Chirurgie Carotidienne - Carotid Surgery
- Mannheim D et al. (2005). "Carotid endarterectomy with a polyurethane patch versus primary closure: a prospective randomized study." J Vasc Surg 41(3): 403-7; discussion 407-8
- Naylor R et al. (2004). "Randomized trial of vein versus dacron patching during carotid endarterectomy: long-term results." J Vasc Surg 39(5): 985-93; discussion 993
- Grego F et al. (2003). "Prospective, randomized study of external jugular vein patch versus polytetrafluoroethylene patch during carotid endarterectomy: perioperative and long-term results." J Vasc Surg 38(6): 1232-40.
- AbuRahma AF et al. (2003). "Prospective randomized trial of carotid endarterectomy with polytetrafluoroethylene versus collagen-impregnated dacron (Hemashield) patching: late follow-up." Ann Surg 237(6): 885-92; discussion 892-3.
- AbuRahma AF et al. (2002). "Prospective randomized study of carotid endarterectomy with polytetrafluoroethylene versus collagen-impregnated Dacron (Hemashield) patching: perioperative (30-day) results." J Vasc Surg 35(1): 125-30
- O'Hara PJ et al. (2002). "A prospective, randomized study of saphenous vein patching versus synthetic patching during carotid endarterectomy." J Vasc Surg 35(2): 324-32
- Marien BJ, et al. (2002). "Bovine pericardium vs dacron for patch angioplasty after carotid endarterectomy: a prospective randomized study." Arch Surg 137(7): 785-8
- Ballotta E et al. (2002). "Carotid endarterectomy contralateral to carotid artery occlusion: analysis from a randomized study." Langenbecks Arch Surg 387(5-6): 216-21
- AbuRahma AF et al. (2001). "Prospective controlled study of carotid endarterectomy with hemashield patch: is it thrombogenic?" Vasc Surg 35(3): 167-74
- Hayes PD et al. (2001). "Randomized trial of vein versus Dacron patching during carotid endarterectomy: influence of patch type on postoperative embolization." J Vasc Surg 33(5): 994-1000
- AbuRahma AF et al. (2000). "Frequency of postoperative carotid duplex surveillance and type of closure: results from a randomized trial." J Vasc Surg 32(6): 1043-51
- Ballotta E et al. (2000). "A prospective randomized study on bilateral carotid endarterectomy: patching versus eversion." Ann Surg 232(1): 119-25
- Cao P et al. (2000). "Eversion versus conventional carotid endarterectomy: late results of a prospective multicenter randomized trial." J Vasc Surg 31(1 Pt 1): 19-30
- AbuRahma AF, et al. (2000). "Perioperative and late stroke rates of carotid endarterectomy contralateral to carotid artery occlusion: results from a randomized trial." Stroke 31(7): 1566-71
- Ballotta EG et al. (1999). "Carotid endarterectomy with patch closure versus carotid eversion endarterectomy and reimplantation: a prospective randomized study." Surgery 125(3): 271-9
- Zannetti S.P et al. (1999). "Intraoperative assessment of technical perfection in carotid endarterectomy: a prospective analysis of 1305 completion procedures. Collaborators of the EVEREST study group. Eversion versus standard carotid endartectomy." Eur J Vasc Endovasc Surg 18(1): 52-8
- Katz, SG, RD Kohl (1996). "Does the choice of material influence early morbidity in patients undergoing carotid patch angioplasty?" Surgery 119(3): 297-301
- AbuRahma AF et al. (1996). "Prospective randomized trial of carotid endarterectomy with primary closure and patch angioplasty with saphenous vein, jugular vein, and polytetrafluoroethylene: perioperative (30-day) results." J Vasc Surg 24(6): 998-1006; discussion 1006-7
- Myers SI et al. (1994). "Saphenous vein patch versus primary closure for carotid endarterectomy: long-term assessment of a randomized prospective study." J Vasc Surg 19(1): 15-22
- Katz DS et al. (1994). "Long-term follow-up for recurrent stenosis: a prospective randomized study of expanded polytetrafluoroethylene patch angioplasty versus primary closure after carotid endarterectomy." J Vasc Surg 19(2): 198-203; discussion 204-5
- Vanmaele RG et al. (1994). "Division-endarterectomy-anastomosis of the internal carotid artery: a prospective randomized comparative study." Cardiovasc Surg 2(5): 573-81
- Ranaboldo CJ et al. (1993). "Randomized controlled trial of patch angioplasty for carotid endarterectomy. The Joint Vascular Research Group." Br J Surg 80(12): 1528-30

