Patch Graft Closure with Carotid Endarterectomy

Patch Closure Versus Primary Closure

The type of closure after a CEA, primary versus patch closure, remains controversial. Most authorities agree that in a small carotid artery (≤4 mm), particularly in the presence of technical difficulties at the internal carotid artery (ICA) end of the arteriotomy, closing with a patch can prevent restenosis. It is not uncommon for lateral tears to occur at the apex of the ICA after the linear arteriotomy is made, and patching can prevent narrowing during primary closure of the arteriotomy. In patients with excessive thickening of the intima of the distal ICA, patching can smooth the transition zone from the CEA site to the residual artery beyond. Patching might also be advisable in patients with kinked arteries, and it can help maintain the lumen and prevent postoperative occlusion. Patching should also be routinely used for redo CEA.

CEA with patch angioplasty is generally believed to decrease the chance of technical errors and has been shown by multiple clinical trials to be more effective than CEA with primary closure in decreasing the incidence of perioperative carotid thrombosis, perioperative stroke, and late restenosis. However, many others believe that inclusion of a patch prolongs the operative time and clamp or shunt time, makes the procedure technically more demanding, and is unnecessary in some patients.

In 1996, we published the largest prospective randomized trial comparing CEA with primary closure versus patching, where 264 CEAs were done with patching (130 vein patch closures and 134 polytetrafluoroethylene [PTFE] patch closures) and 135 CEAs were done with primary closure. The perioperative stroke or death rates were 2.3% for patching versus 6.7% for primary closure (odds ratio [OR], 0.3; 95% confidence interval [CI], 0.1–0.88), and the 50% or greater restenosis rates at 30 months were 5.3% for patching versus 33% for primary closure (OR, 0.11; CI, 0.06–0.19).

In another unique randomized trial, we analyzed 74 patients undergoing bilateral sequential CEAs. Patients were randomized to either patching in the first CEA then primary closure in the second CEA or primary closure in the first and patching in the second; that is, each patient was his or her own control. Primary closure had an ipsilateral stroke rate of 4% versus 0% for CEA with patching, and at a late mean follow-up of 29 months, the incidence of at least 80% restenosis was significantly higher in the primary closure group.

Several randomized, controlled trials (Level I evidence) have been published since the 1990s comparing CEA with patch angioplasty versus primary closure. Table 1 summarizes the results of these randomized, controlled trials. As noted in this table, these trials showed the superiority of patch closure over primary closure in reducing the perioperative stroke or death and the incidence of significant restenosis.

In addition, there were two meta-analyses of the randomized, controlled carotid trials by the Cochrane Collaboration in 2000 and 2004. In an earlier Cochrane meta-analysis of randomized carotid trials, the early postoperative thrombosis, postoperative stroke, and at least 50% restenosis were superior for patching, in contrast to primary closure. In an update of the Cochrane Collaboration meta-analysis in 2004, Bond and colleagues reported the outcome for 1281 patients, including seven controlled carotid trials. Patch angioplasty was associated with a reduction in ipsilateral stroke (1.6% versus 4.8% for primary closure, p = .001), any stroke (1.6% vs. 4.5%, p = .004), stroke or death (2.5% vs. 6.1%, p = .007), arterial occlusion (0.5% vs. 3.6%, p = .0001), and return to the operating room (1.1% vs. 3.1%, p = .01). In long-term follow-up, patch angioplasty was also superior to primary closure in the reduction of ipsilateral stroke (1.6% vs. 4.8%, p = .001), any stroke (1.9% vs. 5.9%, p = .0009), stroke or death (14.6% vs. 24%, p = .004), and late restenosis (4.8% vs. 18.6%, p < .0001) ( Figure 1 ).

One interesting article in support of primary closure has been published. In this study, primary closure was performed with an operating microscope and compared to patch closure with Dacron. Three hundred twenty-eight patients (153 patches vs. 175 primary closures) were compared. All CEAs were performed by a single surgeon. The 30-day perioperative stroke rate was 2.9% for primary closure versus 3.9% for patch closure. Unfortunately, this study was stopped after 328 patients, on the basis of futility. The authors concluded that there was no difference in vessel patency and clinical outcome after microscopic patch angioplasty and direct arteriotomy repair. The authors also concluded that there was no benefit from the routine use of patch angioplasty in microscopic CEA. It is generally believed that this study did not have the statistical power to support their conclusions.

Other nonrandomized trials with level 2 to 4 evidence have been published that support patching over primary closure. Rockman and coworkers reported the results of a nonrandomized trial of 1972 CEAs by 81 surgeons in two states. These included 233 patients with primary closure and 1377 with patch angioplasty. Primary closure had a 5.6% stroke rate versus 2.2% for patch closure ( p = .006). The authors strongly recommended abandonment of primary closure. Kresowik’s group performed a hospital review of a random sample of 10,000 Medicare patients undergoing CEA in 10 Midwestern states during a 12-month period in 1995 to 1996 and in 1998 to 1999. They concluded that stroke and mortality rates were lower in the second period than in the first period (5% vs. 5.6%, p < .05), and two factors were considered responsible for this improvement: patch closure and the increased use of antiplatelet agents ( p < .05).