or greater in the ICA warrant consideration for immediate repair. Findings not requiring revision include flaps <2 mm, as well as isolated ECA defects. Prospectively validated duplex criteria are needed to further define which defects require immediate repair.     

Early carotid endarterectomy in symptomatic patients is associated with poorer perioperative outcomes

OBJECTIVE: The optimal timing of carotid endarterectomy (CEA) after ipsilateral hemispheric stroke is controversial. Although early studies suggested that an interval of about 6 weeks after a completed stroke was preferred, more recent data have suggested that delaying CEA for this period of time is not necessary. With these issues in mind, we reviewed our experience to examine perioperative outcome with respect to the timing of CEA in previously symptomatic patients. METHODS: A retrospective review of a prospectively maintained database of all CEAs performed at our institution from 1992 to 2003 showed that 2537 CEA were performed, of which 1,158 (45.6%) were in symptomatic patients. Patients who were operated on emergently 18 months), and these were excluded from further analysis. Of the remaining 1,046 cases, 62.7% had TIAs and 37.3% had completed strokes as their indication for surgery. Among the entire cohort, patients who underwent early CEA were significantly more likely to experience a perioperative stroke than patients who underwent delayed CEA (5.1% vs 1.6%, P = .002). Patients with TIAs alone were more likely to be operated on early rather than in a delayed fashion (64.3% vs 46.7%, P < .0001), likely reflecting institutional bias in selecting delayed CEA for stroke patients. However, even when examined as two separate groups, both TIA patients (n = 656) and CVA patients (n = 390) were significantly more likely to experience a perioperative stroke when operated upon early rather than in a delayed fashion (TIA patients, 3.3% vs 0.9%, P = .05; CVA patients, 9.4% vs 2.4%, P = .003). There were no significant differences in demographics or other meaningful variables between patients who underwent early CEA and those who underwent delayed CEA. CONCLUSIONS: In a large institutional experience, patients who underwent CEA 相似文献   

Eversion versus conventional carotid endarterectomy: Late results of a prospective multicenter randomized trial

Objective: The durability of carotid endarterectomy (CEA) may be affected by carotid restenosis. The data from randomized trials show that the highest incidence of restenosis after CEA occurs from 12 to 18 months after surgery. The optimal CEA technique to reduce perioperative complications and restenosis rates is still undefined. This study examines the long-term clinical outcome and incidence of recurrent stenosis in patients who undergo eversion CEA. Previously published perioperative results of this study did not show statistically significant differences in study endpoints between the eversion and standard techniques. Methods: From October 1994 to March 1997, 1353 patients with surgical indications for carotid stenosis were randomly assigned to undergo eversion (n = 678) or standard CEA (n = 675; primary closure, 419; patch, 256). Withdrawal from the assigned treatment occurred in 1.6% of the patients (in 13 assigned to eversion CEA, and in nine assigned to standard CEA). The clinical and duplex scan follow-up examination was 99% complete, and the mean follow-up interval was 33 months (range, 12 to 55 months). The primary outcomes were perioperative and late major stroke and death, carotid restenosis (stenosis ≥ 50% of the lumen diameter detected at duplex scanning), and carotid occlusion. The primary evaluation of study outcomes was conducted on the basis of an intention-to-treat analysis. Results: Restenosis was found at duplex scanning in 56 patients (19 in the eversion group, and 37 in the standard group). Within the standard group, the restenosis rates were 7.9% in the primary closure population and 1.5% in the patched population. Of the patients with restenosis, 36% underwent cerebral angiography that confirmed restenosis in all cases. The cumulative restenosis risk at 4 years was significantly lower in the group that underwent treatment with eversion CEA as compared with the standard group (3.6% vs 9.2%; P = .01), with an absolute risk reduction of 5.6% and a relative risk reduction of 62%. Eighteen patients would have had to undergo treatment with eversion CEA to prevent one restenosis during the 4-year period. The incidence rate of ipsilateral stroke was 3.3% in the eversion population and 2.2% in the standard group. There were no significant differences in the cumulative risks of ipsilateral stroke (3.9% for eversion, and 2.2% for standard; P = .2) and death (13.1% for eversion, and 12.7% for standard; P = .7)) in the two groups. Of the 18 variables that were examined for their influence on restenosis, eversion CEA (hazard ratio, 0.3; 95% confidence interval, 0.2 to 0.6; P = .0004) and patch CEA (hazard ratio, 0.2; 95% confidence interval, 0.07 to 0.6; P = .002) were negative independent predictors of restenosis with multivariate Cox proportional hazards regression analysis. Conclusion: The EVEREST (EVERsion carotid Endarterectomy versus Standard Trial) showed that eversion CEA is safe, effective, and durable. No statistically significant differences were found in late outcome between the eversion and standard techniques at the available follow-up examination. (J Vasc Surg 2000;31:19-30.)     

