bello presentation[2]

Telemedicine in the Management

of Congestive Heart Failure

David Bello MD

Chief, Cardiology

Orlando Regional Medical Center

Founder, HeartBuds

Telemedicine in Chronic Disease Management

CMS Story: higher quality, less readmissions, less

cost

Goals of Pilot

Higher patient satisfaction

Higher quality

Less Cost

Less readmissions

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

Physiologic Monitoring

for Heart Failure Management


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

Heart Failure Prevalence, Incidence, Mortality and Hospitalization Rates

Economic Burden of HF and Medicare Reform Initiatives


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


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











http://www.health.org.uk/


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


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.


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

Physiologic Monitoring Worsening Heart Failure/Physiologic Markers of Decompensation

Weight, Blood Pressure, Symptoms

Impedance

Clinical Evaluations


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”


Time Course of Decompensation

Physiologic Markers of Acute Decompensation

15

* Graph adapted from Adamson PB, et al. Curr Heart Fail Reports, 2009.


Physiologic Markers of Acute Decompensation

16

* Graph adapted from Adamson PB, et al. Curr Heart Fail Reports, 2009.


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 mildcongestion

Moderate tosevere congestion

59%24%

17%

Congestion state of patients discharged without congestion at 60 day follow-up3

Maintaineddecongestion

Partial recongestion

Relapse to severecongestion


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

% o

f P

ati

en

ts

Telemonitoring of Symptomsand Weight group

Standard-of-care Group

p = 0.39

p = 0.86

18


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 PointTelemonitoring

n = 354 (%)

Usual care

n = 356 (%)

HR

(95% CI)p

All-cause

mortality15.3 15.4 0.97 (0.67-1.41) 0.87

Cardiovascular-

related mortality11.3 12.9 0.86 (0.56-1.31) 0.49

All-cause

readmission54.2 50.3 1.12 (0.91-1.37) 0.29

19


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%


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 StratificationStudy 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


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

VariableEstimate

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

Hemodynamic Monitoring for

Heart Failure Management Managing Pressures in the Heart Failure Patient


CHAMPION Clinical Trial


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


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


Pulmonary Artery

Pressure Sensor

Patient

Electronics

System

CardioMEMS™

HF Website


26



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


CHAMPION Clinical Trial: The Effect of Pulmonary

Artery Pressure-Guided Therapy on HF

Hospitalizations vs. Standard of CarePatients 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 Hospitalization26 (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


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

26 (9.6%) Exited

< 6 Months

15 (5.6%) Death

11 (4.0%) Other

Primary Endpoint: rate of HF Hospitalization26 (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



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.


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)


31


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 blockerVal-HeFT 23 months 23% 18

Angiotensin

receptor blockerCHARM 40 months 27% 19

PA pressure

monitoringCHAMPION 17 months 33% 4

32


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

Rela

tive R

isk R

eduction

HF Hospitalization Reduction (6 mos follow-up)

P = 0.0080 vs. controlP = 0.0071 vs. control

preserved EF (≥ 40%)

P < 0.0001 vs. control


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



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


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


Telemonitoring with Hemodynamic Guidance

37


Virtual Clinic

38


Hospital-Cardiac Rehab

39


Telemedicine: Partnership

40


Home Monitoring Pharmacy Partnership

41


EMS Partners- Home Health- Partners-Urgent Care

42


Telemedicine Kit

43


Believe in Physical Exam

44


The Vision

45

=


Concepts

46


Industrial & Mechanical Design

Leverage Standard Manufacturing Processes

47

US-2000480 A EN (08/14) | This document is approved for US use only. 48

US-2000480 A EN (08/14) | This document is approved for US use only. 49

bello presentation[2]

Healthcare

us use

heart failure patients

heartbuds us

cost us

chronic heart failure

circ heart failure

treatment of heart failure

significance of heart