Dr Alan Begg explores evidence-based guidance from SIGN on diagnosis, lifestyle modification, and interventions in chronic heart failure
Read this article to learn more about:
- new accredited guidance from the Scottish Intercollegiate Guidelines Network
- diagnostic approaches to chronic heart failure
- newer drug options for chronic heart failure treatment.
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S cottish Intercollegiate Guidelines Network (SIGN) Guideline 147 on the Management of chronic heart failure was launched on 11 March this year.1 The intention initially was to provide an update of the previous guideline (SIGN 95, February 2007);2 the update was to be based on new questions where the evidence had changed, which might lead in turn to new recommendations. However, SIGN has now moved from the previous grading of recommendations to a wording based on the 'strength' of evidence. Recommendations on interventions are now either 'strong' and 'should' or 'should not' be used, or 'conditional' and should be 'considered' on the basis that the intervention will confer more benefit than harm for most patients.
Good practice points, based on the clinical experience of the guideline development group, are still included in the guideline. To provide consistency throughout the new guideline, unchanged recommendations have been reworded in line with the new approach but without performing new literature searches. A 'quick reference guide' for SIGN 147 is also available. This article will focus on the main changes to the guidance.
Classifying heart failure
Heart failure is a clinical syndrome of symptoms and signs (see Table 1, below). The condition can be defined on the basis of whether left ventricular ejection fraction is reduced (HF-REF) or preserved (HF-PEF). SIGN 147 focuses on the management of HF-REF, as only in this category have randomised trials demonstrated a favourable effect of interventions or therapies on outcome. HF-REF is the term used throughout, in preference to other terms such as systolic dysfunction or reduced systolic function. The New York Heart Association (NYHA) classification is used as a stratification tool for assigning heart failure patients to a functional class on the basis of severity and so to guide treatment decisions.
|More specific||Less specific|
|McMurray J, Adamopoulos S, Anker S et al. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail 2012; 14 (8): 803–869.
Reproduced with permission from Oxford University Press.
The common symptoms and signs associated with heart failure are listed in Table 1, above. It is important to be aware that in both categories, no particular feature is both sensitive and specific for the diagnosis and a purely clinical diagnosis is problematic. The range of basic tests and diagnostic approach are outlined in Figure 1, below.
B-type natriuretic peptide (BNP) and N terminal-pro-B-type natriuretic peptide (NT-proBNP) are raised in patients with both HF-REF and HF-PEF, the concentrations tending to rise with deteriorating NYHA class. There is evidence for the clinical effectiveness of using BNP or NT-proBNP as a diagnostic tool and ideally measurement should be done before commencing treatment (see key recommendation 2.1 and text at 3.1.4 of SIGN 147).1 SIGN was unable to identify evidence as to whether the early referral of patients with suspected heart failure with high or moderate BNP levels improves outcome, although NICE noted that levels of BNP can predict hospitalisation and mortality in this group of patients presenting in the community.3 On this basis the recommendations in SIGN 147 on natriuretic peptide levels, although mirroring NICE guidance, have received a lower strength of recommendation:1
- 'Patients with suspected heart failure and a BNP level above 400 pg/ml (116 pmol/litre) or an NT-proBNP level above 2000 pg/ml (236 pmol/litre) may be referred for echocardiography and specialist assessment within two weeks'
- 'Patients with suspected heart failure and a BNP level between 100 and 400 pg/ml (29–116 pmol/litre) or an NT-proBNP level between 400 and 2000 pg/ml (47–236 pmol/litre) may be referred for echocardiography and specialist assessment within six weeks.'
If BNP is not available an electrocardiogram should be used to decide whether or not echocardiography is indicated in patients with suspected heart failure.1
A chest X-ray is an important part of the assessment process, and can help exclude other causes for the symptoms experienced by the patient.1
Strong recommendations in SIGN 147 on lifestyles changes for patients with heart failure are:1
- patients should be advised to refrain from excessive alcohol consumption and strongly encouraged to stop drinking alcohol if the heart failure is alcohol related
- patients should be strongly advised not to smoke and offered smoking cessation advice and support
- patients who are stable in NYHA class II–III should be offered a moderate-intensity supervised exercise training programme to improve exercise tolerance and quality of life:
- in those who are stable, a motivational interviewing style should be used to promote low-intensity physical activity.
