Cydar Guidance Software Studied for Fusion Imaging of Infrarenal Aneurysms During EVAR
June 14, 2017—Findings from the Cydar Infrarenal Endovascular Aneurysm Repair trial were presented by Debra Chong at the Society of Vascular Surgery's (SVS) Vascular Annual Meeting held June 1–3 in San Diego, California. The single-center, prospective, observational trial of fusion imaging in infrarenal aneurysms was conducted by Tara Mastracci, MD, et al at the Royal Free Hospital in London, United Kingdom.
Cydar endovascular three-dimensional (3D) surgical guidance software (Cydar Inc.) has gained US Food and Drug Administration 510(k) clearance and European CE Mark approval.
According to the investigators, Cydar software is a cloud-based technology that can provide imaging guidance by overlaying preoperative 3D vessel anatomy from CT scans onto live fluoroscopic images in both hybrid theaters and on mobile C-arms.
As noted by the investigators, use of 3D fusion has been shown to significantly reduce radiation exposure and contrast utilization in complex endovascular aneurysm repair (EVAR) procedures. The aim of this study was to determine whether radiation dose reduction would occur with the use of fusion imaging in simple, infrarenal repair in all imaging environments.
As summarized by the SVS meeting abstract, the study prospectively enrolled all patients who were treated with EVAR at the Royal Free Hospital from March 2016 to February 2017 and who consented to participation in the trial (n = 36). This group was compared to a retrospective cohort of patients (n = 21) treated in the same center from March 2015 to February 2016. Ruptured aneurysms, as well as complex EVAR case, were excluded. Preoperative and perioperative characteristics were recorded, including parameters of radiation dose as air kerma (AK) and dose area product (DAP).
In the Cydar group versus the control group, there were no significant differences regarding sex, body mass index, and age at the time of repair. The median wire-to-wire operation time and fluoroscopy time were 90 minutes [72.5–105 min] and 29 minutes [22–35.5 min] respectively, without significant differences between both groups.
The investigators reported that AK product was significantly higher in the control group at142 mGy [63–565.5 mGy] compared to 80 mGy [51–109 mGy] in the Cydar group (P = .028). The DAP in the control group was 2173 µGym2 [944.5–8,794 µGym2] compared to 1178.5 µGym2 in the Cydar group [689–2,172 µGym2] (P = .08). No significant differences were found in terms of adverse events, endoleaks, or additional procedures required.
The study showed that when used in simple procedures such as infrarenal aneurysm repair, image-based fusion technology is feasible in both hybrid theaters 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, concluded the investigators at the SVS Vascular Annual Meeting.