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, West Virginia University, MGW, West Virginia, United States
Journal of Vascular Surgery (Impact Factor: 3.02). 02/1998; 27(2):222-32; discussion 233-4. DOI: 10.1016/S0741-5214(98)70353-2
Source: PubMed


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.

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Available from: Patrick Robinson, Oct 02, 2014
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    • "Indeed, vein-patch walls did not develop a thickened intima [26]. However, complications with saphenous vein patch following CEA have been reported, including a longer operating time, a blow-out or patch rupture, potential risk of false aneurysm formation, thrombosis from dilated or aneurismal carotid dilation [4], [27]–[29] in the postoperative period, and restenosis on long-term follow-up [30], [31]. "
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    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.
    Preview · Article · Jan 2013 · PLoS ONE
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    • "The standard approach for the performance of CEA involves a longitudinal arteriotomy from the common to the internal carotid artery followed by removal of the atherosclerotic plaque. There is significant evidence that closing the longitudinal arteriotomy using a patch is superior to primary closure in reducing the risk of restenosis and improving both short and long term clinical outcomes [4] [5] [6] [7] [8] [9]. In addition, patches are commonly used to close arteriotomies in other vascular beds, such as after endarterectomy and bypass operations in the lower extremities. "
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    ABSTRACT: Patch angioplasty is the most common technique used for the performance of carotid endarterectomy. A large number of patching materials are available for use while new materials are being continuously developed. Surprisingly little is known about the mechanical properties of these materials and how these properties compare with those of the carotid artery wall. Mismatch of the mechanical properties can produce mechanical and hemodynamic effects that may compromise the long-term patency of the endarterectomized arterial segment. The aim of this paper was to systematically evaluate and compare the biaxial mechanical behavior of the most commonly used patching materials. We compared PTFE (n  =  1), Dacron (n  =  2), bovine pericardium (n  =  10), autogenous greater saphenous vein (n  =  10), and autogenous external jugular vein (n  =  9) with the wall of the common carotid artery (n  =  18). All patching materials were found to be significantly stiffer than the carotid wall in both the longitudinal and circumferential directions. Synthetic patches demonstrated the most mismatch in stiffness values and vein patches the least mismatch in stiffness values compared to those of the native carotid artery. All biological materials, including the carotid artery, demonstrated substantial nonlinearity, anisotropy, and variability; however, the behavior of biological and biologically-derived patches was both qualitatively and quantitatively different from the behavior of the carotid wall. The majority of carotid arteries tested were stiffer in the circumferential direction, while the opposite anisotropy was observed for all types of vein patches and bovine pericardium. The rates of increase in the nonlinear stiffness over the physiological stress range were also different for the carotid and patching materials. Several carotid wall samples exhibited reverse anisotropy compared to the average behavior of the carotid tissue. A similar characteristic was observed for two of 19 vein patches. The obtained results quantify, for the first time, significant mechanical dissimilarity of the currently available patching materials and the carotid artery. The results can be used as guidance for designing more efficient patches with mechanical properties resembling those of the carotid wall. The presented systematic comparative mechanical analysis of the existing patching materials provides valuable information for patch selection in the daily practice of carotid surgery and can be used in future clinical studies comparing the efficacy of different patches in the performance of carotid endarterectomy.
    Preview · Article · Nov 2011 · Journal of Biomechanical Engineering
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