Basophil activation test with progressively less heated forms of egg distinguishes egg allergic from tolerant children.

BACKGROUND AND OBJECTIVE: Diagnosis of egg allergy through basophil activation testing (BAT) has been mainly performed with an egg white extract or individual egg allergens rather than clinically more representative whole-egg extracts. Impact of heating on whole-egg extract allergenicity remains unassessed.Validating BAT with gradually less heated whole-egg extracts in egg allergy diagnosis and as tolerance marker. METHODS: CD63-based BAT was performed with five progressively less heated extracts from cake, hard-boiled egg, omelet, soft-boiled, and raw egg in 10 egg allergic (EA), 10 complete egg tolerant (ET) and 12 non-egg-sensitized non-allergic (NEA) children. Cutoffs and diagnostic accuracy measures were established through ROC analysis. Changes in basophil response were assessed in 12 baked egg tolerant children undergoing an 8-month gradual egg reintroduction protocol with BAT and oral food challenges prior to each reintroduction step. RESULTS: Basophil responses to all egg extracts were increased in EA, but not in ET and NEA children. Responses decreased progressively with more heated egg extracts. Compared to ET children, EA children showed higher basophil sensitivity for all egg extracts. Negative BAT responses predicted clinical tolerance with a 90-100% sensitivity, 100% specificity, and false positive rate of 2.78%. In comparison, egg sIgE's (<0.35 kUA/L) had a lower specificity of 50-78% with a false positive rate of 40%. Basophil reactivity and sensitivity tended to decrease in baked egg tolerant children undergoing gradual egg reintroduction, concurrent with tolerance development. CONCLUSION: BAT with progressively less heated egg preparations is a sensitive and highly specific tool to discriminate EA from ET children.

Surgical Myocardial Revascularization with a Composite T-graft from the Left Internal Mammary Artery-Comparison of the Great Saphenous Vein with the Radial Artery.

BACKGROUND: Composite T-grafts between left internal mammary artery (LIMA) and radial artery (RA) are a common concept in complete arterial myocardial revascularization. The aim of the present study was to investigate whether the use of the great saphenous vein (SV) instead of RA leads to comparably good results in terms of outcome in this context. METHODS: Patients who underwent myocardial revascularization with a T-graft using RA or a segment of SV to the right coronary artery or circumflex artery between the beginning of 2014 and the end of 2019 at the Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Campus Kiel were included. To minimize surgical variation, only patients were observed by a single senior surgeon in the department. Exclusion criteria were previous cardiac surgery, preoperative extracorporeal circulatory support, off-pump surgery, additional aortocoronary bypasses, and cardiac combination procedures. RESULTS: A total of 115 patients were studied. In 55 patients, the T-graft was placed between the LIMA and SV, and in 60 patients, the T-graft was placed between the LIMA and RA. Patients in the SV group were older (70.6 ± 7.8 vs. 58.5 ± 10.0 years; p < 0.001), suffered more frequently from non-ST elevation myocardial infarction (12.7 vs. 1.7%; p = 0.027), arterial hypertension (83.6 vs. 61.7%; p = 0.009), and atrial fibrillation (18.2 vs. 1.7%; p = 0.003). They were less likely to be active smokers (16.4 vs. 38.3%; p = 0.009) and less likely to have a history of variceal surgery (0 vs. 15.0%; p = 0.003). Calcification of the ascending aorta was also found more frequently in the saphenous group (18.2 vs. 3.3%, p = 0.009). Operative times and number of distal anastomoses did not differ significantly between the two groups. Postoperative deliriums (16.7 vs. 5.0%; p = 0.043) were observed more frequently in venous patients. Wound healing disorders of the leg (11.1 vs. 0%; p = 0.011) did only occur in SV group and wound infections of the arm only in the RA group. Complete follow-up was achieved in 74.8% of cases. Median follow-up was 60.3 (39.6; 73.2) months. Serious adverse cardiac-cerebral events (19.0 vs. 22.7%; p = 0.675) and mortality (14.5 vs. 6.7%; p = 0.167) did not differ significantly between the groups at follow-up. Myocardial infarction (0 vs. 2.5%; p = 1.000) and stroke (0 vs. 7.5%; p = 0.245) were observed exclusively in RA group. Percutaneous coronary intervention was required in single patients of RA group (0 vs. 15.0%; p = 0.028). No patient from either group underwent repeat coronary artery bypass grafting (CABG). The patients of SV group had angiographically competent grafts and open anastomoses. Graft failure was noted in a single patient in RA group, in which case both grafts and native coronary vessels were stented. Kaplan-Meier analysis revealed no significant survival disadvantage for SV group compared with RA group. CONCLUSION: CABG with a composite T-graft between LIMA and a segment of SV may be comparable to bypass surgery with a composite T-graft between LIMA and RA. This might be true in terms of morbidity and mortality over an intermediate-term observation period. The results of our studies give rise to the hypothesis that the decision not to perform aortic bypass anastomosis may be more important than the choice of graft material.

