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CardioMEMS™ HF SYSTEM
Clinical Compendium:
Pulmonary Artery (PA) Pressure-Guided Therapy for Heart Failure Management
The CardioMEMS™ HF System is the first and only FDA-approved heart failure (HF) monitor proven to significantly reduce
HF hospital admissions and improve quality of life in NYHA class III patients.1
When used by clinicians to manage HF, the CardioMEMS HF System is:
ƒƒ Safe and reliable – Demonstrated 98.6% freedom from device or system related complications1
ƒƒ Clinically proven – reduced HF admissions by 37%1 and all-cause 30-day readmissions by 58%2
ƒƒ Proactive and personalized – patient management through direct monitoring of PA pressure and titration of medications
Traditional physiologic markers in the development of acute decompensation in patients suffering from HF such as
intrathoracic impedance, weight, blood pressure and symptoms are late and unreliable3,4 with only moderate sensitivity and
specificity.5-7 Large randomized controlled studies using telemonitoring of these indirect markers have failed to demonstrate
a reduction in HF hospitalizations.3,4,8 This clinical compendium summarizes key studies demonstrating the safety and
efficacy of the CardioMEMS HF System.
PA PRESSURE-GUIDED THERAPY REDUCES HEART FAILURE HOSPITALIZATIONS,
REDUCES 30-DAY READMISSIONS AND IMPROVES QUALITY OF LIFE IN PATIENTS
WITH REDUCED OR PRESERVED EJECTION FRACTION1
The CardioMEMS™ HF System monitors PA pressure measurements from a sensor implanted into the pulmonary artery. The safety
and accuracy of the CardioMEMS™ PA Sensor has been demonstrated in previous studies.9,10 Systolic and diastolic PA pressures were
significantly correlated between the CardioMEMS PA Sensor and traditional Swan-Ganz™ catheter measurements, and between the
CardioMEMS PA Sensor and standard echocardiography.9,10 A feasibility study reported the safe and successful implantation of the
CardioMEMS PA Sensor in a clinical setting with no serious device-related events (n = 17).10 These preliminary studies provided the safety
and accuracy data needed for the pivotal CHAMPION clinical trial and subsequent sub-analyses that support the use of the CardioMEMS HF
System to proactively guide HF management in NYHA Class III patients with reduced or preserved left ventricular ejection fraction (LVEF).
Wireless Pulmonary Artery Haemodynamic Monitoring in
Chronic Heart Failure: A Randomised Controlled Trial
Abraham WT, et al. Lancet, 2011.
1
ƒƒ The aim of this randomized, multicenter, single-blind, controlled
study was to evaluate the safety of the system and the efficacy
of PA pressure-guided therapy on HF hospitalizations.
ƒƒ NYHA Class III HF patients irrespective of LVEF and who
had been hospitalized for HF within the past 12 months
were implanted with the CardioMEMS PA Sensor (n = 550);
patients were randomized to either the treatment group (HF
management guided by PA pressure measurements, n = 270),
or the control group (standard of care management, n = 280).
Key takeaways:
ƒƒ The treatment group required < 1 medication changes per
patient per month compared to the control group (9.1 ± 7.4
vs. 3.8 ± 4.5 changes per patient during first 6 months of
follow-up, p < 0.0001).
ƒƒ During the entire follow-up (mean 15 months), PA pressureguided therapy (treatment group) significantly reduced HF
hospitalizations by 37% compared to the control group
(p < 0.0001, see Figure 1).
ƒƒ The treatment group had a lower risk of death or freedom
from first HF hospitalization during the entire follow-up period
compared to the control group (p = 0.0086).
ƒƒ Mean follow-up time was 15 months.
ƒƒ Both primary safety and efficacy endpoints were met:
Figure 1. Cumulative heart failure hospitalizations during the entire period of
follow-up
ƒƒ Patients had a 98.6% freedom from device- or systemrelated complications (95% CI 97.3-99.4) with no pressuresensor failures (95% CI 99.3-100.0).
ƒƒ During the first 6 months of follow-up, compared to the control
group, the treatment group had:
ƒƒ A greater reduction in PA pressure (-156 vs. 33 mean area
under the curve, p < 0.008).
ƒƒ Fewer patients admitted to the hospital for HF (20%
treatment group vs. 29% control group, p < 0.03).
ƒƒ More days alive outside of the hospital (174.4 ± 31.1 vs.
172.1 ± 37.8 days, p < 0.02).
ƒƒ Better patient quality of life (45 ± 26 vs. 51 ± 25, p = 0.02
based on Minnesota Living with Heart Failure Questionnaire).
Cumulative Number of HF Hospitalizations
ƒƒ The rate of HF hospitalizations at 6 months was reduced by
28% in the treatment group (p = 0.0002).
290
260
240
220
200
180
160
140
120
100
80
60
40
20
0
Control
254 HF Hospitalizations
Treatment
158 HF Hospitalizations
Hazard ratio 0.63
(95% CI 0.52-0.77)
p < 0.0001
0
90
180
270
360
450
540
630
720
810
900
67
82
25
29
10
5
0
1
Days from Implant
# at Risk
Control 280
Treatment 270
267
262
252
244
Abraham WT, et al. Lancet, 2011.1
2 | CardioMEMS™ HF System
Study Duration
37% RRR
p < 0.0001
> 6 Months
45% RRR
p < 0.0001
≤ 6 Months
28% RRR
p < 0.0002
215
210
179
169
137
131
105
108
Impact of Introduction of Pulmonary Artery Pressure
Monitoring for Heart Failure Management: Longitudinal
Results from the CHAMPION Trial
Abraham W, et al. Lancet 201511
ƒƒ This CHAMPION clinical trial analysis evaluated the impact
on HF hospitalizations of the introduction of PA pressure
monitoring in the control group (n = 170) of patients and
continued PA monitoring in the treatment group (n = 177)
during the open access (OA) phase of the trial.
Key takeaways:
ƒƒ The longitudinal analysis confirms the effectiveness of the
CardioMEMS HF System and supports the findings from the
randomized portion of the CHAMPION clinical trial.
ƒƒ Even after adjustment for longitudinal confounders, new access
to PA pressure monitoring for the formerly blinded control group
resulted in a significant reduction in HF hospitalizations.
