Heart Failure: What is It, Who Has It and How to Treat It · Heart Failure: What is It, Who Has It...

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Heart Failure: What is

It, Who Has It and How

to Treat It

Mitchell T. Saltzberg, MD

Medical Director of Heart Failure

What Kinds of Heart Failure ?

Jessup M, et al. N Engl J Med. 2003;348(20):2007-2018.

Normal Heart Stiffened

Heart

Weakened

Heart

© 2000 Heart Failure Society of America, Inc.

What is Heart Failure?

• Heart failure is NOT a heart attack!

• Heart Failure can result from a heart that does

not pump enough blood to meet the body’s

needs

• OR, it can result from a heart that gets too stiff

to allow blood to return to the heart easily

Years from Baseline Exam

Recognized Heart Attack

No Heart Attack

Perception:

I Never Had Any Chest Pain – How Can I Have Heart Trouble ?

Risk Factors for Heart Failure

He J et al. Arch Intern Med 2001;161:996-1002.

Epidemiology of Heart Failure

What Does the Future Hold?

AHA, 2012. Heart and Stroke Statistical Update.

Heart Failure Statistics

5.9 Million Americans living

with HF – 50% with preserved

ejection fraction

22 Million patients worldwide

1.5-2% of US population

Prevalence increases 6-10% in

patients over 65 years

670,000 new cases annually

3.5

5.9

14.2

0

2

4

6

8

10

12

1991 2012 2030

He

art

Fa

ilu

re P

ati

en

ts in

US

(Millio

ns

)

Prevalence of Heart Failure

Circulation. 2012;125:e2-e220; originally published online December 15, 2011;

Incidence of Heart Failure

Circulation. 2012;125:e2-e220; originally published online December 15, 2011;

Shift from Acute to Chronic

Disease Management

0

50

100

150

200

250

300

350

400

1980 1990 2000

Coronary deaths are down by half…

Source: National Hospital Discharge Survey, CDC/NCHS and NHLBI.

0

200

400

600

800

1,000

1,200

1980 1990 2000

But heart failure has almost tripled

Coronary Deaths Heart Failure Hospitalizations

All-Cause 30 Day Readmission Rates

After HF Hospitalization

Perception:

Cardiologists Mostly Treat Heart Failure.

0

25

50

75

100

% o

f P

ati

ents

Cardiologists Primary Care

Kannel WB et al. Am Heart J 1998;136:205-12

Perception:

Does Heart Failure Really Change My Outcome ?

Perception: Heart Failure Can’t Be As Bad As Cancer

European Journal of Heart Failure 3Ž2001.315322

What Kinds of Tests?

Echocardiogram Chest X-Ray

Electrocardiogram

What Can Be Done for Heart Failure?

Jessup M, Brozena S. N Engl J Med 2003;348:2007-18.

Heart Failure Progression

© 2000 Heart Failure Society of America, Inc.

Medicines to Control Symptoms...

• Diuretics: helps to control fluid retention and

reduce swelling

• Digoxin: may reduce the risk of hospitalization

© 2000 Heart Failure Society of America, Inc.

Medicines That Save Lives...

• ACE Inhibitors and Angiotensin Receptor Blockers:

– Dilate or widen blood vessels, increase blood flow

• Beta blockers: helps strengthen the heart’s pumping ability, blocks the body’s response to substances which can damage the heart

• Aldosterone Antagonists: Reduce scar tissue formation primarily

Medicines That Save Lives...

• Ivabradine

– Affects pacemaker function of the heart

– Slows heart rate, improves survival

• Valsartan / Sacubitril

– Combines Angiotensin Blocker and Neprilysin

inhibitor

– Increases levels of endogenous natriuretic peptides

– Improves survival compared to ACE inhibitor alone

Normal Lungs

Devices that Detect Disease

Pulmonary Congestion

Devices that Reduce the Risk of

Re-admission

Pressure-Based Medical Management

Workflow

Website

Patient

Treatment decisions

Care Team

Reviews readings on Web site

Takes pressure readings

Adamson PB, Abraham WT, Aaron M , et al J Card Fail 2011;17:3-10

Longer-term Remote Monitoring

CRT-OFF Increase

Diuretic CRT-ON

Adjust

Diuretic

OLD MODEL

Pt gains __lbs over __days, ankle edema, mild dyspnea

They hope it will go away

They postpone notifying provider because:

A. They have an appt in 2 wks & will tell you then

B. They don’t want to bother you

The problem gets worse.

Patient ends up in ED

at 2am.

Pt comes to your office

significantly symptomatic

More Intense Daily Monitoring of Weights and

Symptoms Does NOT Improve Outcomes

Tele-HF (NEJM 2010)

• 1653 patients randomized to telemonitoring or standard of

care

• Daily weights, BP, and symptoms

• 29,163 physician calls to patients during 6 months

• No difference in hospitalizations

TIM-HF (Circulation 2011)

• 710 patients randomized to telemonitoring or standard of

care

• Daily weights, BP, and symptoms

• No difference in hospitalizations

Stevenson LW, et al Circ Heart Fail 2010;3:580

CHAMPION: CardioMEMS Heart Sensor Allows Monitoring of

Pressure to Improve Outcomes in NYHA Class III Heart Failure

Patients

550 Pts

w/ CM Implants

All Pts Take Daily Readings

Treatment

270 Pts

Management Based on

Hemodynamics + Traditional Info

Control

280 Pts

Management Based on

Traditional Info

Primary Endpoint: HF Hospitalizations at 6 Months

Additional Analysis: HF Hospitalizations at All Days (~15 M mean F/U)

Multiple Secondary Endpoints

Trial Designed by Steering Committee with active FDA input

Prospective, multi-center, randomized, controlled single-blind clinical trial

All subjects followed in their randomized single-blind study assignment until the last patient reached 6 months of follow-up

