Jonathan Mant, MD; Abdallah Al-Mohammad, MD; Sharon Swain, BA(Hons), PhD; Philippe Laramée, DC, MSc; for the Guideline Development Group
Disclaimer: The views expressed in this publication are those of the authors and not necessarily those of the National Institute for Health and Clinical Excellence.
Acknowledgment: The authors thank the members of the Chronic Heart Failure guideline development group.
Financial Support: The National Clinical Guideline Centre was commissioned and funded by the National Institute for Health and Clinical Excellence to write this summary.
Potential Conflicts of Interest: Dr. Mant: Grant (money to institution): National Institute for Health and Clinical Excellence; Support to travel for meetings for the study of other purposes: National Institute for Health and Clinical Excellence; Consultancy (money to institution): Boehringer Ingelheim, PharmaSwiss; Payment for lectures including service on speakers bureaus: Boehringer Ingelheim; Royalties: BMJ Books. Dr. Al-Mohammad:Payment for lectures including service on speakers bureaus: Primary Care 2011; Other: eGuidelines.co.uk. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M11-0261.
Requests for Single Reprints: Jonathan Mant, MD, General Practice and Primary Care Research Unit, University of Cambridge, Cambridge CB2 0SR, United Kingdom; e-mail, email@example.com.
Current Author Addresses: Dr. Mant: General Practice and Primary Care Research Unit, University of Cambridge, Cambridge CB2 0SR, United Kingdom.
Dr. Al-Mohammad: South Yorkshire Cardiothoracic Centre, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield S5 7AU, United Kingdom.
Drs. Swain and Laramée: National Clinical Guideline Centre, Royal College of Physicians of London, London NW1 4LE, United Kingdom.
Author Contributions: Conception and design: J. Mant, A. Al-Mohammad, P. Laramée.
Analysis and interpretation of the data: J. Mant, A. Al-Mohammad, S. Swain, P. Laramée.
Drafting of the article: J. Mant, A. Al-Mohammad, S. Swain, P. Laramée.
Critical revision of the article for important intellectual content: J. Mant, A. Al-Mohammad, P. Laramée.
Final approval of the article: J. Mant, A. Al-Mohammad, P. Laramée.
Statistical expertise: P. Laramée.
Collection and assembly of data: A. Al-Mohammad, S. Swain, P. Laramée.
Members of the guideline development group are listed in the Appendix.
Mant J., Al-Mohammad A., Swain S., Laramée P., ; Management of Chronic Heart Failure in Adults: Synopsis of the National Institute for Health and Clinical Excellence Guideline. Ann Intern Med. 2011;155:252-259. doi: 10.7326/0003-4819-155-4-201108160-00009
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Published: Ann Intern Med. 2011;155(4):252-259.
Appendix: Guideline Development Group Members
The National Institute for Health and Clinical Excellence released its first clinical guideline on heart failure in 2003. This synopsis describes the update of that guideline, which was released in August 2010 and discusses the diagnosis, treatment, and monitoring of heart failure.
Guideline developers considered clinical evidence, health economic analyses, clinical expert opinion, and patient views. Systematic literature searches were performed, and an original decision model assessed the cost-effectiveness of serial measurement of serum natriuretic peptide to monitor patients with chronic heart failure.
First, this guideline update describes the role of serum natriuretic peptide measurement, echocardiography, and specialist assessment in the diagnosis of heart failure. Second, it presents a pathway for pharmacologic treatment, rehabilitation, and pacing therapy (including implantable cardioverter-defibrillator and cardiac resynchronization therapy) for patients with heart failure and left ventricular systolic dysfunction and patients with heart failure and preserved ejection fraction. Finally, it explains the recommendation to monitor patients with heart failure by using serial measurement of serum natriuretic peptide.
Chronic heart failure is a complex clinical syndrome with increasing prevalence (1, 2). This condition causes high hospitalization and mortality rates and carries a substantial economic burden. The National Institute for Health and Clinical Excellence (NICE), which develops clinical practice guidelines for the National Health Service of England and Wales, published its first guideline on heart failure in 2003 (3).
Every 3 years, NICE evaluates the need for guideline updates by using 2 key sources of information. First, literature searches are performed to identify new evidence, warnings issued by licensing agencies, and major changes in costs. Second, the National Clinical Guideline Centre seeks the views of health care professionals and patients. As a result of this process, NICE issued a partial update of the guideline on the management of chronic heart failure in adults in August 2010 (4, 5).
