Background
Fenestrated endovascular aneurysm repair (F-EVAR) has allowed successful treatment
of patients with complex aortic aneurysms. Custom-made devices (CMDs) are manufactured
by companies and tailored to the patient's anatomy to incorporate target vessels,
while there is also the “off label” alternative with the devices modified by a surgeon
in the operating room: surgeon-modified FEVAR (sm-FEVAR). This study aims to present
and compare technical durability of CMDs- and sm-FEVAR for complex abdominal and thoracoabdominal
aortic pathologies.
Methods
A retrospective cohort study was undertaken including all consecutive patients treated
with sm- or CMD-FEVAR during a 3-year period in a single center. Only cases with at
least 3 reno-visceral target vessels were included. Primary outcomes were technical
success, and freedom from endoleak (EL) (Ia or III; all branch related) and re-intervention
during follow-up period. Mortality and morbidity were also recorded.
Results
Thirty-two sm-FEVAR patients (81,3% male) and 79 CMD-FEVAR patients (77,2% male) were
included. Indication for sm-FEVAR was exclusively urgent, while all CMD- FEVAR were
elective. Technical success was similar in sm-FEVAR (100%) and CMD-FEVAR (98,7%) (P = 0.523). Mean follow-up was 16.3 ± 13 and 20 ± 17.3 months for sm-FEVAR and CMD-
FEVAR, respectively (P = 0.28). The freedom from EL Ia rate was 91.7% [standard error (SE) 5.7%] at 12 months
in sm-FEVAR, while it was 97.7% (SE 2.2%) and 92.3% (SE 4.3%) at 12 and 24 months,
respectively in CMD-FEVAR (P = 0.69). The freedom from EL III rate was 95.5% (SE 4.4%) and 88% (SE 8.2%) at 12
and 24 months, respectively in sm-FEVAR, while it was 92.1% (SE 3.8%) and 89.2% (SE
4.7%) at 12 and 24 months, respectively in CMD-FEVAR (P = 0.68). The freedom from re-intervention rate was 91.6% (SE 5.7%) and 84.6% (SE
8.6%) at 12 and 24 months, respectively in sm-FEVAR, while it was 91.7% (SE 4%) and
83.4% (SE 5.9%) at 12 and 24 months, respectively in CMD-FEVAR (P = 0.90). The survival rate was 87.5% (5.8%) and 76.3% (7.9%) at 1 and 12 months,
respectively in sm-FEVAR, while it was 93.7% (2.7%) at 1 month in CMD-FEVAR without
any other death during FU period. No bridging stent occlusions were noted during follow-up
period in any patient.
Conclusion
Sm-FEVAR offers good technical success and mid-term clinical outcomes in urgent cases
of complex aortic pathologies. Its durability is acceptable and comparable to CMD-FEVAR
with a relatively low re-intervention rate.
Keywords
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Article Info
Publication History
Published online: December 22, 2021
Accepted:
December 4,
2021
Received in revised form:
November 26,
2021
Received:
October 25,
2021
Footnotes
Conflict of Interest: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article:
TK has intellectual property with Cook Medical and receives royalties, research, travel and educational grants, and speaking fees from and is a consultant and proctor for Cook Medical. NT receives travel and educational grants, speaking fees from and is proctor for Cook Medical. Rest of the authors declare no conflicts of interest.
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