Angioplastica Primaria nelle SCA:

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1 MALATTIE CARDIOVASCOLARI: DALLA FASE ACUTA ALLA PREVENZIONE, L ACCESSO ALLE TERAPIE NELL ERA ERA DEL RISANAMENTO ECONOMICO Roma, Palazzo Marini Sala delle Colonne 04 Ottobre 2011 Angioplastica Primaria nelle SCA: Indicazioni, Risultati e il Programma Stent for Life Leonardo De Luca, M.D., Ph.D., F.A.C.C. Department of Cardiovascular Sciences Interventional Cardiology Unit European Hospital Rome, Italy leo.deluca@libero.it Conflict of interest: none

2 Hospital Admissions for AMI in Europe per year) millions p tients (m er of pat Numbe Average: 800 Average: 1,934 Data source:

3 Myocardial Infarction with ST-Segment Elevation Before, During, and After PCI

4 AMI Mortality According to Treatment Av: 9.2% Av: 4.9% Av: 9.2% Av: 8.6% AMI mort tality per year (% %) Data source:

5 STEMI Reperfusion Treatment in Europe 100% % % 70% 60% 50% 40% 30% 20% % % Primary PCI Thrombolysis No reperfusion Data source:

6 Annual Incidence of Primary o a y PCIs Cs 600 p-pci / million / year p-pci / million / year p-pci p PCI / million / year <200 p-pci / million / year Data not known

7 2008 ESC Guidelines on Persistent ST-Segment Segment Elevation Time limits 2 h PCI-capable hospital Ambulance Non PCI-capable hospital Primary PCI PCI <2h possible* PCI <2h not possible # pre, in-hospital fibrinolysis 12 h Rescue PCI failed successful 24 h Angiography Time FMC to first balloon inflation # If PCI in not possible <2 h of FMC, Not earlier than 3 h 24/7 service must be shorter than 90 min in patients presenting early (<2 h after symptom onset), with large amount of viable myocardium and low risk of start fibrinolytic therapy as soon as possible after start fibrinolysis bleeding First Medical Contact (FMC) The thick arrow indicates the preferred strategy Van de Werf et al. Eur Heart J 2008;29:2909

8 Compared With the 2003 Guidelines an Important New Recommendation Was Formulated The need for the establishment of networks of hospitals with different levels of technology using the same protocol and connected by an efficient i ambulance service

9 Practical Limitations of Primary PCI as a Universal Reperfusion Strategy Time delays (DBT, transfer time, waiting time for next available ambulance etc.) Availability of invasive facilities Operators skillness and cath lab volume load Reorganization of EMS systems not conducive to making PPCI EMS lacking 12-lead ECG capabilities Not all patients having STEMI are transported by EMS Mandates to transport patients to the nearest facility

10 Clinical Impact of Direct Referral to PCI Following pre-h Diagnosis of STEMI Sym mptom on nset to ba alloon infl lation (minutes s) 50 0 No prehospital diagnosis Admission to local hospital Subsequently transferred t i t ti l h it l Prehospital diagnosis Admission to local hospital Subsequently transferred t i t ti l h it l PRAGUE-1 PRAGUE-2 Prehospital diagnosis Local hospital bypassed. Patients rerouted directly t i t ti l h it l to interventional hospital to interventional hospital to interventional hospital MAASTRICT DANAMI-2 Terkelsen et al. Aashein et al. Terkeisen et al. J Electrocardiology 2005;36:187

11 The Ottawa Hospital Institute STEMI Regional Program

12 The Citywide Ottawa Program Time to Treatment Field transf Inter-hosp. transf %) n Time Patients (% to Balloon portion of P ECG Prop Field transfers Interhospital transfers P<0.001 % p<0.001 p<0.001 Minutes DTB<90 min DTB<120 min Le May RM et al. N Engl J Med 2008;358:231

