Prospective randomized trial of ACUSEAL (Gore-Tex) versus Hemashield-Finesse patching during carotid endarterectomy: early results.
OBJECTIVE
Several studies have reported that carotid endarterectomy (CEA) with patch angioplasty produces superior results compared with primary closure. Conventional polytetrafluoroethylene (PTFE) patching has been shown to have results comparable to autogenous vein patching; however, it requires a prolonged hemostasis time. Therefore, many surgeons use collagen-impregnated Dacron patching (Hemashield [HP]). Recently, we reported a satisfactory hemostasis time using the new hemostatic PTFE patch (ACUSEAL by Gore). This study is the first prospective randomized trial comparing the ACUSEAL patch with the HP Finesse patch.


METHODS
200 CEAs were 1:1 randomized into two patch closure groups (ACUSEAL or Finesse). All patients underwent immediate and 1 month postoperative duplex ultrasound studies. Demographic and clinical characteristics were similar in both groups, including the mean operative diameter of the internal carotid artery and length of arteriotomy.


RESULTS
The overall perioperative ipsilateral stroke rate was 2% (2% ACUSEAL, 2% Finesse; P = 1.0). The perioperative ipsilateral TIA rates were 0% for the ACUSEAL and 2% for the Finesse patch (P = .5). The combined perioperative neurological event (TIA + stroke) rates were 2% for ACUSEAL and 4% for the Finesse (P = .68). The early >or=50% restenosis rate was 0% for ACUSEAL vs 4% for Finesse patching. Two perioperative carotid thromboses were noted with Finesse patching vs none with ACUSEAL patching (P = .50). The combined early morbidity rate (TIA, stroke, and >or=50% restenosis or thrombosis) was 2% for the ACUSEAL patch vs 8% for the Finesse patch (P = .10). The mean hemostasis time for the ACUSEAL and Finesse patches was 5.1 vs 3.7 minutes (P = .01), however, the mean operative times were similar for both groups (P = .61).


CONCLUSIONS
The perioperative neurological events and overall short-term morbidity associated with CEA when using ACUSEAL or Finesse patches were similar. Both patches have short hemostasis times.
AbuRahma
Ali F
AF
Department of Surgery, Robert C. Byrd Health Sciences Center, West Virginia University, Charleston, WV 25304, USA. ali.aburahma@camc.org <ali.aburahma@camc.org>
Stone
Patrick A
PA
Flaherty
Sarah K
SK
AbuRahma
Zachary
Z
D000368:Aged; D016893:Carotid Stenosis; D003094:Collagen / Q000627:therapeutic use*; D016894:Endarterectomy, Carotid; D005260:Female; D006488:Hemostasis, Surgical / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011138:Polytetrafluoroethylene / Q000627:therapeutic use*; D011446:Prospective Studies; D018616:Ultrasonography, Doppler, Duplex
D011138:Polytetrafluoroethylene; D003094:Collagen