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

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

Randomized trial of Legflow® paclitaxel eluting balloon and stenting versus standard percutaneous transluminal angioplasty and stenting for the treatment of intermediate and long lesions of the superficial femoral artery (RAPID trial): Study protocol for a randomized controlled trial

Background: Restenosis after percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) may occur in 45% of patients at 2 years follow-up. Paclitaxel-coated balloons have been found to reduce neointimal hyperplasia, and thus reduce restenosis. Recently, the Legflow® paclitaxel-coated balloon (Cardionovum Sp.z.o.o., Warsaw, Poland) (LPEB) has been introduced. This balloon is covered with shellac, a Food and Drug Administration (FDA) approved natural resin, to obtain an equally distributed tissue concentration of paclitaxel. The RAPID trial is designed to assess restenosis after PTA using the Legflow balloon combined with nitinol stenting versus uncoated balloons with nitinol stenting in SFA lesions >5 cm.Methods/Design: A total of 176 adult patients with Rutherford class 2 to class 6 symptoms due to intermediate (5-15 cm) or long (>15 cm) atherosclerotic lesions in the SFA will be randomly allocated for treatment with LPEB with nitinol stenting or uncoated balloon angioplasty with stenting. Stenting will be performed using the Supera® stent in both groups (IDEV Technologies Inc., Webster, TX). The primary endpoint is the absence of binary restenosis of the treated SFA segment. Secondary outcomes are target lesion revascularization (TLR), clinical and hemodynamic outcome, amputation rate, mortality rate, adverse events, and device-specific adverse events. Follow up consists of four visits in which ankle-brachial indices (ABI), toe pressure measurements, and duplex ultrasound (DUS) will be performed. Furthermore, a peripheral artery questionnaire (PAQ) will be completed by the patients at each follow-up. In the event that DUS reveals a symptomatic >50% restenosis, or a >75% asymptomatic restenosis, additional digital subtraction angiography will be performed with any necessary re-intervention.Discussion: The RAPID trial is a multicenter randomized controlled patient blind trial that will provide evidence concerning whether the use of the Legflow paclitaxel/shellac coated balloons with nitinol stenting significantly reduces the frequency of restenosis in intermediate and long SFA lesions compared to standard PTA and stenting.Trial registration: ISRCTN47846578

Local Ultrasound-Facilitated Thrombolysis in High-Risk Pulmonary Embolism: First Dutch Experience

Purpose To provide insight into the current use and results of ultrasound-facilitated catheter-directed thrombolysis (USAT) in patients with high-risk pulmonary embolism (PE). Introduction Systemic thrombolysis is an effective treatment for hemodynamically unstable, high-risk PE, but is associated with bleeding complications. USAT is thought to reduce bleeding and is therefore advocated in patients with high-risk PE and contraindications for systemic thrombolysis. Methods We conducted a retrospective cohort study of all patients who underwent USAT for high-risk PE in the Netherlands from 2010 to 2017. Characteristics and outcomes were analyzed. Primary outcomes were major (including intracranial and fatal) bleeding and all-cause mortality after 1 month. Secondary outcomes were allcause mortality and recurrent venous thromboembolism within 3 months. Results 33 patients underwent USAT for high-risk PE. Major bleeding occurred in 12 patients (36%, 95% CI 22–53), including 1 intracranial and 3 fatal bleeding. Allcause mortality after 1 month was 48% (16/33, 95% CI 31–66). All-cause mortality after 3 months was 50% (16/ 32, 95% CI 34–66), recurrent venous thromboembolism occurred in 1 patient (1/32, 3%, 95% CI 1–16). Conclusions This study was the first to describe characteristics and outcomes after USAT in a study population of patients with high-risk PE only, an understudied population. Although USAT is considered a relatively safe treatment option, our results illustrate that at least caution is needed in critically ill patients with high-risk PE. Further research in patients with high-risk PE is warranted to guide patient selection

Care after pancreatic resection according to an algorithm for early detection and minimally invasive management of pancreatic fistula versus current practice (PORSCH-trial): design and rationale of a nationwide stepped-wedge cluster-randomized trial

