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Remote Hemodynamic Pressure Monitoring
in the Management of Heart Failure
25th Annual Cardiovascular Symposium
Barry S. Clemson, MD
OSF Ministry Heart Failure Medical Director
November 4, 2016
Heart Failure – A Growing Global Concern
Prevalence and Incidence
Mortality
• Overall 2.1% prevalence: 5.1M heart failure patients
in 20101
• For AHA/ACC stage C/D patients diagnosed with HF:
• 825,000 people ≥ 45 years of age are newly
diagnosed each year with HF.1
• 30% will die in the first year.3-5
• 60% will die within
5 years.5
• 15 M heart failure patients in the ESC 51-member
countries2
• Overall 2-3% prevalence2
HF prevalence in the US is projected to increase 46% from 2012 to 2030,
resulting in > 8M people ≥ 18 years of age with HF.6
1.
2.
3.
4.
5.
6.
AHA 2014 Statistics at a Glance, 2014
The European Society of Cardiology, ESC HF Guideline, 2008
Curtis et al, Arch Intern Med, 2008.
Roger et al. JAMA, 2004.
Cowie et al, EHJ, 2002.
Heidenreich PA et al. Circ Heart Failure 2013.
2
Heart Failure Is Associated with High
Hospitalization and Readmission Rates
• In 2010, there were 1 million
hospitalizations in the US with
HF as the principal diagnosis.1
• Hospitalization rate did not change
significantly from 2000.1
• Average length of hospital stay
• Approximately 5 days (US)2
• 11 days (Europe)3
• HF is also associated with high
readmission rates:
• ~25% all-cause readmission
within 30 days4 and ~50%
within 6 months5
Graph from www.health.org.uk. Bridging the gap: Heart Failure, 2010.
Data from Organization for Economic Cooperation and Development, 2009.
1.
1.
2.
2.
3.
3.
4.
4.
5.
5.
CDCNCHS
NCHS NationalHospital
Hospital DischargeSurvey,
Survey, 2000-2010
CDC
CDC NCHSNational
National HospitalDischarge
Discharge Survey,2000-2010
2000-2010
Yancy
et
al.
JACC,
2006.
Yancy
Yancyetetal.
al.JACC,
JACC,2006.
2006.
Clelandetetal.
al. EuroHeart,2003.
2003.
Cleland
Cleland et al.EuroHeart,
EuroHeart, 2003.
KrumholzHM,
HM,etetal.
al.Circ
CircCardiovas
CardiovasQual
Qual Outcomes2009.
2009.
Krumholz
Krumholz HM, et al. Circ Cardiovas QualOutcomes
Outcomes 2009.
WexlerDJ,
DJ, et al.Am
Am HeartJJ2001.
2001.
Wexler
Wexler DJ,etetal.
al. AmHeart
Heart J 2001.
3
Economic Burden of HF Will Continue to Rise
Through 2030*
• The AHA estimates that the total medical costs for HF are projected to
increase to $70B by 2030  a 2-fold increase from 2013.1
• 50% of the costs are attributed to hospitalization.2
Graph: Heidenreich PA, et al. Circulation Heart Failure 2013.
* Study projections assumes HF prevalence remains constant and
continuation of current hospitalization practices
1. Heidenreich PA, et al. Circulation Heart Failure 2013.
2. Yancy CW, et al. Circulation 2013.
4
Worsening Heart Failure Leading to HF-related
Hospitalizations Contributes to Disease Progression
• With each subsequent HF-related admission, the patient leaves the hospital with a further decrease in cardiac
function.
Graph adapted from: Gheorghiade MD, et al. Am J. Cardiol. 2005
5
HF-related Hospitalizations Are a Strong
Predictor of Mortality1,2
•
Data from the EFFECT study,
n = 9138 patients1
•
Data from Setoguchi et al.,
n = 14,374 patients2
•
•
Among 1 year survivors after index EFFECT-HF discharge,
the number of heart failure hospitalizations
in the preceding year stratified the risk of death in
crude analysis1
Each admission decreases a
patient’s chance of survival.
1. Lee DS, et al. Am J of Med, 2009.
2. Setoguchi S, et al. Am Heart J, 2007.
6
KP cumulative mortality curve for all-cause mortality
after each subsequent hospitalization for HF2
Current HF Management Is Inadequate for Identifying and
Managing Congestion Leading
to Decompensation
Identifying congestion early will lead to early treatment,
prevent hospitalizations and slow the progression of HF.
