Clinical Messages for Fenestrated Endovascular Aortic Repair from the GLOBALSTAR Registry: Outcomes in Salvage Fenestrated Endovascular Aneurysm Repair, Women, and Octogenarians +

Objective Global Collaborators on Advanced Stent Graft Techniques for Aneurysm Repair ( GLOBALSTAR) is a UK registry of complex endovascular aneurysm repair. This study aimed to examine differential outcomes after fenestrated endovascular aortic repair (FEVAR) for the following clinically relevant subgroups: women, octogenarians, and salvage FEVAR procedures to rescue previous failed repairs. Methods This was a retrospective cohort study of GLOBALSTAR. Standard comparative statistics were applied to peri-operative complications; Kaplan–Meier to survival; and cumulative incidence with competing risks to re-intervention and endoleaks. Log rank and Fine–Gray regression tests compared subgroup time to event functions. Results Over follow up of 1 651 FEVARs, salvage FEVARs experienced a significantly higher risk of re-intervention (subdistribution hazard ratio [sHR] 1.79, 95% confidence interval [95% CI] 1.37 – 2.34; p < .001) and graft related endoleaks type 1a or 1b (sHR 2.37, 95% CI 1.45 – 3.88; p = .001) and type 3 (sHR 2.12, 95% CI 1.36 – 3.32; p = .001) than primary FEVAR. There were more secondary ruptures following salvage FEVAR (4.0% vs . 1.7%; p = .073). Women experienced double the incidence of major complication Clavien–Dindo grades 3 – 5 (22.0% vs . 11.9%; p < .001), threefold incidence of major adverse cardiovascular event (5.9% vs . 2.1%; p = .004), and peri-operative death (5.9% vs . 2.1%; p = .006) compared with men. Median survival was 5.7 years (95% CI, 5.1 – 6.3) for 80 – 84 year olds and 4.8 years (95% CI 4.2 – 6.1) for ≥ 85 year olds. At one year, the overall log rank test showed no significant difference across age strata ( p = .11), although octogenarians had worse one year survival than patients aged 65 – 72 years ( p = .030). Conclusion This study generated the following hypotheses: higher rates of re-intervention and graft related endoleak for salvage FEVAR may justify a FEVAR first strategy in appropriate cases, to achieve durable repair. Significantly worse peri-operative outcomes for women require further evaluation and may require changes in pre-operative pathways and case selection. Advanced age alone may not be a strong contraindication to FEVAR and effective case selection may yield acceptable outcomes for octogenarians. This study is limited by its retrospective design but is valuable in terms of its large real world cohort with extended follow up. The results highlight the need for dedicated prospective studies for the three subgroups, to elucidate mechanistic determinants.