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The AGRI committee of the European Parliament requested EFSA to assess the welfare of rabbits farmed in different production systems, including organic production, and to update its 2005 scientific opinion about the health and welfare of rabbits kept for meat production. Considering reproducing does, kits and growing rabbits, this scientific opinion focusses on six different housing systems, namely conventional cages, structurally enriched cages, elevated pens, floor pens, outdoor/partially outdoor systems and organic systems. To compare the level of welfare in the different housing systems and rabbit categories, welfare impact scores for 20 welfare consequences identified from the literature were calculated, taking their occurrence, duration and severity into account. Based on the overall welfare impact score (sum of scores for the single welfare consequences), obtained via a 2-step expert knowledge elicitation process, the welfare of reproducing does is likely (certainty 66-90%) to be lower in conventional cages compared to the five other housing systems. In addition, it is likely to extremely likely (certainty 66-99%) that the welfare of kits is lower in outdoor systems compared to the other systems and that the welfare is higher in elevated pens than in the other systems. Finally, it is likely to extremely likely (certainty 66-99%) that the welfare of growing rabbits is lower in conventional cages compared to the other systems and that the welfare is higher in elevated pens than in the other systems. Ranking of the welfare consequences allowed an analysis of the main welfare consequences within each system and rabbit category. It was concluded that for reproducing does, as well as growing rabbits, welfare consequences related to behavioural restrictions were more prominent in conventional cages, elevated pens and enriched cages, whereas those related to health problems were more important in floor pens, outdoor and organic systems. Housing in organic rabbit farming is diverse, which can result in different welfare consequences, but the overall welfare impact scores suggest that welfare in organic systems is generally good., (© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

This opinion on the killing of rabbits for human consumption ('slaughtering') responds to two mandates: one from the European Parliament (EP) and the other from the European Commission. The opinion describes stunning methods for rabbits known to the experts in the EFSA working group, which can be used in commercial practice, and which are sufficiently described in scientific and technical literature for the development of an opinion. These are electrical stunning, mechanical stunning with a penetrative and non-penetrative captive bolt and gas stunning. The latter method is not allowed in the EU anymore following Council Regulation (EC) No 1099/2009, but may still be practiced elsewhere in the world. Related hazards and welfare consequences are also evaluated. To monitor stunning effectiveness as requested by the EP mandate, the opinion suggests the use of indicators for the state of consciousness, selected on the basis of their sensitivity, specificity and ease of use. Similarly, it suggests indicators to confirm animals are dead before dressing. For the European Commission mandate, slaughter processes were assessed from the arrival of rabbits in containers until their death, and grouped in three main phases: pre-stunning (including arrival, unloading of containers from the truck, lairage, handling/removing of rabbits from containers), stunning (including restraint) and bleeding (including bleeding following stunning and bleeding during slaughter without stunning). Ten welfare consequences resulting from the hazards that rabbits can be exposed to during slaughter are identified: consciousness, animal not dead, thermal stress (heat or cold stress), prolonged thirst, prolonged hunger, restriction of movements, pain, fear, distress and respiratory distress. Welfare consequences and relevant animal-based measures (indicators) are described. Outcome tables linking hazards, welfare consequences, indicators, origins, preventive and corrective measures are developed for each process. Mitigation measures to minimise welfare consequences are also proposed., (© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The EFSA Panel on Plant health was requested to deliver a scientific opinion on how far the existing requirements for the bonsai pine species subject to derogation in Commission Decision 2002/887/EC would cover all plant health risks from black pine ( Pinus thunbergii Parl.) bonsai (the commodity defined in the EU legislation as naturally or artificially dwarfed plants) imported from Japan, taking into account the available scientific information, including the technical information provided by Japan. The relevance of an EU-regulated pest for this opinion was based on: (a) evidence of the presence of the pest in Japan; (b) evidence that P. thunbergii is a host of the pest and (c) evidence that the pest can be associated with the commodity. Sixteen pests that fulfilled all three criteria were selected for further evaluation. The relevance of other pests present in Japan (not regulated in the EU) for this opinion was based on (i) evidence of the absence of the pest in the EU; (ii) evidence that P. thunbergii is a host of the pest; (iii) evidence that the pest can be associated with the commodity and (iv) evidence that the pest may have an impact in the EU. Three pests fulfilled all four criteria and were selected for further evaluation ( Crisicoccus pini, Sirex nitobei and Urocerus japonicus ). For the selected 19 pests, the risk mitigation measures proposed in the technical dossier were evaluated. Limiting factors on the effectiveness of the measures were documented. For each of the 19 pests, an expert judgement is given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including any uncertainties. For all evaluated pests, the median likelihood of the pest freedom is 99.5% or higher and within the 90% uncertainty range it is 99% or higher., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

