Document Type

Article

Publication Date

10-18-2025

Comments

This article is the author's final published version in JVS-Vascular Insights, Volume 4, January 2026, Article number 100314.

The published version is available at https://doi.org/10.1016/j.jvsvi.2025.100314M. Copyright © 2025 THE AUTHOR(S).

Abstract

Background: To characterize the present landscape of physician-modified endograft (PMEG) use and the impact of an institution's investigational device exemption (IDE) status on endograft use by analyzing publication trends and social media coverage.

Methods: We used the social media platform X and three online bibliographic databases to perform a keyword search using the following terms: PMEG, physician-modified endograft, and laser fenestration. Data extracted from X and online articles included authorship, IDE protocol status, pertinent clinical outcome measures, and others. An internet search was performed to determine which institutions offered revascularization with a custom-made device within an IDE protocol and which institutions were performing PMEGs without an IDE. Data were compared using standard methods.

Results: Our search identified 177 X posts and 315 published articles between 2017 and 2024. We found that 61% (109/177) of X post authors were male, and the most frequently mentioned device was Cook (n = 21) followed by Gore (n = 12) and AFX (n = 2). There were 306 articles published in peer-reviewed journals, and 217 articles described at least 10 procedures. An IDE was mentioned in 3.9% of X posts (7/177). Sixty-seven percent of posts (119/177) mentioned a thoracoabdominal repair compared with 18% (32/177) mentioning arches and 15% (26/177) not indicating repair type. Of the 74 posts mentioning the number of branch grafts, 35% (26/74) were three-branch, and 65% (48/74) were four-branch repairs. Of the X posts, 64% (114/177) were related to procedural technique followed by 20% meeting presentations (34/177), 14% education (n = 24), and 2% mentorship (n = 5). The most frequently observed complication was endoleak (n = 8), followed by aneurysmal degeneration (n = 3) and stent migration (n = 1). Among published articles, most institutions were academic (n = 236) and urban (n = 209). Of the 274 articles for which author training history was available, most institutions were in the United States (n = 238) and urban (n = 211). The most frequently reported outcome was endoleak (n = 249), followed by need for reintervention (n = 199), stent migration (n = 57), and aneurysmal degeneration (n = 41). Only 31% of institutions (97/315) had an IDE; the remaining 69% (218/315) were performing PMEGs without an IDE. Of the 144 articles indicating commercial device use, Cook was the most frequently reported platform (n = 97) followed by Gore (n = 47).

Conclusions: PMEG has become a broadly used treatment option for patients with complex thoracoabdominal aortic disease at non-IDE centers. A less restrictive regulatory environment may expand patient access to custom-made devices without sacrificing patient safety standards. Collaboration is needed between vascular surgeons, device manufacturers, and lawmakers to achieve this goal.

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Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.

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English

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