Opportunities for personalised follow-up in breast cancer: the gap between daily practice and recurrence risk.

PURPOSE: Follow-up guidelines barely diverge from a one-size-fits-all approach, even though the risk of recurrence differs per patient. However, the personalization of breast cancer care improves outcomes for patients. This study explores the variation in follow-up pathways in the Netherlands using real-world data to determine guideline adherence and the gap between daily practice and risk-based surveillance, to demonstrate the benefits of personalized risk-based surveillance compared with usual care. METHODS: Patients with stage I-III invasive breast cancer who received surgical treatment in a general hospital between 2005 and 2020 were selected from the Netherlands Cancer Registry and included all imaging activities during follow-up from hospital-based electronic health records. Process analysis techniques were used to map patients and activities to investigate the real-world utilisation of resources and identify the opportunities for improvement. The INFLUENCE 2.0 nomogram was used for risk prediction of recurrence. RESULTS: In the period between 2005 and 2020, 3478 patients were included with a mean follow-up of 4.9 years. In the first 12 months following treatment, patients visited the hospital between 1 and 5 times (mean 1.3, IQR 1-1) and received between 1 and 9 imaging activities (mean 1.7, IQR 1-2). Mammogram was the prevailing imaging modality, accounting for 70% of imaging activities. Patients with a low predicted risk of recurrence visited the hospital more often. CONCLUSIONS: Deviations from the guideline were not in line with the risk of recurrence and revealed a large gap, indicating that it is hard for clinicians to accurately estimate this risk and therefore objective risk predictions could bridge this gap.

In Vivo Quantification of Cardiac-Pulsatility-Induced Motion Before and After Double-Branched Endovascular Aortic Arch Repair.

The Relay®Branch stent-graft (Terumo Aortic, Sunrise, FL, USA) offers a custom-made endovascular solution for complex aortic arch pathologies. In this technical note, a modified electrocardiography (ECG)-gated computed tomography (CT)-based algorithm was applied to quantify cardiac-pulsatility-induced changes of the aortic arch geometry and motion before and after double-branched endovascular repair (bTEVAR) of an aortic arch aneurysm. This software algorithm has the potential to provide novel and clinically relevant insights in the influence of bTEVAR on aortic anatomy, arterial compliance, and stent-graft dynamics.

Geometrical Changes of the Aorta as Predictors for Thromboembolic Events After EVAR With the Anaconda Stent-Graft.

PURPOSE: Thromboembolic events (TE), including limb graft occlusion (LGO) and distal limb embolization (DLE), are common complications after endovascular aneurysm repair (EVAR). The aim of this study was to find predictors for TE in patients treated with the Anaconda stent-graft for infrarenal aneurysms. MATERIALS AND METHODS: Geometrical and anatomical variables were retrospectively analyzed in a consecutive Anaconda cohort. Pre- and postoperative CT scans were used to derive geometrical parameters length, curvature, torsion, and tortuosity index (TI) from the center lumen lines (CLLs). Limb characteristics, pre-to-post EVAR and mid-term-follow-up changes in the parameters were evaluated for their predictive value for TE. RESULTS: Eighty-four patients (mean age 74±8.3 years, 74 men) were enrolled. The risk of TE was lowered with pre-to-post implant decreasing TI (steps of 0.05: OR: 1.30, 95% CI: 1.01-1.66, p=0.04), pre-to-post implant decreasing mean curvature (OR: 1.08, 95% CI: 1.01-1.16, p=0.03), and a larger degree of circumferential common iliac artery (CIA) calcification (OR: 0.98, 95% CI: 0.97-1.00, p=0.03). The only LGO predictor was the caudal relocation of maximal curvature after EVAR (OR: 1.01, 95% CI: 1.00-1.01, p=0.04). Preventors of DLE were CIA diameter (OR: 0.87, 95% CI: 0.76-0.99, p=0.04), circumferential CIA calcification (OR: 0.97, 95% CI: 0.95-1.00, p=0.03), mean and maximal curvature of the preoperative aortoiliac trajectory (OR: 0.86, 95% CI: 0.79-0.94, p<0.01 and OR: 0.97, 95% CI: 0.95-1.00, p=0.03, respectively) and pre-to-postoperative decrease in mean curvature (OR: 1.11, 95% CI: 1.02-1.21, p=0.02). Midterm TE predictors were length (OR: 0.95, 95% CI: 0.89-1.01, p=0.08) and torsion maximum location (OR: 1.01, 95% CI: 0.99-1.01, p=0.10). CONCLUSION: The present study confirms that treatment of infrarenal AAA with an Anaconda stent-graft is related to a relatively high TE rate which decreases with a pre-to-postoperative reduction in curvature and TI, and a larger degree of circumferential CIA calcification. In other words, more aortoiliac straightening and more circumferential CIA calcification may prevent TE development after EVAR with this stent-graft.