EFSA was asked to update the 2015 EFSA risk assessment on Xylella fastidiosa for the territory of the EU. In particular, EFSA was asked to focus on potential establishment, short- and long-range spread, the length of the asymptomatic period, the impact of X. fastidiosa and an update on risk reduction options. EFSA was asked to take into account the different subspecies and Sequence Types of X. fastidiosa . This was attempted throughout the scientific opinion but several issues with data availability meant that this could only be partially achieved. Models for risk of establishment showed most of the EU territory may be potentially suitable for X. fastidiosa although southern EU is most at risk. Differences in estimated areas of potential establishment were evident among X. fastidiosa subspecies, particularly X. fastidiosa subsp. multiplex which demonstrated areas of potential establishment further north in the EU. The model of establishment could be used to develop targeted surveys by Member States. The asymptomatic period of X. fastidiosa varied significantly for different host and pathogen subspecies combinations, for example from a median of approximately 1 month in ornamental plants and up to 10 months in olive, for pauca . This variable and long asymptomatic period is a considerable limitation to successful detection and control, particularly where surveillance is based on visual inspection. Modelling suggested that local eradication (e.g. within orchards) is possible, providing sampling intensity is sufficient for early detection and effective control measures are implemented swiftly (e.g. within 30 days). Modelling of long-range spread (e.g. regional scale) demonstrated the important role of long-range dispersal and the need to better understand this. Reducing buffer zone width in both containment and eradication scenarios increased the area infected. Intensive surveillance for early detection, and consequent plant removal, of new outbreaks is crucial for both successful eradication and containment at the regional scale, in addition to effective vector control. The assessment of impacts indicated that almond and Citrus spp. were at lower impact on yield compared to olive. Although the lowest impact was estimated for grapevine, and the highest for olive, this was based on several assumptions including that the assessment considered only Philaenus spumarius as a vector. If other xylem-feeding insects act as vectors the impact could be different. Since the Scientific Opinion published in 2015, there are still no risk reduction options that can remove the bacterium from the plant in open field conditions. Short- and long-range spread modelling showed that an early detection and rapid application of phytosanitary measures, consisting among others of plant removal and vector control, are essential to prevent further spread of the pathogen to new areas. Further data collection will allow a reduction in uncertainty and facilitate more tailored and effective control given the intraspecific diversity of X. fastidiosa and wide host range., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Article 42 of the European Regulation (EU) 2016/2031, on the protective measures against pests of plants, introduces the concept of 'high risk plants, plant products and other objects' that are identified on the basis of a preliminary assessment to be followed by a commodity risk assessment. Following a request of the European Commission, this Guidance was developed to establish the methodology to be followed when performing a commodity risk assessment for high risk commodities (high risk plants, plant products and other objects). The commodity risk assessment performed by EFSA will be based on the information provided by the National Plant Protection Organisations of non-EU countries requesting a lifting of import prohibition of a high risk commodity. Following international standards on pest risk analysis, this Guidance describes a two-step approach for the assessment of pest risk associated with a specified commodity. In the first step, pests, associated with the commodity, that require risk mitigation measures are identified. In the second step, the overall efficacy of proposed risk reduction options for each pest is evaluated. A conclusion on the pest-freedom status of the commodity is achieved. The method requires key uncertainties to be identified., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

