EndoNaut two-dimensional fusion imaging with a mobile C-arm for endovascular treatment of occlusive peripheral arterial disease

J Vasc Surg. 2022 Feb;75(2):651-659.e1. doi: 10.1016/j.jvs.2021.08.069. Epub 2021 Sep 10.

Abstract

Background: Endovascular treatment has become the first-line strategy for peripheral arterial disease (PAD). Given the number of procedures required, any technology associated with a reduction in radiation exposure and contrast volume is highly relevant. In the present study, we evaluated whether two-dimensional (2D) fusion imaging could reduce the radiation exposure and contrast volume during endovascular treatment of occlusive PAD.

Methods: Our consecutive, retrospective, single-center, nonrandomized comparative trial included patients with PAD at the femoral, popliteal, and/or tibial level, at any clinical stage, if they were candidates for endovascular revascularization. Patients were treated with or without the EndoNaut 2D fusion imaging system (Therenva, Rennes, France) in a nonhybrid room with the same Cios Alpha mobile C-arm (Siemens, Munich, Germany). The indirect dose-area product and contrast medium volume were recorded.

Results: Between March 2018 and April 2020, 255 patients underwent endovascular femoropopliteal revascularization with (n = 124) or without (n = 131) 2D fusion imaging. The volume of injected contrast medium (34.7 ± 13.8 mL vs 51.3 ± 26.7 mL; P < .001) and dose-area product (8.9 ± 9.9 Gy/cm2 vs 13.5 ± 14.0 Gy/cm2; P = .003) were significantly lower for the 2D fusion imaging group than for the control group. A subgroup analysis of complex (TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease C/D) lesions showed similar results. Stratification of the fusion imaging group into three subgroups, according to the procedure dates, showed no effect of a potential learning curve on the operative parameters.

Conclusions: The results from the present study showed a significant reduction in the contrast volume and radiation dose for endovascular treatment of PAD when applying 2D fusion imaging technology. Overall, a reduction of >30% was observed for both operative parameters, without excessive training requirements, highlighting the potential benefits of using 2D fusion imaging when performing endovascular revascularization for PAD.

Trial registration: ClinicalTrials.gov NCT04709991.

Keywords: Artificial intelligence; Contrast agent; Flat panel; Fusion imaging; Hybrid room; Peripheral artery disease; Radiation protection.

Publication types

  • Clinical Trial
  • Comparative Study

MeSH terms

  • Aged
  • Computed Tomography Angiography / methods*
  • Computers, Handheld*
  • Endovascular Procedures / methods*
  • Equipment Design
  • Female
  • Femoral Artery*
  • Follow-Up Studies
  • Humans
  • Imaging, Three-Dimensional / instrumentation*
  • Male
  • Peripheral Arterial Disease / diagnosis
  • Peripheral Arterial Disease / surgery*
  • Retrospective Studies
  • Surgery, Computer-Assisted / instrumentation*

Associated data

  • ClinicalTrials.gov/NCT04709991