Low-Profile Minos (TM) Stent Graft System for Endovascular Abdominal Aorta Aneurysm Repair-Early and Late Outcomes in Elective and Emergent Situations.
The aim of the study was to present the results of a novel abdominal stent graft for patients with abdominal aortic aneurysm (AAA), through 2-year follow-up.
A single-center retrospective review with prospectively collected data was performed to assess the safety and effectiveness of the Minos Abdominal stent device for treating AAAs. We estimated technical success rate, in-hospital and 30-day mortality, and mortality at the end of follow-up as well as complication and reintervention rate in our study cohort. Follow-up imaging assessments consisted of computed tomography angiography at 1 and 6 months and yearly thereafter.
A total of 52 patients (92% males; mean age, 74 ± 6 years) were enrolled with Minos Abdominal stent device from July 2020 until September 2023. Thirty one (60%) patients were asymptomatic while 21 (40%) were symptomatic. The technical success of the endovascular aortic repair was 95% (49 of 52 patients). In 5% (3 of 52) of the cases, cannulation of the contralateral limb was unsuccessful and was converted to aorto-uni-iliac graft. Two (4%) aortic related death were recorded during the 30-day period. The major adverse event rate was 3.8%. The overall mean follow-up was 30 ± 6 months; no aorta-related deaths or graft related complications were observed. Sac shrinkage (>5 mm) has been observed in 70% of patients.
Minos endoprosthesis seems to be safe, effective, and durable for treating AAA either in elective or emergent situations.
Karaolanis GI
，Hadjis D
，Karakosta A
，Bekas N
，Tatsis V
，Tzimas P
，Mitsis M
，Peroulis M
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Impact of Significant Sac Shrinkage on Endograft Tortuosity at 5 Years Postendovascular Aortic Aneurysm Repair: A Retrospective Analysis.
Significant sac shrinkage after endovascular aortic aneurysm repair (EVAR) is generally considered a positive outcome indicative of durable clinical success. However, its impact on endograft configuration is rarely addressed. Sac remodeling and volume loss due to shrinkage can potentially cause deformation of endograft components, resulting in limb angulation and compression. We investigated the hypothesis that significant sac shrinkage could affect endograft tortuosity at 5 years post-EVAR.
We retrospectively reviewed patients who underwent elective EVAR for infrarenal abdominal aortic aneurysm between June 2007 and December 2018. Patients with early postoperative and 5-year follow-up computed tomography images were included. Patients treated with modular bifurcated endografts (Zenith, Endurant, Excluder, and Incraft) were analyzed. The "shrinkage" group comprised patients with >10 mm diameter reduction, while the "stable" group had ± 5 mm diameter change at 5 years. Tortuosity index (TI) was calculated as the ratio of centerline distance to straight-line distance between proximal and distal endograft edges. The association between sac shrinkage and ≥5% increase of TI (≥5%ΔTI) was analyzed for both ipsilateral and contralateral sides.
Of 136 patients enrolled, 80 were in the shrinkage group and 56 in the stable group. On the ipsilateral side, ≥5%ΔTI was observed in 24 cases (17.6%). The patients with ipsilateral ≥5%ΔTI had significantly shorter median neck lengths (22 mm vs. 30 mm, P = 0.030). Sac shrinkage ≥15 mm was negatively associated with ≥5%ΔTI compared to stable sac (P = 0.027). Logistic regression showing sac shrinkage ≥15 mm had a significant negative correlation with ≥5%ΔTI (P = 0.025, hazard ratio [95% confidence interval]: 0.218 [0.057-0.824]). On the contralateral side, ≥5%ΔTI (19 cases, 14.0%) was associated with shorter neck length but not with sac shrinkage. In the shrinkage group, cross-leg positioning resulted in a significant increase in ipsilateral TI at 5 years compared to straight positioning (median ΔTI: 1.8% vs. 0.0%, P = 0.013). No reinterventions for leg-related events were necessary during the 5-year follow-up period.
Contrary to our initial hypothesis, significant sac shrinkage does not adversely affect endograft configuration and may help stabilize tortuosity on the ipsilateral side. However, in patients with crossed-leg configuration, continued vigilant observation may be warranted even after achieving sac shrinkage, as it could exacerbate tortuosity. Shorter neck length was associated with increased tortuosity on both sides. Further research is needed to confirm these findings and consider potential confounding factors, including the impact of different endograft designs.
Sugimoto M
，Osawa T
，Lee C
，Ikeda S
，Kawai Y
，Niimi K
，Banno H
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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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