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

Department of Surgery, Robert C. Byrd Health Sciences Center of West Virginia University, Charleston Area Medical Center, USA.
Journal of Vascular Surgery (Impact Factor: 2.88). 02/1998; 27(2):222-32; discussion 233-4. DOI: 10.1016/S0741-5214(98)70353-2
Source: PubMed

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

  • Catheterization and Cardiovascular Interventions 01/2013; 81(1):E76-E123. · 2.51 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: Background Multiple studies have been conducted that demonstrate the superiority of patch angioplasty over primary closure for carotid endarterectomy (CEA). Patch angioplasty with polytetrafluoroethylene patches (ACUSEAL) have shown results comparable to patch angioplasty with saphenous vein and polyester patches. This is the prospective randomized study to compare the clinical outcomes of CEA using ACUSEAL versus Bovine pericardium patching (Vascu-Guard). Methods Two hundred patients were randomized (1:1) to either ACUSEAL or Vascu-Guard patching. Demographic data/clinical characteristics were collected. Intraoperative hemostasis times and the frequency of re-exploration for neck hematoma were recorded. All patients received immediate and 1-month postoperative duplex ultrasound studies, which were repeated at 6-month intervals. A Kaplan-Meier analysis was used to estimate the risk of restenosis and the stroke-free survival rates. Results The demographics were similar in both groups, except for a higher incidence of current smokers in the ACUSEAL group and more patients with congestive heart failure in the Vascu-Guard group (P=0.02 and 0.03, respectively). The mean operative internal carotid artery diameter and the mean arteriotomy length were similar in both groups. The mean hemostasis time was 4.90 minutes for ACUSEAL patching versus 3.09 minutes for Vascu-Guard (P = 0.027); however, the mean operative times were similar for both groups (ACUSEAL 2.09 hours versus Vascu-Guard 2.16 hours, P=0.669). The incidence of re-exploration for neck hematoma was higher in the Vascu-Guard group; 6.12% versus 1.03% (P=0.1183). The incidence of perioperative ipsilateral neurologic events was 3.09% for ACUSEAL patching versus 1.02% for Vascu-Guard patching (P=0.368). The mean follow-up period was 15 months. The respective freedom from ≥70% carotid restenosis at 1, 2, and 3 years was 100%, 100%, and 100% for ACUSEAL patching versus 100%, 98%, and 98% for Vascu-Guard patching (P = 0.2478). The ipsilateral stroke free rates at 1, 2, and 3 years was 96% for ACUSEAL and 99% for Vascu-Guard patching. Conclusions Although CEA patching with ACUSEAL versus Vascu-Guard differed in hemostasis time, the frequency of re-exploration for neck hematomas was more frequent in the pericardial patch group; however, only one patient had documented suture line bleeding and the surgical reexploration rate likely is not likely to be patch related. There were not any significant differences in perioperative/late neurologic events and late restenosis in the two groups.
    Annals of Vascular Surgery 01/2014; · 0.99 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Carotid endarterectomy (CEA) with patch angioplasty produces greater results than with primary closure; however, there remains uncertainty on the optimal patch material in CEA. A systematic review of randomized controlled trials (RCTs) was performed to evaluate the effect of angioplasty using venous patch versus synthetic patch material, and Dacron patch versus polytetrafluoroethelene (PTFE) patch material during CEA. A multiple electronic health database screening was performed including the Cochrane library, Pubmed, Ovid, EMBASE and Google Scholar on all randomized controlled trials (RCTs) published before November 2012 that compared the outcomes of patients undergoing CEA with venous patch versus synthetic patch. RCTs were included if they compared carotid patch angioplasty with autologus venous patch versus synthetic patch material, or compared one type of synthetic patch with another. Thirteen RCTs were identified. Ten trials, involving 1946 CEAs, compared venous patch with synthetic patch materials. Two trials, involving 400 CEAs in 380 patients, compared Dacron patch with PTFE patch. The hemostasis time in CEA with PTFE patch was significantly longer than with venous patch (P<0.0001), and longer than with Dacron patch (P<0.0001). There was no significant difference of mortality rate, stroke rate, restenosis, and operative time in CEA with venous patch versus synthetic patch material, or in CEA with Dacron patch versus PTFE patch (all P>0.05). One RCT of 95 CEAs in 92 patients compared bovine pericardium with Dacron patch, and demonstrated a statistically significant decrease in intraoperative suture line bleeding with bovine pericardium compared with Dacron patch (P<0.001). The hemostasis time in CEA with PTFE patch was longer than with venous patch or Dacron patch. The overall perioperative and long-term mortality rate, stroke rate, restenosis, and operative time were similar when using venous patch versus synthetic patch material or Dacron patch versus PTFE patch material during CEA. More data are required to clarify differences between different patch materials.
    PLoS ONE 01/2013; 8(1):e55050. · 3.73 Impact Factor


Available from