Telehealth, Telemedicine

1. Telemedicine in the Management
of Congestive Heart Failure
David Bello MD
Chief, Cardiology
Orlando Regional Medical Center
Founder, HeartBuds

2. Telemedicine in Chronic Disease Management
CMS Story: higher quality, less readmissions, less
cost

3. Goals of Pilot
 Higher patient satisfaction
 Higher quality
 Less Cost
 Less readmissions

4. US-2000480 A EN (08/14) | This document is approved for US use only.

5. Physiologic Monitoring
for Heart Failure Management

6. US-2000480 A EN (08/14) | This document is approved for US use only.
Contents
 Heart Failure (HF)
 Prevalence, incidence, mortality and hospitalization rates
 Economic burden of HF and Medicare reform initiatives
 Physiologic Monitoring
 Worsening HF/Physiologic markers of decompensation
 Weight, blood pressure, symptoms
 Impedance
 Clinical evaluations
 Hemodynamic Monitoring for Heart Failure Management
 Managing pressures in the heart failure patient
 CardioMEMS™ HF System
 CHAMPION clinical trial
6

7. Heart Failure
 Prevalence, Incidence, Mortality and Hospitalization Rates
 Economic Burden of HF and Medicare Reform Initiatives

8. US-2000480 A EN (08/14) | This document is approved for US use only.
Heart Failure – A Growing Global Concern
Prevalence and Incidence
 Overall 2.1% prevalence: 5.1M
heart failure patients in 20101
 825,000 people ≥ 45 years of age
are newly diagnosed each year
with HF1
 15 M heart failure patients in the
ESC 51-member countries2
 Overall 2-3% prevalence2
Mortality
 For AHA/ACC stage C/D patients
diagnosed with HF:
 30% will die in the first year. 3-5
 60% will die within 5 years.5
8
1. AHA 2014 Statistics at a Glance, 2014
2. The European Society of Cardiology, ESC HF Guideline, 2008
3. Curtis et al, Arch Intern Med, 2008.
4. Roger et al. JAMA, 2004.
5. Cowie et al, EHJ, 2002.
6. Heidenreich PA et al. Circ Heart Failure 2013.
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

9. US-2000480 A EN (08/14) | This document is approved for US use only.
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 diagnosis1
 Hospitalization rate did not change
significantly from 20001
 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 days and ~50%
within 6 months5
1. CDC NCHS National Hospital Discharge Survey, 2000-2010
2. Yancy et al. JACC, 2006.
3. Cleland et al. EuroHeart, 2003.
4. Krumholz HM, et al. Circ Cardiovas Qual Outcomes 2009.
5. Wexler DJ, et al. Am Heart J 2001.
Graph from www.health.org.uk. Bridging the gap: Heart Failure, 2010.
Data from Organization for Economic Cooperation and Development, 2009.
9
1. CDC NCHS National Hospital Discharge Survey, 2000-2010
2. Yancy et al. JACC, 2006.
3. Cleland et al. EuroHeart, 2003.
4. Krumholz HM, et al. Circ Cardiovas Qual Outcomes 2009.
5. Wexler DJ, et al. Am Heart J 2001.
1. CDC NCHS National Hospital Discharge Survey, 2000-2010
2. Yancy et al. JACC, 2006.
3. Cleland et al. EuroHeart, 2003.
4. Krumholz HM, et al. Circ Cardiovas Qual Outcomes 2009.
5. Wexler DJ, et al. Am Heart J 2001.

10. US-2000480 A EN (08/14) | This document is approved for US use only.
Worsening Heart Failure Leading to HF
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
10

11. US-2000480 A EN (08/14) | This document is approved for US use only.
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
11
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.