BACKGROUND: Pancreatic resection is a major abdominal operation with 50% risk of postoperative complications. A common complication is pancreatic fistula, which may have severe clinical consequences such as postoperative bleeding, organ failure and death. The objective of this study is to investigate whether implementation of an algorithm for early detection and minimally invasive management of pancreatic fistula may improve outcomes after pancreatic resection. METHODS: This is a nationwide stepped-wedge, cluster-randomized, superiority trial, designed in adherence to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. During a period of 22 months, all Dutch centers performing pancreatic surgery will cross over in a randomized order from current practice to best practice according to the algorithm. This evidence-based and consensus-based algorithm will provide da

Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI): Study protocol for a randomized controlled trial

Background: Chronic mesenteric ischemia (CMI) is the result of insufficient blood supply to the gastrointestinal tract and is caused by atherosclerotic stenosis of one or more mesenteric arteries in > 90% of cases. Revascularization therapy is indicated in patients with a diagnosis of atherosclerotic CMI to relieve symptoms and to prevent acute-on-chronic mesenteric ischemia, which is associated with high morbidity and mortality. Endovascular therapy has rapidly evolved and has replaced surgery as the first choice of treatment in CMI. Bare-metal stents (BMS) are standard care currently, although retrospective studies suggested significantly highe

How to define the hemodynamic significance of an equivocal iliofemoral artery stenosis: review of literature and outcomes of an international questionnaire

Purpose: The goal of the study was to review current literature regarding the diagnosis of equivocal (50–70%) iliofemoral artery stenosis and compare these findings with the daily practice of an international panel of endovascular experts. Methods: The Medline Database was searched for relevant publications, and an electronic survey was sent to experts in the field covering the following topics: definition of an equivocal iliofemoral artery stenosis, angiographic visualization and investigation protocols of an equivocal stenosis, intra-arterial pressure measurements, and definition of hemodynamic significance of an equivocal iliofemoral artery stenosis using a physiologic measure. Results: Of the 37 invited endovascular experts, 21 (53.8%) agreed to participate in the survey. Analysis of existing literature shows that the level of evidence for diagnosing equivocal iliofemoral artery stenosis is mediocre and is not being implemented by experts in the field. Conclusion: Studies have shown that a stenosis of between 50% and 70% iliofemoral lumen diameter reduction shows a wide range of trans-stenotic pressure gradients. Equivocal iliofemoral artery stenosis can best be identified using three-dimensional quantitative vascular analysis software. Although evidence for a clear hemodynamic cutoff point is weak, performing trans-lesion intra-arterial pressure measurements at rest and during maximal hyperemia is preferred. Diagnosing iliofemoral artery stenosis solely on lumen diameter reduction is inadequate

A geometry-based model for non-invasive estimation of pressure gradients over iliac artery stenoses

The aim of this study was to develop and verify a model that provides an accurate estimation of the trans-lesion hyperemic pressure gradient in iliac artery stenoses in seconds by only using patient-specific geometric properties obtained from 3-dimensional rotational angiography (3DRA). Twenty-one patients with symptomatic peripheral arterial disease (PAD), iliac artery stenoses and an ultrasound based peak systolic velocity ratio between 2.5 and 5.0 underwent 3DRA and intra-arterial pressure measurements under hyperemic conditions. For each lesion, geometric properties were extracted from the 3DRA images using quantitative vascular analysis software. Hyperemic blood flow was estimated based on stenosis geometry using an empirical relation. The geometrical properties and hyperemic flow were used to estimate the pressure gradient by means of the geometry-based model. The predicted pressure gradients were compared with in vivo measured intra-arterial pressure measurements performed under hyperemic conditions. The developed geometry-based model showed good agreement with the measured hyperemic pressure gradients resulting in a concordance correlation coefficient of 0.86. The mean bias ± 2SD between the geometry-based model and in vivo measurements was comparable to results found by evaluating the actual computational fluid dynamics model (−1.0 ± 14.7 mmHg vs −0.9 ± 12.7 mmHg). The developed model estimates the trans-lesional pressure gradient in seconds without the need for an additional computational fluid dynamics software package. The results justify further study to assess the potential use of a geometry-based model approach to estimate pressure gradient on non-invasive CTA or MRA, thereby reducing the need for diagnostic angiography in patients suffering from PAD

A metamodeling approach for instant severity assessment and uncertainty quantification of iliac artery stenoses

