Comprehensive geriatric assessment in patients undergoing transcatheter aortic valve implantation–rationale and design of the European CGA-TAVI registry

Abstract Purpose Aortic stenosis (AS) is the most common valvular abnormality in the elderly population. For inoperable patients or those at high-risk for surgery, transcatheter aortic valve implantation (TAVI) has become an alternative therapeutic option. The aim of the “Comprehensive geriatric assessment for transcatheter aortic valve implantation” (CGA-TAVI) registry is to evaluate the effectiveness of TAVI from the perspective of the geriatrician and to identify patient characteristics and indicators related to complications and clinical benefits for patients with symptomatic severe calcified degenerative AS undergoing TAVI. Materials and methods The CGA-TAVI registry is an international, multi-center, prospective, observational registry across Europe with consecutive patient enrolment. The registry will enrol up to 200 patients with AS undergoing TAVI, starting August 2013. CGA-TAVI has two co-primary objectives: (1) Establish predictive value of Comprehensive geriatric assessment (CGA) for mortality and/or hospitalization in TAVI patients. (2) Demonstrate CGA changes within 3 months after TAVI. Secondary objectives are: (1) Establish predictive value of CGA in TAVI patients for all-cause hospitalization, TAVI-related hospitalization, and nursing home admission. (2) Develop a comprehensive score for the assessment of TAVI patient prognosis. Conclusions The data obtained from the CGA-TAVI registry will supplement previous results to document the potential value of the effectiveness of TAVI from the perspective of geriatricians and will allow the assessment of the predictive value of CGA for mortality and/or hospitalization in elderly TAVI patients. Keywords Aortic stenosis; Transcatheter aortic valve implantation (TAVI); Comprehensive geriatric assessment (CGA); Registry; Predictor

Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary.

The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.

Assessing agriculture-water relationships: a Pan-European multidimensional modelling approach.

This paper aims at developing a simulation framework to jointly assess agricultural and water issues. While the strong linkages between water, food, and the environment call for an integrated and multidisciplinary modelling approach, a complete and consistent modelling system to evaluate food-water relationships in Europe was missing so far. The spatial economic simulation model for agriculture CAPRI, which comprises a set of environmental indicators to assess food-environment interrelations within European regions, has been extended to account for food-water links. This modelling framework enables simulating the potential impact of climate change and water availability on agricultural production at the EU regional level, as well as looking at the sustainable use of water, the implementation of water policies or the integration of water issues in the Common Agricultural Policy

Option contracts for allocating water in inter-basin transfers: the case of the Tagus-Segura Basin in Spain

Users in the Mediterranean region face significant water supply risks. Water markets mechanisms can provide flexibility to water systems run in tight situations. The largest water infrastructure in the Iberian Peninsula connects the Segura and Tagus Basins. Stakeholders and politicians in the Tagus Basin have asked that water transfers between the two basins be eventually phased out. The need to increase the statutory minimum environmental flow in the middle Tagus and to meet new urban demands is going to result in a redefinition of the Transfer?s management rules, leading to a reduction in the transferable volumes. To minimise the consequences of such restrictions to irrigators in the Segura Basin who depend on the transferred volumes, we propose the establishment of water option contracts between both basins that represents an institutional innovation with respect to previous inter-basin spot market experiences. Based on the draft of the new Tagus Basin Plan, we propose both a modification of the Transfer?s management rule and an innovative inter-basin option contract. The main goal of the paper is to define this contract and evaluate it with respect to non-market scenarios. We also assess the resulting impact on environmental flows in the Tagus River and water availability for users in the Segura Basin, together with the economic impacts of such contract on both basins. Our results show that the proposed option contract would reduce the impact of a change in the transfer?s management rule, and reduce the supply risks of the recipient area.

