Partial renal coverage in endovascular aneurysm repair causes unfavorable renal flow patterns in an infrarenal aneurysm model.

OBJECTIVE: To achieve an optimal sealing zone during endovascular aneurysm repair, the intended positioning of the proximal end of the endograft fabric should be as close as possible to the most caudal edge of the renal arteries. Some endografts exhibit a small offset between the radiopaque markers and the proximal fabric edge. Unintended partial renal artery coverage may thus occur. This study investigated the consequences of partial coverage on renal flow patterns and wall shear stress (WSS). METHODS: In vitro models of an abdominal aortic aneurysm were used to visualize pulsatile flow using two-dimensional particle image velocimetry under physiologic resting conditions. One model served as control and two models were stented with an Endurant endograft (Medtronic Inc, Minneapolis, Minn), one without and one with partial renal artery coverage with 1.3 mm of stent fabric extending beyond the marker (16% area coverage). The magnitude and oscillation of WSS, relative residence time, and backflow in the renal artery were analyzed. RESULTS: In both stented models, a region along the caudal renal artery wall presented with low and oscillating WSS, not present in the control model. A region with very low WSS (<0.1 Pa) was present in the model with partial coverage over a length of 7 mm compared with a length of 2 mm in the model without renal coverage. Average renal backflow area percentage in the renal artery incrementally increased from control (0.9%) to the stented model without (6.4%) and with renal coverage (18.8%). CONCLUSIONS: In this flow model, partial renal coverage after endovascular aneurysm repair causes low and marked oscillations in WSS, potentially promoting atherosclerosis and subsequent renal artery stenosis. Awareness of the device-dependent offset between the fabric edge and the radiopaque markers is therefore important in endovascular practice.

Two-Year Outcomes of the Nellix EndoVascular Aneurysm Sealing System for Treatment of Abdominal Aortic Aneurysms.

PURPOSE: To analyze the 2-year outcomes of endovascular aneurysm sealing (EVAS) according to 2 versions of the instructions for use (IFU). METHODS: A retrospective study was conducted involving 355 consecutive patients treated with the first-generation EVAS device from April 2013 to December 31, 2015, at 3 high-volume centers. Out of 355 patients treated with EVAS, 264 were elective asymptomatic infrarenal EVAS procedures suitable for analysis. In this cohort, 168 (63.3%) patients were treated within the IFU 2013 criteria; of these 48 (18.2%) were in compliance with the revised IFU 2016 version. RESULTS: Overall technical success was 98.2% (165/168) in the IFU 2013 group and 97.9% (47/48) in the IFU 2016 subgroup (p=0.428). The 2-year freedom from reintervention estimates were 89.7% (IFU 2013) and 95.7% (IFU 2016), with significantly more reinterventions in the first 45 cases (p=0.005). The stenosis/occlusion estimates were 6.5% (IFU 2013) and 4.2% (IFU 2016; p=0.705). Nine (5.4%) endoleaks (8 type Ia and 1 type Ib) were observed within the IFU 2013 cohort; 3 (2.1%) were in the IFU 2016 subgroup (p=0.583). Migration ≥10 mm or ≥5 mm requiring intervention was reported in 12 (7.1%) patients in the IFU 2013 cohort but none within the IFU 2016 subgroup. Ten (6.0%) patients demonstrated aneurysm growth in the IFU 2013 cohort, of which 2 (4.2%) were in the IFU 2016 subgroup. Overall survival and freedom from aneurysm-related death estimates at 2 years were 90.9% and 97.6% in the IFU 2013 cohort (IFU 2016: 95.5% and 100.0%). The prevalence of complications seemed lower within IFU 2016 without significant differences. CONCLUSION: This study shows acceptable 2-year results of EVAS used within the IFU, without significant differences between the 2 IFU versions, though longer follow-up is indicated. The refined IFU significantly reduced the applicability of the technique.

Anatomical Predictors of Endoleaks or Migration After Endovascular Aneurysm Sealing.

