Assessment of changes in stent graft geometry after chimney endovascular aneurysm sealing.

BACKGROUND: Chimney endovascular aneurysm sealing (ch-EVAS) could potentially minimize gutter-associated endoleaks in patients with juxtarenal abdominal aortic aneurysms resulting from the use of the conformable endobags surrounding the chimney stent grafts (ch-SGs). The aim of the present study was to quantify the (non)apposition of the endobags in the proximal aortic neck, migration of the endograft stent frames, and changes in geometry of the ch-SGs during the follow-up period. METHODS: The prospective data from 20 patients undergoing elective ch-EVAS were retrospectively reviewed. The aortic anatomy was analyzed on preoperative and postoperative computed tomography scans. The (non)apposition of the endobags in the aortic neck, Nellix (Endologix, Irvine, Calif) stent frame migration, and chimney graft geometry and migration were assessed. RESULTS: The median preoperative infrarenal neck length was 4.0 mm (interquartile range [IQR], 0-6.0 mm). The median seal length in the juxtarenal aortic neck at the first follow-up was 23.0 mm (IQR 18.0-30.8 mm). Five type IA endoleaks were identified on postoperative imaging; one at 1 month and four newly diagnosed at 1 year. Of these five type IA endoleaks, two were type Is1 (not extending into the aneurysm sac) and did not need reintervention and other three were type Is2 (extending into the aneurysm sac). One of these patients died of malignancy before reintervention could be performed. Bilateral ch-SG occlusions in one patient were documented at the 1-month follow-up (patient needed hemodialysis) and two patients with a new single ch-SG occlusion were found at the 1-year follow-up. No reinterventions were performed for the ch-SG occlusions. An occluded Nellix stent frame in one patient was treated with femorofemoral crossover bypass. Kaplan-Meier estimate of reintervention-free survival was 85.0% after 1 year. Migration ≥5 mm of the proximal end of the Nellix stent frames was observed in 20.0% of the patients, but no reintervention was performed at the 1-year follow-up. Imaging showed 20.1% of the available sealing surface was not used, and the nonapposition surface increased to 30.6% of the preoperative aortic neck surface at 1 year. Median migration was 3.5 mm (IQR, 2.4-5.0 mm) and 3.1 mm (IQR, 2.0-4.8 mm) for the left and right proximal end of the Nellix stent frames, respectively, and was 3.0 mm (IQR, 2.2-4.8 mm) for the proximal end of the ch-SGs at 1 year of follow-up. CONCLUSIONS: Substantial distal migration of the Nellix endograft and positional changes of the ch-SGs in the juxtarenal aortic neck were observed at 1 year of follow-up, resulting in a 25.0% type IA endoleak rate, with three of these type IA endoleaks extending into the aneurysm sac. The reintervention-free survival rate was 85.0% at 1 year in this cohort of 20 patients. Careful follow-up after ch-EVAS is advised because changes are often subtle. The authors have stopped the ch-EVAS procedure so far. Long-term follow-up data on the stability of the Nellix endograft and the consequences of migration on ch-SGs is required before this technique should be used in clinical practice.

Haemodynamics in Different Flow Lumen Configurations of Customised Aortic Repair for Infrarenal Aortic Aneurysms.

OBJECTIVE: Customised aortic repair (CAR) is a new and minimally invasive technique for the endovascular treatment of abdominal aortic aneurysms (AAAs). The aneurysm is completely sealed with a non-contained, non-cross linked polymer, while a new flow lumen is created with balloons. For CAR, the haemodynamically most favourable balloon and flow lumen configuration has not been established before; therefore, four flow parameters were assessed in an in vitro model. METHODS: Three in vitro balloon configurations were implanted in an in vitro AAA model; a configuration with crossing balloons (CC) and two parallel configurations (PC1 and PC2). These three models were consecutively placed in a flow system that mimics physiological flow conditions. Laser particle imaging velocimetry (PIV) was used to resolve spatial and temporal flow patterns during the cardiac cycle. In house built algorithms were used to analyse the PIV data for the computing of (i) flow velocity; (ii) vorticity; (iii) wall shear stress (WSS); and (iv) time averaged wall shear stress (TAWSS). RESULTS: Suprarenal flow patterns were similar in all models. The CC showed a higher infrarenal velocity than PC1 and PC2 (38 cm/s vs. 23 cm/s vs. 23 cm/s), and a higher vorticity at the crossing of the lumens (CC: 337/s; PC1 127/s; PC2: 112/s). The lowest vorticity was observed in PC2, especially in the infrarenal neck (CC: 200/s; PC1 164/s; PC2: 98/s). Although WSS and TAWSS varied between configurations, values were in the within non-pathological range. CONCLUSION: The flow lumens created by three balloon configurations used in an in vitro model of CAR have been studied, and resulted in different haemodynamics. The differences in velocity and lower vorticity, especially at the crossing section of the two balloons, showed that PC2 has favourable haemodynamics compared with the CC and PC1. Future research will be focused on the clinical applicability of CAR based on the PC2 design.