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.

In Vitro Geometry Analysis of Fenestrations in Endovascular Aneurysm Repair.

PURPOSE: Changes in the flared end of balloon-expandable covered stent (BECS) may precede BECS-associated complications but are not regularly assessed with computed tomographic angiography (CTA) after fenestrated endovascular aneurysm repair (FEVAR). Validation of the flare geometric analysis (FGA) and assessment of intraobserver and interobserver variability are investigated in this study. METHODS: Two series of 3 BeGraft BECSs (Bentley InnoMed GmbH, Hechingen, Germany) and 1 series of 3 Advanta V12 BECSs (Getinge AB, Göteborg, Sweden) were deployed in 3 side branches (45°, 60°, and 90° aortic branch angles) of an aorta phantom model. A standard post-FEVAR CTA scan was acquired. Computed tomographic angiography-derived measurements consisted of centerline reconstructions and placement of 3-dimensional coordinate markers by 2 observers in a vascular workstation. Flare geometric analysis calculates 3 BECS parameters: the circumferential flare-to-fenestration distance (FFD), which is the distance from the proximal end of the flare to fenestration, and diameters at the proximal end of the flare (Dflare) and at the fenestration (Dfenestration). Computed tomographic angiography-derived measurements were validated against microscopy measurements. Bland-Altman plots were used to determine the intraobserver and interobserver variability of the BECS parameters and intraclass correlation coefficient (ICC). RESULTS: For each BECS, the FFD at 4 equidistant quadrants of the circumference, Dflare, and Dfenestration were calculated. The mean difference and repeatability coefficient (RC) of the validation were 0.8 (2.1) mm for FFD, 0.4 (1.0) mm for Dflare, and -0.2 (1.2) mm for Dfenestration. The mean intraobserver and interobserver difference (RC) was 0.5 (1.6) mm and 0.7 (2.6) mm for FFD, 0.1 (0.6) mm and 0.1 (0.7) mm for Dflare, and -0.1 (0.8) mm and -0.8 (1.0) mm for Dfenestration. The mean ICC of intraobserver variability was 0.86 for FFD, 0.94 for Dflare, and 0.78 for Dfenestration. The mean ICC of interobserver variability was 0.77 for FFD, 0.92 for Dflare, and 0.48 for Dfenestration. CONCLUSION: This study showed that FGA of the flared ends of BECS can be performed with high accuracy in a phantom model, with good intraobserver and interobserver variability. Flare geometric analysis can be used to determine flare geometry of the BECS on standard post-FEVAR CTA scans.

[18F]FDG-PET/CT radiomics for the identification of genetic clusters in pheochromocytomas and paragangliomas.

