Mapping the coordination and cooperation mechanisms of risk communication on feed/food safety in the EU.

The mapping of the EU coordination and cooperation mechanisms of risk communication in the field of food safety (i.e. encompassing all matters pertaining to the feed and food chain) was conducted for the European Food Safety Authority (EFSA), following a mandate by the European Commission, to inform the General Plan for Risk Communication that the Commission will set out. This study focuses on communication activities in 'peacetime' situations (i.e. non-crisis) on the published outputs of risk assessment and risk management. This is a specific part of the risk communication process defined in the General Food Law. Data were collected through an online survey of competent authority organisations involved in risk communication at national and regional levels in the EU-27 Member States and Norway; and interviews with selected organisations at Member State, EU and international levels. Based on these data, this report provides an overview of the current information flow of risk communication, in terms of whether and how organisations at all levels receive, produce, and disseminate risk communication material. The existing flows in each country are described and mapped in flow charts. Flows are also presented for each of the EU/international organisations involved in risk communication on food safety. A number of relevant networks are identified that actively engage in sharing/exchanges of risk communication material on food safety, including networks managed by EFSA. This project also highlighted certain challenges in current risk communication systems, and recommendations are made to address them. At national level, these are: an increase in resources dedicated to coordinating communication on EU food safety issues, to improve capacity to undertake this task; strengthen the cooperation and coordination between authorities involved in risk communication activities to ensure a more proactive approach. In addition, recommendations are provided to enhance further collaboration of communication activities at all levels (between Member States and with EFSA; between EU Agencies), so that the coordination of risk communication at EU level follows a partnership approach.

Novel flat-panel cone-beam CT compared to multi-detector CT for assessment of acute ischemic stroke: A prospective study.

PURPOSE: Cone beam CT (CBCT) imaging assessment of acute ischemic stroke (AIS) patients with large-vessel occlusion (LVO) in the angiosuite may improve stroke workflow and decrease time to recanalization. In order for this workflow to gain widespread acceptance, current CBCT imaging needs further development to improve image quality. Our study aimed to compare the image quality of a new CBCT protocol performed directly in the angiosuite with imaging from multidetector CT as a gold standard. METHODS: AIS patients with an LVO who were candidates for endovascular treatment were prospectively included in this study. Following conventional multidetector CT (MDCT), patients underwent unenhanced cone beam CT (XperCT, Philips) imaging in the angiosuite, using two different protocols: a standard 20.8 s XperCT and/or an improved 10.4 s XperCT protocol. Images were evaluated using both qualitative and quantitative methods. RESULTS: We included 65 patients in the study. Patients received CBCT imaging prior to endovascular treatment; 18 patients were assessed with a standard 20.8 s protocol scans and 47 with a newer 10.4 s scan. The quantitative analysis showed that the mean contrast-to-noise ratio (CNR) was significantly higher for the newer 10.4 s protocol compared with the 20.8 s protocol (2.08 +/- 0.64 vs. 1.15 +/- 0.27, p < 0.004) and the mean image noise was significantly lower for the 10.4 s XperCTs when compared with the 20.8 s XperCTs (6.30 +/- 1.34 vs. 7.82 +/- 2.03, p=<0.003). Qualitative analysis, including 6 measures of image quality, demonstrated that 74.1 % of the 10.4 s XperCT scans were ranked as 'Acceptable' for assessing parenchymal imaging in AIS patients(scoring 3-5 points on a 5-point Likert-scale), compared with 32.4 % of the standard 20.8 s XperCT and 100 % of the MDCT scans. Compared to the MDCT studies, 83 % of the 10.4 s XperCT scans were deemed sufficient image quality for a direct-to-angiosuite selection, compared to only 11 % for the standard 20.8 s scans. The largest image quality improvements included grey/white matter differentiation (59 % improvement), and reduction of image noise and artefacts (63 % & 50 % improvement, respectively). CONCLUSIONS: Continued advances in cone-beam CT allow marked improvements in image quality for the assessment of brain parenchyma, which supports a direct-to-angiosuite approach for AIS patients eligible for thrombectomy treatment.

