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European Heart Journal Supplements (2014) 16 (Supplement A), A45–A47 doi:10.1093/eurheartj/sut011 How to evaluate healthcare systems in primary angioplasty Francesco Fedele* and Massimo Mancone Department of Cardiovascular, Respiratory, Nephrology, Anesthesiology and Geriatric Sciences, ‘Sapienza’ University of Rome, Policlinico ‘Umberto I’, Viale del Policlinico 115, Italy KEYWORDS Primary PCI; STEMI; Quality evaluation; Healthcare system Primary percutaneous coronary intervention (P-PCI) is the gold-standard treatment for ST-elevation myocardial infarction (STEMI). The main goals of a healthcare system in the setting of STEMI are two: first of all to reduce the time delays between diagnosis and P-PCI; secondly to increase the per cent of STEMI patients treated with P-PCI. The aim of this article was to propose a quality evaluation of healthcare system, identifying and defining measurable elements in the setting of P-PCI. Primary percutaneous coronary intervention (P-PCI) represents the gold-standard treatment for patients presenting with ST-elevation myocardial infarction (STEMI). Primary percutaneous coronary intervention has become the leading mode of reperfusion and the standard of treatment in the majority of European countries, in the USA, and in other ‘developed’ nations. Nevertheless, numerous differences exist in terms of time and rates of utilization of P-PCI, among nations and also in singular country regions.1,2 In Europe, beginning from 2003, a progressive raise of STEMI patients reperfused with P-PCI was observed. In this setting, the leading example is represented by Czech Republic, where the rate of P-PCI reperfused hospitalized STEMI is more than 90%. These differences are mainly due to: lack of interventional cardiologists and/or nurses and other support staff; cultural problems (internists and noninvasive cardiologists prefer use thrombolysis); geographical differences (rural and urban areas); the presence of a faulty network.2 The main goals of a healthcare system in the setting of STEMI are two: first of all to reduce the time delays between diagnosis and P-PCI; secondly to increase the per cent of STEMI patients treated with P-PCI. An ‘operative’ Network organization, involving prehospitals services, community hospitals, and P-PCI centres (‘24/7’), is crucial to ensure prompt, effective, and accomplished myocardial reperfusion. Consequently, * Corresponding author. Tel: +39 06 49979021; Fax: +39 06 49979060, Email: [email protected] a deepened quality evaluation of the healthcare system is mandatory to point out ‘threatening crossroads’ and correctable defects.3,4 The aim of this article is to identify and evaluate the chain rings that depict the ‘way’ of the patient among diagnosis, P-PCI, hospital stay, discharge, and follow-up. In literature, there are numerous papers focalized to identify a correct methodology of quality assessment.3–5 The first step to analyze and evaluate a healthcare system is to identify and to define measurable elements. Measurable elements are normally derived from guidelines. The majority of published papers on performance measures focalized their attention on the clinical application of international guidelines. Identifying performance measures The first measure to perform in a country or a region is the per cent of the hospitalized STEMI patients treated with primary PCI: the target should be a rate .90%. According to ESC guidelines, diagnosis, achieving a 12-leads electrocardiography, should be performed at the time of first medical contact (FMC). The FMC is the moment when the starter shoots the gun and starts to count the seconds. For this reason, to understand the definition of FMC is crucial; it refers to the initial patient assessment independently from who (physician or para-medic) and where (pre-hospital setting or hospital setting) starts the contact. Considering the FMC we could have different Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2013. For permissions please email: [email protected] A46 F. Fedele and M. Mancone Figure 1 The complex healthcare systems in primary angioplasty setting. times and consequently delays. The key delays are: (i) the patient delay (time between symptoms onset and FMC); (ii) delay between FMC and diagnosis (it should be ≤10 min); (iii) delay between FMC and the wire positioning in culprit vessel during P-PCI (it should be ≤90 and ≤60 min in the high-risk patients with large anterior infarct or in the early presenter within 2 h); (iv) door to balloon time (it refers to P-PCI-capable hospital and it should be ≤60 min).4 In particular, the delay between FMC and P-PCI is the strongest indicator of quality of healthcare systems. In fact, involving pre-hospitals services, community hospitals, and P-PCI centres, it reflects the entire organization and the functionality of the STEMI network in a defined geographic area. Differently, from a patient perspective, the most important time is total ischaemic time (delay between symptom on set and reperfusion), in other world ‘time is muscle’. In fact, in a recent published paper, using cardiac magnetic resonance, we demonstrated that the total ischaemic time determines the extent of reversible and irreversible myocardial damage.6 Nevertheless, in a recent published paper on the New England Journal of Medicine, the authors retrospectively analyzed a population of 96.738 STEMI patients treated with P-PCI. They observed a significant reduction in terms of door-to-balloon time between the period 2005–06 and the period 2008–09 (83 vs. 67 min; P , 0.001); however, the significant reduction of doorto-balloon time was not associated with a reduction in 30-day mortality.7 This paper suggests that the ‘Time’ is not all, and additional strategies are needed to reduce in-hospital mortality. Other performance measures that should be evaluated to analyze a correct therapeutic ‘way’ in a healthcare system in the setting of P-PCI patients could be reassumed schematically analysing the four different steps: catheterization-laboratory; coronary care-unit; discharge; follow-up.4,5 Catheterization laboratory: (i) Per cent of patients treated with: aspirin, clopidogrel, prasugrel, ticagrelor, bivaluridin, unfractionated heparin; (ii) Per cent of patients treated with: drug-eluting stent, thrombectomy, radial approach; (iii) number of P-PCI/year, number of P-PCI/year/ operator. Coronary care-unit, discharge and follow-up: (i) length of stay in the coronary care unit; hospital stay; (ii) per cent of patients treated and discharged with: b-blockers, statin, angiotensin-converting enzyme Evaluation of healthcare systems in primary angioplasty (iii) (iv) (v) (vi) inhibitors, angiotensin-receptor blockers, aldosterone antagonists, DAPT; assessment of infarct size and left ventricular function: echocardiography and/or cardiac magnetic resonance per cent; per cent of multivessel patients evaluated for residual ischaemia and viability; per cent of patients that start a rehabilitation programme; per cent of patients followed-up: to optimize therapy, to identify patients who will need ICD or CRT; re-hospitalization rate; mortality rate. A47 2. 3. 4. In conclusion, the evaluation of a healthcare system in the primary angioplasty setting is complex and includes different actors and perspectives. It starts from the patient-centred approach and arrive to an international perspective, going through physicians, para-medical figures, network organization, technology, hospitals, region and nations (Figure 1). 5. Conflict of interest: none declared. 6. References 1. Widimsky P, Wijns W, Fajadet J, de Belder M, Knot J, Aaberge L, Andrikopoulos G, Baz JA, Betriu A, Claeys M, Danchin N, Djambazov S, Erne P, Hartikainen J, Huber K, Kala P, Klinceva M, Kristensen SD, 7. Ludman P, Ferre JM, Merkely B, Milicic D, Morais J, Noc M, Opolski G, Ostojic M, Radovanovic D, De Servi S, Stenestrand U, Studencan M, Tubaro M, Vasiljevic Z, Weidinger F, Witkowski A, Zeymer U. Reperfusion therapy for ST elevation acute myocardial infarction in Europe: description of the current situation in 30 countries. Eur Heart J 2010;31:943–957. Laut KG, Gale CP, Pedersen AB, Fox KA, Lash TL, Kristensen SD. 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