OBJECTIVES: Based on germline and somatic mutation profiles, pheochromocytomas and paragangliomas (PPGLs) can be classified into different clusters. We investigated the use of [18F]FDG-PET/CT radiomics, SUVmax and biochemical profile for the identification of the genetic clusters of PPGLs. METHODS: In this single-centre cohort, 40 PPGLs (13 cluster 1, 18 cluster 2, 9 sporadic) were delineated using a 41% adaptive threshold of SUVpeak ([18F]FDG-PET) and manually (low-dose CT; ldCT). Using PyRadiomics, 211 radiomic features were extracted. Stratified 5-fold cross-validation for the identification of the genetic cluster was performed using multinomial logistic regression with dimensionality reduction incorporated per fold. Classification performances of biochemistry, SUVmax and PET(/CT) radiomic models were compared and presented as mean (multiclass) test AUCs over the five folds. Results were validated using a sham experiment, randomly shuffling the outcome labels. RESULTS: The model with biochemistry only could identify the genetic cluster (multiclass AUC 0.60). The three-factor PET model had the best classification performance (multiclass AUC 0.88). A simplified model with only SUVmax performed almost similarly. Addition of ldCT features and biochemistry decreased the classification performances. All sham AUCs were approximately 0.50. CONCLUSION: PET radiomics achieves a better identification of PPGLs compared to biochemistry, SUVmax, ldCT radiomics and combined approaches, especially for the differentiation of sporadic PPGLs. Nevertheless, a model with SUVmax alone might be preferred clinically, weighing model performances against laborious radiomic analysis. The limited added value of radiomics to the overall classification performance for PPGL should be validated in a larger external cohort. KEY POINTS: • Radiomics derived from [18F]FDG-PET/CT has the potential to improve the identification of the genetic clusters of pheochromocytomas and paragangliomas. • A simplified model with SUVmax only might be preferred clinically, weighing model performances against the laborious radiomic analysis. • Cluster 1 and 2 PPGLs generally present distinctive characteristics that can be captured using [18F]FDG-PET imaging. Sporadic PPGLs appear more heterogeneous, frequently resembling cluster 2 PPGLs and occasionally resembling cluster 1 PPGLs.

Systematic Review of Health Economic Evaluations Focused on Artificial Intelligence in Healthcare: The Tortoise and the Cheetah.

OBJECTIVES: This study aimed to systematically review recent health economic evaluations (HEEs) of artificial intelligence (AI) applications in healthcare. The aim was to discuss pertinent methods, reporting quality and challenges for future implementation of AI in healthcare, and additionally advise future HEEs. METHODS: A systematic literature review was conducted in 2 databases (PubMed and Scopus) for articles published in the last 5 years. Two reviewers performed independent screening, full-text inclusion, data extraction, and appraisal. The Consolidated Health Economic Evaluation Reporting Standards and Philips checklist were used for the quality assessment of included studies. RESULTS: A total of 884 unique studies were identified; 20 were included for full-text review, covering a wide range of medical specialties and care pathway phases. The most commonly evaluated type of AI was automated medical image analysis models (n = 9, 45%). The prevailing health economic analysis was cost minimization (n = 8, 40%) with the costs saved per case as preferred outcome measure. A total of 9 studies (45%) reported model-based HEEs, 4 of which applied a time horizon >1 year. The evidence supporting the chosen analytical methods, assessment of uncertainty, and model structures was underreported. The reporting quality of the articles was moderate as on average studies reported on 66% of Consolidated Health Economic Evaluation Reporting Standards items. CONCLUSIONS: HEEs of AI in healthcare are limited and often focus on costs rather than health impact. Surprisingly, model-based long-term evaluations are just as uncommon as model-based short-term evaluations. Consequently, insight into the actual benefits offered by AI is lagging behind current technological developments.

68Ga-PSMA Cerenkov luminescence imaging in primary prostate cancer: first-in-man series.

PURPOSE: Currently, approximately 11-38% of prostate cancer (PCa) patients undergoing radical prostatectomy have a positive surgical margin (PSM) on histopathology. Cerenkov luminescence imaging (CLI) using 68Ga-prostate-specific membrane antigen (68Ga-PSMA) is a novel technique for intraoperative margin assessment. The aim of this first-in-man study was to investigate the feasibility of intraoperative 68Ga-PSMA CLI. In this study, feasibility was defined as the ability to distinguish between a positive and negative surgical margin, imaging within 45 min and low radiation exposure to staff. METHODS: Six patients were included in this ongoing study. Following perioperative i.v. injection of ~ 100 MBq 68Ga-PSMA, the prostate was excised and immediately imaged ex vivo. Different acquisition protocols were tested, and hotspots on CLI images from the intact prostate were marked for comparison with histopathology. RESULTS: By using an acquisition protocol with 150 s exposure time, 8 × 8 binning and a 550 nm shortpass filter, PSMs and negative surgical margins (NSMs) were visually correctly identified on CLI in 3 of the 5 patients. Two patients had a hotspot on CLI from cancer < 0.1 mm from the excision margin. CONCLUSION: Overall, the study showed that 68Ga-PSMA CLI is a feasible and low-risk technique for intraoperative margin assessment in PCa. The remaining patients in this ongoing study will be used to assess the diagnostic accuracy of the technique. TRIAL REGISTRATION: NL8256 registered at www.trialregister.nl on 04/11/20109.

