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Background: The Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) reconstruction is an endovascular technique, developed to reconstruct the aortic bifurcation in the most optimal anatomical and physiological manner. Short-term data were promising, but long-term data are still lacking. The objective was to report the long-term outcomes of CERAB for extensive aorto-iliac occlusive disease and to identify predictors for loss of primary patency. Methods: Consecutive electively treated patients with CERAB for aorto-iliac occlusive disease in a single hospital were identified and analyzed. Baseline and procedural data and follow-up were collected at 6-weeks, 6 months, 12 months, and annually thereafter. Technical success, procedural, and 30-day complications were evaluated, as well as overall survival. Patency and freedom from target lesion revascularization rates were analyzed using Kaplan Meier curves. Uni- and multivariate analysis were performed to identify possible predictors of failure. Results: One hundred and sixty patients were included (79 male). Indication for treatment was intermittent claudication for 121 patients (75.6%) and 133 patients (83.1%) had a TASC-II D lesion. Technical success was obtained in 95.6% of patients and the 30-day mortality rate was 1.3%. The 5-year primary, primary-assisted, and secondary patency rates were 77.5%, 88.1%, and 95.0%, respectively, with a freedom-from clinically driven target lesion revascularization (CD-TLR) rate of 84.4%. The strongest predictor of loss of primary patency of CERAB was a previous aorto-iliac intervention (odds ratio [OR]=5.36 (95% confidence interval [CI]: 1.30; 22.07), p=0.020). In patients not previously treated in the aorto-iliac tract, 5-year primary, primary assisted, and secondary patency rates were 85.1%, 94.4%, and 96.9%, respectively. At 5-year follow-up, an improved Rutherford was found in 97.9% of patients and the freedom from major amputation rate was 100%. Conclusion: The CERAB technique is related to good long-term outcomes, particularly in primary cases. In patients that had prior treatment for aorto-iliac occlusive disease, there were more reinterventions and therefore surveillance should likely be more intense. Clinical Impact: The Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) reconstruction was designed to improve outcomes of endovascular treatment of extensive aorto-iliac occlusive disease. At 5-year follow-up clinical improvement was found in 97.9% of patients without major amputations. The 5-year overall primary, primary-assisted, and secondary patency rates were 77.5%, 88.1%, and 95.0%, respectively, with a freedom-from clinically driven target lesion revascularization rate of 84.4%. Significantly better patency rates were observed for patients that were never treated before in the target area. The data implicate that CERAB are a valid treatment option for patients with extensive aorto-iliac occlusive disease. For patients previously treated in the target area, other treatment options might be considered, or more intensive follow-up surveillance is warranted. [ABSTRACT FROM AUTHOR]

Objective: To study the influence of diabetes mellitus (DM) and metformin treatment on aneurysm sac remodeling after endovascular aneurysm repair (EVAR). Methods: A retrospective single-center cohort analysis was conducted on consecutive patients who underwent elective EVAR for an infrarenal abdominal aortic aneurysm (AAA) between January 2011 and December 2021. Differences between study groups were analyzed and Kaplan–Meier analysis were employed to describe overall and reintervention-free survival. Cox regression analysis was performed to identify predictors of sac shrinkage. Results: A total of 529 patients were included: 74 (14.0%) had DM and metformin treatment, 26 (4.9%) had DM without metformin treatment, and 429 (81.1%) did not have DM. At one-year follow-up, diabetic patients showed significantly less sac shrinkage compared to non-diabetic patients (40.0% vs. 52.0%; p = 0.038), with a trend toward more stable sac behavior in diabetic patients (52% vs. 42%; p = 0.055). At last follow-up, sac shrinkage was significantly less in diabetic patients on metformin treatment compared to non-diabetics (48.6% vs. 59.9%; p = 0.047). No differences in sac shrinkage were observed between diabetics with and without metformin treatment. The presence of endoleak was significantly higher in groups showing stable sac behavior and growth. Through nine-year follow-up, overall survival was significantly less in diabetic patients compared to non-diabetic ones (23.5% vs. 37.5%; p < 0.001). Conclusions: This study showed a negative impact of diabetes mellitus and metformin treatment on sac shrinkage following EVAR. The presence of any type of endoleak was associated with reduced sac shrinkage at both time points. Overall survival was significantly lower in diabetic patients compared to non-diabetic patients. [ABSTRACT FROM AUTHOR]

Purpose: 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. Methods: 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. Results: 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. Conclusions: 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. [ABSTRACT FROM AUTHOR]