1. Mannheim, D., B. Weller, et al. (2005). "Carotid endarterectomy with a polyurethane patch versus primary closure: a prospective randomized study." J Vasc Surg 41(3): 403-7; discussion 407-8.
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.

2. Naylor, R., P. D. Hayes, et al. (2004). "Randomized trial of vein versus dacron patching during carotid endarterectomy: long-term results." J Vasc Surg 39(5): 985-93; discussion 993.
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.

3. Grego, F., M. Antonello, et al. (2003). "Prospective, randomized study of external jugular vein patch versus polytetrafluoroethylene patch during carotid endarterectomy: perioperative and long-term results." J Vasc Surg 38(6): 1232-40.
OBJECTIVES: The purpose of this study was to evaluate the relative risks and advantages of using external jugular vein (EJV) patch, compared with polytetrafluoroethylene (PTFE) patch, during carotid endarterectomy. The primary end point was the relevant neurologic complication rate (RNCR; fatal or disabling stroke) at any time during follow-up. Secondary end points included stroke-free survival, 30-day and long-term mortality, recurrent stenosis rate (> or =50%), occlusion, patch infection, aneurysm formation, and other local complications. METHODS: The study, a prospective randomized clinical trial carried out at a single center, was divided into two 3-year phases: December 1996 to March 1999, when patients were enrolled, and March 1999 to March 2002, which was the follow-up period. Inclusion criteria included an external jugular vein suitable for patching, defined as vein diameter 3 mm or larger and absence of collateral vessels noted on preoperative color duplex ultrasound scans. Patients were prospectively randomized 1:1 to receive either the EJV (n = 80; group A) or synthetic (n = 80; group B) patch. RESULTS: Carotid endarterectomy and patching was performed by one surgeon. At 30 months the RNCR-free rate, analyzed with the Kaplan-Meier method, was 98.7% for group A (1 ipsilateral lethal stroke) and 94.6% for group B (4 ipsilateral disabling strokes), and remained stable to 60 months. No statistical difference was observed with the log-rank test. Stroke-free survival rate was 100% for group A and 98.7% for group B at 1 year, 98.7% for group A and 93.6% for group B (1 ipsilateral minor stroke) at 30 months, and was unchanged at 60 months. Life table analysis demonstrated freedom from significant recurrent stenosis (> or =50%) of 97.5% for both groups at 6 months, 93.6% for group A and 92.2% for group B at 30 months, and 90.2% for group A and 86.7% for group B at 60 months. No statistical difference was observed with the log-rank test. In no patients was recurrent stenosis greater than 70%. No aneurysm formation was noted during follow-up. CONCLUSIONS: We can conclude, with the power limitation of the study, that carotid endarterectomy can be safely performed with either the EJV or PTFE patch. Advantages of the EJV for carotid angioplasty include no cost for material, low risk for graft infection, and preservation of the saphenous vein.