12. US-2000480 A EN (08/14) | This document is approved for US use only.
Economic Risks of HF Readmissions in the US
Medicare’s Hospital Readmissions Reduction program penalizes
hospitals that have above average all-cause readmissions within
30 days following HF discharge.
1. Dharmarajan K, et al. JAMA. 2013;309(4):355-363.
2. Linden A, Adler-Milstein J. Health Care Finance Rev. 2008;29(3):1-11.
3. CMS Hospitals Readmissions Reductions Program of the Patient Protection and Affordable Care Act (PPACA), 2010.
24.8%national average 30-day
readmissions rate1,2
Fiscal Year 2013 2014 2015+
% payment withholding up to 1% up to 2% up to 3%
Percent withholding of all inpatient Medicare payments will
increase to up to 3% by 2015 and beyond.3
12

13. Physiologic Monitoring
 Worsening Heart Failure/Physiologic Markers of Decompensation
 Weight, Blood Pressure, Symptoms
 Impedance
 Clinical Evaluations

14. US-2000480 A EN (08/14) | This document is approved for US use only.
Pulmonary Artery Pressure
Left Heart Failure Right Heart Failure
Left Atrial Pressure Cardiac Output Right Atrial Pressure
Dyspnea
Orthopnea
Pulmonary Edema
Peripheral Edema
Fatigue
Confusion
Renal Insufficiency
Heptic Insufficiency
Renal Insufficiency
Peripheral Edema
Increases in Pressure Start the Cycle of Worsening
Heart Failure
14
Adapted from Jaski BE, “Basics of Heart Failure A Problem Solving Approach”
 



15. US-2000480 A EN (08/14) | This document is approved for US use only.
Time Course of Decompensation
Physiologic Markers of Acute Decompensation
15
* Graph adapted from Adamson PB, et al. Curr Heart Fail Reports, 2009.

16. US-2000480 A EN (08/14) | This document is approved for US use only.
Physiologic Markers of Acute Decompensation
16
* Graph adapted from Adamson PB, et al. Curr Heart Fail Reports, 2009.

17. US-2000480 A EN (08/14) | This document is approved for US use only.
Current HF Management Is Inadequate For
Identifying and Managing Congestion Leading
to Decompensation
 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
1. Adams KF, et al. Am Heart J. 2005
2. Krum H and Abraham WT. Lancet 2009
3. Lala A, et al. JCF 2013
Identifying congestion early will lead to early treatment,
prevent hospitalizations and slow the progression of HF.
17
60%
40%
Congestion state at discharge
Absent or mild
congestion
Moderate to
severe congestion
59%24%
17%
Congestion state of patients discharged
without congestion at 60 day follow-up3
Maintained
decongestion
Partial recongestion
Relapse to severe
congestion

18. US-2000480 A EN (08/14) | This document is approved for US use only.
TELE-HF Trial: Telemonitoring of Weight and
Symptoms Do Not Reduce Readmission or Death
 Randomized study of 1653 patients
 Primary endpoint: Readmission for any reason or death from any cause
within 180 days after enrollment
 Control group = Standard-of-care (no telemonitoring)
 Treatment group = telemonitoring of symptoms and weight
 Results: No difference in number of deaths, readmissions or days in hospital
Chaudhry SI, et al. N Engl J Med, 2010.
0
10
20
30
40
50
60
Re-hospitalization Death
%ofPatients
Telemonitoring of Symptoms
and Weight group
Standard-of-care Group
p = 0.39
p = 0.86
18

19. US-2000480 A EN (08/14) | This document is approved for US use only.
TIM-HF Trial: Telemonitoring of Weight and Blood
Pressure Do Not Reduce Readmission or Mortality
 Randomized study of 710 patients
 Primary Endpoint: Total Mortality
 Control Group: Standard-of-care (no telemonitoring)
 Treatment Group: Telemonitoring of weight and BP information
 Results: No difference in all-cause death or HF hospitalizations
Koehler F et al, Circulation 2011.
End Point
Telemonitoring
n = 354 (%)
Usual care
n = 356 (%)
HR
(95% CI)
p
All-cause
mortality
15.3 15.4 0.97 (0.67-1.41) 0.87
Cardiovascular-
related mortality
11.3 12.9 0.86 (0.56-1.31) 0.49
All-cause
readmission
54.2 50.3 1.12 (0.91-1.37) 0.29
19