In Vitro Quantification of Gutter Formation and Chimney Graft Compression in Chimney EVAR Stent-Graft Configurations Using Electrocardiography-Gated Computed Tomography.

PURPOSE: To assess the dynamic behavior of chimney grafts during the cardiac cycle. METHODS: Three chimney endovascular aneurysm repair (EVAR) stent-graft configurations (Endurant and Advanta V12, Endurant and Viabahn, and Endurant and BeGraft) were placed in silicone aneurysm models and subjected to physiologic flow. Electrocardiography (ECG)-gated contrast-enhanced computed tomography was used to visualize geometric changes during the cardiac cycle. Endograft and chimney graft surface, gutter volume, chimney graft angulation over the center lumen line, and the D-ratio (the ratio between the lengths of the major and minor axes) were independently assessed by 2 observers at 10 time points in the cardiac cycle. RESULTS: Both gutter volumes and chimney graft geometry changed significantly during the cardiac cycle in all 3 configurations (p<0.001). Gutters and endoleaks were observed in all configurations. The largest gutter volume (232.8 mm3) and change in volume (20.7 mm3) between systole and diastole were observed in the Endurant-Advanta configuration. These values were 2.7- and 3.0-fold higher, respectively, compared to the Endurant-Viabahn configuration and 1.7- and 1.6-fold higher as observed in the Endurant-BeGraft configuration. The Endurant-Viabahn configuration had the highest D-ratio (right, 1.26-1.35; left, 1.33-1.48), while the Endurant-BeGraft configuration had the lowest (right, 1.11-1.17; left, 1.08-1.15). Assessment of the interobserver variability showed a high correlation (intraclass correlation >0.935) between measurements. CONCLUSION: Gutter volumes and stent compression are dynamic phenomena that reshape during the cardiac cycle. Compelling differences were observed during the cardiac cycle in all configurations, with the self-expanding (Endurant-Viabahn) chimney EVAR configurations having smaller gutters and less variation in gutter volume during the cardiac cycle yet more stent compression without affecting the chimney graft surface.

Validation of a New Methodology to Determine 3-Dimensional Endograft Apposition, Position, and Expansion in the Aortic Neck After Endovascular Aneurysm Repair.

PURPOSE: To validate a novel methodology employing regular postoperative computed tomography angiography (CTA) scans to assess essential factors contributing to durable endovascular aneurysm repair (EVAR), including endograft deployment accuracy, neck adaptation to radial forces, and effective apposition of the fabric within the aortic neck. METHODS: Semiautomatic calculation of the apposition surface between the endograft and the infrarenal aortic neck was validated in vitro by comparing the calculated surfaces over a cylindrical silicon model with known dimensions on CTA reconstructions with various slice thicknesses. Interobserver variabilities were assessed for calculating endograft position, apposition, and expansion in a retrospective series of 24 elective EVAR patients using the repeatability coefficient (RC) and the intraclass correlation coefficient (ICC). The variability of these calculations was compared with variability of neck length and diameter measurements on centerline reconstructions of the preoperative and first postoperative CTA scans. RESULTS: In vitro validation showed accurate calculation of apposition, with deviation of 2.8% from the true surface for scans with 1-mm slice thickness. Excellent agreement was achieved for calculation of the endograft dimensions (ICC 0.909 to 0.996). Variability was low for calculation of endograft diameter (RC 2.3 mm), fabric distances (RC 5.2 to 5.7 mm), and shortest apposition length (RC 4.1 mm), which was the same as variability of regular neck diameter (RC 0.9 to 1.1 mm) and length (RC 4.0 to 8.0 mm) measurements. CONCLUSION: This retrospective validation study showed that apposition surfaces between an endograft and the infrarenal neck can be calculated accurately and with low variability. Determination of the (ap)position of the endograft in the aortic neck and detection of subtle changes during follow-up are crucial to determining eventual failure after EVAR.

