TY - JOUR
T1 - 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
AU - U.S. Fenestrated and Branched Aortic Research Consortium
AU - Tenorio, Emanuel R.
AU - Schanzer, Andres
AU - Timaran, Carlos H.
AU - Schneider, Darren B.
AU - Mendes, Bernardo C.
AU - Eagleton, Matthew J.
AU - Farber, Mark A.
AU - Parodi, F. Ezequiel
AU - Gasper, Warren J.
AU - Beck, Adam W.
AU - Sweet, Matthew P.
AU - Zettervall, Sara L.
AU - Huang, Ying
AU - Oderich, Gustavo S.
N1 - Publisher Copyright:
© 2023 Society for Vascular Surgery
PY - 2023/7
Y1 - 2023/7
N2 - Objective: The purpose of this study was to evaluate the effect of directional branches (DBs) bridging stent choice on target artery (TA) outcomes during fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms. Methods: Patients enrolled in nine prospective physician-sponsored investigational device exemption 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 (HSGs). 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 SESGs in 1205 TAs (50%), BESGs in 1095 TAs (45%), and HSGs 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 and 2020. The median follow-up was 15 months (interquartile range, 6-35 months). At 5 years, BESGs had significantly lower freedom from TA instability (78% ± 4% vs 88% ± 1% vs 96% ± 2%; log-rank P =.010), freedom from TA endoleaks (87% ± 3% vs 97% ± 1% vs 99% ± 1%; log-rank P <.001), and freedom from TA reintervention (83% ± 4% vs 95% ± 1% vs 99% ± 2%; log-rank P <.001) compared with 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 BESGs compared with DBs targeted by SESGs and HSGs (83% ± 6% vs 98% ± 1% vs 100%; log-rank P <.001; and 70% ± 10% vs 92% ± 1% vs 96% ± 4%; log-rank P =.022). For mesenteric arteries, DBs targeted by BESGs had lower freedom from TA instability, endoleak, and reintervention than SESGs or HSGs. 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: hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.94-0.99), stent diameter (+1 mm: HR, 0.67; 95% CI, 0.57-0.80), and BESG (HR, 1.8; 95% CI, 1.1-2.9). Conclusions: DBs incorporated using BESGs had lower freedom from TA instability, TA endoleak, and TA reintervention compared with 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.
AB - Objective: The purpose of this study was to evaluate the effect of directional branches (DBs) bridging stent choice on target artery (TA) outcomes during fenestrated-branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms. Methods: Patients enrolled in nine prospective physician-sponsored investigational device exemption 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 (HSGs). 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 SESGs in 1205 TAs (50%), BESGs in 1095 TAs (45%), and HSGs 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 and 2020. The median follow-up was 15 months (interquartile range, 6-35 months). At 5 years, BESGs had significantly lower freedom from TA instability (78% ± 4% vs 88% ± 1% vs 96% ± 2%; log-rank P =.010), freedom from TA endoleaks (87% ± 3% vs 97% ± 1% vs 99% ± 1%; log-rank P <.001), and freedom from TA reintervention (83% ± 4% vs 95% ± 1% vs 99% ± 2%; log-rank P <.001) compared with 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 BESGs compared with DBs targeted by SESGs and HSGs (83% ± 6% vs 98% ± 1% vs 100%; log-rank P <.001; and 70% ± 10% vs 92% ± 1% vs 96% ± 4%; log-rank P =.022). For mesenteric arteries, DBs targeted by BESGs had lower freedom from TA instability, endoleak, and reintervention than SESGs or HSGs. 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: hazard ratio [HR], 0.97; 95% confidence interval [CI], 0.94-0.99), stent diameter (+1 mm: HR, 0.67; 95% CI, 0.57-0.80), and BESG (HR, 1.8; 95% CI, 1.1-2.9). Conclusions: DBs incorporated using BESGs had lower freedom from TA instability, TA endoleak, and TA reintervention compared with 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.
KW - Balloon-expandable stent grafts
KW - Branch construction
KW - Bridging stent
KW - Complex abdominal aortic aneurysm
KW - Directional branches
KW - Fenestrated-branched endovascular repair
KW - Self-expandable stent grafts
KW - Thoracoabdominal aortic aneurysm
UR - http://www.scopus.com/inward/record.url?scp=85153204656&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85153204656&partnerID=8YFLogxK
U2 - 10.1016/j.jvs.2023.03.025
DO - 10.1016/j.jvs.2023.03.025
M3 - Article
C2 - 36948277
AN - SCOPUS:85153204656
SN - 0741-5214
VL - 78
SP - 10-28.e3
JO - Journal of vascular surgery
JF - Journal of vascular surgery
IS - 1
ER -