New imaging technology system reduces patient radiation dose during peripheral arterial endovascular interventions

Background: Radiation exposure and imaging quality are among the main concerns in endovascular procedures. The Clear VD11 PURE platform technology system (Siemens Healthineers, Erlangen, Germany) has been reported to lower the radiation dose and improve image quality. In the present study, we evaluated whether the radiation dose during peripheral arterial endovascular procedures had decreased after implementation of this new imaging system. Methods: The patient characteristics (age, gender, body mass index [BMI]), procedure type (diagnostic, balloon angioplasty, atherectomy, stenting), body location (aortoiliac, superficial femoral artery, tibial artery), reference air kerma (RAK), kerma area product (KAP), and fluoroscopy time (FT) were recorded during peripheral artery interventions performed 1 year before (group A) and 1 year after (group B) the CLEAR system upgrade. The procedures were performed in an Artis zeego hybrid room (Siemens Healthineers) with the same providers. A general linear model was used to estimate the average difference between groups adjusted by procedure type and patient age, gender, and BMI. Additionally, to control for variations in case complexity, groups A and B were matched by age, gender, BMI, lesion location, and intervention type. Propensity score matching and a paired t test were used to compare the KAP, RAK, and FT stratified by single intervention procedures. Results: A total of 487 endovascular procedures were performed: 209 in group A and 278 in group B. A total of 111 single intervention procedures from each group were matched (1:1), with a mean age of 61 ± 8 years and a BMI of 26.5 ± 4 kg/m². The median KAP, RAK, and FT for group A were 28.8 Gy · cm² (interquartile range [IQR], 24-34 Gy · cm²), 146 mGy (IQR, 123-173 mGy), and 12 minutes (IQR, 10-14 minutes), respectively. The median KAP, RAK, and FT for group B were 18.3 Gy · cm² (IQR, 16-22 Gy · cm²), 71.2 mGy (IQR, 60-85 mGy), and 10.4 minutes (IQR, 9-12 minutes), respectively. The KAP, RAK, and FT were significantly decreased in group B by 24% (P = .005), 41% (P < .001), and 22% (P = .002), respectively, compared with the values for group A. Stratified by single intervention procedures, the KAP and RAK had decreased significantly in group B (36% [P = .002] and 51% [P < .001], respectively) compared with group A. The FT decrease of 13% in group B was not statistically significant (P = .20). Conclusions: Use of the Clear VD11 PURE platform system (Siemens Healthineers) reduced the patient radiation dose by 51% during endovascular peripheral interventions. The similar FTs for the matched single intervention procedures before and after the upgrade indicated consistent case complexity and surgeon practice. This platform appears to be an effective system for lowering the radiation dose.