Diagnostic Utility of Three-Dimensional Rotational Angiography in Congenital Cardiac Catheterization.

We evaluated the diagnostic utility of the three modalities of three-dimensional rotational angiography (3DRA): rotational angiography (RA), multiplanar reformat (MPR) and three-dimensional angiographic reconstruction (3D-R) in pediatric cardiac catheterization. The 3DRA studies were classified by anatomy of interest based on our injection protocol: pulmonary arteries (PA), aorta, cavopulmonary connection (CPC), and others. Retrospective review of 3DRA images by two reviewers for each modality was conducted with grading as inferior, similar, or superior in comparison with the diagnostic quality of fixed-plane angiography (FPA). The percentages of grades for each modality were averaged. Weighted kappa statistic was used to evaluate inter-rater reliability. In total, 114 3DRA studies were performed on 87 patients between August 2010 and March 2012. Median age was 2.7 years (1 day-48.4 years) and median weight 12.1 kg (3.6-106.5 kg). For RA: 79.4 % of the studies were of diagnostic quality and 52.2 % were superior; 3D-R: 82 % were of diagnostic quality and 65.8 % were superior; and MPR: 83.5 % were of diagnostic quality and 63 % were superior. Overall 3DRA technologies (RA, 3D-R, MPR) were of diagnostic quality or better in 111/114 (97.4 %) studies and 103/114 (90.4 %) were judged superior. Most common reasons for inferior grading were limited opacification and metallic artifact. In pediatric cardiac catheterization, 3DRA imaging was of diagnostic quality and frequently provided additional clinically relevant data when compared to FPA.

Feasibility and Safety of Using a Fused Echocardiography/Fluoroscopy Imaging System in Patients with Congenital Heart Disease.

BACKGROUND: Fused real-time three-dimensional transesophageal echocardiography and fluoroscopy has been used in adult patients during percutaneous mitral valve and aortic valve procedures. The use of fused echocardiographic/x-ray fluoroscopic imaging (FEX) in pediatric patients undergoing congenital heart disease catheterization has not been evaluated for feasibility and safety. The aims of this study were to assess the feasibility and safety of FEX for interventional guidance and to perform a comparison of atrial septal defect (ASD) device closure using this technology with traditional guidance methods. METHODS: Prospective evaluation of FEX in congenital cardiac interventions was conducted. A subset of patients with ASD closures were compared with patients with historical ASD closures with and without FEX. The interventionalist and echocardiographer rated the anatomic quality of the fusion imaging as (1) excellent, (2) good, or (3) poor. In addition, the utility of FEX procedural guidance was graded as (1) superior, (2) no added benefit, or (3) inferior to that of standard guidance by fluoroscopy and transesophageal echocardiography. RESULTS: FEX was successfully used in 26 procedures on 25 patients with congenital heart disease from January 2013 to February 2015. The median age was 9 years (range, 3-26 years), and the median weight was 29 kg (range, 16-77 kg). Twenty-six procedures were performed, including ASD closure, Fontan fenestration closure, and transcatheter valve placement in the tricuspid valve position. There was reduced fluoroscopy time and radiation dose in patients with ASDs who underwent imaging using this new technology (P < .001 and P < .03, respectively). There were no statistically significant differences in procedural times between the two groups. Anatomic definition was rated as excellent in 20 of 26 procedures, with the remaining six rated was good. Twenty-one of 26 procedures were graded as superior (81%), and five of 26 (19%) were graded as providing no added benefit. There were no complications in any of the procedures. CONCLUSIONS: In this early experience, FEX is feasible and safe in patients undergoing congenital heart disease catheterization and provides useful guidance in the majority of interventional procedures. There were relative reductions in fluoroscopy time and radiation dose with the use of FEX for ASD closure.

Use of short roll C-arm computed tomography and fully automated 3D analysis tools to guide transcatheter aortic valve replacement.