An ethnopharmacological and historical analysis of “Dictamnus”, a European traditional herbal medicine

Ethnopharmacological relevance and background: “Dictamnus” was a popular name for a group of medicinal herbaceous plant species of the Rutaceae and Lamiaceae, which since the 4th century have been used for gynaecological problems and other illnesses BCE and still appear in numerous ethnobotanical records. Aims: This research has as four overarching aims: Determining the historical evolution of medical preparations labelled “Dictamnus” and the different factors affecting this long-standing herbal tradition. Deciphering and differentiating those medicinal uses of “Dictamnus” which strictly correspond to Dictamnus (Rutaceae), from those of Origanum dictamnus and other Lamiaceae species. Quantitatively assessing the dependence from herbal books, and pharmaceutical tradition, of modern Dictamnus ethnobotanical records. Determining whether differences between Western and Eastern Europe exist with regards to the Dictamnus albus uses in ethnopharmacology and ethnomedicine. Methods: An exhaustive review of herbals, classical pharmacopoeias, ethnobotanical and ethnopharmacological literature was conducted. Systematic analysis of uses reported which were standardized according to International Classification of Diseases – 10 and multivariate analysis using factorial, hierarchical and neighbour joining methods was undertaken. Results and discussion: The popular concept “Dictamnus” includes Origanum dictamnus L., Ballota pseudodictamnus (L.) Benth. and B. acetabulosa (L.) Benth. (Lamiaceae), as well as Dictamnus albus L. and D. hispanicus Webb ex Willk. (Rutaceae), with 86 different types of uses. Between 1000 and 1700 CE numerous complex preparations with “Dictamnus” were used in the treatment of 35 different pathologies. On biogeographical grounds the widespread D. albus is a far more likely prototypical “Dictamnus” than the Cretan endemic Origanum dictamnus. However both form integral parts of the “Dictamnus” complex. Evidence exists for a sufficiently long and coherent tradition for D. albus and D. hispanicus, use to treat 47 different categories of diseases. Conclusions: This approach is a model for understanding the cultural history of plants and their role as resources for health care. “Dictamnus” shows how transmission of traditional knowledge about materia medica, over 26 centuries, represents remarkable levels of development and innovation. All this lead us to call attention to D. albus and D. hispanicus which are highly promising as potential herbal drug leads. The next steps of research should be to systematically analyse phytochemical, pharmacological and clinical evidence and to develop safety, pharmacology and toxicology profiles of the traditional preparations.

The ‘Lisbonisation’ of the European Parliament: Assessing progress, shortcomings and challenges for democratic accountability in the area of freedom, security and justice. CEPS Paper on Liberty and Security in Europe No. 58, September 2013

This paper examines the performance of the European Parliament in EU AFSJ law and policy-making from the entry into force of the Lisbon Treaty until the end of the first half of 2013. The paper situates the EP in the new post-Lisbon institutional setting, documenting its transition to ‘AFSJ decision-maker’, and its new powers to shape and make policy covering the EU’s internal and external security agenda. While the paper finds that the EP has become an active co-owner of the EU AFSJ post-Lisbon, with the Parliament demonstrating a dynamic adjustment to its new post-Lisbon role and powers, the authors identify a set of new developments and challenges that have arisen in the conduct of democratic accountability by the EP in the AFSJ since 2009, which call for critical reflection ahead of the new parliamentary term 2014-2019 and the post-2014 phase of the EU’s AFSJ.

Humanitarian Visas: Option or obligation?. CEPS Liberty and Security in Europe No. 68, 27 October 2014

Third-country nationals seeking protection have no EU-wide legal channels at present for entering EU territory and triggering protection mechanisms under the Common European Asylum System. As a result, many embark on hazardous journeys, with concomitant risks and loss of human life. The absence of ‘protection-sensitive’ mechanisms for accessing EU territory, along with EU external and extraterritorial border and migration management and control, undermine Member States' refugee and human rights obligations. Humanitarian visas may offer a remedy in this regard by enabling third-country nationals to apply in situ for entry to EU territory on humanitarian grounds or because of international obligations. This study asks whether the existing Visa Code actually obliges Member States to issue humanitarian visas. It also examines past implementation of humanitarian visa schemes by Member States and considers whether more could be done to encourage them to make use of existing provisions in EU law. Finally, with a Commission proposal for Visa Code reform on the table, it asks whether there is now an opportunity to lay down clear rules for humanitarian visa schemes.