ƒƒ Following completion of the randomized access (RA) period
(mean follow-up of 18 months), all patients were managed
utilizing PA pressure monitoring with the CardioMEMS HF
System (mean follow-up of 13 months) and evaluated in a
longitudinal analysis.
ƒƒ New access to PA pressures in the control group resulted in a
48% reduction in HF hospitalization rates (0.36 vs. 0.68, HR
0.52, 95% CI 0.40-0.69, p < 0.0001). See Figure 2.
ƒƒ The low HF hospitalization rate in the treatment group during
the randomized access period was maintained in the open
access period (0.45 vs. 0.48, HR 0.93, 95% CI 0.70-1.22,
p = 0.5838). See Figure 2.
Figure 2. CHAMPION Clinical Trial: Longitudinal Results with Open Access to All Patients
Confirm Effectiveness of PA Pressure Monitoring in Reducing HF Hospitalizations
Control Group
0.9
0.8
0.8
Randomized Access – 0.68
0.6
0.5
New access
to PA pressure
0.4
Open Access – 0.36
0.3
0.2
0.1
0
180
0.6
Randomized Access – 0.48
0.5
0.4
Open Access – 0.45
0.3
0.2
0.1
Control
Former Control
0.0
0.7
Annualized Hazard Rates
0.7
Annualized Hazard Rates
Treatment Group
0.9
Treatment
Former Treatment
0.0
360 540 720 900 1080 1260
Days from Implant
HR 0.52 (0.40-0.69)
0
180
360 540 720 900 1080 1260
Days from Implant
HR 0.93 (0.70-1.22)
HR 0.56 (0.38-0.83), P = 0.0040
Abraham W, et al. Lancet 2015
CardioMEMS™ HF System | 3
Impact of Wireless Pulmonary Artery Pressure Monitoring
on Heart Failure Hospitalizations and 30-Day Readmissions
in Medicare-Eligible Patients with NYHA Class III Heart
Failure: Results from the CHAMPION Trial
CardioMEMS Heart Sensor Allows Monitoring of Pressures
to Improve Outcomes in NYHA Class III Heart Failure
Patients (CHAMPION) Trial: Impact of Hemodynamic
Guided Care on Patients with Preserved Ejection Fraction
Adamson et al., Circulation 2014.2
Adamson PB, et al. Journal of Cardiac Failure, 2010.12
ƒƒ This data analysis from the CHAMPION clinical trial compared
30-day readmissions and HF hospitalizations between Class
III HF patients 65 years or older monitored with PA pressure to
those managed with standard of care (SOC) over an average of
18 months.
ƒƒ This sub-analysis of the CHAMPION clinical trial evaluated the
effect of PA pressure-guided therapy with the CardioMEMS™
HF System in NYHA Class III patients with preserved ejection
fraction (HFpEF).
ƒƒ 245 patient were included in the analysis; 120 in the PA
pressure treatment group and 125 in the SOC control group.
ƒƒ In this analysis, patients managed with PA pressure compared
to those managed according to SOC experienced:
ƒƒ 58% reduction in all-cause 30-day readmissions (0.07 vs.
0.18, HR 0.42, p = 0.0062)*
ƒƒ 78% reduction in HF 30-day readmissions (0.02 vs. 0.10,
HR 0.22, p = 0.0027)*
ƒƒ 49% reduction in HF hospitalizations (0.34 vs. 0.67, HR 0.51,
p < 0.0001)*
ƒƒ Of the HFpEF patients (n = 115), 59 were randomized to the
treatment group (PA pressure-guided therapy) and 56 to the
control group (standard of care).
Key takeaway:
ƒƒ PA pressure-guided therapy significantly reduced HF
hospitalizations for HFpEF patients in the treatment group by
50% and 60% compared to those patients in the control group
at 6 and 15 months, respectively (p < 0.0001 and p < 0.0004,
respectively).
Effect of CRT on Heart Failure Related Hospitalizations
in Patients with Reduced EF Utilizing Remote Pulmonary
Artery Pressures in the CHAMPION Trial
*event rates are based on events/patient year
Weiner S, et al. Heart Rhythm, 2011.13
Key takeaways:
ƒƒ This sub-analysis of the CHAMPION clinical trial evaluated the
effect of PA pressure-guided therapy with the CardioMEMS HF
System in patients with reduced ejection fraction (rEF < 40%,
n = 430) with and without a cardiac resynchronization therapy
(CRT) device.
ƒƒ This retrospective analysis of the CHAMPION clinical trial
demonstrated that PA pressure-guided management of
Medicare-eligible HF patients significantly reduced 30-day
readmissions, which may help to alleviate the economic burden
associated with HF readmissions.
ƒƒ This analysis supports results from the CHAMPION clinical trial
results demonstrating a 37% reduction in HF hospitalizations
and improved quality of life with PA pressure-guided HF
management in NYHA Class III HF patients irrespective of
Medicare eligibility.1
ƒƒ 40% (171 of 430) of rEF patients had CRT devices; of this
cohort, 82 patients were in the treatment and 89 in the
control group.
ƒƒ 60% (259 of 430) of rEF patients did not have CRT devices;
of this cohort, 126 patients were in the treatment group and
42 in the control group.
Key takeaways:
ƒƒ Remote PA pressure data in the treatment group resulted in
similar reductions in HF hospitalization in patients with and
without a CRT device, suggesting that HF management guided
by PA pressures may provide additive benefits to CRT therapy.
ƒƒ For patients in the rEF-CRT group, those who received
PA pressure-guided therapy had significantly fewer HF
hospitalizations (RRR = 24%, p = 0.0264).
ƒƒ For patients in the rEF-no CRT group, PA pressure-guided
therapy resulted in an RRR = 23%.
4 | CardioMEMS™ HF System
Targeting Pulmonary Artery Pressures in the Treatment of
Chronic Heart Failure: Insights from the CHAMPION Trial
Adamson P, et al. European Heart Journal, 2012.14
ƒƒ This CHAMPION clinical trial sub-analysis determined if remote
access to PA pressure data may provide a method to identify
and treat high filling pressures in HF patients at increased risk
for decompensation (n = 550).
