Renal and Visceral Artery Configuration During the First Year of Follow-Up After Fenestrated Aortic Aneurysm Repair Using the Anaconda Stent-graft: A Prospective Longitudinal Multicenter Study With ECG-Gated CTA Scans.

OBJECTIVE: The performance of fenestrated endovascular aortic aneurysm repair (FEVAR) may be compromised by complications related to the dynamic vascular environment. The aim of this study was to analyze the behavior of FEVAR bridging stent configurations during the cardiac cycle and during follow-up to improve our understanding on treatment durability. DESIGN: Twenty-one patients presenting with complex abdominal aortic aneurysms (AAAs; 9 juxtarenal/6 pararenal/3 paravisceral/1 thoracoabdominal aortic aneurysm type IV), treated with a fenestrated Anaconda (Terumo Aortic, Inchinnan, Scotland, UK) with Advanta V12 bridging stents (Getinge, Merrimack, NH, USA), were prospectively enrolled in a multicenter observational cohort study and underwent electrocardiogram (ECG)-gated computed tomographic angiography (CTA) preoperatively, at discharge, 7-week, and 12-month follow-ups. METHODS: Fenestrated endovascular aortic aneurysm repair stability was assessed considering the following variables: branch angle as the angle between the aorta and the target artery, end-stent angle as the angle between the end of the bridging stent and the native artery downstream from it, curvature and tortuosity index (TI) to describe the bending of the target artery. Body-bridging stent stability was assessed considering bridging stent flare lengths, the distances between the proximal sealing stent-ring and fenestrations and the distance between the fenestration and first apposition in the target artery. RESULTS: Renal branch angles significantly increased after FEVAR toward a perpendicular position (right renal artery from median 60.9°, inter quartile range [IQR]=44.2-84.9° preoperatively to 94.4°, IQR=72.6-99.8°, p=0.001 at 12-month follow-up; left renal artery [LRA], from 63.7°, IQR=55.0-73.0° to 94.3°, IQR=68.2-105.6°, p<0.001), while visceral branch angles did not. The mean dynamic curvature only decreased for the LRA from preoperative (3.0, IQR=2.2-3.8 m-1) to 12-month follow-up (1.9, IQR=1.4-2.6 m-1, p=0.027). The remaining investigated variables did not seem to show any changes over time in this cohort. CONCLUSIONS: Fenestrated endovascular aortic aneurysm repair for complex AAAs using the Anaconda fenestrated stent-graft and balloon-expandable Advanta V12 bridging stents demonstrated stable configurations up to 12-month follow-up, except for increasing renal branch angles toward perpendicular orientation to the aorta, yet without apparent clinical consequences in this cohort. CLINICAL IMPACT: This study provides detailed information on the cardiac-pulsatility-induced (dynamic) and longitudinal geometry deformations of the target arteries and bridging stents after fenestrated endovascular aortic aneurysm repair (FEVAR) up to 12-month follow-up. The configuration demonstrated limited dynamic and longitudinal deformations in terms of branch angle, end-stent angle, curvature, and tortuosity index (TI), except for the increasing renal branch angles that go toward a perpendicular orientation to the aorta. Overall, the results suggest that the investigated FEVAR configurations are stable and durable, though careful consideration of increasing renal branch angles and significant geometry alterations is advised.

Electrocardiography-gated computed tomography angiography analysis of cardiac pulsatility-induced motion and deformation after endovascular aneurysm sealing with chimney grafts.

