PRESENTAZIONE DELLA CONSENSUS CONFERENCE: PROGETTUALITA E CONDIVISIONE DELL ANMCO

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1 PRESENTAZIONE DELLA CONSENSUS CONFERENCE: PROGETTUALITA E CONDIVISIONE DELL ANMCO Consensus Conference sui Modelli Gestionali nello Scompenso Cardiaco Firenze, 3-4 Dicembre 2005 Giuseppe Di Pasquale Presidente ANMCO

2 PREVALENCE OF HEART FAILURE, BY AGE, AND Percent Age (Years) Source: National Health and Nutrition Examination Survey ( and ). National Center for Health Statistics

3 Heart Failure Prevalence Will Double in 30 Years 12 HF Prevalence in Western Europe (Millions) Aging population Coronary disease management Source: New Medicine Reports 1997 ; 1999 Heart and Stroke Statistical Update, AHA

4 Survival % Comparative Survival from Common Cancers and Heart Failure Years after diagnosis Breast Prostate Heart Failure Colon Mc Murray, E. Heart J 1998 (Suppl. L)

5 Epidemiologia e Costi dei Ricoveri per Scompenso Cardiaco negli Ospedali Italiani ( ) N. Ricoveri DRG % '96 '97 '98 '99 '00 ' Fonte: Ministero della Salute

6 Epidemiologia e Costi dei Ricoveri per Scompenso Cardiaco negli Ospedali italiani ( ) Comparazione Trend DRG più frequenti Parti Esofago-gastriti Cataratta Mal di schiena Scompenso Cardiaco '96 '97 '98 '99 '00 '01 3 Fonte: Ministero Salute

7 ANMCO Research Center (2005) Epidemiology (E) Clinical Trial (RCT) Outcomes Research (OR) CV Prevention CHD Arrhythmias Heart Failure IN-CP# (E) HEART Survey (E) SPS (E) GOSPEL (RCT) CARDIO-SIS (RCT) ORIGIN * (RCT) SCOUT * (RCT) ONTARGET* (RCT) DYDA# (E) BEAUTIFUL* (RCT) BLITZ 2 (E) OAT (RCT) G-CSF ISS# (RCT) IN-ACS (E, OR) ACTIVE * (RCT) GISSI-AF (RCT) IN-CHF (E) Survey Acute HF (E) AREA IN-CHF (RCT) GISSI-HF (RCT) CandHeart *# (RCT) EVEREST* (RCT) Euro Heart Surveys, Osservatorio MinSal Total: 24 projects * Endorsement # Forthcoming

8 The line of research in heart failure RCTs in AMI: GISSI 1,2,3: dominant prognostic role of LV ( ) dysfunction and heart failure in postinfarct patients Surveys : SEOSI: 3,921 in-outpatients with HF enrolled in 12 days ( ) EARISA: 6,030 in-patients (1,089 with HF) enrolled in 12 days Registry: IN-CHF ~25,000 HF outpatients enrolled in 10 years ( ) Outcome studies: - OSCUR, TEMISTOCLE performed in both ( ) cardiology and internal medicine wards ~ 3,000 patients enrolled in 12 days - BRING UP 1 and 2 to induce an appropriate use of β-blockers RCT in HF GISSI-HF, ~7,057 patients enrolled ( ) Survey in acute HF 2,807 patients, 6 month outcome ( )

9 Informazioni su pazienti ambulatoriali con scompenso cronico sono state raccolte da 152 Centri Cardiologici da Marzo 1995 al Marzo 2004 usando un software dedicato IN CHF Centri Cardiologici IN-CHF ITALY Nord 42% 41% Centro 26% 24% Sud 32% 35% Marzo Pazienti Visite

10 IN-CHF (21909 Paz) CARATTERISTICHE DEMOGRAFICHE IN CHF Età mean±sd 65±13 a 41% < 70 a >=70 a Sesso 29% M 59% 71% F Classe NYHA Eziologia 27% I - II 29% 16.0% CI IPERT 73% III-IV 16.% 39.0% CMD ALTRA

11 1-year total and sudden mortality in patients with congestive heart failure (IN-CHF Registry on 11,070 patients) 36.7% Sudden death Non sudden mortality 24.8% 11.7% 4.1% 13.0% 18.4% 2.8% 6.4% NYHA I Adjusted RR 1 95%CI NYHA II 2.14 [ ] NYHA III 3.77 [ ] NYHA IV 5.54 [ ]

12 I registri da fotografia della realtà al miglioramento della qualità delle cure Un modo diverso ma complementare di leggere i dati Un modo diverso ma complementare di usare i registri

