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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
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
Survey on ACUTE HEART FAILURE
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
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%)
Survey on ACUTE HEART FAILURE
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
Survey on ACUTE HEART FAILURE
ANMCO Research Center
Survey on ACUTE HEART FAILURE
ANMCO Research Center
CLINICAL PRESENTATION(2571 patients)
43.2%De Novo HF
55.6%Worsening CHF
1.2%End-Stage HF
Survey on ACUTE HEART FAILURE
ANMCO Research Center
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%
Survey on ACUTE HEART FAILURE
ANMCO Research Center
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
Survey on Acute Heart Failure
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
Survey on Acute Heart Failure
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
Survey on ACUTE HEART FAILURE
ACS
Kaplan Meier survival curves
Acute HF
Chronic HF
Survey on ACUTE HEART FAILURE
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