Percutaneous Edge-to-Edge Mitral Valve Repair with the Mitraclip System in Barlow's Disease

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Ambiente e clima della Sicilia durante gli ultimi 20 mila anni

Environment and Climate in Sicily over the last 20, 000 years. (IT ISSN 0394-3356, 2010). A series of recent studies shed light on the central Mediterranean, and Sicily, climate and environment, starting from the last glacial maximum (about 20 ka cal BP). In the present paper, we examine most of these works, in order to unravel environmental changes of the past, mainly in terms of temperature, atmospheric pattern, precipitation, vegetation and faunal associations. The climate of the last glacial maximum was characterised by very low temperature and by repeated northerlies penetration, even during summer. Low precipitation values led to a steppe- or semisteppe-like vegetation pattern, dominated by herbs and shrubs. Episodes of climatic anomaly, characterised by lower temperature and strengthened wind activity, could have occurred during the Holocene, as testified by micropaleontological and geochemical investigations carried out on the southern Tyrrhenian Sea and in the northern Sicily Channel. In the terrestrial record, there is evidence of drought at 8.2 ka cal BP, from the isotopic composition of a stalagmite recovered near Palermo, and of prolonged drought intervals during the Little Ice Age in the Erice village (Trapani). The vegetation pattern shows the development of Mediterranean Maquis in coastal sites and deciduous forests in sub-montane and montane regions, approximately from the Holocene base. The human impact is the main factor that forced the present vegetation pattern, as a consequence of intensive land-use, which started about 2.7 ka cal BP, when Greek colonies were first established. Human activity is however superimposed on a natural trend towards aridity, with climatic forces still not fully understood

Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

: In the European Union (EU) the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, whereas authorizing the placing on the market of medical devices is decentralized to independent 'conformity assessment' organizations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the medical device directives, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details-which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE-MD project (Coordinating Research and Evidence for Medical Devices) will run until March 2024; here we describe how it may contribute to the development of regulatory science in Europe

Evolving paradigms in antithrombotic therapy for anticoagulated patients undergoing coronary stenting

A sizable proportion of coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI) with stent implantation have an indication for treatment with oral anticoagulant therapy (OAC). The coexistence of atrial fibrillation (AF) and the need for PCI expose patients to a higher risk of developing thrombotic complications, and a multitargeted antithrombotic treatment strategy, addressing both platelet- and coagulation-mediated triggering mechanisms of thrombosis, is necessary for ensuring full protection from ischemic hazards. The increased bleeding risk identified with triple antithrombotic therapy has driven the search for alternative treatment modalities and pharmacological combination strategies aimed at achieving an optimal balance between safety and efficacy in this complex clinical scenario. Over a short time period, the paradigms surrounding the management of patients undergoing PCI who require OAC have substantially evolved. In this review, we summarize and critically evaluate the results of recent randomized clinical trials investigating the pharmacological management of patients who, in addition to antiplatelet therapy, have an indication for OAC treatment before or at the time of a PCI procedure