Outcomes using inverted iliac limb bifurcate components in fenestrated/branched endografting.
The use of standard bifurcate pieces in fenestrated/branched endovascular aortic repair (F/BEVAR) requires adequate length from the lowest branch or fenestration to the aortic bifurcation. In patients with prior aortic surgery, the aortic bifurcation is often artificially established in a more proximal position, compromising the infrarenal length, which hinders the placement of a standard bifurcate component below the fenestrated/branched component. Short bifurcate bodies using an inverted contralateral limb have been purpose-built to address this challenge. However, reported outcomes for this device remain limited, with specific concerns about the durability of the inverted iliac limb sealing region. We sought to evaluate outcomes of F/BEVAR using an investigational inverted iliac limb bifurcate, manufactured by Cook Medical.
This study was a retrospective review of prospectively maintained data from the US-Aortic Research Consortium from 2005 to 2022. Patients were included if they underwent F/BEVAR for thoracoabdominal or complex abdominal aortic aneurysms. Patients were excluded if they did not have a bifurcate device placed. Patients were then compared based on the use of an inverted iliac limb or standard bifurcate component. The primary outcome for this study was technical success. Secondary outcomes included 30-day mortality, freedom from ischemic leg complications, freedom from type I endoleaks (TIELs), freedom from type II endoleaks (TIIELs), freedom from type III endoleaks (TIIIELs), and graft component separations.
A total of 1944 patients met study criteria with 442 (22.8%) inverted iliac limb bifurcates and 1502 (77.2%) standard bifurcates. Patients who received inverted iliac limbs were more likely to have had prior aortic surgery (63.8% vs 28.5%; P < .001). Patients receiving inverted iliac limbs had longer procedure times (265 minutes; interquartile range [IQR], 201-342 minutes vs 241 minutes; IQR, 186-313 minutes; P < .001), more contrast use (89 mL [IQR, 55-135 mL] vs 109 mL [IQR, 75-156 mL]; P < .001), and higher estimated blood loss (250 mL [IQR, 150-500 mL] vs 250 mL [IQR, 110-400 mL]; P = .042). There were no differences in rates of technical success (97.3% vs 96.1%; P = .310), rates of endoleaks upon completion of the case (18.0% vs 21.4%; P = .123), or 30-day mortality rates (1.8% vs 2.5%; P = .466) between patients receiving inverted iliac limb and standard bifurcated components. There were no differences in cumulative survival, freedom from limb ischemia, freedom from aneurysm rupture, and freedom from TIIIELs over the course of 5 years between patients receiving inverted bifurcates and standard bifurcated components. Patients with inverted iliac limb bifurcate components had decreased freedom from reinterventions, TIELs, and TIIELs. After adjustment for potential confounders, the use of an inverted iliac limb was not associated with reinterventions (hazard ratio,1.044; 95% confidence interval, 0.849-1.285; P = .682). There was a total of 2 component separations (0.1%) of the bifurcate component from the fenestrated/branched component over the study period, both of which occurred in the standard bifurcate components.
The use of investigational inverted iliac limb bifurcate components is a safe option with favorable mid-term outcomes in patients who are not anatomical candidates for standard bifurcate components. Patients undergoing investigational inverted iliac limb bifurcate component implantation had decreased freedom from reinterventions, which likely corresponds with the complexity of repair associated with them.
Khoury MK
，Beck AW
，Farber MA
，Gasper W
，Lee WA
，Oderich G
，Parodi FE
，Schanzer A
，Schneider D
，Sweet M
，Timaran CH
，Eagleton MJ
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Beta Blockers are Associated with Increased Mortality Without a Decrease in Reinterventions After Endovascular Abdominal Aortic Repair (EVAR).
Predictors of sac behavior after endovascular aortic aneurysm repair (EVAR) and the impact of sac behavior on long-term survival are not well known. There are limited multicenter trials studying the impact of beta blockers (BBs) on sac behavior. BBs have consistently failed to show a benefit on abdominal aortic aneurysm sac regression in patients with connective tissue disorders and the general population. This study aims to assess the association between BBs and sac behavior after EVAR.
