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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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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Mid-Term Outcomes of the Iliac Branch Endoprosthesis with Standardized Combinations of Bridging Stent-Grafts for Endovascular Treatment of Aortoiliac Disease with or Without Co-existing Hypogastric Aneurysms (The HYPROTECT Study).
To evaluate retrospectively the 2-year outcomes of the Gore Excluder Iliac Branch Endoprosthesis (IBE) in patients with and without coexisting hypogastric artery (HA) aneurysms in a large contemporary multicentric European experience using dedicated bridging devices.
The study included all consecutive patients treated at participating institutions with the Gore Excluder IBE device who received a covered stent (i.e., stent-graft) from the same manufacturer. Technical success was defined as deployment of endografts with complete exclusion of the aneurysm(s), patency of target vessels, and absence of type 1 and 3 endoleak. Assessment of follow-up outcomes included freedom from HA branch instability defined as the composite cumulative endpoint of any HA branch-related complication.
A total of 437 patients were included for analysis from 22 European vascular surgery centers. Patients were categorized into two subgroups: subgroup A (n = 269) if they did not have concomitant hypogastric aneurysms, otherwise they were categorized into subgroup B (n = 168). Finally, 78 (18%) had bilateral IBE with a total of 515 IBE included in the study. Balloon expandable stents were deployed in 19 (6.3%) subgroup A patients compared with 46 (21.7%,) in subgroup B, p < .001. The two-year estimate for freedom of HA branch instability was significantly higher for patients in group A as compared with patients in group B (94% vs. 90%, p = .045). At univariate regression, the number of stent-grafts used was associated with higher risk of iliac branch instability (p = .021), while in multivariate regression for the use of more than 2 bridging stent-grafts the risk of instability increased by 2.35 times.
This large contemporary European multicentric experience with the use of the Gore Excluder IBE in patients with or without associated HA aneurysms shows satisfactory mid-term outcomes when the device is used in conjunction with both self-expandable and balloon-expanding stent-grafts from the same manufacturer. Although primary patency of the iliac branch was as high as 90%, caution and strict follow-up must be exercised when multiple bridging stent-grafts are used over longer distances.
D'Oria M
，Pitoulias G
，Lepidi S
，Bellosta R
，Reijnen MMPJ
，Simonte G
，Pratesi G
，Usai MV
，Gargiulo M
，Dias N
，Ferrer C
，Benedetto F
，Veraldi GF
，Duppers P
，Noya JF
，Wiersema A
，Spanos K
，Troisi N
，Moniaci D
，Antonello M
，Trimarchi S
，de Vries JP
，Abisi S
，Pitoulias A
，Taneva GT
，Donas KP
，HYPROTECT Study Group
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