The update summarized in this synopsis focuses on the role of symptoms and signs, B-type serum natriuretic peptides (BNP) (specifically, BNP and N-terminal fragment of prohormone BNP [NT-proBNP]) levels, and echocardiography in the diagnosis of heart failure. It also focuses on pharmacologic treatment of heart failure and incorporating recommendations from the NICE Technology Appraisal Committee on the roles of cardiac resynchronization therapy and implantable cardioverter-defibrillators (ICDs) in the management of heart failure (6, 7). Finally, this update focuses on disease monitoring, specifically the serial measurement of serum natriuretic peptide and telemonitoring.
The guideline applies to nonpregnant adults with symptoms of chronic heart failure. It does not apply to persons with acute heart failure or acute exacerbations of chronic heart failure.
The guideline was developed in accordance with the methods described in the 2009 NICE guidelines manual (8) and summarized in previous publications (9, 10). In brief, systematic literature searches identified published literature relevant to the clinical issues previously described. The cutoff date for all searches was October 2009. The databases, search dates, and search terms varied for each question. The guideline development group (GDG) posed several questions designed to cover the topics included in the scope of the review and aimed to explore the new emerging evidence base. The search strategies are outlined in Appendix D of the full guideline (11).
Table 1 provides the MEDLINE search strategy for chronic heart failure. Only articles published in English were included. Systematic reviews or randomized, controlled trials were included, but lower-quality evidence, such as cohort studies, were included only if these trials were unavailable.
In addition to the systematic literature reviews, an original decision model was constructed to assess the cost-effectiveness of using serial measurement of serum natriuretic peptide to monitor patients with chronic heart failure, because the cost-effectiveness of this intervention versus that of current practice is uncertain. The GDG included general practitioners, specialist nurses, a consultant physician consultant cardiologists, and 2 members representing patients and caregivers.
The technical team that supported guideline development included a chair, clinical advisor, project manager, information scientist, research fellow, and health economist. The technical team attended each GDG meeting and met approximately 2 weeks before each GDG meeting to discuss the draft review of the clinical and health economic evidence. Each GDG member completed a declaration of potential conflicts of interest form, updated this form throughout the development process, and managed potential conflicts of interest in accordance with NICE policy (9).
The guideline developers evaluated the strength of evidence by using an adaptation of the Grading of Recommendations Assessment, Development and Evaluation Working Group's toolbox (www.gradeworkinggroup.org) (8). Table 2 summarizes this method for grading the quality of evidence.
A clinician with expertise in heart failure reviewed the draft of the guideline. The guideline was also available on the NICE Web site for 8 weeks, during which registered stakeholders, including patient groups, were invited to comment. The guideline was modified on the basis of these reviews.
The full NICE chronic heart failure guideline (5) contains the complete list of recommendations, as well as the evidence underpinning these recommendations. Appendix E of the guideline (11) includes evidence tables that summarize studies comprising the clinical and health economic evidence.
Figure 1 summarizes the recommendations for diagnosis of heart failure. Diagnosis should begin with a detailed history and physical examination if heart failure is suspected. Other investigations include electrocardiography and consideration of chest radiography, peak flow measurement or spirometry, and blood tests (including renal, liver, and thyroid function studies; a lipid profile; complete blood count; and measurement of blood glucose). These studies and the history and physical examination are performed in part to consider possible aggravating factors and alternative diagnoses.
Normal serum natriuretic peptide levels are defined as BNP levels <100 ng/L or NT-proBNP levels <400 ng/L. Raised serum natriuretic peptide levels are defined as BNP levels between 100 ng/L and 400 ng/L or NT-proBNP levels between 400 ng/L and 2000 ng/L. High serum natriuretic peptide levels are defined as BNP levels >400 ng/L or NT-proBNP levels >2000 ng/L. BNP = B-type natriuretic peptide; NT-proBNP = N-terminal fragment of prohormone BNP.
Patients without previous myocardial infarction should undergo measurement of serum natriuretic peptide with subsequent echocardiography, and specialist evaluation is indicated if these levels are elevated. Patients with a history of myocardial infarction should proceed directly to echocardiography and specialist evaluation; if the echocardiogram is normal, then clinicians should consider measuring serum natriuretic peptide.