Determination of the coplanar view is a critical component of transcatheter aortic valve replacement (TAVR). The safety and accuracy of a novel reduced angular range C-arm computed tomography (CACT) approach coupled with a fully automated 3D analysis tool package to predict the coplanar view in TAVR was evaluated. Fifty-seven patients with severe symptomatic aortic stenosis deemed prohibitive-risk for surgery and who underwent TAVR were enrolled. Patients were randomized 2:1 to CACT vs. angiography (control) in estimating the coplanar view. These approaches to determine the coplanar view were compared quantitatively. Radiation doses needed to determine the coplanar view were recorded for both the CACT and control patients. Use of CACT offered good agreement with the actual angiographic view utilized during TAVR in 34 out of 41 cases in which a CACT scan was performed (83 %). For these 34 cases, the mean angular magnitude difference, taking into account both oblique and cranial/caudal angulation, was 1.3° ± 0.4°, while the maximum difference was 7.3°. There were no significant differences in the mean total radiation dose delivered to patients between the CACT and control groups as measured by either dose area product (207.8 ± 15.2 Gy cm(2) vs. 186.1 ± 25.3 Gy cm(2), P = 0.47) or air kerma (1287.6 ± 117.7 mGy vs. 1098.9 ± 143.8 mGy, P = 0.32). Use of reduced-angular range CACT coupled with fully automated 3D analysis tools is a safe, practical, and feasible method by which to determine the optimal angiographic deployment view for guiding TAVR procedures.

A Radiation Dose Reduction Technology to Improve Patient Safety During Cardiac Catheterization Interventions.

OBJECTIVES: A novel radiation dose reduction technology was evaluated in a cardiac catheterization laboratory during routine clinical care to determine if it could reduce radiation dose to patients undergoing coronary angiography and percutaneous coronary intervention. These results were compared to patients undergoing similar procedures in a cardiac catheterization laboratory without this technology. BACKGROUND: There is a safety priority in clinical care to reduce X-ray radiation dose to patients in order to lower the risk of deterministic and stochastic effects. Dose reduction technologies must be verified in clinical settings to prove if they reduce X-ray radiation dose and to what extent. METHODS: Radiation dose data and procedure characteristics of 268 consecutive patients were collected and analyzed from a cardiac catheterization laboratory with dose reduction technology installed (referred to as Lab A, n = 135) and from a cardiac catheterization laboratory without this technology (referred as Lab B, n = 133). RESULTS: For diagnostic procedures, the median total dose-area product in Lab A was reduced by 46% (P < 0.0001) compared to Lab B, with no differences in terms of body mass index (P = 0.180), total fluoroscopy times (P = 1), number of acquired images (P = 0.920), and contrast medium (P = 0.660). For interventional procedures, the median total dose-area product in Lab A was reduced by 34% (P = 0.015) compared to Lab B, with no differences in terms of body mass index (P = 0.665), total fluoroscopy times (P = 0.765), number of acquired images (P = 0.923), and contrast medium (P = 0.969). CONCLUSIONS: This new dose reduction technology significantly reduces X-ray radiation dose without affecting fluoroscopy time, number of images, and contrast medium used during diagnostic and interventional coronary procedures.

Multimodality 3-dimensional image integration for congenital cardiac catheterization.

Cardiac catheterization procedures for patients with congenital and structural heart disease are becoming more complex. New imaging strategies involving integration of 3-dimensional images from rotational angiography, magnetic resonance imaging (MRI), computerized tomography (CT), and transesophageal echocardiography (TEE) are employed to facilitate these procedures. We discuss the current use of these new 3D imaging technologies and their advantages and challenges when used to guide complex diagnostic and interventional catheterization procedures in patients with congenital heart disease.

Dynamic volume vs respiratory correlated 4DCT for motion assessment in radiation therapy simulation.