Purpose: To analyze sac evolution patterns in matched patients with hostile neck anatomy (HNA) treated with standard endovascular aneurysm repair (sEVAR) and endosutured aneurysm repair (ESAR). Methods: Observational retrospective study using prospectively collected data between June 2010 and December 2019. ESAR group data were extracted from the primary arm of the PERU registry with an assigned identifier (NCT04100499) at 8 centers and those from the sEVAR came from 4 centers. Suitability for inclusion required: no proximal endograft adjuncts (besides EndoAnchor use), ≤15 mm neck length and minimum of 12-months follow-up imaging. Bubble-shaped neck (noncylindrical short neck with discontinuous seal) aspect was analyzed. Both groups were analyzed using propensity score matching (PSM) for aortic neck length, width, angulation, and device fixation type. Main outcome assessed was sac evolution patterns (sac expansion and regression were defined as >5mm increase or decrease, of the maximum sac diameter respectively; all AAAs within this ±5 mm range in diameter change were considered stable) and secondary outcomes were type-Ia endoleaks; other endoleaks and mortality. A power analysis calculation >80% was confirmed for sac regression evaluation. Results: After exclusions, PSM resulted in 96 ESAR and 96 sEVAR patients. Mean imaging follow-up (months) was 44.4±21.3 versus 43.0±19.6 (p=0.643), respectively. The overall number of patients achieving sac regression was higher in the ESAR group (n =57, 59.4% vs n =31, 32.3%; p<0.001) and the cumulative sac regression achieved at 5 years was 65% versus 38% (p=0.003) in favor of the ESAR group. There were no statistically significant differences in type-Ia endoleak and/or other endoleaks. Univariate analysis for sac regression patients in the sEVAR and ESAR group individually showed the bubble-shape neck as a predictor of sac regression failure. There were no statistical differences in overall and aneurysm-related mortality. Conclusion: Endosutured aneurysm repair provided improved rates of sac regression for patients with AAA and HNA when compared with sEVAR at midterm and up to 5 years, despite similar rates of type-Ia endoleaks, and the need to consider some important limitations. The presence of bubble-shaped neck was a predictor of sac regression failure for both groups equally. Clinical Impact: The use of EndoAnchors aids and improves EVAR treatment in hostile neck anatomies by an increased rate of sac regression when compared to EVAR treatment alone in up to 5 year analysis. Moreover, a trend to reduced number of type Ia endoleaks is also achieved, although not significant in the present study. This data, adds to current and growing evidence on the usefulness of EndoAnchors for AAA endovascular treatment. [ABSTRACT FROM AUTHOR]

Purpose: Thromboembolic events (TE), including limb graft occlusion (LGO) and distal limb embolization (DLE), are common complications after endovascular aneurysm repair (EVAR). The aim of this study was to find predictors for TE in patients treated with the Anaconda stent-graft for infrarenal aneurysms. Materials and Methods: Geometrical and anatomical variables were retrospectively analyzed in a consecutive Anaconda cohort. Pre- and postoperative CT scans were used to derive geometrical parameters length, curvature, torsion, and tortuosity index (TI) from the center lumen lines (CLLs). Limb characteristics, pre-to-post EVAR and mid-term-follow-up changes in the parameters were evaluated for their predictive value for TE. Results: Eighty-four patients (mean age 74±8.3 years, 74 men) were enrolled. The risk of TE was lowered with pre-to-post implant decreasing TI (steps of 0.05: OR: 1.30, 95% CI: 1.01-1.66, p=0.04), pre-to-post implant decreasing mean curvature (OR: 1.08, 95% CI: 1.01-1.16, p=0.03), and a larger degree of circumferential common iliac artery (CIA) calcification (OR: 0.98, 95% CI: 0.97-1.00, p=0.03). The only LGO predictor was the caudal relocation of maximal curvature after EVAR (OR: 1.01, 95% CI: 1.00-1.01, p=0.04). Preventors of DLE were CIA diameter (OR: 0.87, 95% CI: 0.76-0.99, p=0.04), circumferential CIA calcification (OR: 0.97, 95% CI: 0.95-1.00, p=0.03), mean and maximal curvature of the preoperative aortoiliac trajectory (OR: 0.86, 95% CI: 0.79-0.94, p<0.01 and OR: 0.97, 95% CI: 0.95-1.00, p=0.03, respectively) and pre-to-postoperative decrease in mean curvature (OR: 1.11, 95% CI: 1.02-1.21, p=0.02). Midterm TE predictors were length (OR: 0.95, 95% CI: 0.89-1.01, p=0.08) and torsion maximum location (OR: 1.01, 95% CI: 0.99-1.01, p=0.10). Conclusion: The present study confirms that treatment of infrarenal AAA with an Anaconda stent-graft is related to a relatively high TE rate which decreases with a pre-to-postoperative reduction in curvature and TI, and a larger degree of circumferential CIA calcification. In other words, more aortoiliac straightening and more circumferential CIA calcification may prevent TE development after EVAR with this stent-graft. [ABSTRACT FROM AUTHOR]