Health-related quality of life, emotional burden, and neurocognitive function in the first generation of metastatic melanoma survivors treated with pembrolizumab: a longitudinal pilot study.

PURPOSE: The aim of this study was to assess the evolution of health-related quality of Life (HRQoL), emotional burden, and neurocognitive function in the first-generation metastatic melanoma survivors treated with pembrolizumab. METHODS: Survivors were defined as patients who achieved a durable remission for at least 6 months after initiating pembrolizumab in a single-center observational study (N = 141). A semi-structured interview was performed at baseline. Neurocognitive computerized testing and patient-reported outcomes were collected at 4 time points to assess HRQoL using the EORTC QLQ-C30 and the HADS to assess anxiety and depression. RESULTS: Out of 35 eligible patients, 25 were recruited and completed baseline assessment (18 female; median age 58 years [range 28-86]; 24 completed the 1-year follow-up phase. Median time since diagnosis was 30 months (range 12-84); median time since initiation of pembrolizumab was 19 months (range 6-42). At all visits, survivors reported a significantly lower global HRQoL, lower physical, emotional, cognitive, role, and social functioning compared with the European Mean of the healthy population. Fifteen patients (64%) had clinical levels of anxiety/depression at one time point during follow-up. The clinical interview revealed that 12 patients (48%) suffered from Cancer-Related-Post-Traumatic-Stress disorder, of whom 7 (28%) developed transient suicidal ideation, 1 patient made a suicide attempt. Neurocognitive testing revealed cognitive impairment in 8 patients (32%). CONCLUSIONS: Metastatic melanoma survivors, treated successfully with pembrolizumab, are at risk for suffering from emotional distress and neurocognitive impairment with a persistent impact on their HRQOL. Timely detection in order to offer tailored care is indicated.

Cooperation in Microbial Populations: Theory and Experimental Model Systems.

Cooperative behavior, the costly provision of benefits to others, is common across all domains of life. This review article discusses cooperative behavior in the microbial world, mediated by the exchange of extracellular products called public goods. We focus on model species for which the production of a public good and the related growth disadvantage for the producing cells are well described. To unveil the biological and ecological factors promoting the emergence and stability of cooperative traits we take an interdisciplinary perspective and review insights gained from both mathematical models and well-controlled experimental model systems. Ecologically, we include crucial aspects of the microbial life cycle into our analysis and particularly consider population structures where ensembles of local communities (subpopulations) continuously emerge, grow, and disappear again. Biologically, we explicitly consider the synthesis and regulation of public good production. The discussion of the theoretical approaches includes general evolutionary concepts, population dynamics, and evolutionary game theory. As a specific but generic biological example, we consider populations of Pseudomonas putida and its regulation and use of pyoverdines, iron scavenging molecules, as public goods. The review closes with an overview on cooperation in spatially extended systems and also provides a critical assessment of the insights gained from the experimental and theoretical studies discussed. Current challenges and important new research opportunities are discussed, including the biochemical regulation of public goods, more realistic ecological scenarios resembling native environments, cell-to-cell signaling, and multispecies communities.

