Rohan Basu, Joshua Davis, Alexa Hughes, Alan Sawchuk, Raghu Motaganahalli, Andres Fajardo
Pararenal FEVAR using the ZFEN platform demonstrated no statistically significant differences in freedom from reintervention or overall survival compared to juxta/infrarenal FEVAR. However, the study is underpowered to prove true equivalence due to sample size and low event rates. Reintervention rates remain high, primarily due to endoleaks within the first 2-3 years. While few aneurysm-related deaths were observed, long-term outcomes remain uncertain due to substantial loss to follow-up. Consequently, late endoleaks, ruptures, and reinterventions may be underestimated. These data suggest pararenal ZFEN outcomes do not statistically differ from juxta/infrarenal outcomes, though uncertainty remains, requiring ongoing long-term surveillance.
OBJECTIVES: The Zenith Fenestrated (ZFEN) platform is commercially available in the US for fenestrated endovascular aortic repair (FEVAR) in infrarenal abdominal aortic aneurysms (AAA) with neck lengths ≥4 mm. However, ZFEN has been used outside manufacturer instructions for use for AAA with shorter necks or more proximal extents. Long-term data characterizing ZFEN results in these real-world applications is limited. We describe the mid- to long-term outcomes of our early experience using ZFEN for FEVAR in the pararenal segment.
METHODS: We reviewed all ZFEN repairs performed between April 2012 and April 2017 at an academic referral center. Cases done using modified grafts or for EVAR salvage were excluded. Results up to eight years of follow-up using ZFEN were compared between FEVAR for pararenal AAA versus juxta/infrarenal AAA. Primary outcomes included freedom from reintervention and overall survival.
RESULTS: There were 90 cases included (26 pararenal, 64 juxta/infrarenal). At 8-years, estimated freedom from reintervention was 67.4% versus 57.6% (p=0.93), while overall survival was 35.9% versus 42.3% (p=0.46) in the pararenal and juxta/infrarenal groups, respectively. In the series overall, 25 patients (27.8%) required reintervention, with 7 (26.9%) in the pararenal group versus 18 in the juxta/infrarenal group (28.1%). Reinterventions were most often performed for endoleaks.
CONCLUSIONS: Pararenal FEVAR using the ZFEN platform demonstrated no statistically significant differences in freedom from reintervention or overall survival compared to juxta/infrarenal FEVAR. However, the study is underpowered to prove true equivalence due to sample size and low event rates. Reintervention rates remain high, primarily due to endoleaks within the first 2-3 years. While few aneurysm-related deaths were observed, long-term outcomes remain uncertain due to substantial loss to follow-up. Consequently, late endoleaks, ruptures, and reinterventions may be underestimated. These data suggest pararenal ZFEN outcomes do not statistically differ from juxta/infrarenal outcomes, though uncertainty remains, requiring ongoing long-term surveillance.