Good practice recommendations
SIGN 147 makes several good practice recommendations in relation to dietary change. These are:1
- aim for a salt intake of less than 6 g/day:
- do not use 'low salt' substitutes, owing to their higher potassium content
- use a tailored approach to fluid restriction advice for those with frequent episodes of decompensated heart failure
- regular daily weighing should be encouraged and any weight gain of 1.5 to 2 kg in 2 days should be reported
- avoid cranberry and grapefruit juice in certain situations (e.g. cranberry juice may increase the potency of warfarin, and grapefruit juice may interfere with the liver metabolism of simvastatin)
- St John's wort supplements should not be taken, because of drug interactions (e.g. with warfarin, digoxin, eplerenone, and selective serotonin reuptake inhibitors [SSRIs]).
The main therapeutic approach, based on a large number of high-quality clinical trials, has not changed although there is now also a place for the addition of newer drugs (see Figure 2, below).
Beta blockers should be started in all patients (NYHA class II–IV) as soon as their condition is stable, whereas angiotensin-converting enzyme inhibitors (ACE-I) should be given in all NYHA functional classes. If the patient is intolerant of a ACE-I they should be given an angiotensin receptor blocker (ARB) but only in class II–IV. An ARB should be considered as an addition to an ACE-I if the patient is unable to tolerate a mineralocorticoid receptor antagonist. Patients with ongoing symptoms, class II–IV and left ventricular ejection fraction <=35% despite optimal treatment should be given a mineralocorticoid receptor antagonist unless contraindicated by renal impairment (eGFR >=4 or 5) and elevated serum potassium (>5 mmol/l).
SIGN 147 states that drugs such as sacubitril/valsartan and ivabradine and also intravenous iron should only be initiated under the guidance of a heart failure specialist.
A combination of sacubitril/valsartan has now been accepted for use in NHS Scotland as well as by NICE4 and the SIGN 147 guideline group has outlined the circumstances in which it should be used (see Figure 2, above). The evidence is based on the PARADIGM trial, which was terminated early because of the overwhelming benefit shown by sacubitril/valsartan when compared with enalapril.5 The primary outcome of death from cardiovascular causes or a first hospitalisation for heart failure occurred in 21.8% of patients with the new combination compared with 26.5% on the enalapril group. This mortality benefit was irrespective of mode of cardiovascular death (sudden cardiac or worsening heart failure)6 and the number needed to treat in the trial was 21 to prevent one death from cardiovascular causes or hospitalisation, and 32 to prevent one cardiovascular death.5 Only a small number of patients in the trial were in class IV so the efficacy of the drug in this group is less certain.5
Angioedema was non-significantly more common with the combination (0.45% v 0.24%)5 so SIGN 147 recommends that the ACE-I should be stopped for 36 hours before initiating sacubitril/valsartin to minimise the risk of this side-effect.1
Based on NICE Technology Appraisal 388,4 the British Medical Journal has reported that for £3 a day, the new drug could cut deaths and reduce more than 30,000 hospital admissions for heart failure that occur every year in England.7 The SIGN 147 guideline group, however, did not feel that there was evidence for the benefit of BNP-guided therapy when using sacubitril/valsartan.1
In the SHIFT study, in a clearly defined group of patients, cardiovascular deaths or hospitalisations for heart failure were reduced in the ivabradine group (24% compared with 29% in the placebo group) and there was also a reduction in deaths due to heart failure.8 The Scottish Medicines Consortium found that the addition of ivabradine to standard care was cost effective if the resting heart rate remained >=75 beats per minute despite optimal standard therapy with beta blockers. It is on this basis that the guideline group has recommended this heart rate threshold rather than the >=70 beats per minute in the SHIFT trial.8 The recommendation states that patients who are eligible for ivabradine should have had a hospital admission in the previous 12 months and have stabilised on standard therapy for at least 4 weeks.1
Erythropoietin is not recommended for patients with heart failure who have reduced ejection fraction and iron deficiency, although in some patients therapy with intravenous iron should be considered if certain conditions are met (see Figure 2, above).
