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Transcript of I Registri: quello che sappiamo e quello che vorremmo sapere Michele Senni U.S.D. Medicina...
I Registri:I Registri:quello che sappiamo e quello che quello che sappiamo e quello che
vorremmo saperevorremmo sapere
Michele SenniMichele Senni U.S.D. Medicina CardiovascolareU.S.D. Medicina Cardiovascolare
Dipartimenti Cardiovascolare e di Medicina InternaDipartimenti Cardiovascolare e di Medicina InternaOspedali Riuniti - BergamoOspedali Riuniti - Bergamo
SCOMPENSO CARDIACO ACUTO: NUOVE ACQUISIZIONI
Why Focus on Acute Heart Failure?
Clinical trials in heart failure: Focus on… Omit… - Stable outpatients - Criteria for admission to
hospital - Systolic dysfunction - Treatments for acute heart
failure
- Enroll relatively younger - Diastolic dysfunction pts and exclude many pts with co-morbidities
CausesCauses of hospital of hospital admissionsadmissions Medical Medical DRG – DRG – YearYear 2003 2003
324.
975
190.
340
134.
501
125.
081
123.
310
113.
959
101.
547
0
50.000
100.000
150.000
200.000
250.000
300.000
350.000Vaginal delivery
HF - shock
Esofagitis,gastroenterites
Chemiotherapy
Cerebrovasculardiseases
COPD
Psicosis
NumberNumber
By By courtesycourtesy: : Carlo Donati, Ministero de lla SaluteCarlo Donati, Ministero de lla Salute
1997
200.000
150.000
100.000
50000
1996 1998 1999 2000 2001
TemporalTemporal TrendsTrends in in HospitalizationsHospitalizations in in ItalyItaly
DRG 127DRG 127
127.043127.043
190.340190.340
+ 67%+ 67%
2002 2003
Definition of a Patient Registry
A registry is an observational study of actual medical practice
Registries do not specify that any specific treatment be given or procedure be performed
Registries collect data on what is done based on clinical circumstances
Data are analyzed in a periodic fashion to permit analysis of trends
Advantages
All inclusive. Patients with co-morbidities, women of child
bearing potential, elderly included. “Real-world”
Can provide detailed information of patient characteristics,
treatment strategies, and outcomes of interest
Disadvantages
Potential selection, observational, and investigator bias and can
be confounded by variety of factors
Observational Studies
Registries or surveys
• TEMISTOCLE Survey1
• EuroHeart Failure Survey2
• ADHERE registry3
• Impact-HF4 • ANMCO Survey (Survey on Acute Heart Failure) 5
• Registro Niguarda6
• EFFECT7
• EFICA8
• OPTIMIZE-HF9
1- Di Lenarda Am Heart J 2003
2- Cleland Eur Heart J 2002
3- Adams Am Heart J 2005
4 -O’Connor J Cardiac Failure2005
5- Tavazzi Eur Heart J 2006
6- Oliva Cardiologia 2003
7- Lee. JAMA 2003
8- Zannand Eur Heart J 2002
9- Fonarow JAMA 2005
Registries or surveys
• TEMISTOCLE Survey1
• EuroHeart Failure Survey II2
• ADHERE registry3
• Impact-HF4 • ANMCO Survey (Survey on Acute Heart Failure)5
• Registro Niguarda6
• EFFECT7
• EFICA8
• OPTIMIZE-HF9
1- Di Lenarda Am Heart J 2003
2- Cleland Eur Heart J 2002
3- Adams Am Heart J 2005
4 -O’Connor J Cardiac Failure2005
5- Tavazzi Eur Heart J 2006
6- Oliva Cardiologia 2003
7- Lee. JAMA 2003
8- Zannand Eur Heart J 2002
9- Fonarow JAMA 2005
SCREENING2807 consecutive patients admitted with a
diagnosis of acute HF from March 1 to May 31, 2005
in 206 cardiology with ICU
STUDY POPULATION
INCLUSION CRITERIA
NYHA III-IV Class (in AMI patients Killip class III-IV) or pulmonary edema or cardiogenic shock
Intravenous drug therapy
Survey on ACUTE HEART FAILURE
Tavazzi et al. Eur Heart J 2006
Registro282 ospedali community, tertiary e accademiciTutte le regioni degli USATutti i ricoveri con diagnosi di scompenso acuto (ICD-9)
Electronic case report
Anonimo: possibili più ospedalizzazioni per lo stesso paziente
1° paz: 1 ottobre 2001Fino a 4 gennaio 2004: 107.362 ospedalizzazioni
Adams et al. Am Heart J 2005
ADHERE
Euro Heart Failure Survey II (October 2004 - August 2005)
• 30 countries
• 133 hospitals
• Emergency area, internal medicine, cardiology
wards, CCU, ICU
• 3.580 patients enrolled with heart failure
• Inclusion criteria: dyspnea, signs of HF and lung
congestion on chest X-ray
