ABSTRACT
PURPOSE: Radiation exposure for vascular interventionalists is still a concern. The aim of this study was to assess the value of advanced imaging guidance on radiation exposure and iodinated contrast volume during endovascular treatment of lower extremity arterial disease (LEAD). MATERIALS AND METHODS: It was a prospective, randomized, monocentric, pilot, single-operator study, conducted from June 2018 to October 2019. Consecutive patients requiring a preoperative computed tomography angiography (CTA) for a symptomatic LEAD and scheduled for an iliac and/or femoropopliteal endovascular repair in a hybrid room were included. Patients were randomly assigned to the use of fusion imaging guidance (Vessel Navigator®, Philips) or not. The primary endpoint was the dose area product (DAP, Gy.cm²). Secondary endpoints were DAP for fluoroscopy, DAP for fluorography, Air Kerma, fluoroscopy time, volume of contrast, and number of digital subtraction angiography (DSA). Data were expressed in median [Q1-Q3]. RESULTS: In all, 64 of the 77 patients enrolled (34 in fusion group, 30 in control group, 82% men, 65.8 years [61-71]) were included. Groups were similar in terms of comorbidities, BMI (26 kg/cm2 [24-28]), but lesion location were not equally distributed (p=0.004). There was no significant difference between the groups regarding DAP (31.6 Gy.cm2 [23.4; 46.9] for fusion group vs 25.6[16.9; 34.0] Gy.cm2; p=0.07), Air Kerma (160 mGy [96;3365] vs 115 mGy [76;201]; p=0.12, fluoroscopy time (560 seconds [326;960] vs 454 seconds [228;1022]; p=0.44), contrast volume (60 ml [42;80] vs 50 ml [40;66]; p=0.10), or operative time (68 minutes [55;90] vs 46 minutes [30;80]; p=0.06). The median number of DSA was 14 [10-18] in the fusion group versus 11 [6-18]; p=0.049. CONCLUSION: Fusion imaging guidance does not affect radiation exposure and contrast volume during endovascular revascularisation of iliac and femoropopliteal occlusive disease in a hybrid room environment.
ABSTRACT
BACKGROUND: The benefits of imaging guidance using a new fully automated fusion process (CYDAR) have been demonstrated during endovascular aortic aneurysm repair, but little is known about its use during aorto-iliac occlusive disease endovascular revascularization. The aim of this study was to evaluate the influence of CYDAR image fusion guidance during endovascular treatment of symptomatic aorto-iliac occlusive lesions, compared with control patients treated using standard 2D fluoroscopy alone. METHODS: This is a single-center randomized controlled pilot study that recruited patients undergoing aorto-iliac endovascular revascularization. RESULTS: Between January 2019 and February 2020, 37 patients with symptomatic aorto-iliac lesions were enrolled: 18 were assigned to the fusion group and 19 to the control group. Patients and lesions characteristics were well balanced between both study groups. The technical success of the procedure was 100% in the Fusion group and 94% in the control group. All radiation-related parameters were lower in the fusion compared to the control group, including: median DAP 18.5 Gy.cm2 vs. 21.8 Gy.cm2; Air Kerma 0.10 Gy vs. 0.12 Gy; fluoroscopy dose 4.2 Gy.cm2 vs. 5.1 Gy.cm2; and number of DSA 7.5 vs. 8. The volume of iodinated contrast used was higher in the fusion group: 41 mL vs. 30 mL. The total procedure time was the same in both groups:60 min vs. 60 min. CONCLUSIONS: The results of this pilot study suggest the use of fusion imaging in endovascular treatment of aorto-iliac disease results in reduction in radiation-related measured parameters with no change in procedure time and higher doses of iodinated contrast used. These results need to be further investigated in a larger, adequately powered study.
