Leveraging Guidelines: Understanding Heart Failure, Organizing Care. Commentary on the 2010 NICE Chronic Heart Failure Guideline Update

Guidelines are written for clinicians. The uneven uptake of recommendations to date may reflect ambivalence in the clinician's perception of the status of ‘guidance’, a vulnerability to new evidence and academic disparagement, and a lack of systematic guideline empowerment. As the current political and fiscal environment drives a reappraisal of healthcare organization, with a focus on commissioning ‘Quality’, the role of guidelines may be changing. The National Institute for Health and Clinical Effectiveness (NICE) recently published an updated version of the 2003 chronic heart failure guidelines.1 Following a pre-specified scope directing independent analysis of evidence, several new recommendations have been produced (Box ). The purpose of these recommendations can broadly be summarized through two interlinked themes. The first and most immediate is the need for optimization; of the diagnostic opportunity, of the therapeutic strategy and of the organization of care. The second is a more conceptual need for greater understanding of the broader issue of the ‘congestive syndrome’, which increasingly predominates in ageing populations. Key recommendations Diagnosis Treatment Rehabilitation Monitoring Discharge planning The diagnosis of heart failure is often opportunistic, and frequently delayed. In diagnosing heart failure, no specific strategy had been recommended in the 2003 guidance, with use of natriuretic peptides (NP) seen as an optional adjunct to the electrocardiogram. Uptake was limited. On the basis of new data, a health technology analysis of NP,2 and evidence of persistent early attrition following the diagnosis of heart failure,3 direct referral for echocardiography and specialist assessment is now recommended for patients with suspected heart failure and a history of prior myocardial infarction (MI). This should occur within 2 weeks. Where MI has not occurred, NP should be measured, with the urgency of referral dictated by the degree of NP elevation. Concern has been expressed over the demand this may place upon services, however, the prognostic power of NP (a ‘death hormone’ to one independent expert), was felt by the guideline group to demand a response time at least comparable with the perhaps less ‘malignant’ cancers, for which 2 week referral is mandatory in England. While most therapies for left ventricular systolic dysfunction (LVSD) are well-established, randomized controlled trials published since 2003 have clarified the role and timing of medications; device therapy lies within another review area. The revised guidelines now recommend the combination of both angiotensin-converting enzyme (ACE) inhibitors (or angiotensin-receptor blockers if truly intolerant) and beta-blockers as ‘first line’ therapy. In common with other guidelines the addition of ‘second line’ treatment with an aldosterone antagonist, angiotensin-receptor blocker or the combination of nitrate and hydralazine should be considered, in appropriate populations, if symptoms persist. Although heart failure with preserved ejection fraction (HFpEF) is recognized as an increasing problem, it remains poorly understood. The absence of any treatment recommendations reflects the lack of benefit seen in limited studies to date. For all patients with heart failure, the importance of physical activity, with emotional and psychological support, is reflected in a new recommendation that patients should be included in group, exercise-based rehabilitation programmes. While supported by a strong evidence base, the variability of the exercise regimens reviewed precluded the identification of any specific methodology. The potential benefits of earlier diagnosis and optimal treatment are mediated through the context in which care is delivered. Evidence that both specialist supervision4,5 and nurse-led management programmes improve outcome is recognized in the updated recommendation that the initial diagnosis should be made by a specialist (in conjunction with formal echocardiographic assessment). Specialist supervision is also recommended where symptoms persist or worsen, or the patient is hospitalized. The updated definition of specialist (Box ) is the product of lengthy interaction between external stakeholders and the eight clinicians on the group (one epidemiologist, one physician, one specialist heart failure nurse, two general practitioners, and three cardiologists). While healthcare systems may argue over whom best meets these responsibilities and how the necessary skills should be verified, there was unanimity among the clinicians (and two patient representatives) that specialist oversight of care was mandatory. The definition of a specialist Throughout this guideline, the term ‘specialist’ denotes a physician with subspecialty interest in heart failure (often a consultant cardiologist) who leads a specialist multidisciplinary heart failure team of professionals with appropriate competencies from primary and secondary care. The team will involve, where necessary, other services (such as rehabilitation, tertiary care and palliative care) in the care of individual patients In optimizing continuity of care, the interface between hospital and community is particularly important. Although the focus of clinical programmes, research on discharge planning is scant, thus the new guidelines endorse the 2003 recommendations. The guideline scope included review of both ‘tele-health’ and NP to maintain patient stability in the community; however, the guideline group was unable to produce firm recommendations, in part because of the heterogeneity of the evidence, but primarily due to the dominant confounding influence of organized systems of care. Importantly therefore, in the new guideline a multidisciplinary approach spanning primary and secondary care is embedded within the definition of specialist. While review and clarification of the current evidence is important and worthwhile, the process is, of necessity, retrospective. It would be easy, with new clinical trial evidence emerging,6 to argue that this guideline is already outdated. To make such a case, however, would be to miss both the potential impact of the guideline on how we understand heart failure, and the impact of the current economic climate on how care is organized. Since the 2003 guideline there has emerged a lesser certainty about the broader entity of heart failure. While LVSD is clearly defined and treatment options are well-evidenced, how