13 All-causes and CV Mortality According to Method of Diagnosis and Referral rtality Mo (%) No pre-hospital diagnosis (n=216) Pre-hospital diagnosis, no direct referral to primary PCI (n=83) Pre-hospital diagnosis and direct referral to primary PCI (n=460) 0 Log-rank P= Years J.T. Sorensen et al. Eur Heart J 2011; 32:439

14 Time Intervals According to Referral Method and Geographic Area Group 1 Group 2 Group 3 No pre-hosp Pre-hosp Pre-hosp diagnosis diagnosis, no diagnosis and (n=216) direct referral direct referral (n=83) (n=460) P Symptom-balloon time, min <0.001 Rural Urban EMS contact-balloon time, min <0.001 Rural Urban EMS contact-balloon time 120 min, % 32 % 33 % 86 % <0.001 Rural 15 % 28 % 83 % Urban 48 % 46 % 89 % Sorensen JT et al. Eur Heart J 2011; 32:430

15 In the last 4 yrs the volume of wireless broadband network is up 8,000 %

16 Washington DC Area Hospitals: Ongoing Project... Supported by AT&T, to give an iphone to everyone who treats STEMI patients, including the emergency-room room doctors and paramedics, and develop a special iphone application that can securely transmit high-quality ECG information from the field to the hospital to speed the diagnosis of STEMI. The ECG data can also be easily stored in an electronic medical record.

17 Proportion of STEMI Patients Arriving at First Hospital via EMS in Europe ng via EMS (%) STEM MI patien nts arrivi Average: 51% European countries UK Sweden Austria Czech Rep Israel Serbia Spain Slovakia Italy Turkey Greece Data source:

18 The System Delay

19 Delays from Symptom Onset to Primary PCI Patients Transported by the EMS Field triaged to a PCI center Symptom Arrival at onset EMS call PCI center Primary PCI Patient Delay Transportation Delay Door to balloon Delay Prehospital System Delay Treatment Delay System Delay Transferred from local hospitals Symptom Arrival at Departure from Arrival at onset EMS call Local hospital local hospital PCI center Primary PCI Patient Delay Transportation Delay Local Hospital Delay Interhospital Delay Door to balloon Delay Prehospital System Delay (before arrival at PCI center) System Delay Treatment Delay Terkelsen CJ, et al. JAMA 2010;304:763

20 Delays from Symptom Onset to Primary PCI Patients Transported by the EMS Terkelsen CJ, et al. JAMA 2010;304:763

21 Strategies for reducing the door-to-balloon time in STEMI Bradley EH, et al. N Engl J Med 2006;355:2308

22 Health Care Agency of the Italian Region Emilia-Romagna January 2003 ESC Guidelines: Pi Primary PCI Gold standard for STEMI 2003 Thrombolysis PTCA shock and ctd. to TBL Thrombolysis and transfer to Hub High risk PCI High and not high risk PCI Network implementation (transition) Saia F. et al, Heart 2009;95:370

23 Health Care Agency of the Italian Region Emilia-Romagna Reperfusion Treatment Patients with STEMI < 12h (85%) 23,7 41,2 No reperfusion Reperfusion % ,8 76, Saia F. et al, Heart 2009;95:370

24 Health Care Agency of the Italian Region Emilia-Romagna % In-hospital mortality % ARR 28 % RRR p = , Saia F. et al, Heart 2009;95:370

25 AMI Network in Italy Trentino-Alto Adige Friuli-Venezia Giulia Valle d'aosta Lombardia Veneto Piemonte Emilia-Romagna Liguria Marche Toscana Umbria Abruzzi Molise Lazio Puglia Campania Basilicata Calabria Sardegna Sicilia White: No ECG Light Blue:ECG without teletransmission Dark Blue:ECG with teletransmission