Towards area wide management of insect vectored viruses of tomatoes in the Bowen district.

The Bowen region of Northern Queensland is an important winter production area for tomatoes in Australia. There are three economically important viruses in the region that affect tomato, Tomato yellow leaf curl virus (TYLCV), Tomato spotted wilt virus (TSWV) and Potato leafroll virus (PLRV), which are vectored by whiteflies, thrips and aphids, respectively. An area wide management approach is required to lower the primary inoculum throughout the district. To this end, we undertook investigations into the virus incidence and alternative hosts for the virus and vectors in different cropping regions throughout the district, as well as local management options such as insecticide application and possible non-host cover crops for the wet-season break in production. The initial incidence of Potato leafroll virus was very high, most probably due to abnormal weather patterns for the district, and has ceased to be a problem. Tomato yellow leaf curl virus is a continual problem even at the beginning of the season, indicating large reservoir host(s) in the environment. Only four alternative hosts have been identified: Stachytarpheta jamaicensis (TSWV), Solanum americanum (PLRV and TYLCV) Trianthema portulacastrum (TYLCV), and Amaranthus viridis(TLYCV). Different insecticide and application options were trialled for protection against Tomato yellow leaf curl virus, with the best possible option yielding marketable fruit more than ninety percent of a resistant hybrid. A trial of yield vs time of infection of TYLCV found that whitefly exclusion for 6 weeks post-transplant yielded an average increase of nearly three kilograms of marketable fruit per plant. A number of pulse crops have been confirmed as non-hosts of tomato yellow leaf curl for use as cover crops in the wet-season break. Most of the production has moved to dual resistant TYLCV/TSWV hybrids, though an area wide management program still needs to be established to reduce the primary inoculum throughout the district, giving growers more varietal options, especially early in the season.

[Bleeding in patients receiving dual antiplatelet therapy after acute coronary syndrome - significance, prevention and interdisciplinary management]. / Interdisziplinäres Management von Blutungen unter dualer antithrombozytärer Therapie nach akutem Koronarsyndrom.

For secondary prevention of acute coronary syndrome, guidelines recommend dual antiplatelet therapy with acetylsalicylic acid and a P2Y12 receptor antagonist such as clopidogrel, prasugrel or ticagrelor for a period of 12 months. Premature discontinuation of dual antiplatelet therapy is associated with an increased risk of ischaemic events. However, antiplatelet therapy is also associated with an increased risk of bleeding that should not be under- or overestimated. To ensure an optimal care of patients receiving dual antiplatelet therapy after an acute coronary syndrome, an interdisciplinary group of experienced experts in the fields of cardiology, cardiac surgery, gastroenterology, anaesthesiology, intensive care and haemostaseology gathered bleeding-related information and developed recommendations relevant to daily clinical practice. These include the significance of bleeding events in the course of treatment, measures for bleeding prevention and the adequate care of patients with bleedings.

Disease burden of congenital cytomegalovirus infection at school entry age: study design, participation rate and birth prevalence.

Congenital cytomegalovirus infection (cCMV) may lead to symptoms at birth and long-term consequences. We present a nationwide, retrospective cohort study on the outcome of cCMV up to age 6 years. For this study we identified cCMV, using polymerase chain reaction, by analysing dried blood spots, which are taken shortly after birth for neonatal screening. The group of children with cCMV were compared to a group of children who were cCMV negative at birth. Data were collected about their health and development up to age 6 years. Parents of 73 693 children were invited to participate, and 32 486 (44·1%) gave informed consent for testing of their child's dried blood spot for CMV. Of the 31 484 dried blood spots tested, 156 (0·5%) were positive for cCMV. Of these, four (2·6%) children had been diagnosed with cCMV prior to this study. This unique retrospective nationwide study permits the estimation of long-term sequelae of cCMV up to the age of 6 years. The birth prevalence of cCMV in this study was 0·5%, which is in line with prior estimates. Most (97·4%) children with cCMV had not been diagnosed earlier, indicating under-diagnosis of cCMV.