Heart failure is associated with a poor prognosis, poor quality of life, and high health care costs. Pharmacologic therapy can improve these outcomes. Prompt diagnosis enables appropriate use of effective treatment. Thus, echocardiography and specialist evaluation should be available within 2 weeks of presentation if patients have a history of myocardial infarction or high serum natriuretic peptide levels and no later than 6 weeks after presentation if the serum natriuretic peptide levels are increased but not high (Figure 1).
Clinical signs and symptoms are of limited use in the diagnosis of heart failure. Moderate- to high-quality evidence shows that measurement of serum natriuretic peptide levels (both BNP and NT-proBNP) has high sensitivity but only moderate specificity for diagnosis of heart failure. The GDG noted that the consensus-based recommendations of the European Society of Cardiology (12) were consistent with cutoff levels proposed in an economic analysis that was appraised for the NICE guideline (13) and therefore adopted the same levels recommended by the European Society of Cardiology (Figure 1).
Economic analysis suggested that it was more cost-effective to directly refer patients with a higher probability of heart failure for echocardiography without first measuring serum natriuretic peptide (13). The GDG reviewed the evidence for possible indicators of high probability of heart failure from the history and clinical features and considered that a history of myocardial infarction was the most reliable of the clinical features predictive of heart failure when ascertained by a generalist. Patients with normal serum natriuretic peptide levels are unlikely to have heart failure and therefore do not require referral for echocardiography; however, therapy with diuretics, angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs), or β-blockers will reduce these levels.
Echocardiography also has an important role in excluding valve disease, assessing systolic and diastolic function, and detecting intracardiac shunts. The National Institute for Health and Clinical Excellence recommends that echocardiography be performed on high-resolution equipment by experienced operators trained in the relevant professional standards. Specialist involvement is recommended to accurately identify the cause of heart failure, including correctable causes.
Figure 2 summarizes the recommendations for treatment of heart failure. Clinicians should focus on managing comorbid conditions, such as hypertension, ischemic heart disease, and diabetes mellitus, in patients with preserved ventricular function. Patients with left ventricular systolic dysfunction should receive both an ACE inhibitor and a β-blocker as first-line therapy.
The term “licensed for heart failure” refers to drugs that have been approved for use for the given indication by regulatory agencies in the United Kingdom. ACE = angiotensin-converting enzyme; ARB = angiotensin-receptor blocker; CRT = cardiac resynchronization therapy; ICD = implantable cardioverter-defibrillator; MI = myocardial infarction; NICE = National Institute for Health and Clinical Excellence.
* For more information on drug treatment, see Appendix J to the NICE clinical guideline on heart failure (11) and the NICE clinical guideline on chronic kidney disease (14).
† Consider using an ICD according to the recommendations described in the NICE technology appraisal on ICDs (7).
‡ New York Heart Association class III to IV.
§ Not all ARBs are licensed for use in heart failure in combination with ACE inhibitors.
|| New York Heart Association class II to III.
¶ This does not include persons of mixed race. For more information, see the full NICE chronic heart failure guideline (5).
** Consider using a CRT according to the recommendations described in the NICE technology appraisal on CRT (6).
If ACE inhibitors are not tolerated, ARBs are an alternative. Patients who are intolerant of both ACE inhibitors and ARBs should receive combination therapy with hydralazine and a nitrate. In patients with persistent symptoms, specialist referral is warranted for consideration of additional drug therapy, cardiac resynchronization therapy, and an ICD.
The GDG found insufficient evidence to recommend specific therapies for heart failure with preserved ejection fraction, other than treatment of comorbid conditions and diuretic therapy to manage fluid retention. Although most trials evaluating rehabilitation recruited only patients with left ventricular systolic dysfunction, the GDG recommended offering rehabilitation to patients with heart failure with preserved ejection fraction, because the symptoms and prognosis of this condition are similar to those of left ventricular systolic dysfunction.
High-quality evidence shows that ACE inhibitors and β-blockers reduce morbidity and increase survival in patients with left ventricular systolic dysfunction (14–17). New low-quality evidence shows that β-blockers reduce mortality in older adults (age ≥65 years) but do not lead to statistically significant differences in quality of life or number of hospitalizations in this age group (18). High-quality evidence shows that no difference exists between selective β-blockers (for example, metoprolol) and nonselective β-blockers (for example, carvedilol) on the combined end point of mortality and hospitalization, and moderate-quality evidence from 1 trial shows lower mortality when the nonselective β-blocker carvedilol is used (19). High-quality evidence shows that the same outcomes are achieved whether ACE inhibitor or β-blocker therapy is started first (20).