• 90% of HF hospitalizations present with symptoms of pulmonary congestion.1,2
• Post hoc analysis of 463 acute decompensated HF patients from DOSE-HF and CARRESS-HF trials showed:
• 40% of patients are discharged with moderate to severe congestion.3
• Of patients decongested at discharge, 41% had severe or partial re-congestion by 60 days.3
Congestion state at discharge
Maintained
decongestion
Absent or mild
congestion
Moderate to severe
congestion
Congestion state of patients discharged without
congestion at 60 day follow-up3
17%
40%
60%
24%
Partial recongestion
59%
Relapse to severe
congestion
1. Adams KF, et al. Am Heart J. 2005
2. Krum H and Abraham WT. Lancet 2009
3. Lala A, et al. JCF 2013
7
Time Course of Decompensation
HF management has relied on patient-reported symptoms, as well as impedance,
blood pressure and weight gain changes that often
manifest only after decompensation has begun.
Physiologic Markers of Acute Decompensation
* Graph adapted from Adamson PB, et al. Curr Heart Fail Reports, 2009.
8
Managing Pressures in the Heart Failure Patient
Pressures
When patients are stable
 Their pressures remain very stable over time.
When patient’s decompensate
 Pressures increase, leading to exacerbation.
The pressures return to baseline when
the exacerbation is treated
and volume returns to normal
Managing to targeted
pressure ranges
Adamson PB, et al. Curr Heart Fail Reports, 2009
9
Patient
 Pressures reflect the underlying volume state
in HF patients.
 Strongly supports the hypothesis that measuring
those pressures frequently or continuously using
implantable devices and managing those pressures
may be a superior management strategy.
 Can reduce overall pressures and ultimately
lead to a reduction in HF events.
CardioMEMS™ HF System
The CardioMEMS™ HF System provides ambulatory pulmonary artery (PA) pressure monitoring
PA Sensor is permanently
implanted in the distal pulmonary
artery via a right-heart
catheterization procedure.
Patient-initiated sensor readings
are wirelessly transmitted to an
external electronics unit
Data stored in a secure
website for clinicians
to access and review.
Directly monitoring PA pressure not only enables early detection of
worsening heart failure, but also allows the titration of medications for
proactive and personalized patient management.
10
CHAMPION Clinical Trial: The Effect of Pulmonary Artery
Pressure-Guided Therapy on HF Hospitalizations vs.
Standard of Care
Patients with moderate NYHA class III HF for at least 3 months, irrespective of LVEF and a HF
hospitalization within the past 12 months were included in the study.
550 Pts w/CMEMS Implants
All Pts Take Daily readings
Treatment
270 Pts
Management Based on
PA Pressure +Traditional Info
26 (9.6%) Exited
< 6 Months
15 (5.6%) Death
11 (4.0%) Other
Control
280 Pts
Management Based on
Traditional Info
Primary Endpoint: Rate of HF Hospitalization
26 (9.6%) Exited
< 6 Months
20 (7.1%) Death
6 (2.2%) Other
Secondary Endpoints:
 Change in PA Pressure at 6 months
 No. of patients admitted to hospital for HF
 Days alive outside of hospital
 QOL
Abraham WT, et al. Lancet, 2011.
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
26 (9.6%) Exited
< 6 Months
15 (5.6%) Death
11 (4.0%) Other
Control
280 Pts
Management Based on
Traditional Info
Primary Endpoint: rate of HF Hospitalization
PA pressures were managed to target goal
pressures by physicians with appropriate
titration of HF medications.
26 (9.6%) Exited
< 6 Months
20 (7.1%) Death
6 (2.2%) Other
Secondary Endpoints included:
 Change in PA Pressure at 6 months
 No. of patients admitted to hospital for HF
 Days alive outside of hospital
 QOL
Target Goal PA Pressures:
 PA Pressure Systolic 15 – 35 mmHg
 PA Pressure diastolic 8 – 20 mmHg
 PA Pressure mean 10 – 25 mmHg
Abraham WT, et al. Lancet, 2011.
12
CHAMPION Clinical Trial: PA Pressure-guided
Therapy Reduces HF Hospitalizations
Patients managed with PA pressure data
had significantly fewer HF hospitalizations
as compared to the control group.
