Johannes T. Boersen

Changes in Aortoiliac Anatomy After Elective Treatment of Infrarenal Abdominal Aortic Aneurysms with a Sac Anchoring Endoprosthesis

OBJECTIVE Endovascular aortic sealing (EVAS) with the Nellix endosystem (Endologix, Irvine, CA, USA) is a new concept to treat infrarenal abdominal aortic aneurysms (AAAs). By sealing the aneurysm, potential endoleaks may be avoided. Early results of EVAS are good, but no data have been published regarding peri-procedural changes in aortoiliac anatomy. In this study, 27 consecutive patients who underwent elective EVAS repair of an AAA were reviewed. METHOD Specific AAA (diameter, length from renal arteries to aortic bifurcation, supra- and infrarenal neck angulation, AAA volume, thrombus volume, and flow lumen volume), and iliac artery characteristics (length, angulation, location of most severe angulation with reference to the origin of the common iliac artery) were determined from pre- and post-procedural reconstructed computed tomography angiograms. RESULTS No type I or II endoleaks were seen at 30 day follow up. Total AAA volume, suprarenal and infrarenal angulation, as well as aortic neck diameter did not change significantly post-EVAS. AAA flow lumen increased significantly (mean difference -4.4 mL, 95% CI 2.0 to -8.6 mL) and AAA thrombus volume decreased (mean difference 3.2 mL, 95% CI 2.0 to -1.1 mL). AAA length (125.7 mm vs. 123.1 mm), left common iliac artery length (57.6 mm vs. 55.3 mm), and right and left maximum iliac artery angulation (right 37.4° vs. 32.2°; left: 43.9° vs. 38.4°) were reduced significantly and the location of maximum angulation was further from the iliac artery origin post-EVAS, suggesting slight straightening of the aortoiliac anatomy. CONCLUSION Most aortoiliac anatomic characteristics remained unchanged post-EVAS. Filling of the endobags to a pressure of 180 mmHg may lead to lost thrombus volume in some patients, probably because liquid is squeezed into lumbar or the inferior mesenteric artery. The absolute differences in pre- and post-EVAS aortoiliac lengths were small, so pre-operative sizing is accurate for determining stent length.

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.

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. Clinical Relevance: Aortoiliac occlusive disease involving the aortic bifurcation is treated with kissing stents on a regular basis. The midterm and long‐term results cannot compete with open aortic repair, possibly because of disturbed blood flow. In response to the varying clinical results, several stent configurations have been introduced, most of them promoting a more physiologic reconstruction of the aortic bifurcation to ensure undisturbed blood flow. However, the hemodynamic differences between frequently used aortoiliac stent configurations have never been quantified. Insight into the local hemodynamics expands the knowledge on the interaction between stent geometry and blood flow. Furthermore, the results complement current clinical results and aid vascular specialists in their choice of stent configuration.

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.

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. Clinical Relevance: Most endografts for endovascular aortic aneurysm repair involve a modular stent design, and the design could vary in the location of the flow divider. Endovascular aneurysm sealing based on polymer filling of endobags surrounding dual stent frames was recently introduced. This study focuses on effects of a dual‐lumen configuration in the abdominal aorta after endovascular aneurysm sealing on flow and wall shear stress proximal and distal to the stents in comparison with two endovascular aneurysm repair endografts and an aneurysm control by in vitro flow visualization.

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.

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.

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.

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. Clinical Relevance: The location of the proximal markers of endovascular aneurysm repair devices is not always at the most proximal site of the graft material, and as such, part of the coverage material may be placed over the orifice of the renal artery. A recent analysis showed an incidence of inadvertent partial coverage of 28%. The association of a slight renal artery coverage with adverse flow patterns in this study stresses the importance of avoiding any renal artery coverage during deployment of the main body. The results further act to emphasize the importance of optimal C‐arm adjustment to obtain a perpendicular projection of the lowermost renal artery.

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. Clinical Relevance Chimney endovascular aneurysm repair and chimney endovascular aneurysm sealing are used more commonly for elective repair of juxtarenal abdominal aortic aneurysms. Gutter formation and chimney graft compression may occur because of a mismatch in architecture between the chimney stent grafts and the endograft or endosystem, and this may induce a risk for complications such as type Ia endoleaks and stent thrombosis. This benchtop study evaluated gutter formation and chimney stent graft compression for various chimney endovascular aneurysm repair and chimney endovascular aneurysm sealing configurations in relation to renal flow.