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Outcomes of Physician-Modified Fenestrated/Branched Endografts for Endovascular Aortic Aneurysm Repair in the Setting of Prior Failed EVAR
Mark Asirwatham1, Varun Konanki1, Spencer J Lucas2, Murray Shames1, Dean J Arnaoutakis1
1University of South Florida, Tampa, FL;2University of South Dakota, Sioux Falls, SD

Objectives: Endovascular treatment of aortic aneurysms involving the renal-mesenteric arteries typically requires a fenestrated/branched endovascular aneurysm repair (F//BEVAR) with a custom-made device (CMD), especially in the setting of prior failed endovascular aneurysm repair (EVAR). However, CMD availability is limited to select centers and thus physician-modified endografts (PMEGs) are an alternative treatment platform. Currently, there is no data on the outcomes of F/BEVAR using PMEG in the setting of failed prior EVAR. The purpose of this study was to evaluate the use of F/BEVAR with PMEG in patients with prior failed EVAR.
Methods: A prospective database of consecutive patients treated at a single-center with F/BEVAR using a PMEG device between March 2021 and August 2022 were retrospectively reviewed. The cohort was stratified by whether there was a failed EVAR present prior to PMEG. Demographics, operative details, postoperative complications were compared between the groups using univariate analysis. One-year survival and freedom from type 1 or 3 endoleak were compared between the groups using Kaplan-Meier method.
Results: A total of 84 patients underwent F/BEVAR with a PMEG device during the study period, 21 (25%) of which were in the setting of prior failed EVAR. Patients with prior failed EVAR had similar age (75.08.3years vs 71.39.0; p=.097), male gender (n=19[90%] vs n=46[73%]; p=.135), and comorbid conditions except for higher incidence of moderate-to-severe COPD (n=7[33%] vs n=7[11%]; p=.037) and CAD (n=15[71%] vs n=28[44%]; p=.044). For the entire cohort, aneurysm diameter was 65.412.6mm and aneurysm extent was juxtarenal/pararenal in 38% and extent I-V thoracoabdominal in 62%, with no differences between the groups(Table). Twelve (14%) patients presented with symptomatic/ruptured aneurysms. The average number of target arteries incorporated per patient was 3.8. Four different aortic devices were modified with a significantly greater proportion of Terumo TREO devices used in the failed EVAR group (p=.024)(Table). There were no differences in procedure time, radiation dose, or iodinated contrast used between the groups(Table). Overall technical success was 99% and the mean length of stay was 8.38.6 days. Rates of postoperative complications (n=6[29%] vs n=14[22%]; p=.564) and 30-day mortality (n=0[0%] vs n=2[3%]; p=1.00) were similar between groups. For the overall cohort, the rates of type 1 or 3 endoleak, branch vessel stenosis/occlusion, and reintervention were 4%, 1%, and 7%, respectively, with no difference between groups. One-year survival (94% vs 82%, p=.404) was similar between groups(Figure).
Conclusions: F/BEVAR using PMEG is a safe and effective treatment for patients with aneurysms involving the renal-mesenteric arteries, even in the setting of prior failed EVAR where additional technical challenges may be present. Additional follow-up is warranted to demonstrate long-term efficacy, but early results are encouraging and similar to those using CMDs.
Table. Operative variables and outcomes of patients who under F/BEVAR with PMEG device

VariableTotal (n=84)Failed EVAR (n=21)No EVAR(n=63)P-value
Aneurysm Extent.284
Juxtarenal6 (7)1 (5)5 (8)
Pararenal26 (31)7 (33)19 (30)
Extent I TAAA5 (6)0 (0)5 (8)
Extent II TAAA6 (7)1 (5)5 (8)
Extent III TAAA13 (15)1 (5)12 (19)
Extent IV TAAA26 (31)10 (48)16 (25)
Extent V TAAA2 (2)1 (5)1 (2)
Maximum aneurysm diameter, mm65.4 (12.6)67.0 (10.4)64.8 (13.3).481
Number target arteries incorporated/patient3.8 (0.6)3.7 (0.7)3.8 (0.6).37
Aortic device modified.024
Cook Alpha17 (20)2 (10)15 (24)
Cook TX217 (20)1 (5)16 (25)
Cook ZFen1 (1)0 (0)1 (2)
Terumo Aortic TREO49 (58)18 (86)31 (49)
Dose area product, Gy x cm2439 (239)361 (166)466 (255).081
Cumulative air kerma, mGy3,052 (1,613)2,834 (1,657)3,128 (1,604).476
Iodinated contrast use, mL80 (27)73 (22)83 (28).155
Fluoroscopy time, minutes78 (37)80 (39)77 (37).754
Procedure time, minutes243 (108)255 (122)239 (103).564
Technical Success83 (99)21 (100)62 (98)1.00
Length of stay, days8.3 (8.6)7.4 (4.7)8.6 (9.5).590
Any postoperative complication20 (24)6 (29)14 (22).564
Access site complication3 (4)1 (5)2 (3).250
Myocardial infarction1 (1)0 (0)1 (2)1.00
Respiratory complication8 (10)3 (14)5 (8).406
Acute renal failure8 (10)3 (14)5 (8).406
Permanent spinal cord ischemia3 (4)1 (5)2 (3)1.00
30-day mortality2 (2)0 (0)2 (3)1.00
Reintervention6 (7)2 (10)4 (6).637
Any endoleak21 (29)4 (20)17 (33).390
Type I or III endoleak3 (4)0 (0)3 (6).555
Branch vessel stenosis/occlusion1 (1)0 (0)1 (2)1.00


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