PURPOSE: Conventional (i.e., respiratory-correlated) 4DCT exploits the repetitive nature of breathing to provide an estimate of motion; however, it has limitations due to binning artifacts and irregular breathing in actual patient breathing patterns. The aim of this work was to evaluate the accuracy and image quality of a dynamic volume, CT approach (4D(vol)) using a 320-slice CT scanner to minimize these limitations, wherein entire image volumes are acquired dynamically without couch movement. This will be compared to the conventional respiratory-correlated 4DCT approach (RCCT). METHODS: 4D(vol) CT was performed and characterized on an in-house, programmable respiratory motion phantom containing multiple geometric and morphological "tumor" objects over a range of regular and irregular patient breathing traces obtained from 3D fluoroscopy and compared to RCCT. The accuracy of volumetric capture and breathing displacement were evaluated and compared with the ground truth values and with the results reported using RCCT. A motion model was investigated to validate the number of motion samples needed to obtain accurate motion probability density functions (PDF). The impact of 4D image quality on this accuracy was then investigated. Dose measurements using volumetric and conventional scan techniques were also performed and compared. RESULTS: Both conventional and dynamic volume 4DCT methods were capable of estimating the programmed displacement of sinusoidal motion, but patient breathing is known to not be regular, and obvious differences were seen for realistic, irregular motion. The mean RCCT amplitude error averaged at 4 mm (max. 7.8 mm) whereas the 4D(vol) CT error stayed below 0.5 mm. Similarly, the average absolute volume error was lower with 4D(vol) CT. Under irregular breathing, the 4D(vol) CT method provides a close description of the motion PDF (cross-correlation 0.99) and is able to track each object, whereas the RCCT method results in a significantly different PDF from the ground truth, especially for smaller tumors (cross-correlation ranging between 0.04 and 0.69). For the protocols studied, the dose measurements were higher in the 4D(vol) CT method (40%), but it was shown that significant mAs reductions can be achieved by a factor of 4-5 while maintaining image quality and accuracy. CONCLUSIONS: 4D(vol) CT using a scanner with a large cone-angle is a promising alternative for improving the accuracy with which respiration-induced motion can be characterized, particularly for patients with irregular breathing motion. This approach also generates 4DCT image data with a reduced total scan time compared to a RCCT scan, without the need for image binning or external respiration signals within the 16 cm scan length. Scan dose can be made comparable to RCCT by optimization of the scan parameters. In addition, it provides the possibility of measuring breathing motion for more than one breathing cycle to assess stability and obtain a more accurate motion PDF, which is currently not feasible with the conventional RCCT approach.

Closed bore XMR (CBXMR) systems for aortic valve replacement: active magnetic shielding of x-ray tubes.

Hybrid closed bore x-ray/MRI systems are being developed to improve the safety and efficacy of percutaneous aortic valve replacement procedures by harnessing the complementary strengths of the x-ray and MRI modalities in a single interventional suite without requiring patient transfer between two rooms. These systems are composed of an x-ray C-arm in close proximity (approximately 1 m) to an MRI scanner. The MRI magnetic fringe field can cause the electron beam in the x-ray tube to deflect. The deflection causes the x-ray field of view to shift position on the detector receptacle. This could result in unnecessary radiation exposure to the patient and the staff in the cardiac catheterization laboratory. Therefore, the electron beam deflection must be corrected. The authors developed an active magnetic shielding system that can correct for electron beam deflection to within an accuracy of 5% without truncating the field of view or increasing exposure to the patient. This system was able to automatically adjust to different field strengths as the external magnetic field acting on the x-ray tube was changed. Although a small torque was observed on the shielding coils of the active shielding system when they were placed in a magnetic field, this torque will not impact their performance if they are securely mounted on the x-ray tube and the C-arm. The heating of the coils of the shielding system for use in the clinic caused by electric current was found to be slow enough not to require a dedicated cooling system for one percutaneous aortic valve replacement procedure. However, a cooling system will be required if multiple procedures are performed in one session.

Closed-bore XMR (CBXMR) systems for aortic valve replacement: x-ray tube imaging performance.