Two-dimensional (2D) or three-dimensional (3D) models of blood flow in stenosed arteries can be used to patient-specifically predict outcome metrics, thereby supporting the physicians in decision making processes. However, these models are time consuming which limits the feasibility of output uncertainty quantification (UQ). Accurate surrogates (metamodels) might be the solution. In this study, we aim to demonstrate the feasibility of a generalized polynomial chaos expansion-based metamodel to predict a clinically relevant output metric and to quantify the output uncertainty. As an example, a metamodel was constructed from a recently developed 2D model that was shown to be able to estimate translesional pressure drops in iliac artery stenoses (-0.9 ± 12.7 mmHg, R2 = 0.81). The metamodel was constructed from a virtual database using the adaptive generalized polynomial chaos expansion (agPCE) method. The constructed metamodel was then applied to 25 stenosed iliac arteries to predict the patient-specific pressure drop and to perform UQ. Comparing predicted pressure drops of the metamodel and in vivo measured pressure drops, the mean bias (-0.2 ± 13.7 mmHg) and the coefficient of determination (R2 = 0.80) were as good as of the original 2D computational fluid dynamics (CFD) model. UQ results of the 2D and metamodel were comparable. Estimation of the uncertainty interval using the original 2D model took 14 days, whereas the result of the metamodel was instantly available. In conclusion, it is feasible to quantify the uncertainty of the output metric and perform sensitivity analysis (SA) instantly using a metamodel. Future studies should investigate the possibility to construct a metamodel of more complex problems

Aortic curvature instead of angulation allows improved estimation of the true aorto-iliac trajectory

Objective: Supra- and infrarenal aortic neck angulation have been associated with complications after endovascular aortic aneurysm repair. However, a uniform angulation measurement method is lacking and the concept of angulation suggests a triangular oversimplification of the aortic anatomy. (Semi-)automated calculation of curvature along the center luminal line describes the actual trajectory of the aorta. This study proposes a methodology for calculating aortic (neck) curvature and suggests an additional method based on available tools in current workstations: curvature by digital calipers (CDC). Methods: Proprietary custom software was developed for automatic calculation of the severity and location of the largest supra- and infrarenal curvature over the center luminal line. Twenty-four patients with severe supra- or infrarenal angulations (≥45°) and 11 patients with small to moderate angulations (<45°) were included. Both CDC and angulation were measured by two independent observers on the pre- and postoperative computed tomographic angiography scans. The relationships between actual curvature and CDC and angulation were visualized and tested with Pearson's correlation coefficient. The CDC was also fully automatically calculated with proprietary custom software. The difference between manual and automatic determination of CDC was tested with a paired Student t test. A p-value was considered significant when two-tailed α <.05. Results: The correlation between actual curvature and manual CDC is strong (.586-.962) and even stronger for automatic CDC (.865-.961). The correlation between actual curvature and angulation is much lower (.410-.737). Flow direction angulation values overestimate CDC measurements by 60%, with larger variance. No significant difference was found in automatically calculated CDC values and manually measured CDC values. Conclusion: Curvature calculation of the aortic neck improves determination of the true aortic trajectory. Automatic calculation of the actual curvature is preferable, but measurement or calculation of the curvature by digital calipers is a valid alternative if actual curvature is not at hand

What is needed to make cardiovascular models suitable for clinical decision support?: a viewpoint paper

The potential impact of hemodynamic and vascular wall models on the diagnosis, treatment, and well-being of thousands of patients suffering from cardiovascular diseases, is tremendous. Despite the potential impact, it is not straightforward to use these models for individualized diagnosis and intervention planning (model predictive decision support). Major challenges are the adaptation of the models to patient-specific conditions and the necessary uncertainty assessment of the simulated outcome measures.In this manuscript, we will present our view on what is needed to make cardiovascular models suitable for clinical decision support. Hereto, we will first describe how an engineer might support clinical decisions. Secondly, we will give a description of the challenges faced by the engineers. Finally we will introduce an innovative approach in which model personalization is guided by sensitivity analysis, and in which the effect of input uncertainties and model assumptions (acknowledged model errors) on model predictions are considered during model corroboration. The approach is illustrated by two different vascular cases.Hopefully our view will be useful in bringing models from the pre-clinical phase to the clinical phase where they will actually be used for model predictive decision support