NICE has accredited the process used by SIGN to produce clinical guidelines and the accreditation is applicable to guidelines developed using the standard SIGN process. Healthcare Improvement Scotland reviews Multiple Technology Assessments (MTAs) produced by NICE and this MTA guidance is used by NHS Scotland if felt to be applicable to Scotland. The recommendations in SIGN 147 on cardiac resynchronisation therapy and implantable cardioverter defibrillators (see para 6.1 and table under para 2.4) reflect the advice given in NICE MTA 3149 and have not been updated by the development group, so there are no changes to the QRS interval cut-off points.
Depression is common in patients with heart failure and any associated increased mortality risk may be related to morbidity and re-hospitalisation.1 There is insufficient evidence to advise on what screening or assessment tools to use for depression in patients with heart failure, and correlating symptoms such as loss of appetite and fatigue may be difficult in this group of patients. SIGN 147 states that a tricyclic antidepressant should not be used in patients with heart failure, and the benefit overall of SSRIs has yet to be shown.1
Therapist-delivered cognitive behaviour therapy should, however, be considered for patients with heart failure and clinical depression. Six months of treatment has been shown to improve depression and there is also some evidence for improvements in anxiety, fatigue, mental and heart-failure related quality of life, social functioning, and hospitalisations.1,10,11
The guideline notes that there is a lack of robust randomised control trial evidence to support the best means of identifying patients with a palliative care need, what those needs are, how to deliver care, and the impact of anticipatory care planning. Studies do illustrate high rates of unmet need in symptom control, communication, decision making, emotional support, coordination of care, and quality end-of-life care. There is a need to extrapolate strategies from palliative care in cancer to general palliative care delivered by the usual health care team, who should be appropriately trained and have access to specialist teams as needed. The guideline does provide a good practice point on considering low-dose opioids titrated against effect for breathlessness after optimising management. There was no evidence for the use of benzodiazepines.1
There has been no update on the chapter on models of care, which has recommendations on comprehensive discharge planning and post-hospital discharge follow up by a specialist nurse who can initiate and adjust medication. Multidisciplinary follow up should include pharmacy input with feedback to clinicians on optimising pharmacological interventions.
Implementation of SIGN 147 is the responsibility of each NHS board, encouraged and supported by SIGN.1 Issues that need to be addressed are the availability of BNP testing in Scotland, the use of newer drugs, where intravenous iron is administered, and the practitioners required to deliver cognitive behaviour therapy.
The Heart Failure Hub: 'has been established as a subgroup of [The] National Advisory Committee on Heart Disease in order to take forward a national programme of work in relation to heart failure. The group brings together clinicians, managers, the voluntary sector and patients to ensure a coordinated approach to tackling the many challenges facing heart failure teams in NHS Boards across Scotland.' (Michael Matheson MP, responding to a question in the Scottish Parliament about action taken to improve the treatment and care of people with heart failure.)12 Tackling these challenges will aid implementation of SIGN 147 and members of the hub are currently facilitating a series of meetings across Scotland to raise awareness of the new guideline. A national audit that shows improved outcomes should in time indicate successful implementation of the recommendations contained in this updated guideline.
- Heart failure is a clinical syndrome of symptoms and signs:
- SIGN 147 focuses on the management of heart failure in patients with reduced ejection fraction
- BNP and NT-proBNP levels are raised in patients with heart failure:
- natriuretic peptide levels should be measured (or an electrocardiogram used if BNP testing is not available) to decide whether echocardiography is needed in people with suspected heart failure
- A chest X-ray can help to exclude other causes for the patient's symptoms
- SIGN 147 includes lifestyle recommendations on:
- alcohol reduction/cessation where heart failure is alcohol related
- smoking cessation advice and support
- moderate-intensity supervised exercise programmes and motivational interviewing to promote low-intensity physical activity
- dietary changes
- Pharmacological therapies are updated to include options for using newer drugs in certain situations:
- newer drugs (e.g. sacubitril/valsartan, ivabradine) and intravenous iron should only be initiated under the guidance of a heart failure specialist
- sacubitril/valsartan has been accepted for use in NHS Scotland and by NICE
- ivabradine, in addition to standard care, is recommended in certain situations
- intravenous iron therapy should be considered if certain conditions are met
- Patients with heart failure should be screened for depression:
- therapist-led cognitive behaviour therapy should be considered
- Discharge planning should be comprehensive and include input from a specialist nurse
- The usual health team should be supported to deliver end-of-life care extrapolated from palliative cancer care, with access to specialist advice as needed
- low-dose opioids can be considered for people with dyspnoea.
