Transcript OPTIMIZE-HF PSF JACC

Characteristics, Treatments, and
Outcomes of Patients With Preserved
Systolic Function Hospitalized for Heart
Failure: A Report From the OPTIMIZEHF 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
Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.
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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
Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.
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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
Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.
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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.
Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.
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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, guidelinerecommended 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
Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.
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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
Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.
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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
Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.
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OPTIMIZE-HF Hospital Characteristics
Total Hospitals
(N=259), n (%)
Follow-Up Hospitals
(N=91), n (%)
31 (12)
58 (22)
103 (40)
38 (15)
13 (5)
16 (6)
118 (48)
34 (14)
163 (67)
68 (27)
44 (17)
87 (34)
56 (22)
9 (10)
21 (23)
40 (44)
13 (14)
4 (4)
4 (4)
48 (55)
9 (10)
62 (70)
27 (30)
14 (16)
34 (38)
15 (17)
Bed size: 0 to 99
100 to 249
250 to 499
500 to 749
750
Unknown
Academic*
Transplant program*
Interventional† (CABG/PCI)
Region‡: Midwest
Northeast
South
West
* N=246, n=88; † N=245, n=88; ‡ N=255, n=90.
CABG/PCI = coronary artery bypass graft/percutaneous coronary intervention.
Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.
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OPTIMIZE-HF Patient Characteristics
Hospital Cohort
(N=48,612)
Follow-Up Cohort
(N=5,791)
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
Age, mean (years)
Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.
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Distribution of LVEF in Patients Hospitalized
With Primary Discharge Diagnosis of HF
Documented LVEF Measured
Prior to or During Hospitalization
5,000
4,183
4,000
3,814
Patients (n)
3,506
3,193
2,924 2,947
3,000
2,345
2,812 2,806
2,331
1,833
2,000
1,270
1,137
1,000
553
274
100
44
0
05
610
1115
16- 21- 26- 31- 36- 41- 46- 51- 56- 61- 66- 71- 7620 25 30 35 40 45 50 55 60 65 70 75 80
Left Ventricular Ejection Fraction (%)
Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.
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10
1
81- 86- 91- 9685 90 95 100
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Patient Characteristics at Hospital
Admission by LVSD vs PSF
Characteristic
Age, mean (years)
LVSD
(n=20,118)
40%≤ EF ≤50% EF >50%
P Value*
(n=7,321)
(n=10,072)
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
Noninsulin-treated diabetes
(%)
24
26
25
.418
Hypertension (%)
66
74
77
<.0001
24.3
45
61
<.0001
Mean LVEF %
*P value (40%≤ EF ≤50% vs EF >50%).
PSF = preserved systolic function.
Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.
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Patient Physical Exam Findings at
Hospital Admission by LVSD vs PSF
Patients
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
Characteristic
PSF = LVEF 40%.
Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.
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HF Treatments Applied at Discharge
by LVSD vs PSF
LVSD
100
Eligible Patients Treated (%)
90
80
P<.0001
P<.0001
83
P=.004
75
70
70
60
PSF
P<.0001
58
P=.0003
50
44
40
P=.0009
68
62
60
53
56
52
40
P<.0001
30
P<.0001
20
9
10
21
12
9
0
ACE
Inhibitor
ARB
β-Blocker
Ald Ant
Statin
Complete
Smoking Warfarin for
Discharge Cessation
Atrial
Instructions Counseling Fibrillation
*Statin use among patients with CAD, cerebrovascular accident/transient ischemic attack, diabetes, hyperlipidemia, or
peripheral vascular disease.
PSF = LVEF 40%.
Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.
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In-Hospital Outcomes by LVSD vs PSF
LVSD
PSF
P=.237
7
6.0
6
5.7
P=.237
5
4.0
4.0
4
P.0001
3.9
2.9
3
2
1
0
Length of Stay,
Mean (days)
PSF = LVEF 40%.
Length of Stay,
Median (days)
Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.
In-Hospital Mortality
(%)
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Patient Outcomes by LVSD vs PSF
Outcome
In-hospital mortality:
all patients
LVSD
40%≤ EF ≤50% EF >50%
(n=20,118)
(n=7,321)
(n=10,072)
P Value*
3.9
3.0
2.9
.647
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
Follow-Up Cohort
*P value (40%≤ EF ≤50% vs EF >50%).
Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.
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60- to 90-Day Survival by LVSD vs PSF
Survival Function
1.00
P=.459
0.95
0.90
0.85
0.80
No LVSD
LVSD
0.75
0
10
20
30
40
50
60
70
80
90
Survival Time in Days Since Discharge
LVSD
No LVSD
2,294
2,604
2,188
2,471
*P value (40%≤ EF ≤50% vs EF >50%).
Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.
1,994
2,195
469
441
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ACEI/ARBs and Post-Discharge
Outcomes in PSF (Unadjusted)
Survival Function
1.00
P=.052
0.95
0.90
0.85
0.80
No ACEI/ARB
ACEI/ARB
0.75
0
10
20
30
40
50
60
70
80
90
Survival Time in Days Since Discharge
ACEI/ARB
No ACEI/ARB
1,288
595
1,249
560
Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.
1,138
515
269
149
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β-Blockers and Post-Discharge
Outcomes in PSF (Unadjusted)
Survival Function
1.00
P=.7741
0.95
0.90
0.85
0.80
No β-blocker
β-blocker
0.75
0
10
20
30
40
50
60
70
80
90
Survival Time in Days Since Discharge
β-blocker
No β-blocker
1,425
543
1,365
525
Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.
1,245
484
292
119
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Risk- and Propensity-Adjusted Analysis of
Discharge Medication Use in Patients with PSF
Post-discharge
Mortality
Hazard
Ratio
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
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%.
Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.
95% Hazard Ratio
Confidence Limits
P Value
P Value
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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-andeffect relationships
Fonarow GC, et al. J Am Coll Cardiol. 2007;50:768777.
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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.