OBJECTIVE: To evaluate the proximal stability of the chimney endovascular aneurysm sealing configuration (chEVAS) during the cardiac cycle by investigating the cardiac pulsatility-induced movement and deformation. METHODS: We retrospectively analyzed postoperative electrocardiogram-gated computed tomography angiography scans of 11 chEVAS cases (9 primary chEVAS plus 2 chEVAS-in-chEVAS). ChEVAS procedures were conducted between September 2013 and June 2016. Motion and deformation of the EVAS stents, the chimney grafts, and the stented branch vessels were evaluated during the cardiac cycle using an established combination of image registration and segmentation techniques. RESULTS: Electrocardiogram-gated computed tomography angiography scans of 11 chEVAS configurations including 22 EVAS stents and 20 chimney grafts were analyzed. The three-dimensional displacement was at most 1.7 mm for both the EVAS stents and the chimney grafts. The maximum change in distance between components was no more than 0.4 mm and did not differ between EVAS-to-EVAS stent and EVAS stent-to-chimney stent (0.2 ± 0.1 mm vs 0.2 ± 0.1 mm; P = .823). The mean change in chimney deflection angle was 1.2 ± 0.7°; the maximum change was greatest for the superior mesenteric artery (SMA) (2.6°). The EVAS stent-to-chimney angles for the left renal artery, right renal artery, and SMA varied on average by 0.7 ± 0.3° (range, 0.4°-1.3°), 1.0 ± 0.3° (range, 0.5°-1.7°), and 0.8 ± 0.4° (range, 0.3°-1.3°), respectively, during the cardiac cycle. The end-stent angles for the left renal artery, right renal artery, and SMA varied on average by 1.7 ± 0.9° (range, 0.5°-3.3°), 1.9 ± 0.8° (range, 0.7°-3.3°), and 1.3 ± 0.4° (range, 0.7°-1.6°), respectively, during the cardiac cycle. Overall, the end-stent angles varied on average by 1.7 ± 0.8° (range, 0.5°-3.3°). CONCLUSIONS: The chEVAS configuration proved to be stable during the cardiac cycle, as demonstrated by minimal cyclical changes in distance between device components and angulation between the EVAS stents and the chimney grafts. The limited deflection angles of the chimney grafts decrease the risk of bending fatigue, but the more apparent change in end-stent angle distal to the chimney graft may raise concerns regarding late branch occlusion or stenosis.

Geometric Remodeling of the Perirenal Aortic Neck at and Adjacent to the Double Sealing Ring of the Anaconda Stent-Graft After Endovascular Aneurysm Repair.

Purpose: To evaluate if the radial force of the double sealing ring of the Anaconda stent-graft induces dilatation in the perirenal aortic neck adjacent to the rings. Materials and Methods: This study evaluated the serial electrocardiogram-gated computed tomography scans of 15 abdominal aortic aneurysm patients (mean age 72.8±3.7 years; 14 men) who were treated electively using an Anaconda stent-graft. Follow-up scans were conducted before discharge and at 1, 6, 12, and 24 months after endovascular repair. Diameter and area were assessed perpendicular to the aortic centerline along the perirenal aortic neck, which was subdivided into 3 zones: the suprastent, the stent, and the infrastent zones. Measurements were performed independently by 2 experienced observers using dedicated 3-dimensional image processing software. Results: Between discharge and the 2-year follow-up the diameter and area remained stable in the suprastent zone [average diameter change: -0.1±0.4 mm (-0.4%±1.7%), p=0.893; average area change: -2.9±17.2 mm2 (-0.7%±3.4%), p=0.946], increased in the stent zone [average diameter change: +1.9±1.0 mm (+7.3%±4.0%), p<0.001; average area change: +84.3±48.3 mm2 (+15.5%±8.7%), p<0.001], and diverged in the infrastent zone [average diameter change: -0.8±2.2 mm (-2.3%±7.4%), p>0.99; average area change: -34.6±102.3 mm2 (-4.1%±14.8%), p>0.99; increased in 4 patients, decreased in 9 patients]. Conclusion: After Anaconda implantation the infrarenal aortic neck accommodated to the expansion of the sealing rings at the stent zone. Below the stent zone the neck diameter decreased in the majority of patients, while an increase was related to downstream displacement of the main body. A decrease in size in the infrastent zone may contribute to durable sealing and fixation. A personalized follow-up scheme based on geometric neck remodeling should be feasible if our observations are confirmed in larger, long-term studies.

Quantitative Stent Graft Motion in ECG Gated CT by Image Registration and Segmentation: In Vitro Validation and Preliminary Clinical Results.