20. US-2000480 A EN (08/14) | This document is approved for US use only.
1. Abraham WT, et al. Congest Heart Fail, 2011.
2. Conraads VM, et al. EHJ, 2011.
3. Yu CM, et al. Circulation, 2005.
4. St. Jude Medical. Bradycardia and Tachycardia Devices Merlin® Patient Care System Help Manual, 2012.
Sensitivity of Impedance
 Intra-thoracic impedance has been shown to be more sensitive than
weight changes.1
 Impedance still has a high false-positive rate1-3 when used to predict
acute events.
Note:
 Results from FAST1 and MID-HeFT3 are not included in the table above as these studies
used a broader definition of True Positive and therefore cannot be compared to the results
from SENSE-HF.
 Definition for True Positive was comparable but not the same in the calculations for Sensitivity,
FP/pt/yr, and PPV% between SENSE-HF and DEFEAT-PE, therefore these numbers should not
be directly compared.
20
Study FP/pt/yr PPV % Sensitivity %
SENSE-HF2 1 4.7 20.7-42.1
DEFEAT-PE4 0.96 16.07 26.6%

21. US-2000480 A EN (08/14) | This document is approved for US use only.
1. Whellan DJ, et al. JACC, 2010.
2. Cowie MR, et al. EHJ 2013.
Impedance Monitoring Combined with Multiple
Device-Derived Diagnostics May Be Used in
Risk Stratification
Study Description Implication
PARTNERS-HF1
Impedance monitoring combined
with device diagnostics
High (> 100) fluid index threshold identified
patients at a 3.9-fold risk of HF hospitalization
with pulmonary congestion (p < 0.0001)
HF Risk Score2
Development and validation of combining
multiple device-derived diagnostic parameters
into a single-dynamic HF risk score
HF risk score may be used to triage patients at
a higher risk for HF events in the next 30 days
21

22. US-2000480 A EN (08/14) | This document is approved for US use only.
Clinical Examination has Limited Reliability in
Assessing Filling Pressures
Data from clinical evaluations has poor sensitivity and predictive value
in determining hemodynamic profile.
22
* Table adapted from Capomolla S, et al. Eur J Heart Failure, 2005.
Capomolla, 2005. N = 366
Variable
Estimate
of
Sensitivity
(%)
Specificity
(%)
PPV
(%)
NPV
(%)
JVP
Edema
RAP 48
10
78
94
60
55
69
60
Pulse Press Cardiac Index 27 69 52 44
S3
Dyspnea
Rales
PCWP 36
50
13
81
73
90
69
67
60
54
57
48

23. Hemodynamic Monitoring for
Heart Failure Management
 Managing Pressures in the Heart Failure Patient
 CardioMEMS™ HF System
 CHAMPION Clinical Trial

24. US-2000480 A EN (08/14) | This document is approved for US use only.
Managing Pressures in the Heart Failure Patient
Pressures Patient
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
 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.
Managing to targeted
pressure ranges
 Can reduce overall pressures and ultimately
lead to a reduction in HF events.
24
Adamson PB, et al. Curr Heart Fail Reports, 2009

25. US-2000480 A EN (08/14) | This document is approved for US use only.
COMPASS Trial Sub-Analysis
Higher Chronic PA Pressures Increase the Risk of HF Events
Stevenson L et al. Circ Heart Fail 2010;3:580-587
25

26. US-2000480 A EN (08/14) | This document is approved for US use only.
Pulmonary Artery
Pressure Sensor
Patient
Electronics
System
CardioMEMS™
HF Website
CardioMEMS™ HF System
26

27. US-2000480 A EN (08/14) | This document is approved for US use only.
CardioMEMS™ HF System
The pulmonary artery pressure
sensor is implanted via a right
heart catheterization procedure
via femoral vein approach.
27
Target location for pulmonary
artery pressure sensor

28. US-2000480 A EN (08/14) | This document is approved for US use only.
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.
Abraham WT, et al. Lancet, 2011.
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
26 (9.6%) Exited
< 6 Months
15 (5.6%) Death
11 (4.0%) Other
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
28

29. US-2000480 A EN (08/14) | This document is approved for US use only.
CHAMPION Clinical Trial: Managing to
Target PA Pressures
Abraham WT, et al. Lancet, 2011.
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
26 (9.6%) Exited
< 6 Months
15 (5.6%) Death
11 (4.0%) Other
Primary Endpoint: rate of HF Hospitalization
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
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
29

30. US-2000480 A EN (08/14) | This document is approved for US use only.
Abraham WT, et al. Lancet, 2011.
CHAMPION Clinical Trial: PA Pressure-guided
Therapy Reduces HF Hospitalizations
30
Patients managed with PA pressure data had significantly fewer
HF hospitalizations as compared to the control group.

