Prospective randomized trial of ACUSEAL (Gore-Tex) versus Hemashield-Finesse patching during carotid endarterectomy: early results.

EvidenceUpdates, 2007

, Prospective randomized trial of ACUSEAL (Gore-Tex) versus Hemashield-Finesse patching during carotid endarterectomy: early results.
ali.aburahma@camc.org <ali.aburahma@camc.org> BACKGROUND/PURPOSE: 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.
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.
Demographic and clinical characteristics were similar in both groups, including the mean operative diameter of the internal carotid artery and length of arteriotomy.
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).
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).