4. AbuRahma, A. F., E. S. Hopkins, et al. (2003). "Prospective randomized trial of carotid endarterectomy with polytetrafluoroethylene versus collagen-impregnated dacron (Hemashield) patching: late follow-up." Ann Surg 237(6): 885-92; discussion 892-3.
OBJECTIVE: To compare the late clinical outcome and incidence of recurrent stenosis after carotid endarterectomy (CEA) with polytetrafluoroethylene (PTFE) versus Hemashield patching. SUMMARY BACKGROUND DATA: Several randomized trials have confirmed the advantages of patching over primary closure when performing CEA. METHODS: Two hundred CEAs (180 patients) were randomized into 100 with PTFE patching and 100 with Hemashield. All patients underwent postoperative color duplex ultrasounds at 1, 6, and 12 months, and every year thereafter. The mean follow-up was 26 months. Kaplan-Meier analysis was used to estimate the risk of re-stenosis, stroke, and stroke-free survival. A multivariate analysis of various risk factors was also done. RESULTS: Demographic and clinical characteristics were similar in both groups. The incidence of all ipsilateral strokes (early and late) was 8% (7% perioperative) for Hemashield versus 0% for PTFE patching. Both groups had similar mortality rates. The cumulative stroke-free rates at 6, 12, 24, and 36 months were 93%, 93%, 93%, and 89% for Hemashield versus 100%, 100%, 100%, and 100% for PTFE patching. The cumulative stroke-free survival rates at 6, 12, 24, and 36 months were 90%, 89%, 87%, and 79% for Hemashield versus 98%, 98%, 92%, and 92% for PTFE patching. Kaplan-Meier analysis also showed that freedom from 50% or greater re-stenosis at 6, 12, 24, and 36 months was 89%, 81%, 73%, and 66% for Hemashield versus 100%, 100%, 100%, and 92% for PTFE. Similarly, the freedom from 70% or greater re-stenosis at 6, 12, 24, and 36 months was 93%, 91%, 86%, and 78% for Hemashield versus 100%, 100%, 100%, and 100% for PTFE. Univariate and multivariate analyses of demographic and preoperative risk factors showed that only Hemashield was significantly associated with a higher incidence of 70% or greater recurrent stenosis. CONCLUSIONS: PTFE patching was superior to Hemashield in lowering the incidence of postoperative ipsilateral strokes and late recurrent stenosis.

5. AbuRahma, A. F., R. S. Hannay, et al. (2002). "Prospective randomized study of carotid endarterectomy with polytetrafluoroethylene versus collagen-impregnated Dacron (Hemashield) patching: perioperative (30-day) results." J Vasc Surg 35(1): 125-30.
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.

6. O'Hara, P. J., N. R. Hertzer, et al. (2002). "A prospective, randomized study of saphenous vein patching versus synthetic patching during carotid endarterectomy." J Vasc Surg 35(2): 324-32.
OBJECTIVE: The objective of this study was the determination of whether the choice of either autogenous saphenous vein (ASV) or synthetic material for patch angioplasty significantly influences the results after carotid endarterectomy (CEA). METHODS: With Institutional Review Board approval, 195 patients (145 men and 50 women; mean age, 69 years) who underwent 207 CEAs were prospectively randomized to arteriotomy closure with ASV or synthetic patches from July 1996 to January 2000. One hundred and one patients (52%) were randomized to the ASV cohort, and 94 (48%) were randomized to the synthetic cohort. Aside from a slight gender imbalance (70% versus 79% male in the ASV versus the synthetic group), there were no clinically important differences in baseline demographic variables, risk factors, or surgical indications between the ASV and synthetic groups. RESULTS: With all 207 randomized procedures on an intent-to-treat basis, there were two early (<30 days) postoperative deaths (1%). There were three perioperative strokes in the ASV cohort (3.0%) and two in the synthetic cohort (2.1%; P =.99). Two of these early strokes occurred in a subset of nine patients who received neither patch material, all after randomization but before CEA. Two patients in each group had late strokes. The cumulative freedom from stroke rate at 1 year (ASV, 94%; synthetic, 95%) was virtually identical for both cohorts. With the 125 patients who had at least one postoperative duplex scan, the incidence rate of recurrent (>or=60%) carotid stenosis was 4.8% (three of 62) for the ASV group and 6.3% (four of 63) for the synthetic group (P =.99). CONCLUSION: No significant differences in the stroke, mortality, or restenosis rates were shown between the ASV and the synthetic cohorts. While conceding the power limitations inherent in this study, we conclude that CEA may be safely performed with similar early results with ASV or synthetic patches.

