People with heart disease and diseased leg arteries often undergo investigations and treatments that involve placing a needle into the main artery in the groin (endovascular procedures, for example diagnostic arteriogram, angioplasty, cardiac catheterization). One possible complication is the formation of a large swelling in the artery (a pseudoaneurysm) in the groin. This happens when the hole that the needle makes in the wall of the artery does not seal properly afterwards and blood collects, causing pain, swelling and bruising. Small pseudoaneurysms may clot spontaneously or surgery may be required. Less invasive treatment is now possible to stop the blood flow into the swelling. This involves sedation or analgesia to allow pressure to be placed over the puncture in the artery using a special mechanical device or a probe guided by ultrasound. Another option is injection of a clotting agent (thrombin) through the skin into the swelling.
The review authors searched the medical literature and found four randomised controlled trials. No new studies were included in this update. Application of pressure (compression) with a mechanical device for some 30 minutes caused clotting of the blood in the pseudoaneurysm in three-quarters of people (38 people aged between 40 and 85 years) within 24 hours. It made no difference if the probe was placed blindly or using ultrasound. A further study of 168 people found that compression caused clotting of the pseudoaneurysm in more than 90% of people at 24 hours; again, using ultrasound did not seem to make any difference. Injection of bovine thrombin appeared to be more effective that ultrasound-guided compression (in two studies, including 68 patients in total). There are, however, concerns about allergy to the thrombin and introduction of infectious agents, thought to be responsible for transmission of some degenerative diseases, as well as the possibility of causing a blood clot in the artery. No complications were reported in these studies apart from one deep vein thrombosis in the people treated with compression.
The limited evidence base appears to support the use of thrombin injection as an effective treatment for femoral pseudoaneurysm. A pragmatic approach may be to use compression (blind or ultrasound-guided) as first-line treatment, reserving thrombin injection for those in whom the compression procedure fails.
Femoral pseudoaneurysms may complicate up to 8% of vascular interventional procedures. Small pseudoaneurysms can spontaneously clot, but sometimes definitive treatment is needed. Surgery has traditionally been considered the 'gold standard' treatment, although it is not without risk in patients with severe cardiovascular disease. Less invasive treatment options such as Duplex ultrasound-guided compression and percutaneous thrombin injection are available, however, evidence of their efficacy is limited. This is an update of a Cochrane review first published in 2006.
To assess the effects of different treatments for femoral pseudoaneurysms resulting from endovascular procedures, specifically assessing less invasive treatment options such as blind manual or mechanical compression, ultrasound-guided compression, or percutaneous thrombin injection.
For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched October 2013) and CENTRAL (2013, Issue 9).
Randomised controlled trials (RCTs) comparing two treatments for femoral pseudoaneurysms following vascular interventional procedures were considered for inclusion in the review.
Four studies were included in the analyses comparing: manual compression versus ultrasound-guided compression; ultrasound-guided application of a mechanical device (FemoStop) versus blind application; and ultrasound-guided compression versus percutaneous thrombin injection (two studies). There were no studies with a surgical intervention arm. Data were extracted independently by both authors.
Compression (manual or FemoStop) was effective in achieving pseudoaneurysm thrombosis although ultrasound-guided application failed to confer any benefit (risk ratio (RR) 0.96; 95% confidence interval (CI) 0.88 to 1.04).
Percutaneous thrombin injection was more effective than a single session of ultrasound-guided compression in achieving primary pseudoaneurysm thrombosis within individual RCTs but merged data failed to show statistical significance (RR 2.81; 95% CI 0.44 to 18.13). There was no statistically significant difference in the length of hospital stay between the two groups and no complications were reported apart from one deep vein thrombosis in the compression group.