13 ACE-INHIBITOR PRESCRIPTIONS BY YEAR (%) 82,1 83,1 80,8 80,0 IN CHF ARBs PRESCRIPTIONS BY YEAR (%) 17,5 IN CHF 78,4 12,3 12,9 13,0 75,1 75,2 72,4 73,9 75,0 4,8 5,3 6,0 8, IN-CHF BETABLOCKER PRESCRIPTIONS BY YEAR (%) 35,7 51,7 52,6 56,6 0,0 0, DIGITALIS PRESCRIPTION BY YEAR (%) 68,9 66,3 63,5 61,9 58,2 52,7 45,0 39,7 37,5 IN CHF 24,5 25,7 30,6 14,9 18,4 8,

14 IN-CHF BETABLOCKER PRESCRIPTIONS BY YEAR (%) BRING-UP 1 BRING-UP 2 51,7 52,6 56,6 24,5 25,7 35,7 8,2 14,9 18,

15 Mortalità per tutte le Cause ad 1anno per Classe NYHA (%) , , ,8 8,5 11,2 Classe NYHA Adjusted Risk 0 I 1.00 II 1.70 III 2.92 IV 4.22 [ ][ ][ ] Totale IN CHF

16 Ospedalizzazioni per tutte le cause ad 1anno per classe NYHA 50 (%) 40 31,4 37, ,1 19,8 22, Classe NYHA Adjusted risk I 1.00 II 1.41 III 2.19 IV 2.31 [ ][ ][ ] Totale IN CHF

17 Studi fisiopatologici Trials clinici Registri osservazionali

18 Studi fisiopatologici Trials clinici Registri osservazionali

19 Prevalence of wide QRS in the study population (N =5517) Wide QRS > 120 msec LBBB >120 msec + morphologic criteria RBBB >120 msec + morphologic criteria Wide QRS (36.5%) LBBB (25.2%) RBBB (6.2%) Normal QRS (63.5%) Other wide QRS (6.1%)

20 Mortality rate in patients with or without wide QRS 1-Year All-Cause Mortality 20 p< Study population % p< No wide QRS Wide QRS 0 Total mortality Sudden Death

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22 Survey on ACUTE HEART FAILURE Comparison of decompensated HF with AMI Decompensated Acute myocardial Heart failure infarction Hospitalization (1997 in US) 957, ,000 Mortality 10% at 60 days 10% at 30 days Readmission rate High Low Guidelines for risk stratification No Yes Guidelines for therapy No Yes Large randomized trials No Yes MEDLINE citations ( ) Am Heart J 2003; 145: S18-25

23 Survey on ACUTE HEART FAILURE POPOLAZIONE DELLO STUDIO SCREENING Pazienti ricoverati consecutivamente con diagnosi di scompenso cardiaco acuto (209 Centri; 1 Marzo 31 Maggio 2004) CRITERI DI INCLUSIONE!Classe NYHA III-IV ( in caso di pazienti con IMA classe Killip III-IV) o Edema polmonare o Shock cardiogeno!necessità di terapia infusionale per scompenso!consenso informato ANMCO Research Center

24 Survey on ACUTE HEART FAILURE STUDY POPULATION SCREENING 2807 consecutive patients admitted with a diagnosis of acute HF from March 1 to May 31, 2005 INCLUSION CRITERIA!NYHA III-IV Class (in AMI patients Killip class III-IV) or pulmonary edema or cardiogenic shock! Intravenous drug therapy! Informed consent for data handling

25 Survey on ACUTE HEART FAILURE STUDY SETTING AHF Registry (204 hospitals) ITALY (386 hospitals) North 89 (44%) 165 (43%) Center 42 (20%) 90 (23%) South 73 (36%) 131 (34%) With Cath Lab 63 (31%) 115 (30%)

26 Survey on ACUTE HEART FAILURE REGISTRY POPULATION (2571 patients) Age (mean±sd) 73±11 n. % Age >75 years Female sex COPD Renal failure History of hypertension Diabetes - treated with insuline ANMCO Research Center

27 Survey on ACUTE HEART FAILURE CLINICAL PRESENTATION (2571 patients) 55.6% Worsening CHF 43.2% De Novo HF 1.2% End-Stage HF ANMCO Research Center

28 Survey on ACUTE HEART FAILURE ETIOLOGY (2571 patients) 46.4% Ischemic 4.3% Not determined 49.3% Non ischemic Ischemic 46.4% Valvular 11.4% Dilatative 13.9% Hypertensive 14.7% Alcoholic 0.7% Other 8.7% Not determinable 2.3% Unknown 1.9% ANMCO Research Center

29 Survey on ACUTE HEART FAILURE HOSPITAL DISCHARGE (2571 patients) Lenght of stay Median n. of days 9 25%-75% 6-13 ICU 68.5% Median n. of days 4 25%-75% 2-6 ANMCO Research Center

30 Survey on Acute Heart Failure IN-HOSPITAL DEATH (205 patients) 7.5% 7.1% 8.6% 7.3% De Novo (n. 93) Worsening HF (n. 109) Transplant List (n. 3) Total (n. 205)

