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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