ƒƒ At implant, the mean PA pressure was similar in both control
and treatment groups (31.8 ± 10.7 and 31.3 ± 11.1 mmHg,
respectively).
ƒƒ Average PA pressures increased during the 6 weeks prior to
HF hospitalizations in both groups (p < 0.0001) and decreased
significantly after successful in-hospital decongestion
(p < 0.0001).
ƒƒ Treatment patients with HF hospitalizations had lower pressures
compared to control patients with HF hospitalizations at all
timepoints prior to hospitalization.
ƒƒ Treatment patients also had lower PA pressures compared
to the control patients regardless of hospitalization type (HFrelated or non-HF related).
The Malignant Effect of Acute Decompensation in
Patients with Chronic Heart Failure: Insights from the
CHAMPION Trial
Abraham WT, et al. European Heart Journal, 2012.16
ƒƒ This CHAMPION clinical trial sub-study reports on the impact of
obtaining remote PA pressure data and the effect on patient.
ƒƒ This CHAMPION clinical trial sub-study reports on the impact
of obtaining remote PA pressure data and the effect on patient
mortality and quality of life (n = 550).
ƒƒ Patients in both treatment (n = 270) and control (n = 280)
groups who did not experience a HF hospitalization had a
66% reduction in mortality (HR 0.34, 95% CI 0.22-0.54,
p < 0.0001).
ƒƒ The treatment group had a significant 27% reduction in the
risk of HF hospitalization or death (HR 0.73, 95% CI 0.57-0.94,
p = 0.015).
ƒƒ Among patients who did not experience a HF hospitalization,
those in the treatment group had an improved quality of life
compared to those in the control group (Minnesota Living with
Heart Failure Questionnaire, 43.2 vs. 48.9, p = 0.0377).
Key takeaways:
Key takeaway:
ƒƒ Higher PA pressures and increases in PA pressure were both
associated with increased risk for HF hospitalizations.
ƒƒ The PA pressure monitoring system may reduce the risk of HF
hospitalization and mortality while improving a patient’s quality
of life.
ƒƒ HF treatment strategies that target both high PA pressure
and increases in PA pressures may be effective strategies for
lowering the risk of decompensation in chronic HF patients.
Benefits of Pulmonary Artery Pressure Monitoring Extend
to Reduction of All-Cause Rehospitalizations
Adamson P, et al. J Am Coll Cardio 2014.15
ƒƒ In this CHAMPION clinical trial sub-analysis, the impact of other
causes of rehospitalizations was evaluated.
ƒƒ Total all-cause rehospitalizations were significantly reduced with
the CardioMEMS HF System for patients in the treatment group
compared to patients in the control group (554 vs. 672,
p < 0.0032).
ƒƒ 38% of the rehospitalizations were for a primary HF diagnosis.
ƒƒ The number needed to treat (NNT) to prevent 1 event per
year was 4.
ƒƒ Death or all-cause rehospitalizations were significantly reduced
for patients in the treatment group compared to patients in the
control group (604 vs. 736, p = 0.0017).
Key takeaway:
ƒƒ PA pressure-guided HF management not only reduces HF
rehospitalizations, but also reduces all-cause rehospitalizations.
CardioMEMS™ HF System | 5
PA PRESSURE-GUIDED THERAPY REDUCES HEART FAILURE HOSPITALIZATIONS
AND IMPROVES SURVIVAL IN HF REDUCED EF PATIENTS ON GUIDELINE-DIRECTED
MEDICAL THERAPY
The CHAMPION clinical trial demonstrated a significant reduction in HF hospitalizations and a trend toward better survival when patients
were managed in the treatment group with the CardioMEMS™ HF System.1 In retrospective data analysis specific patient populations,
however, significant reductions in both HF hospitalizations and mortality were observed.17,18
Pulmonary Artery Pressure Management in Heart Failure
Patients with Reduced Ejection Fraction Significantly
Reduces Heart Failure Hospitalizations and Mortality Above
and Beyond Background Guideline-Directed Medical Therapy
Abraham W, et al. ACC 2015 Abstract 902-04.17
ƒƒ This retrospective data analysis from the CHAMPION clinical
trial evaluated whether HFrEF patients on guideline-directed
medical therapy (ACE inhibitor or ARB and beta blocker) could
benefit from PA pressure management.
ƒƒ The analysis showed that patients on guideline-directed
medical therapy (GDMT) managed with PA pressures had a
43% reduction in HF hospitalizations and 57% reduction in
mortality over the patients in the control group managed with
standard of care (see Figure 3).
Key takeaway
ƒƒ The data demonstrates that neurohormonal control combined
with hemodynamic optimization through PA pressure
management led to substantial incremental clinical benefit.
ƒƒ 456 study patients were analyzed and of those 337 met the
criteria of GDMT from the treatment and control groups, n = 163
and n = 174, respectively, with an average follow-up of 17 months.
Figure 3. CHAMPION clinical trial sub-analysis: Reduced HF hospitalizations and
improved survival in HFrEF patients on GDMT managed with PA pressure
HFrEF Patients on ACE/ARB and Beta Blocker Prior to Implant
0.7
0.69
[HR 0.57, 95% CI 0.45-0.74, p = 0.0001]
0.6
0.5
0.39
0.4
100
90
43% Reduction
0.3
0.2
80
Survival Probability (%)
Annualized HF Hospitalization Rate
0.8
HFrEF Patients on ACE/ARB and Beta Blocker Prior to Implant
70
60
57% Reduction
50
40
30
[HR 0.43, 95% CI 0.24-0.76, p = 0.0026]
20
Guideline-Directed Standard of
Care (Control Group)
10
0
PA Pressure-Guided HF
Management (Treatment Group)
0
90
0.1
180 270 360 450 540 630 720 810 900 990
Days after PA Pressure Sensor Implant
# at Risk
174
Control
Treatment 163
Guideline-Directed Standard of Care
(Control Group)
PA Pressure-Guided HF Management
(Treatment Group)
Abraham W, et al. ACC 2015
6 | CardioMEMS™ HF System
165
159
158
152
Abraham W, et al. ACC 2015
151
149
131
126
105
106
79
86
60
73
39
48
16
26
7
5
3
1
Pulmonary Artery Pressure Management in Heart Failure
Patients with Cardiac Resynchronization Therapy or
Implantable Cardioverter Defibrillator Devices Significantly
Reduces Heart Failure Hospitalizations and Mortality
Above and Beyond Background Guideline-Directed
Medical Therapy
ƒƒ In patients on GDMT with a CRT device managed with PA
pressures there was a 64% reduction in mortality vs. patients
in the control group on GDMT with a CRT managed with SOC
(see Figure 5).