Assessment of Dynamic Change of Coronary Artery Geometry and Its Relationship to Coronary Artery Disease, Based on Coronary CT Angiography.

To investigate the relationship between dynamic changes of coronary artery geometry and coronary artery disease (CAD) using computed tomography (CT). Seventy-one patients underwent coronary CT angiography with retrospective electrocardiographic gating. End-systolic (ES) and end-diastolic (ED) phases were automatically determined by dedicated software. Centerlines were extracted for the right and left coronary artery. Differences between ES and ED curvature and tortuosity were determined. Associations of change in geometrical parameters with plaque types and degree of stenosis were investigated using linear mixed models. The differences in number of inflection points were analyzed using Wilcoxon signed-rank tests. Tests were done on artery and segment level. One hundred thirty-seven arteries (64.3%) and 456 (71.4%) segments were included. Curvature was significantly higher in ES than in ED phase for arteries (p = 0.002) and segments (p < 0.001). The difference was significant only at segment level for tortuosity (p = 0.005). Number of inflection points was significantly higher in ES phase on both artery and segment level (p < 0.001). No significant relationships were found between degree of stenosis and plaque types and dynamic change in geometrical parameters. Non-invasive imaging by cardiac CT can quantify change in geometrical parameters of the coronary arteries during the cardiac cycle. Dynamic change of vessel geometry through the cardiac cycle was not found to be related to the presence of CAD.

Analysis of the position of EndoAnchor implants in therapeutic use during endovascular aneurysm repair.

OBJECTIVE: The aim of this study was to analyze the penetration depth, angles, distribution, and location of deployment of individual EndoAnchor (Medtronic Vascular, Santa Rosa, Calif) implants. METHODS: Eighty-six primary and revision arm patients (procedural success, 53; persistent type IA endoleak, 33) treated for type IA endoleaks with a total of 580 EndoAnchor implants from a subset of the Aneurysm Treatment Using the Heli-FX Aortic Securement System Global Registry (ANCHOR) were included in this study. Procedural success was defined as the absence of a type IA endoleak on the first postprocedural computed tomography scan after the EndoAnchor implantation procedure. Endograft malapposition along the circumference was assessed at the first postoperative computed tomography scans and expressed as clock-face range and width in degrees and normalized such that the center was translated to 0 degrees. The position and penetration of each EndoAnchor implant were measured as the clock-face orientation. EndoAnchor implant penetration into the aortic wall was categorized as follows: good penetration, ≥2 mm; borderline penetration, <2 mm or ≥2-mm gap between the endograft and aortic wall; or no penetration. The orthogonal and longitudinal angles between the EndoAnchor implant and the interface plane of the aortic wall were determined. Location of deployment was investigated for each EndoAnchor implant and classified as maldeployed when it was above the fabric or in a gap >2 mm between the endograft and aortic wall due to >2-mm thrombus or positioning of the EndoAnchor implant below the aortic neck. RESULTS: A total of 170 (29%) EndoAnchor implants had maldeployment and were therefore beyond recommended use and not useful. After EndoAnchor implantation, the procedural success and persistent type IA endoleak groups had 3 (1%) and 4 (2%) EndoAnchor implants positioned above the fabric as well as 60 (18%) and 103 (42%) placed in a gap >2 mm, respectively. The amount of EndoAnchor implants with good, borderline, and no penetration was significantly different between both groups (success vs type IA endoleak) after exclusion of maldeployed EndoAnchor implants (235 [87.4%], 14 [5.2%], and 20 [7.4%] vs 97 [68.8%], 18 [12.8%], and 26 [18.4%], respectively; P < .001). Good penetration EndoAnchor implants were more closely aligned with a 90-degree orthogonal angle than the borderline penetration and nonpenetrating EndoAnchor implants. The longitudinal angle was more distributed, which was observed through all three penetration groups. CONCLUSIONS: In this subcohort of ANCHOR patients, almost 30% of the EndoAnchor implants had maldeployment, which may be prevented by careful preoperative planning and measured intraoperative deployment. If endoleaks are due to >2-mm gaps, EndoAnchor implants alone may not provide the intended sealing, and additional devices should be considered.

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.

Changes in Apposition of Endograft Limbs in the Iliac Arteries After Endovascular Aneurysm Repair: Determination With New Computed Tomography-Applied Software.