This Guidance describes a two-phase approach for a fit-for-purpose method for the assessment of plant pest risk in the territory of the EU. Phase one consists of pest categorisation to determine whether the pest has the characteristics of a quarantine pest or those of a regulated non-quarantine pest for the area of the EU. Phase two consists of pest risk assessment, which may be requested by the risk managers following the pest categorisation results. This Guidance provides a template for pest categorisation and describes in detail the use of modelling and expert knowledge elicitation to conduct a pest risk assessment. The Guidance provides support and a framework for assessors to provide quantitative estimates, together with associated uncertainties, regarding the entry, establishment, spread and impact of plant pests in the EU. The Guidance allows the effectiveness of risk reducing options (RROs) to be quantitatively assessed as an integral part of the assessment framework. A list of RROs is provided. A two-tiered approach is proposed for the use of expert knowledge elicitation and modelling. Depending on data and resources available and the needs of risk managers, pest entry, establishment, spread and impact steps may be assessed directly, using weight of evidence and quantitative expert judgement (first tier), or they may be elaborated in substeps using quantitative models (second tier). An example of an application of the first tier approach is provided. Guidance is provided on how to derive models of appropriate complexity to conduct a second tier assessment. Each assessment is operationalised using Monte Carlo simulations that can compare scenarios for relevant factors, e.g. with or without RROs. This document provides guidance on how to compare scenarios to draw conclusions on the magnitude of pest risks and the effectiveness of RROs and on how to communicate assessment results., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

To meet the general requirement for transparency in EFSA's work, all its scientific assessments must consider uncertainty. Assessments must say clearly and unambiguously what sources of uncertainty have been identified and what is their impact on the assessment conclusion. This applies to all EFSA's areas, all types of scientific assessment and all types of uncertainty affecting assessment. This current Opinion describes the principles and methods supporting a concise Guidance Document on Uncertainty in EFSA's Scientific Assessment, published separately. These documents do not prescribe specific methods for uncertainty analysis but rather provide a flexible framework within which different methods may be selected, according to the needs of each assessment. Assessors should systematically identify sources of uncertainty, checking each part of their assessment to minimise the risk of overlooking important uncertainties. Uncertainty may be expressed qualitatively or quantitatively. It is neither necessary nor possible to quantify separately every source of uncertainty affecting an assessment. However, assessors should express in quantitative terms the combined effect of as many as possible of identified sources of uncertainty. The guidance describes practical approaches. Uncertainty analysis should be conducted in a flexible, iterative manner, starting at a level appropriate to the assessment and refining the analysis as far as is needed or possible within the time available. The methods and results of the uncertainty analysis should be reported fully and transparently. Every EFSA Panel and Unit applied the draft Guidance to at least one assessment in their work area during a trial period of one year. Experience gained in this period resulted in improved guidance. The Scientific Committee considers that uncertainty analysis will be unconditional for EFSA Panels and staff and must be embedded into scientific assessment in all areas of EFSA's work., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Uncertainty analysis is the process of identifying limitations in scientific knowledge and evaluating their implications for scientific conclusions. It is therefore relevant in all EFSA's scientific assessments and also necessary, to ensure that the assessment conclusions provide reliable information for decision-making. The form and extent of uncertainty analysis, and how the conclusions should be reported, vary widely depending on the nature and context of each assessment and the degree of uncertainty that is present. This document provides concise guidance on how to identify which options for uncertainty analysis are appropriate in each assessment, and how to apply them. It is accompanied by a separate, supporting opinion that explains the key concepts and principles behind this Guidance, and describes the methods in more detail., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The Plant Health Panel reviewed the paper by Guarnaccia et al. (2017) and compared their findings with previous predictions on the establishment of Phyllosticta citricarpa . Four species of Phyllosticta were found by Guarnaccia et al. (2017) in Europe. P. citricarpa and P. capitalensis are well-defined species, with P. citricarpa recorded for the first time in Europe, confirming predictions by Magarey et al. (2015) and EFSA (2008, 2014, 2016) that P. citricarpa can establish in some European citrus-growing regions. Two new species P. paracitricarpa and P. paracapitalensis were also described, with P. paracitricarpa (found only in Greece) shown to be pathogenic on sweet orange fruits. Genotyping of the P. citricarpa isolates suggests at least two independent introductions, with the population in Portugal being different from that present in Malta and Italy. P. citricarpa and P. paracitricarpa were isolated only from leaf litter in backyards. However, since P. citricarpa does not infect or colonise dead leaves, the pathogen must have infected the above living leaves in citrus trees nearby. Guarnaccia et al. (2017) considered introduction to be a consequence of P. citricarpa having long been present or of illegal movement of planting material. In the Panel's view, the fruit pathway would be an equally or more likely origin. The authors did not report how surveys for citrus black spot (CBS) disease were carried out, therefore their claim that there was no CBS disease even where the pathogen was present is not supported by the results presented. From previous simulations, the locations where Guarnaccia et al. (2017) found P. citricarpa or P. paracitricarpa were conducive for P. citricarpa establishment, with number of simulated infection events by pycnidiospores comparable to sites of CBS occurrence outside Europe. Preliminary surveys by National Plant Protection Organisations (NPPOs) have not confirmed so far the findings by Guarnaccia et al. (2017) but monitoring is still ongoing., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Previous introductions of highly pathogenic avian influenza virus (HPAIV) to the EU were most likely via migratory wild birds. A mathematical model has been developed which indicated that virus amplification and spread may take place when wild bird populations of sufficient size within EU become infected. Low pathogenic avian influenza virus (LPAIV) may reach similar maximum prevalence levels in wild bird populations to HPAIV but the risk of LPAIV infection of a poultry holding was estimated to be lower than that of HPAIV. Only few non-wild bird pathways were identified having a non-negligible risk of AI introduction. The transmission rate between animals within a flock is assessed to be higher for HPAIV than LPAIV. In very few cases, it could be proven that HPAI outbreaks were caused by intrinsic mutation of LPAIV to HPAIV but current knowledge does not allow a prediction as to if, and when this could occur. In gallinaceous poultry, passive surveillance through notification of suspicious clinical signs/mortality was identified as the most effective method for early detection of HPAI outbreaks. For effective surveillance in anseriform poultry, passive surveillance through notification of suspicious clinical signs/mortality needs to be accompanied by serological surveillance and/or a virological surveillance programme of birds found dead (bucket sampling). Serosurveillance is unfit for early warning of LPAI outbreaks at the individual holding level but could be effective in tracing clusters of LPAIV-infected holdings. In wild birds, passive surveillance is an appropriate method for HPAIV surveillance if the HPAIV infections are associated with mortality whereas active wild bird surveillance has a very low efficiency for detecting HPAIV. Experts estimated and emphasised the effect of implementing specific biosecurity measures on reducing the probability of AIV entering into a poultry holding. Human diligence is pivotal to select, implement and maintain specific, effective biosecurity measures., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Following the 2014 EFSA's Panel on Plant Health scientific opinion on the pest categorisation of the spider mite Eotetranychus lewisi, the European Commission requested the Panel to perform a pest risk assessment and evaluate the risk reduction options. A stochastic model was used to assess entry, establishment and spread and related uncertainties. In the EU, E. lewisi has only been reported to occur in Portugal (Madeira). Entry pathways assessed were strawberry plants for planting from the USA, poinsettia and raspberry plants for planting, and orange and lemon fruits from third countries. Entry is most likely via poinsettia. Under current EU phytosanitary requirements, there is around a one in ten chance that E. lewisi will establish outdoors over the next 10 years. Although unlikely, establishment would most likely occur in southern Europe where environmental conditions, temperature and host density, are most suitable. If E. lewisi did establish, pest spread is expected to be mainly human assisted, most likely the mite being transported long distances on plants for planting. Nevertheless, while remaining a regulated pest, spread would be slow and most likely confined to one NUTS 2 area after 10 years. Under a scenario with enhanced measures (pest free place of production) at origin, the Panel's assessment indicate that it is extremely unlikely that E. lewisi would establish within 10 years hence spread is also extremely unlikely. The absence of trade of host plants from Madeira to other parts of the EU could explain why E. lewisi has not spread to other EU Member States. E. lewisi is reported as reducing yield and quality of peaches and poinsettia and is regarded as a growing concern for strawberry and raspberry growers in the Americas. The Panel concludes that should E. lewisi be introduced in the EU similar impacts could be expected., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