Nieminen et al. Eur Heart J 2006
Registri Scompenso Acuto
Età
70 72 73 60 65
0
2 0
4 0
6 0
8 0Età media (anni)
Registri RCT
Euro Heart
ADHERE
ANMCO
VMAC
OPTIME
Registri Scompenso AcutoSesso femminile
39 52 39
20 21
0102030405060708090
100
Registri RCT
%
ses
so
fem
min
ile
Euro Heart
ADHERE
ANMCO
VMAC
OPTIME
Registri Scompenso Acuto
Eziologia
4 6
11
1 5
1 4ANMCO Survey
5529
10 6EuroHeart Survey
5 5
1 5
1 5
1 5ADHERE Registry
ISCHEMICA
IPERTENSIVA
VALVOLARE
IDIOPATICA
ANMCO Survey on Acute Heart Failure
CLINICAL PRESENTATION(2807 patients)
44.0%De Novo HF
54.8%Worsening CHF
1.2%Transplant list
ANMCO Survey on Acute Heart Failure
CLINICAL PRESENTATION(2807 patients)
25.8%NYHA III
16.9%NYHA IV
49.6%Pulmonary Edema
7.7%Cardiogenic Shock
ISCHEMIC EPISODE AS PRECIPITATING FACTOR OF AHF
(2807 patients)
De Novo HF(n. 1235)
Worsening CHF(n. 1537)
Transplant list(n. 35)
YESNO
39.8%27.4% 31.4%
60.2%72.6% 68.6%
0
20
40
60
80
100
ANMCO Survey on Acute Heart Failure
%
Registri Scompenso Acuto
LVEF > 40%
34
34
46
0 20 40 60 80 100
ANMCO
EuroHeart
ADHERE
%
*
*LVEF 45%
Prevalence of valvular dysfunction
EuroHeart Survey II
Registri Scompenso Acuto
Comorbilità
30
31
19
24
30
17
38
44
33
65
73
53
0 20 40 60 80 100
ANMCO
ADHERE
EuroHeart
%
IPERTENSIONE
DIABETE
INSUFF. RENALE
PNEUMOPATIA
Registri Scompenso Acuto
Terapia Farmacologica e.v.
93 89 95 39 21 5129 15 25
0
20
40
60
80
100
Diuretici Vasodil. Inotropi
%EuroHeart
ADHERE
ANMCO
IN-HOSPITAL IV TREATMENTS(2807 patients)
Nitrates 51.3%Nitroglycerin 49.5%Nitroprusside 2.7%Inotropes 24.6%Dopamine 18.5%Dobutamine 12.9%Enoximone 0.6%Levosimendan 0.8%Epinephrine 1.3%Norepinephrine 0.6%
Registri Scompenso Acuto
Terapia Non Farmacologica
5 6
1 5 20,2
8 10 5,5
0
2
4
6
8
10
VAM CPA VAD Rivasc.
%EuroHeart
ADHERE
ANMCO
Registri Scompenso Acuto
Prescrizione Trattamenti Farmacologici Raccomandati
80
78 84 61
57 46
47
66
0
10
20
30
40
50
60
70
80
90
A C E i/A R B s B eta -b lo cc . A n ti-a ld o s t.
%
pz.
dim
ess
i
ADHERE
ANMCO
Euro Heart
Registri Scompenso Acuto
Degenza Media
9
4
9
1
3
5
7
9
11
13
15
E uroH ear t A D H E R E A N M C O
gio
rni
Registri Scompenso Acuto
Mortalità Intraospedaliera
1
3
5
7
9
11
13
15
E u ro H ea rt A D H E R E A N M C O
6.6%
4%
7.3%
%
IN-HOSPITAL DEATH(205 patients)
5.0% 6.5%
25.4%
7.3%
NYHA III-IV(n. 60)
Pulmonaryedema(n. 90)
Cardiogenicshock(n. 55)
Total(n. 205)
Independent predictors of in-hospital all-cause death
VariablesWald
Chi-SquarePr >
ChiSqOR 95% CI
IV inotropes 36.6012 <.0001 3.129 2.162-4.528SBP at entry (continuous) 32.2091 <.0001 0.984 0.978-0.989Elevated Troponin 20.1565 <.0001 2.147 1.538-2.997EF not available vs EF>40% 18.1822 <.0001 2.792 1.742-4.476Age (continuous) 14.6410 0.0001 1.035 1.017-1.053BUN >100 vs <50 12.7944 0.0003 2.116 1.403-3.192Sodium (continuous) 8.9909 0.0027 0.952 0.922-0.983Prior renal failure 8.3819 0.0038 1.747 1.198-2.550De novo HF vs Worsenig HF 7.1042 0.0077 1.632 1.138-2.340Hemoglobin (continuous) 6.2815 0.0122 0.904 0.835-0.978RV not detectable vs not dilated 5.8835 0.0153 1.623 1.097-2.400Paroxysmal AF 4.9637 0.0259 0.594 0.376-0.939Prior Revascularization 4.4510 0.0349 0.605 0.380-0.965
L Tavazzi et al. Eur Heart J 2006
ADHERE CART: Predictors of Mortality
SYS BP 115SYS BP 115n=24,933n=24,933
SYS BP 115SYS BP 115n=7,150n=7,150
SYS BP 115SYS BP 115n=7,150n=7,150
6.41%6.41%n=5,102n=5,1026.41%6.41%
n=5,102n=5,10215.28%15.28%N=2,048N=2,04815.28%15.28%N=2,048N=2,048
21.94%21.94%n=620n=620
12.42%12.42%n=1,425n=1,42512.42%12.42%n=1,425n=1,425
5.49%5.49%n=4,099n=4,0995.49%5.49%
n=4,099n=4,0992.14%2.14%
n=20,834n=20,834
BUN 43BUN 43N=33,324N=33,324
Greater thanGreater thanLess thanLess than
2.68%2.68%n=25,122n=25,122
8.98%8.98%n=7,202n=7,2028.98%8.98%
n=7,202n=7,202
Cr 2.75Cr 2.752,0452,045
Cr 2.75Cr 2.752,0452,045
Highest to Lowest Risk CohortHighest to Lowest Risk CohortOR 12.9 (95% CI 10.4-15.9)OR 12.9 (95% CI 10.4-15.9)
Fonarow Circulation 2003;108:IV-693Fonarow Circulation 2003;108:IV-693
< > ><
< >
Registri Scompenso Acuto
Follow Up
21 ,9 38 ,1
0
1 0
2 0
3 0
4 0
A N M C O
%
(6 mesi)
MORTALITA’
RIOSPEDALIZZ.
