Efficacy and safety of percutaneous treatment of iatrogenic femoral artery pseudoaneurysm by biodegradable collagen injection

OBJECTIVES The goal of this study was to assess the safety and efficacy of femoral artery, pseudoaneurysm (FAP) closure by collagen injection. BACKGROUND The FAP is an infrequent but troublesome complication after percutaneous transfemoral catheter procedures. If ultrasound-guided compression repair (UGCR) fails, vascular surgery is indicated. We have developed a less invasive method to close FAPs percutaneously, by injecting collagen and, thus, inducing clotting within the aneurysm. METHODS Via a 9F needle or 11F sheath, a biodegradable adhesive bovine collagen is injected percutaneously into the FAP, guided by, angiography from the contralateral site, RESULTS From 1993 to 2000, compression and UGCR had failed to obliterate 110 FAPs. These patients have been treated by collagen injection. Mean age of the patients was 65.6 +/- 10.2 years (range: 32 to 85 years), and 50% were women. Immediate closure of the FAP was achieved in 107/110 patients (97.3%) without any complication or adverse effect. In one patient the collagen could not be applied due to unfavorable anatomy. One patient needed a second session of collagen injection. In one patient too much collagen was inserted, which resulted in external compression of the artery, and surgical intervention was required. The overall success rate was 108/110 (98%, 95% confidence interval: 93.5% to 99.8%). Among the patients with successful procedures, there were no recurrences during six months follow-up. CONCLUSIONS The percutaneous treatment of iatrogenic FAP, by injection with collagen, is an effective and safe strategy.. This method provides an excellent therapeutic alternative to the traditional surgical management, (C) 2002 by the American College of Cardiology Foundation.