Patching in Carotid Endarterectomy: Evidence and Guidelines

The Settled Question of 'Patch or No Patch' in Carotid Endarterectomy

The question of whether to use a patch during carotid endarterectomy (CEA) has been settled through extensive research and clinical trials. The decision to use a patch is based on evidence from 23 randomized controlled trials (RCTs) that compared different closure techniques. These trials demonstrated that patched CEA, particularly with polytetrafluoroethylene (PTFE) or bovine pericardium, and eversion CEA (eCEA) resulted in lower 30-day stroke and death rates compared to primary closure. Primary closure showed the highest rates of these adverse outcomes.

Furthermore, a meta-analysis of 10 RCTs involving over 2,000 patients highlighted that routine patching significantly reduced the risk of 30-day ipsilateral stroke and internal carotid artery (ICA) thrombosis compared to primary closure. Patients undergoing primary closure were more likely to require additional surgery within 30 days. Long-term outcomes also favored patching, with significant reductions in late ipsilateral stroke, any stroke, and re-stenosis rates compared to primary closure.

Registry data further supports the preference for patching, showing lower peri-operative stroke and transient ischemic attack (TIA) rates when using bovine pericardium or polyester patches. These patches also demonstrated lower one-year re-stenosis rates compared to primary closure.

Despite the strong evidence favoring routine patching, no RCTs have directly compared routine versus selective patching strategies. Current guidelines, including those from the European Society for Vascular Surgery (ESVS) and the Society for Vascular Surgery (SVS), recommend routine patch closure for conventional CEA. This aligns with the German-Austrian guidelines, which advise that the choice of technique should be left to the operating surgeon.

Understanding Patching in Carotid Endarterectomy

Patching in carotid endarterectomy (CEA) is a surgical technique used to close the arteriotomy after removing plaque from the carotid artery. This method involves applying a patch material to widen the artery and reinforce the surgical site, aiming to reduce complications such as restenosis and stroke.

The introduction of patching was driven by the need to improve outcomes after CEA. Studies have shown that primary closure, where the artery is sewn shut without a patch, is associated with higher rates of restenosis and stroke. In contrast, patching techniques, particularly those using materials like polytetrafluoroethylene (PTFE) or bovine pericardium, have demonstrated lower rates of 30-day stroke or death and reduced restenosis compared to primary closure. For example, a meta-analysis highlighted that routine patching significantly reduces the risk of 30-day ipsilateral stroke (1.5% with patching vs. 4.5% with primary closure) and late ipsilateral stroke (1.6% with patching vs. 4.8% with primary closure).

Additionally, patching has been associated with a lower likelihood of returning to the operating room within 30 days post-surgery. This technique also shows a reduced incidence of late stroke and restenosis, emphasizing its role in enhancing long-term vascular health.

The choice of patch material can vary, with options including vein, PTFE, polyester, and bovine pericardium. Each material has its benefits, but the overall goal remains to minimize complications and improve patient outcomes. Current guidelines recommend routine patching over primary closure for conventional CEA, reflecting its established benefits in clinical practice.

Comparative Evidence for Stroke and Restenosis in Carotid Endarterectomy

In analyzing the outcomes of carotid endarterectomy (CEA), significant evidence from randomized controlled trials and meta-analyses highlights the effectiveness of different closure techniques. Notably, eversion CEA and patch closure methods, particularly using polytetrafluoroethylene (PTFE) or bovine pericardium, exhibit the lowest 30-day rates of stroke and death. In contrast, primary closure shows the highest risk within the same timeframe.

When examining restenosis rates, eversion CEA again leads with the lowest, followed by patch closures using PTFE or bovine pericardium. Polyester patches and primary closure have a higher likelihood of restenosis. The evidence also points out that vein patching has a minimal risk of complications such as blowouts or infections, with a reported rate of 0.2%.

The meta-analysis involving 10 RCTs indicates that routine patching significantly reduces the risk of ipsilateral stroke to 1.5%, compared to 4.5% with primary closure. It also minimizes the likelihood of internal carotid artery thrombosis to 0.5% versus 3.1% for primary closure. Furthermore, patients undergoing primary closure are more prone to require additional surgery within 30 days. However, no significant differences were found in terms of peri-operative death, fatal stroke, or cranial nerve injury.

Data from the SVS-VQI registry aligns with these findings, showing that using bovine pericardium or polyester for patching lowers the risk of peri-operative stroke or TIA compared to vein patch, PTFE patch, or primary closure. Over a one-year period, re-stenosis rates are lower with bovine pericardial, polyester, and vein patches as opposed to primary closure. Routine patching also demonstrates clear benefits in reducing the incidence of late ipsilateral stroke, overall stroke, and re-stenosis compared to primary closure. Although no RCTs have yet examined the differences between routine and selective patching, existing guidelines recommend routine patch closure over primary arteriotomy closure for better outcomes in conventional CEA.

Patch Materials in Carotid Endarterectomy

Carotid endarterectomy (CEA) involves several patch materials, each with distinct outcomes. The commonly used materials include vein patches, polytetrafluoroethylene (PTFE), polyester, bovine pericardium, and polyurethane. Among these, PTFE and bovine pericardial patches have shown favorable results, with lower rates of 30-day stroke or death compared to primary closure.

Eversion CEA and patching with PTFE or bovine pericardium are associated with the lowest rates of re-stenosis. In contrast, primary closure and polyester patches tend to result in higher re-stenosis rates. Vein patches, although effective, carry a small risk of blowout and infection, reported at 0.2%.

Meta-analyses indicate that routine patching significantly reduces the risk of 30-day ipsilateral stroke and ICA thrombosis compared to primary closure. Patients undergoing primary closure are more likely to require reoperation within 30 days. Furthermore, bovine pericardial and polyester patches show lower peri-operative stroke/TIA rates compared to vein or PTFE patches and primary closure.

In terms of long-term outcomes, routine patching offers significant reductions in late ipsilateral stroke, any stroke, and re-stenosis compared to primary closure. Despite these findings, no randomized controlled trials have directly compared routine versus selective patching strategies. Current guidelines recommend routine patch closure for conventional CEA, with the choice of technique left to the surgeon's discretion.

Recommendations and Surgeon Discretion in Carotid Endarterectomy Patching

The European Society for Vascular Surgery (ESVS) guidelines recommend routine patch closure for conventional carotid endarterectomy, rather than primary closure. This recommendation aligns with the 2021 Society for Vascular Surgery (SVS) guidelines, emphasizing the advantages of patch closure in reducing rates of stroke and re-stenosis within 30 days post-operation. Specifically, routine patching has been associated with significant reductions in ipsilateral stroke and internal carotid artery thrombosis compared to primary closure.

The choice of patch material can also impact outcomes. Bovine pericardial and polyester patches have been reported to lower peri-operative stroke and transient ischemic attack (TIA) rates compared to other materials like vein or PTFE patches. Additionally, these materials, along with vein patches, have demonstrated lower one-year re-stenosis rates than primary closure.

Despite these guidelines, the German-Austrian guidelines take a different approach, leaving the decision between eversion carotid endarterectomy (eCEA) and patched CEA to the discretion of the operating surgeon. This allows the surgeon to tailor the technique based on individual patient factors and their own clinical experience. While no randomized controlled trials have compared routine patching with selective patching, the existing evidence supports routine patching for its benefits in reducing both early and late post-operative complications.