Obiettivi di un Registro Scompenso Cardiaco Acuto
Descrivere le caratteristiche demografiche Descrivere le caratteristiche demografiche e cliniche dei pazienti ospedalizzatie cliniche dei pazienti ospedalizzatiEvidenziare gli attuali modelli di gestione Evidenziare gli attuali modelli di gestione di questi pazientidi questi pazientiDefinire le strategie di trattamento Definire le strategie di trattamento associate ai migliori outcomes clinici e al associate ai migliori outcomes clinici e al più efficiente utilizzo delle risorsepiù efficiente utilizzo delle risorseAiutare nella valutazione e nel Aiutare nella valutazione e nel miglioramento della qualità dell’assistenzamiglioramento della qualità dell’assistenza
Performance Indicators for Heart Failure Patient Care (JCAHO)
HF-1: n=28,776; HF-2: n=34,397; HF-3: n=12,725; HF-4: n=5,475Fonarow J Card Failure 2003;9:S79
29
8373
36
0
10
20
30
40
50
60
70
80
90
100
HF-1 Complete Discharge Instructions HF-2 LVF Measured or Scheduled
HF-3 ACE Inhibitor at Discharge for LVSD HF-4 Smoking Cessation
Performance Indicator
Pat
ien
ts T
reat
ed (
%)
Trends in Quality of Care at Discharge in ADHERE: Q1 2002 to Q4 2003
0
20
40
60
80
100
Discharge Instructions
HF-1
LVEF Measurement
HF-2
ACE Inhibitor Use
HF-3
Smoking Cessation
HF-4
Q1 2002
Q2 2002
Q3 2002
Q4 2002
Q1 2003
Q2 2003
Q3 2003
Q4 2003
Q1 2002 n= 8,198Q1 2002 n= 8,198Q2 2002 n=11,289Q2 2002 n=11,289Q3 2002 n=14,430Q3 2002 n=14,430Q4 2002 n=16,925Q4 2002 n=16,925
Q1 2002 n= 8,198Q1 2002 n= 8,198Q2 2002 n=11,289Q2 2002 n=11,289Q3 2002 n=14,430Q3 2002 n=14,430Q4 2002 n=16,925Q4 2002 n=16,925
Q1 2003 n=17,735Q1 2003 n=17,735Q2 2003 n=16,719Q2 2003 n=16,719Q3 2003 n=13,984Q3 2003 n=13,984Q4 2003 n= 10,265Q4 2003 n= 10,265
Q1 2003 n=17,735Q1 2003 n=17,735Q2 2003 n=16,719Q2 2003 n=16,719Q3 2003 n=13,984Q3 2003 n=13,984Q4 2003 n= 10,265Q4 2003 n= 10,265
Baseline Characteristics Similar All 8 Quarters
70%P<0.0001
116%P<0.0001
5%P=0.003 4%
P=0.003
Studi Osservazionali e RegistriScompenso Acuto
Il Futuro…• Individuazione e validazione di nuovi
trattamenti farmacologici e non
• Identificazione e sperimentazione di modelli di continuità assistenziale.
• Integrazione dei dati scompenso cardiaco cronico/scompenso cardiaco acuto nella popolazione reale
Acute Exacerbations May Contribute to the Progression of the Disease
Time
Ven
tric
ula
r fu
nct
ion
Acute event
With each event, hemodynamic alterations and myocardial damage contribute to progressive ventricular dysfunction
From Gheorghiade . Am J Cardiol 2005 (modified)
Acute Exacerbations May Contribute to the Progression of the Disease
Time
Ven
tric
ula
r fu
nc
tio
n
Acute event
With each event, hemodynamic alterationsand myocardial damagecontribute to progressive ventricular dysfunction
From Gheorghiade . Am J Cardiol 2005 (modified)