Apposition and Positioning of the Nellix EndoVascular Aneurysm Sealing System in the Infrarenal Aortic Neck.

PURPOSE: To investigate the initial proximal position and seal of the Nellix EndoVascular Aneurysm Sealing (EVAS) system in the aortic neck using a novel methodology. METHODS: Forty-six consecutive patients who underwent elective EVAS for an abdominal aortic aneurysm were retrospectively selected and dichotomized into an early (n=23) and a late (n=23) group. The aortic neck morphology and aortic neck surface (ANS) were determined on preoperative computed tomography (CT) scans; the endograft position and nonapposition surface (NAS) were determined on the 1-month CT scans. The position of the proximal endobag boundary was measured by 2 experienced observers to analyze the interobserver variability for the EVAS NAS measurements. The shortest distance from the lowest renal artery to the endobag (shortest fabric distance) and the shortest distance from the endobag to the end of the infrarenal neck (shortest sealing distance) were determined. The intraclass correlation coefficients (ICCs) are presented with the 95% confidence interval (CI). Continuous data are presented as the median and interquartile range (IQR: Q3 - Q1). RESULTS: There were no differences between the early and late EVAS groups regarding aortic neck morphology except for the neck calcification circumference [41° (IQR 33°) vs 87° (IQR 60°), respectively; p=0.043]. Perfect agreement was observed for the NAS (ICC 0.897, 95% CI 0.780 to 0.956). The NAS as a percentage of the preoperative ANS was 47% (IQR 43) vs 49% (IQR 49) for the early vs late groups, respectively (p=0.214). The shortest fabric distances were 5 mm (IQR 5) and 4 mm (IQR 7) for the early and late groups, respectively (p=0.604); the shortest sealing distances were 9 mm (IQR 13) and 16 mm (IQR 17), respectively (p=0.066). CONCLUSION: Accurate positioning of the Nellix EVAS system in the aortic neck may be challenging. Despite considerable experience with the system, still around half of the potential seal in the aortic neck was missed in the current series, without improvement over time. This should be considered during preoperative planning and may be a cause of a higher than expected complication rate. Detailed post-EVAS nonapposition surface can be determined with the described novel methodology that takes into account the sometimes irregularly shaped top of the sealing endobags.

Determination of Endograft Apposition, Position, and Expansion in the Aortic Neck Predicts Type Ia Endoleak and Migration After Endovascular Aneurysm Repair.

PURPOSE: To describe the added value of determining changes in position and apposition on computed tomography angiography (CTA) after endovascular aneurysm repair (EVAR) to detect early caudal displacement of the device and to prevent type Ia endoleak. METHODS: Four groups of elective EVAR patients were selected from a dataset purposely enriched with type Ia endoleak and migration (>10 mm) cases. The groups included cases of late type Ia endoleak (n=36), migration (n=9), a type II endoleak (n=16), and controls without post-EVAR complications (n=37). Apposition of the endograft fabric with the aortic neck, shortest distance between the fabric and the renal arteries, expansion of the main body (or dilatation of the aorta in the infrarenal sealing zone), and tilt of the endograft toward the aortic axis were determined on the first postoperative and the last available CTA scan without type Ia endoleak or migration. Differences in these endograft dimensions were compared between the first vs last scan and among the 4 groups. RESULTS: No significant differences in endograft configurations were observed among the groups on the first postoperative CTA scan. On the last CTA scan before a complication arose, the position of the fabric relative to the renal arteries, expansion of the main body, and apposition of the fabric with the aortic neck were significantly different between the type Ia endoleak (median follow-up 15 months) and migration groups (median follow-up 23 months) compared with the control group (median follow-up 19 months). Most endograft dimensions had changed significantly compared with the first postoperative CTA scan for all groups. Apposition had increased in the control group but had decreased significantly in the type Ia endoleak and migration groups. CONCLUSION: Progressive changes in dimensions of the endograft within the infrarenal neck could be detected on regular CTA scans before the complication became urgent in many patients.

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.

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.

A Semiautomated Method for Measuring the 3-Dimensional Fabric to Renal Artery Distances to Determine Endograft Position After Endovascular Aneurysm Repair.

