presentazione della consensus conference: … · esofago-gastriti cataratta mal di schiena...

Consensus Conference Consensus Conference sui Modelli Gestionalisui Modelli Gestionalinello Scompenso Cardiaconello Scompenso Cardiaco

PRESENTAZIONE DELLA CONSENSUS CONFERENCE:PROGETTUALITA� E CONDIVISIONE DELL�ANMCO

Giuseppe Di PasqualeGiuseppe Di PasqualePresidente Presidente ANMCOANMCO

Firenze, 3-4 Dicembre 2005

PREVALENCE OF HEART FAILURE, BY AGE, 1976-80 AND 1988-91

Source: National Health and Nutrition Examination Survey (1976-80 and 1988-91). National Center for Health Statistics

30 35 40 45 50 55 60 65 70 75 80

Age (Years)

10

8

6

4

2

0

Perc

ent

1976-801988-91

Heart Failure Prevalence Will Double in 30 Years

� Aging population � Coronary disease

management

HF Prevalence in Western Europe (Millions)

5.3

10.6

0

2

4

6

8

10

12

2000 2010 2020 2030

Source: New Medicine Reports 1997 ; 1999 Heart and Stroke Statistical Update, AHA

0102030405060708090

100

0 1 2 3 4 5

Comparative Survival fromCommon Cancers and Heart Failure

Breast

ProstateHeart FailureColon

Years after diagnosisMc Murray, E. Heart J 1998 (Suppl. L)

Survival%

0

50.000

100.000

150.000

200.000

'96 '97 '98 '99 '00 '01

DRG 127

177.276N. Ricoveri

+ 39.5%+ 39.5%

Epidemiologia e Epidemiologia e CCosti dei osti dei RRicoveriicoveri per Scompenso per Scompenso CCardiaco ardiaco negli Ospedali negli Ospedali IItalianitaliani (1996(1996--2001) 2001)

Fonte: MinisteroFonte: Ministero della della SaluteSalute

127.043

Epidemiologia e Epidemiologia e CCosti dei osti dei RRicoveriicoveri per Scompenso per Scompenso CCardiaco ardiaco negli Ospedali italiani (1996negli Ospedali italiani (1996--2001) 2001)

0

50.000

100.000

150.000

200.000

250.000

300.000

350.000

'96 '97 '98 '99 '00 '01

PartiEsofago-gastritiCatarattaMal di schienaScompenso Cardiaco

Comparazione Trend DRG più frequenti

5°5°

3°3°

Fonte: MinisteroFonte: Ministero SaluteSalute

ANMCO Research Center (2005)Epidemiology (E) Clinical Trial (RCT) Outcomes Research (OR)

IN-CHF (E)Survey Acute HF (E)AREA IN-CHF (RCT)

GISSI-HF (RCT)CandHeart *# (RCT)EVEREST* (RCT)

BLITZ 2 (E)OAT (RCT)

G-CSF ISS# (RCT)IN-ACS (E, OR)

IN-CP# (E)HEART Survey (E)

SPS (E)GOSPEL (RCT)

CARDIO-SIS (RCT)ORIGIN * (RCT)SCOUT * (RCT)

ONTARGET* (RCT)DYDA# (E)

BEAUTIFUL* (RCT)

Total: 24 projectsEuro Heart Surveys, Osservatorio MinSal

ACTIVE * (RCT)GISSI-AF (RCT)

* Endorsement # Forthcoming

Heart FailureArrhythmiasCHDCV Prevention

The line of research in heart failure

RCTs in AMI: GISSI 1,2,3: dominant prognostic role of LV (1986-1995) dysfunction and heart failure in postinfarct patients

Surveys : SEOSI: 3,921 in-outpatients with HF enrolled in 12 days(1995-1996) EARISA: 6,030 in-patients (1,089 with HF) enrolled in 12 days

Registry: IN-CHF ~25,000 HF outpatients enrolled in 10 years(1995 → ...)Outcome studies: - OSCUR, TEMISTOCLE performed in both (1998-2001) 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(2002-2007)Survey in acute HF 2,807 patients, 6 month outcome (2004-2005)

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•Centri Cardiologici

IN-CHF ITALYNord 42% 41%Centro 26% 24%Sud 32% 35%

Informazioni su pazienti ambulatoriali con scompenso cronico sono state raccolte da 152 Centri Cardiologici da Marzo 1995 al Marzo 2004 usando un software dedicato

