Prospective study of carotid endarterectomy with modified polytetrafluoroethylene (ACUSEAL) patching: early and late results.
OBJECTIVE
Carotid endarterectomies (CEAs) with standard polytetrafluoroethylene (PTFE) patching have been shown to have results comparable with those of autogenous vein patching; however, prolonged bleeding through needle holes in PTFE is a commonly recognized problem. This is the first study of CEA using a new hemostatic modified PTFE patch (GORE-TEX) analyzing the early and late outcomes.


METHODS
Two hundred consecutive CEAs were entered into this protocol. All patients had an immediate postoperative carotid duplex ultrasound scan that was repeated at 1 month and every 6 to 12 months thereafter. A Kaplan-Meier analysis was used to estimate the stroke-free survival and the risk of restenosis. The mean follow-up was 21 months (range, 1 to 48 months).


RESULTS
The perioperative stroke rate was 1.5% (1% ipsilateral and 0.5% contralateral, two minor strokes and one major stroke) with no perioperative mortality or perioperative carotid thrombosis. The incidence of perioperative transient ischemic attacks was 3.5% (2.5% ipsilateral and 1% contralateral). The mean hemostasis time after completion of the patching was 3 minutes, in contrast to 14 minutes for conventional PTFE (in a previous study). The rates of freedom from ipsilateral strokes at 1, 2, 3, and 4 years were 99%, 99%, 99%, and 99%, respectively. The cumulative stroke-free survival rates at 1, 2, 3, and 4 years were 98%, 96%, 93%, and 93%, respectively. The rates of freedom from > or =70% restenosis at 1, 2, 3, and 4 years were 97%, 97%, 94%, and 94%, respectively.


CONCLUSIONS
CEAs with a new modified PTFE patch are safe, have low perioperative stroke rates, are durable, and have an acceptable hemostasis time.
AbuRahma
Ali F
AF
Robert C. Byrd Health Science Center, West Virginia University, Charleston Area Medical Center, USA. ali.aburahma@camc.org
Stone
Patrick A
PA
Welch
Christine A
CA
Hofeldt
Matthew J
MJ
Hass
Stephen M
SM
Perry
William
W
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000295:instrumentation*; D016893:Carotid Stenosis / Q000175:diagnosis / Q000601:surgery; D018572:Disease-Free Survival; D016894:Endarterectomy, Carotid / Q000379:methods*; D005260:Female; D005465:Fluorocarbon Polymers; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D055502:Secondary Prevention; D020521:Stroke / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D018616:Ultrasonography, Doppler, Duplex
D005465:Fluorocarbon Polymers; C010946:polytetrafluoroethane