OBJECTIVES: The dynamic endovascular environment of stent grafts may influence long term outcome after endovascular aneurysm repair (EVAR). The sealing and fixation of a stent graft to the aortic wall is challenged at every heartbeat, yet knowledge of the cardiac induced dynamics of stent grafts is sparse. Understanding the stent-artery interaction is crucial for device development and may aid the prediction of failure in the individual patient. The aim of this work was to establish quantitative stent graft motion in multiphasic electrocardiogram (ECG) gated computed tomography (CT) by image registration and segmentation techniques. METHODS: Experimental validation was performed by evaluating a series of ECG gated CT scans of a stent graft moving at different amplitudes of displacement at different virtual heart rates using a motion generating device with synchronised ECG triggering. The methodology was further tested on clinical data of patients treated with EVAR devices with different stent graft designs. Displacement during the cardiac cycle was analysed for points on the fixating stent rings, the branches or fenestrations, and the spine. RESULTS: Errors for the amplitude of displacement measured in vitro at individual points on the wire frame were at most 0.3 mm. In situ cardiac induced displacement of the devices was found to differ per location and also depended on the type of stent graft. Displacement during the cardiac cycle was greatest in a fenestrated device and smallest in a chimney graft sac anchoring endosystem, with maximum displacement varying from 0.0 to 1.4 mm. There was no substantial displacement measurable in the spine. CONCLUSIONS: A novel methodology to quantify and visualise stent graft motion in multiphasic ECG gated CT has been validated in vitro and tested in vivo. This methodology enables further exploration of in situ motion of different stent grafts and branch stents and their interaction with native vessels.

Evolution of the Proximal Sealing Rings of the Anaconda Stent-Graft After Endovascular Aneurysm Repair.

PURPOSE: To provide insight into the evolution of the saddle-shaped proximal sealing rings of the Anaconda stent-graft after endovascular aneurysm repair (EVAR). METHODS: Eighteen abdominal aortic aneurysm patients were consecutively enrolled in a single-center, prospective, observational cohort study (LSPEAS; Trialregister.nl identifier NTR4276). The patients were treated electively using an Anaconda stent-graft with a mean 31% oversizing (range 17-47). According to protocol, participants were to be followed for 2 years, during which 5 noncontrast electrocardiogram-gated computed tomography scans would be conducted. Three patients were eliminated within 30 days (1 withdrew, 1 died, and a third was converted before stent-graft deployment), leaving 15 patients (mean age 72.8±3.7 years; 14 men) for this analysis. Evolution in size and shape (symmetry) of both proximal infrarenal sealing rings were assessed from discharge to 24 months using dedicated postprocessing algorithms. RESULTS: At 24 months, the mean diameters of the first and second ring stents had increased significantly (first ring: 2.2±1.0 mm, p<0.001; second ring: 2.7±1.1 mm, p<0.001). At 6 months, the first and second rings had expanded to a mean 96.6%±2.1% and 94.8%±2.7%, respectively, of their nominal diameter, after which the rings expanded slowly; ring diameters stabilized to near nominal size (first ring, 98.3%±1.1%; second ring, 97.2%±1.4%) at 24 months irrespective of initial oversizing. No type I or III endoleaks or aneurysm-, device-, or procedure-related adverse events were noted in follow-up. The difference in the diametric distances between the peaks and valleys of the saddle-shaped rings was marked at discharge but became smaller after 24 months for both rings (first ring: median 2.0 vs 1.2 mm, p=0.191; second ring: median 2.8 vs 0.8 mm; p=0.013). CONCLUSION: Irrespective of initial oversizing, the Anaconda proximal sealing rings radially expanded to near nominal size within 6 months after EVAR. Initial oval-shaped rings conformed symmetrically and became nearly circular through 24 months. These findings should be taken into account in planning and follow-up.

Evaluation of electrocardiogram-gated computed tomography angiography to quantify changes in geometry and dynamic behavior of the iliac artery after placement of the Gore Excluder Iliac Branch Endoprosthesis.

BACKGROUND: The GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) is designed to treat iliac aneurysms with preservation of blood flow through the internal iliac artery (IIA). Little is known about the influence of IBE placement on the IIA geometry. This study aimed to provide detailed insights in the dynamic behavior and geometry of the common iliac artery (CIA) and IIA trajectory and how these are influenced after treatment with an IBE. METHODS: Pre- and postoperative electrocardiogram-gated computed tomography angiography (ECG-gated CTA) scans were acquired in a prospective study design and analyzed with in-house written algorithms designed for aorto-iliac and endoprosthesis deformation evaluation. Cardiac pulsatility-induced motion patterns and pathlengths were computed by tracking predefined locations on the aorto-iliac tract. Centerlines through the CIA-IIA trajectory were used to investigate the static and dynamic geometry, including curvature, torsion, length and Tortuosity Index (TI). RESULTS: Fourteen CIA-IIA trajectories were analyzed before and after IBE placement. Cardiac pulsatility-induced motion and pathlengths increased after IBE placement, especially at mid IIA and the first IIA bifurcation (P≤0.04). After IBE placement, static and dynamic curvature, length and TI decreased significantly (P<0.05). Furthermore, the average dynamic torsion increased significantly (P=0.030). The remaining geometrical outcomes were not statistically significant. CONCLUSIONS: The placement of an IBE device stiffens and straightens the CIA-IIA trajectory. Its relation with clinical outcome is yet to be investigated, which can be done thoroughly with the ECG-gated CTA algorithms used in this study.

