Current standards in disease management
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Transcript Current standards in disease management
HEART FAILURE
DISEASE MANAGEMENT
STANDARDS
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© 2016 Novartis Pharma AG, July 2016, GLCM/HTF/0028c
Current standards in disease management
What is heart failure and what are the treatment guidelines?
How is heart failure defined?
According to European Society of Cardiology (ESC) guidelines, “HF is a clinical syndrome characterized by typical symptoms
(e.g. breathlessness, ankle swelling and fatigue) that may be accompanied by signs (e.g. elevated jugular venous pressure,
pulmonary crackles and peripheral oedema) caused by a structural and/or functional cardiac abnormality, resulting in a reduced
cardiac output and/or elevated intracardiac pressures at rest or during stress.”1
DEFINITIONS OF HFrEF, HFmrEF AND HFpEF1
Type of HF
1
HFrEF
Symptoms
CRITERIA
2
3
HFmrEF
signsa
Symptoms
HFpEF
Symptoms signsa
signsa
LVEF <40%
LVEF 40% to 49%
LVEF 50%
–
1. Elevated levels of
natriuretic peptidesb;
2. At least one additional
criterion:
a. relevant structural heat
disease (LVH and/or
LAE),
b. diastolic dysfunction
1. Elevated levels of
natriuretic peptidesb;
2. At least one additional
criterion:
a. relevant structural heat
disease (LVH and/or
LAE),
b. diastolic dysfunction
a. Signs may not be present in the early stages of HF (especially in HFpEF) and in patients treated with diuretics.
b. BNP >35 pg/mL and/or NT-proBNP >125 pg/mL.
Adapted from Ponikowski P, et al. Eur Heart J. 2016 [Epub ahead of print]
ESC = European Society of Cardiology; EF = ejection fraction; HFrEF = heart failure with reduced ejection fraction; HFmrEF = heart failure with mid-range ejection fraction;
HFpEF = heart failure with preserved ejection fraction; LAE = left atrial enlargement; LVEF = left ventricular ejection fraction; LVH = left ventricular hypertrophy;
NT-proBNP = N-terminal pro-B type natriuretic peptide.
1. Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and
treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the
ESC. Eur Heart J. 2016 [Epub ahead of print]. 2. Fauci AS, Braunwald E, Kasper DL, et al, eds. Harrison's Principles of Internal Medicine. 17th ed. New York: McGraw-Hill;
2008. 3. Ponikowski P, Anker SD, AlHabib KF, et al. Heart failure: preventing disease and death worldwide. ESC Heart Failure. 2014;1(1):4-25.
Current standards in disease management
What is heart failure and what are the treatment guidelines?
NYHA classification is important for evaluating patient symptoms
The New York Heart Association (NYHA) functional classification is widely used and accepted based on exercise capacity and
symptoms of the disease.1
NEW YORK HEART ASSOCIATION (NYHA) CLASSES1
NYHA class I
• No limitation on physical
activity
• No overt symptoms
NYHA class II
NYHA class III
• Slight limitation on physical
activity
• Comfortable at rest, but
ordinary physical activity
causes symptoms of heart
failure
• Marked limitation on
physical activity
• Comfortable at rest, but
less than ordinary activity
causes symptoms of heart
failure
NYHA class IV
• Inability to carry on any
activity without symptoms
• Presence of symptoms
even at rest
Adapted from Ponikowski P, et al. Eur Heart J. 2016 [Epub ahead of print]
NYHA= New York Heart Association.
1. Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and
treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the
ESC. Eur Heart J. 2016 [Epub ahead of print]. 2. Fauci AS, Braunwald E, Kasper DL, et al, eds. Harrison's Principles of Internal Medicine. 17th ed. New York: McGraw-Hill;
2008. 3. Ponikowski P, Anker SD, AlHabib KF, et al. Heart failure: preventing disease and death worldwide. ESC Heart Failure. 2014;1(1):4-25.
Current standards in disease management
What is heart failure and what are the treatment guidelines?
