Prospective randomized trial of ACUSEAL versus Vascu-Guard patching in carotid endarterectomy

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Background—Multiple studies have been conducted that demonstrate the superiority of patch angioplasty over primary closure for carotid endarterectomy (CEA). Patch angioplasty with polytetrafluorethylene 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 VascuGuard 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.