Purpose: To validate new computed tomography (CT)-applied software used to determine endograft limb position and apposition after endovascular aneurysm repair (EVAR). Materials and Methods: Twelve EVAR patients (mean age 81±6 years; 10 men) with distal stent-graft extensions for 15 (3 bilateral) type Ib endoleaks during follow-up were selected based on the availability of the following CT studies: pre-EVAR, 1 month, and the penultimate scan prior to the scan disclosing the type Ib endoleak. Twelve patients (mean age 82±7 years; 11 men) without endoleak and a similar interval between the primary EVAR procedure and the penultimate CT scan of the endoleak group were selected as controls using measurements from both endograft limbs (n=21, 3 excluded). Prototype Vascular Imaging Analysis software was adapted to calculate 6 parameters for the distal apposition zone: fabric distance, shortest apposition length, endograft diameter, iliac seal surface (ISS), iliac endograft apposition surface (IEAS), and percentage of iliac surface coverage (IEAS/ISS × 100). Measurements were performed on the preoperative, first postoperative, and penultimate/matched follow-up CT scans. Interobserver variability was assessed with the intraclass correlation coefficient (ICC). Continuous data are presented as the median [interquartile range (IQR) Q1, Q3]. Results: CTA follow-up was not significantly different between the endoleak and control groups [30 months (IQR 18, 58) vs 36 months (IQR 21, 59), p=0.843]. Interobserver agreement was good to excellent for all parameters (ICC 0.879-0.985). Preoperative anatomy and endograft dimensions on the first follow-up CTA scan did not differ significantly between the groups. When the penultimate CTA scan was compared with the first postoperative CT scan, endograft dimensions had significantly changed in the endoleak group; importantly, apposition was significantly decreased, and fabric distance was significantly increased, indicating limb retraction. Differences in changes in endograft dimensions were significant between the groups. Conclusion: New CT-applied software was introduced to visualize apposition and position changes of endograft limbs during follow-up. The software demonstrated good-to-excellent interobserver agreement and enabled accurate analysis of post-EVAR endograft dimensions. Significant changes in apposition and position were observed with the software on the penultimate CT scan prior to diagnosis of type Ib endoleak.

Effect of Different EndoAnchor Configurations on Aortic Endograft Displacement Resistance: An Experimental Study.

Purpose: This study investigated the effect of different EndoAnchor configurations on aortic endograft displacement resistance in an in vitro model. Materials and Methods: An in vitro model was developed and validated to perform displacement force measurements on different EndoAnchor configurations within an endograft and silicone tube. Five EndoAnchor configurations were created: (1) 6 circumferentially deployed EndoAnchors, (2) 5 EndoAnchors within 120° of the circumference and 1 additional, contralateral EndoAnchor, (3) 4 circumferentially deployed EndoAnchors, (4) 2 rows of 4 circumferentially deployed EndoAnchors, and (5) a configuration of 2 columns of 3 EndoAnchors. An experienced vascular surgeon deployed EndoAnchors under C-arm guidance at the proximal sealing zone of the endograft. A constant force with increments of 1 newton (N) was applied to the distal end of the endograft. The force necessary to displace a part of the endograft by 3 mm was defined as the endograft displacement force (EDF). Two video cameras recorded the measurements. Videos were examined to determine the exact moment 3-mm migration had occurred at part of the endograft. Five measurements were performed after each deployed EndoAnchor for each configuration. Measurements are given as the median and interquartile range (IQR) Q1, Q3. Results: Baseline displacement force measurement of the endograft without EndoAnchors resulted in a median EDF of 5.1 N (IQR 4.8, 5.2). The circumferential distribution of 6 EndoAnchors resulted in a median EDF of 53.7 N (IQR 49.0, 59.0), whereas configurations 2 through 5 demonstrated substantially lower EDFs of 29.0 N (IQR 28.5, 30.1), 24.6 N (IQR 21.9, 27.2), 36.7 N, and 9.6 N (IQR 9.4, 10.0), respectively. Decreasing the distance between the EndoAnchors over the circumference of the endograft increased the displacement resistance. Conclusion: This in vitro study demonstrates the influence EndoAnchor configurations have on the displacement resistance of an aortic endograft. Parts of the endograft where no EndoAnchor has been deployed remain sensitive to migration. In the current model, the only configuration that rivaled a hand-sewn anastomosis was the one with 6 EndoAnchors. A circumferential distribution of EndoAnchors with small distances between EndoAnchors should be pursued, if possible. This study provides a quantification of different EndoAnchor configurations that clinicians may have to adopt in clinical practice, which can help them make a measured decision on where to deploy EndoAnchors to ensure good endograft fixation.