Abraham WT, et al. Lancet, 2011.
13
CHAMPION Clinical Trial: Both Primary Safety Endpoints
and All Secondary Endpoints Were
Met at 6 months
Device-related or system-related complications
Treatment
(n = 270)
Control
(n = 280)
3 (1%)
3 (1%)
Primary Safety
Endpoints
Total 8 (1%)*
Pressure-sensor failures
Change from baseline in PA mean pressure
(mean AUC [mm Hg x days])
Number and proportion of patients hospitalized for HF (%)
Secondary
Endpoints
Days alive and out of hospital for HF (mean ± SD)
Quality of life (Minnesota Living with Heart Failure
Questionnaire, mean ± SD)
P-value
< 0.0001
0
0
< 0.0001
-156
33
0.008
55 (20%)
80 (29%)
0.03
174.4 ± 31.1
172.1 ± 37.8
0.02
45 ± 26
51± 25
0.02
* Total of 8 DSRCs including 2 events in Consented not implanted patients (n = 25)
Abraham WT, et al. Lancet, 2011.
14
CHAMPION Clinical Trial: HF Meds Can Be More Effectively
Titrated with Pulmonary Artery (PA) Pressure Information
Total Medication Changes/
Patient/Month
2
P < 0.0001
1.5
0.88
< 1 incremental medication
change/patient/month
1
Based on PA pressure
Based on Signs and
Symptoms
0.5
0.67
0.65
Treatment
Control
0
Compared to the control group, patients managed with PA
pressures had significantly more total medication changes,
resulting in < 1 incremental medication change/month.
Costanzo MR, et al. Journal of Cardiac Failure, 2011
15
CHAMPION Clinical Trial: PA Pressure-Guided Therapy
Improves Outcomes in CRT Patients1 and in Patients
With Preserved Systolic Function2
HF Hospitalization Reduction
(6 mos follow-up)
Relative Risk Reduction
60%
P < 0.0001 vs. control
50%
40%
P = 0.0071 vs. control
P = 0.0080 vs. control
with CRT
without CRT
30%
20%
10%
0%
HFpEF
preserved EF (≥ 40%)
1. Weiner et al. Heart Rhythm, 2011 Additional data on file.
2. Adamson et al. JCF Nov 2010.
16
CHAMPION Clinical Trial: The number needed to treat (NNT) to prevent one
HF-related hospitalization is improved vs. other therapies
Intervention
Trial
Mean Duration of
Randomized FollowUp
Annualized Reduction
in HF Hospitalization
Rates
NNT per year to
Prevent 1 HF
Hospitalization
Beta-blocker
COPERNICUS
10 months
33%
7
Aldosterone
antagonist
RALES
24 months
36%
7
CRT
CARE-HF
29 months
52%
7
Beta-blocker
MERIT-HF
12 months
29%
15
ACE inhibitor
SOLVD
41 months
30%
15
Aldosterone
antagonist
EMPHASIS-HF
21 months
38%
16
Digoxin
DIG
37 months
24%
17
Angiotensin receptor
blocker
Val-HeFT
23 months
23%
18
Angiotensin receptor
blocker
CHARM
40 months
27%
19
PA pressure
monitoring
CHAMPION
17 months
33%
4
Sub Analysis of
HFpEF
CHAMPION
17 months
50%
2
CHAMPION Clinical Trial: PA Pressure-Guided Therapy
Benefits Patients with Common HF Comorbidities
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)
Comorbidity
1.
2.
3.
4.
5.
6.
Strickland WL, et al. JACC 2011
Criner G, et al. European Respiratory Journal, 2012
Martinez F, et al. European Respiratory Journal, 2012
Benza R, et al. Journal of Cardiac Failure, 2012
Miller AB, et al. JACC, 2012
Abraham WT, et al. HFSA, 2014
18
Summary: CHAMPION Clinical Trial
Pulmonary Artery Pressure
Managing pressures to
target goal ranges:
Medication Changes based on Pulmonary
Artery Pressure (p < 0.0001)
 PA Pressure systolic 15–35 mmHg
 PA Pressure diastolic 8–20 mmHg
 PA Pressure mean 10–25 mmHg
Pulmonary Artery Pressure Reduction
(p = 0.008)
Reduction in Heart Failure Hospitalizations
(p < 0.0001)
Quality of Life Improvement
(p = 0.024)
Abraham WT, et al. Lancet, 2011.