7. Marien, B. J., J. D. Raffetto, et al. (2002). "Bovine pericardium vs dacron for patch angioplasty after carotid endarterectomy: a prospective randomized study." Arch Surg 137(7): 785-8.
HYPOTHESIS: Bovine pericardium (BP) demonstrates improved intraoperative hemostasis and equivalent perioperative morbidity compared with Dacron when used as patch material for angioplasty following carotid endarterectomy. OBJECTIVE: To prospectively compare BP and Dacron patch angioplasty after carotid endarterectomy in a randomized fashion. METHODS: Ninety-five consecutive primary carotid endarterectomies were performed in a prospective randomized fashion in 92 patients. Fifty-one procedures were performed using BP and 44 using Dacron. Intraoperative suture line bleeding was subjectively evaluated by observing bleeding at 3 and 4 minutes following carotid cross-clamp removal and then objectively weighing the sponge used to tamponade bleeding during these time intervals. Perioperative morbidity, including cervical wound hematoma, transient ischemic attack, and stroke, and perioperative mortality were recorded. Statistical analysis was performed using paired t tests, chi(2) analysis, Fisher exact test, or multiple linear regression as appropriate. RESULTS: Suture line bleeding at 3 minutes was present in 7 (14%) of 51 patients in the BP group and 24 (55%) of 44 patients in the Dacron group (P<.001). Suture line bleeding evaluated at 4 minutes was present in 2 (4%) of 51 patients in the BP group and 13 (30%) of 44 patients in the Dacron group (P =.001). Net +/- SEM sponge weight (total intraoperative suture line bleeding) was 6.25 +/- 0.55 g in the BP group and 16.34 +/- 1.85 g in the Dacron group (P<.001). Total suture line bleeding was significantly affected by activated clotting time; however, multivariate analysis demonstrated that bleeding was significantly less with BP (P<.001) even after adjusting for differences in activated clotting time. CONCLUSIONS: Bovine pericardium demonstrated a statistically significant decrease in intraoperative suture line bleeding compared with Dacron. Handling characteristics were judged by the surgeons to be superior for BP. Therefore, we believe BP may be an alternative to Dacron when performing patch angioplasty of the carotid artery after endarterectomy.

8. Ballotta, E., G. Da Giau, et al. (2002). "Carotid endarterectomy contralateral to carotid artery occlusion: analysis from a randomized study." Langenbecks Arch Surg 387(5-6): 216-21.
BACKGROUND AND AIMS: Many studies have reported the benefits of carotid endarterectomy (CEA) contralateral to an occluded internal carotid artery (ICA), with varying results. This study analyzed perioperative and late outcomes in a recent trial in which patients were randomized to carotid eversion endarterectomy (CEE) or traditional CEA with patching (CEAP). PATIENTS AND METHODS: In 336 primary CEAs (310 patients) 68 were contralateral to an occluded ICA (group I). The remaining 268 CEAs served as control group (group II). All patients underwent clinical follow-up and duplex ultrasonography at 1, 6, and 12 months and every year thereafter. Endpoints of the study were early and late neurological events, and deaths. RESULTS: Group I had a significantly higher incidence of perioperative electroencephalic changes and need for shunting. The perioperative stroke rate in group I was almost three times as high as in group II, but the difference was not significant. Similarly, the perioperative minor neurological event and death rates, as with the cumulative stroke-free and survival rates at 1, 3, and 5 years, were comparable in the two groups. CONCLUSIONS: CEA contralateral to an occluded ICA can be implemented with perioperative stroke and mortality rates and late stroke-free and survival rates comparable to CEA with no contralateral ICA occlusion.

9. AbuRahma, A. F., P. A. Robinson, et al. (2001). "Prospective controlled study of carotid endarterectomy with hemashield patch: is it thrombogenic?" Vasc Surg 35(3): 167-74.
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.

