Pre and post- discharge management.

1. Acute Heart Failure Essentials:
Pre- and Post-Discharge Management
William T. Abraham, MD, FACP, FACC, FAHA, FESC
Professor of Medicine, Physiology, and Cell Biology
Chair of Excellence in Cardiovascular Medicine
Director, Division of Cardiovascular Medicine
Associate Dean for Clinical Research
Director, Clinical Trials Management Office
Deputy Director, Davis Heart & Lung Research Institute
The Ohio State University
Division of Cardiovascular Medicine

2. 2

3. 3
Four Clinical States of Heart Failure
Time
Stable
1
Stable
1
Pre-Acute
Heart Failure
2
Acute
Heart Failure
(Hospitalization)
3
Post-Acute
Heart Failure
4
Days to Weeks

4. 4
Pre-Acute Heart Failure: Opportunity to
Prevent Hospitalization
Time
Pre-Acute
Heart Failure
2
Days to Weeks

5. How Do We Prevent Heart Failure Hospitalizations?
Maintain Optimal Fluid / Pressure Status
Too “Wet” (High Pressures)
Increased symptoms, increased risk of
hospitalization, increased risk of
arrhythmias, increased mortality
“Just Right” (Normal Pressures)
Feel well, low risk for hospitalization or
death
Too “Dry” (Low Pressures)
Hypotension, dizziness, risk of syncope,
worsening kidney function

6. 6
Pre-Acute Heart Failure: The Development
of Acute Decompensation
Physiologic markers of the development of acute decompensation:
Pressure
Changes
Impedance
Changes
Weight Changes,
HF Symptoms
Hospitalization
Time
Stable
Decompensation
Autonomic
Adaptation

7. 7
Pre-Acute Heart Failure: The Development
of Acute Decompensation
Physiologic markers of the development of acute decompensation:
Pressure
Changes
Impedance
Changes
Weight Changes,
HF Symptoms
Hospitalization
Time
Stable
Decompensation
Autonomic
Adaptation
Unreliable, late, and
indirect markers8,9
May be used in
risk stratification,
but not actionable4-7Enables proactive
and personalized HF
management1-3
1. Steimle AE, et al. Circulation, 1997
2. Abraham WT, et al. Lancet, 2011
3. Ritzema J, et al. Circulation, 2010
4. Abraham WT, HFSA, 2009
5. Conraads VM, et al. EHJ, 2011
6. Whellan DJ, et al. JACC, 2010
7. van Veldhuisen DJ, et al. Circulation, 2011
8. Chaudry SI, et al. NEJM 2010
9. Anker SD, et al. AHA 2010

8. The Pulmonary Artery Pressure
Measurement System*
Catheter-based delivery system
*FDA approved May 28, 2014
MEMS-based pressure sensor
Home electronics PA Measurement database

9. 9
CHAMPION: CardioMEMS Heart Sensor Allows Monitoring of
Pressure to Improve Outcomes in NYHA Class III Heart Failure
Patients
550 Pts
w/ CM Implants
All Pts Take Daily
Readings
Treatment
270 Pts
Management Based on
Hemodynamics + Traditional Info
Control
280 Pts
Management Based on
Traditional Info
Primary Endpoint: HF Hospitalizations at 6 Months
Additional Analysis: HF Hospitalizations at All Days (~15 M mean F/U)
Multiple Secondary Endpoints
§ Trial Designed by
Steering Committee with
active FDA input
§ Prospective, multi-center,
randomized, controlled
single-blind clinical trial
§ All subjects followed in
their randomized single-
blind study assignment
until the last patient
reached 6 months of
follow-up
§ 64 US Centers
§ PIs: William Abraham,
Phil Adamson
Abraham WT, et al. Lancet 2011

10. 10
Hypothesis of the CHAMPION Trial
Medications should be adjusted based on
pulmonary artery pressures
unless contraindicated by clinical status of patient
In addition to basing treatment
on signs and symptoms
Heart failure
hospitalizations

11. CHAMPION Clinical Trial: Managing to
Target PA Pressures
550 Pts w/CMEMS Implants
All Pts Take Daily readings
Treatment
270 Pts
Management Based on
PA Pressure +Traditional Info
Control
280 Pts
Management Based on
Traditional Info
ther
Primary Endpoint: rate of HF Hospitalization
26 (
Secondary Endpoints included:
§ Change in PA Pressure at 6 months
§ No. of patients admitted to hospital for HF
§ Days alive outside of hospital
§ QOL
PA pressures were managed to target goal
pressures by physicians with appropriate
titration of HF medications.
Target Goal PA Pressures:
§ PA Pressure Systolic 15 – 35 mmHg
§ PA Pressure diastolic 8 – 20 mmHg
§ PA Pressure mean 10 – 25 mmHg
Adamson PB, et al., J Card Fail 2011
Abraham WT, et al., Lancet 2011
Treatment Recommendations
for Elevated PA Pressures
• Add or increase diuretic
– increase/add loop diuretic
– change loop diuretic
– add thiazide diuretic
– IV loop diuretic
• Add or increase vasodilator
– add or increase nitrate

12. Cumulative HF Hospitalizations Reduced
At 6 Months and Full Duration of Randomized Study
0
20
40
60
80
100
120
140
160
180
200
220
240
260
280
Days from Implant
0 90 180 270 360 450 540 630 720 810 900
270 262 244 210 169 131 108 82 29 5 1
280 267 252 215 179 137 105 67 25 10 0
No. at Risk
Treatment
Control
Treatment (158 HF Hospitalizations)
Control (254 HF Hospitalizations)
Study Duration
37% RRR, p < 0.0001
≤ 6 Months
28% RRR,
p = 0.0002
> 6 Months
45% RRR,
p < 0.0001

