Purpose: To describe and validate a new methodology for visualizing and quantifying 3-dimensional (3D) displacement of the stent frames of the Nellix endosystem after endovascular aneurysm sealing (EVAS). Methods: The 3D positions of the stent frames were registered to 5 fixed anatomical landmarks on the post-EVAS computed tomography (CT) scans, facilitating comparison of the position and shape of the stent frames between consecutive follow-up scans. Displacement of the proximal and distal ends of the stent frames, the entire stent frame trajectories, as well as changes in distance between the stent frames were determined for 6 patients with >5-mm displacement and 6 patients with <5-mm displacement at 1-year follow-up. The measurements were performed by 2 independent observers; the intraclass correlation coefficient (ICC) was used to determine interobserver variability. Results: Three types of displacement were identified: displacement of the proximal and/or distal end of the stent frames, lateral displacement of one or both stent frames, and stent frame buckling. The ICC ranged from good (0.750) to excellent (0.958). No endoleak or migration was detected in the 12 patients on conventional CT angiography at 1 year. However, of the 6 patients with >5-mm displacement on the 1-year CT as determined by the new methodology, 2 went on to develop a type Ia endoleak in longer follow-up, and displacement progressed to >15 mm for 2 other patients. No endoleak or progressive displacement was appreciated for the patients with <5-mm displacement. Conclusion: The sac anchoring principle of the Nellix endosystem may result in several types of displacement that have not been observed during surveillance of regular endovascular aneurysm repairs. The presented methodology allows precise 3D determination of the Nellix endosystems and can detect subtle displacement better than standard CT angiography. Displacement >5 mm on the 1-year CT scans reconstructed with the new methodology may forecast impaired sealing and anchoring of the Nellix endosystem.
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.
Purpose: To validate computed tomography angiography (CTA)–applied software to assess apposition, dilatation, and position of endografts in the proximal and distal landing zones after thoracic endovascular aortic repair (TEVAR) of thoracic aortic aneurysm. Materials and Methods: Twenty-two patients (median age 75.5 years; 11 men) with a degenerative descending thoracic aortic aneurysm treated with TEVAR with at least one postoperative CTA were selected from a single center’s database. New CTA-applied software was used to determine the available apposition surface in the proximal and distal landing zones, apposition of the endograft fabric with the aortic wall, shortest apposition length, endograft inflow and outflow diameters, shortest distance between the left subclavian artery and the proximal endograft fabric, and shortest distance between the celiac trunk and the distal endograft fabric on each CTA. Interobserver variability for these parameters was assessed with the repeatability coefficient and the intraclass correlation coefficient. Results: Excellent interobserver agreement was found for all measurements. Interobserver variability of surface and shortest apposition length calculations was larger for the distal site compared with the proximal site, with a mean difference of 10% vs 2% of the mean available apposition surface, 12% vs 5% of the endograft apposition surface, and 16% vs 8% of the shortest apposition length, respectively. Inflow and outflow diameters of the endograft showed low variability, with a mean difference of 0.1 mm with 95% of the interobserver difference within 1.8 mm. Mean interobserver differences of the proximal and distal shortest fabric distances were 1.0 and 0.9 mm (both 2% of the mean lengths). Conclusion: Assessment of apposition, dilatation, and position of the proximal and distal parts of an endograft in the descending thoracic aorta is feasible after TEVAR with the new software. Interobserver agreement for all measured parameters was excellent for the proximal and distal landing zones. The new method allows detection of subtle changes during follow-up. However, a larger study is needed to quantify how parameters change over time in complicated and uncomplicated TEVAR cases and to define the real added value of the new methodology.
Preclinical studies showed that thrombi can be permeable and may, therefore, allow for residual blood flow in occluded arteries of patients having acute ischemic stroke. This perviousness may increase tissue oxygenation, improve thrombus dissolution, and augment intra-arterial treatment success. We hypothesize that the combination of computed tomographic angiography and noncontrast computed tomography imaging allows measurement of contrast agent penetrating a permeable thrombus, and it is associated with improved outcome.Thrombus and contralateral artery attenuations in noncontrast computed tomography and computed tomographic angiography images were measured in 184 Multicenter Randomized Clinical trial of Endovascular treatment of acute ischemic stroke in the Netherlands (MR CLEAN) patients with thin-slice images. Two quantitative estimators of the thrombus permeability were introduced: computed tomographic angiography attenuation increase (Δ) and thrombus void fraction (ε). Patients were dichotomized as having a pervious or impervious thrombus and associated with outcome, recanalization, and final infarct volume.Patients with Δ≥10.9 HU (n=81 [44%]) and ε≥6.5% (n=77 [42%]) were classified as having a pervious thrombus. These patients were 3.2 (95% confidence interval, 1.7-6.4) times more likely to have a favorable outcome, and 2.5 (95% confidence interval, 1.3-4.8) times more likely to recanalyze, for Δ based classification, and similarly for ε. These odds ratios were independent from intravenous or intra-arterial treatment. Final infarct volume was negatively correlated with both perviousness estimates (correlation coefficient, -0.39 for Δ and -0.40 for ε).This study shows that simultaneous measurement of thrombus attenuation in noncontrast computed tomography and computed tomographic angiography allows for quantification of thrombus perviousness. Thrombus perviousness is strongly associated with improved functional outcome, smaller final infarct volume, and higher recanalization rate.
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.
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.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.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.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.
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).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).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).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.
Purpose: To investigate changes in penetration depths and angles of EndoAnchor implants with initially good penetration after therapeutic use in endovascular aneurysm repair. Materials and Methods: Patients were selected from the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR; ClinicalTrials.gov identifier NCT01534819). Inclusion criteria were (1) EndoAnchor implantation to treat intraoperative or late type Ia endoleak and (2) at least 2 postoperative computed tomography angiography (CTA) scans. Exclusion criteria were the use of adjunct procedures. Based on these criteria, 54 patients (44 men) with 360 EndoAnchor implants were eligible for this analysis. Penetration depth of each EndoAnchor implant into the aortic wall was judged as (1) good (≥2-mm penetration), (2) borderline (<2 mm or when there was a gap between the endograft and the aortic wall), or (3) no penetration. The penetration depth and longitudinal angles of EndoAnchors with good penetration were investigated on the last available postprocedure CTA scan. Endoleaks were also analyzed. Results: EndoAnchor penetration on the first postprocedure CTA scan was good in 187 (51.9%), borderline in 69 (19.2%), and missing in 104 (28.9%). On the last CTA scan, 182 (97.4%) of the 187 initially well-positioned EndoAnchors remained good. Five (2.6%) EndoAnchors in 4 patients changed configuration over time (4 became borderline and 1 became nonpenetrating), all without any clinical sequelae. The median orthogonal angles of the EndoAnchor implants with good penetration on the first and last CTA scans were 92° [interquartile range (IQR) 85, 98] and 90° (IQR 84, 97), respectively (p=0.822); for longitudinal angles, medians of 85° (IQR 71, 96) and 84° (IQR 70, 96) were found (p=0.043). Of the 18 (33%) patients who had a type Ia endoleak on the first postprocedure CTA, 6 resolved over time. Median follow-up was 13 months, during which no new type Ia endoleak was found. Conclusion: Despite the small number of EndoAnchors analyzed, this study showed that the sustainability of EndoAnchor implants with initially good penetration is satisfactory at 1-year follow-up. The vast majority of EndoAnchor implants with good penetration initially remained in good position; <3% of implants became borderline or nonpenetrating, without any clinical consequence.
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.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.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.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.