Abraham W, et al., HRS 2015 Abstract AB37-03.18
ƒƒ This analysis builds on the data presented by Abraham, et al.
at ACC 2015, which showed that patients on GDMT benefited
from PA pressure monitoring.17 With this new analysis, the data
shows that even on top of optimal medical therapy and CRT or
ICD devices, PA pressure management still results in additional
benefit to decrease HF hospitalizations and reduce mortality.
ƒƒ This retrospective data analysis from the CHAMPION clinical
trial evaluated whether patients with a CRT or ICD on guidelinedirected medical therapy (ACE inhibitor or ARB and beta
blocker) could benefit from PA pressure management.
ƒƒ 275 study patients were analyzed from the treatment and
control groups, n = 129 and n = 146, respectively, with an
average follow-up of 18 months.
ƒƒ The analysis showed that patients with a CRT or ICD on
guideline-directed medical therapy (GDMT) managed with
PA pressures had:
Key takeaways
ƒƒ These improvements are likely attributable primarily to PA
pressure-guided changes in diuretic and vasodilator therapies but
possibly also to PA pressure-guided changes in neurohormonal
antagonist therapies.
ƒƒ 43% reduction in HF hospitalizations (HR 0.57, 95%
CI 0.44-0.74, p < 0.0001)
ƒƒ 30% reduction in all-cause hospitalization HR 0.70, 95%
CI 0.60-0.82, p < 0.0001)
ƒƒ 53% reduction in mortality (HR 0.47, 95% CI 0.26-0.87,
p = 0.014) over the patients in the control group managed
with standard of care (see Figures 4 and 5).
Figure 4. CHAMPION clinical trial sub-analysis: Improved survival in patients
with a CRT-D or ICD on GDMT managed with PA pressure
Patients with CRT-D or ICD devices on ACEi/ARB and Beta Blocker Therapy
2.0
1.8
43% Reduction
[HR 0.57, 95% CI 0.44-0.74, p = 0.0001]
1.81
30% Reduction
[HR 0.70, 95% CI 0.60-0.82, p = 0.0001]
Annualized Hospitalization Rate
1.6
1.4
1.27
1.2
1.0
0.8
0.6
0.77
0.44
Guideline-Directed Standard of Care
(Control Group)
0.4
0.2
PA Pressure-Guided HF Management
(Treatment Group)
0.0
HF Hospitalization Rates
All-cause Hospitalization Rates
Abraham W, et al., HRS 2015 Abstract AB37-03
CardioMEMS™ HF System | 7
Figure 5. CHAMPION clinical trial sub-analysis: Improved survival in patients
with a CRT-D or ICD on GDMT managed with PA pressure
PA Pressure-Guided HF Management Reduces
All-Cause Mortality in CRT-D Population Therapy
100
90
80
100
90
80
70
70
60
Survival Probability (%)
Survival Probability (%)
Patients with CRT-D or ICD devices on
ACEi/ARB and Beta Blocker Therapy
53% Reduction
50
[HR 0.47, 95% CI 0.26-0.87, p = 0.014]
40
30
20
Guideline-Directed Standard of Care
(Control Group)
10
PA Pressure-Guided HF Management
(Treatment Group)
0
0
180
360
540
720
900
1080
60
64% Reduction
50
[HR 0.36, 95% CI 0.14-0.89, p = 0.028]
40
30
20
Guideline-Directed Standard of Care
(Control Group)
10
PA Pressure-Guided HF Management
(Treatment Group)
0
0
180
132
120
110
98
Abraham W, et al., HRS 2015 Abstract AB37-03
8 | CardioMEMS™ HF System
65
68
32
38
540
720
900
1080
2
3
0
0
Days after PA Pressure Sensor Implant
Days after PA Pressure Sensor Implant
# at Risk
146
Control
Treatment 129
360
7
6
0
0
# at Risk
79
Control
Treatment 63
71
56
58
49
33
31
15
16
PA PRESSURE-GUIDED MANAGEMENT HAS BEEN SHOWN TO BE COST EFFECTIVE
In today’s value-based healthcare purchasing environment, a new therapy should demonstrate overall value in its potential to reduce
utilization costs and improve patient outcomes.19 Data from the CHAMPION clinical trial was used as input into a cost-effectiveness model
that returned a value below the accepted threshold established for cost effectiveness.
Cost Effectiveness Assessment of Pulmonary Artery
Pressure Monitoring for Heart Failure Management
Adamson P, et al., HRS 2015 Abstract AB36-01.20
ƒƒ This economic analysis to determine the cost-effectiveness of PA
pressure monitoring was based on CHAMPION clinical trial data.
ƒƒ A Markov cohort simulation model was used to approximate
the course of management observed in the CHAMPION clinical
trial for the Treatment (PA pressure management) and Control
(SOC) groups.
ƒƒ CHAMPION clinical trial data was used to estimate the event
rates, mortality and quality-of-life.
Key takeaways:
ƒƒ This economic analysis showed an ICER of $30,167 per quality
adjusted life year (QALY) based on all-cause comprehensive
management of HF patients modeled over a 5-year time
horizon.
ƒƒ The ICER of $30,167 is below the US accepted ICER threshold
of $50,000 per QALY and well under the World Health
Organization threshold of approximately $160,000 for the
US (based on GDP).21,22
ƒƒ Cost effectiveness is attributive to a reduction in HF
hospitalization rates.
ƒƒ The base case follow-up period was 5 years and costs related to
all-cause comprehensive management were used.
ƒƒ In this economic analysis PA pressure-guided management of
CardioMEMS HF System indicated patients showed:
ƒƒ Incremental cost-effectiveness ratio (ICER) of $30,167
comparing comprehensive management over a 5-year time
horizon hospitalizations.
