The quality of evidence is downgraded by study limitations (inadequate allocation concealment), by inconsistency (variability in results), and by imprecise results (few patients and wide confidence intervals).
A Cochrane review [Abstract] 1 included 4 studies with a total of 274 subjects. There were no RCTs comparing surgery (traditionally considered as the 'gold standard' treatment) with another treatment. The included studies compared 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 (2 studies).
Ultrasound-guided application of the FemoStop compression device achieved thrombosis of the pseudoaneurysm at 12 to 24 hours in 15 patients (79%), compared to 14 patients (74%) with blind application of the FemoStop. Ultrasound-guided compression achieved thrombosis of the pseudoaneurysm within 24 hours in 90% of patients compared to 95% of patients with simple manual compression. At two days, thrombosis was achieved in 98% of patients in both groups. Merged data from these 2 studies showed that ultrasound-guided compression conferred no advantage over blind compression in terms of achieving primary thrombosis of the pseudoaneurysm (RR 0.96, 95% CI 0.88 to 1.04; 2 studies, n=206).
Percutaneous thrombin injection was more effective than a single session of ultrasound-guided compression in achieving primary pseudoaneurysm thrombosis within individual RCTs (RR 6.20, 95% CI 1.98 to 19.43, n=30; RR 1.44, 95% CI 1.06 to 1.97, n=38) but merged data failed to show statistical significance (RR 2.81; 95% CI 0.44 to 18.13 with statistical heterogeneity, I2 =90%; 2 studies, n=68). 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. The authors state that there are potentially serious complications with thrombin (e.g. allergy, introduction of infectious agents, thought to be responsible for transmission of some degenerative diseases, and the possibility of causing a blood clot in the artery), although none were reported in the included RCTs.
A pragmatic approach may be to consider compression (with or without ultrasound) as first-line treatment, reserving thrombin injection for those in whom the procedure fails.
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