Heart Failure Guidelines 2016

What’s New?

Michel KOMAJDA
IHU ICAN - Département de Cardiologie
CHU Pitié-Salpétrière
Université Pierre et Marie Curie, Paris
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 MAJOR CHANGES

1. A new term « HF with mid range ejection fraction »

(HFmrEF).
2. A new algorithm for the diagnosis of HF.
3. Recommendations on prevention of HF.
4. Indications for the use of Sacubitril / Valsartan in
HF with reduced ejection fraction (HFrEF).
5. Indications for cardiac resynchronisation therapy.
6. A new algorithm for the diagnosis and the
management of acute HF.
7. A list of drugs contra-indicated in HFrEF.

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 WHAT DOES NOT CHANGE ?

First line therapies in chronic heart failure with

1 reduced ejection fraction (HFrEF).

2 Indications for implantable cardiac defibrillator

Lack of evidence for the treatment of HF with

3 preserved ejection fraction.

4 Gaps in evidence.

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 Definition

HF is a clinical syndrome characterized by

typical symptoms (e.g. breathlessness and
fatigue) that may be accompanied by signs
(e.g.ankle swelling, 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.

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 A new algorithm for the diagnosis
of chronic HF

 Based on clinical probability of HF

 Based on the assessment of

circulating natriuretic peptides, and
on transthoracic echocardiography.

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 Diagnostic algorithm for a diagnosis of heart
failure of non-acute onset

PATIENT WITH SUSPECTED HFa

(non-acute onset

ASSESSMENT OF HF PROBABILITY

I. Clinical history:
History of CAD (MI, revascularization)
History of arterial hypertension
Exposition to cardiotoxic drug / radiation
Use of diuretics
Orthopnoea / paroxysmal nocturnal dyspnoea

2. Physical examination:
Rales
Bilateral ankle oedema
Heart murmur
Jugular venous dilatation
Laterally displaced/broadened apical beat

3. ECG:
Any abnormality
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 Diagnostic algorithm for a diagnosis of heart
failure of non-acute onset
3. ECG:
Any abnormality All absent

 I present

Assessment NATRIURETIC PEPTIDES

of natriuretic No
HF unlikely:
peptides not routinely Consider other
. NT-proBNP  125 pg/mL diagnosis
done in clinical practice . BNP  35 pg/mL

Yes

ECHOCARDIOGRAPHY Normal

If HF confirmed (based on all available data):

determine aetiology and stard appropriate
treatment

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 9

A New Classification
Heart failure with preserved, mid-range and reduced EF
Type of HF HFrEF HFmrEF HFpEF
I Symptoms ± Signs² Symptoms ± Signs² Symptoms ± Signs²
2 LVEF < 40% LVEF 40 – 49% LVEF  50%
3 1. Elevated levels of
1. Elevated levels of
CRITERIA

- natriuretic peptidesb,
natriuretic peptidesb,
2. At least, one additional
2. At least, one additional
criterion:
criterion:
a. relevant structural
a. Relevant structural
heart disease (LVH
heart disease (LVH
and/or LAE);
and/or LAE),
b. diastolic dysfunction
b. Diastolic dysfunction
(for details see
(for details see
Section 4.3.2).
Section 4.3.2).

The only category with evidence based medicine is HF rEF

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 Prevention of heart failure

 Treatment of risk factors (hypertension, diabetes, obesity,

smoking cessation).

 Use of statins in patients with or at high risk of coronary

artery disease.

 Use of ACE-I in patients with asymptomatic left ventricular

dysfunction /stable CAD.

 -Use of beta-blockers in those with asymptomatic left

ventricular dysfunction and a history of myocardial infarction.

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 Objectives of the treatment of heart
failure with reduced
ejection fraction
 Reduce mortality
 Improve
 clinical status
 functional capacity
 quality of life, prevent hospital admission

Preventing HF hospitalizations and

improving functional capacity.