PURPOSE: To identify preoperative anatomical aortic characteristics that predict seal failures after endovascular aneurysm sealing (EVAS) and compare the incidence of events experienced by patients treated within vs outside the instructions for use (IFU). METHODS: Of 355 patients treated with the Nellix EndoVascular Aneurysm Sealing System (generation 3SQ+) at 3 high-volume centers from March 2013 to December 2015, 94 patients were excluded, leaving 261 patients (mean age 76±8 years; 229 men) for regression analysis. Of these, 83 (31.8%) suffered one or more of the following events: distal migration ⩾5 mm of one or both stent frames, any endoleak, and/or aneurysm growth >5 mm. Anatomical characteristics were determined on preoperative computed tomography (CT) scans. Patients were divided into 3 groups: treated within the original IFU (n=166), outside the original IFU (n=95), and within the 2016 revised IFU (n=46). Categorical data are presented as the median (interquartile range Q1, Q3). RESULTS: Neck diameter was significantly larger in the any-event cohort vs the control cohort [23.7 mm (21.7, 26.3) vs 23.0 mm (20.9, 25.2) mm, p=0.022]. Neck length was significantly shorter in the any-event cohort [15.0 mm (10.0, 22.5) vs 19.0 mm (10.0, 21.8), p=0.006]. Maximum abdominal aortic aneurysm (AAA) diameter and the ratio between the maximum AAA diameter and lumen diameter in the any-event group were significantly larger than the control group (p=0.041 and p=0.002, respectively). Regression analysis showed aortic neck diameter (p=0.006), neck length (p=0.001), and the diameter ratio (p=0.011) as significant predictors of any event. In the comparison of events to IFU status, 52 (31.3%) of 166 patients in the inside the original IFU group suffered an event compared to 13 (28.3%) of 46 patients inside the 2016 IFU group (p=0.690). CONCLUSION: Large neck diameter, short aortic neck length, and the ratio between the maximum AAA and lumen diameters are preoperative anatomical predictors of the occurrence of migration (⩾5 mm), any endoleak, and/or aneurysm growth (>5 mm) after EVAS. Even under the refined 2016 IFU, more than a quarter of patients suffered from an event. Improvements in the device seem to be necessary before this technique can be implemented on a large scale in endovascular AAA repair.

Evolution of Computed Tomography Imaging the First Year after Endovascular Sealing of Infrarenal Aortic Aneurysms Using the Nellix Device.

BACKGROUND: The Nellix endovascular aneurysm sealing (EVAS) system is an alternative endovascular treatment option for infrarenal aortic aneurysms (AAAs), with a unique appearance on computed tomography angiography (CTA). Normal evolution of post-EVAS CTA appearance follow-up is still largely unknown and important to timely detect eventual complications. The objective is to assess the normal appearance of CTA images 30 days and 1 year after EVAS in 50 consecutive patients. METHODS: Fifty patients treated with Nellix EVAS for an infrarenal AAA were included from 3 hospitals. Using dedicated software, a total of 150 CTA scans were analyzed by predetermined variables per anatomical segment. RESULTS: Thirty days post-EVAS, there was a slight, but not statistically significant, increase in AAA diameter that returned to the preoperative value after 1 year. A shift in total aortic volume distribution was observed without changing aortic diameter, including a trend toward a decreased thrombus volume (85.6 ± 49.1 mL and 78.8 ± 35.5 mL at 30 days and 1 year, respectively, P < 0.242) and a slight, but statistically significant, increase in polymer volume (68.2 ± 34.1 mL and 71.9 ± 35.2 mL at 30 days and 1 year, respectively, P < 0.001). The ß-angle (P = 0.06) and iliac artery angulation (P < 0.001) decreased after implant. The latter returned to its original state after 1 year, whereas the neck straightening remained. Over time, there was a significant decrease in radiodensity in the middle of the polymer-filled endobags with an increase at its edges (P < 0.05). Thrombus radiodensity significantly increased over the first year (P < 0.05). Diameters of the infrarenal neck and common iliac arteries remained unchanged, no endoleaks were observed, and the position of the device was stable. CONCLUSIONS: Change of CT appearance after EVAS is unique, and as such, the judgment of these images requires experience. The appearance of the endobags in respect to volume and radiodensity differ from classic EVAR. Normal changes over time are observed in aortoiliac angulation, volumes, and radiodensities.

Subtraction computed tomography imaging to detect endoleaks after endovascular aneurysm sealing with sac anchoring.

