Objectives: 1. Report pre-operative, operative and post-operative characteristics for FEVAR. 2. Report the incidence of the following long-term outcomes for FEVAR: o Primary outcomes: all-cause mortality. o Secondary outcomes: re-intervention, aneurysm-related mortality, secondary sac rupture. 3. Compare survival between populational subgroups, namely octogenarians versus non-octogenarians and males versus females.
Methods: Study design: retrospective cohort study of the GLOBALSTAR registry. Inclusion criteria: aneurysmal disease irrespective of anatomy and custom-made FEVAR alone in adults. Pre-operative, operative and post-operative data were collected according to a standardised protocol. Time-to-event analyses were conducted for survival, aneurysm-related mortality, re-intervention, endoleak and target vessel patency. Subgroup analyses were conducted for octogenarians and sexes.
Results: 1651 patients across 15 centres were included. Median age was 75 years [IQR, 69-79] and 87.9% were male.
Estimated survival at 3, 5 and 10 years was 79.5% [95%CI, 77.6-81.5%], 64.1% [61.7-66.6%] and 30.5% [27.7-33.5%] with a median survival of 6.9 years [95%CI, 6.6-7.2]. There were 104 aneurysm-related deaths during follow-up; aneurysm-related mortality was 6.7% at 10 years [5.4-8.0%]. There were 36 secondary sac ruptures over the length of follow-up.
Cumulative incidence of re-intervention at 3, 5 and 7 years was 21.5% [95%CI, 19.5-23.6%], 25.6% [23.3-27.8%] and 27.6% [25.3-30.0%]. Graft-related complications accounted for 73.9% of re-interventions.
Women had significantly worse 2-year survival (81.1%, [75.8-86.7%]) than men (86.1%, [84.3-87.9%]) (p= 0.04), driven by peri-operative mortality. Beyond 2 years, differences in survival were not significant. Women were observed to have a significantly higher proportion of: death on index admission (6.2% vs 2.2%, p= 0.003) and MACE (8.4% vs 2.8%, p < 0.001).
Octogenarians had equivalent survival (89.4% [86.4-92.4%]) to non-octogenarians (92.1% [90.7-93.6%]) up to 1 year (p= 0.07). Octogenarians' median survival was 5.4 years [95% CI, 5.0-6.1].
Conclusions: Long-term outcomes for FEVAR appear acceptable, with low rates of secondary sac rupture. FEVAR carries risk, especially of re-intervention, but is a reasonable treatment option for complex AAAs, including for octogenarians with effective case selection. Peri-operative mortality is significantly higher in women and warrants further investigation. Re-intervention was principally driven by graft-related indications suggesting effective graft surveillance is key to long-term durability.
.jpeg.jpg "Aurelien M. Gueroult, MBBS photo")