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 Treatment
Algorithm for
HFrEF

We are HFA
 Initial management of symptomatic HF with
reduced ejection fraction.

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 Therapeutic algorithm for a patient with persistent
symptomatic HF with reduced ejection fraction.

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 SHIFT
CV death / HF hospitalization

40
Placebo
30 p<0.0001 -18%

20 Ivabradine

10

0
0 6 12 18 24 30
Months

Swedberg K, et al. Lancet 2010;376: 875-885.

 If-channel inhibitor

Ivabradine is indicated in patients with:

 symptomatic HFrEF and LVEF ≤35%
 in sinus rhythm and with a heart rate ≥70 bpm
 who had been hospitalized for HF within the previous 12
months.

The European Medicines Agency (EMA) approved

ivabradine for use in Europe in patients with HFrEF with
LVEF ≤35% and in sinus rhythm with a resting heart rate ≥75
bpm, because in this group ivabradine conferred a survival
benefit.
 Main side effects :bradycardia, blurred vision
 LCZ 696: Angiotensin
Receptor Neprilysin Inhibitor

Heart Failure
Natriuretic Peptide System Renin Angiotensin System
pro-BNP Angiotensinogen
(liver secretion)

Angiotensin I
BNP

NT-pro BNP LCZ696

Angiotensin II
O O
Neprilysin N
OH

Inactive
X HN

O
HO
O

OH
N
N
X AT1 receptor
N NH

fragments O

Vasodilation AHU377 Valsartan

Vasoconstriction
 blood pressure ↓  blood pressure
 sympathetic tone LBQ657
aldosterone levels  sympathetic tone
 fibrosis  aldosterone
 hypertrophy  fibrosis
17
Natriuresis/Diuresis  hypertrophy
 PARADIGM HF
Cardiovascular death / Heart Failure hospitalisation

40

Enalapril 1117
32 (n=4212)
Kaplan-Meier Estimate of

914
Cumulative Rates (%)

24
LCZ696
(n=4187)
16

HR = 0.80 (0.73-0.87)
8 P = 0.0000002
Number needed to treat = 21
0
0 180 360 540 720 900 1080 1260

Patients at Risk Days After Randomization

LCZ696 4187 3922 3663 3018 2257 1544 896 249
Enalapril 4212 3883 3579 2922 2123 1488 853 236

JJV McMurray et al, NEJM 2014 online

 Angiotensin receptor neprilysin inhibitor
(Sacubitril/Valsartan)

 LCZ 696 is indicated in patients with:

 ambulatory, symptomatic HFrEF
 LVEF ≤35%
 elevated plasma NP levels (BNP ≥150 pg/mL or NT-proBNP ≥600
pg/mL)
 estimated GFR (eGFR) ≥30 mL/min/1.73 m2 of body surface area
 who are able to tolerate treatment with enalapril (at least 10 mg b.i.d.)

 Side effects:
 symptomatic hypotension.
 risk of angioedema (ACEI should be withheld for at least 36 h
before initiating LCZ696).
Therapeutic algorithm for a patient with symptomatic HF with
reduced ejection fraction. Next steps

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 Other pharmacological treatments recommended in
selected patients with symptomatic
(NYHA Class II-IV) HFrEF

 Angiotensin II type I receptor blockers

 ARBs are recommended only as an alternative in patients intolerant of
an ACEI.

 The combination of ACEI/ARB should be restricted to symptomatic

HFrEF patients receiving a beta-blocker who are unable to tolerate an
MRA, and must be used under strict supervision.

 Combination of hydralazine and isosorbide dinitrate

 There is no clear evidence to suggest the use of this fix-dose
combination therapy in all patients with HFrEF.
 This combination may be considered in patients who can tolerate
neither ACEi nor ARB.
 Other treatments with less certain benefit in
symptomatic patients
with HFrEF

Digoxin and other digitalis glycosides

 Digoxin may be considered in patients in sinus rhythm to reduce
the risk of hospitalisation in symptomatic patients with HFrEF
 It is only recommended for the treatment of patients with HFrEF
and AF with rapid ventricular rate when other therapeutic options
cannot be pursued

 Digitalis should always be prescribed under specialist supervision.