Background Early detection of small type I endoleaks after endovascular aneurysm sealing is mandatory because they can rapidly progress and lead to severe complications. Recognition of endoleaks can be challenging due to the appearances on computed tomography unique to endovascular aneurysm sealing. We aimed to validate the accuracy and added value of subtraction computed tomography imaging using a post-processing software algorithm to improve detection of endovascular aneurysm sealing-associated endoleaks on postoperative surveillance imaging. Methods The computed tomography scans of 17 patients (16 males; median age: 78, range: 72-84) who underwent a post-endovascular aneurysm sealing computed tomography including both non-contrast and arterial phase series were used to validate the post processing software algorithm. Subtraction images are produced after segmentation and alignment. Initial alignment of the stent segmentations is automatically performed by registering the geometric centers of the 3D coordinates of both computed tomography series. Accurate alignment is then performed by translation with an iterative closest point algorithm. Accuracy of alignment was determined by calculating the root mean square error between matched 3D coordinates of stent segmentations. Results The median root mean square error after initial center of gravity alignment was 0.62 mm (IQR: 0.55-0.80 mm), which improved to 0.53 mm (IQR: 0.47-0.69 mm) after the ICP alignment. Visual inspection showed good alignment and no manual adjustment was necessary. Conclusions The possible merit of subtraction computed tomography imaging for the detection of small endoleaks during surveillance after endovascular aneurysm sealing was illustrated. Alignment of different computed tomography phases using a software algorithm was very accurate. Further studies are needed to establish the exact role of this technique during surveillance after endovascular aneurysm sealing compared to less invasive techniques like contrast-enhanced ultrasound.

Benchtop quantification of gutter formation and compression of chimney stent grafts in relation to renal flow in chimney endovascular aneurysm repair and endovascular aneurysm sealing configurations.

BACKGROUND: The chimney technique has been successfully used to treat juxtarenal aortic aneurysms. The two main issues with this technique are gutter formation and chimney graft (CG) compression, which induce a risk for type Ia endoleaks and stent thrombosis, respectively. In this benchtop study, the geometry and renal artery flow of chimney endovascular aneurysm repair configurations were compared with chimney configurations with endovascular aneurysm sealing (ch-EVAS). METHODS: Seven flow phantoms were constructed, including one control and six chimney endovascular aneurysm repairs (Endurant [Medtronic Inc, Minneapolis, Minn] and AFX [Endologix Inc, Irvine, Calif]) or ch-EVAS (Nellix, Endologix) configurations, combined with either balloon-expandable or self-expanding CGs with an intended higher positioning of the right CG in comparison to the left CG. Geometric analysis was based on measurements at three-dimensional computed tomography angiography and included gutter volume and CG compression, quantified by the ratio between maximal and minimal diameter (D-ratio). In addition, renal artery flow was studied in a physiologic flow model and compared with the control. RESULTS: The average gutter volume was 343.5 ± 142.0 mm3, with the lowest gutter volume in the EVAS-Viabahn (W. L. Gore & Associates, Flagstaff, Ariz) combination (102.6 mm3) and the largest in the AFX-Advanta V12 (Atrium Medical Corporation, Hudson, NH) configuration (559.6 mm3). The maximum D-ratio was larger in self-expanding CGs than in balloon-expandable CGs in all configurations (2.02 ± 0.34 vs 1.39 ± 0.13). The CG compression had minimal influence on renal volumetric flow (right, 390.7 ± 29.4 mL/min vs 455.1 mL/min; left, 423.9 ± 28.3 mL/min vs 410.0 mL/min in the control). CONCLUSIONS: This study showed that gutter volume was lowest in ch-EVAS in combination with a Viabahn CG. CG compression was lower in configurations with the Advanta V12 than with Viabahn. Renal flow is unrestricted by CG compression.

Hemodynamic comparison of stent configurations used for aortoiliac occlusive disease.