Moderate-quality evidence demonstrates that ARBs reduce hospitalizations for heart failure and improve quality of life but do not have a statistically significant effect on survival (21). Low-quality evidence shows that adding ARBs to ACE inhibitors reduces the risk for first hospitalization, and moderate-quality evidence shows that ARBs improve quality of life but do not affect mortality (22, 23). High-quality evidence shows that combination therapy with ARBs and ACE inhibitors increases the risk for hyperkalemia, and low-quality evidence demonstrates that it increases serum creatinine levels (23). High-quality evidence also demonstrates that adding ARBs to ACE inhibitors and β-blockers reduces the composite outcome of cardiovascular mortality and hospitalization for heart failure (24).
First-line therapy with β-blockers and ACE inhibitors is indicated for all patients with heart failure with left ventricular systolic dysfunction, regardless of the severity of their symptoms. However, concern remains that β-blockers are still underutilized in certain subgroups; therefore, the GDG recommended that these agents be considered for all patients with left ventricular systolic dysfunction, including older adults and persons with peripheral vascular disease, erectile dysfunction, diabetes mellitus, interstitial pulmonary disease, and irreversible chronic obstructive pulmonary disease. β-Blockers should be introduced in a “start-low, go-slow” manner, with heart rate, blood pressure, and clinical status reviewed after each dose titration to avoid adverse effects, such as symptomatic bradycardia and hypotension.
The GDG considered that the lower mortality associated with the nonselective β-blocker carvedilol versus the selective β-blocker metoprolol tartrate may be related to the short-acting metoprolol tartrate used in that trial (19). Selective β-blockers, such as bisoprolol and metoprolol succinate, used in other randomized clinical trials have a similar effect on heart failure mortality as carvedilol (25–27). Because the evidence base for β-blockers in heart failure has been established only for some β-blockers (bisoprolol, metoprolol succinate, carvedilol, and nebivolol), the GDG recommended that therapy in patients who develop heart failure while already receiving treatment for a comorbid condition should be switched to one of these β-blockers.
The GDG noted the current practice of readily switching from ACE inhibitor to ARB therapy whenever patients experience adverse effects. It considered the stronger evidence base for ACE inhibitors than for ARBs and therefore recommended this switch only if the adverse effects of ACE inhibitor therapy are intolerable. Regardless of which drug is used, monitoring renal function in patients receiving these drugs is important.
There are 3 choices for second-line treatment for patients with heart failure with left ventricular systolic dysfunction: aldosterone antagonists (28), ARBs, and combination therapy with hydralazine and a nitrate (29). Deciding which agent to use should take into account the severity of heart failure, the ethnicity of the patient, and comorbid conditions. The addition of aldosterone antagonists or ARBs requires close monitoring of potassium levels and renal function.
Separate NICE committees reviewed evidence for cardiac resynchronization therapy and for ICDs, and their recommendations were incorporated into the treatment algorithm (Figure 2) (6, 7). Patients with heart failure with left ventricular systolic dysfunction who remain symptomatic despite first- and second-line therapy should be considered for advanced electrical therapy (cardiac resynchronization therapy) if they fulfill the indications given in the NICE technology appraisal on cardiac resynchronization therapy (6). These criteria are a left ventricular ejection fraction less than 35% and a QRS duration on electrocardiography of 150 ms or higher or between 120 ms and 149 ms in patients with mechanical dyssynchrony on echocardiography.
Implantable cardioverter-defibrillators can be considered for patients at any stage of heart failure who have left ventricular systolic dysfunction if the patients fulfill the criteria in the NICE technology appraisal on ICDs (7). These criteria are sustained ventricular tachycardia or nonsustained ventricular tachycardia that is inducible on electrophysiologic testing if the left ventricular ejection fraction is less than 35%, or a QRS duration of 120 ms or higher on electrocardiography if the left ventricular ejection fraction is less than 30%.
Moderate-quality evidence shows that exercise rehabilitation reduces hospital admissions for heart failure and increases long-term quality of life almost exclusively in patients with heart failure with left ventricular systolic dysfunction. However, the GDG considered that a supervised group exercise–based rehabilitation program that includes psychological and educational components should be offered to all patients with heart failure, provided that they are stable and do not have a condition or device that would preclude an exercise-based program.
