Background: 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.
Objectives: 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.
Search strategy: The Cochrane Peripheral Vascular Diseases Group searched their Specialised Register (last searched December 2008) and the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2008, Issue 4). Additional searches were also made of the bibliographies of papers found through the electronic searches, and by handsearching relevant journals.
Selection criteria: Randomised controlled trials (RCTs) comparing two treatments for femoral pseudoaneurysms following vascular interventional procedures were considered for inclusion in the review.
Data collection and analysis: 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.
Main results: 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.
Authors' conclusions: 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.