Geometrical changes in Anaconda endograft limbs after endovascular aneurysm repair: A potential predictor for limb occlusion.

The emergence of limb occlusion after endovascular aneurysm repair may be related to the conformational changes between the endograft structure and the patient's anatomy. This study analyzed detailed geometric changes of Anaconda endograft (Terumo Aortic, Inchinnan, Scotland, UK) limbs during the cardiac cycle-based computed tomography on serial imaging after graft implantation. Fifteen patients (mean age 72.8 ± 3.7 years; 14 men) underwent postoperative electrocardiogram-gated computed tomography scans according to a prospective study design between April 2014 and May 2017. Changes in curvature, length of the limbs, and distances between successive stent rings (inter-ring distance) of the endograft limbs during a 2-year follow-up period were quantified using meticulous image processing methods involving image registration, centerline extraction, and model-based stent-ring segmentation. From discharge to 24 months, mean curvature increased significantly by 9.6 m-1 (standard deviation [SD], 11.1 m-1; 95% confidence interval [CI], 3.4 to 15.8 m-1; P = .002) for the right limbs and by 6.1 m-1 (SD 9.4 m-1; 95% CI, 0.8 to 11.5 m-1; P = .21) for the left limbs. The length of the right limbs decreased significantly, by 9.5 mm (SD 7.6 mm; 95% CI, 3.5 to 15.6 mm; P = .002); the length of the left limbs decreased by 10.1 mm (SD 5.1 mm; 95% CI, 5.9 to 14.2 mm; P < .001). The minimal inter-ring distance decreased by 0.36 mm (SD 0.26 mm; 95% CI, 0.17 to 0.55 mm; P < .001) for the right limbs and 0.35 mm (SD 0.19 mm; 95% CI, 0.21 to 0.49 mm; P < .001) for the left limbs. Cardiac pulsatility-induced changes in curvature, limb length, and inter-ring distance were negligible (2%, 0.3% and 0.3%, respectively). Changes in the geometry of the Anaconda endograft limbs after endovascular aortic aneurysm repair were observed during a 2-year follow-up manifest as an increase in curvature, shortening of the stent-graft limbs, and a corresponding decrease in inter-ring distance. These stent-graft conformational changes could result in inward folding of the graft fabric, which may relate to the emergence of limb occlusion. Further investigation of these metrics in a larger cohort involving patients with and without occlusions may allow determination of their predictive value.

An open source image processing method to quantitatively assess tissue growth after non-invasive magnetic resonance imaging in human bone marrow stromal cell seeded 3D polymeric scaffolds.

Monitoring extracellular matrix (ECM) components is one of the key methods used to determine tissue quality in three-dimensional (3D) scaffolds for regenerative medicine and clinical purposes. This is even more important when multipotent human bone marrow stromal cells (hMSCs) are used, as it could offer a method to understand in real time the dynamics of stromal cell differentiation and eventually steer it into the desired lineage. Magnetic Resonance Imaging (MRI) is a promising tool to overcome the challenge of a limited transparency in opaque 3D scaffolds. Technical limitations of MRI involve non-uniform background intensity leading to fluctuating background signals and therewith complicating quantifications on the retrieved images. We present a post-imaging processing sequence that is able to correct for this non-uniform background intensity. To test the processing sequence we investigated the use of MRI for in vitro monitoring of tissue growth in three-dimensional poly(ethylene oxide terephthalate)-poly(butylene terephthalate) (PEOT/PBT) scaffolds. Results showed that MRI, without the need to use contrast agents, is a promising non-invasive tool to quantitatively monitor ECM production and cell distribution during in vitro culture in 3D porous tissue engineered constructs.