Use of Fibre Optic RealShape Technology during Complex Endovascular Aortic Repair: Results of a Transatlantic Registry

Objective The present study describes the first transatlantic multicentre results of catheterisation success rates and radiation reducing effect of Fiber Optic RealShape (FORS) technology in complex endovascular aortic repair (EVAR) procedures. Methods All target vessel catheterisations during complex EVAR procedures were analysed per protocol, focusing on the technical success of FORS and the impact of FORS on navigation time and radiation exposure, measured by fluoroscopy time (FT), fluoroscopy rate (FR), cumulative air kerma (CAK), and kerma area product (KAP) by comparing successful FORS with conventional catheterisations. Results During 313 complex EVARs, 812 FORS attempts of 1 037 visceral target catheterisations resulted in an overall technical success of 62.8% (fenestrations 66.2% vs. branches 54.1%; p = .001). Successful FORS catheterisation was statistically significantly faster through fenestrations (5.0 minutes [interquartile range {IQR} 3.0, 7.0] vs. 6.5 minutes [IQR 3.0, 13.0]; p < .001) but not through branches (6.0 minutes [IQR 4.0, 11.0] vs. 7.0 minutes [IQR 4.0, 12.0]; p = .24), compared with conventional catheterisation. Successful FORS usage resulted in reduced radiation compared with conventional catheterisations in fenestrations (FT FORS 0.9 minutes [IQR 0.4, 1.9], conventional 4.1 minutes [IQR 1.9, 77], p < .001; FR FORS 21.3% [IQR 10.0, 35.0], conventional 62.1% [IQR 51.7, 71.9], p < .001; CAK FORS 16.5 mGy [IQR 5.0, 48.3], conventional 93.9 mGy [IQR 42.0, 223.8], p < .001; KAP FORS 2.0 Gy·cm 2 [IQR 0.7, 4.7], conventional 7.0 Gy·cm 2 [IQR 2.7, 15.8], p < .001) and branches (FT FORS 1.4 minutes [IQR 0.6, 2.6], conventional 4.1 minutes [IQR 1.8, 7.4], p < .001; FR FORS 21.8% [IQR 12.5, 37.7], conventional 60.6% [IQR 46.1, 68.0], p < .001; CAK FORS 58.0 mGy [IQR 15.1, 132.4], conventional 94.7 mGy [IQR 44.5, 238.5], p < .001; KAP FORS 6.0 Gy·cm 2 [IQR 2.0, 11.6], conventional 6.8 Gy·cm 2 [IQR 3.5, 18.2], p < .004). Conclusion This multicentre study showed the potential of FORS technology to reduce radiation exposure during visceral target catheterisation in complex EVARs with reasonable technical success.