PURPOSE: To report a methodology for 3-dimensional (3D) assessment of the stent-graft deployment accuracy after endovascular aneurysm repair (EVAR). METHODS: A methodology was developed and validated to calculate the 3D distances between the endograft fabric and the renal arteries over the curve of the aorta. The shortest distance between one of the renal arteries and the fabric (SFD) and the distance from the contralateral renal artery to the fabric (CFD) were determined on the first postoperative computed tomography (CT) scan of 81 elective EVAR patients. The SFDs were subdivided into a target position (0-3 mm distal to the renal artery), high position (partially covering the renal artery), and low position (>3 mm distal to the renal artery). Data are reported as the median (interquartile range, IQR). RESULTS: Intra- and interobserver agreements for automatic and manual calculation of the SFD and CFD were excellent (ICC >0.892, p<0.001). The median SFD was 1.4 mm (IQR -0.9, 3.0) and the median CFD was 8.0 mm (IQR 3.9, 14.2). The target position was achieved in 44%, high position in 30%, and low position in 26% of the patients. The median slope of the endograft toward the higher renal artery was 2.5° (IQR -5.5°, 13.9°). CONCLUSION: The novel methodology using 3D CT reconstructions enables accurate evaluation of endograft position and slope within the proximal aortic neck. In this series, only 44% of endografts were placed within the target position with regard to the lowermost renal artery.

Aortic Curvature Is a Predictor of Late Type Ia Endoleak and Migration After Endovascular Aneurysm Repair.

PURPOSE: To evaluate the association between aortic curvature and other preoperative anatomical characteristics and late (>1 year) type Ia endoleak and endograft migration in endovascular aneurysm repair (EVAR) patients. METHODS: Eight high-volume EVAR centers contributed 116 EVAR patients (mean age 81±7 years; 103 men) to the study: 36 patients (mean age 82±7 years; 31 men) with endograft migration and/or type Ia endoleak diagnosed >1 year after the initial EVAR and 80 controls without early or late complications. Aortic curvature was calculated from the preoperative computed tomography scan as the maximum and average curvature over 5 predefined aortic segments: the entire infrarenal aortic neck, aneurysm sac, and the suprarenal, juxtarenal, and infrarenal aorta. Other morphological characteristics included neck length, neck diameter, mural neck calcification and thrombus, suprarenal and infrarenal angulation, and largest aneurysm sac diameter. Independent risk factors were identified using backward stepwise logistic regression. Relevant cutoff values for each of the variables in the final regression model were determined with the receiver operator characteristic curve. RESULTS: Logistic regression identified maximum curvature over the length of the aneurysm sac (>47 m-1; p=0.023), largest aneurysm sac diameter (>56 mm; p=0.028), and mural neck thrombus (>11° circumference; p<0.001) as independent predictors of late migration and type Ia endoleak. CONCLUSION: Aortic curvature is a predictor for late type Ia endoleak and endograft migration after EVAR. These findings suggest that aortic curvature is a better parameter than angulation to predict post-EVAR failure and should be included as a hostile neck parameter.

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.

Chimney technique in combination with a sac-anchoring endograft for juxtarenal aortic aneurysms: technical aspects and early results.

BACKGROUND: Juxtarenal aortic aneurysms (JAAs) pose clinical challenges for vascular specialists. Chimney endovascular sealing (Ch-EVAS) might be an ideal endovascular solution in the treatment of JAAs. We present technical aspects and early clinical results of a multicenter experience with Ch-EVAS. METHODS: This was a retrospective, multicenter study. Between November 2014 and March 2016, 16 patients underwent elective endovascular repair of JAAs with Ch-EVAS of 1 or 2 renal and/or superior mesenteric artery vessels. Essential technical steps, early complications, chimney stent patency, gutter formation, type IA endoleak, 30-day outcome, renal function, and neck characteristics were the endpoints. RESULTS: There were 26 chimney stents implanted with 100% technical success. The intraoperative death and 30 day mortality was 0%. Secondary interventions were required in 3 patients each due to type IA endoleak, limb occlusion and brachial dissection. The latter patient presented with renal chimney stent occlusion and required hemodialysis. One patient was known to have a pulmonary malignancy and left-sided carotid stenosis and sustained a left hemispheric stroke after the endovascular procedure. The preoperative median aortic neck length was 3 mm, after Ch-EVAS the median seal length between endobags and the aortic neck was 25 mm. No further significant changes in neck morphology were found at the one-month follow-up. CONCLUSIONS: Ch-EVAS is an off-the-shelf solution to treat JAAs with high technical success. Longer-term follow-up with a substantial number of patients can answer the question of whether Ch-EVAS is a sustainable technique that is preferred over open surgery or fenestrated endovascular aneurysm repair.