BNP=B-type natriuretic peptide; NT-proBNP=N terminal-pro-B-type natriuretic peptide
GP commissioning messages
written by Dr David Jenner, GP, Cullompton, Devon
- SIGN Guideline 147 was developed specifically for use in Scotland but has some learning points for CCGs in England
- CCGs should:
- update their formularies to accommodate the new efficacious drugs (ivabradine and sacubitril/valsartan) but indicate if these are for specialist initiation
- ensure the relevant guidance from NICE MTA 314, which is reflected in SIGN 147, informs their commissioning of expensive cardiac resynchronisation therapy and implantable defibrillators
- BNP testing should be universally available to primary care as an initial test to help establish a diagnosis of heart failure and indicate the need for specialist referral
- Depression is a common complication of chronic heart failure and can be treated with CBT
- In England CBT can be provided through the IAPT programme, which forms part of an important national target for CCGs.
SIGN=Scottish Intercollegiate Guidelines Network; MTA=multiple technology appraisal; BNP=B-type natriuretic peptide; CBT=cognitive behaviour therapy; IAPT=improving access to psychological therapies
Read the Guidelines summary of SIGN guideline 147 on the Management of chronic heart failure for more recommendations on how to support patients with chronic heart failure
- Scottish Intercollegiate Guidelines Network. Management of chronic heart failure. SIGN 147. Edinburgh: SIGN, 2016. Available at: www.sign.ac.uk/guidelines/fulltext/147
- Scottish Intercollegiate Guidelines Network. Management of chronic heart failure. SIGN 95. Edinburgh: SIGN, 2007.
- NICE. Chronic heart failure in adults: management. NICE Clinical Guideline 108. NICE, 2010. Available at: www.nice.org.uk/guidance/cg108
- NICE. Sacubitril valsartan for treating symptomatic chronic heart failure with reduced ejection fraction. NICE Technology Appraisal Guidance 388. NICE, 2016. Available at: www.nice.org.uk/guidance/ta388
- McMurray J, Packer M, Desai A et al for the PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. New Engl J Med 2014; 371 (11): 993–1004.
- Desai A, McMurray J, Packer M et al. Effect of the angiotensin-receptor-neprilysin inhibitor LCZ696 compared with enalapril on mode of death in heart failure patients. Eur Heart J 2015; 36 (30): 1990–1997.
- Wise J. NICE approves innovative treatment for moderate to severe heart failure. News. BMJ 2016; 353: i2402.
- Swedberg K, Komajda M, Böhm M et al on behalf of the SHIFT Investigators. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. Lancet 2010; 376 (9744): 875–885.
- NICE. Implantable cardioverter defibrillators and cardiac resynchronisation therapy for arrhythmias and heart failure. NICE Technology Appraisal Guidance 314. NICE, 2014. Available at: www.nice.org.uk/guidance/ta314
- Freedland K, Carney R, Rich M et al. Cognitive behavior therapy for depression and self-care in heart failure patients: a randomized clinical trial. JAMA Intern Med 2015; 175 (11): 1773–1782.
- Woltz P, Chapa D, Friedmann E et al. Effects of interventions on depression in heart failure: a systematic review. Heart Lung 2012; 41 (5): 469–483.
- British Society for Heart Failure.BSH Parliamentary Events: Questions asked at Scottish Parliament. Available at: www.bsh.org.uk/meetings/bsh-parliamentary-events/scotland-parliamentary-event/questions-asked-at-scottish-parliament/ (accessed 15 May 2016). G