Heart failure is a chronic, progressive syndrome with an unpredictable and sometimes fluctuating clinical course. Monitoring this clinical course is potentially important to ensure that patients are receiving optimal therapy (which may require up-titration or down-titration). Developers of the 2003 NICE guideline on heart failure agreed on general principles of monitoring (3). However, since then, new evidence has emerged on serial monitoring of serum natriuretic peptide levels and use of telemonitoring. The guideline update included 1 new recommendation about monitoring, namely, that clinicians should consider specialist monitoring of serum natriuretic peptide levels in some patients (for example, persons in whom up-titration of pharmacologic therapy with such agents as ACE inhibitors and β-blockers is problematic or those with a history of hospitalization for exacerbations of heart failure).
Moderate-quality evidence demonstrates that therapy guided by serum natriuretic peptide levels results in a medium-term (defined as 9 to 15 months) reduction in hospitalizations for heart failure. Moderate-quality evidence demonstrates that serum natriuretic peptide–guided therapy does not reduce mortality, change quality of life, or reduce hospitalizations for any cause. However, evidence shows different effects of this therapy in different age groups. Moderate-quality evidence shows that serum natriuretic peptide–guided therapy reduces mortality in persons younger than 75 years of age but not in persons older than 75 years. A cost-effectiveness analysis specifically performed for this guideline demonstrated that serial serum natriuretic peptide monitoring was cost-effective when used by specialists (11).
Moderate-quality evidence shows that telemonitoring reduces mortality and hospitalization for any reason but does not improve quality of life or decrease hospitalization for heart failure. Significant heterogeneity was observed among the results of different trials. It was unclear whether the observed benefits associated with telemonitoring were due to the telemonitoring itself or to the improved access to care related to telemonitoring. As such, the guideline does not include a recommendation for telemonitoring. Nevertheless, studies show the potential for this technique to be used to extend specialist monitoring to a larger proportion of persons with heart failure.
The partial update of the NICE guideline on chronic heart failure made important changes to the previous guideline in England and Wales in diagnosis and treatment. In diagnosis, the guideline focuses on using both a history of myocardial infarction and an increase in serum natriuretic peptide levels to guide further assessment. It also recommends time limits within which patients should receive both echocardiography and clinical assessment by a specialist.
In treatment, the guideline encourages increased use of β-blockers and ACE inhibitors as first-line therapy in patients with heart failure and left ventricular systolic dysfunction and proposes options for second-line therapy (aldosterone antagonists, ARBs, or combination therapy with a nitrate and hydralazine). It also recommends offering group exercise–based rehabilitation programs to all patients with heart failure with stable symptoms and no definite contraindications. The GDG did not believe that sufficient evidence existed to recommend any specific pharmacologic therapies for heart failure with preserved ejection fraction or to recommend telemonitoring. Serial measurement of serum natriuretic peptide levels is only recommended for selected patients receiving specialist care.
Evidence has continued to emerge since the publication of the 2010 update of the NICE clinical guideline on heart failure. EMPHASIS-HF (Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure) studied patients with chronic heart failure due to left ventricular systolic dysfunction with mild symptoms (defined as New York Heart Association class II heart failure). It found significant reductions in hospitalization and mortality when eplerenone therapy is started in patients hospitalized during the preceding 6 months or with persistent moderate elevation in serum natriuretic peptide levels (defined as BNP levels ≥250 ng/L, or NT-proBNP levels ≥500 ng/L in men and 750 ng/L in women) (30). SHIfT (Systolic Heart Failure Treatment with the If Inhibitor Ivabradine Trial) showed that ivabradine, a blocker of the If channel in the sinoatrial node, significantly reduced unplanned hospitalization and mortality in patients with heart failure due to left ventricular systolic dysfunction whose heart rate remains higher than 70 beats/min (31).
A large trial of telemonitoring for patients with a recent hospitalization for heart failure found no evidence that this intervention reduced hospital readmission or mortality (32). The RAFT (Resynchronisation/Defibrillation for Ambulatory Heart Failure Trial) reported that addition of cardiac resynchronization therapy in patients with an ICD with mild to moderate heart failure reduced all-cause mortality and hospitalization but increased adverse events (33).
It is unclear what effect, if any, these trials would have had on the recommendations if their results had been available before the guideline was published. The continuing emergence of new evidence emphasizes the importance of regular reviews and updates of the evidence base underpinning national guidelines and that clinicians should be alert to potential new advances that have not been captured in guidelines.
