Image quality and safety of automated carbon dioxide digital subtraction angiography in femoropopliteal lesions: Results from a randomized single-center study.

Abstract Purpose To evaluate the image quality and the safety of automated carbon dioxide (CO2) digital subtraction angiography (DSA). Materials and Methods Fifty patients receiving DSA for femoropopliteal peripheral arterial disease (PAD) were enrolled in this single-center prospective study. All patients received iodinated contrast media (ICM) and CO2 as a contrast agent in the same target lesion. As a primary endpoint, four raters independently evaluated the angiography images based on overall image quality, visibility of collaterals, and assessment of stenoses/occlusions. Inter-rater agreement was assessed using the intraclass correlation coefficient (ICC) and differences between the raters were evaluated using Friedmann´s test. Secondary endpoints were procedure safety and patient pain assessment. Results Inter-rater agreement between CO2-DSA and ICM-DSA images was fair to excellent for overall image quality (ICC: 0.399–0.748), fair to excellent for the visibility of collaterals (ICC: 0.513–0.691), and poor to excellent for the assessment of stenoses/occlusions (ICC: -0.065–0.762). There were no significant differences between the raters. Two patients had a hematoma, one reported pain related to puncture, one became nauseous, and one vomited. No other adverse events were observed. Reported pain scores were significantly higher for CO2-DSA vs. ICM-DSA (1.25 vs. 0625; p  Conclusion CO2-DSA using automated injection system in combination with proprietary post-processing software is safe and comparable diagnostic test compared to ICM-DSA.