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Heart failure is increasing in prevalence.1 This is in part due to reduced mortality as a result of major advances in treatment since 1986, when the VHEFT-I study was published.2 It is also associated with ageing of the population, and longer survival of people with conditions that lead on to heart failure such as ischaemic heart disease, hypertension and atrial fibrillation.
The incidence and prevalence of heart failure rise with age. In the 1980s the Framingham study of those aged ≥45 years found that the age-adjusted prevalence of overt heart failure was 24/1000 in men and 25/1000 in women.3 In Finland the prevalence of heart failure in those aged 75–86 years was 8.2%.4 The EPIC study found that the prevalence of heart failure in those aged >25 years in Portugal was 4.36%.5
The annual age-adjusted incidence of heart failure in the Framingham study (in the 1980s) was 7.2 cases/1000 in men and 4.7 cases/1000 in women.3 The annual incidence rises steeply with advancing age to 40 cases per 1000 for those aged >75 years.6 Furthermore, the Hillingdon study found that the incidence of heart failure rises to 1% per annum in the population over 85 years of age.7 The mortality of new cases of heart failure is 14% at 6 months.8 Hospitalised patients with heart failure have a 10% inpatient mortality rate, and up to 32% mortality rate at 1 year.9
In 2003, the National Institute for Health and Clinical Excellence (NICE) produced its clinical guideline on the diagnosis and management of chronic heart failure.10 This provided detailed guidance for healthcare professionals on the full spectrum of care for patients with heart failure. Since then, advances in the evidence base necessitated a partial update of the guideline, published in 2010, covering diagnosis, pharmacological therapy, monitoring and rehabilitation of these patients.11 The guideline covers patients with heart failure with left ventricular systolic dysfunction (HF-LVSD) and those with preserved ejection fraction (HFPEF).11
There are significant changes to the diagnostic algorithm recommended by NICE in 2010 compared with 2003. These include giving a central role to natriuretic peptide testing, ensuring that diagnosis is made within a specific time frame, and stressing the importance of specialist assessment in addition to echocardiography in making the final diagnosis. Unchanged from 2003 is the recommendation that transthoracic two-dimensional (2D) echocardiography is required in patients with heart failure to help establish the diagnosis and to exclude important valve disease, assess the systolic (and diastolic) function of the (left) ventricle and detect intracardiac shunts.11
Central role for natriuretic peptide testing
In the 2003 guideline, ECG and natriuretic peptide testing were recognised to be useful ‘rule out’ tests in that a normal ECG and low natriuretic peptide levels made a diagnosis of heart failure unlikely. There is now evidence that natriuretic peptides are superior to ECG in diagnosing heart failure, and that adding ECG to natriuretic peptide testing does not increase accuracy,12 so in the 2010 guideline natriuretic peptide testing alone is recommended to determine which patients should be referred for echocardiography and specialist assessment (except in cases of previous myocardial infarction—see below). It is recognised that the higher the natriuretic peptide level, the worse the prognosis and the higher the likelihood of a positive diagnosis of heart failure.13 Therefore, more urgent referral is recommended when the natriuretic peptide level is high (see below).
Expediting the diagnosis
Once patients have developed symptoms and signs of heart failure they are at increased risk of hospitalisation and death, particularly in the first few weeks after onset.13 These adverse outcomes can be modified by timely therapeutic interventions. Therefore, NICE recommends specialist clinical asssessment and echocardiography within 2–6 weeks from presentation. A history of myocardial infarction in someone presenting with symptoms and signs suggestive of heart failure is a strong predictor that heart failure is the diagnosis. Therefore, NICE now recommends that in such cases, the echocardiogram and specialist clinical assessment should be provided within 2 weeks without prior natriuretic peptide testing. Those with no previous myocardial infarction should have their serum natriuretic peptide measured. If the natriuretic peptide level is elevated, then the echocardiogram and the specialist clinical opinion should be within 2 weeks where the natriuretic peptide is high (brain natriuretic peptide (BNP) >400 pg/ml (116 pmol/l) or N-terminal pro-BNP (NT-proBNP) >2000 pg/ml (236 pmol/l)), or within 6 weeks if the natriuretic peptide is raised (BNP 100–400 pg/ml (29–116 pmol/l) or NT-proBNP 400–2000 pg/ml (47–236 pmol/l)). Patients with natriuretic peptides below the threshold (BNP <100 pg/ml (29 pmol/l) or NT-proBNP <400 pg/ml (47 pmol/l)) who are not on therapeutic agents known to lower the level of the natriuretic peptide are unlikely to have heart failure.
