Long-term durability of a physician-modified endovascular graft

We present a unique assessment confirming the long-term durability of a physician-modified endograft deployed as part of an Investigational Device Exemption clinical trial (NCT# 01538056). After receiving an intact postmortem aorta 7 years after the index procedure, we performed microcomputed tomogr...

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Bibliographic Details
Published in:Journal of vascular surgery 2020-02, Vol.71 (2), p.628-634
Main Authors: Hurd, Jason R., Tatum, Billi, Grillo, Jenna, Arthurs, Zachary, Singh, Niten, Fong, Hanson, Sarikaya, Mehmet, Allen-Kline, Brenda, Starnes, Benjamin W.
Format: Article
Language:English
Subjects:
Fenestrated EVAR
Juxtarenal abdominal aortic aneurysm
Physician-modified
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Summary:We present a unique assessment confirming the long-term durability of a physician-modified endograft deployed as part of an Investigational Device Exemption clinical trial (NCT# 01538056). After receiving an intact postmortem aorta 7 years after the index procedure, we performed microcomputed tomography, necropsy, and metallurgical analysis on the specimen. Microcomputed tomography showed a single strut fracture not noted during previous surveillance. Necropsy revealed no graft fabric compromise, and examination of all three visceral fenestrations showed excellent alignment with no evidence of degradation. Analysis of the strut fracture implicated an initially small, fatigue-induced crack that likely succumbed during postmortem handling.
ISSN:0741-5214
1097-6809
DOI:10.1016/j.jvs.2019.04.471