The NICE guidelines are broadly consistent with other international guidelines, including those of the European Society of Cardiology and the American College of Cardiology/American Heart Association (12, 34). Minor differences in recommendations reflect the target audience, methodology, and importance attached to cost-effectiveness. For example, the European Society of Cardiology guidelines on diagnosis recommend that all patients with symptoms suggestive of heart failure undergo echocardiography and measurement of serum natriuretic peptide levels, whereas NICE recommends selective use of these investigative tools. The American College of Cardiology/American Heart Association guidelines focus on evaluating patients with heart failure rather than determining whether a patient has this syndrome.
The recommendations for treatment from each of these 3 guidelines are very similar. This fact is perhaps not surprising because the guidelines are all based on a substantial evidence base of high-quality randomized, controlled trials for which there is less scope for differing interpretations or consensus-based opinion.
A key obstacle to full implementation of the updated NICE clinical guideline on chronic heart failure is concern about its effect on health care expenditure. However, heart failure will be diagnosed earlier and more accurately in patients who are managed according to this guideline, and these patients will receive earlier therapy with agents known to improve survival and substantially reduce hospitalization rate. In England and Wales, NICE published an implementation document based on the chronic heart failure guideline that showed a net savings of £19 000 per 100 000 persons if all of the recommendations were implemented (35). A key priority in implementation is that all clinicians have access to measurement of serum natriuretic peptide to facilitate diagnosis of heart failure.
Jonathan Mant, Abdallah Al-Mohammad, Mark Davis, Paresh Dawda, Jane Gilmour, Suzanna Hardman, Francisco Leyva, Hugh McIntyre, Richard Mindham, and Adrian Price. Disclosures of conflicts interest of the guideline development group members are available at www.nice.org.uk/nicemedia/live/13099/50531/50531.pdf.
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David L. Simel
Durham Veterans Affairs Medical Center
August 31, 2011
Are specialist physicians required to make a diagnosis of heart failure?
While I accept the evidence-base that suggests specialists and coordinated-care in heart failure clinics can create better outcomes than "usual" care, I cannot find the evidence base (Appendix E of the NICE guideline) that supports the need for a specialist assessment to diagnose chronic heart failure in patients with prior myocardial infarctions. Figure 1 suggests that a generalist physician can make a diagnosis of chronic heart failure in patients without myocardial infarction; these same physicians ought to be able to do this in patients with prior myocardial infarctions. Since generalists are capable of reviewing echocardiogram reports (generated by appropriately trained echocardiographers) that tells them whether the patient has a preserved ejection fraction, systolic dysfunction, or other cardiac abnormality as suggested in Figure 1(e.g. diastolic dysfunction, valvular disease, asymmetric septal hypertrophy, etc), they can further classify their heart failure patients. I have no problem with referral to cardiologists or CHF management clinics at that point, but I don't see the evidence for referral to a "specialist assessment" to make the diagnosis in the first place.
Thomas E. Finucane
Johns Hopkins University School of Medicine
September 13, 2011
Downplaying history and physical examination is harmful
To the Editor:
The NIHCE guidelines for management of chronic heart failure in adults being (Ref1), reasonably enough, by describing the problem as "a complex clinical syndrome." The diagnostic algorithm begins with a detailed history and a clinical examination.
The authors then say, however, "Clinical signs and symptoms are of limited use in the diagnosis of heart failure." This must surely be a misprint.
The next node down in their algorithm is either "Specialist assessment and Doppler echocardiography," or "Measure serum natriuretic peptide". Are these the real tools to make the diagnosis of heart failure? This seems to me another example of Gizmo Idolatry. (Ref 2)
Clinical evaluation is central in nearly all complex clinical syndromes; history is almost everything in diagnosing ischemic heart disease, stroke, dementia, and more. Downplaying history and physical examination is harmful in many ways to current doctors and their patients. And it seems to belittle the diagnosis and management of heart failure in the decades before development of echocardiography and assays for serum natriuretic peptide testing.
Thomas E. Finucane Johns Hopkins Bayview Medical Center
1. Mant J, Al-Mohammad A, Swain S, Laram?e P; for the Guideline Development Group. Management of Chronic Heart Failure in Adults: Synopsis of the National Institute for Health and Clinical Excellence Guideline. Ann Intern Med. 2011;155:252-259.