31 Survey on Acute Heart Failure SURVIVAL STATUS AT 6 MONTHS (available for 1976 pts, 70.4%) All-cause deaths: 432 p< p= ,7% 18,6% 24,5% 14,3% 20,9% 19,4% 21,9% De Novo Wors. HF Transpl. List NYHA III-IV Pulm. edema Cardiog. shock Total population

32 Survey on Acute Heart Failure ALL-CAUSE HOSPITALIZATIONS FROM DISCHARGE TO 6 MONTHS p<ns 39,6% 36,6% 39,2% 38,1% NYHA III-IV Pulmonary edema Cardiogenic shock Total Hospitalization

33 All-cause death according to the ESC clinical profiles In-hospital 3.2% 6.8% 5.1% Hypertensive HF Pulmonary edema Acute decompensated HF In-hospital 25.4% Cardiogenic shock 11.5% Hypertensive HF 6 months 20.1% 21.6% Pulmonary edema Acute decompensated HF * EPA/NYHA III-IV, SBP>180/DBP>110mmHg, not EF 40% 6 months 40.7% 40.7% Cardiogenic shock 25.4% 15.6% 19.7% 21.8% 3.9% 6.9% 5.2% Hypertensive HF Pulmonary edema Acute decompensated HF Cardiogenic shock Hypertensive HF Pulmonary Acute Cardiogenic edema decompensated HF shock ** EPA/NYHA III-IV, SBP>160mmHg, not EF 40%

34 Survey on ACUTE HEART FAILURE Kaplan Meier survival curves ACS Chronic HF Acute HF

35 Survey on ACUTE HEART FAILURE Kaplan Meier survival curves ACS Chronic HF Acute HF

36 Which approaches have been tested or are under study in CHF? Haemodynamic inotropic neurohormonal antiinflammatory mechanical cell transplant cell proliferation.. And why not a metabolic hypothesis?

37 CLINICAL DIAGNOSIS OF CHF Entry visit * Eligible patients (informed consent) R1 n-3 PUFA Placebo 1 g daily If eligible for statin R2 Rosuvastatin 10 mg daily Placebo clinical visits and drug delivery at 1**, 3*, 6*, 12*, 18, 24*, 30, 36* months * the following laboratory tests must be performed: hemoglobin, white cell count, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, uricoemia, glucose levels, total CK, ALT, AST, creatinine, potassium, sodium ** the same tests plus an EF measure only for the patients enrolled at hospital discharge after an episode of worsening of HF

38 The Italian virtuous cycle Surveys Registries Process and appropriateness Research (Italian Network Studies) (Surveys: SEOSI, BLITZ etc) Patient-oriented, cooperative research (GISSI studies, Gospel, Area IN-CHF, CardioSys etc) PARTICIPATION Active incorporation process (Up studies) Suggestions Recommendations guidelines (Educational programmes, Investigator Meetings)

39 Medicina d Urgenza Centro Trapianti Cardiologo Territorio Cardiologo Ospedale Paziente con Scompenso Cardiaco Infermiere Geriatra Riabilitazione Cardiologica Internista MMG Servizi Sociali

40 Società Scientifiche e Associazioni Partecipanti AIMEF CONACUORE SICOA ANCE FADOI SICP ANMCO FIC SIGG APRO GICR SIMEU ARCA METIS SIMG ATO SIC SIMI SNAMID Altre Collaborazioni Ministero della Salute; Istituto Superiore di Sanità; ASR Marche; ASR Friuli Venezia-Giulia; ASL Monza; ASL Pavia; Osservatorio Epidemiologico Regione Sicilia; Provincia Autonoma Bolzano; Regione Basilicata, Dipartimento Salute, Sicurezza e Solidarietà Sociale.

41 Disease Management dello Scompenso Cardiaco Consensus Conference Proposta di diversi modelli gestionali-assistenziali integrati Ospedale-Territorio Responsabili Amministrativi e politici regionali (ASL-ASR-Assessorati) Sucessive sperimentazioni locali Sottocomitato Scientifico per la Prevenzione del Rischio Cardiovascolare CCM Ministero della Salute Referenti Regionali Società Scientifiche aderenti

42 Consensus Conference sui Modelli Gestionali nello Scompenso Cardiaco Chairmen Andrea Di Lenarda (Area Scompenso Cardiaco) Vincenzo Cirrincione (Area Management & Qualità) Coordinatori dei Gruppi di Lavoro G. Gigli Epidemiologia R. De Maria Assorbimento di Risorse A. Mortara Modelli Gestionali L. Tarantini Prevenzione e Screening G. Alunni Il pz con SC acuto G. Cacciatore Il pz stabile oligoasintomatico F. Oliva Il pz con SC avanzato candidabile a trapianto G. Pulignano Il pz con SC anziano e/o con comorbilità

43 CON LA COLLABORAZIONE DI MERCK PHARMA

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