Patients undergoing EVAR registered in Vascular Quality Initiative (2003-2021) stratified by BB and no BB on discharged after an index procedure were assessed at follow-up of 30 days and 1 year. The primary outcomes included mortality and reintervention at 30 days and 1 year. The causes of reintervention were also studied at the defined time endpoints. Categorical and continuous variables were analyzed separately for association between the 2 groups. A P value of <0.05 was considered statistically significant.
A total of 50,411 patients, stratified by BB (28,866; 57.3%), and no BB (21,545; 42.7%) were studied. Patients with hypertension, diabetes, chronic obstructive pulmonary disease, coronary artery disease, prior history of coronary artery bypass graft or percutaneous coronary intervention, prior angioplasty or stent, lower extremity bypass, carotid surgery, major amputation, and smokers were more likely to be on a BB at the time of discharge (P < 0.05). There was no significant difference in reinterventions when comparing patients with and without BB (P = 0.061). At 30-day follow-up, there was no significant difference between the 2 groups for any cause of reintervention. At 1-year follow-up, patients on BB were less likely to need reintervention for graft occlusion (no BB 18.70%, BB 11.77%, P = 0.002). There was no significant difference in reintervention for all other causes at 1-year follow-up. There was an increase in 30-day (no BB 0.20%, BB 0.33%, P = 0.007) and 1-year mortality (no BB 2.35%, BB 3.19%, P < 0.001) in patients on BBs. A time to event adjusted analysis based on Cox proportional hazard model revealed a 26% higher risk of 1-year mortality for patients on BB (hazard ratio: 1.26 [1.10-1.41] P < 0.001).
Despite theoretical benefits of BBs on aneurysm behavior, review of the largest national vascular surgery database shows that patients on BBs do not have lower incidence of endovascular reinterventions after EVAR while additionally showing a higher mortality in this patient population.
Vicario-Feliciano R
，Zil-E-Ali A
，Aziz F
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Outcomes of fenestrated and branched endovascular aneurysm repair with an inverted contralateral limb.
To report technical success and evaluate clinical outcomes of fenestrated and branched endovascular aortic repair (F/B-EVAR) incorporating a contralateral inverted limb.
Patients who underwent F/B-EVAR with a custom-made bifurcated device containing an inverted limb between January 2010 and September 2023 were retrospectively analyzed. Time-to-event data were analyzed using the Kaplan-Meier method.
A total of 32 patients (26 men; mean age 77±6.2 years) were included in the analysis. Technical success was achieved in 28 patients (87.5%). Two technical failures resulted from misplaced contralateral limbs in patients with previous endovascular aortic repair (EVAR), necessitating one open conversion due to a type 3b endoleak, and one femoro-femoral crossover bypass after occlusion of a misplaced contralateral limb. Additionally, two technical failures were attributed to a type 3c endoleak and a type 1c endoleak, originating from a fenestrated device at the level of the left and right renal artery, respectively. One patient (3.1%) died <30 days post-operatively due to a subdural hemorrhage. Estimated patient survival after 1 and 2 years was 92.7%±5.1%, and 74.3%±10.1%, respectively. No aneurysm-related deaths were observed. During the median follow-up of 13 months, one (3.1%) inverted limb occluded, in addition to the occlusion resulting from a misplaced contralateral limb, and was treated with a femoro-femoral crossover bypass. One target vessel (right renal artery) occluded (0.9%), resulting in a permanent, significantly reduced renal function. Freedom from overall reintervention after 1 and 2 years was 73.5%±8.0% and 68.3%±9.0%, respectively. An additional four patients (12.5%) presented with a type 3c endoleak during follow-up scans, three of which originated from fenestrations at the level of the renal stents. There were no junctional problems between the inverted limb device and the main endograft, and no significant correlation was found between the one-sealing-stent inverted limb device design and the onset of type 3 endoleak (log-rank P=.064).
F/B-EVAR incorporating an inverted limb can be a viable endovascular option to manage complex aneurysms with a short renal artery to bifurcation distance. However, using the inverted limb presents a notable technical challenge and could be associated with a higher need for reintervention. Carefully confirming correct cannulation of the inverted limb is warranted.
Huistra EWM
，Tielliu IFJ
，de Vries JPM
，Zeebregts CJ
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ResearchGate
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