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Spanos K, Kölbel T, Heidemann F, et al. Early and mid-term durability of surgeon-modified and custom-made fenestrated devices for the treatment of complex aortic pathology. Ann Vasc Surg. 2021;doi: 10.1016/j.avsg.2021.12.006.
Spanos, K., Kölbel, T., Heidemann, F., Debus, E. S., Rohlffs, F., & Tsilimparis, N. (2021). Early and mid-term durability of surgeon-modified and custom-made fenestrated devices for the treatment of complex aortic pathology. Annals of vascular surgery, . https://doi.org/10.1016/j.avsg.2021.12.006
Spanos, Kostantinos, et al. "Early and mid-term durability of surgeon-modified and custom-made fenestrated devices for the treatment of complex aortic pathology." Annals of vascular surgery vol. (2021). doi: https://doi.org/10.1016/j.avsg.2021.12.006
Spanos K, Kölbel T, Heidemann F, Debus ES, Rohlffs F, Tsilimparis N. Early and mid-term durability of surgeon-modified and custom-made fenestrated devices for the treatment of complex aortic pathology. Ann Vasc Surg. 2021 Dec 22; doi: 10.1016/j.avsg.2021.12.006. Epub 2021 Dec 22. PMID: 34954035.
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Ann Vasc Surg. 2021 Dec 22; doi: 10.1016/j.avsg.2021.12.006. Epub 2021 Dec 22.

Early and mid-term durability of surgeon-modified and custom-made fenestrated devices for the treatment of complex aortic pathology.

Annals of vascular surgery

Kostantinos Spanos, Tilo Kölbel, Franziska Heidemann, E Sebastian Debus, Fiona Rohlffs, Nikolaos Tsilimparis

Affiliations

  1. German Aortic Center Hamburg, Department of Vascular Medicine, University Heart Center, Hamburg, Germany.
  2. German Aortic Center Hamburg, Department of Vascular Medicine, University Heart Center, Hamburg, Germany; Department of Vascular Surgery, Hospital, LMU Munich, Munich, Germany.

PMID: 34954035 DOI: 10.1016/j.avsg.2021.12.006

Abstract

OBJECTIVE: 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 centre. Only cases with at least three 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: 32 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.

Copyright © 2021. Published by Elsevier Inc.

Keywords: Abdominal Aortic Aneurysm; Endovascular Aortic Repair; Fenestrated and Branched Endovascular Aortic Repair; Physician-modified Stent Graft; Ruptured Aneurysm; Surgeon-modified Stent Graft; Thoracoabdominal Aortic Aneurysm

Conflict of interest statement

Declaration of 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: FH, KS, FR and ES

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