Prospective Randomized Trial of ACUSEAL Versus Vascu-Guard Patching in Carotid Endarterectomy

Abstract

Background Multiple studies have been conducted that demonstrate the superiority of patch angioplasty over primary closure for carotid endarterectomy (CEA). Patch angioplasty with poly-tetrafluorethylene patches (ACUSEAL) have shown results comparable to patch angioplasty with saphenous vein and polyester patches. This is a 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 reexploration 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 min for ACUSEAL patching vs. 3.09 min for Vascu-Guard (P = 0.027); however, the mean operative times were similar for both groups (ACUSEAL 2.09 hr vs. Vascu-Guard 2.16 hr, P = 0.669). The incidence of reexploration for neck hematoma was higher in the Vascu-Guard group; 6.12% vs. 1.03% (P = 0.1183). The incidence of perioperative ipsilateral neurologic events was 3.09% for ACUSEAL patching vs. 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 were 100%, 100%, and 100% for ACUSEAL patching vs. 100%, 98%, and 98% for Vascu-Guard patching (P = 0.2478). The ipsilateral stroke-free rates at 1, 2, and 3 years were 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 reexploration for neck hematomas was more frequent in the pericardial patch group; however, only 1 patient had documented suture line bleeding and the surgical reexploration rate is not likely to be patch related. There were not any significant differences in perioperative/late neurologic events and late restenosis in the 2 groups.

Influence of local hemostatic and antiplatelet agents on the incidence of bleeding complications in carotid endarterectomies

“…Overall, we could not find any significant difference between these subgroups, which is in accordance to previous studies [16,23]. The use of synthetic patches might lead to prolonged time to primary hemostasis within the suture line but does not bare an increased risk for secondary bleeding.…”

Restenosis after Carotid Interventions and Its Relationship with Recurrent Ipsilateral Stroke: A Systematic Review and Meta-analysis

“…However, even if this were true for CAS patients, it would not change the main message because only one late ipsilateral stroke occurred during follow-up in patients suspected of having a restenosis > 70% during follow-up. Interestingly, if only RCTs where DUS findings were corroborated with MRA or angiography were analysed, zero of 31 patients with an asymptomatic restenosis > 70% after CEA suffered a late ipsilateral stroke, 13,14,17 which would suggest that the true risk of late stroke in patients with corroborated 70e99% restenoses after CEA might be even lower than was observed in this metaanalysis. However, for the purpose of this meta-analysis, it had to be assumed that any diagnosis of "restenosis > 70%" was correct, but it is accepted that this may not always have been the case.…”

“…5 In three RCTs, magnetic resonance angiography (MRA) or digital subtraction angiography were used for corroboration whenever a restenosis > 70% was suspected on DUS. 13,14,17 Rates of restenosis > 70% after CEA Eleven RCTs (4249 patients) 4e7,11e17 reported restenosis rates > 70% or occlusion (Table 2) after any type of CEA (eversion, traditional, patched, primarily closed). Over a mean of 47 months, the prevalence of restenosis > 70% (or occlusion) was 5.8% (95% CI 4.1e8.2).…”

“…In three of nine RCTs, anyone suspected of having a "restenosis > 70%" on DUS surveillance underwent corroborative MRA or digital subtraction angiography. 13,14,17 In retrospect, many of the velocity criteria adopted by the RCTs in Table 1 were lower than referenced (above), raising the possibility that some may not have been > 70%. However, even if this were true for CAS patients, it would not change the main message because only one late ipsilateral stroke occurred during follow-up in patients suspected of having a restenosis > 70% during follow-up.…”

Comparative Review of the Treatment Methodologies of Carotid Stenosis

“…29 When pCEA using PTFE was compared with bovine pericardium pCEA, a prospective randomized study resulted in comparable neurological events and death in both the groups. 34 Eversion Carotid Endarterectomy versus Prosthetic pCEA and Primary Closure…”