2. Leff B, Finucane TE. Gizmo idolatry. JAMA. 2008;299:1830-2.
John E. Madias
Mount Sinai School of MMedicine
September 18, 2011
Clinical Indices for the Diagnosis, Management, and Monitoring of Patients with Heart Failure
The synopsis of the updated in August 2010 clinical guidelines of The National Institute for Health and Clinical Excellence published in the Journal (1) provide for required study by all concerned with the diagnosis, treatment, and monitoring of patients with heart failure (HF), but also raises many questions, particularly because it highlights a prevalent dissociation between recommended operational algorithms and the set of ways and means by which clinicians practice. The document includes the clich? that history taking and physical examination are not sensitive or specific enough to diagnose, manage, or monitor patients with HF, and thus one needs to resort to laboratory methods for help.
Center stage in the guidelines update occupies the employment of ?- type serum natriuretic peptides (BNP) (specifically, BNP and N-terminal fragment of prohormone BNP [NT-pro BNP]) measured levels in the need for referral for echocardiography, or consultation by a cardiologist, for the diagnosis of HF and use of serial BNP measurements in monitoring this condition. Nowhere in the document weighing of the patients or use of the electrocardiogram (ECG) are being discussed as contributory to the diagnostic effort. In contrast to these, what transpires in countless emergency rooms, in-patient wards, intensive care units, and out-patient general and cardiology clinics world-wide is a focused history taking and physical examination, obtaining the patients' body weight, and recording of an ECG on first contact with a patient with known or suspected HF, with a comparison of the garnered information to corresponding data for patients who have previously been diagnosed with HF.
This concerned reader does not intent to propose an alternative diagnostic and monitoring HF algorithm to the one expounded in the synopsis of the guidelines, but to highlight an omission currently in vogue in clinical trials and guidelines alike, i.e., the systematic non- reference to the patients' body weight and ECG, both of which are available at the "point of care", instead of hours after the clinical encounter, as is the case for BNP or other laboratory HF indices. In reference to body weight, the value during a patient's evaluation in comparison to the known by the patient most recent weight or by comparison to previously checked and documented values in the clinical record, provide an immense insight to the presence, or status of compensation of HF in a patient with reduced or preserved left ventricular ejection fraction, even in the absence of evidence of peripheral edema by the most meticulous clinical assessment; indeed the patient's extra fluid accumulation in the body tissues and organs may often amount to many kilograms without the slightest hint provided by an exam by an expert clinician (2).
In reference to the ECG, one should consider the lengthy litany of clinical insights provided which pertain to the presence or absence of bradycardia or tachycardia, atrial and ventricular arrhythmias, sino- atrial, atrio-ventricular and intra-ventricular blocks, evidence of left or right atrial and ventricular hypertrophy, previous myocardial infarction, prolonged QTc, and many more, including the wealth of supportive to the diagnosis contributions immediately accrued by comparison of the index ECG to available previous tracings. Finally mere gauzing of the negative component of the P-wave in lead V1 or duration of the P-waves, or the amplitude of the QRS complexes, particularly in ECG limb leads or lead aVR, can provide by comparison of ?2 ECGs in a patient's file, a clear index of a patient's status of HF clinical compensation (3). Attenuation/augmentation of the amplitude of QRS complexes is due to decrease/increase of body volume conductor electrical resistivity, engendered by increased/decreased fluid engorgement of tissues and organs enveloping the heart (3). Most modern ECG automated and interpretive diagnostic algorithms provide quantitative data instantly upon recording of the ECG, and such information has been found to be as good as BNP in the management of patients with HF (4).
1. Mant J, Al-Mohammad A, Swain S, Laram?e P; for the Guideline Development Group. Management of Chronic Heart Failure in Adults: Synopsis of the National Institute for Health and Clinical Excellence Guideline. Ann Intern Med. 2011;155:252-259.
2. Fauci AS, et al., editors. Harrison's Principles of Internal Medicine, 17th ed. New York: McGraw-Hill Medical Publishing Division; p. 231.
3. Madias JE. Why Recording of an Electrocardiogram Should be Required in Every Inpatient and Outpatient Encounter of Patients with Heart Failure. Pacing Clin Electrophysiol. 2011;34:963-7.
4. Kataoka H, Madias JE. Changes in the amplitude of electrocardiogram QRS complexes during follow-up of heart failure patients. J Electrocardiol. 2011 44:394.e1-9.
