A Prospective Observational Trial of Fusion Imaging in Infrarenal Aneurysms

J Vasc Surg. 2018 Dec;68(6):1706-1713.e1. doi: 10.1016/j.jvs.2018.04.015. Epub 2018 May 24.

Abstract

Objective: Use of three-dimensional fusion has been shown to significantly reduce radiation exposure and contrast material use in complex (fenestrated and branched) endovascular aneurysm repair (EVAR). Cydar software (CYDAR Medical, Cambridge, United Kingdom) is a cloud-based technology that can provide imaging guidance by overlaying preoperative three-dimensional vessel anatomy from computed tomography scans onto live fluoroscopy images both in hybrid operating rooms and on mobile C-arms. The aim of this study was to determine whether radiation dose reduction would occur with the addition of fusion imaging to infrarenal repair in all imaging environments.

Methods: All patients who consented to involvement in the trial and who were treated with EVAR in our center from March 2016 until April 2017 were included. A teaching session about radiation protection and Cydar fusion software use was provided to all operators before the start of the fusion group enrollment. This group was compared with a retrospective cohort of patients treated in the same center from March 2015 to March 2016, after a dedicated program of radiation awareness and reduction was introduced. Ruptured aneurysms and complex EVAR were excluded. Preoperative and perioperative characteristics were recorded, including parameters of radiation dose, such as air kerma and dose-area product. Results were expressed in median and interquartile range.

Results: Forty-four patients were prospectively enrolled and compared with 21 retrospective control patients. No significant differences were found in comparing sex, body mass index, and age at repair. The median operation time (wire to wire) and fluoroscopy time were 90 (75-105) minutes and 30 (22-34) minutes, respectively, without significant differences between groups (P = .56 and P = .36). Dose-area product was nonsignificantly higher in the control group, 21.7 (8.9-85.9) Gy cm2, compared with the fusion group, 12.4 (7.5-23.4) Gy cm2 (P = .10). Air kerma product was significantly higher in the control group, 142 (61-541) mGy, compared with 82 (51-115) mGy in the fusion group (P = .03). The number of digital subtraction angiography runs was significantly lower in the fusion group (8 [6-11]) compared with the control group (10 [9-14]); (P = .03). There were no significant differences in the frequency of adverse events, endoleaks, or additional procedures required.

Conclusions: When it is used in simple procedures such as infrarenal aneurysm repair, image-based fusion technology is feasible both in hybrid operating rooms and on mobile systems and leads to an overall 50% reduction in radiation dose. Fusion technology should become standard of care for centers attempting to maximize radiation dose reduction, even if capital investment of a hybrid operating room is not feasible.

Trial registration: ClinicalTrials.gov NCT02592733.

Keywords: Advanced imaging guidance software; Automated overlay; EVAR; Imaging fusion; Radiation exposure.

Publication types

  • Observational Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Aneurysm, Abdominal / diagnostic imaging*
  • Aortic Aneurysm, Abdominal / surgery*
  • Aortography / adverse effects
  • Aortography / methods*
  • Cloud Computing
  • Computed Tomography Angiography / adverse effects
  • Computed Tomography Angiography / methods*
  • Endovascular Procedures / adverse effects
  • Endovascular Procedures / methods*
  • Feasibility Studies
  • Female
  • Fluoroscopy
  • Humans
  • Imaging, Three-Dimensional / adverse effects
  • Imaging, Three-Dimensional / methods*
  • Male
  • Predictive Value of Tests
  • Prospective Studies
  • Radiation Dosage
  • Radiation Exposure / adverse effects
  • Radiation Exposure / prevention & control
  • Radiographic Image Interpretation, Computer-Assisted / methods*
  • Radiography, Interventional / adverse effects
  • Radiography, Interventional / methods*
  • Retrospective Studies
  • Risk Factors
  • Surgery, Computer-Assisted / adverse effects
  • Surgery, Computer-Assisted / methods*
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT02592733