Sustainability of Individual EndoAnchor Implants in Therapeutic Use to Treat Type Ia Endoleak After Endovascular Aneurysm 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.

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.

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.

Vessel wall enhancement of intracranial aneurysms: fact or artifact?

OBJECTIVE: For patients with subarachnoid hemorrhage (SAH) and multiple intracranial aneurysms, it is often challenging to identify the ruptured aneurysm. Some investigators have asserted that vessel wall imaging (VWI) can be used to identify the ruptured aneurysm since wall enhancement after contrast agent injection is presumably related to inflammation in unstable and ruptured aneurysms. The aim of this study was to determine whether additional factors contribute to aneurysm wall enhancement by assessing imaging data in a series of patients. METHODS: Patients with symptoms of SAH who subsequently underwent VWI in the period between January 2017 and September 2018 were eligible for study inclusion. Three-dimensional turbo spin-echo sequences with motion-sensitized driven-equilibrium preparation pulses were acquired using a 3-T MRI scanner to visualize the aneurysm wall. Identification of the ruptured aneurysm was based on aneurysm characteristics and hemorrhage distributions on MRI. Complementary imaging data (CT, DSA, MRI) were used to assess potential underlying enhancement mechanisms. Additionally, aneurysm luminal diameter measurements on MRA were compared with those on contrast-enhanced VWI to assess the intraluminal contribution to aneurysm enhancement. RESULTS: Six patients with 14 aneurysms were included in this series. The mean aneurysm size was 5.8 mm (range 1.1-16.9 mm). A total of 10 aneurysms showed enhancement on VWI; 5 ruptured aneurysms showed enhancement, and 1 unruptured but symptomatic aneurysm showed enhancement on VWI and ruptured 1 day later. Four unruptured aneurysms showed enhancement. In 6 (60%) of the 10 enhanced aneurysms, intraluminal diameters appeared notably smaller (≥ 0.8 mm smaller) on contrast-enhanced VWI compared to their appearance on multiple overlapping thin slab acquisition time of flight (MOTSA-TOF) MRA and/or precontrast VWI, suggesting that enhancement was at least partially in the aneurysm lumen itself. CONCLUSIONS: Several factors other than the hypothesized inflammatory response contribute to aneurysm wall enhancement. In 60% of the cases in this study, enhancement was at least partially caused by slow intraaneurysmal flow, leading to pseudo-enhancement of the aneurysm wall. Notwithstanding, there seems to be clinical value in differentiating ruptured from unruptured aneurysms using VWI, but the hypothesis that we image the inflammatory cell infiltration in the aneurysm wall is not yet confirmed.

Insufficient slow-flow suppression mimicking aneurysm wall enhancement in magnetic resonance vessel wall imaging: a phantom study.

OBJECTIVE: MR vessel wall imaging (VWI) is increasingly performed in clinical settings to support treatment decision-making regarding intracranial aneurysms. Aneurysm wall enhancement after contrast agent injection is expected to be related to aneurysm instability and rupture status. However, the authors hypothesize that slow-flow artifacts mimic aneurysm wall enhancement. Therefore, in this phantom study they assess the effect of slow flow on wall-like enhancement by using different MR VWI techniques. METHODS: The authors developed an MR-compatible aneurysm phantom model, which was connected to a pump to enable pulsatile inflow conditions. For VWI, 3D turbo spin echo sequences-both with and without motion-sensitized driven equilibrium (MSDE) and delay alternating with nutation for tailored excitation (DANTE) preparation pulses-were performed using a 3-T MR scanner. VWI was acquired both before and after Gd contrast agent administration by using two different pulsatile inflow conditions (2.5 ml/sec peak flow at 77 and 48 beats per minute). The intraluminal signal intensity along the aneurysm wall was analyzed to assess the performance of slow-flow suppression. RESULTS: The authors observed wall-like enhancement after contrast agent injection, especially in low pump rate settings. Preparation pulses, in particular the DANTE technique, improved the performance of slow-flow suppression. CONCLUSIONS: Near-wall slow flow mimics wall enhancement in VWI protocols. Therefore, VWI should be carefully interpreted. Preparation pulses improve slow-flow suppression, and therefore the authors encourage further development and clinical implementation of these techniques.

