Percutaneous femoral closure following stent-graft placement: use of the Perclose device.

Purpose: To describe our early clinical experience using the Prostar Perclose device for arterial closure after placement of a stent-graft.

Methods: Sixty-three patients had stent-graft devices placed for iliac (n = 7), abdominal aortic (n = 43) or thoracic applications (n = 13). The devices were introduced through 18 Fr (22 Fr O.D.) (n = 3), 16 Fr (20 Fr O.D.) (n = 15), 14 Fr (18 Fr O.D.) (n = 44) or 12 Fr (14 Fr O.D.) (n = 38) sheaths. After Perclose deployment, the arteriotomies were dilated to the appropriate sizes for the deployment sheaths. All patients were anticoagulated during the procedure. After stent-graft deployment, hemostasis was achieved by the Perclose sutures that were in place. All the femoral sites were followed with physical examination and CT angiography (CTA).

Results: The follow-up periods have ranged from 2 to 18 months (mean 7.5 months). All 100 femoral sites were closed without the need for surgical closure. In 4% (4/100) of the femoral sites, the Perclose sutures were pulled out while securing the knots and these patients required manual compression. In 2% (2/100) of the sites, additional manual compression was required after successful deployment of the Perclose devices. In 1% (1/100) of the femoral sites, there was acute femoral popliteal thrombosis perhaps related to common femoral artery narrowing at the site of Perclose deployment. In 5% (5/100) of the femoral sites, pseudoaneurysms were seen on follow-up CTA examinations. In 1% (1/100) of patients, there was infection at the puncture site requiring surgical bypass. In 1% (1/100) of patients, there was a stable, asymptomatic intimal dissection at the puncture site. By CTA criteria, none of the patients have developed stenotic lesions at the sites of Perclose deployment with follow-up periods limited to 6 months. Fifty-one of 63 patients (81%) patients ambulated within 4-6 hr.

Conclusion: The Perclose device, when placed prior to arterial dilatation, can be used to achieve hemostasis for stent-graft procedures. The device used in this manner is associated with complications, the most common being pseudoaneurysm formation. The long-term effect on the femoral arteries is uncertain.