Changes in the expression of neurotransmitter receptors in Parkin and DJ-1 knockout mice--A quantitative multireceptor study.

Parkinson's disease (PD) is a well-characterized neurological disorder with regard to its neuropathological and symptomatic appearance. At the genetic level, mutations of particular genes, e.g. Parkin and DJ-1, were found in human hereditary PD with early onset. Neurotransmitter receptors constitute decisive elements in neural signal transduction. Furthermore, since they are often altered in neurological and psychiatric diseases, receptors have been successful targets for pharmacological agents. However, the consequences of PD-associated gene mutations on the expression of transmitter receptors are largely unknown. Therefore, we studied the expression of 16 different receptor binding sites of the neurotransmitters glutamate, GABA, acetylcholine, adrenaline, serotonin, dopamine and adenosine by means of quantitative receptor autoradiography in Parkin and DJ-1 knockout mice. These knockout mice exhibit electrophysiological and behavioral deficits, but do not show the typical dopaminergic cell loss. We demonstrated differential changes of binding site densities in eleven brain regions. Most prominently, we found an up-regulation of GABA(B) and kainate receptor densities in numerous cortical areas of Parkin and DJ-1 knockout mice, as well as increased NMDA but decreased AMPA receptor densities in different brain regions of the Parkin knockout mice. The alterations of three different glutamate receptor types may indicate the potential relevance of the glutamatergic system in the pathogenesis of PD. Furthermore, the cholinergic M1, M2 and nicotinic receptors as well as the adrenergic α2 and the adenosine A(2A) receptors showed differentially increased densities in Parkin and DJ-1 knockout mice. Taken together, knockout of the PD-associated genes Parkin or DJ-1 results in differential changes of neurotransmitter receptor densities, highlighting a possible role of altered non-dopaminergic, and in particular of glutamatergic neurotransmission in PD pathogenesis.

Neurotransmitter receptor density changes in Pitx3ak mice--a model relevant to Parkinson's disease.

Parkinson's disease (PD) is the second most common neurodegenerative disorder, characterized by alterations of nigrostriatal dopaminergic neurotransmission. Compared to the wealth of data on the impairment of the dopamine system, relatively limited evidence is available concerning the role of major non-dopaminergic neurotransmitter systems in PD. Therefore, we comprehensively investigated the density and distribution of neurotransmitter receptors for glutamate, GABA, acetylcholine, adrenaline, serotonin, dopamine and adenosine in brains of homozygous aphakia mice being characterized by mutations affecting the Pitx3 gene. This genetic model exhibits crucial hallmarks of PD on the neuropathological, symptomatic and pharmacological level. Quantitative receptor autoradiography was used to characterize 19 different receptor binding sites in eleven brain regions in order to understand receptor changes on a systemic level. We demonstrated striking differential changes of neurotransmitter receptor densities for numerous receptor types and brain regions, respectively. Most prominent, a strong up-regulation of GABA receptors and associated benzodiazepine binding sites in different brain regions and concomitant down-regulations of striatal nicotinic acetylcholine and serotonergic receptor densities were found. Furthermore, the densities of glutamatergic kainate, muscarinic acetylcholine, adrenergic α1 and dopaminergic D2/D3 receptors were differentially altered. These results present novel insights into the expression of neurotransmitter receptors in Pitx3(ak) mice supporting findings on PD pathology in patients and indicating on the possible underlying mechanisms. The data suggest Pitx3(ak) mice as an appropriate new model to investigate the role of neurotransmitter receptors in PD. Our study highlights the relevance of non-dopaminergic systems in PD and for the understanding of its molecular pathology.

In vivo quantification of the apical fixation forces of different mitral valved stent designs in the beating heart.