does one reconcile the role of echocardiography as ‘gold standard’, with the growing epidemiological evidence that ejection fraction is normally distributed in populations with heart failure,7 and that prognosis is unaffected8 by the physiologically and conceptually misguided9,10 dichotomization of the ejection fraction continuum. Is reference to the ejection fraction as preserved (let alone normal) helpful, or a confusing legacy? Is our difficulty in understanding HFpEF a ‘failing’ of echocardiography, of the clinician or of the classification? By providing an alternative and reasonably robust measure of left ventricular dysfunction irrespective of the ejection fraction, NP offer a useful new discriminator. That they make no distinction between the cause of the ventricular ‘stress’ is a potential disadvantage—NP can be elevated in sepsis for example. A powerful advantage, however, is that they offer an index of cardiac dysfunction (and prognosis) that more closely reflects the clinical and epidemiological picture of heart failure as a continuum. Although lacking specificity, NPs allow us to see heart failure through a lens not clouded by echocardiography. This is important. In placing NP as the first discriminating test for many with suspected heart failure two consequences arise. First the purpose of echocardiography becomes one of helping to ‘explain’ the elevated NP result, a task subtly different and perhaps more demanding than its historical role as arbiter of heart failure. In addition there may be many patients in whom the echo ‘fails’ to explain the elevated NP. Notwithstanding cries that this will breed confusion, the light cast upon the prevalence and morbidity of the ‘congestive syndrome’ will challenge us to more fully understand heart failure. We have also seen repeated epidemiological studies indicating that standards of usual care in heart failure fall short of that seen in clinical studies or in managed care systems.11 Recent observational and registry studies suggest that, within countries, uptake of evidence-based medication increases over time,12 and may be associated with improved outcome,13 however, sub-optimal dosage and under-utilization in groups such as the elderly persist. The ongoing ESC-HF pilot study14 is investigating whether such improvement is uniform, or subject to national differences in ‘care attitudes’ and the organization of services. However, the pace of this change is slow and any direct association with the publication of guidelines uncertain. What we do know is that well-organized multi-professional teams, integrating secondary and primary healthcare, improve outcomes.15 We also know that the prevalence of heart failure is increasing. At a time of financial constraint, the burden imposed by rising heart failure (re)admissions is driving an increased emphasis on optimizing care to reduce non-elective admission. Herein lies a paradox clearly visible to healthcare economists. Guidelines recommend evidence-based interventions, which, if implemented should improve both the quality and outcome of care. Better outcome includes fewer hospital admissions, which reduces the cost of care. It takes little imagination to close this loop. Deliver adherence to guideline-based performance indicators (through incentives?) and by proxy improve quality of care; then measure and compare outcomes. Such ‘pay for performance’ systems already exist in the USA, where improvement in the quality of care is reported to be associated with reduced morbidity and cost,16 and are being adopted in pilot sites in the UK. As part of a consultation on major reorganization, the National Health Service recently published an NHS Outcomes Framework17 that envisages key performance indicators. ‘Quality Standards’ for stroke are already being implemented by Commissioners and are in development heart failure. While such ‘accountability’ in care delivery may be inevitable, the processes needed to deliver indicators that are fit for purpose require clarification.18 A patient with suspected heart failure should receive a prompt, accurate diagnosis. Where heart failure is confirmed optimal treatment should be available through a system of care that transcends boundaries. At least for patients with LVSD, as new treatment options diminish and treatment strategies become more established, attention turns to the organization and delivery of care. In emphasizing the organizational components within the management of chronic heart failure, the 2010 NICE guideline builds on the recent ESC guidance.19 Thus to diagnose heart failure, the NICE guidance moves away from the historic interplay of signs, symptoms and non-specific diagnostic tests, to a simplified diagnostic strategy based solely on history of MI, clinical suspicion, history, and biomarker. This, and time-specified specialist review should lead to faster diagnosis and initiation of treatment. Multidisciplinary care, although common to both guidelines is a central component of the new guidance, driven by a focus on the role of the heart failure specialist. This is new and challenging—the word specialist is mentioned only in the context of renal impairment and palliative care in the ESC text. Yet we know there are gaps in care—we expect specialist-led teams for cancer—why not for heart failure? Beyond organization is a need to understand the wider picture of heart failure. If ‘preserved’ ejection fraction predominates in hospitalized heart failure patients, as has been suggested by recent studies,8 then it is to this area that our attention will need to turn if we are to address the increasing burden of heart failure seen in aging populations. As a start we need to include them in care planning. A diagnostic strategy based upon NP, and inclusive multidisciplinary care will highlight this population and their needs. At the heart of all guidance is the knowledge that our organization and understanding of heart failure can improve. Hitherto clinicians may have perceived guidelines as more of an option than a mandate. This may need to change as healthcare systems increasingly seek to leverage guidelines to maximize the quality and outcome of care. It is up to clinicians to guide this process. Conflict of interest: The opinions expressed are those of H.F.M. who was a member of the guideline development group. H.F.M. has received reimbursement from the pharmaceutical industry for conference expenditure and attendance, and for consultancy and lecturing. A record of conflicts of interest relating to the guideline update is available through www.guidance.nice.org.uk.