PRESENTAZIONE DELLA CONSENSUS CONFERENCE ... - ANMCO · PREVALENCE OF HEART FAILURE, BY AGE,...
Transcript of PRESENTAZIONE DELLA CONSENSUS CONFERENCE ... - ANMCO · PREVALENCE OF HEART FAILURE, BY AGE,...
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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
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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
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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
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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%
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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
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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
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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
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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
•
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Marzo 200421909 Pazienti
91546 Visite
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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
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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
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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
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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
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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
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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
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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
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Studi fisiopatologici
Trials clinici
Registri osservazionali
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Studi fisiopatologici
Trials clinici
Registri osservazionali
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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%)
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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
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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
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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
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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
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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
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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
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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
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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%
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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
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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
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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
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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
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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%
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Kaplan Meier survival curves
Acute HF
Chronic HF
Survey on ACUTE HEART FAILURE
ACS
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Kaplan Meier survival curves
Acute HF
Chronic HF
Survey on ACUTE HEART FAILURE
ACS
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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 ?
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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
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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)
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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
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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.
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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
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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
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CON LA COLLABORAZIONE DI
MERCK PHARMA
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