CardioMEMS™ HF System | 9
PA PRESSURE-GUIDED THERAPY HAS BEEN SHOWN TO CONSISTENTLY REDUCE HF
HOSPITALIZATIONS IN PATIENTS WITH COMMON HEART FAILURE COMORBIDITIES
HF is often associated with a variety of comorbidities such as respiratory disease, coronary artery disease and atrial fibrillation. These
comorbidities contribute to disease progression and may alter the response to treatment.23 This section highlights additional sub-analyses
from the CHAMPION clinical trial that consistently show that PA pressure-guided therapy reduces HF hospitalizations in patients with
common HF comorbidities. Table 1 summarizes the rate of HF hospitalizations across the different studies.
Comorbidity
HF hospitalization rate reduction
at 15 months in treatment group
N size (control)
N size (treatment)
History of myocardial infarction 24
137
134
46% (p < 0.001 vs. control)
COPD25,26
96
91
41% (p = 0.0009 vs. control)
Pulmonary hypertension
163
151
36% (p = 0.0002 vs. control)
AF
135
120
41% (p < 0.0001 vs. control)
150
147
42% (p = 0.00001 vs. control)
27
28
Chronic kidney disease
29
Table 1. Patients with common HF comorbidities have consistent reduction in HF hospitalizations with PA pressure-guided therapy
Benefits of Pulmonary Artery Pressure Monitoring in
Patients with NYHA Class III Heart Failure and Chronic
Kidney Disease: Results from the CHAMPION Trial
Abraham W, et al. J Card F, 2014.29
ƒƒ This subgroup data analysis from the CHAMPION clinical trial
compared heart failure hospitalizations between Class III HF
patients with chronic kidney disease (CKD) monitored (mean
follow-up of 18 months) with pulmonary artery (PA) pressure
(n = 150) to those managed with standard of care SOC (n = 147).
ƒƒ When CKD patients were managed with PA pressures, heart
failure hospitalization rates were significantly reduced (42%)
compared to patients with CKD managed according to standard
of care (0.48 vs. 0.83, HR 0.58, p < 0.001).
ƒƒ Changes in CKD indicators (creatinine and GFR) were not
adversely affected in the PA pressure monitored group.
Key takeaways:
ƒƒ Chronic kidney disease in patients with HF is a frequent
comorbidity that is associated with worse clinical outcomes,
including higher HF hospitalization rates.
ƒƒ For HF patients with CKD, pulmonary artery (PA) pressure
monitoring reduced heart failure hospitalizations by 42%
compared to standard of care HF management.
ƒƒ Intensified HF medical therapy as a result of PA pressure
monitoring was safe and did not adversely affect renal function.
The Utility of Remote Wireless Pulmonary Artery
Pressure Monitoring in Patients with or without a
History of Myocardial Infarction: Experience from
the CHAMPION Trial
Strickland WL, et al. JACC 2011.24
ƒƒ This sub-analysis of the CHAMPION clinical trial determined
if PA pressure monitoring affected the clinical outcomes of
patients with and without a history of myocardial infarction (MI).
ƒƒ 271 of the 550 NYHA Class III HF patients enrolled in the
CHAMPION clinical trial had a history of MI and were randomized
to either the control (n = 137) or treatment (n = 134) groups.
ƒƒ At 6 months, there was a 2.2-day benefit of days alive outside
the hospital for patients in the treatment group; at 15 months,
this increased to 30.1 days.
Key takeaway:
ƒƒ At 6 months and for the full study duration (mean 15 months),
remote PA pressure monitoring had a significant reduction in
HF hospitalizations for patients with and without a history of MI
in the treatment group versus control (see Table 2).
RRR at 6 months for
treatment group
RRR at 15 months for
treatment group
History
of MI
30% (p < 0.0039 vs. control)
46% (p < 0.0001 vs. control)
No MI
25% (p = 0.016 vs. control)
23% (p = 0.021 vs. control)
Table 2. Relative Risk Reduction of HF Hospitalizations
10 | CardioMEMS™ HF System
Impact of Wireless Implanted Pulmonary Artery Pressure
Monitoring System in Heart Failure Patients with
Comorbid Chronic Obstructive Pulmonary Disease
Criner G, et al. European Respiratory Journal, 2012.25
Heart Failure Hospitalizations are Reduced in Heart
Failure Patients with Comorbid Pulmonary Hypertension
Using a Wireless Implanted Pulmonary Artery Pressure
Monitoring System
Benza R, et al. Journal of Cardiac Failure, 2012.27
ƒƒ The purpose of this CHAMPION clinical trial sub-analysis
was to evaluate if PA pressure-guided therapy reduced HF
hospitalizations in a cohort of patients with comorbid chronic
obstructive pulmonary disease (COPD, n = 187).
ƒƒ This CHAMPION clinical trial sub-analysis evaluated the effect of
PA pressure monitoring in HF patients with comorbid pulmonary
hypertension (PHTN, mean PA pressure > 25 mmHg).
ƒƒ Reductions in PA pressure were analyzed using an area
under the curve (AUC) methodology.
ƒƒ A total of 314 out of the 550 patients from the CHAMPION
clinical trial also exhibited PHTN.
ƒƒ There was an overall reduction in PA pressures: patients in the
treatment group (n = 91) had an average AUC reduction of 202
mmHg days compared to the increase of 107 mmHg days in
the control group (n = 96, p = 0.03).
Key takeaway:
ƒƒ At 15 months, there was a 41% reduction in HF hospitalization
rates in the treatment group vs. control (0.55 vs. 0.96, HR 0.59,
95% CI 0.44-0.81, p = 0.0009).
Respiratory Event Hospitalizations are Reduced in Heart
Failure Patients with Comorbid Chronic Obstructive
Pulmonary Disease Using a Wireless Implanted Pulmonary
Artery Pressure Monitoring System
ƒƒ Patients in the PHTN cohort were further stratified by
transpulmonary gradient (TPG) and pulmonary vascular
resistance (PVR).
ƒƒ 67% (213/314) of PHTN patents had a TPG ≤ 15.