The aim of this study was the quantification of the apical fixation forces of mitral valved stents for the first time. A test set-up was developed to measure the forces acting on the apical fixation of mitral valved stents. Twenty pigs received a self-expanding valved stent in the mitral position via a transapical approach in an off-pump procedure. Following stent deployment in the beating heart, the apical fixation forces were recorded following a standardized protocol and normalized. The apical fixation force of two different valved stent designs (AP: sole apical fixation, n = 10; SA: additional sub-annular fixation, n = 10) was compared to quantify the impact of the design change. Force measurement was successfully conducted in 18 of 20 animals (design AP: n = 10; design SA: n = 8). Evaluation showed higher mean forces and amplitude in the group with sole apical fixation (p = 0.046; Table 1). The impact of the additional sub-annular fixation was shown by a significant reduction of the force acting upon the apex of the heart. Quantification of these in vivo forces provides important information about the impact of different stent designs and might provide an objective parameter for stent performance evaluation in clinical application.

Development of a new deuterium-deuterium (D-D) neutron generator for prompt gamma-ray neutron activation analysis.

A new deuterium-deuterium (D-D) neutron generator has been developed by Adelphi Technology for prompt gamma neutron activation analysis (PGNAA), neutron activation analysis (NAA), and fast neutron radiography. The generator makes an excellent fast, intermediate, and thermal neutron source for laboratories and industrial applications that require the safe production of neutrons, a small footprint, low cost, and small regulatory burden. The generator has three major components: a Radio Frequency Induction Ion Source, a Secondary Electron Shroud, and a Diode Accelerator Structure and Target. Monoenergetic neutrons (2.5MeV) are produced with a yield of 10(10)n/s using 25-50mA of deuterium ion beam current and 125kV of acceleration voltage. The present study characterizes the performance of the neutron generator with respect to neutron yield, neutron production efficiency, and the ionic current as a function of the acceleration voltage at various RF powers. In addition the Monte Carlo N-Particle Transport (MCNP) simulation code was used to optimize the setup with respect to thermal flux and radiation protection.

Monte Carlo simulation of explosive detection system based on a Deuterium-Deuterium (D-D) neutron generator.

An explosive detection system based on a Deuterium-Deuterium (D-D) neutron generator has been simulated using the Monte Carlo N-Particle Transport Code (MCNP5). Nuclear-based explosive detection methods can detect explosives by identifying their elemental components, especially nitrogen. Thermal neutron capture reactions have been used for detecting prompt gamma emission (10.82MeV) following radiative neutron capture by (14)N nuclei. The explosive detection system was built based on a fully high-voltage-shielded, axial D-D neutron generator with a radio frequency (RF) driven ion source and nominal yield of about 10(10) fast neutrons per second (E=2.5MeV). Polyethylene and paraffin were used as moderators with borated polyethylene and lead as neutron and gamma ray shielding, respectively. The shape and the thickness of the moderators and shields are optimized to produce the highest thermal neutron flux at the position of the explosive and the minimum total dose at the outer surfaces of the explosive detection system walls. In addition, simulation of the response functions of NaI, BGO, and LaBr3-based γ-ray detectors to different explosives is described.

Cardiac surgery in Germany during 2013: a report on behalf of the German Society for Thoracic and Cardiovascular Surgery.

On the basis of a voluntary registry of the German Society for Thoracic and Cardiovascular Surgery (GSTCVS), data of all cardiac surgical procedures performed in 79 German cardiac surgical units during the year 2013 are presented. In 2013, a total of 99,128 cardiac surgical procedures (implantable cardioverter defibrillator [ICD] and pacemaker procedures excluded) were submitted to the registry. More than 13.8% of the patients were older than 80 years, which remains equal in comparison to the previous year. In-hospital mortality in 40,410 isolated coronary artery bypass grafting procedures (84.5% on-pump and 15.5% off-pump) was 2.9%. In 29,672 isolated valve procedures (including 7,722 catheter-based procedures), an in-hospital mortality of 4.7% was observed. This long-lasting registry of the GSTCVS will continue to be an important tool for quality control and voluntary public reporting by illustrating current facts and developments of cardiac surgery in Germany.

Superconducting magnetic Wollaston prism for neutron spin encoding.