As requested by the European Commission, the EFSA Panel on Plant Health (PLH) Panel assessed the risk of Diaporthe vaccinii in the EU, focusing on entry, establishment, spread and impacts on cultivated and wild Vaccinium species, the principal hosts being American and European cranberry and blueberry. Several outbreaks occurred in the EU since 1956, but most were eradicated except in Latvia. The Panel considered entry via fruits and plants for planting. The risk of establishment from discarded infected berries is much lower than from infected plants for planting, of which, potted plants and cuttings pose the greatest risk, while plug plants, derived from tissue culture and grown in pest free structures, pose a low risk. Nine per cent of the EU is highly suitable for establishment of the pathogen, mostly in the SE and NE. Following establishment, the pathogen could spread naturally over short range, and by human assistance over long range. Calculations with an integrated model for entry, establishment and spread, indicate that with current regulations, over a period of 5 years, a few hundred cultivated Vaccinium plants and several thousand Vaccinium plants in natural ecosystems would contract the disease. The associated loss of commercial production is small, less than one tonne of berries per year. On natural vegetation, the median impact after 5 years was estimated to be negligible affecting a negligible proportion of the natural Vaccinium population (2 × 10 -8 ). However, the uncertainty of this estimate was high, due to uncertainty about the rate of spread; in a worst-case scenario (99th percentile), almost 1% of plants in natural areas would become infected. Complete deregulation (scenario A1) was predicted to increase the impact substantially, especially in natural areas, while additional measures (scenario A2) would effectively eliminate the entry of infected plants for planting, further reducing the impacts below the current situation., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

