Results of the search
For this 2013 update, no new studies were included and one new study was excluded (Lewandowski 2011). See Figure 1.
Four studies were considered for inclusion in the review.
Chatterjee 1999: this study recruited 38 patients with iatrogenic pseudoaneurysms over a two-year period (12 from cardiac catheterisation, 18 following coronary angioplasty, two following electrophysiological studies, and six following percutaneous transluminal angioplasty). The main inclusion criterion was that the pseudoaneurysm was compressible on ultrasound. Patients with local infection, critical limb ischaemia, skin necrosis, and a pseudoaneurysm arising above the level of the inguinal ligament were excluded. In both treatment groups, the pseudoaneurysm was compressed using a FemoStop compression device, which is a pneumatic plastic dome secured around the patient's waist with an adjustable belt. Compression was used for 20 minutes initially, with a further 20 minutes if needed. Patients were randomised into ultrasound-guided application of the FemoStop (n = 19) or blind application over the puncture site (n = 19). The two groups were matched for age, sex, pseudoaneurysm diameter, pseudoaneurysm track diameter (communication between pseudoaneurysm and native artery), use of anticoagulants, and use of antiplatelet drugs. The primary outcome measure was successful thrombosis of the pseudoaneurysm.
Paschalidis 2006: this study recruited patients with pseudoaneurysms following cardiac or peripheral catheterisation over a 28-month period. One hundred and eighty-five patients were diagnosed; 17 were excluded because of imminent pseudoaneurysm rupture, massive haematoma, skin necrosis, infection, and ischaemia; 168 patients were then randomised into manual compression (n = 84) or ultrasound-guided compression (n = 84). Manual compression involved direct pressure over the arterial puncture site until the pulsation in the haematoma or palpable thrill over the artery disappeared (maximum compression time 60 minutes); ultrasound-guided compression was applied using the authors' standard protocol, up to a maximum time of 60 minutes. Patients in both groups had a repeat ultrasound at 24 hours; for failed pseudoaneurysm thrombosis, re-treatment was allowed using the same protocol up to a maximum of three treatments. The two groups were matched for age, sex, pseudoaneurysm size, and use of antithrombotic drugs. The primary outcome measure was successful thrombosis of the pseudoaneurysm within 24 hours.
Lonn 2004: this study recruited 30 patients with iatrogenic pseudoaneurysms over a 22-month period (26 from a coronary artery intervention, four from a peripheral vascular intervention). Consecutive patients with compressible pseudoaneurysms were considered for inclusion in the study. Patients with local skin infection, previous exposure to bovine thrombin, severe allergy, or a pseudoaneurysm neck > 10 mm were excluded. Patients were randomised to ultrasound-guided compression (n = 15) or ultrasound-guided thrombin injection (n = 15). Compression was undertaken using the FemoStopIIPLUS compression device (Radi Medical Systems, Uppsala, Sweden). Compression above diastolic pressure was used initially for 30 minutes, followed by a second 30-minute period if needed. A further 30 minutes of compression was then used at 40 mm Hg followed by two hours at 20 mm Hg. In the thrombin group, a 25-G or 22-G needle attached to a syringe containing 1 ml of bovine thrombin (1000 U/ml) was placed in the pseudoaneurysm cavity under ultrasound control. Injection was stopped once flow ceased in the pseudoaneurysm cavity. The two groups were matched for age, sex, aetiology, use of anticoagulants, and use of antiplatelet drugs. The primary outcome measure was successful thrombosis of the pseudoaneurysm within 24 hours. The secondary outcome measures were thrombosis within 48 hours (allowing for repeat treatments), complication rates, and length of hospital stay.
Liu 2006: this study recruited 38 patients with intervention-induced pseudoaneurysms but did not state whether all pseudoaneurysms were compressible. Exclusion criteria were not stated; neither was the age and sex distribution between the two groups. Patients were randomised to percutaneous thrombin injection (n = 19) or ultrasound-guided compression. The protocols for both treatment arms were not explained in the published abstract. Patients underwent Duplex ultrasound at three days and seven days. The primary outcome measure was successful thrombosis of the pseudoaneurysm at 72 hours. Seconday outcome measures were thrombosis at seven days and change in volume of the haematoma.
One additional study was excluded for this 2013 update (Lewandowski 2011). Details of the excluded studies can be found within the Characteristics of excluded studies table.