10. Hayes, P. D., H. Allroggen, et al. (2001). "Randomized trial of vein versus Dacron patching during carotid endarterectomy: influence of patch type on postoperative embolization." J Vasc Surg 33(5): 994-1000.
PURPOSE: A recent overview indicated that although routine patching is safer than routine primary closure after carotid endarterectomy (CEA), there is no systematic evidence that patch type influences outcome. However, most surgeons still believe that prosthetic patches are probably more thrombogenic than vein patches. This study tested the hypothesis that there was no difference in thrombogenicity between the different patch types. METHODS: A total of 274 patients undergoing 276 CEAs were randomized to either Dacron-patch closure (n = 137) or vein-patch closure (n = 139). All patients with an accessible cranial window were monitored for 3 hours postoperatively with transcranial Doppler scanning (TCD). The number of emboli and rate of embolization were quantified with the requirement for selective dextran therapy to control high rates of postoperative embolization. All patients were assessed postoperatively and again at 30 days by a neurologist, and all patients underwent a duplex examination at 30 days. RESULTS: The 30-day death/any stroke rate was 2.2% for patients in the Dacron-patch group and 3.6% for patients in the vein-patch group (P =.72). Patients in the Dacron-patch group had a higher incidence of postoperative emboli (median, 5; interquartile range, 0-10.5) than patients in the vein-patch group (median, 3; interquartile range, 1-17; P =.028). However, the incidence of detecting more than 50 emboli was virtually identical, and patch type had no effect on the incidence of high-rate, sustained embolization that required dextran therapy (5.3% for Dacron, 3.7% for vein). No patient had a carotid thrombosis at 30 days. CONCLUSION: Sustained, high-rate embolization, previously shown to be highly predictive of progression to carotid thrombosis, appears to be patient dependent, rather than related to patch type.

11. AbuRahma, A. F., P. A. Robinson, et al. (2000). "Frequency of postoperative carotid duplex surveillance and type of closure: results from a randomized trial." J Vasc Surg 32(6): 1043-51.
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.

12. Ballotta, E., L. Renon, et al. (2000). "A prospective randomized study on bilateral carotid endarterectomy: patching versus eversion." Ann Surg 232(1): 119-25.
OBJECTIVE: To compare the clinical outcome and restenosis incidence of patients who underwent carotid endarterectomy with patch closure (CEAP) on one side and carotid eversion endarterectomy (CEE) on the other. SUMMARY BACKGROUND DATA: Although a few investigators have compared the results of CEAP versus CEE, no reports have compared the outcome of CEAP versus CEE in the same patient. METHODS: Eighty-six patients were randomly selected for sequential surgical treatment involving either CEAP/CEE or CEE/CEAP. All patients underwent postoperative duplex ultrasound study and clinical follow-up at 1, 6, and 12 months and every year thereafter. Various factors were analyzed to ascertain any association with restenosis, and Kaplan-Meier analysis was used to estimate the risk of restenosis. RESULTS: Demographic and clinical data were similar in the CEAP and CEE groups. The selective shunting rate was statistically higher in the CEAP group. There were no perioperative deaths. Although the incidence of perioperative ipsilateral stroke was not significant, CEAP patients had a rate of combined transient ischemic attacks and strokes that approached statistical significance. The mean follow-up was 40 months. CEAP patients had a significantly higher incidence of restenosis and combined occlusive events and restenoses. Kaplan-Meier analysis showed that CEE had a significantly better cumulative patency rate than CEAP and that freedom from restenoses at 24 and 36 months was 87% and 83% for CEAP and 98% and 98% for CEE, respectively. CONCLUSIONS: CEE is less likely to cause perioperative neurologic complications and restenoses than CEAP. The significantly higher rate of unilateral recurrence suggests that local factors play a more important role than systemic factors in the occurrence of restenosis.

13. Cao, P., G. Giordano, et al. (2000). "Eversion versus conventional carotid endarterectomy: late results of a prospective multicenter randomized trial." J Vasc Surg 31(1 Pt 1): 19-30.
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.