31. US-2000480 A EN (08/14) | This document is approved for US use only.
CHAMPION Trial: Both Primary Safety Endpoints
and All Secondary Endpoints Were Met at 6 months
Treatment
(n = 270)
Control
(n = 280)
P-value
Primary
Safety
Endpoints
Device related or system-related
complications
3 (1%) 3 (1%)
Total 8 (1%)* < 0.0001
Pressure-sensor failures 0 0 < 0.0001
Secondary
Endpoints
Change from baseline in PA mean
pressure (mean AUC [mm Hg x days])
-156 33 0.008
Number and proportion of patients
hospitalized for HF (%)
55 (20%) 80 (29%) 0.03
Days alive and out of hospital for
HF (mean ± SD)
174.4 ± 31.1 172.1 ± 37.8 0.02
Quality of life (Minnesota Living
with Heart Failure Questionnaire,
mean ± SD)
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.
31

32. US-2000480 A EN (08/14) | This document is approved for US use only.
CHAMPION Clinical Trial: The Number Needed
to Treat (NNT) to Prevent One HF-related
Hospitalization is Lower vs. Other Therapies
Intervention Trial
Mean Duration
of Randomized
Follow-Up
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
32

33. US-2000480 A EN (08/14) | This document is approved for US use only.
CHAMPION Clinical Trial: PA Pressure-Guided
Therapy Improves Outcomes in CRT Patients1 and
in Patients with Preserved Systolic Function2
33
1. Weiner et al. Heart Rhythm, 2011 Additional data on file..
2. Adamson et al. JCF Nov 2010.
0%
10%
20%
30%
40%
50%
60%
with CRT without CRT HFpEF
RelativeRiskReduction
HF Hospitalization Reduction
(6 mos follow-up)
P = 0.0080 vs. controlP = 0.0071 vs. control
preserved EF (≥ 40%)
P < 0.0001 vs. control

34. US-2000480 A EN (08/14) | This document is approved for US use only.
Pulmonary Artery Pressure
Medication Changes based on Pulmonary
Artery Pressure (p < 0.0001)
Pulmonary Artery Pressure Reduction
(p = 0.008)
Reduction in Heart Failure Hospitalizations
(p < 0.0001)
Quality of Life Improvement
(p = 0.024)
Managing pressures to
target goal ranges:
 PA Pressure systolic 15–35 mmHg
 PA Pressure diastolic 8–20 mmHg
 PA Pressure mean 10–25 mmHg
Summary: CHAMPION Clinical Trial
34
Abraham WT, et al. Lancet, 2011.

35. US-2000480 A EN (08/14) | This document is approved for US use only.
Summary: Managing Pressures to Maintain Health
and Manage Acute Events
Enables proactive
and personalized
HF management 1-3
May be used in
risk stratification,
but not actionable4-7
Unreliable, late, and
indirect markers8,9
* Graph adapted from Adamson PB, et al.
Curr Heart Fail Reports, 2009.
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
35

36. US-2000480 A EN (08/14) | This document is approved for US use only.
Heart Failure
36
 Telemonitoring with hemodynamic monitoring has
shown no benefits in the absence of interventional
guidelines
 Telemonitoring without hemodynamics have shown
limited benefits in management of heart failure
patients

37. US-2000480 A EN (08/14) | This document is approved for US use only.
Telemonitoring with Hemodynamic Guidance
37

38. US-2000480 A EN (08/14) | This document is approved for US use only.
Virtual Clinic
38

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Hospital-Cardiac Rehab
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Telemedicine: Partnership
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Home Monitoring Pharmacy Partnership
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EMS Partners- Home Health- Partners-Urgent Care
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Telemedicine Kit
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Believe in Physical Exam
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The Vision
45
=

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Concepts
46

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Industrial & Mechanical Design
Leverage Standard Manufacturing Processes
47

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50. US-2000480 A EN (08/14) | This document is approved for US use only.