Effect of bridging stent graft selection for directional branches on target artery outcomes of fenestrated-branched endovascular aortic repair in the United States Aortic Research Consortium.

INTRODUCTION: The purpose of this study was to evaluate the effect of directional branches (DB) bridging stent choice on target artery (TA) outcomes during fenestrated-branched endovascular repair (FB-EVAR) of complex abdominal (CAAAs) and thoracoabdominal aortic aneurysms (TAAAs).

METHODS: Patients enrolled in nine prospective physician-sponsored investigational device exemption (PS-IDE) studies in the United States between 2005 and 2020 were analyzed. All patients who had at least one TA incorporated by DB using either self-expandable (SESGs), balloon-expandable (BESGs), or hybrid stent graft combinations (HSG). Endpoints were TA patency and freedom from TA endoleak, instability, and reintervention.

RESULTS: There were 800 patients with 2426 renal-mesenteric arteries incorporated by DBs. DB stent selection was SESG in 1205 TAs (50%), BESGs in 1095 TAs (45%), and HSG in 126 TAs (5%). SESGs were predominantly used in the first three quartiles of the study period, whereas BESGs comprised 75% of all stents between 2017-2020. The median follow-up was 15 (6-35) months. At 5-years, BESGs had significantly lower freedom from TA instability (78±4% vs. 88±1% vs. 96±2%, log-rank =.010), freedom from TA endoleaks (87±3% vs. 97±1% vs. 99±1%, log-rank <.001), and freedom from TA reintervention (83±4% vs. 95±1% vs. 99±2%, log-rank <.001) compared to SESGs or HSGs, respectively. For renal arteries, there was no difference in freedom from TA instability for BESGs, SESGs, or HSGs. However, freedom from TA endoleaks and reintervention were lower for renal arteries targeted by BESG compared to DBs targeted by SESGs and HSG (83%±6% vs. 98%±1% vs. 100%, log-rank < .001, and 70%±10% vs. 92%±1% vs. 96%±4%, log-rank = .022). For mesenteric arteries, DBs targeted by BESGs had lower freedom from TA instability, endoleak, and reintervention than SESGs or HSG. In stent-specific analysis, iCAST BESGs had the lowest freedom from TA instability either for renal or mesenteric arteries, primarily due to higher rates of TA endoleaks. There was no difference in patency in any scenario. Independent predictors of TA instability were age (+1-year, HR 0.97, 95% CI 0.94-0.99), stent diameter (+1mm, HR 0.67, 95% CI 0.57-0.80), and BESG (HR 1.8; 95% CI 1.1-2.9).

CONCLUSION: DBs incorporated using BESGs had lower freedom from TA instability, TA endoleak, and TA reintervention compared to SESGs and HSGs. The patency of DBs was not affected by the type of stent construction. The observed performance disadvantage associated with BESGs appears to have largely been driven by iCAST usage.