fonarow gc, et al. j am coll cardiol. 2007;50:768 777. characteristics, treatments, and outcomes of...

Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.

Characteristics, Treatments, and Outcomes of Patients With Preserved Systolic Function Hospitalized for Heart Failure: A Report From the OPTIMIZE-HF Registry (Organized Program To Initiate life-saving treatMent In hospitaliZEd patients with Heart Failure)

Gregg C. Fonarow MD, FACC, Wendy Gattis Stough PharmD, William T. Abraham MD, FACC, Nancy M. Albert PhD, RN, Mihai Gheorghiade MD, FACC, Barry H. Greenberg MD, FACC, Christopher M. O'Connor MD, FACC, Jie Lena Sun MS, Clyde W. Yancy MD, FACC, James B. Young MD, FACC and OPTIMIZE-HF Investigators and Hospitals


2

Disclosures

• Funding Support– GlaxoSmithKline funded the OPTIMIZE-HF registry

under the guidance of the OPTIMIZE-HF Steering Committee and funded data collection and management by Outcome Sciences, Inc (Cambridge, MA) and analysis of registry data at Duke Clinical Research Institute (Durham, NC)

• Individual author disclosures are listed in the manuscript


3

Heart Failure and Preserved Systolic Function

• A substantial portion of patients with heart failure (HF) have relatively normal or preserved systolic function (PSF)

• Heart failure with PSF has been defined as the presence of HF symptoms in patients with a documented left ventricular ejection fraction (EF) of >40% or >50%, depending on the study

• Few data are available in patients with HF and PSF that describe outcomes or guide management strategies


4

Study Objective

• The objective of this study was to evaluate the characteristics, treatments, and outcomes of patients with preserved and reduced systolic function heart failure in a large, representative population of patients from all regions of the country.


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OPTIMIZE-HF Program Objectives

• OPTIMIZE-HF is a national performance improvement initiative to improve guidelines adherence in patients hospitalized with HF

• Overall OPTIMIZE-HF program objectives: – Improve medical care and education of patients

hospitalized with HF – Accelerate initiation of HF evidence-based, guideline-

recommended therapies by starting these therapies before hospital discharge in appropriate patients without contraindications

– Increase understanding of barriers to use of ACEIs, -blockers, and other guideline-recommended therapies in eligible HF patients


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OPTIMIZE-HF Process-of-Care Intervention and Registry• “Process-of-care” intervention

– Enhanced inpatient HF care and education– Enhanced discharge planning– Care maps, pathways, and standardized order sets that

encouraged adoption of evidence-based therapies • ACEI and -blocker initiation before discharge• JCAHO performance indicators

– Educational programs to encourage adoption by providers

• Web-based registry – Tracks treatment rates and changes following

performance interventions– Captures JCAHO/ORYX Quality of Care indicators– Benchmarks comparisons between institutions– Enhances understanding of barriers to uptake


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OPTIMIZE-HF Performance Improvement Registry Protocol• Eligibility

– Adults hospitalized for episode of new or worsening HF as primary cause of admission, or with significant HF symptoms that develop during hospitalization when the initial reason for admission was not HF

– Includes patients with systolic dysfunction and/or isolated diastolic dysfunction (HF with preserved systolic function)

– Any admission satisfying JCAHO HF core measure criteria

• Prespecified subgroup (10%) with 60–90-day follow-up data– Survival, readmissions, and medical regimen– Informed consent required for follow-up

• The registry coordinating center was Outcome Sciences, Inc


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OPTIMIZE-HF Hospital CharacteristicsTotal Hospitals(N=259), n (%)

Follow-Up Hospitals(N=91), n (%)

Bed size: 0 to 99 31 (12) 9 (10)

100 to 249 58 (22) 21 (23)

250 to 499 103 (40) 40 (44)

500 to 749 38 (15) 13 (14)

750 13 (5) 4 (4)

Unknown 16 (6) 4 (4)

Academic* 118 (48) 48 (55)

Transplant program* 34 (14) 9 (10)

Interventional† (CABG/PCI) 163 (67) 62 (70)

Region‡: Midwest 68 (27) 27 (30)

Northeast 44 (17) 14 (16)

South 87 (34) 34 (38)

West 56 (22) 15 (17)

* N=246, n=88; † N=245, n=88; ‡ N=255, n=90.

