Prospective randomized trial of ACUSEAL (Gore-Tex) vs Finesse (Hemashield) patching during carotid endarterectomy: Long-term outcome

Abstract

Carotid endarterectomy with ACUSEAL patching and Finesse patching had similar stroke-free rates and stroke-free survival rates. The mean hemostasis time for the ACUSEAL patch was 1.4 minutes longer than that for the Finesse patch; however, the Finesse patch had higher restenosis rates than the ACUSEAL patch.

Processes of care for carotid endarterectomy: Surgical and anesthesia considerations

“…The perioperative stroke rates for both groups were comparable (2%). The long-term follow-up of the same study was also published recently, 40 which showed that the stroke-free survival rates were comparable for both patches, however, the freedom from Ն70% restenosis at 1, 2, and 3 years was 98%, 96%, and 98%, respectively, for ACUSEAL vs 92%, 85%, and 79% for the Finesse patch (P ϭ .04). The difference between the 5-minute hemostasis time for the ACUSEAL patch and the 3.7 minute hemostasis time for the Finesse patch was statistically significant, however, its clinical significance is debatable.…”

“…21,23,25,30,31,40,54 Unfortunately, our experience with the use of bovine pericardial patching has been limited, however, several recently published studies have confirmed a favorable clinical outcome using this patch after CEA. [55][56][57] Biasi et al 55 reported on their 9-year experience with the use of bovine pericardial patch angioplasty during CEA.…”

Proposed duplex velocity criteria for carotid restenosis following carotid endarterectomy with patch closure

“…The demographic/clinical characteristics of these patients have been published previously. 9 When our standard velocity criteria (for nonoperated arteries -PSV of Ն140 c/s was optimal in detecting Ն50% stenosis) 5 were applied, 37% and 10% of patients were classified to have Ն50% to Ͻ70% and Ն70% to 99% restenosis vs 11.3% and 11.3% on CTA/angiography, respectively (P Ͻ .001, Kappa ϭ 0.4829, weighted Kappa ϭ 0.6334).…”

“…The results of the comparison of these two patch materials were presented previously. 9 Both patches were 8 mm wide, manufacturerdesigned, and with a similar tapering at the end towards the ICA, ie, there was not any discrepancy in the size of both patches, and the length of both patches were comparable.…”

“…11 Another limitation of this study is the fact that it is a retrospective analysis of prospectively collected data of a previously published randomized trial comparing two patch materials. 9 Therefore, the proposed diagnostic criteria will need to be validated in a prospective trial. Other limitations include the use of PSV as a threshold for the CTA/angiogram, which may bias the findings towards the PSV as being the most accurate predictor for restenosis, in comparison to using the ICA/CCA ratio or the EDVs.…”