BACKGROUND: Endovascular treatment of aortoiliac occlusive disease entails the use of multiple stents to reconstruct the aortic bifurcation. Different configurations have been applied and geometric variations exist, as quantified in previous work. Other studies concluded that specific stent geometry seems to affect patency. These variations may affect local flow patterns, resulting in different wall shear stress (WSS) and oscillating shear index (OSI). The aim of this study was to compare the effect of different stent configurations on flow perturbations (recirculation and fluid stasis), WSS, and OSI in an in vitro setup. METHODS: Three different stent configurations were deployed in transparent silicone models: bare-metal kissing (BMK) stents, covered kissing (CK) stents, and the covered endovascular reconstruction of the aortic bifurcation (CERAB) configuration. Transparent covered stents were created with polyurethane to enable visualization. Models were placed in a circulation setup under physiologic flow conditions. Time-resolved laser particle image velocimetry techniques were used to quantify the flow, and WSS and OSI were calculated. RESULTS: The BMK configuration did not show flow disturbances at the inflow section, and WSS values were similar to the control. An area of persistent low flow was observed throughout the cardiac cycle in the area between the anatomic bifurcation and neobifurcation. The CK model showed recirculation zones near the inflow area of the stents with a resulting low average WSS value and high OSI. The proximal inflow of the CERAB configuration did not show flow disturbances, and WSS values were comparable to control. Near the inflow of the limbs, a minor zone of recirculation was observed without changes in WSS values. Flow, WSS, and OSI on the lateral wall of the proximal iliac artery were undisturbed in all models. CONCLUSIONS: The studied aortoiliac stent configurations have distinct locations where flow disturbances occur, and these are related to the radial mismatch. The CERAB configuration is the most unimpaired physiologic reconstruction, whereas BMK and CK stents have their typical zones of flow recirculation.

Classification of gutter type in parallel stenting during endovascular aortic aneurysm repair.

OBJECTIVE: Gutters can be described as the loss of continuous apposition between the main body of the endograft, the chimney stent graft, and the aortic wall. Gutters have been associated with increased risk of type IA endoleaks and are considered to be the Achilles' heel of chimney endovascular aneurysm repair (ch-EVAR). However, there is no classification yet to classify and quantify gutter types after ch-EVAR. METHODS: Different gutter types can be distinguished by their morphologic appearance in two- and three-dimensional views and reconstructed slices perpendicular to the center lumen line. RESULTS: Three main categories are defined by (1) the most proximal beginning of the gutter, (2) the length of gutter alongside the endograft, and (3) its distal end. Type A gutters originate at the proximal fabric of an endograft, type B gutters originate as loss of apposition of the chimney stent graft in the branch vessel, and type C gutters start below the fabric of the endograft. To determine eventual changes of gutter size during follow-up computed tomography angiograms (CTAs), measurements may be performed with dedicated software on the follow-up CTA scan to assess the extent of gutters over the aortic circumference, ranging from 0° to 360° of freedom, together with the maximum gap between the endograft material and the aortic wall as it appears on reconstructed axial CTA scan slices. CONCLUSIONS: The proposed gutter classification enables a uniform nomenclature in the current ch-EVAR literature and a more accurate risk assessment of gutter-associated endoleaks. Moreover, it allows monitoring of eventual progression of gutter size during follow-up.

Flow and wall shear stress characterization after endovascular aneurysm repair and endovascular aneurysm sealing in an infrarenal aneurysm model.

BACKGROUND: Endovascular aneurysm repair (EVAR) with a modular endograft has become the preferred treatment for abdominal aortic aneurysms. A novel concept is endovascular aneurysm sealing (EVAS), consisting of dual endoframes surrounded by polymer-filled endobags. This dual-lumen configuration is different from a bifurcation with a tapered trajectory of the flow lumen into the two limbs and may induce unfavorable flow conditions. These include low and oscillatory wall shear stress (WSS), linked to atherosclerosis, and high shear rates that may result in thrombosis. An in vitro study was performed to assess the impact of EVAR and EVAS on flow patterns and WSS. METHODS: Four abdominal aortic aneurysm phantoms were constructed, including three stented models, to study the influence of the flow divider on flow (Endurant [Medtronic, Minneapolis, Minn], AFX [Endologix, Irvine, Calif], and Nellix [Endologix]). Experimental models were tested under physiologic resting conditions, and flow was visualized with laser particle imaging velocimetry, quantified by shear rate, WSS, and oscillatory shear index (OSI) in the suprarenal aorta, renal artery (RA), and common iliac artery. RESULTS: WSS and OSI were comparable for all models in the suprarenal aorta. The RA flow profile in the EVAR models was comparable to the control, but a region of lower WSS was observed on the caudal wall compared with the control. The EVAS model showed a stronger jet flow with a higher shear rate in some regions compared with the other models. Small regions of low WSS and high OSI were found near the distal end of all stents in the common iliac artery compared with the control. Maximum shear rates in each region of interest were well below the pathologic threshold for acute thrombosis. CONCLUSIONS: The different stent designs do not influence suprarenal flow. Lower WSS is observed in the caudal wall of the RA after EVAR and a higher shear rate after EVAS. All stented models have a small region of low WSS and high OSI near the distal outflow of the stents.