14. AbuRahma, A. F., P. Robinson, et al. (2000). "Perioperative and late stroke rates of carotid endarterectomy contralateral to carotid artery occlusion: results from a randomized trial." Stroke 31(7): 1566-71.
BACKGROUND AND PURPOSE: Several previous studies have reported the benefits of carotid endarterectomy (CEA) contralateral to carotid occlusion with mixed results, but none of these were randomized except for the North American Symptomatic Carotid Endarterectomy Trial. The purpose of this study was to analyze the results of surgery in patients with contralateral carotid artery occlusion in a randomized trial in which randomization was done according to the method of closure. METHODS: In 399 CEAs (357 patients) that were randomized into primary closure versus patching, 49 had contralateral occlusion. Strokes were designated as ipsilateral if they arose from the same CEA side and contralateral if they arose from the occluded side. A Kaplan-Meier analysis was used to estimate perioperative strokes and stroke-free survival in patients with contralateral occlusion (group A) versus those without contralateral occlusion (group B). RESULTS: Demographic characteristics and mean follow-up for both groups were similar (group A, 40 months; group B, 33 months). Group A had a higher incidence of contralateral transient ischemic attacks (TIAs) (12.2% versus 0.9%; P<0.0001), contralateral strokes (2% versus 0%; P=0.025), and combined contralateral TIAs/strokes (14.3% versus 0.9%; P<0.0001). The rates for perioperative and all strokes (operative and late) were 2% and 4. 1% (2% ipsilateral and 2% contralateral strokes) for group A and 2. 9% and 3.4% (all ipsilateral) for group B (P=0.60 and 0.85, respectively). The rates for perioperative and all TIAs were 0% and 14.3% for group A versus 2.6% and 6.3% for group B (P=0.918 and P=0. 08, respectively). The rates for perioperative and all neurological events (TIA and stroke) were 2% and 18.4% for group A and 5.4% and 9. 7% for group B (P=0.27 and 0.113, respectively). The cumulative stroke-free survival rates at 5 years were 84% for group A and 77% for group B (P>0.1). The cumulative stroke-free survival rates at 5 years for symptomatic and asymptomatic patients in group A and group B were also similar. The perioperative and late deaths were similar for both groups (group A, 8%; group B, 14%). CONCLUSIONS: Group A had a higher incidence of contralateral TIAs and strokes than group B; however, the perioperative and all late stroke rates and survival rates of CEA were comparable in patients with and without contralateral occlusion.

15. Ballotta, E., G. Da Giau, et al. (1999). "Carotid endarterectomy with patch closure versus carotid eversion endarterectomy and reimplantation: a prospective randomized study." Surgery 125(3): 271-9.
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.

16. Zannetti, S., P. Cao, et al. (1999). "Intraoperative assessment of technical perfection in carotid endarterectomy: a prospective analysis of 1305 completion procedures. Collaborators of the EVEREST study group. Eversion versus standard carotid endartectomy." Eur J Vasc Endovasc Surg 18(1): 52-8.
OBJECTIVE: to define the incidence of technical defects and the impact of technical errors on ipsilateral carotid occlusion, ipsilateral stroke, and early restenosis rates, we analysed 1305 patients undergoing carotid completion procedures. DESIGN: prospective multicentre study. PATIENTS AND METHODS: adequacy of CEA was assessed intraoperatively by angiography in 1004 (77%), by angioscopy in 299 (22%), and by duplex scan in two patients (1%). Arteriograms and angioscopic findings were interpreted at the time of the procedure by the operating surgeon, who also established the need for immediate surgical revision. RESULTS: perioperatively, 13 major strokes (0.9%, all ipsilateral) and six deaths (0.4%) were recorded. Overall, 112 defects (9%) were identified intraoperatively: 81 (72%) were located in the common carotid artery (CCA) or internal carotid artery (ICA), and 31 (28%) in the external carotid artery. In 48 patients (4%) the defects were revised. Logistic regression analysis revealed that carotid plaque extension >2 cm on the ICA was a positive independent predictor of CEA defects (odds ratio (OR) 1.5p=0.03). A significant association was found between the incidence of revised defects of the CCA and ICA and perioperative ipsilateral stroke (OR 11.5p=0.0002). In contrast, patients with minor non-revised defects had an ipsilateral stroke rate comparable to that of patients with no defects (p=0.4). No significant association was found between revised or non-revised defects and occurrence of restenosis/occlusion at 6-month follow-up. CONCLUSIONS: the incidence of major technical defects during CEA is low, yet the perioperative neurological prognosis of patients with major defects warranting revision is poor. Completion angiography or angioscopy and possible correction of defects did not protect per se from an unfavourable early outcome after CEA. Therefore, surgical excellence is mandatory to achieve satisfactory results after CEA.