A magnetic Wollaston prism can spatially split a polarized neutron beam into two beams with different neutron spin states, in a manner analogous to an optical Wollaston prism. Such a Wollaston prism can be used to encode the trajectory of neutrons into the Larmor phase associated with their spin degree of freedom. This encoding can be used for neutron phase-contrast radiography and in spin echo scattering angle measurement (SESAME). In this paper, we show that magnetic Wollaston prisms with highly uniform magnetic fields and low Larmor phase aberration can be constructed to preserve neutron polarization using high temperature superconducting (HTS) materials. The Meissner effect of HTS films is used to confine magnetic fields produced electromagnetically by current-carrying HTS tape wound on suitably shaped soft iron pole pieces. The device is cooled to ~30 K by a closed cycle refrigerator, eliminating the need to replenish liquid cryogens and greatly simplifying operation and maintenance. A HTS film ensures that the magnetic field transition within the prism is sharp, well-defined, and planar due to the Meissner effect. The spin transport efficiency across the device was measured to be ~98.5% independent of neutron wavelength and energizing current. The position-dependent Larmor phase of neutron spins was measured at the NIST Center for Neutron Research facility and found to agree well with detailed simulations. The phase varies linearly with horizontal position, as required, and the neutron beam shows little depolarization. Consequently, the device has advantages over existing devices with similar functionality and provides the capability for a large neutron beam (20 mm × 30 mm) and an increase in length scales accessible to SESAME to beyond 10 µm. With further improvements of the external coupling guide field in the prototype device, a larger neutron beam could be employed.

The German Aortic Valve Registry (GARY): in-hospital outcome.

BACKGROUND: Aortic stenosis is a frequent valvular disease especially in elderly patients. Catheter-based valve implantation has emerged as a valuable treatment approach for these patients being either at very high risk for conventional surgery or even deemed inoperable. The German Aortic Valve Registry (GARY) provides data on conventional and catheter-based aortic procedures on an all-comers basis. METHODS AND RESULTS: A total of 13 860 consecutive patients undergoing repair for aortic valve disease [conventional surgery and transvascular (TV) or transapical (TA) catheter-based techniques] have been enrolled in this registry during 2011 and baseline, procedural, and outcome data have been acquired. The registry summarizes the results of 6523 conventional aortic valve replacements without (AVR) and 3464 with concomitant coronary bypass surgery (AVR + CABG) as well as 2695 TV AVI and 1181 TA interventions (TA AVI). Patients undergoing catheter-based techniques were significantly older and had higher risk profiles. The stroke rate was low in all groups with 1.3% (AVR), 1.9% (AVR + CABG), 1.7% (TV AVI), and 2.3% (TA AVI). The in-hospital mortality was 2.1% (AVR) and 4.5% (AVR + CABG) for patients undergoing conventional surgery, and 5.1% (TV AVI) and AVI 7.7% (TA AVI). CONCLUSION: The in-hospital outcome results of this registry show that conventional surgery yields excellent results in all risk groups and that catheter-based aortic valve replacements is an alternative to conventional surgery in high risk and elderly patients.

Transapical mitral valve implantation: the Lutter valve.

  The development of transcatheter techniques for treatment of severe mitral valve regurgitation in the beating heart is focus of recent research. An off-pump treatment technique poses great benefits, particularly for multimorbid patients, often being non-compliant to the gold standard treatment, being open heart surgery with use of a cardiopulmonary bypass. Thereto, two approaches are being followed: transcatheter valve repair and transcatheterimplantation of a valved stent into the native mitral valve annulus. A valved stent has to provide safe and secure fixation within the high pressure system of the left heart. One of the main challenges in the development of such a valved stent is the complex anatomy of the mitral valve, with no clearly defined structures for device anchorage. Our group has developed a self-expanding nitinolvalved stent for transapical implantation in the beating heart. During the development process of thevalved stent, different design iterations were conducted to decrease the risk of paravalvular leakages, to enhance the reproducibility and to improve the overall stent performance. This article reviews the major milestones passedin the development process of our mitral valved stent and advances achieved withinthe last years. Multiple design iterations lead to a prototype providing secure stent deployment, hig h reproducibility, low paravalvular leakages and only mild stent deformation in the beating heart. In future, further long-term in vivo trials have to be conducted before attempting the step towards clinical application of this novel device.