The Panel on Plant Health performed a pest risk assessment on Radopholus similis , the burrowing nematode for the EU. The quantitative assessment focused on entry, establishment, spread and impact on tropical and subtropical ornamental host plants, the main pathways for entry of R. similis into the EU. Infested consignments are expected to enter the risk assessment area on ornamentals under all scenarios. For citrus, which is a closed pathway for entry, outdoor establishment was assessed. Establishment may only take place after successful transfer from ornamental plants to citrus production systems. This event is called 'shift' in this assessment, to indicate that this is an unusual transfer. It has been estimated that establishment of this nematode in the open field in the EU citrus production areas under current temperatures is possible in most parts of the citrus production area in the EU. Temperature conditions will prevent the nematode from establishing only in the northernmost citrus areas and at higher altitudes in the south. Host plants for planting originating from infested places of production (greenhouses) within the risk assessment area are considered the main pathway for spread within the risk assessment area. Under current climatic conditions, the population of R. similis is not expected to reach damaging population levels in the open field. In case of increased temperatures due to global warming, the nematode population may reach damaging levels in very few places outdoors. Currently, main impact is considered for ornamental greenhouse production in the risk assessment area. Impact will be either caused by direct plant growth reductions or loss due to phytosanitary measures applied on regulated plants. Despite the fact that R. similis is globally considered as one of the most destructive plant parasitic nematodes, the impact in the risk assessment area is considered low., (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Background and Aim of the Study: Managing patients with asymptomatic severe aortic stenosis (AS) remains a major challenge. Myocardial as well as cardiocirculatory reserve have been hypothesized to predict outcome in patients with asymptomatic AS., Methods: A total of 48 patients (indexed aortic valve area 0.39 +/- 0.12 cm2/m2; ejection fraction (EF) 67 +/- 7%) underwent spiroergometry and dobutamine stress echocardiography. Death or valve surgery served as a combined endpoint for follow up., Results: Thirty-seven patients reached the endpoint after a mean of 756 days (range: 100-2146 days). Age- and gender-corrected univariate Cox proportional analysis revealed the presence of mild obstructive lung disease, stroke work loss (SWL), end-systolic diameter index, and E/Flow propagation velocity as the best predictive clinical, valvular, cardiostructural, and left ventricular filling pressure parameters, respectively. After inclusion of these parameters into a baseline multivariable Cox proportional hazard model, SWL (HR 1.21 per rise of 1 unit, CI 1.08-1.35, p = 0.0005) and female gender (HR 3.37, CI 1.50-7.59, p = 0.0044) were independently predictive. Similarly, the best-performing myocardial parameter, EF after dobutamine, was independently predictive (HR 0.75 per 5 units, CI 0.57-0.99, p = 0.035) after inclusion. The best-performing exercise capacity parameter, Watt(max), was of borderline significance (HR 0.93 per 5 units, CI 0.86-1.00, p = 0.0505). For each parameter, cut-off values were determined by time-dependent receiver-operator characteristics. The Kaplan-Meier curves of the patients above versus below the cut-offs differed significantly for SWL (p = 0.001), Wattm (p = 0.001), and gender (p = 0.013)., Conclusion: Besides SWL and female gender, the EF after dobutamine as well as highest exercise stress intensity reached are helpful in determining the prognosis of asymptomatic patients with moderate-severe AS.

We demonstrate how a conventional confocal spinning-disk (CSD) microscope can be converted into a doubly resolving image scanning microscopy (ISM) system without changing any part of its optical or mechanical elements. Making use of the intrinsic properties of a CSD microscope, we illuminate stroboscopically, generating an array of excitation foci that are moved across the sample by varying the phase between stroboscopic excitation and rotation of the spinning disk. ISM then generates an image with nearly doubled resolution. Using conventional fluorophores, we have imaged single nuclear pore complexes in the nuclear membrane and aggregates of GFP-conjugated Tau protein in three dimensions. Multicolor ISM was shown on cytoskeletal-associated structural proteins and on 3D four-color images including MitoTracker and Hoechst staining. The simple adaptation of conventional CSD equipment allows superresolution investigations of a broad variety of cell biological questions.