Regional Wage and Employment Responses to Market Potential in the EU. Bruges European Economic Research (BEER) Papers 3/November 2005

Recent theoretical work on economic geography emphasizes the interplay of transport costs and plant-level increasing returns. In these models, the spatial distribution of demand is a key determinant of economic outcomes. In one strand, it is argued that higher demand gives rise to a more than proportionate increase in production, a result known as the home market effect. Another strand emphasizes the effects of market sizes on factor prices. We highlight the theoretical connection between these two strands. Using data on 57 European regions, we show how wages and employment respond to differentials in what we call real market potential, a discounted sum of demands derived from the theory.

A case for adjusting fiscal consolidation in the eurozone. European Policy Brief No. 14, January 2013

Fiscal consolidation is essential to ensure the sustainability of eurozone countries’ public debt. However, as a principle, consolidation should not be pursued at a pace unnecessarily undermining growth in the short term. Repeated downward revisions of growth call for the use of the flexibility foreseen in the EU fiscal framework. The Commission should adapt the deadlines for fiscal correction to prevent excessive, pro-cyclical adjustment in 2013. In turn, adequate surveillance and coordination must ensure structural adjustments constitute the core of fiscal consolidation plans.

The case for a European unemployment benefit scheme. CEPS Commentary, 19 May 2015

In this CEPS Commentary, Ilaria Maselli and Miroslav Beblavý argue that the European economic governance system needs to be equipped with a supranational automatic stabiliser that would kick-in automatically in the event of an economic downturn, to avoid unduly burdening national public finances. In their view, the option of creating an unemployment benefit system for the euro area should be given serious consideration. The possible variations of such a system and their implications will be the subject of in-depth study at CEPS over the coming year.

Migration and Asylum Data for Policy-making in the European Union – The problem with numbers. CEPS Liberty and Security in Europe No. 89/March 2016

Among many other problems, the migration, humanitarian and policy crises in the European Union in 2015 and early 2016 have highlighted a pressing need for reliable, timely and comparable statistical data on migration, asylum and arrivals at national borders. In this fast-moving policy field, data production and the timeliness of dissemination have seen some improvements but the sources of data remain largely unchanged at national level. In this paper the author examines the reasons for some of the problems with the data for policy and for public discussion, and makes a set of recommendations that call for a complete and updated inventory of data sources and for an evaluation of the quality of data used for policy-making.

A proposal to revive the European Fiscal Framework. Bruegel Policy Contribution ISSUE 2016/07 MARCH 2016

Pro-cyclical fiscal tightening might be one reason for the anaemic economic recovery in Europe, raising questions about the effectiveness of the EU’s fiscal framework in achieving its two main objectives: public debt sustainability and fiscal stabilisation. • In theory, the current EU fiscal rules, with cyclically adjusted targets, flexibility clauses and the option to enter an excessive deficit procedure, allow for large-scale fiscal stabilisation during a recession. However, implementation of the rules is hindered by the badly-measured structural balance indicator and incorrect forecasts, leading to erroneous policy recommendations. The large number of flexibility clauses makes the system opaque. • The current inefficient European fiscal framework should be replaced with a system based on rules that are more conducive to the two objectives, more transparent, easier to implement and which have a higher potential to be complied with. • The best option, re-designing the fiscal framework from scratch, is currently unrealistic. Therefore we propose to eliminate the structural balance rules and to introduce a new public expenditure rule with debt-correction feedback, embodied in a multi-annual framework, which would also support the central bank’s inflation target. A European Fiscal Council could oversee the system.

A Crisis for the Ages: The European Union and the migration Crisis. Jean Monnet/Robert Schuman Paper Series Vol. 15 Special, October 2015

Five months ago most European citizens were unaware of the number of refugees seeking to reach the richest EU Member States like Germany, France, Sweden and the United Kingdom. The first wake up call for Europe was after the Lampedusa tragedy costing the lives of more than 300 refugees on October 3rd, 2013.1 Europeans were shocked, as the world was, to wake up to hear about such tragedy taking place at their doorstep. From 2013 to 2015, the issue of mass-migration from Syria, Eritrea, Somalia and other countries in the region left the front pages of newspapers and the minds of Europeans, but had remained extremely present in the world of experts and the International Organization for Migration (IOM) was calling for actions. The second wake-up call, which marked the beginning of the seriousness of the crisis, was the shipwreck where an estimated 900 migrants died on April 19th, 2015 off the coast of Italy.