INCHF

•

•

Marzo 200421909 Pazienti

91546 Visite

IN-CHF (21909 Paz)CARATTERISTICHE DEMOGRAFICHE

Classe NYHA

27%

73%

I - II

III-IV

Sesso

29%

71%

MF

Eziologia

16.0%

39.0%16.%

29%CI

IPERT

CMD

ALTRA

< 70 a

>=70 a

Età

59%

41%

mean±SD65±13 a

INCHF

1-year total and sudden mortality in patients withcongestive heart failure (IN-CHF Registry on 11,070 patients)

NYHA I1

NYHA II2.14

[1.33-3.44]

NYHA III3.77

[2.32-6.12]

NYHA IV5.54

[3.23-9.48]

2.8% 6.4%13.0%

18.4%4.1%

11.7%

24.8%

36.7%

Sudden death

Non sudden mortality

Adjusted RR95%CI

I registri da fotografia della realtàal miglioramento della qualità delle cure

Un modo diverso ma complementare di leggere i dati

Un modo diverso ma complementare di usare i registri

82,183,1

80,880,0

78,4

75,1 75,2

72,473,9 75,0

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004

ACE-INHIBITOR PRESCRIPTIONS BY YEAR (%)

INCHF

ARBs PRESCRIPTIONS BY YEAR (%) INCHF

0,0 0,8

4,8 5,36,0

8,0

12,312,9 13,0

17,5

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004

IN-CHFBETABLOCKER PRESCRIPTIONS BY YEAR (%)

8,2

14,918,4

24,5 25,7

35,7

51,7 52,656,6

1995 1996 1997 1998 1999 2000 2001 2002 2003

INCHFDIGITALIS PRESCRIPTION BY YEAR (%)

68,966,3 63,5 61,9

58,252,7

45,039,7 37,5

30,6

1995 1996 1997 1998 1999 2000 2001 2002 2003 2004

IN-CHFBETABLOCKER PRESCRIPTIONS BY YEAR (%)

8,2

14,918,4

24,5 25,7

35,7

51,7 52,656,6

1995 1996 1997 1998 1999 2000 2001 2002 2003

BRING-UP 1

BRING-UP 2

Totale

Mortalità per tutte le Cause ad 1anno per Classe NYHA

3,8

8,5

18,2

30,0

11,2

0

10

20

30

40

50

IV

4.22[2.94-6.05]

III

2.92[2.15-3.96]

II

1.70[1.26-2.29]

I

1.00AdjustedRisk

(%)

Classe NYHA

INCHF

Totale

Ospedalizzazioni per tutte le cause ad 1anno per classe NYHA

13,1

19,8

31,437,0

22,5

0

10

20

30

40

50

IV

2.31[1.71-3.10]

III

2.19[1.79-2.66]

II

1.41[1.17-1.69]

I

1.00Adjustedrisk

(%)

Classe NYHA

INCHF

Studi fisiopatologici

Trials clinici

Registri osservazionali

LBBB (25.2%)

RBBB (6.2%)

Other wide QRS (6.1%)Normal QRS (63.5%)

Prevalence of wide QRS in the study population (N°=5517)

Wide QRS > 120 msecLBBB >120 msec + morphologic criteriaRBBB >120 msec + morphologic criteria

Wide QRS (36.5%)

Mortality rate in patients with or without wide QRS

Wide QRS

No wide QRS

Study population

1-Year All-Cause Mortality

%

0

5

10

15

20

Total mortality Sudden Death

11.914.2

10.6

5.5 4.96.7

p<0.0001

p<0.0001

Comparison of decompensated HF with AMI

Decompensated Acute myocardial Heart failure infarction

________________________________________________________Hospitalization (1997 in US) 957,000 800,000Mortality ∼ 10% at 60 days ∼ 10% at 30 daysReadmission rate High LowGuidelines for risk stratification No YesGuidelines for therapy No YesLarge randomized trials No YesMEDLINE citations (1997-2002) 291 7245

Am Heart J 2003; 145: S18-25

Survey on ACUTE HEART FAILURE

SCREENINGPazienti ricoverati consecutivamente con diagnosi di

scompenso cardiaco acuto (209 Centri; 1 Marzo � 31 Maggio 2004)

POPOLAZIONE DELLO STUDIO

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

SCREENING2807 consecutive patients admitted with a diagnosis

of acute HF from March 1 to May 31, 2005

STUDY POPULATION

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


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%)


REGISTRY POPULATION(2571 patients)

Age (mean±SD) 73±11n. %

Age >75 years 1187 46.2Female sex 1027 40.0COPD 750 29.2Renal failure 630 24.5History of hypertension 1681 65.4Diabetes- treated with insuline

997359

38.836.0





CLINICAL PRESENTATION(2571 patients)

43.2%De Novo HF

55.6%Worsening CHF

1.2%End-Stage HF



ETIOLOGY(2571 patients)