Choosing appropriate thresholds is problematic. With maximum sensitivity (so that the least cases of heart failure are missed), the specificity of natriuretic peptide testing is low, with the result that many patients would be referred for echocardiography and specialist assessment who did not have heart failure. The thresholds for natriuretic peptides adopted by NICE are the same as those used in the European Society of Cardiology heart failure guidelines of 2008.14 This was based on them being close to the thresholds found to be cost-effective in the diagnosis of heart failure in the Mant et al Health Technology Appraisal.12 The use of these thresholds takes into consideration the most appropriate sensitivity and specificity level in cohorts of patients with suspected heart failure and includes patients with HFPEF and HF-LVSD.
Importance of specialist assessment
The 2003 guideline stressed the importance of the echocardiography being performed on high resolution equipment by experienced operators trained to the relevant professional standards. In the light of the difficulties in establishing the diagnosis in patients with HFPEF, the importance of early therapy in HF-LVSD and the importance of selecting patients for further investigations and interventions, the 2010 guidelines go further, and recommend that specialist assessment is combined with echocardiography to make the diagnosis. Although the management of patients with chronic heart failure in the guideline is delivered by a specialist multidisciplinary heart failure team, who will decide who is the most appropriate team member to address a particular clinical problem, the responsibility for the ‘initial specialist assessment’ lies with the ‘specialist’ who is a physician with a subspeciality interest in heart failure (often a consultant cardiologist). The specialist leads the specialist multidisciplinary heart failure team that includes appropriate competencies from primary and secondary care.11 The diagnosis algorithm is given in figure 1.
The therapeutic algorithm was built on the basis of dividing patients according to the results of echocardiography into those with impaired left ventricular contraction (HF-LVSD) and those with preserved left ventricular ejection fraction (HFPEF).
Heart failure with preserved ejection fraction
Since 2003, randomised controlled trials have been published evaluating the effectiveness of angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in HFPEF.15–17 There have been no studies specifically looking at β-blockers (BBs) in HFPEF, but one trial included a substantial proportion of people with HFPEF, for whom outcomes were reported separately.18 NICE did not feel that there was sufficient weight of evidence to recommend any of these agents as standard therapy in HFPEF, and endorsed the 2003 recommendations that such patients are treated with diuretics to relieve congestion.10 11 While ACEI, ARBs and BBs are not recommended as treatments specifically for HFPEF, it was recognised that management of co-morbidities of HFPEF such as hypertension, ischaemic heart disease and diabetes mellitus would often involve use of these agents.11
Heart failure with left ventricular systolic dysfunction
Historically ACEIs were commenced before BBs (and this sequencing of therapy was endorsed in the 2003 guideline).10 Since 2003, however, there is some evidence to show similar outcome irrespective of which agent is commenced first.19 Therefore, the 2010 guideline does not specify a favoured drug to start first, and maintains the emphasis on aiming to establish patients on both agents, with doses up-titrated as tolerated up to the maximum doses tested in the clinical trials. Thus, in addition to diuretics, all patients with HF-LVSD should be treated with the combination of an ACEI and BB licensed for heart failure in a ‘start low, go slow’ fashion, while monitoring the renal function (for ACEIs and some BBs), blood pressure (for ACEIs and BBs) and heart rate (for BBs). These two classes of treatment have proven effectiveness in improving symptoms, and reducing hospitalisation and mortality rates.
In the light of concern that use of BBs remains suboptimal, a new recommendation was added emphasising that such drugs could be used in a variety of patients with heart failure, including older adults and those with peripheral vascular disease, erectile dysfunction, diabetes mellitus, interstitial pulmonary disease and chronic obstructive pulmonary disease without reversibility.11
Since 2003, more evidence has become available as to the effectiveness of ARBs as a possible substitute for ACEIs in HF-LVSD. However, the evidence base remains stronger for ACEIs than ARBs, so the guideline stresses that the latter should be used to replace ACEIs only where the side effects of ACEIs are intolerable.11
Very rarely, patients who are intolerant to both ACEIs and ARBs can be considered for the combination of both hydralazine and nitrates along the lines of the VHEFT-I trial.2
Those who remain symptomatic despite optimal therapy with ACEIs and BBs can be considered for the addition of a second-line pharmacological agent for HF-LVSD. NICE recommended that such a decision should be taken by a specialist. These second-line agents have proven efficacy when combined with first-line treatment in reducing heart failure morbidity and mortality (aldosterone antagonists or the combined hydralazine and nitrate), or reducing the combined end point of hospitalisation and mortality (ARBs).