Key takeaways:
ƒƒ At 15 months, patients in the treatment group had a 51%
reduction in HF hospitalization vs. control (0.60 vs. 0.94,
HR = 0.64, 95% CI 0.51-0.81, p = 0.0002).
ƒƒ PHTN patients in the treatment group with TPG > 15 had 30%
reduction in HF hospitalization vs. control (p = 0.08).
Martinez F, et al. European Respiratory Journal, 2012.26
ƒƒ This study determined if PA pressure monitoring impacts
the number of respiratory event hospitalizations (REH) in HF
patients with a medical history of COPD (n = 187).
Key takeaway:
ƒƒ At 15 months, patients in the treatment group (n = 91) had a
62% reduction in REH (0.12 vs. 0.31, HR 0.38, 95% CI 0.210.71, p = 0.0023).
CardioMEMS™ HF System | 11
Limitations of Right Heart Catheterization in the Diagnosis
and Risk Stratification of Patients with Pulmonary
Hypertension: Insights from the CHAMPION Trial
Raina A, et al. ISHLT 2014. Abstract.30
ƒƒ This CHAMPION sub-study compared the use of the
CardioMEMS HF System with right heart catheterization
(RHC) to diagnose and stratify risk in patients with pulmonary
hypertension (PH).
ƒƒ RHC identified 320 patients with PH (defined as mean PA
pressure > 25 mmHg) and among these patients mean PA
pressure obtained from RHC was similar to the CardioMEMS
HF System’s first week PA pressure.
ƒƒ RHC also identified 217 patients without PH (defined as mean
PA pressure readings ≤ 25 mmHg) and 51% of them met this
definition according to data obtained from the CardioMEMS
HF System (18.5 for the RHC vs. 18.4 for the CardioMEMS HF
System, p = 0.9208).
ƒƒ The other 49% of patients identified by RHC as not having PH
had first week mean PA pressure readings > 25 mmHg with the
CardioMEMS HF System, indicating PH.
ƒƒ Among the 217 patients using the CardioMEMS HF System
diagnosed by RHC as non-PH, the 49% with first week mean
PA pressure reading > 25 mph had significantly higher HFH
rates than the 51% of patients with readings ≤ 25 mmHg (0/49
vs. 0.25/yr., p = < 0.0001).
Key takeaways:
ƒƒ This analysis suggests that using RHC alone may result in PH
underdiagnoses in patients with HF.
ƒƒ In this study, the more frequent PA pressure monitoring with
the CardioMEMS HF System provided better diagnostic and risk
stratification compared with single RHC.
Impact of Remote, Wireless Pulmonary Artery
Hemodynamic Monitoring in Patients with Atrial
Fibrillation and Chronic Heart Failure: Insights from
the CHAMPION Trial
Miller AB, et al. JACC, 2012.28
ƒƒ This CHAMPION clinical trial sub-analysis compared the
baseline characteristics and impact of PA pressure-guided
therapy on hospitalization rate in patients with a history of atrial
fibrillation (AF, n = 255) compared to those with normal sinus
rhythm (n = 200).
ƒƒ The AF cohort had significant baseline differences compared
to the sinus rhythm cohort (older: 65 vs. 59, more often male:
80% vs. 66%, more frequently had CRT or CRT-D devices:
44% vs. 27%, higher mean PA pressures: 30.2 vs.
28.5 mmHg, etc.).
Key takeaways:
ƒƒ AF patients in the treatment group had a significantly lower HF
hospitalization rate than those in the control group at 6 months
(37%, p = 0.0004) and 15 months (41%, p < 0.0001).
ƒƒ AF patients had a 57% higher HF hospitalization rate vs.
non-AF patients (0.47 vs. 0.30 events/patient, p < 0.0001).
A Wireless Hemodynamic Pressure Sensor Before and
After Ventricular Assist Device Placement: A Sub-Study of
the CHAMPION Trial
Feldman D, et al. Journal of Heart and Lung Transplantation,
2011.31
ƒƒ This sub-analysis of the CHAMPION clinical trial evaluated the
effect of PA pressure-guided therapy on optimizing medications,
pump parameters and timing of ventricular assist device (VAD)
intervention and transplantation in patients receiving a left
ventricular assist device (LVAD) (n = 27).
Key takeaway:
ƒƒ LVAD patients who received PA pressure-guided therapy (15/27
patients) had significantly shorter times to VAD intervention
(p = 0.001), more changes to medical therapy based on
hemodynamic information (p = 0.025), and shorter times
between VAD intervention and heart transplantation (p = 0.001).
12 | CardioMEMS™ HF System
PA PRESSURE MONITORING ENABLES PROACTIVE AND PERSONALIZED GUIDANCE
OF MEDICATION MANAGEMENT IN HF PATIENTS
Medication management is a challenging aspect in the overall treatment strategy for chronic HF patients. The range of effective medication
doses for each patient varies widely and may change frequently over the course of treatment. The following sub-analyses show that PA
pressure monitoring may provide early and reliable assessment of volume status and feedback on treatment response, enabling clinicians
to tailor optimal medication strategies for patients suffering from chronic HF.
Medical Management Guided by Pulmonary Artery
Pressures in NYHA Functional Class III Heart
Failure Patients
Costanzo MR, et al. Journal of Cardiac Failure, 2011.32
ƒƒ This CHAMPION clinical trial sub-analysis closely compared
the medical management strategy of the treatment and
control groups.
ƒƒ By 6 months, dosage increases of ACE/ARB, beta blockers and
nitrates were greater in the treatment group than in the control
group (0.11 vs. 0.00 change in fraction of maximal dose for ACE/
ARB, p = 0.0042; 0.07 vs. 0.01 change in fraction of maximal
dose for beta blockers, p = 0.0481; 17.5 mg vs. 3.7 mg dosage
change for nitrates, p = 0.0422).
ƒƒ Although diuretics were the most frequently adjusted drugs, at
6 months the total diuretic dose was similar between groups
(p = 0.1214).
Key takeaways:
ƒƒ The PA pressure-guided management required < 1 incremental
medication changes per patient per month (1.55 vs. 0.65
changes/patient/month, p < 0.0001).