University of Cambridge
September 28, 2011
We are grateful to Dr Finucane for his comments and agree with him regarding the central role of history and physical examination in the evaluation of heart failure (and other complex clinical syndromes). It is through history and examination that a clinician will suspect heart failure as a diagnosis, and consider potential aggravating factors and alternative diagnoses.(1) However, the limitations of symptoms and signs alone need to be acknowledged. A systematic review of the evidence found that individual symptoms and signs are of limited use in the diagnosis of heart failure.(2) Furthermore, diagnoses of heart failure by generalists may be inaccurate: a review of 103 patients with a diagnostic label of heart failure in UK primary care confirmed this diagnosis after echocardiography and review in only 35 (34%) patients.(3)
Echocardiography is required in people with suspected heart failure not only in order to help establish whether or not the syndrome is present, but also to help identify the underlying cardiac abnormality, such as left ventricular systolic dysfunction or valve disease. This is vital, since subsequent management is underpinned by such knowledge.(1) There is a strong evidence base that serum natriuretic peptides are a useful test to rule out heart failure, and thus can reduce the use of echocardiography in people with normal heart function.(1,2) The central role of natriuretic peptides and echocardiography in the National Institute for Health & Clinical Excellence (NICE) guideline does not reflect "Gizmo Idolatory", but rather a considered application of the principles of evidence based medicine.
We are grateful to Dr Simel for the comments, but feel that he may have misinterpreted the algorithm. The guidelines recommend all patients with heart failure should have specialist assessment and echocardiography. People with a previous history of myocardial infarction who present with symptoms and signs suggestive of heart failure have a higher likelihood of a positive diagnosis than someone without such a history.(2) Cost effectiveness analysis suggests that it is more cost-effective to refer such people straight for echocardiography and specialist assessment without the prior use of natriuretic peptide testing as a 'rule out' test.(2) In the case of people with symptoms and signs of heart failure, but no prior history of myocardial infarction, the diagnostic algorithm recommends that the generalist refers such people on for echocardiography and specialist assessment if serum natriuretic peptides are raised.
Jonathan Mant, Abdallah Al-Mohammad and Sharon Swain
1. National Clinical Guideline Centre. Chronic heart failure: management of chronic heart failure in adults in primary and secondary care. Full version of NICE Clinical Guideline 108. London: National Clinical Guideline Centre; 2010.
2. Mant J, Doust J, Roalfe A, Barton P, Cowie MR, Glasziou P, et al. Systematic review and individual patient data meta-analysis of diagnosis of heart failure, with modelling of implications of different diagnostic strategies in primary care. Health Technol Assess. 2009;13:1-207. [PMID: 19586584]
3. Hobbs FDR, Davis RC, Roalfe AK, Hare R, Davies MK, Kenkre JE. Reliability of N-terminal pro-brain natriuretic peptide assay in diagnosis of heart failure: cohort study in representative and high risk community populations. BMJ 2002;324;1498- doi:10.1136/bmj.324.7352.1498
Authors of the published synopsis.
September 30, 2011
Response to Madias
We welcome the letter from Madias, and the opportunity it provides to set in context the partial update of the NICE guideline, the synopsis of which he commented on. (1) We agree that weighing of patients and use of ECGs are central to the monitoring of people with heart failure. The evidence base for these aspects of care have not changed significantly since the original NICE guideline was published in 2003,(2) so were not considered in the partial update. The general principles of monitoring that were agreed in 2003 (that were referred to in our synopsis, but not explicitly stated), included: a clinical assessment of functional capacity, fluid status, cardiac rhythm, cognitive status and nutritional status.(2) Assessment of fluid status was considered to include changes in body weight, extent of jugular venous distension, lung crackles and hepatomegaly, extent of peripheral oedema, and lying and standing blood pressure. Assessment of cardiac rhythm was considered to be chiefly by clinical examination, but to include 12 lead ECG or 24 hour electrocardiographic monitoring if suspicion of arrhythmia.(2)
1. Mant J, Al-Mohammad A, Swain S, Laramee P for the Guideline Development Group. Management of chronic heart failure in adults: synopsis of the National Institute for Health & Clinical Excellence Guideline. Annals of Internal Medicine 2011; 155:252-259
2. National Institute for Health & Clinical Excellence. Chronic Heart Failure (Clincal Guideline 5), London: Royal College of Physicians, 2003.
Authors of NICE synopsis
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