New Imaging Technology System Reduces Patient Radiation Dose During Peripheral Arterial Endovascular Interventions
Alejandro Pizano, Ali Khurram, Khalil Chamseddin, Carlos Timaran, Shadman Baig, Michael Shih, Jeffrey Guild, Melissa L. Kirkwood
University of Texas Southwestern Medical Center, Dallas, TX
INTRODUCTION: Radiation exposure and imaging quality are among the main concerns in endovascular procedures. The CLEAR MAX imaging technology system (VD11 PURE platform, Siemens Healthineers, Erlangen, Germany) claims to lower radiation dose while improving image quality. This study evaluated whether the radiation dose during peripheral arterial endovascular procedures decreases after implementing this new imaging system.
METHODS: Patient characteristics (age, gender, body mass index), procedure type (diagnostic, balloon angioplasty, atherectomy, and stenting), body location (aortoiliac, superficial femoral artery, and tibial artery), reference air kerma (RAK), kerma area product (KAP), and fluoroscopy time (FT) were recorded during peripheral artery interventions performed one year before (group A) and one year after (group B) the CLEAR MAX system upgrade. Procedures were performed in an Artis Q.zen hybrid room (Siemens Healthineers, Erlangen, Germany) with the same providers. A general linear model was used to estimate the average difference between groups adjusted by procedure type, patient age, gender, and BMI. Additionally, to control for variations in case complexity, group A and group B were matched by age, gender, BMI, lesion location, and intervention type. A propensity score matching, and a paired t-test were used to compare groups for the KAP, RAK, and FT stratified by single intervention procedures.
RESULTS: In total, 487 endovascular procedures were collected; 209 in group A and 278 in group B. 111 single intervention procedures from each group were matched (1:1) with a mean age of 61 ± 8 years and a body mass index of 26.5 ± 4 (range: min-max = 18-39). Median (IQR) KAP, RAK, and FT of group A were 28.8 Gycm2 (24-34), 146 mGy (123-173), and 12 min (10-14), respectively. Median KAP, RAK, and FT of group B was 18.3 Gycm2 (16-22), 71.2 mGy (60-85), and 10.4 min (9-12). KAP, RAK, and FT were statistically significantly decreased in group B by 24% (P<.001), 41% (P<.001), and 22% (p=.002) respectively, compared to group A. Stratified by one procedure, group B KAP and RAK decreased statistically significant by 36% (P<.001) and 51% (P<.001) compared to group A. The group B FT decrease of 13% was not significantly different (p=.2).
CONCLUSIONS: The CLEAR MAX (VD11 PURE platform) system reduces patient radiation dose up to 51% during endovascular peripheral interventions. The statistically similar fluoroscopy times for matched single intervention procedures before and after the upgrade indicate consistent case complexity and surgeon practice. This platform appears to be an effective system in lowering the radiation dose while maintaining image quality. 
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