The Influence of Positioning of the Nellix Endovascular Aneurysm Sealing System on Suprarenal and Renal Flow: An In Vitro Study.

PURPOSE: To examine the influence of device positioning and infrarenal neck diameter on flow patterns in the Nellix endovascular aneurysm sealing (EVAS) system. METHODS: The transition of the aortic flow lumen into two 10-mm-diameter stents after EVAS creates a mismatched area. Flow recirculation may affect local wall shear stress (WSS) profiles and residence time associated with atherosclerosis and thrombosis. To examine these issues, 7 abdominal aortic aneurysm flow phantoms were created, including 3 unstented controls and 3 stented models with infrarenal neck diameters of 24, 28, and 32 mm. Stents were positioned within the instructions for use (IFU). Another 28-mm model was created to evaluate lower positioning of the stents outside the IFU (28-mm LP). Flow was visualized using optical particle imaging velocimetry (PIV) and quantified by time-averaged WSS (TAWSS), oscillatory shear index (OSI), and relative residence time (RRT) in the aorta at the anteroposterior (AP) midplane, lateral midplane, and renal artery AP midplane levels. RESULTS: Flow in the aorta AP midplane was similar in all models. Vortices were observed in the stented models in the lateral midplane near the anterior and posterior walls. In the 32-mm IFU and 28-mm LP models, a steady state of vortices appeared, with varying location during a cycle. In all models, a low TAWSS (<10-2 Pa) was observed at the anterior wall of the aorta with peak OSI of 0.5 and peak RRT of 104 Pa-1. This region was more proximally located in the stented models. The 24- and 28-mm IFU models showed flow with a higher velocity at the renal artery inflow compared to controls. TAWSS in the renal artery was lower near the orifice in all models, with the largest area in the 24-mm IFU model. OSI and RRT in the renal artery were near zero for all models. CONCLUSION: EVAS enhances vorticity proximal to the seal zone, especially with lower positioning of the device and in larger neck diameters. Endobags just below the renal artery affect the flow profile in a minor area of this artery in 24- and 28-mm necks, while lower stent positioning does not influence the renal artery flow profile.

Aortic curvature as a predictor of intraoperative type Ia endoleak.

OBJECTIVE: Hostile infrarenal neck characteristics are associated with complications such as type Ia endoleak after endovascular aneurysm repair. Aortic neck angulation has been identified as one such characteristic, but its association with complications has not been uniform between studies. Neck angulation assumes triangular oversimplification of the aortic trajectory, which may explain conflicting findings. By contrast, aortic curvature is a measurement that includes the bending rate and tortuosity and may provide better predictive value for neck complications. METHODS: Data were retrieved from the Heli-FX (Aptus Endosystems, Inc, Sunnyvale, Calif) Aortic Securement System Global Registry (ANCHOR). One cohort included patients who presented with intraoperative endoleak type Ia at the completion angiogram as the indication for EndoAnchors (Aptus Endosystems), and a second cohort comprised those without intraoperative or late type Ia endoleak (controls). The aortic trajectory was divided into six segments with potentially different influence on the stent graft performance: suprarenal, juxtarenal, and infrarenal aortic neck (-30 to -10 mm, -10 to 10 mm, and 10-30 mm from the lowest renal artery, respectively), the entire aortic neck, aneurysm sac, and terminal aorta (20 mm above the bifurcation to the bifurcation). Maximum and average curvature were automatically calculated over the six segments by proprietary custom software. Aortic curvature was compared with other standard neck characteristics, including neck length, neck diameter, maximum aneurysm sac diameter, neck thrombus and calcium thickness and circumference, suprarenal angulation, infrarenal angulation, and the neck tortuosity index. Independent risk factors for intraoperative type Ia endoleak were identified using backwards stepwise logistic regression. For the variables in the final regression model, suitable cutoff values in relation to the prediction of acute type Ia endoleak were defined with the area under the receiver operating characteristic curve. RESULTS: The analysis included 64 patients with intraoperative type Ia endoleak and 79 controls. Logistic regression identified only aortic neck calcification and aortic curvature, expressed over the juxtarenal aortic neck, the aneurysm sac, and the terminal aorta, as independent predictors of intraoperative type Ia endoleak. CONCLUSIONS: Together with aortic neck calcification, aortic curvature appears to be the best predictor of intraoperative type Ia endoleak, as expressed within the juxtarenal aortic neck, the aneurysm sac, and the terminal aorta. Aortic neck angulation was not a predictor for acute failure. Aortic curvature may provide a better anatomic characteristic to define patients at risk for early complications after endovascular aneurysm repair.