Caution should be exerted in females, in the elderly and in patients
with reduced renal function.
 Treatments not recommended in symptomatic
patients
with HFrEF

Statins

Oral anticoagulants and antiplatelet therapy

 Except in patients with atrial fibrillation
 There is no evidence on the benefits of antiplatelet drugs in patients with
HF without accompanying CAD, whereas there is a substantial risk of GI
bleeding.

Renin inhibitors
 It is not presently recommended as an alternative to an ACEI or ARB
ATMOSPHERE
Main Outcomes

McMurray JJV et al. N Engl J Med 2016;374:1521-1532

 Treatments (or combinations of treatments) that may cause
harm in patients with symptomatic
(NYHA Class II–IV) HFrEF

Recommendations Classa Levelb

Thiazolidinediones (glitazones) are not recommended in
patients with HF, as they increase the risk of HF worsening III A
and HF hospitalization.
NSAIDs or COX-2 inhibitors are not recommended in
patients with HF, as they increase the risk of HF worsening III B
and HF hospitalization.
Diltiazem or verapamil are not recommended in patients with
HFrEF, as they increase the risk of HF worsening and HF III C
hospitalization.
The addition of an ARB (or renin inhibitor) to the combination
of an ACE-I and an MRA is not recommended in patients with
III C
HF, because of the increased risk of renal dysfunction and
hyperkalaemia.

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 ESC Heart Failure Guidelines

Manage HF co-morbidities in all heart

failure patients.

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EMPAREG OUTCOME

Zinman B et al. N Engl J Med 2015;373:2117-2128

 ESC Heart Failure Guidelines:
devices

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 Implantable cardioverter-defibrillator in
patients with heart failure

Recommendations Class Level

Secondary prevention
An ICD is recommended to reduce the risk of sudden death and all-cause mortality in patients who have
I A
recovered from a ventricular arrhythmia causing haemodynamic instability, and who are expected to
survive for >1 year with good functional status.
Primary prevention
An ICD is recommended to reduce the risk of sudden death and all-cause mortality in patients
with symptomatic HF (NYHA Class II–III), and an LVEF ≤35% despite ≥3 months of OMT, provided
they are expected to survive substantially longer than one year with good functional status, and
they have:
• IHD (unless they have had an MI in the prior 40 days – see below). I A
• DCM. I B
ICD implantation is not recommended within 40 days of an MI as implantation at this time does not
III A
improve prognosis.
ICD therapy is not recommended in patients in NYHA Class IV with severe symptoms refractory to
pharmacological therapy unless they are candidates for CRT, a ventricular assist device, or cardiac III C
transplantation.
Patients should be carefully evaluated by an experienced cardiologist before generator replacement,
IIa B
because management goals and the patient’s needs and clinical status may have changed.

A wearable ICD may be considered for patients with HF who are at risk of sudden cardiac death for a
IIb C
limited period or as a bridge to an implanted device.

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 Recommendations for cardiac resynchronization
therapy implantation in patients with heart failure

Recommendations Classa Levelb

CRT is recommended for symptomatic patients with HF in sinus rhythm with a QRS
duration  150 msec and LBBB QRS morphology and with LVEF  35% despite I A
OMT in order to improve symptoms and reduce morbidity and mortality.

CRT should be considered for symptomatic patients with HF in sinus rhythm with a
QRS duration  150 msec and non-LBBB QRS morphology and with LVEF  IIa B
35% despite OMT in order to improve symptoms and reduce morbidity and mortality.

CRT is recommended for symptomatic patients with HF in sinus rhythm with a QRS
duration of 130-149 msec and LBBB QRS morphology and with LVEF  35% I B
despite OMT in order to improve symptoms and reduce morbidity and mortality.