ƒƒ The decreased HF hospitalization rate in the treatment group
may be due to proactive titration of medical therapy guided
by PA pressure measurements provided by the CardioMEMS
HF System.
Diuretic Use Guided by a Wireless Implanted Pulmonary
Artery Pressure Monitoring System in NYHA Class
III Heart Failure Patients: Observations from the
CHAMPION Trial
Costanzo MR, et al. Circulation, 2012.33
ƒƒ This CHAMPION clinical trial sub-analysis study determined
if adjustments to diuretic therapy in response to wireless
PA pressure monitoring were associated with reduced HF
hospitalization rates (n = 550).
ƒƒ At baseline, a similar percent of HF patients in control (n = 280)
and treatment (n = 270) groups were receiving diuretics (91.9%
and 94.2%, respectively).
ƒƒ At 6 months, diuretics were more frequently adjusted in the
treatment group than the control group (1,267 vs. 498 times,
p < 0.0001).
ƒƒ 49.7% (629/1267) of the adjustments in 57.4% (155/270)
of the patients resulted from detection of increasing PA
pressures.
ƒƒ 75.4% (107/142) of the changes in 17% (46/270) of those
patients occurred after detection of declining PA pressures.
ƒƒ The 89 treatment patients with increased loop diuretic dose
had a lower rate of HF hospitalizations than the 68 control
patients with similarly increased diuretic doses (0.32 vs. 0.70,
p = 0.0014).
ƒƒ HF hospitalization rates were similar in the 134 treatment and
173 control patients without diuretic dose changes (0.28 vs.
0.27, p = NS).
Key takeaway:
ƒƒ Wireless, remote PA pressure monitoring enables physicians to
effectively increase and decrease diuretic doses in HF patients,
resulting in reduced HF hospitalization rates.
CardioMEMS™ HF System | 13
Pressure for Action: Implantable Pulmonary Artery
Pressure Sensor Measurements Alone Beat Clinical Signs
to Guide Prevention of Heart Failure Hospitalizations
Goldberg L, et al. HRS 2015 Abstract 36-02.34
Key takeaways:
ƒƒ HF hospitalization rates (events/patient year) were significantly
reduced if a patient’s diuretic management therapies were
managed by:
ƒƒ PA pressure only compared to clinical signs (67% reduction), or
ƒƒ Data analysis from the CHAMPION clinical trial during the
6-month primary endpoint period
ƒƒ 550 Patients: 270 in the Treatment group and 280 in the
Control group.
ƒƒ All interventions for patients in the PA pressure-managed group
were characterized prospectively by investigators as triggered
primarily by clinical findings OR by changes in PA pressure.
ƒƒ HF hospitalization rates were lowest in patients for whom all
diuretic interventions were triggered by PA pressure (.39 events/
patient year), despite this cohort having the highest baseline PA
pressure (see Figure 6).
ƒƒ PA pressure and clinical signs compared to clinical signs
(46% reduction).
ƒƒ Heart failure hospitalization rates were most effectively reduced
by a management strategy based on PA pressures without
reliance upon clinical changes.
ƒƒ This supports the strategy of early intervention prior to clinical
signs to avert clinical decompensation and heart failure
readmissions.1,2
ƒƒ There was a statistically significant 67% relative risk reduction
of HF hospitalizations if a patient’s diuretic interventions were
managed with PA pressure alone vs. clinical signs only (HR
0.33, 95% CI 0.16-0.59, p = 0.0007).
Figure 6. HF hospitalization Rates by Diuretic Management Strategy
1.3
HF Hospitalization Rate (events/year)
1.2
1.17
1.22
67% Reduction
1.1
Managed Patients vs. Control Group
[HR 0.33, 95% CI 0.16-0.59, p = 0.0007]
1.0
0.9
0.8
0.7
0.63*
0.6
0.5
0.39*
0.4
0.3
0.2
0.1
0.0
Control Group
PAP Managed Patients
PAP Managed Patients
PAP Managed Patients
Baseline PA Mean
= 30.0 mmHg
Baseline PA Mean
= 30.5 mmHg
Baseline PA Mean
= 29.0 mmHg
Baseline PA Mean
= 32.0 mmHg
(Clinical Triggered Rx Only)
(Clinical Triggered Rx Only)
(Clinical and PAP Triggered Rx)
*p = 0.05 vs. Control Patients (unmonitored)
14 | CardioMEMS™ HF System
(PAP Triggered Rx Only)
References
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Medicine, 32, 2266-2273.
24. Strickland, W. L., Parrott, C. W., Abraham, W. T., Adamson, P. B., Corcoran, K, Cowart, P., & Yadav,
J. (2011). The utility of remote wireless pulmonary artery pressure monitoring in patients with or
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Whellan, D. J., Ousdigian, K. T., Al-Khatib, S. M., Pu, W., Sarkar, S., Porter, C. B., . . .
PARTNERS Study Investigators. (2010). Combined heart failure device diagnostics identify
patients at higher risk of subsequent heart failure hospitalizations: results from PARTNERS HF
(Program to Access and Review Trending Information and Evaluate Correlation to Symptoms
in Patients With Heart Failure) study. Journal of the American College of Cardiology, 55, 18031810.
25. Criner, G., Bourge, R., Benza, R., Adamson, P. B., Abraham, W. T., Yadav, J., . . . Martinez, F.
(2012). Impact of wireless implanted pulmonary artery pressure monitoring system in heart failure
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40(Suppl 56), P9761.
8.
van Veldhuisen, D. J., Braunschweig, F., Conraads, V., Ford, I., Cowie, M. R., Jondeau, G., . . .
DOT-HF Investigators. (2011). Intrathoracic impedance monitoring, audible patient alerts, and
outcome in patients with heart failure. Circulation, 124, 1719-1726.
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Verdejo, H. E., Castro, P. F., Concepción, R., Ferrada, M. A., Alfaro, M. A., Alcaíno, M. E., . .
. Bourge, R. C. (2007). Comparison of a radiofrequency-based wireless pressure sensor to
Swan-Ganz catheter and echocardiography for ambulatory assessment of pulmonary artery
pressure in HF. Journal of the American College of Cardiology, 50, 2375-23782.