The Shiga toxin-producing Escherichia coli O104:H4 outbreak in Germany in 2011 required the development of appropriate tools in real-time for tracing suspicious foods along the supply chain, namely salad ingredients, sprouts, and seeds. Food commodities consumed at locations identified as most probable site of infection (outbreak clusters) were traced back in order to identify connections between different disease clusters via the supply chain of the foods. A newly developed relational database with integrated consistency and plausibility checks was used to collate these data for further analysis. Connections between suppliers, distributors, and producers were visualized in network graphs and geographic projections. Finally, this trace-back and trace-forward analysis led to the identification of sprouts produced by a horticultural farm in Lower Saxony as vehicle for the pathogen, and a specific lot of fenugreek seeds imported from Egypt as the most likely source of contamination. Network graphs have proven to be a powerful tool for summarizing and communicating complex trade relationships to various stake holders. The present article gives a detailed description of the newly developed tracing tools and recommendations for necessary requirements and improvements for future foodborne outbreak investigations.

Background and Aim of the Study: Patients with moderate-severe aortic stenosis (AS) who maintain that they have no symptoms pose a decision-making dilemma. In order to determine whether or not preoperative symptoms were related to outcomes in these patients, results were compared after aortic valve replacement (AVR) in asymptomatic and symptomatic AS patients with a preserved left ventricular ejection fraction (LVEF)., Methods: Twenty asymptomatic and 18 symptomatic AS patients were investigated retrospectively, with clinical and echocardiographic studies being performed before and at 610 +/- 409 days after AVR. The patients' cardiopulmonary function was monitored using spiroergometry., Results: Symptomatic AS patients improved their exercise tolerance after surgery more than asymptomatic patients, although exercise tolerance and LVEF remained lower in symptomatic patients. On comparing all postoperative objective changes between the groups, a difference was observed only for aortic valve area index. Improvements in left ventricular structure, diastolic function, and filling pressures after AVR were similar in both groups. Systolic function, as assessed by tissue Doppler, was improved only in the symptomatic group. Regression analyses identified preoperative exercise tolerance as the strongest independent determinant of postoperative functional outcome. The postoperative LVEF was independently predicted by the preoperative LVEF and exercise tolerance., Conclusion: Asymptomatic patients with moderate-severe AS and preserved systolic function exhibited similar improvements in cardiac remodeling, diastolic function, and filling pressures following AVR, compared to symptomatic patients. Differences in exercise tolerance and systolic function observed preoperatively between these groups were decreased after AVR.

Background: PAPP-A is promising in improving risk stratification and invasive treatment decisions in stable cardiovascular patients. We evaluated the prognostic value of pregnancy-associated plasma protein A (PAPP-A) measured by a novel assay in stable cardiovascular patients., Methods: We investigated 228 stable cardiovascular outpatients. Blood was drawn for PAPP-A measurement after echocardiography and ergometry prior to heart catheterization. Angiographically we determined severity as well as qualitative characteristics suspect for vulnerability of coronary lesions. After 1108±297 days, follow-up information was obtained by questionnaire mailings and interviews by phone., Results: 104 patients had coronary stenosis≥70%, 75 had B-type lesions≥50%, 46 showed complex lesions, and 68 were suspected to have vulnerable lesions. Median PAPP-A was 1.76 (interquartile range 1.21, 2.63) μIU/ml in the entire cohort. PAPP-A concentrations did not differ in dependence on coronary artery findings. A cutpoint of 2.7 μIU/ml was derived from receiver-operator characteristics for outcome measures. For this cutoff, Cox proportional hazard models with 19 further clinical variables showed that PAPP-A was predictive for all-cause death (HR 4.73, 95% CI 1.46-15.31, p=0.01), all-cause death or nonfatal infarction (HR 4.01, 95% CI 1.58-10.13, p=0.003) and all-cause death, nonfatal myocardial infarction or hospitalization (HR 1.96, 95% CI 1.03-3.70, p=0.04). The predictive value of PAPP-A did not change substantially after correction for values of cardiac troponin, using a highly sensitive cardiac troponin I research assay., Conclusions: PAPP-A, measured by a new, monoclonal antibody-based assay is a promising prognostic marker in patients with stable cardiovascular disease and an indication for heart catheterization., (Copyright © 2011 Elsevier B.V. All rights reserved.)

