Prospective, randomized study of external jugular vein patch versus polytetrafluoroethylene patch during carotid endarterectomy: perioperative and long-term results.
OBJECTIVE
The purpose of this study was to evaluate the relative risks and advantages of using external jugular vein (EJV) patch, compared with polytetrafluoroethylene (PTFE) patch, during carotid endarterectomy. The primary end point was the relevant neurologic complication rate (RNCR; fatal or disabling stroke) at any time during follow-up. Secondary end points included stroke-free survival, 30-day and long-term mortality, recurrent stenosis rate (> or =50%), occlusion, patch infection, aneurysm formation, and other local complications.


METHODS
The study, a prospective randomized clinical trial carried out at a single center, was divided into two 3-year phases: December 1996 to March 1999, when patients were enrolled, and March 1999 to March 2002, which was the follow-up period. Inclusion criteria included an external jugular vein suitable for patching, defined as vein diameter 3 mm or larger and absence of collateral vessels noted on preoperative color duplex ultrasound scans. Patients were prospectively randomized 1:1 to receive either the EJV (n = 80; group A) or synthetic (n = 80; group B) patch.


RESULTS
Carotid endarterectomy and patching was performed by one surgeon. At 30 months the RNCR-free rate, analyzed with the Kaplan-Meier method, was 98.7% for group A (1 ipsilateral lethal stroke) and 94.6% for group B (4 ipsilateral disabling strokes), and remained stable to 60 months. No statistical difference was observed with the log-rank test. Stroke-free survival rate was 100% for group A and 98.7% for group B at 1 year, 98.7% for group A and 93.6% for group B (1 ipsilateral minor stroke) at 30 months, and was unchanged at 60 months. Life table analysis demonstrated freedom from significant recurrent stenosis (> or =50%) of 97.5% for both groups at 6 months, 93.6% for group A and 92.2% for group B at 30 months, and 90.2% for group A and 86.7% for group B at 60 months. No statistical difference was observed with the log-rank test. In no patients was recurrent stenosis greater than 70%. No aneurysm formation was noted during follow-up.


CONCLUSIONS
We can conclude, with the power limitation of the study, that carotid endarterectomy can be safely performed with either the EJV or PTFE patch. Advantages of the EJV for carotid angioplasty include no cost for material, low risk for graft infection, and preservation of the saphenous vein.
Grego
Franco
F
Division of Vascular Surgery, Department of Medical and Surgical Sciences, University of Padua, Via Giustiniani 2, Padua 35125, Italy. franco.grego@unipd.it
Antonello
Michelle
M
Lepidi
Sandro
S
Bonvini
Stefano
S
Deriu
Giovanni P
GP
D000368:Aged; D000369:Aged, 80 and over; D001807:Blood Vessel Prosthesis / Q000009:adverse effects*; D016893:Carotid Stenosis / Q000401:mortality / Q000601:surgery*; D016894:Endarterectomy, Carotid / Q000009:adverse effects* / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D002546:Ischemic Attack, Transient / Q000209:etiology / Q000401:mortality; D007601:Jugular Veins / Q000637:transplantation*; D008297:Male; D008875:Middle Aged; D011138:Polytetrafluoroethylene / Q000009:adverse effects*; D011446:Prospective Studies; D012008:Recurrence; D020521:Stroke / Q000209:etiology / Q000401:mortality; D016896:Treatment Outcome
D011138:Polytetrafluoroethylene