A hybrid closed-bore x-ray/MRI system (CBXMR) is proposed to improve the safety and efficacy of percutaneous aortic valve replacement procedures. In this system, an x-ray C-arm will be positioned about 1 m from the entrance of a 1.5 T MRI scanner. The CBXMR system will harness the complementary strengths of both modalities to guide and deploy a bioprosthetic valve into the aortic annulus of the heart without coronary artery obstruction. A major challenge in constructing this system is ensuring proper operation of a rotating-anode x-ray tube in the MRI magnetic fringe field environment. The electron beam in the x-ray tube responsible for producing x rays can be deflected by the fringe field. However, the clinical impact of electron beam deflection in a magnetic field has not yet been studied. Here, the authors investigated changes in focal spot resolving power, field of view shift, and field of view truncation in x-ray images as a result of electron beam deflection. The authors found that in the fringe field acting on the x-ray tube at the clinical location for the x-ray C-arm (4 mT), focal spot size increased by only 2%, so the fringe field did not limit the resolving power of the x-ray system. The magnetic field also caused the field of view to shift by 3 mm. This shift must be corrected to avoid unnecessary primary radiation exposure to the patient and the staff in the cardiac catheterization laboratory. The fringe field was too weak to cause field of view truncation.

Closed bore XMR (CBXMR) systems for aortic valve replacement: investigation of rotating-anode x-ray tube heat loadability.

In order to improve the safety and efficacy of percutaneous aortic valve replacement procedures, a closed bore hybrid x-ray/MRI (CBXMR) system is proposed in which an x-ray C-arm will be positioned with its isocenter approximately =1 m from the entrance of a clinical MRI scanner. This system will harness the complementary strengths of both modalities to improve clinical outcome. A key component of the CBXMR system will be a rotating anode x-ray tube to produce high-quality x-ray images. There are challenges in positioning an x-ray tube in the magnetic fringe field of the MRI magnet. Here, the effects of an external magnetic field on x-ray tube induction motors of radiography x-ray tubes and the corresponding reduction of x-ray tube heat loadability are investigated. Anode rotation frequency f(aode) was unaffected when the external magnetic field Bb was parallel to the axis of rotation of the anode but decreased when Bb was perpendicular to the axis of rotation. The experimental f(anode) values agreed with predicted values to within +/-3% over a Bb range of 0-30 mT. The MRI fringe field at the proposed location of the x-ray tube mounted on the C-arm (approximately =4 mT) reduced f(anode) by only 1%, so x-ray tube heat loadability will not be compromised when using CBXMR systems for percutaneous aortic valve replacement procedures. Eddy current heating power in the rotor due to an MRI fringe field was found to be two orders of magnitude weaker than the heating power produced on the anode due to a fluoroscopic exposure, so eddy current heating had no effect on x-ray tube heat loadability.

Somatic cell nuclear transfer in the pig: control of pronuclear formation and integration with improved methods for activation and maintenance of pregnancy.

To clone a pig from somatic cells, we first validated an electrical activation method for use on ovulated oocytes. We then evaluated delayed versus simultaneous activation (DA vs. SA) strategies, the use of 2 nuclear donor cells, and the use of cytoskeletal inhibitors during nuclear transfer. Using enucleated ovulated oocytes as cytoplasts for fetal fibroblast nuclei and transferring cloned embryos into a recipient within 2 h of activation, a 2-h delay between electrical fusion and activation yielded blastocysts more reliably and with a higher nuclear count than did SA. Comparable rates of development using DA were obtained following culture of embryos cloned from ovulated or in vitro-matured cytoplasts and fibroblast or cumulus nuclei. Treatment of cloned embryos with cytochalasin B (CB) postfusion and for 6 h after DA had no impact on blastocyst development as compared with CB treatment postfusion only. Inclusion of a microtubule inhibitor such as nocodozole with CB before and after DA improved nuclear retention and favored the formation of single pronuclei in experiments using a membrane dye to reliably monitor fusion. However, no improvement in blastocyst development was observed. Using fetal fibroblasts as nuclear donor cells, a live cloned piglet was produced in a pregnancy that was maintained by cotransfer of parthenogenetic embryos.