46.4%Ischemic

49.3%Non ischemic

4.3%Not determined

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%



HOSPITAL DISCHARGE(2571 patients)

Lenght of stayMedian n. of days 925%-75% 6-13

ICU 68.5%Median n. of days 425%-75% 2-6

IN-HOSPITAL DEATH(205 patients)

7.5% 7.1% 8.6% 7.3%

De Novo(n. 93)

Worsening HF(n. 109)

TransplantList

(n. 3)

Total(n. 205)

Survey on Acute Heart Failure

SURVIVAL STATUS AT 6 MONTHS(available for 1976 pts, 70.4%)

All-cause deaths: 432

De Novo Wors.HF

Transpl.List

NYHAIII-IV

Pulm.edema

Cardiog.shock

Totalpopulation

18,6%24,5%

14,3%20,9% 19,4%

40,7%

21,9%

p<0.0001

p=0.0056


39,6% 36,6% 39,2% 38,1%

NYHA III-IV Pulmonaryedema

Cardiogenicshock

Total

Hospitalization

ALL-CAUSE HOSPITALIZATIONS FROM DISCHARGE TO 6 MONTHS

p<NS


In-hospital 6 months

All-cause death according to the ESC clinical profiles

In-hospital 6 months

3.9% 6.9% 5.2%

25.4%

15.6%19.7% 21.8%

40.7%

HypertensiveHF

Acute decompensated

HF

Pulmonaryedema

Cardiogenicshock

HypertensiveHF

Acute decompensated

HF

Pulmonaryedema

Cardiogenicshock

3.2%6.8% 5.1%

25.4%

11.5%

20.1% 21.6%

40.7%

HypertensiveHF

Acute decompensated

HF

Pulmonaryedema

Cardiogenicshock

HypertensiveHF

Acute decompensated

HF

Pulmonaryedema

Cardiogenicshock

* EPA/NYHA III-IV, SBP>180/DBP>110mmHg, not EF≤ 40%

** EPA/NYHA III-IV, SBP>160mmHg, not EF≤ 40%

Kaplan Meier survival curves

Acute HF

Chronic HF


ACS

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 ?

CLINICAL DIAGNOSIS OF CHFEntry visit *

Eligible patients(informed consent)

n-3 PUFA Placebo 1 g dailyR1

If eligible for statin

Rosuvastatin Placebo10 mg daily

R2

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

The Italian virtuous cyclePatient-oriented,

cooperative research(GISSI studies, Gospel,

Area IN-CHF, CardioSys etc)

PARTICIPATION

�Active�incorporation

process(Up studies)

Suggestions

Recommendations

guidelines

(Educational programmes, Investigator Meetings)

SurveysRegistriesProcess and appropriatenessResearch(Italian Network Studies)(Surveys: SEOSI, BLITZ etc)

Paziente con Scompenso

Cardiaco

Medicina d�UrgenzaMedicina d�Urgenza

Centro TrapiantiCentro

Trapianti

Cardiologo Ospedale

Cardiologo Ospedale

Cardiologo Territorio

Cardiologo Territorio

InternistaInternista

GeriatraGeriatra

InfermiereInfermiere

Riabilitazione Cardiologica

Riabilitazione Cardiologica

MMGMMGServizi SocialiServizi Sociali

Società Scientifiche e Associazioni Partecipanti

AIMEF CONACUORE SICOAANCE FADOI SICPANMCO FIC SIGGAPRO GICR SIMEUARCA METIS SIMGATO SIC SIMI

SNAMID

Altre CollaborazioniMinistero 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.

Consensus ConferenceConsensus Conference

Disease Management dello Scompenso Cardiaco

Proposta di diversi modelli gestionali-assistenziali integrati

Ospedale-Territorio

Proposta di diversi modelli gestionali-assistenziali integrati

Ospedale-Territorio

Sucessive sperimentazioni localiSucessive sperimentazioni locali

Sottocomitato Scientificoper la Prevenzione

del Rischio CardiovascolareCCM � Ministero della Salute

Sottocomitato Scientificoper la Prevenzione

del Rischio CardiovascolareCCM � Ministero della Salute

Responsabili Amministrativi e politici

regionali(ASL-ASR-Assessorati)

Responsabili Amministrativi e politici

regionali(ASL-ASR-Assessorati)

Referenti Regionali Società

Scientifiche aderenti

Referenti Regionali Società

Scientifiche aderenti

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

CON LA COLLABORAZIONE DI

MERCK PHARMA

presentazione della consensus conference: … · esofago-gastriti cataratta mal di schiena...

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