17. Katz, S. G. and R. D. Kohl (1996). "Does the choice of material influence early morbidity in patients undergoing carotid patch angioplasty?" Surgery 119(3): 297-301.
BACKGROUND: This study was undertaken to determine whether the choice of material influences the early morbidity of patients undergoing carotid patch angioplasty. METHODS: Before undergoing carotid endarterectomy, 190 patients were randomized to receive 207 patch closures with either Dacron (USCI Sauvage knitted velour) or saphenous vein harvested from the thigh. RESULTS: One hundred seven Dacron and 100 vein patch angioplasties were performed. No significant difference was seen between the two groups in patient age, sex preoperative risk factors, or indication for operation (p > 0.25 for each variable). Among the patients undergoing Dacron patch angioplasty three strokes (two temporary and one permanent), seven episodes of bleeding requiring reoperation, and two neck wound infections requiring rehospitalization occurred. The final 32 patients with Dacron patch closures had their anticoagulation reversed and had no bleeding complications. Complications inpatients undergoing vein patch closure included one fatal perioperative stroke, two episodes of bleeding requiring reoperation including one patch rupture, and three groin infections requiring hospitalization. No significant difference was seen between the two groups in the rate of perioperative stroke (p = 0.62), episodes of bleeding (p = 0.17), or infection (p = >0.67). CONCLUSIONS: Carotid patch angioplasty can be performed with an acceptably low complication rate with either Dacron or vein, and the choice of patch material does not clinically affect patient morbidity. However, reversal of anticoagulation is recommended to minimize bleeding complications in patients undergoing Dacron patch angioplasty.

18. AbuRahma, A. F., J. H. Khan, et al. (1996). "Prospective randomized trial of carotid endarterectomy with primary closure and patch angioplasty with saphenous vein, jugular vein, and polytetrafluoroethylene: perioperative (30-day) results." J Vasc Surg 24(6): 998-1006; discussion 1006-7.
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.

19. Myers, S. I., R. J. Valentine, et al. (1994). "Saphenous vein patch versus primary closure for carotid endarterectomy: long-term assessment of a randomized prospective study." J Vasc Surg 19(1): 15-22.
PURPOSE: This study examines the long-term results of a randomized prospective study comparing primary versus saphenous vein patch (VP) closure after carotid endarterectomy (CEA). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

20. Katz, D., S. O. Snyder, et al. (1994). "Long-term follow-up for recurrent stenosis: a prospective randomized study of expanded polytetrafluoroethylene patch angioplasty versus primary closure after carotid endarterectomy." J Vasc Surg 19(2): 198-203; discussion 204-5.
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.

21. Vanmaele, R. G., P. E. Van Schil, et al. (1994). "Division-endarterectomy-anastomosis of the internal carotid artery: a prospective randomized comparative study." Cardiovasc Surg 2(5): 573-81.
Saphenous vein patch angioplasty is reported to yield superior results for carotid endarterectomy. In order to evaluate an alternative technique, which leaves the saphenous vein intact for other possible graft purposes, 200 carotid endarterectomies were included in a prospective randomized comparative study. Patients were randomized to two statistically equivalent groups: one group underwent classical carotid endarterectomy through a longitudinal incision with saphenous vein patch angioplasty; the other had endarterectomy through an oblique division of the internal carotid followed by in situ anastomosis. Cross-clamping time was approximately 5min shorter with the division-endarterectomy-anastomosis technique. The overall perioperative (< 30 days) mortality rate was 2.5% and cumulative mortality-morbidity rate 8% in the patch group compared with 4% in the other (P > 0.05). There were significantly more cranial nerve injuries in the patch group, most of which were transient (P < 0.01). The mean follow-up was 365 days. The late mortality rate was 5.5%. There were no late permanent or fatal strokes, but 3% of patients sustained mild transient neurological events. Only three significant (> 60%) stenoses developed during follow-up, all within 9 months. Dilatation and disturbed flow were more pronounced in the patch group (P < 0.05). There were no statistically significant differences between both techniques on mortality, disabling neurological morbidity and recurrent stenosis. In conclusion, the results of the division-endarterectomy-anastomosis technique are equivalent to those with patch angioplasty, leaving the patient's venous capital intact.

22. Ranaboldo, C. J., A. A. Barros D'Sa, et al. (1993). "Randomized controlled trial of patch angioplasty for carotid endarterectomy. The Joint Vascular Research Group." Br J Surg 80(12): 1528-30.
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.

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