CRT may be considered for symptomatic patients with HF in sinus rhythm with a
QRS duration of 130-149 msec and non-LBBB QRS morphology and with LVEF
 35% despite OMT in order to improve symptoms and reduce morbidity and IIb B
mortality.
CRT should be considered for patients with LVEF  35% in NYHA Class III-Ivc
despite OMT in order to improve symptoms and reduce morbidity and mortality, if
they are in AF and have a QRS duration  130 msec provided a strategy to ensure IIa B
bi-ventricular capture is in place or the patient is expected to return to sinus rhythm.
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 Acute heart failure

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Clinical profiles of patients with acute heart failure based on
the presence/absence of congestion
and/or hypoperfusion

CONGESTION (‒) CONGESTION (+)

Pulmonary congestion
Orthopnoea/paroxysmal nocturnal dyspnoea
Peripheral (bilateral) oedema
Jugular venous dilatation
Congested hepatomegaly
Gut congestion, ascites
HYPOPERFUSION (‒) Hepatojugular reflux

WARM-DRY WARM-WET

HYPOPERFUSION (+)
Cold sweated extremities
Oliguria
Mental confusion COLD-DRY COLD-WET
Dizziness
Narrow pulse pressure

Hypoperfusion is not synonymous with hypotension, but often hypoperfusion is accompanied by hypotension

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 Management of patients with acute heart failure
based on clinical profile
during an early phase

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 PATIENT WITH ACUTE HEART FAILURE

Bedside assessment to identify haemodynamic profiles

PRESENCE OF CONGESTION ?
Yes No
(95% of all AHF patients) (5% of all AHF patients)
‘’Wet’’ patient ‘Dry’’ patient

ADEQUATE PERIPHERAL PERFUSION ?

Yes No
Yes No
‘Dry and warm’ Dry and cold’
Adequately perfused Hypoperfused,
= Compensated Hypovolemic
‘Wet and Warm’ patient
(typically elevated or normal systolic
Adjust oral Consider fluid challenge
blood pressure) therapy Consider inotropic agent
if still hypoperfused

‘’Wet and Cold’’ patient

Vascular type – Cardiac type –
fluid accumulation fluid accumulation Systolic blood pressure <90 mmHg
Hypertension Congestion
prédominates prédominates Yes No

• Inotropic agent • Vasodilators

• Consider vasopressor in • Diuretics
• Vasodilator • Diuretic refractory cases • Consider inotropic agent
• Diuretic • Vasodilator • Diuretic (when perfusion in refractory cases
• Ultrafiltration corrected)
(consider if diuretic • Consider mechanical
resistance) circulatory support if no
response to drugs
 ESC Heart Failure Guidelines :
Ten Commandments

Enrol the patients with HF in a multidisciplinary

care management program in order to reduce the
risk of HF hospitalization and mortality.

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 Gaps in evidence
Clinicians responsible for managing patients with HF must frequently make treatment
decisions without adequate evidence or a consensus of expert opinion. The following
is a short list of selected, common issues that deserve to be addressed in future
clinical research:
 Indications for ICDs in specific subgroups (e.g. ARVC and HFmrEF / HFpEF) and
optimal selection of ICD candidates.
 QRS morphology or duration as a predictor of response to CRT.
 CRT in patients with AF.
 Efficacy of PV ablation as a rhythm-control strategy in patients with AF.
 Interventional approach to recurrent, live-threatening ventricular tachyarrhythmias.
 The role of remote monitoring strategies in HF.
 Non-surgical (percutaneous) correction of functional mitral and tricuspid
regurgitations.
 Identification of indications for coronary angiography/revascularization in patients
with HF and chronic stable CAD;
 Effects of novel LVADs as destination therapy and bridge to transplantation.
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Heart Failure 2017 29 April – 2 May 2017

4 days of scientific exchange

108 scientific sessions

6 148 healthcare professionals

100 + countries represented

2010 abstracts and cases submitted

300 expert faculty members

2000m exhibition space

2

40 industry sessions and workshops

Call for abstracts opens on November 3

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