Purpose: Contemporary diagnostic modalities, including contrast-enhanced computed tomography (CTA) and duplex ultrasound, have been insufficiently able to predict endograft thrombosis. This study introduces an implementation of image-based computational fluid dynamics (CFD), by exemplification with 4 patients treated with an endograft for occlusive disease of the superficial femoral artery (SFA). The potential of personalized CFD for predicting endograft thrombosis is investigated. Materials and Methods: Four patients treated with endografts for an occluded SFA were retrospectively included. CFD simulations, based on CTA and duplex ultrasound, were compared for patients with and without endograft thrombosis to investigate potential flow-related causes of endograft thrombosis. Time-averaged wall shear stress (TAWSS) was computed, which highlights areas of prolonged residence times of coagulation factors in the graft. Results: CFD simulations demonstrated normal TAWSS (>0.4 Pa) in the SFA for cases 1 and 2, but low levels of TAWSS (<0.4 Pa) in cases 3 and 4, respectively. Primary patency was achieved in cases 1 and 2 for over 2 year follow-up. Cases 3 and 4 were complicated by recurrent endograft thrombosis. Conclusion: The presence of a low TAWSS was associated with recurrent endograft thrombosis in subjects with otherwise normal anatomic and ultrasound assessment and a good distal run-off. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of the study was to provide a consensus definition of the infrarenal sealing zone and develop an algorithm to determine when and if adjunctive procedure(s) or reintervention should be considered in managing patients undergoing endovascular aortic repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA). Methods: A European Advisory Board (AB), made up of 11 vascular surgeons with expertise in EVAR for AAA, was assembled to share their opinion regarding the definition of preoperative and postoperative infrarenal sealing zone. Information on their current clinical practice and level of agreement on proposed reintervention paths was used to develop an algorithm. The process included 2 virtual meetings and 2 rounds of online surveys completed by the AB (Delphi method). Consensus was defined as reached when ≥ 8 of 11 (73%) respondents agreed or were neutral. Results: The AB reached complete consensus on definitions and measurement of the pre-EVAR target anticipated sealing zone (TASZ) and the post-EVAR real achieved sealing zone (RASZ), namely, the shortest length between the proximal and distal reference points as defined by the AB, in case of patients with challenging anatomies. Also, agreement was achieved on a list of 4 anatomic parameters and 3 prosthesis-/procedure-related parameters, considered to have the most significant impact on preoperative and postoperative sealing zones. Furthermore, the agreement was reached that in the presence of visible neck-related complications, both adjunctive procedure(s) and reintervention should be contemplated (100% consensus). In addition, adjunctive procedure(s) or reintervention can be considered in the following cases (% consensus): insufficient sealing zone on completion imaging (91%) or on the first postoperative computed tomography (CT) scan (91%), suboptimal sealing zone on completion imaging (73%) or postoperative CT scan (82%), and negative evolution of the actual sealing zone over time (91%), even in the absence of visible complications. Conclusions: AB members agreed on definitions of the pre- and post-EVAR infrarenal sealing zone, as well as factors of influence. Furthermore, a clinical decision algorithm was proposed to determine the timing and necessity of adjunctive procedure(s) and reinterventions. [ABSTRACT FROM AUTHOR]

Objective: To identify and analyze the published in vitro benchtop experiments for the assessment of endovascular techniques used for the treatment of juxtarenal abdominal aortic aneurysms (jAAAs). Data sources: Scopus, PubMed, and Web of Science. Review methods: A systematic literature search was carried out throughout March 2021 following PRISMA guidelines. Two investigators independently performed title and abstract screening to reveal all benchtop testing evaluating the endovascular treatment of jAAA. Results: A total of 19 studies were included, 8 evaluating fenestrated (FEVAR) and 11 parallel grafts (PGs). FEVAR studies used different custom testing apparatus (n=7) or 3D-printed models (n=1) to analyze dislodgement and migration resistance, misalignment consequences and causation, and bridging stents' radial force, flareability, fatigue, and fracture resistance. All PG studies used silicone-based models to analyze optimal oversizing, sealing length, gutter behavior, and possible reduction. Test evaluation in FEVAR in vitro testing was based on pullout force analysis (N=5), photo evaluation (n=1), fluoroscopy (n=1), X-rays (n=4), CT analysis (n=3), macro- and microscopic evaluation (n=4), water permeability (n=1), and fatigue simulator testing (n=1), while it was based on CT analysis in all PG studies adding ECG-gate in one study. The most frequently tested devices were Zenit (Cook) (n=7), Endurant (Medtronic) (n=5), and Excluder (Gore) (n=5) as main grafts, and Advanta V12 (n=14) as the bridging device. Conclusions: This systematic review presents a broad analysis of the current in vitro methods evaluating the endovascular treatment of jAAA. Fundamental issues have been benchtop tested in both FEVAR and PGs. The analysis of the included studies allowed to recommend an optimal testing design. In vitro testing is a potential tool to further elucidate points of attention hard to investigate in vivo to finally enhance the endovascular treatment outcomes. Future in vitro studies are needed to evaluate the in vitro performance of all indistinctively used devices in the clinical practice. [ABSTRACT FROM AUTHOR]