The evidence base at the time of evidence review for the NICE guideline-partial update suggested that an aldosterone antagonists (spironolactone or eplerenone) should be added in the presence of symptoms of moderate to severe heart failure (New York Heart Association (NYHA) class III–IV), and where heart failure follows in the first 4 weeks after an acute myocardial infarction.11 20 21
Since the release of the NICE update, the Emphasis-HF trial was published online on 14 November 2010. In the Emphasis-HF trial, eplerenone at a mean dose of 39 mg or placebo was added to optimal first-line therapy (93–94% were on an ACEI, ARB or both; and >86% were on BBs) in 2737 patients aged ≥55 years with mild symptoms of heart failure (NYHA class II), who had either been hospitalised in the last 6 months, or their natriuretic peptide levels were still elevated despite therapy at (BNP ≥250 pg/ml or NT-proBNP of ≥500 pg/ml in men or ≥750 pg/ml in women). Use of eplerenone was associated with significantly lower rates of hospitalisation and mortality (from heart failure, cardiovascular causes and all causes).22
The addition of either an aldosterone antagonists or an ARB to treatment to an ACEI requires close monitoring of renal function and serum potassium.
The third option for second-line therapy is to use the combination of hydralazine and nitrate. This results in arterial and venous dilatation which reduces preload and afterload, respectively. This combination was the first intervention proven to improve prognosis in heart failure.2 ACEIs were subsequently shown to be superior to this combination in VHEFT-II in 1991.25 Thus, their use became limited largely to those intolerant to ACEIs (and later to ARBs), until the impact of race on response to ACEIs became recognised26 and the subsequent AHEFT study showed that patients with symptoms of moderate to severe heart failure of African-Caribbean origin derived further survival benefit from adding this combination to optimal heart failure therapy.27
Where indicated, therapy with a defibrillator may be considered.28 In addition, patients with HF-LVSD who remain symptomatic despite optimal first- and second-line treatments, and who have dys-synchrony should be considered for cardiac resynchronisation therapy with multisite pacemakers.29
Patients with either continuing symptoms or repeated admissions despite optimal therapy can be considered for treatment with digoxin.10
A new class of drug not previously used in heart failure is ivabradine. This is an inhibitor of the If current in the sinoatrial node. Ivabradine was originally marketed as an antianginal agent. However, shortly after the publication of the NICE guidelines for chronic heart failure-partial update, the SHIFT trial was published.30 In this trial, 6558 patients hospitalised because of heart failure in the preceding year, in sinus rhythm with a heart rate ≥70 bpm, and who were taking BBs if tolerated, were randomised to ivabradine or placebo. Ivabradine reduced heart failure hospitalisation by 26% and heart failure mortality by 26%.
NICE did not consider the potential place of ivabradine in the therapeutic pathway since the publication of SHIFT postdated the publication of the NICE update. While ivabradine appears a promising new agent; interpretation of the results of SHIFT will depend upon the extent to which the study population is felt to truly have been on optimal β-blockade.
The treatment algorithm is given in figure 2.
Many of the recommendations on monitoring from 2003 were carried forward in the 2010 guidelines.10 11 Heart failure is characterised by recurrent hospitalisation, and by an unpredictable though on the whole progressive course. Thus, monitoring is an essential component of care of these patients. Patients may wish to be involved in their management, particularly in monitoring their weight, fluid balance and sometimes their vital signs. Monitoring also includes regular assessment of the renal profile, nutritional status, rhythm and electrocardiographic parameters such as the development of left bundle branch block.11
Two areas where there has been considerable new evidence since 2003 have been in evaluation of the potential role of telemonitoring and of natriuretic peptides to monitor disease progression. The NICE guideline does not recommend the use of telemonitoring, as it is not clear whether the benefits associated with telemonitoring were due to frequent health professional contact with which telemonitoring was associated, or due to the use of telemonitoring.11 Monitoring of natriuretic peptides was helpful in patients with high risk of readmission, such as those already hospitalised. The impact of such monitoring appears to be mediated by improving the up-titration of therapy.11
Since 2003, there have been a number of trials published looking specifically at rehabilitation in patients with heart failure. These trials show that exercise-based rehabilitation can lead to better exercise tolerance, improved quality of life and reduced hospitalisation for heart failure. Therefore, NICE recommends that stable patients with heart failure should be offered group-exercise-based rehabilitation that includes continuing education and psychological support.11 This rehabilitation should be designed for patients with heart failure, but may be incorporated within existing cardiac rehabilitation programmes.
