title: 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 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 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.
authors.affiliation: Department of Surgery, Robert C. Byrd Health Sciences Center of West Virginia University, Charleston, WV. Electronic address: pstone@camc.org.
authors.forename: Patrick A
authors.initials: PA
authors.lastname: Stone
authors.affiliation: Department of Surgery, Robert C. Byrd Health Sciences Center of West Virginia University, Charleston, WV.
authors.forename: Ali F
authors.initials: AF
authors.lastname: AbuRahma
authors.affiliation: Department of Surgery, Robert C. Byrd Health Sciences Center of West Virginia University, Charleston, WV.
authors.forename: Albeir Y
authors.initials: AY
authors.lastname: Mousa
authors.affiliation: Department of Surgery, Robert C. Byrd Health Sciences Center of West Virginia University, Charleston, WV.
authors.forename: David
authors.initials: D
authors.lastname: Phang
authors.affiliation: Department of Surgery, Robert C. Byrd Health Sciences Center of West Virginia University, Charleston, WV.
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Hass
authors.affiliation: Department of Surgery, Division of Vascular and Endovascular Surgery, Charleston Area Medical Center: Health Education and Research Institute, Charleston, WV.
authors.forename: Asmita
authors.initials: A
authors.lastname: Modak
authors.affiliation: Department of Surgery, Robert C. Byrd Health Sciences Center of West Virginia University, Charleston, WV.
authors.forename: David
authors.initials: D
authors.lastname: Dearing
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty / Q000009:adverse effects / Q000295:instrumentation*; D000818:Animals; D002343:Carotid Artery, Internal / Q000601:surgery*; D016893:Carotid Stenosis / Q000150:complications / Q000175:diagnosis / Q000601:surgery*; D002417:Cattle; D016894:Endarterectomy, Carotid / Q000009:adverse effects; D005260:Female; D006406:Hematoma / Q000209:etiology / Q000601:surgery; D006488:Hemostasis, Surgical / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D064593:Heterografts; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010496:Pericardium / Q000637:transplantation*; D011138:Polytetrafluoroethylene; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D012086:Reoperation; D012307:Risk Factors; D020521:Stroke / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014903:West Virginia
chemical_list: D011138:Polytetrafluoroethylene