Effect of abdominal aortic endoprostheses on arterial pulse wave velocity in an in vitro abdominal aortic flow model.

OBJECTIVE: Aortic pulse-wave-velocity (aPWV) is a measure for arterial stiffness, which is associated with increased cardiovascular risk. Recent evidence suggests aPWV increases after endograft-placement for aortic aneurysms. The aim of this study was to investigate the influence of different aortic endoprostheses on aPWV and structural stiffness in vitro. APPROACH: Three different abdominal aortic endoprostheses (AFX, Endurant II, and Nellix) were implanted in identical silicone aneurysm models. One model was left untreated, and another model contained an aortic tube graft (Gelweave). The models were placed in an in vitro flow set-up that mimics physiological flow. aPWV was measured as the transit time of the pressure wave over the flow trajectory of the suprarenal to iliac segment. Structural stiffness corrected for lumen diameter was calculated for each model. RESULTS: aPWV was significantly lower for the control compared to the AFX, Endurant, Nellix and tube graft models (13.00 ± 1.20, 13.40 ± 1.17, 18.18 ± 1.20, 16.19 ± 1.25 and 15.41 ± 0.87 m s-1, respectively (P < 0.05)). Structural stiffness of the AFX model was significant lower compared to the control model (4718 N m-1 versus 5115 N m-1 (P < 0.001), respectively), whereas all other models showed higher structural stiffness. SIGNIFICANCE: Endograft placement resulted in a higher aPWV compared to a non-treated aortic flow model. All models showed increased structural stiffness over the flow trajectory compared to the control model, except for the AFX endoprosthesis. Future studies in patients treated with an endograft are needed to evaluate the current results in vivo.

Validation of pre-procedural aortic aneurysm volume calculations to estimate procedural fill volume of endobags in endovascular aortic sealing.

BACKGROUND: Endovascular aortic sealing (EVAS) with a sac anchoring endoprosthesis excludes abdominal aortic aneurysms based on polymer filling of endobags. Primary objective was to assess the reliability of pre-procedural computed tomography (CT) scans based calculations of required endobag volume in relation to intraoperative volume of the endobags. METHODS: Forty elective EVAS patients were included. Pre-procedural estimations of endobag volume were based on CT segmentations of aortic flow lumen volume, including both automated and manually-adjusted segmentations, performed by two experienced users. Additionally, changes in maximum AAA diameter, thrombus volume and total AAA volume were calculated from pre- and post-procedural CT scans. RESULTS: Automatically determined volumes were comparable to manually-adjusted calculations (75.3 vs. 75.7 mL) and inter-observer agreement regarding pre-EVAS calculations of prefill volume appeared almost perfect with an intra-class correlation coefficient of 0.98 (95% CI: 0.96-0.99). The mean pressure of the endobags was 185 mmHg. Manually-adjusted pre-procedural volume calculations underestimated procedural volume of the endobags (-11.3±9.9 mL). Differences between pre-EVAS and procedural volume measurements were independent from endobag pressure (r=-0.06, P=0.72), prepocedural thrombus volume (r=-0.303, P=0.057) and changes in total AAA volume (r=0.02, P=0.91). A significant association was determined between differences in pre-EVAS and endobag volume versus changes in thrombus volume pre- and post-procedural (r=0.39, P=0.01). CONCLUSIONS: In this validation study, pre-procedural volume measurements underestimate the actual fill volume of the endobags. It should be advised to perform a prefill of the endobags during the EVAS procedure.