Clinical Evaluation of a Novel Compression Device For Ultrasound-Guided Repair of Femoral Artery Pseudoaneurysms: A Double-Blind Clinical Trial

نویسندگان
doi
10.5812/iranjradiol-146118
چکیده

Background: Femoral artery pseudoaneurysm is a well-known complication after conventional angiography. Today, the treatment of choice for this condition is noninvasive repair using manual ultrasound-guided compression. Objectives: This study aimed to evaluate the efficacy of a novel compression device in improving angiography-induced pseudoaneurysm treatment compared to manual ultrasound-guided compression repair. Results: The study was performed on 22 patients (13 males/9 females) with a mean age of 65.5 ± 3.5 years divided into two groups of device-assisted (n = 11) and manual ultrasound-guided (n = 11) compression repair. The two groups did not differ significantly in terms of demographic variables or initial ultrasound variables associated with the pseudoaneurysm. The device-assisted compression group was found to have lower pain intensity (5.0 ± 1.0 vs. 6.0 ± 0.8; P = 0.024) and a significantly higher success rate (100% vs. 45.5%; P = 0.004) compared to the manual compression group. None of the patients showed any side effects. Conclusion: This preliminary study showed that the proposed device is completely safe and may improve the success rate while decreasing pain scores during ultrasound-guided compression procedures. Using a large multicenter study design, evaluating the efficacy of the novel device for hemostasis during sheath removal and adding new equipment to the device, such as manometers to apply controlled pressure, are suggested for future studies.