Alberto CremonesiPresident of the Italian Society of Interventional Cardiology (SICI-GISE)Head of the Cardiovascular Department at Maria Cecilia HospitalCotignola (RA)Italy
The EAPCI and SICI-GISE share a vision of interventional cardiovascular medicine. Since the creation of EAPCI, SICI-GISE has been a strong participant believing that the Association represents an outstanding platform for clinical and scientific exchange. For SICI-GISE, the synergy created when the EAPCI was formed –the former ESC Working Group 10, EuroIntervention and EuroPCR– is essential to its success. SICI-GISE dedicates a large part of its energy and time to research and education through the GISE Foundation. Working in collaboration with industry partners –based upon a clearly defined code of conduct– SICI-GISE promotes clinical research and postgraduate educational programmes. Our national society also believes that optimising European communications among all national interventional cardiology working groups is a strength of the EAPCI.
For the EAPCI and SICI-GISE, 2013 sees new challenges and common goals. The critical and unstable economic situation is a key factor which affects not only the quality of our therapeutic process, but also patient access to innovation. The economic downturn unavoidably involves a greater scrutiny of all public expenditures, health system included. This translates into stricter approval criteria for treatment by interventional medicine generated by the net balance between efficacy, safety and health technology assessment which plays a more important role in the stakeholders’ decision making. It is crucial that the EAPCI working with the National Societies carefully take these circumstances into account, understanding that if the current situation is not approached with care it has the potential for negative implications for our field.
From my perspective as SICI-GISE President, the exchange between the EAPCI board and the national societies is more important than ever: important because we need to share our strategic decisions concerning areas of scientific interest (clinical research, registries and accreditation) in order to create more homogeneous and common goals. In this way we can turn the crisis into great opportunities: “together we achieve more” should be seen through our shared commitment.
A joint project of the EAPCI, EuroPCR, EUCOMED, the ESC Working Group on Acute Cardiac Care and SICI-GISE: Country champion: Giulio Guagliumi; Project manager: Leonardo De Luca
Italy was one of the first countries in Europe to perform primary percutaneous coronary intervention (p-PCI) and some regions are still the model for the ST-elevation myocardial infarction (STEMI) network organisation. At the same time, other regions have yet to develop a model allowing each STEMI patient to receive the best reperfusion treatment, resulting in an annual rate of p-PCI well below the national average or the standard of 600/million inhabitants/year that is recommended by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and the European Society of Cardiology (ESC). Data from the Italian Society of Invasive Cardiology (SICI-GISE) shows that in 2011 approximately 28,500 p-PCI have been performed by the 260 cathlabs located across the country –an increase of 2.2% compared to 2010– with an average of 470 primary PCI/million inhabitants/year.
Through SICI-GISE, Italy has become a signatory of the Stent for Life (SFL) Declaration at the Stockholm ESC Annual Congress in August 2010. Taking into consideration the existing realities in different territorial networks for STEMI now present in Italy, we developed a series of selective regional action plans examining the specific background of each area and drawing-up a network plan development, meeting the quality standards at the national level in alliance with recognised organisations. In order to ensure the success of SFL initiative and access to p-PCI, we turned to the combined support and participation of many stakeholders and partners including: interventional cardiologists, clinical cardiologists, the emergency medical system, government representatives, industry, advocacy groups and the patients themselves.
Seven areas with unmet clinical needs were identified as primary SFL target in Italy: Five main regions in the south of Italy such as Campania, Sicilia, Puglia, Basilicata and Calabria; and two major areas in the north: the districts of Piemonte and Veneto. Approximately 21 million inhabitants are potentially involved (35% of the total population).
In all these regions we are working to implement local STEMI treatment guidelines, identifying and eliminating specific barriers to the application of the STEMI guidelines. Over these last years we have conducted several meetings with the health commissions of the target regions that embraced the SFL project, developing plans to reorganise their STEMI care system.
Sicilia issued a regional legal decree on the organisation of their STEMI network several months after the kick-off of the Italian SFL programme. In this regional law, based on the consensus document produced by the steering committee of SFL Italia, all specific duties and requirements of EMS, emergency rooms, CCUs and cathlabs involved in the network, along with the standards for data collection in order to ensure quality control, have been clearly stated. The STEMI network is expected to officially become operational at the end of 2013. In the meantime, regional health administrations and four macro-areas committees are directing all their effort on EMS staff training with certified courses on advanced life support and including ECG interpretation as well as structural improvements in EMS management by equipping the vast majority of ambulances with ECG radio-transmission capability.
