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

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. Patients and Method: A double-blind, randomized clinical trial was performed on patients with femoral angiography-induced pseudoaneurysm in the Radiology Department of Ghaem Hospital, Mashhad, Iran. Based on color Doppler ultrasound exams, patients diagnosed with a pseudoaneurysm within 72 hours of angiography were included in the study. Patients were excluded if they had complete blockage, complete pseudoaneurysm thrombosis, abscess, surface tissue infection, or open wound in the area. The patients were allocated to a manual ultrasound-guided compression group or a device-assisted compression group using simple randomization with a sealed envelope method. After collecting demographic data, the patients underwent an ultrasound exam of the groin to determine and record the size of the pseudoaneurysm and the ratio of thrombosis to open lumen. The therapeutic success rate was defined as complete lumen thrombosis after conducting the compression procedure one to three times. Also, the pain score was measured during compression using the Visual Analog Scale based on a scale of 0 - 10. The duration of successful procedures was also documented. The patients were monitored for 6 hours for any side effects. The level of statistical significance was set at P < 0.05 for all tests. 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.