26 Primary PCI/ inhabitants In Italy % +150 N

27 Population per 24/7 primary PCI centre Average: 917,614 millions) Population (m European countries Data source:

28 Number of ppci in STEMI and BDP in Different Countries Widimsky P et al.. Eur Heart J 2009

29 Costs 1-Year Follow-Up Sweden P=0.038 Societal perspective Euros P= P=0.001 Janzon A, et al. Am Heart J 2010;160:322

30

31 Stent for Life Initiative Objectives 1. Define regions/countriesntries with an unmet medical need in the optimal treatment of ACS. 2. Implement an action program to increase patient access to primary PCI where indicated: To increase the use of primary PCI to more than 70% among all ST segment elevation myocardial infarction patients, To achieve primary PCI rates of more than 600 per one million inhabitants per year, To offer 24/7 service for primary PCI procedures at all invasive facilities to cover the country STEMI population need.

32 Lessons Learned For Primary PCI Implementation Emergency medical services (EMS) EMS staff training is more important that the EMS staff structure ECG teletransmission Networks and infrastructure Regional networks, involving EMS, non-pci hospitals and PCI centres. Cover an area comprising a population of approximately 0.5 million (0.3-1 Mln) people The network should work to please all (patients and all network members) Transport, time delays Bypass the nearest non-pci H as well as the ER or ICU in the PCI-centre Cathlab staffing, organisation of cathlab work Economic approach: 1 cardiologist (on call) + 1 nurse (staying in the cathlab 24/7), with additional staff (whenever necessary) coming from the ICU Financial aspects and political issues Motivating the existing (available) staff or increasing the cathlab staff Registries, quality control Public campaigns Knot J, et al. EuroIntervention 2009;5:299

33 Unirsi per fare la differenza e riuscire a cambiare EMSStaff Staff Medici di Pronto Soccorso Pazienti Cardiologi Interventisti Partners industriali Cardiologi di UTIC KoL Esperti Costo efficacia Esponenti istituzioni sanitarie e amministrazioni regionali Esperti Organizzazione di rete Medici di Medicina Generale

34 Stent for Life Initiative ITALIA

35 Stent for Life Italia 35 Regioni i Inhabitant t N Mean Age Piemonte ,7 Valle d Aosta ,5 Lombardia ,9 Trentino Alto Adige ,4 Veneto ,8 Friuli Venezia Giulia ,2 Liguria ,1 Emilia Romagna ,4 Toscana ,0 Umbria ,6 Marche ,1 Lazio ,7 Abruzzo ,5 Molise ,0 Campania ,5 Puglia ,3 Basilicata ,6 Calabria ,5 Sicilia ,0 Sardegna ,0

36 Stent for Life Initiative ITALIA

37 TREATMENT OF ACUTE MYOCARDIAL INFARCTION IN EUROPE: REVIEW OF CURRENT MODELS AND PROPOSAL OF OPTIMAL COMMON STANDARDS London July 1st, 2011

38 Key Activities for the Next Months Schedule further audience with some local l health h commissioners i in order to illustrate in detail the initiative and the plans of action Attend and support local health commissions meetings for planning and/or implementing primary PCI networks Design a survey on health costs of STEMI reperfusion in a target region without a primary PCI network and compare the results with a region where a well organized STEMI system is present Organize SFL meetings with key opinion leaders and policy makers in each target region II Edition of IMA Web Network Involve new industry ypartners in the initiative

39 IMA Web Network, II Edition 1 Form for each Hospital 1 Form for each 118 Area

40 Analisi Costo-efficacia (CEA) In un contesto di risorse economiche sempre più limitate, è cruciale la valutazione dei benefici apportati dalle tecnologie in relazione ai costi maggiori introdotti Necessità di combinare evidenza clinica ed efficienza economica Analisi costo-efficacia Rosanna Tarricone

41 The Tension between Needing to Improve Care and Knowing How to do it! The need to improve the quality of care for STEMI pts is urgent. We cannot wait! Any effort must be made to shorten delays and to improve quality Emulating successful organizations can speed effective improvement National Societies have to make every effort to ensure that the messages derived from international guidelines are relayed at national and regional level, in order to make sure that t the proposed strategies t and recommendations are implemented locally

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