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. 2025 Feb 18.
doi: 10.1097/SLA.0000000000006676. Online ahead of print.

Multicenter Prospective Evaluation of Patient Radiation Exposure During Fenestrated-Branched Endovascular Aortic Repair: A Ten-year Experience

Thomas Mesnard  1 , Ying Huang  1 , Andres Schanzer  2 , Carlos H Timaran  3 , Darren B Schneider  4 , Bernardo C Mendes  5 , Matthew J Eagleton  6 , Mark A Farber  7 , F Ezequiel Parodi  7 , Warren J Gasper  8 , Adam W Beck  9 , Matthew P Sweet  10 , Sara L Zetterval  10 , Anthony Lee  11 , Gustavo S Oderich  1 ; United States Aortic Research Consortium
Affiliations

Multicenter Prospective Evaluation of Patient Radiation Exposure During Fenestrated-Branched Endovascular Aortic Repair: A Ten-year Experience

Thomas Mesnard et al. Ann Surg. .

Abstract

Objective: To assess patient radiation exposure as reflected by cumulative air kerma (CAK) and dose area product (DAP) during fenestrated-branched endovascular aortic repair (FB-EVAR).

Summary background data: Patient radiation exposure during FB-EVAR has been reported inconsistently.

Methods: Data from 2,111 patients enrolled in 10 physician-sponsored investigational device exemption studies (2012-2022) were analyzed from the United States Aortic Research Consortium database. Procedures were performed using seven fixed imaging systems (A to G). Patients were classified into three groups by imaging era: 2012-2015 (Group 1), 2016-2018 (Group 2), and 2019-2022 (Group 3). Primary endpoints were CAK and DAP risk factors, assessed using linear mixed-effect models. Secondary endpoints were diagnostic reference levels (DRL) for FB-EVAR.

Results: Of the 2,111 patients (71% males; mean 74±9 years years-old) treated by FB-EVAR; 263 (12%) were in Group 1, 541 (26%) in Group 2, and 1,307 (62%) in Group 3. Use of ≥4 vessel stent-graft designs increased from 69% (Group 1) to 79% (Group 3) (P<0.001). Median CAK decreased from 3,644 mGy (Group 1) to 1,753 mGy (Group 3), and DAP from 441 Gy.cm² to 208 Gy.cm² (P<0.001). Higher BMI, iliac branch device (IBD) use, and longer fluoroscopy time (FT) were associated with increased CAK and DAP, while experienced operators and systems D, F, and G were protective (P<0.05). DRLs for Group 3 were 2,800 mGy (CAK) and 340 Gy.cm² (DAP).

Conclusions: Radiation exposure during FB-EVAR significantly decreased over time. Higher BMI, IBD use, and FT were linked to increased exposure, while experienced operator and System D, F or G were protective. Trial registration: URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02043691 NCT00583817 NCT00483249 NCT01937949 NCT02050113 NCT02323581 NCT01874197 NCT01654133 NCT02266719.

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Conflict of interest statement

Conflicts of Interest and Source of Funding: No source of funding. Conflicts of interest: A. Schanzer: Consultant: Cook, Phillips, Artivion with all proceeds to UMass Foundation; Discussion of commercial products which involve off-label or investigational uses: research support provided through the US-Aortic Research Consortium. M. Farber: Consultant: Gore, ViTAA medical, Centerline Biomedical, Cook; Discussion of commercial products which involve off-label or investigational uses: research support provided through the US-Aortic Research Consortium. M. Sweet: Discussion of commercial products which involve off-label or investigational uses: research support provided through the US-Aortic Research Consortium. A. Lee: Discussion of commercial products which involve off-label or investigational uses: research support provided through the US-Aortic Research Consortium. M. Eagleton: Other: research support provided through the US-Aortic Research Consortium. G. Oderich: Consultant: GE, Cook, Gore, Centerline Biomedical; Other: research support GE scientific advisory board, Cook, Centerline Biomedical. A. W. Beck: Consultant: Artivion, Cook Medical, Medtronic, Philips, Terumo Aortic; Discussion of commercial products which involve off-label or investigational uses: This project involves Investigational Device Exemption utilizing Cook Medical custom branched and fenestrated endografts; research support provided through the US-Aortic Research Consortium.

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