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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
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What Kinds of Heart Failure ?
Jessup M, et al. N Engl J Med. 2003;348(20):2007-2018.
Normal Heart Stiffened
Heart
Weakened
Heart
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© 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
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Years from Baseline Exam
Recognized Heart Attack
No Heart Attack
Perception:
I Never Had Any Chest Pain – How Can I Have Heart Trouble ?
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Risk Factors for Heart Failure
He J et al. Arch Intern Med 2001;161:996-1002.
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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
)
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Prevalence of Heart Failure
Circulation. 2012;125:e2-e220; originally published online December 15, 2011;
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Incidence of Heart Failure
Circulation. 2012;125:e2-e220; originally published online December 15, 2011;
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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
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All-Cause 30 Day Readmission Rates
After HF Hospitalization
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Perception:
Cardiologists Mostly Treat Heart Failure.
0
25
50
75
100
% o
f P
ati
ents
Cardiologists Primary Care
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Kannel WB et al. Am Heart J 1998;136:205-12
Perception:
Does Heart Failure Really Change My Outcome ?
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Perception: Heart Failure Can’t Be As Bad As Cancer
European Journal of Heart Failure 3Ž2001.315322
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What Kinds of Tests?
Echocardiogram Chest X-Ray
Electrocardiogram
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What Can Be Done for Heart Failure?
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Jessup M, Brozena S. N Engl J Med 2003;348:2007-18.
Heart Failure Progression
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© 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
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© 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
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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
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Normal Lungs
Devices that Detect Disease
Pulmonary Congestion
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Devices that Reduce the Risk of
Re-admission
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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
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Longer-term Remote Monitoring
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CRT-OFF Increase
Diuretic CRT-ON
Adjust
Diuretic
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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
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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
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Stevenson LW, et al Circ Heart Fail 2010;3:580
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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
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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
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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
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Mechanical Cardiac Support and
Cardiac Transplantation
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Devices that Assist the Heart
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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