64 US Centers

PIs: William Abraham, Phil Adamson

Abraham WT, Adamson PB, et al. Lancet 2011

Subject Status Weekly ≥ 2-3x per

week until

optivolemic

≥ 2-3x per

week until

pressure

stabilizes

Opti-volemic: minimal symptoms and evidence

of poor perfusion. PAS 15-35/ PAD 8-20/ PAM

10-25 mmHg X

Hyper-volemic: Congestive symptoms. Daily,

weekly, acute pressure above opti-volemic ranges X

Hypo-volemic: Poor perfusion in absence of s/s

of congestion. Daily, weekly, acute pressure

below opti-volemic ranges X

Medication modification X

Significant deviations in trend data X

Recommended Frequency of HF Pressure

Measurement System Review

Adamson PB, Abraham WT, et al. J Card Fail 2011

Cumulative HF Hospitalizations Reduced At 6 Months and Full Duration of Randomized Study

Cu

mu

lati

ve

Nu

mb

er

of

HF

Ho

sp

ita

liza

tio

ns

0

20

40

60

80

100

120

140

160

180

200

220

240

260

280

Days from Implant

0 90 180 270 360 450 540 630 720 810 900

270 262 244 210 169 131 108 82 29 5 1280 267 252 215 179 137 105 67 25 10 0

No. at RiskTreatmentControl

Treatment (158 HF Hospitalizations)Control (254 HF Hospitalizations)

Study Duration

37% RRR, p < 0.0001

≤ 6 Months

28% RRR,

p = 0.0002

> 6 Months

45% RRR,

p < 0.0001

Abraham WT, Adamson PB, et al. Lancet 2011

Mechanical Cardiac Support and

Cardiac Transplantation

Devices that Assist the Heart

Who makes someone a candidate ?

• End – stage heart disease

– Limited activity, low Ejection Fraction

• Inability to survive to transplantation

• Contraindication to transplantation

• Patients requiring a “bridge” to survive

• Preserved “end organ” function

• Strong family support system in place

Left Ventricular Assist Devices

A surgically implanted, rotary continuous-flow device in parallel with the native left ventricle – Left ventricle to ascending aorta

Percutaneous driveline

Electrically powered – Batteries & line power

Fixed speed operating mode

Home discharge

Novel Design and Operation

Flexible conduits

Textured surfaces

– Resists clot formation

Can replace up to 100 % of left ventricular function

Longer term support – only one moving part

Patient Selection Criteria

• Left ventricular Ejection Fraction < 25 %

• Documented low exercise capacity by

treadmill or bike testing

• Advanced symptoms for 2 of 3 last months

• Dependence on heart stimulants or other

mechanical support options

• Thorough evaluation by the VAD multi-

disciplinary team

HeartMate II Clinical Study Functional Status - 6 Minute Walk

0

50

100

150

200

250

300

Baseline 1 mo 3 mo 6 mo

LVAD Duration

Mete

rs

n= 271 235 175 128

30 + 88

166 + 168

244 + 218

285 + 235

HeartMate II Clinical Trial Functional Status - NYHA Class I or II

0

25

50

75

100

Baseline 1 mo 3 mo 6 mo

LVAD Duration

Perc

en

t o

f p

ati

en

ts

NYHA II

NYHA I

59%

83% 82%

0%*

n= 259 213 169 120

* 98% were NYHA Class IV at Baseline

HeartMate II Clinical Trial Minnesota Living With Heart Failure

0

10

20

30

40

50

60

70

80

Baseline 1 mo 3 mo 6 mo

LVAD Duration

Ab

so

lute

Sco

re

n=226 201 166 120

71 + 24

58 + 27

44 + 24 38 + 25

Better

QoL

Absolute Scores

+18% +38% +47%

% = improvement

from baseline

HeartMate II Clinical Trial Kansas City Cardiomyopathy Questionnaire

0

10

20

30

40

50

60

70

Baseline 1 mo 3 mo 6 mo

LVAD Duration

Ab

so

lute

Sco

re

n=224 204 165 118

31 + 26

47 + 23

57 + 21 63 + 22

Overall Summary Scores Better

QoL

+42% +84% +103%

% = improvement

from baseline

Heart Transplant Candidacy Considerations

• End-stage cardiac disease

• Absence of serious systemic illness or other medical

conditions that may affect immediate or long-term

survival

• Age 70 or with a life expectancy of at least 5-10 years

• Strong social support network, especially family

• Free from active drug, nicotine or alcohol abuse

• Weight less than 135% of IBW or BMI < 42

HEART TRANSPLANTATION Kaplan-Meier Survival (1/1982-6/2005)

0

20

40

60

80

100

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22

Years

Su

rviv

al

(%)

Half-life = 10.0 years

Conditional Half-life = 13.0 years

N=70,702

ISHLT

2007

N at risk at 22

years: 33

HEART TRANSPLANTATION Kaplan-Meier Survival (1/1982-6/2005)

J Heart Lung Transplant 2007;26: 769-781

ADULT HEART RECIPIENTS Functional Status of Surviving Recipients

(Follow-up: 1995 - June 2006)

0%

20%

40%

60%

80%

100%

1 Year (N =

15,388)

3 Years (N =

13,600)

5 Years (N =

11,698)

7 Years (N =

9,306)

No Activity Limitations Performs with Some AssistanceRequires Total Assistance

ISHLT 2007

J Heart Lung Transplant 2007;26: 769-781

Summary

• Heart failure incidence is still increasing

• Treatment is approached in a stepwise

manner as the disease progresses

• Recent approvals of new heart failure

medications

• Transplant volumes stable / decreasing

• Mechanical circulatory support device

implants continue to increase

– Devices continue to get smaller / more durable

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