10. Abraham, W. T., Adamson, P. B., Hasan, A., Bourge, R. C., Pamboukian, S. V., Aaron, M. F., &
Raval, N. Y. (2011). Safety and accuracy of a wireless pulmonary artery pressure monitoring
system in patients with heart failure. American Heart Journal, 161, 558-566.
11. Abraham, W.T., Stevenson, L.W., Bourge, R.C., Lindenfeld, J. A., Bauman, J. G., Adamson, P.
B., & CHAMPION Trial Study Group. (2015). Sustained efficacy of pulmonary artery pressure
to guide adjustment of chronic heart failure therapy: complete follow-up results from the
CHAMPION randomised trial. The Lancet. 2015 Nov 8 [Epub ahead of print]
12. Adamson, P. B., Abraham, W. T., Bourge, R. C., Lynne W. Stevenson, L. W., & Yadav, J. (2010).
CardioMEMS heart sensor allows monitoring of pressures to improve outcomes in NYHA class
III heart failure patients (CHAMPION) trial: Impact of hemodynamic guided care on patients
with preserved ejection fraction. Journal of Cardiac Failure, 16, 913.
23. Lang, C. C., Mancini, D. M. (2008). Management of comorbidities in heart failure. London: Springer.
26. Martinez, F., Bourge, R., Benza, R., Abraham, W. T., Adamson, P. B., Yadav, J., . . . Criner, G.
(2012). Respiratory event hospitalizations are reduced in heart failure patients with comorbid
chronic obstructive pulmonary disease using a wireless implanted pulmonary artery pressure
monitoring system. The European Respiratory Journal, 40(Suppl 56), 2832.
27. Benza, R., Bourge, R., Adamson, P., Abraham, W., & Yadav, J. (2012). Heart failure hospitalizations
are reduced in heart failure patients with comorbid pulmonary hypertension using a wireless
implanted pulmonary artery pressure monitoring system. Journal of Cardiac Failure, 18(Suppl 8),
S99.
28. Miller, A. B., Teerlink, J., Carson, P., Levy, W., Chung, E., Gilbert, E., . . . Abraham, W. (2012).
Impact of remote, wireless pulmonary artery hemodynamic monitoring in patients with atrial
fibrillation and chronic heart failure: insights from the CHAMPION clinical trial. Journal of the
American College of Cardiology, 59(13 Suppl), E868.
29. Abraham, W. T., Adamson, P. B., Stevenson, L. W., & Yadav, J. (2014). Benefits of pulmonary
artery pressure monitoring in patients with NYHA class III heart failure and chronic kidney disease:
results from the CHAMPION Trial. Journal of Cardiac Failure, 20(Suppl S93).
30. Raina, A., Bourge, R. C., Abraham, W., Adamson, P., Bauman, J., Yadav, J., & Benza, R. L. (2014,
April) Limitations of right heart catheterization in the diagnosis and risk stratification of patients with
pulmonary hypertension: insights from the CHAMPION trial. Abstract presented at International
Society for Heart and Lung Transplantation, San Diego, CA.
13. Weiner, S., Abraham, W. T., Adamson, P. B., Neville, S., & Henderson, J. (2011). Effect of CRT
on heart failure related hospitalizations in patients with reduced EF utilizing remote pulmonary
artery pressures in the CHAMPION trial. Heart Rhythm, 8 (5 Suppl), S437.
31. Feldman, D., Naka, Y., Cabuay, B., Yakayama, H., Bauman, J., Cowart, P., . . . Moazami, N. (2011).
A wireless hemodynamic pressure sensor before and after ventricular assist device placement:
A sub-study of the CHAMPION trial. The Journal of Heart and Lung Transplantation, 30(Suppl 4),
S86.
14. Adamson, P. B., Abraham, W. T., Stevenson, L., Bourge, R., Raval, N., Bauman, J. . . . Yadav, J.
(2012). Targeting pulmonary artery pressures in the treatment of chronic heart failure: insights
from the CHAMPION clinical trial. European Heart Journal, 33(Abstract Suppl), 650-651.
32. Costanzo, M. R., Abraham, W. T., Adamson, P. B., Cowart, P. A., Corcoran, K. M., & Ginn, G. L.
(2011). Medical management guided by pulmonary artery pressures in NYHA functional class III
heart failure patients. Journal of Cardiac Failure, 17(Suppl 8), S93. Abstract 299.
15. Adamson P. B., Abraham, W. T., Stevenson, L., Neville, S., Cowart, P., & Yadav, J. (2014).
Benefits of pulmonary artery pressure monitoring extend to reduction of all-cause
rehospitalizations. Journal of the American College of Cardiology, 63, A746.
33. Costanzo, M. R., Adamson, P. B., Abraham, W. T., Jeffries, B., Neville, S., Cowart, P., . . . Jadav,
J. S. (2012). Diuretic use guided by a wireless implanted pulmonary artery pressure monitoring
system in NYHA class III heart failure patients: Observations from the CHAMPION trial. Circulation,
126, A19396. Abstract 19396.
16. Abraham, W. T., Adamson, P. B., Raval, N., Stevenson, J. Bauman, J., Neville, S., . . . Yadav,
J. (2012). The malignant effect of acute decompensation in patients with chronic heart failure:
Insights from the CHAMPION trial. European Heart Journal, 33(Abstract Supplement), 962.
17. Abraham, W. T., Adamson, P. B., Stevenson, L., Costanzo, M. R., Bourge, R., Bauman, J., &
Yadav, J. (2015, March). Pulmonary artery pressure management in heart failure patients with
reduced ejection fraction significantly reduces heart failure hospitalizations and mortality above
and beyond background guideline-directed medical therapy. Abstract 902-04 presented at ACC
2015, San Diego, California.
34. Goldberg, L. R., Desai, A. S., Costanzo, M. R., Stevenson, L. W., Adamson, P. B., Heywood, J. T.,
& Abraham, W. T. (2015, May). Pressure for action: implantable pulmonary artery pressure sensor
measurements alone beat clinical signs to guide prevention of heart failure hospitalizations. Abstract
AB36-02 presented at HRS 2015, Boston.
CardioMEMS™ HF System | 15
SJMprofessional.com/CardioMEMS
Rx Only
Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
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