Recommended guidelines for care1
The overall goals for chronic heart failure management,
including patients with established HFrEF, “are to improve
their clinical status, functional capacity and quality of life,
prevent hospital admission and reduce mortality.”
• Recent studies have shown that including a focus on
reducing hospitalisations can be highly important to patients
and health care systems
Treatment effectiveness at slowing or preventing progressive
worsening of disease can be determined by reductions in the
rates of both hospital admissions and mortality.
Green indicates a class I recommendation; yellow indicates a class IIa recommendation.
ACEI = angiotensin-converting enzyme inhibitor; ARB = angiotensin receptor blocker; ARNI = angiotensin receptor neprilysin inhibitor;
BNP = B-type natriuretic peptide; CRT = cardiac resynchronization therapy; HF = heart failure; HFrEF = heart failure with reduced
ejection fraction; H-ISDN = hydralazine and isosorbide dinitrate; HR = heart rate; ICD = implantable cardioverter defibrillator; LBBB = left
bundle branch block; LVAD = left ventricular assist device; LVEF = left ventricular ejection fraction; MR = mineralocorticoid receptor; NTproBNP = N-terminal pro-B type natriuretic peptide; NYHA = New York Heart Association; OMT = optimal medical therapy; VF =
ventricular fibrillation; VT = ventricular tachycardia.
a. Symptomatic = NYHA Class II–IV; b. HFrEF = LVEF <40%; c. If ACE inhibitor not tolerated/contra-indicated, use ARB; d. If MR
antagonist not tolerated/contra-indicated, use ARB; e. With a hospital admission for HF within the last 6 months or with elevated
natriuretic peptides (BNP > 250 pg/mL or NTproBNP > 500 pg/mL in men and 750 pg/mL in women); f. With an elevated plasma
natriuretic peptide level (BNP ≥ 150 pg/mL or plasma NT-proBNP ≥ 600 pg/mL, or if HF hospitalization within recent 12 months plasma
BNP ≥ 100 pg/mL or plasma NT-proBNP ≥ 400 pg/mL); g. In doses equivalent to enalapril 10 mg b.i.d; h. With a hospital admission for
HF within the previous year; i. CRT is recommended if QRS ≥ 130 msec and LBBB (in sinus rhythm); j. CRT should/may be considered
if QRS ≥ 130 msec with non-LBBB (in a sinus rhythm) or for patients in AF provided a strategy to ensure bi-ventricular capture in place
(individualized decision).
© European Society of Cardiology 2016 - All Rights Reserved
1. Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and
treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the
ESC. Eur Heart J. 2016 [Epub ahead of print]. 2. Fauci AS, Braunwald E, Kasper DL, et al, eds. Harrison's Principles of Internal Medicine. 17th ed. New York: McGraw-Hill;
2008. 3. Ponikowski P, Anker SD, AlHabib KF, et al. Heart failure: preventing disease and death worldwide. ESC Heart Failure. 2014;1(1):4-25.
Current standards in disease management
What is heart failure and what are the treatment guidelines?
Recommended treatment guidelines in patients with symptomatic
(NYHA class II–IV) HFrEF
PHARMACOLOGICAL TREATMENTS INDICATED IN POTENTIALLY ALL PATIENTS WITH SYMPTOMATIC
(NYHA FUNCTIONAL CLASS II–IV) HFrEF*
Classa
Levelb
An ACEIc is recommended, in addition to a beta-blocker, for symptomatic patients
with HFrEF to reduce the risk of HF hospitalisation and death
I
A
A beta-blocker is recommended, in addition to an ACEIc for patients with stable,
symptomatic HFrEF to reduce the risk of HF hospitalisation and death
I
A
An MRA is recommended for patients with HFrEF, who remain symptomatic
despite treatment with an ACEIc and a beta-blocker, to reduce the risk of HF
hospitalisation and death
I
A
Recommendations
a. Class of recommendation; b. Level of evidence; c. Or ARB, if ACEI is not tolerated/contraindicated
Adapted from Ponikowski P, et al. Eur Heart J. 2016 [Epub ahead of print]
ACEI = angiotensin-converting enzyme inhibitor; ARB = angiotensin receptor blocker; HF = heart failure;
HFrEF = heart failure with reduced ejection fraction; MRA = mineralocorticoid receptor
*Level of evidence A represents data derived from multiple randomised clinical trials or meta-analyses. Level of evidence B however, includes data derived from a single randomised
clinical trial or large non-randomised studies. Consensus of opinion of the experts and/or small studies, retrospective studies, and registries, are classified under level of evidence C.
1. Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of
acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J.
2016 [Epub ahead of print]. 2. Fauci AS, Braunwald E, Kasper DL, et al, eds. Harrison's Principles of Internal Medicine. 17th ed. New York: McGraw-Hill; 2008. 3. Ponikowski P, Anker
SD, AlHabib KF, et al. Heart failure: preventing disease and death worldwide. ESC Heart Failure. 2014;1(1):4-25.
Current standards in disease management
What is heart failure and what are the treatment guidelines?
Other recommended treatment guidelines in patients with symptomatic
(NYHA class II–IV) HFrEF
OTHER PHARMACOLOGICAL TREATMENTS RECOMMENDED IN SELECTED PATIENTS WITH SYMPTOMATIC
(NYHA FUNCTIONAL CLASS II–IV) HFrEF*
Classa
Levelb
Diuretics are recommended in order to improve symptoms and exercise capacity in patients with signs and/or symptoms of
congestion
I
B
Diuretics should be considered to reduce the risk of HF hospitalisation in patients with signs and/or symptoms of congestion
IIa
B
I
B
Ivabradine should be considered to reduce the risk of HF hospitalisation and cardiovascular death in symptomatic patients with
LVEF ≤35%, in sinus rhythm and a resting heart rate ≥70 bpm despite treatment with an evidence-based dose of beta-blocker
(or maximum tolerated dose below that), ACEI (or ARB), and an MRA (or ARB)
IIa
B
Ivabradine should be considered to reduce the risk of HF hospitalisation and cardiovascular death in symptomatic patients with
LVEF ≤35%, in sinus rhythm and a resting heart rate ≥70 bpm who are unable to tolerate or have contra-indications for a
beta-blocker. Patients should also receive an ACEI (or ARB) and an MRA (or ARB)
IIa
C
Recommendations
Diuretics
ARNI
Sacubitril/valsartan is recommended as a replacement for an ACEI to further reduce the risk of HF hospitalisation and death in
ambulatory patients with HFrEF who remain symptomatic despite optimal treatment with an ACEI, a beta-blocker and an MRAc
If-channel inhibitor
a. Class of recommendation; b. Level of evidence; c. Patient should have elevated natriuretic peptides (plasma BNP ≥ 150 pg/mL or plasma NT-proBNP ≥ 600 pg/mL, or if HF hospitalization within the last
12 months, plasma BNP ≥ 100 pg/mL or plasma NT-proBNP ≥ 400 pg/mL) and able to tolerate enalapril 10 mg b.i.d.
Adapted from Ponikowski P, et al. Eur Heart J. 2016 [Epub ahead of print]
ACEI = angiotensin-converting enzyme inhibitor; ARB = angiotensin receptor blocker; ARNI = angiotensin receptor neprilysin inhibitor; BNP = B-type natriuretic peptide; bpm = beats per minute; HF = heart failure;
HFrEF = heart failure with reduced ejection fraction; LVEF = left ventricular ejection fraction; MRA = mineralocorticoid receptor antagonist; NT-proBNP = N-terminal pro-B type natriuretic peptide; NYHA = New York
Heart Association.
*Level of evidence A represents data derived from multiple randomised clinical trials or meta-analyses. Level of evidence B however, includes data derived from a single randomised clinical trial or large nonrandomised studies. Consensus of opinion of the experts and/or small studies, retrospective studies, and registries, are classified under level of evidence C.
1. Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure
of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 [Epub ahead of print]. 2. Fauci AS, Braunwald E, Kasper
DL, et al, eds. Harrison's Principles of Internal Medicine. 17th ed. New York: McGraw-Hill; 2008. 3. Ponikowski P, Anker SD, AlHabib KF, et al. Heart failure: preventing disease and death worldwide. ESC Heart
Failure. 2014;1(1):4-25.
Current standards in disease management
What is heart failure and what are the treatment guidelines?
Other recommended treatment guidelines in patients with symptomatic
(NYHA class II–IV) HFrEF (cont’d)
OTHER PHARMACOLOGICAL TREATMENTS RECOMMENDED IN SELECTED PATIENTS WITH SYMPTOMATIC
(NYHA FUNCTIONAL CLASS II–IV) HFrEF*
Classa
Levelb
I
B
IIb
C
Hydrazine and isosorbide dinitrate should be considered in self-identified black patients with LVEF <35% or with an LVEF
<45% combined with a dilated LV in NYHA Class III–IV despite treatment with an ACEI, a beta-blocker and an MRA to reduce
the risk of HF hospitalisation and death
IIa
B
Hydralazine and isosorbide dinitrate may be considered in symptomatic patients with HFrEF who can tolerate neither an ACEI
nor an ARB (or they are contra-indicated) to reduce the risk of death
IIb
B
Recommendations
ARB
An ARB is recommended to reduce the risk of HF hospitalisation and cardiovascular death in symptomatic patients unable to
tolerate an ACEI (patients should also receive a beta-blocker and an MRA)
An ARB may be considered to reduce the risk of HF hospitalisation and death in patients who are symptomatic despite
treatment with a beta-blocker who are unable to tolerate an MRA
Hydralazine and isosorbide dinitrate
a. Class of recommendation; b. Level of evidence.
Adapted from Ponikowski P, et al. Eur Heart J. 2016 [Epub ahead of print]
ACEI = angiotensin-converting enzyme inhibitor; ARB = angiotensin receptor blocker; HF = heart failure; HFrEF = heart failure with reduced ejection fraction; LVEF = left ventricular
ejection fraction; MRA = mineralocorticoid receptor antagonist; NYHA = New York Heart Association.
*Level of evidence A represents data derived from multiple randomised clinical trials or meta-analyses. Level of evidence B however, includes data derived from a single randomised
clinical trial or large non-randomised studies. Consensus of opinion of the experts and/or small studies, retrospective studies, and registries, are classified under level of evidence C.
1. Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of
acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J.
2016 [Epub ahead of print]. 2. Fauci AS, Braunwald E, Kasper DL, et al, eds. Harrison's Principles of Internal Medicine. 17th ed. New York: McGraw-Hill; 2008. 3. Ponikowski P, Anker
SD, AlHabib KF, et al. Heart failure: preventing disease and death worldwide. ESC Heart Failure. 2014;1(1):4-25.
Current standards in disease management
What is heart failure and what are the treatment guidelines?
Benefits of a multidisciplinary approach to care
During the management of heart failure, it is imperative to provide a system of care that
ensures optimal management of every patient. Thus, a multifaceted approach to care –
focused on holistic management, including exercise training and multidisciplinary
management programmes, patient monitoring, and palliative care – can play an important
role in the lives of heart failure patients.1
Despite these treatment strategies, the survival rate for heart failure patients across the
globe is poor. Continuing research and new pharmacological treatments are essential to
addressing unmet needs in caring for patients with heart failure.2,3
For further information regarding the quality of care measures recommended by ESC,
please click here.
1. Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of
acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J.
2016 [Epub ahead of print]. 2. Fauci AS, Braunwald E, Kasper DL, et al, eds. Harrison's Principles of Internal Medicine. 17th ed. New York: McGraw-Hill; 2008. 3. Ponikowski P, Anker
SD, AlHabib KF, et al. Heart failure: preventing disease and death worldwide. ESC Heart Failure. 2014;1(1):4-25.