Physician-Modified Endografts Achieve Similar Patient Survival and Target Visceral Vessel Related Outcomes to Factory-Made Fenestrated Endografts in Treating Complex Aortic Pathology.

BACKGROUND

The purpose of this study was to conduct a real-world comparison of visceral stent branch related outcomes and patient survival in physician-modified endografts (PMEGs) versus factory-made fenestrated endografts (FMFEs).

METHODS

After exclusions, 544 PMEG and 1638 FMFE were identified in the Vascular Quality Initiative between 2014 and 2022. The four primary outcomes analyzed with Kaplan-Meier were freedom from mortality, new onset dialysis, visceral ischemia, and visceral stent-graft reintervention in follow-up. Multivariable Cox regression was also performed for visceral reintervention in follow-up utilizing variables with a univariable P < 0.10. Comparison of baseline demographics and co-morbidities in the PMEG versus FMFE group were performed as was univariable risks for perioperative adverse outcomes.

RESULTS

PMEG patients were a more comorbid cohort highlighted by: larger aneurysms; higher mean number of visceral vessels stented; higher rates of hypertension, anemia, prior coronary revascularization, prior open aortic surgery, and greater than 50% stenosis in one of the visceral target arteries (P < 0.01 for all). Further, PMEG patients had a 3-fold higher rate of intervention for a primary pathology of aortic dissection (9.7% vs. 2.3%, P < 0.001). Mean follow-up for survival was 1.9 years for PMEG and 3.0 years for FMFE. Mean follow-up for visceral stent-related data was 1.07 and 1.19 years for PMEG and FMFE, respectively. There was no significant difference between the PMEG and FMFE groups in mortality, new onset dialysis or intestinal ischemia in follow-up. Univariable Kaplan-Meier analysis for freedom from visceral stent branch reintervention showed an increased rate for PMEG (log rank P = 0.002). However, multivariable Cox regression rendered this nonsignificant (hazard ratio [HR] 1.25, P = 0.406) due to significantly more branches being treated on average in the PMEG group (3.48 vessels versus 3.01, P < 0.001). The only variable which achieved multivariable significance in association with visceral stent reintervention was the mean number of vessels stented (HR 2.15, P < 0.001).

CONCLUSION

Physician-modified fenestrated visceral segment endografts achieve similar mid-term freedom from mortality, visceral stent-graft reintervention, new onset dialysis, and intestinal ischemia relative to custom FMFEs. This is despite PMEG patients being a significantly more comorbid cohort, with more visceral vessels involved and more dissection related aneurysms.