Analysis of physician-modified endograft utilization using online databases and social media
Year: 2025
Type: article
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.
Source: JVS-Vascular Insights
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,000
OpenAlex ID: W4415339637