Objective: This study reports the Duplex Assessment 2-year outcomes of the Primary Arm and Secondary Arm of the GORE EXCLUDER Thoracoabdominal Branched Endoprosthesis (TAMBE) pivotal trial for complex abdominal aortic aneurysm repair. Methods: This multicenter, nonrandomized, prospective study of the TAMBE device included patients enrolled in the Primary, Continued Access, and Secondary study Arm of Extent I- IV thoracoabdominal aortic aneurysms and pararenal aneurysms. The duplex protocol was developed specifically for this patient population. Results: This study analyzed data from 102 Primary Arm and 25 Secondary Arm individuals. Bridging stent grafts were deployed to incorporate 407 target vessels (mean 1.6/per vessel; range, 1-4). The Core lab-reported duplex values are reported herein and are notably lower than values seen with occlusive disease, bare metal stents, and fenestrated endovascular aortic aneurysm repair (EVAR). Conclusions: Duplex assessment of the TAMBE device may provide a mechanism of surveillance for branch devices. Further work is in progress to determine discriminatory thresholds for reintervention.
ClinicalTrials.gov: NCT03728985
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