[Basic standards for a department of cardiac surgery. Quality requirements for the care of cardiac patients in connection with operations on the heart, the heart vessels and thoracic organ transplantation]. / Basisstandards einer Fachabteilung für Herzchirurgie. Qualitätsanforderungen für die Versorgung von herzkranken Patientinnen und Patienten im Zusammenhang mit Operationen/Eingriffen am Herzen, den herznahen Gefäßen und der thorakalen Organtransplantation.

Current evolutions and substantial amendments of the German health care system in combination with distinguished progress in cardiac surgery over the past years require both a reflection of principles in patient-centered care and an update of basic standard requirements for a department of cardiac surgery in Germany. In due consideration of the data from the voluntary registry of the German Society for Thoracic and Cardiovascular Surgery, this article accurately defines core requirements for a cardiac surgical department (cardiac surgery on-site), subdivided into facilities, staff and processes. If based on these standards, one may anticipate that cardiac surgical care is performed under appropriate conditions leading to an intrinsic benefit for patients.

Unprotected left main coronary artery disease. Surgical therapy.

Coronary artery bypass grafting (CABG) has been established as a safe concept in the treatment of unprotected left main coronary artery (ULMCA) disease and is considered the first-line treatment in current interdisciplinary guidelines. Regardless of the complexity of the lesion and the concomitant diseases, CABG is associated with excellent long-term results. Randomized controlled trials investigating the role of percutaneous coronary intervention in the setting of ULMCA lesions are frequently underpowered and suggest that, when restricted to less complex lesions, percutaneous coronary intervention is associated with results comparable to surgery. Thus, there is an urgent need for further randomized controlled trials RCTs with all-comers design to supply precise data under real-life conditions representative of the left main stem anatomy. Until then, an interdisciplinary approach to patients with ULMCA lesions is mandatory in view of the existing guidelines.

The German Aortic Valve Registry (GARY): a nationwide registry for patients undergoing invasive therapy for severe aortic valve stenosis.

Background The increasing prevalence of severe aortic valve defects correlates with the increase of life expectancy. For decades, surgical aortic valve replacement (AVR), under the use of extracorporeal circulation, has been the gold standard for treatment of severe aortic valve diseases. In Germany ~12,000 patients receive isolated aortic valve surgery per year. For some time, percutaneous balloon valvuloplasty has been used as a palliative therapeutic option for very few patients. Currently, alternatives for the established surgical procedures such as transcatheter aortic valve implantation (TAVI) have become available, but there are only limited data from randomized studies or low-volume registries concerning long-time outcome. In Germany, the implementation of this new technology into hospital care increased rapidly in the past few years. Therefore, the German Aortic Valve Registry (GARY) was founded in July 2010 including all available therapeutic options and providing data from a large quantity of patients.Methods The GARY is assembled as a complete survey for all invasive therapies in patients with relevant aortic valve diseases. It evaluates the new therapeutic options and compares them to surgical AVR. The model for data acquisition is based on three data sources: source I, the mandatory German database for external performance measurement; source II, a specific registry dataset; and source III, a follow-up data sheet (generated by phone interview). Various procedures will be compared concerning observed complications, mortality, and quality of life up to 5 years after the initial procedure. Furthermore, the registry will enable a compilation of evidence-based indication criteria and, in addition, also a comparison of all approved operative procedures, such as Ross or David procedures, and the use of different mechanical or biological aortic valve prostheses.Results Since the launch of data acquisition in July 2010, almost all institutions performing aortic valve procedures in Germany joined the registry. By now, 91 sites which perform TAVI in Germany participate and more than 15,000 datasets are already in the registry.Conclusion The implementation of new or innovative medical therapies needs supervision under the conditions of a well-structured scientific project. Up to now relevant data for implementation of TAVI and long-term results are missing. In contrast to randomized controlled trials, GARY is a prospective, controlled, 5-year observational multicenter registry, and a real world investigation with only one exclusion criterion, the absence of patients' written consent.