Background: We compared the effect of different loading conditions, parameters of structural heart disease and extracardiac confounders on NT-proBNP to validate the application of NT-proBNP for a characterisation of loading conditions and clinical course of patients with chronic heart diseases., Methods: NT-proBNP was measured in 15 controls and 34 patients with preserved ejection fraction and chronic pressure (by aortic stenosis) or volume overload (by aortic or mitral regurgitation) before and after physical as well as dobutamine stress. Myocardial fibrosis was evaluated by contrast-enhanced cardiovascular magnetic resonance., Results: In patients with elevated NT-proBNP due to chronic pressure or volume overloaded ventricles, physical and dobutamine stress were associated with only marginal nonsignificant additional NT-proBNP responses. Univariate analyses showed that myocardial fibrosis has the greatest effect on NT-proBNP (P < 0.01). Forward regression analyses revealed left ventricular filling, systolic function, the presence of valvular heart disease, serum creatinine and responses to dobutamine stress as independent determinants of NT-proBNP (P < 0.05 each)., Conclusion: NT-proBNP cannot be used simply to characterise intensity of ventricular load. Character and duration of loading conditions, cardiac structure and function, as well as confounders should be considered when NT-proBNP is used for clinical follow-up assessment.

Background: How to use the information from novel high sensitivity troponin assays in stable cardiac patients is unclear. Preliminary data from randomized controlled trial analyses suggest it helps with risk stratification. We investigated the determinants, diagnostic impact and prognostic value of a novel high-sensitive cardiac troponin I (hs-cTnI) assay in patients with stable cardiac disease., Methods: hs-cTnI was measured with a pre-commercial assay in 222 outpatients after clinical testing before cardiac catheterization. Mean follow-up was 1103+/-299 days., Results: hs-cTnI was detectable in all patients (median (interquartile range) 6.20 (4.85;8.25) ng/l). Creatinine (p<0.001), systolic wall stress (p=0.004), the presence of myocardial impairment (p=0.049) and coronary artery stenosis > or = 70% (p=0.050) were predictors of hs-cTnI concentration. hs-cTnI values could not distinguish elevations due to myocardial abnormalities from those related to coronary artery abnormalities. Patients with elevations above the 99th percentile had a higher rate of hospitalizations but otherwise prognosis was not predicted robustly by hs-cTnI values., Conclusion: Stable cardiovascular patients have detectable hs-cTnI concentrations irrespective of their underlying disease. In this heterogeneous group of patients with diverse etiologies for cardiac disease, values were not helpful in distinguishing the etiology of the elevations or in predicting prognosis., (Copyright 2010 Elsevier B.V. All rights reserved.)

Cardiac troponins play a major role in the diagnostic work-up of acute coronary syndrome/myocardial infarction. Elevations were demonstrated also in other, rather nonischemic diseases like pulmonary embolism or acute heart failure. Stepwise improvement in the accuracy of the commercially available assays allowed detection of low-level concentrations of cardiac troponins, which were previously partially classified to be normal (between the limit of detection and the 99 th percentile by < 10% coefficient of variance). These low concentrations were associated with the detection of chronic cardiovascular pathologies and an increased risk of future cardiovascular events. Recently, ten to 100 times more sensitive assays (so-called high sensitive or ultra sensitive assays) have been developed. The clinical importance of those now measurable troponin values is currently under intensive investigation. The expected additional clinical and prognostic information from such low- and even lowest-level troponin values pose a special challenge. Specifically, the question has been raised, whether the established single cutoff approach for diagnosing myocardial infarction should not be complemented by another, lower cutoff usable for the detection of other (stable) cardiovascular pathologies with lower but still substantial risk.