Intracranial aneurysm growth: consistency of morphological changes.

OBJECTIVE: Previous studies have shown a relation between growth and rupture of intracranial aneurysms. Additionally, several morphological characteristics are frequently measured to estimate rupture risk. Little is known about how the rupture risk is associated with morphological characteristic changes during growth. The aim of this study was to provide insights into how morphological characteristics, associated with rupture, change during an aneurysm's growth. METHODS: The authors retrospectively identified patients with longitudinal MRA images of unruptured growing aneurysms. The MRA images had an in-plane resolution of 0.2-0.5 mm and a slice thickness of 0.2-0.75 mm. Therefore, growth was defined as an increase of at least 0.5 mm in two directions or 1 mm in one direction. Using the MRA images, the authors semiautomatically segmented the aneurysm and the perianeurysmal vasculature. Twelve morphological characteristics were automatically measured. These characteristics were related to size (diameter, height, width, neck diameter, volume, surface area, aspect ratio, height-width ratio, and bottleneck factor) and shape (ellipticity index, nonsphericity index, and undulation index) of the aneurysm. Morphological characteristics before and after growth were compared using the Wilcoxon signed-rank test. RESULTS: The authors included 31 patients with 38 growing aneurysms. The aneurysms' growth was detected after a mean of 218 weeks (range 23-567 weeks). A significant increase was seen in all size-related characteristics, and the bottleneck factor also significantly increased (from a median of 1.00 [IQR 0.85-1.04] to 1.03 [IQR 0.93-1.18]), while the ellipticity index decreased (from a median of 0.26 [IQR 0.25-0.28] to 0.25 [IQR 0.24-0.26]). The changes in size ratios and shape indices varied largely among patients. Larger aneurysms more often showed an increase in shape ratios. CONCLUSIONS: Although aneurysm growth, size-related characteristics, bottleneck factor, and ellipticity index changed significantly during growth, most size ratios and shape indices showed inconsistent changes among aneurysms. This suggests that, for an accurate rupture prediction, morphological parameters need to be reassessed after growth.

Absence of Cortical Vein Opacification Is Associated with Lack of Intra-arterial Therapy Benefit in Stroke.

Purpose To assess the degree of cortical vein opacification in patients with internal carotid artery or middle cerebral artery (MCA) stroke and to evaluate the relationship with treatment benefit from intra-arterial therapy (IAT). Materials and Methods Written informed consent was obtained from all patients in the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands. From the trial's database, all patients (recruited from December 2010 until March 2014) with baseline computed tomographic (CT) angiograms were retrospectively included. Enhancement of the vein of Labbé, sphenoparietal sinus, and superficial middle cerebral vein was graded by one neuroradiologist, as follows: 0, not visible; 1, moderate opacification; and 2, full opacification. The sum for the ipsilateral hemisphere was calculated, resulting in the cortical vein opacification score (COVES) (range, 0-6). Primary outcome was the modified Rankin Scale score at 90 days. Association with treatment according to full cortical vein score and different dichotomized cutoff points was estimated with ordinal logistic regression. Interobserver agreement was assessed by two separate observers who reviewed 100 studies each. Results In total, 397 patients were analyzed. Interaction of the cortical vein score with treatment was significant (P = .044) when dichotomized COVES was 0 versus more than 0. The adjusted odds ratio for shift toward better functional outcome was 1.0 (95% confidence interval [CI]: 0.5, 2.0) for a COVES of 0 (n = 123) and 2.2 (95% CI: 1.6, 4.1) for a COVES greater than 0 (n = 274). The multirater κ value was 0.73. Conclusion In this study, patients with acute middle cerebral artery stroke with absence of cortical vein opacification in the affected hemisphere (COVES = 0) appeared to have no benefit from IAT, whereas patients with venous opacification (COVES >0) were shown to benefit from IAT. © RSNA, 2017 Clinical trial registration nos. NTR(1804) and ISRCTN10888758 Online supplemental material is available for this article.