CABG/PCI = coronary artery bypass graft/percutaneous coronary intervention.


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OPTIMIZE-HF Patient CharacteristicsHospital Cohort

(N=48,612)Follow-Up Cohort

(N=5,791)

Age, mean (years) 73.1 72.0

Male (%) 48 51

Caucasian (%) 74 78

Ischemic etiology (%) 46 42

LVEF, mean (%) 39.0 36.9

LVSD (% of those assessed) 48.8 53.2

Insulin-treated diabetes (%) 17 17

Non–insulin-treated diabetes (%) 25 26

Hypertension (%) 71 72

Rales (%) 64 62

Mean SBP (mmHg) 143 140

Mean heart rate (bpm) 87 86

Mean sodium (mEq/L) 136.7 136.8

Mean serum creatinine (mg/dL) 1.8 1.7

Mean hemoglobin (g/dL) 12.1 12.2


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44

1,137

2,345

4,183

3,506

3,814

2,924 2,947

2,331

2,812 2,806

3,193

1,833

1,270

553274

100 32 10 10

1,000

2,000

3,000

4,000

5,000

Pa

tie

nts

(n

)

0-5

6-10

11-15

16-20

21-25

26-30

31-35

36-40

41-45

46-50

51-55

56-60

61-65

66-70

71-75

76-80

81-85

86-90

91-95

96-100

Distribution of LVEF in Patients Hospitalized With Primary Discharge Diagnosis of HF

Left Ventricular Ejection Fraction (%)

Documented LVEF Measured Prior to or During Hospitalization


11

Patient Characteristics at Hospital Admission by LVSD vs PSF

CharacteristicLVSD

(n=20,118)40%≤ EF ≤50%

(n=7,321)EF >50%

(n=10,072)P Value*

Age, mean (years) 70.4 74.3 75.6 <.0001

Male (%) 62 48 32 <.0001

African American (%) 21 15 15 .880

Atrial arrhythmia (%) 28 33 32 .179

Ischemic etiology (%) 54 49 32 <.0001

Insulin-treated diabetes (%) 15 18 16 .013

Noninsulin-treated diabetes (%)

24 26 25 .418

Hypertension (%) 66 74 77 <.0001

Mean LVEF % 24.3 45 61 <.0001

*P value (40%≤ EF ≤50% vs EF >50%).

PSF = preserved systolic function.


12

Patient Physical Exam Findings at Hospital Admission by LVSD vs PSF

CharacteristicPatients

With LVSD(n=20,118)

Patients With PSF(n=21,149)

P Value

Dyspnea at rest (%) 44 44 .194

Dyspnea on exertion (%) 63 62 .206

Rales (%) 63 65 .001

Jugular venous distension (%) 33 26 .0001

Mean SBP (mmHg) 135 149 .0001

Mean heart rate (bpm) 89 85 .0001

Mean sodium (mEq/L) 138 138 .0001

Mean BNP (pg/mL) 1635 977 .0001

Mean troponin I (ng/mL) 1.60 0.74 .0001

Mean serum creatinine (mg/dL) 1.70 1.73 .0001

Mean hemoglobin (g/dL) 12.53 11.86 .0001

PSF = LVEF 40%.


13

HF Treatments Applied at Discharge by LVSD vs PSF

75

58

912

83

70

21

9

4440

6053

6862

5652

0

10

20

30

40

50

60

70

80

90

100

ACEInhibitor

ARB β-Blocker Ald Ant Statin CompleteDischarge

Instructions

SmokingCessation

Counseling

Warfarin forAtrial

Fibrillation

LVSD PSF

P<.0001

P<.0001

P<.0001

Eli

gib

le P

atie

nts

Tre

ate

d (

%)

P<.0001

P=.0003

P<.0001

P=.004

P=.0009

*Statin use among patients with CAD, cerebrovascular accident/transient ischemic attack, diabetes, hyperlipidemia, or peripheral vascular disease.