Long-term impact of the Vascular Study Group of New England carotid patch quality initiative

ObjectivePatch angioplasty has been shown to decrease rates of restenosis after carotid endarterectomy (CEA). In 2003, the Vascular Study Group of New England (VSGNE) implemented its first quality initiative aimed at increasing the rates of patch closure after CEA. This study reports the effects of that initiative on the rate of patch closure in the VSGNE and also postoperative and 1-year CEA outcomes.MethodsPatients undergoing CEA (N = 14,636) within the VSGNE between 2003 and 2014 were studied. Rates of in-hospital postoperative events (death, ipsilateral stroke or transient ischemic attack [TIA], and return to the operating room for bleeding) and events during 1 year of follow-up (stroke or TIA and restenosis >70% or occlusion) were compared by repair type—patch closure, primary closure, or eversion. One-year follow-up events were also compared over time and by annualized surgeon volume.ResultsDuring the 12 years studied, patch use increased from 71% to 91% (P < .001). There was no difference in postoperative death or ipsilateral stroke or TIA between the repair types. However, there was a statistically lower rate of return to the operating room for bleeding (P < .001), 1-year stroke or TIA (P < .003), and 1-year restenosis or occlusion (P < .001) with patch closure. Overall, the rates of 1-year stroke or TIA and restenosis decreased over time in the VSGNE. The initiative affected patch closure rates and outcomes of high-volume surgeons (>47 CEAs/y) the most. High-volume surgeons increased patch use from 50% to 90% and decreased their restenosis rates from 9.0% to 1.2% and 1-year stroke or TIA from 4.9% to 1.9% (P < .001).ConclusionsThe VSGNE carotid patch quality initiative successfully increased the rates of CEA patch closure. During the same time, there has been a decrease in postoperative bleeding requiring reoperation and 1-year ipsilateral neurologic events and restenosis or occlusion.     

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.     

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.     

Restenosis after carotid endarterectomy performed with routine intraoperative duplex ultrasonography and arterial patch closure: a contemporary series

The restenosis rates of 5% to 15% have been reported after carotid endarterectomy (CEA). We undertook this investigation to determine whether the routine practice of carotid artery patch closure and intraoperative completion duplex ultrasonography would result in lower rates of carotid restenosis after CEA. All consecutive carotid endarterectomies performed between 2000 and 2004 at a single institution were reviewed retrospectively. Patients underwent CEA using a longitudinal arteriotomy, followed by routine patching and intraoperative completion duplex ultrasonography. Only patients with at least one postoperative duplex scan performed at a minimum of 180 days after CEA were included. During the 5-year study period, 407 consecutive carotid endarterectomies were performed, with a combined 30-day stroke and mortality rate of 2.5%; 217 patients (53%) had one or more duplex ultrasound examinations performed at least 180 days after CEA. The mean follow-up duration was 692 days. Of the patients who underwent intraoperative intervention based on the results of the completion duplex study, none experienced restenosis, stroke, or death. CEA that is performed with routine patching and intraoperative duplex completion ultrasonography is a safe, durable operation with restenosis rates below those commonly reported.