13. Reduction in Hospitalizations Over Full
Duration of Randomized Study
Treatment
(n=270)
Control
(n=280)
Absolute
Reduction
Relative
Reduction p-value
HR (CI)
Heart Failure
Hospitalizations
182 279 97
0.67
(0.55 – 0.80)
<0.0001
Death or
Heart Failure
Hospitalizations
232 343 111 0.69
(0.59 – 0.82)
<0.0001
Results from Andersen Gill model
Hazard Ratio (HR) and 95% Confidence Interval (CI)
All Cause
Hospitalizations
554 672 118
0.84
(0.75 – 0.95)
0.0032
Death or All
Cause
Hospitalizations
604 736 132
0.84
(0.76 – 0.94)
0.0017

14. Ejection Fraction
Randomization
Group
Number of
Heart Failure
Hospitalizations
Annualized Rate of
Hospitalization for
Heart Failure
Hazard Ratio
(95% CI)
[p-value]
≥40%
Treatment Group
(n=62)
29 0.43 0.50
(0.35-0.70)
[p<0.0001]
Control Group
(n=57)
59 0.86
≥50%
Treatment Group
(n=35)
13 0.41 0.30
(0.18-0.48)
[p<0.0001]
Control Group
(n=31)
31 1.39
<40%
Treatment Group
(n=208)
153 0.67 0.74
(0.63-0.89)
[p=0.0010]
Control Group
(n=222)
220 0.90

15. PA Pressure-Guided Therapy Benefits
Patients with Common HF Comorbidities
Comorbidity N size (control) N size (treatment)
HF Hospitalization rate
reduction at 15 months
in treatment group
History of myocardial
infarction1 137 134
46%
(p < 0.001 vs. control)
COPD2,3 96 91
41%
(p = 0.0009 vs. control)
Pulmonary
hypertension4 163 151
36%
(p = 0.0002 vs. control)
AF5 135 120
41%
(p < 0.0001 vs. control)
Chronic Kidney Disease6 150 147
42%
(p = 0.0001 vs. control)
1. Strickland WL, et al. JACC 2011
2. Criner G, et al. European Respiratory Journal, 2012
3. Martinez F, et al. European Respiratory Journal, 2012
4. Benza R, et al. Journal of Cardiac Failure, 2012
5. Miller AB, et al. JACC, 2012
6. Abraham et al., HFSA 2014

16. Impact of PA Pressure Guided HF Management
on HF Hospitalizations in GDMT Population
0.39
0.69
HFrEF Patients on ACE/ARB and Beta Blocker Prior to
Implant
HF hospitalization rates
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
AnnualizedHFHospitalizationRate
PA Pressure Guided HF Management (Treatment Group)
Guideline Directed Standard of Care (Control Group)
43% Relative Risk Reduction
[HR 0.57, 95% CI 0.45-0.74, p<0.0001]
Number needed to treat: 3
Abraham et al. ACC 2015

17. Impact of PA Pressure Guided HF Management on
All-Cause Mortality in GDMT Population
57% Relative Risk Reduction
[HR 0.43, 95% CI 0.24-0.76, p=0.0026]
Number needed to treat: 7
Abraham et al. ACC 2015

18. 18
Post-Acute Heart Failure: Opportunity to
Prevent Rehospitalization
Time
Post-Acute
Heart Failure
4
Days to Weeks

19. 19
Post-Acute Heart Failure: Relapse Before
Recovery
More than 50% of ADHF patient discharged from the hospital are still “wet” and
do not receive adequate ongoing diuresis as outpatients1
Rehospitalization
Time
Stable
Hospitalization
1Adams KF, et al., Am Heart J 2006

20. 117
31
18
60
13
4
HF Hospitalizations All Cause 30 Day Readmissions HF 30 Day Readmissions
0
20
40
60
80
100
120
Number of Hospitalizations
Control (Standard of Care) Treatment (PA pressure monitoring)
§ Retrospective analysis of patients 65 years or older (n = 245)
§ Compared 30-day readmissions and HF hospitalizations between
patients managed with
PA pressure vs Standard of Care
§ Results showed statistically significant reductions in readmissions and
HF hospitalizations
in treatment group
CHAMPION Clinical Trial: Substantial reduction in
30-day readmissions in Medicare-eligible patients
Adamson, et al. AHA 2014
58% reduction
p = 0.0062
78% reduction
p = 0.0027
In Medicare-eligible patients 65 years or older PA pressure monitoring with the
CardioMEMS™ HF System significantly reduced 30-day readmissions
49% reduction
p < 0.0001

21. 21
What Else Can We Do to Prevent
Rehospitalization?
Yancy CW, et al., Circulation 2013
Accessed at http://circ.ahajournals.org/content/128/16/e240

22. Ohio State Post-Discharge Management
§ Nurse navigator calls patient 48 hours post-
discharge to review discharge instruction (diet,
medications) and assess how the patient is doing
§ Nurse practitioner sees the patient 7 days post-
discharge for comprehensive in-clinic assessment,
diuretic dose adjustment, and GDMT dose titration
if indicated
§ Heart failure physician sees patient 3-4 weeks
post-discharge comprehensive in-clinic
assessment, diuretic dose adjustment, and GDMT
dose titration if indicated

23. Other Post-Discharge Considerations
§ Many patient continue to exhibit some degree of
resistance to oral diuretics
§ May need to consider outpatient use of
intravenous (or subcutaneous?) diuretic therapy
§ May use Emergency Department Observation Unit
to treat relapsing patients, before they require
rehospitalization
§ Revaluate for precipitating causes of worsening
heart failure