The key recommendations of the NICE guideline on chronic heart failure are given in box 1.
Key priorities for implementation of the chronic heart failure NICE clinical—guideline 108
Refer patients with suspected heart failure and previous myocardial infarction (MI) urgently, to have transthoracic Doppler 2D echocardiography and specialist assessment within 2 weeks. (new 2010)
Measure serum natriuretic peptides (B-type natriuretic peptide (BNP) or N-terminal pro-B-type natriuretic peptide (NTproBNP)) in patients with suspected heart failure without previous MI. (new 2010)
Because very high levels of serum natriuretic peptides carry a poor prognosis, refer patients with suspected heart failure and a BNP level above 400 pg/ml (116 pmol/litre) or an NTproBNP level above 2000 pg/ml (236 pmol/litre) urgently, to have transthoracic Doppler 2D echocardiography and specialist assessment within 2 weeks. (new 2010)
Offer both ACE inhibitors and beta-blockers licensed for heart failure to all patients with heart failure due to left ventricular systolic dysfunction. Use clinical judgement when deciding which drug to start first. (new 2010)
Offer beta-blockers licensed for heart failure to all patients with heart failure due to left ventricular systolic dysfunction, including:
Older adults and
Patients with:—peripheral vascular disease—erectile dysfunction—diabetes mellitus—interstitial pulmonary disease and—chronic obstructive pulmonary disease (COPD) without reversibility. (new 2010)
Seek specialist advice and consider adding one of the following if a patient remains symptomatic despite optimal therapy with an ACE inhibitor and a beta-blocker:
An aldosterone antagonist licensed for heart failure (especially if the patient has moderate to severe heart failure (NYHA class III–IV) or has had an MI within the past month) or
An angiotensin II receptor antagonist (ARB) licensed for heart failure (especially if the patient has mild to moderate heart failure (NYHA class II–III)) or
Hydralazine in combination with nitrate (especially if the patient is of African or Caribbean origin and has moderate to severe heart failure (NYHA class III–IV)). (new 2010)
Offer a supervised group exercise-based rehabilitation programme designed for patients with heart failure.
Ensure the patient is stable and does not have a condition or device that would preclude an exercise-based rehabilitation programme.
Include a psychological and educational component in the programme.
The programme may be incorporated within an existing cardiac rehabilitation programme. (new 2010)
All patients with chronic heart failure require monitoring. This monitoring should include:
a clinical assessment of functional capacity, fluid status, cardiac rhythm (minimum of examining the pulse), cognitive status and nutritional status;
a review of medication, including need for changes and possible side effects;
serum urea, electrolytes, creatinine and eGFR. (2003, amended 2010).
When a patient is admitted to hospital because of heart failure, seek advice on their management plan from a specialist in heart failure. (new 2010)
Patients with heart failure should generally be discharged from hospital only when their clinical condition is stable and the management plan is optimised. Timing of discharge should take into account patient and carer wishes, and the level of care.
Palliative care and end of life
The palliative care aspects of management of heart failure were not formally considered in the update, but the importance of this aspect of care and the continued relevance of the recommendations from 2003 were endorsed.10 Issues of sudden death and living with uncertainty are pertinent to all patients with heart failure. The opportunity to discuss these issues should be available at all stages of care. The palliative needs of patients and carers should be identified, assessed and managed at the earliest opportunity. This aspect of care is not exclusive to specialist palliative care services, but remains an essential component of good care given by all health professionals looking after patients with heart failure. Access to specialist palliative care opinion and involvement should be via the multidisciplinary heart failure team.
The implementation of the new chronic heart failure NICE guidance will put initial demands on an already financially stretched health service through provision of natriuretic peptide to all primary care physicians, provision of faster and coherent diagnostic processes and availability of rehabilitation. However, all these interventions are of proven cost-effectiveness, and will result in reduced morbidity and mortality. In the long run, these implementation costs should be offset by a reduced hospitalisation rate. It is estimated that the full implementation of the guidance will save the health service in England the sum of £9.7 million, and a sample population of 100 000 people could expect an annual saving of £19 000.31
Competing interests AA-M was the Clinical Advisor to the Guideline Development Group at NICE producing the Clinical Guideline 108. JM was the Chair of the Guideline Development Group at NICE producing Clinical Guideline 108. Both authors are current members of the Topic Expert Group at NICE producing the Quality Standards for Heart Failure.
Provenance and peer review Commissioned; not externally peer reviewed.