Physician-modified Endografts in Real-world Practice: Comparable Outcomes to IDE Centers and the Need for Quality Registries
Recommended Citation
Halabi M, Chamseddine H, Shepard A, Kabbani L, Nypaver T, Weaver M, Onofrey K, Sullivan B, Hafeez MS, Peshkepija A. Physician-modified Endografts in Real-world Practice: Comparable Outcomes to IDE Centers and the Need for Quality Registries. J Vasc Surg 2025; 82:e50.
Document Type
Conference Proceeding
Publication Date
9-1-2025
Publication Title
J Vasc Surg
Abstract
Objectives: To evaluate early outcomes of physician-modified endografts (PMEGs) for complex abdominal aortic aneurysms (CAAAs) at our institution and compare results to those of investigational new device (IDE) centers. Methods: A retrospective review of all patients at a quaternary medical center who received a PMEG for CAAA repair between 2022 and 2024 was performed. Demographics, procedural metrics, and postoperative outcomes were collected. Descriptive statistics summarized baseline characteristics, operative variables, and follow-up outcomes. Technical success was defined on an intention-to-treat basis. Bivariate analysis was performed to compare our outcomes with those reported by IDE centers. Results: A total of 70 (68% male; mean age, 75 years) patients underwent repair. The majority were former smokers (52%) and had hypertension (78%) or hyperlipidemia (68%). History included prior open aortic repair (3%) and prior endovascular aneurysm repair (22%), 32% of patients were symptomatic. Mean aneurysm diameter was 67 mm. Aneurysm types treated include juxtarenal (37%), pararenal (22%), and thoracoabdominal (38%; 11% type IV) aneurysms. Median operative time was 270 minutes, fluoroscopy time was 80 minutes, median contrast volume was 131.5 mL, and technical success was 95%. Within the first 30 days, type I endoleaks were absent, and type III endoleaks occurred in 2.8%, acute kidney injury in 24.2%, spinal cord ischemia in 7.1% (three patients permanent and two transient), mortality was 5.7%, and 14.2% required reintervention. At 12 months (n = 14), branch stent graft patency was 96% with no additional mortality. Comparisons to IDE centers are detailed in Table I (operative metrics) and Table II (postoperative outcomes). Conclusions: This study demonstrates the feasibility and safety of PMEGs in real-world practice, with outcomes comparable with IDE centers despite higher radiation and AKI rates. The technical success rate (95%) and midterm branch patency (96%) support PMEG as a viable option for CAAA repair. Our data suggest centers outside IDE may achieve similar results with adequate institutional support and expertise. These findings underscore the need for standardized quality registries to validate PMEG outcomes and guide broader adoption. [Formula presented] [Formula presented]
Volume
82
First Page
e50