19
CHAMPION Clinical Trial: Longitudinal Results With
Open Access to All Patients Confirm Effectiveness of PA
Pressure Monitoring
550 Pts w/CMEMS Implants
All Pts Take Daily readings
Randomized Access (Part 1)
Treatment Mean Follow-up 17.6 months Control
270 Pts
280 Pts
Management Based on
Management Based on
PA Pressure +Traditional Info
Traditional Info
26 (9.6%) Exited < 6 Months
15 (5.6%) Death
11 (4.0%) Other
26 (9.6%) Exited < 6 Months
20 (7.1%) Death
6 (2.2%) Other
Open Access / Unblinded Control Group (Part 2)
Mean follow-up 13 months
Study exits: 58
31 (17.5%) Death
27 (15.2%) Other
Former Treatment
177 Pts
Management Based on
PA Pressure + Traditional Info
Former Control
170 Pts
Management Based on
PA Pressure + Traditional Info
n = 119
n = 127
Study exits: 43
21 (12.3%) Death
22 (12.9%) Other
Abraham W, et al. ACC 2014
20
CHAMPION Clinical Trial: Longitudinal results with
Open Access to All Patients Confirm Effectiveness of PA
Pressure Monitoring
Abraham W, et al. ACC 2014
21
CardioMEMS™ HF System Work Flow
Indicated for all NYHA Class III HF patients who have been hospitalized for
HF in the prior year.
Contraindicated for patients with an inability to take dual antiplatelet or anticoagulants
for one month post implant.
Identification > Implant > Lower Baseline > Maintenance
22
Pulmonary Artery Pressure Database
Trend Data
Reading
Discrete data
Systolic:
24
Mean:
19
Diastolic:
16
Heart Rate:
81
seconds
23
Elevated PA Mean Pressure Treatment Strategies
Elevated PA Pressure (Hyper-volemic)
PA Pressure trending above the normal hemodynamic range
Add or increase diuretic
- increase/add loop diuretic
- change loop diuretic
- add thiazide diuretic
- IV loop diuretic
Add or increase vasodilators
- add or increase nitrate
Re-evaluate PA pressures
2-3 days per week until PA pressures stabilize
Evaluate other etiologies
if PA pressures remain elevated i.e. dietary indiscretion,
sleep apnea, etc.
24
Case Studies
Case Study – Subject 12-013
75-year-old female
ICM EF 30-35%
CM Implant 8/29/2008
MEDICAL HISTORY
BASELINE HF MEDICATIONS
HEMODYNAMICS AT IMPLANT
 Hypertension
Lisinopril 5 mg QD
PA
34/10 (20)
 Valvular heart disease
Carvedilol 12.5 mg BID
PCWP
25
Furosemide 40 mg QD
CO
3.5
 Moderate MR, Mild TR, Mild AR
 Atrial fibrillation
Digoxin 0.125mg QD
BASELINE VITALS
 Diabetes
 Chronic renal insufficiency
BP
144/69
 Iron deficiency anemia
HR
64
 Sick sinus syndrome
Weight
130 lbs.
BMI
23.8
 s/p pacemaker
 Pulmonary hypertension
 Echo 9/2007 RSVP
50-60 mmHg
BASELINE LABS
SCr
1.2
GFR
47
26
Titration and Switching Loop Diuretic
and Addition of Thiazide Diuretic
27
Case Study – Subject 06-010
69-year-old male
ICM EF 35%
CM Implant 1/11/2008
MEDICAL HISTORY
BASELINE HF MEDICATIONS
HEMODYNAMICS AT IMPLANT
 Coronary artery disease
Lisinopril 20 mg QD
PA
40/25(29)
s/p ICD
Carvedilol 6.25 mg BID
PCWP
17
 Mitral valve disease
Furosemide 40 mg QD
CO
4.0
 Ventricular fibrillation
Amiodarone 200 mg QD

BASELINE VITALS
 CABGx2
 Arterial stent of the kidney
BP
124/88
 Mitral valve repair
HR
72
 Thyroid disease
Weight
180 lbs.
 Gout
BMI
26.6
 Acute renal failure
BASELINE LABS
 Chronic anemia
 AAA repair
SCr
1.3
GFR
58
28
Initiation of Long-acting Nitrates
29