Safety and efficacy of the Perclose suture-mediated closure device following carotid artery stenting under clopidogrel platelet blockade

Abstract

The aim of this study was evaluation of a closure device (Perclose, Menlo Park, Calif.) for closure of the femoral artery access site in patients undergoing aggressive anticoagulation and platelet blockade after carotid stenting. Fifty-five patients who received clopidogrel in addition to aspirin and heparin as medication for carotid stenting were included for suture of the femoral access site after using 7- or 8-F guide catheters. The technical success, the time for suture, the clotting parameters, and complications were examined. Follow-up investigations, including ultrasound and clinical examinations, were performed. The groin was checked for possible hematoma, pseudoaneurysm, arteriovenous fistula, and local infection. Technical success was obtained in 51 of 54 patients (94%) after a mean procedure time of 6 min (range 5-10 min). The suture device was not used in one patient (2%) for anatomical reasons and failed to obtain hemostasis in 3 of 54 (6%) patients. In 4 of 54 patients (7%) bleeding was observed at the punctured site 4-6 h after intervention which was treated by a compression bandage. The mean dedicated activated clotting time was 137 s (range 29-287 s) before intervention and 349 s (150-958 s) just before deploying the Perclose device. During follow-up after 2 days (range 2-6 days) and 6 months no further complications of the puncture site were observed except for two large groin hematomas. No major complications occurred. Closure of the femoral access site after carotid stenting using a Perclose closure device is safe and effective even in patients receiving an aggressive anticoagulation and antiplatelet therapy.

Carotid stenting and bivalirudin with and without vascular closure: 3‐year analysis of procedural outcomes

“…The CREATE Pivotal Trial investigators [42] reported a groin “injury” rate with heparin of 3.3% ( n = 419), with no major clinical sequelae. Zorger and coworkers [43] observed 4% incidence of large hematomas in 54 patients undergoing CS with heparin. A lower 0.6% ( n = 475) groin complication rate was reported using the Perclose device following CS, but this may have been partly due to inconsistent use of heparin [44].…”

2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS Guideline on the Management of Patients With Extracranial Carotid and Vertebral Artery Disease: Executive summary

“…53,196,198,247,[252][253][254][255][256][257][258] Among the general risks is access-site injury, which complicates 5% of cases, but most such injuries involve pain and hematoma formation and are self-limited. [259][260][261][262] Contrast-induced nephropathy has been reported in <1% of cases, because CAS is generally avoided in patients with severe renal dysfunction. 263 The results of observational studies suggest that EPDs reduce rates of adverse events during CAS [264][265][266] when operators are experienced with the apparatus 56 ; in unfamiliar hands, the devices are associated with worse clinical outcomes 67,178,180 and a higher rate of stroke.…”

2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/ SCAI/SIR/SNIS/SVM/SVS Guideline on the Management of Patients With Extracranial Carotid and Vertebral Artery Disease: Executive Summary

“…Among the general risks is access-site injury, which complicates 5% of cases, but most such injuries involve pain and hematoma formation and are self-limited (259)(260)(261)(262). Contrast-induced nephropathy has been reported in <1% of cases, because CAS is generally avoided in patients with severe renal dysfunction (263).…”