The aim of the study was to evaluate whether markers of myocardial injury and ischemia are helpful in detecting coronary artery disease (CAD) in patients with stable angina. Venous blood was obtained before and after a bicycle exercise test in 47 outpatients with suspected CAD for measurement of cardiac troponin I (cTnI), heart-type fatty acid binding protein, and glycogen phosphorylase BB. Patients with a coronary artery stenosis >/=70% in diameter (n = 33) were compared with patients with coronary narrowing <50% (controls, n = 14). None of the markers increased after bicycle exercise testing. cTnI measured before and after exercise was higher in the CAD group than in controls (p <0.001). The area under the curve for diagnosis was greater when the cTnI value was detectable than with stress testing alone. In conclusion, baseline cTnI was of value in detecting CAD and also during follow-up in predicting the need for further revascularization.

The Federal Institute for Risk Assessment wants to be a competent scientific adviser for politics, administration and the public in risk evaluation and risk communication regarding consumer products. Fields of research needed for this advice are compared with the research universities have to carry out. Examples were given.

Background: Due to encouraging results of studies investigating the effects of physical activity and training on cardiovascular diseases and due to the integration of preventive strategies into disease management programs by public health organizations, it is expected that a larger population, including cardiovascular patients, will increasingly participate in physical activity, fitness programs, and sports. However, a reduction in cardiovascular events and all-cause mortality by regular physical activity is accompanied by an increased mortality during exertion, as yet, there is no satisfactory definition of risk for all cardiovascular diseases and patient groups., Risk Evaluation: A cost-effective preparticipation screening has to consider both the low incidence of events resulting from different diseases which requires subtle diagnostics and the intention of granting the larger population simple access to exercise programs and sports. There is a substantial difference in the risk profile for fatal events in athletes and young fitness program participants on the one hand and older (> 35 years) exercising people with a higher incidence of common cardiovascular diseases on the other. Additionally, a potential exercise-induced progression of chronic heart diseases should be excluded. New imaging techniques, laboratory markers, and genetic indicators will hopefully improve the quality of risk assessment., Conclusion: Establishing standards for diagnostics and risk assessment as well as different types of exercise and training programs, all of which need to be transformed into national guidelines, could help to reduce risks without limiting access to physical exercise and therapy. However, an element of risk will remain if rational cost-effectiveness ratios are to be applied.

Background: Exercise therapy has a well-established place in the primary and secondary prevention of cardiovascular disease. But its evidence-based application, or even its development, within the framework of planned disease management programs in Germany is hampered by the limitations in the structural quality of the health/fitness facilities., Method: Review of the literature concerning the current structure of cardiovascular exercise therapy in Germany and the USA, including current guidelines for exercise therapy in primary and secondary prevention., Results: The "heart groups" represent the only organization in Germany to adhere to certain quality standards, although certain limitations in the procedural quality of their programs must be acknowledged (the evidence-based securing of the programs is relatively restricted), and their overall capacity is limited. Alternative organizations, such as fitness centers or sports clubs, do not yet offer standards of quality or safety. In the USA, in particular, there are established guidelines for exercise therapy which are edited, evidence-based, peer-reviewed and applicable to all suppliers of exercise therapy., Conclusion: We suggest that such standards should be brought into operation within the German context and that,as far as possible, they should be extended to include statements of mode and duration of training. The resulting guidelines, after being implemented as standards, could serve as the basis for a certification procedure applicable to all health/fitness facilities.

Background: In severe heart failure, increased values of cardiac troponins have been detected during decompensation. In this study, we investigated whether an increase of cardiac troponin I can be observed after symptom-limited exercise and after an exercise training session in patients with moderate heart failure., Methods: Twenty-seven patients with moderate heart failure (New York Heart Association II-III, ejection fraction 31% +/- 8%) were compared with 9 patients with mild heart failure and 10 subjects without heart failure. They underwent a symptom-limited exercise test and a bicycle exercise training session at >80% of maximal heart rate over 20 to 30 minutes. Plasma cTnI levels were measured at baseline, after symptom-limited exercise (hourly for 5 hours), and after training (4 and 10 hours)., Results: Patients with moderate heart failure showed an increase of cTnI from 37 +/- 49 pg/mL to 73 +/- 59 pg/mL (P <.001) after symptom-limited exercise. Four patients with moderate and 1 with mild heart failure and normal cTnI values at rest showed an increase of cTnI above 100 pg/mL after acute exercise but not after training. Subjects without heart failure had lower cTnI levels at rest and significantly lower values after symptom-limited exercise and training (P <.05 for each)., Conclusion: Patients with symptomatic heart failure reveal an increase of cTnI after symptom-limited exercise at levels that indicate minor myocardial damage. The prognostic impact of this finding should, therefore, be further investigated.