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

Purpose: To evaluate the image quality and the safety of automated carbon dioxide (CO ₂ ) 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 CO ₂ 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 CO ₂ -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 CO ₂ -DSA vs. ICM-DSA (1.25 vs. 0625; p < 0.028).
Conclusion: CO2-DSA using automated injection system in combination with proprietary post-processing software is safe and comparable diagnostic test compared to ICM-DSA.
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