In this target region of SFL Italia, we are conducting a survey on health costs of STEMI reperfusion, in partnership with the CERGAS (Centro di Ricerche sulla Gestione dell’assistenza Sanitaria Sociale), Bocconi University of Milan, Milan. This survey will analyse the impact, in terms of cost/effectiveness, before and after the set-up and implementation of a network for p-PCI. The first phase of this analysis (reperfusion therapy before the official start of the STEMI network) has been completed, and the preliminary data have been recently presented to the regional health authorities.
At the end of 2010 the regional health authorities of Campania issued a decree for the development of a hospital and territorial network for STEMI care. After several meetings with local health commissioners, SFL Italia promoted the creation of a regional commission for the definition of single provincial protocols for the STEMI network, assessment of the actual status of EMS, development of ECG radio-transmission capabilities and the training of EMS staff. During this year a pilot project on the STEMI network is planned to begin in the province of Avellino and Benevento.
In May 2011 the Piemonte Region conducted a two-month survey on the modalities of access to hospital care for STEMI patients, the modalities of reperfusion treatment and subsequent outcomes. This registry demonstrated that hospital access of patients was via EMS in 51% of cases, that p-PCI was performed in 78% of cases and that 18% of patients did not receive any reperfusion treatment, with an overall in-hospital mortality of 4.3%. After these data, with the support of SFL, a task force for the implementation of a pilot regional STEMI network in metropolitan Turin was established and a web-based registry for monitoring the quality of performances in STEMI patients has been implemented.
In the Veneto, SFL is supporting a snapshot registry (Venere-2) on reperfusion modalities in STEMI patients in order to better identify local barriers for using established STEMI routes and implementing the utilisation of p-PCI.
Although both regions of Puglia and Basilicata issued a regional law for the creation of STEMI networks several years ago, and 100% of EMS ambulances are equipped with with ECG radio-transmission devices (more than 306,000 ECG were transmitted over the last six years in Puglia alone), the majority of STEMI patients, especially in suburban areas, are transported to the nearest hospital. SFL Italia organised several meetings with local health authorities and EMS committees producing a document that was presented to regional government on the reassessment of regional networks involving EMS, non-PCI hospitals and PCI centres in order to implement p-PCI services more effectively. After this commitment, the rate of p-PCI in the metropolitan area of Bari increased substantially in the last few months.
The Italian Society of Invasive Cardiology is an association of professionals who, because of their work in health care, teaching and research, are dedicated to the further study, development and implementation of advances in haemodynamics and interventional cardiology. The Association’s activity is dedicated to the promotion of scientific, cultural, technical, organisational developments as well as the regulatory environment affecting industry and is deeply involved in the implementation of clinical trials, conferences, courses, publications, legislative updates and contacts with the institutions. “(From the Statute of the Italian Society of Invasive Cardiology, Title I, Article 2).
In this complex era of evidence-based medicine in which drugs and technology are rapidly evolving, the evaluation of new procedures in terms of effectiveness, safety, cost/effectiveness and affordability is one of the main concerns of the interventional cardiology community. SICI-GISE believes that as a scientific society we can be a key player in providing rigorous and reliable data from investigator driven trials, as well as position papers on the most challenging and debated fields to navigate through the large amount of information nowadays available.
It is from this perspective that SICI-GISE has become the official sponsor of two important investigator-driven randomised trials:
– MATRIX (P.I.: Marco Valgimigli). The Minimising Adverse haemorrhagic events by TRansradial access site and systemic Implementation of AngioX (MATRIX) is an international multicentre open-label randomised trial assessing the efficacy and safety of the transradial vs. transfemoral interventions, as well as bivalirudin monotherapy vs. unfractionated heparin plus provisional use of glycoprotein IIb/IIIa inhibitor in a broad population suffering from acute coronary syndromes (ACS).
– OCTAVIA (P.I.: Giulio Guagliumi). Optical Coherence Tomography Assessment of gender diVersity In primary Angioplasty (OCTAVIA) is a randomised clinical trial whose primary goal is to improve the prevention and treatment of myocardial infarction (MI) in women.
SICI-GISE publishes position papers for the Italian interventional community. These are not intended as a substitute for European Guidelines, but as useful tools for Italian specialists.
– 2006 (updated in 2008 and 2013): the first position paper on logistic standards for Italian cathlabs.
– 2012: papers on TAVI, a consensus document on PFO closure, one on the management of antiplatelet therapy in patients treated with stent implantation undergoing surgery.
– Coming soon: position papers on LAA closure, drug-eluting balloon use, management of peripheral artery disease.
– MitraClip™ and FFR position papers are in the pipeline.
SICI/GISE is also involved monitoring new technologies through national registries:
– TAVI has begun, LAA closure, surgical paravalvular leak closure, MitraClip™ and bioresorbable vascular scaffold are about to begin.
Our mission: To reduce the burden of cardiovascular disease
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