PSF = LVEF 40%.


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In-Hospital Outcomes by LVSD vs PSF

0

1

2

3

4

5

6

7 P=.237

P=.237 P.0001

LVSD PSF

Length of Stay,Mean (days)

Length of Stay,Median (days)

In-Hospital Mortality(%)

6.05.7

4.0 4.0 3.9

2.9

PSF = LVEF 40%.


15

Patient Outcomes by LVSD vs PSF

OutcomeLVSD

(n=20,118)40%≤ EF ≤50%

(n=7,321)EF >50%

(n=10,072)P Value*

In-hospital mortality: all patients

3.9 3.0 2.9 .647

Follow-Up Cohort

Post-discharge mortality 9.8 9.2 9.3 .887

Rehospitalization 29.9 29.0 30.9 .366

Post-discharge mortality/rehospitalization

36.1 35.1 36.8 .436

*P value (40%≤ EF ≤50% vs EF >50%).


16

LVSD 2,294 2,188 1,994 469No LVSD 2,604 2,471 2,195 441

60- to 90-Day Survival by LVSD vs PSF

Survival Time in Days Since Discharge

LVSDNo LVSD

Su

rviv

al F

un

ctio

n

0.75

0.80

0.85

0.90

0.95

1.00

0 10 20 30 40 50 60 70 80 90

P=.459

*P value (40%≤ EF ≤50% vs EF >50%).


17

ACEI/ARBs and Post-Discharge Outcomes in PSF (Unadjusted)

No ACEI/ARB ACEI/ARB

Su

rviv

al F

un

ctio

n

0 10 20 30 40 50 60 70 80 90

P=.052

Survival Time in Days Since Discharge

0.75

0.80

0.85

0.90

0.95

1.00

ACEI/ARB 1,288 1,249 1,138 269No ACEI/ARB 595 560 515 149


18

β-Blockers and Post-Discharge Outcomes in PSF (Unadjusted)

No β-blocker β-blocker

Su

rviv

al F

un

ctio

n

0.75

0.80

0.85

0.90

0.95

1.00

0 10 20 30 40 50 60 70 80 90

P=.7741

Survival Time in Days Since Dischargeβ-blocker 1,425 1,365 1,245 292No β-blocker 543 525 484 119


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Risk- and Propensity-Adjusted Analysis of Discharge Medication Use in Patients with PSF

Post-discharge Mortality

Hazard Ratio

95% Hazard Ratio Confidence Limits

P Value

ACEI/ARB vs no ACEI/ARB

1.141 0.812 1.603 .447

β-Blocker vs no β-Blocker

1.209 0.872 1.675 .255

Post-discharge Death and/or Hospitalization

Odds Ratio

95% Odds Ratio Confidence Limits

P Value

ACEI/ARB vs no ACEI/ARB

0.909 0.692 1.196 .497

β-Blocker vs no β-Blocker

0.923 0.723 1.179 .523

PSF = LVEF 40%.


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Limitations

• The present observations include only hospitalized patients with HF, a population known to be at increased risk of adverse outcomes

• Left ventricular function was not assessed in 7,345 patients (15%), and these patients were excluded

• Follow-up data were collected only from a pre-specified subset of patients and extended only 60 to 90 days after hospital discharge

• Despite extensive covariate and propensity adjustment, residual confounding cannot be excluded, thus may only be demonstrating associations, rather than cause-and-effect relationships


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Conclusions• Data from the OPTIMIZE-HF reveal a high prevalence of

HF with PSF

• These patients have a similar post-discharge mortality risk and equally high rates of rehospitalization as patients with HF and LVSD

• No differences in clinical outcomes were seen with different definitions for PSF

• Despite the burden to patients and health care systems, data are lacking on effective management strategies for patients with HF and PSF

• Large well designed clinical trials are critically needed to identify effective management strategies for this population

fonarow gc, et al. j am coll cardiol. 2007;50:768 777. characteristics, treatments, and outcomes of...

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