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)