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| Team Leader: Dr David Fone |
Date of completion: 30.9.98 |
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This bulletin is a supplement to, not a substitute for, professional skills and experience. Users are advised to consult the supporting evidence for a consideration of all the implications of a recommendation. | |
| The Statements | The Evidence |
| 5.1 Clinical guidelines | |
| 5.1a.
Heart failure is characterised by breathlessness, fatigue and fluid
retention resulting from pump failure of the heart. It is a major public
health problem, affecting around 1% of the general population and 10% of
the elderly; 50% of patients die within a five year periodi.
Evidence-based guidelines are available for the evaluation and
management of heart failurei-iv. (Health gain notation - 1 "beneficial") |
i. Konstam M,
Dracup K, Baker D, et al. Heart Failure: Evaluation and Care of
Patients With Left-Ventricular Systolic dysfunction. Clinical
Practice Guideline Number 11 AHCPR. Rockville, MD: Agency for Health
Care Policy and Research and the National Heart, Lung and Blood Institute,
Public Health Service, U.S. Department of Health and Human Services,
1994 http://text.nlm.nih.gov/ftrs/pick?dbName=lvdq&ftrsK=33721&cp=1&t=924604716&collect=ahcpr (Type V evidence - expert opinion and review of randomised controlled trials, non-randomised and observational studies) ii. Williams JF Jr, Bristow MR, Fowler MB, et al. ACC/AHA guidelines for the evaluation and management of heart failure: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (committee on evaluation and management of heart failure). Circulation 1995;92:2764-84 http://www.americanheart.org/Scientific/statements/1995/ 21955555.html Type V evidence - expert opinion) iii. Cleland JGF, Erdmann E, Ferrari R, et al. Guidelines for the diagnosis of heart failure. European Heart Journal 1995;16:741-51 (Type V evidence - expert opinion) iv. Remme WJ. The treatment of heart failure. European Heart Journal 1997;18:736-53 (Type V evidence - expert opinion) |
| 5.2 Echocardiography | |
| 5.2a.
Echocardiography to assess left-ventricular performance and valve
structure and function is a critical step in the evaluation and management
of patients with suspected or clinically evident heart
failurei. Guidelines for the clinical application of
echocardiography are availableii. (Health gain notation - 1 "beneficial")
|
i. Konstam M,
Dracup K, Baker D, et al. Heart Failure: Evaluation and Care of
Patients With Left-Ventricular Systolic dysfunction. Clinical
Practice Guideline Number 11 AHCPR. Rockville, MD: Agency for Health
Care Policy and Research and the National Heart, Lung and Blood Institute,
Public Health Service, U.S. Department of Health and Human Services,
1994 http://text.nlm.nih.gov/ftrs/pick?dbName=lvdq&ftrsK=33721&cp=1&t=924604716&collect=ahcpr (Type V evidence - expert opinion and review of randomised controlled trials, non-randomised and observational studies) ii. Cheitlin MD, Alpert JS, Armstrong WF, et al. ACC/AHA guidelines for the clinical application of echocardiography: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (committee on clinical application of echocardiography). Journal of the American College of Cardiology 1997;29:862-79 http://www.americanheart.org/Scientific/statements/1997/ 039703toc.html (Type V evidence - expert opinion) |
| 5.3 Immunisation | |
| 5.3a.
Influenza and pneumococcal immunisation are effective in patients
with heart failurei. (Health gain notation - 1 "beneficial") |
i. See
Respiratory Diseases bulletin in this series.
|
| 5.4 Drug therapy | |
| 5.4a.
Angiotensin converting enzyme (ACE) inhibitors reduce
mortality and morbidity in patients with chronic heart failure. However
this benefit may be limited to patients with relatively poor left
ventricular ejection fraction. A consistent effect among a broad range of
patients and different ACE inhibitors is seen. The largest reductions with
treatment are observed in the first 90 daysi. (Health gain notation - 1 ‘beneficial’) |
i. Garg R, Yusuf S. Overview of
randomised trials of angiotensin-converting enzyme inhibitors on mortality
and morbidity in patients with heart failure. Journal of the American
Medical Association 1995;273:1450-56. In: Database of Reviews
of Effectiveness. The Cochrane Library, Issue 4. Oxford:
Update Software, 1998 (Type I evidence - systematic review and meta-analysis of 7105 patients in 32 trials comparing ACE inhibitors with placebo) |
| 5.4b.
Early economic analyses suggest ACE inhibitors are
cost-effective therapy. The balance between overall savings and costs
depends on the proportion of patients whose treatment is initiated by the
general practitioneri. (Health gain notation - 2 "likely to be beneficial") Caveat: Further up-to-date analyses are requiredii.
|
i. ACE Inhibitors
in the treatment of chronic heart failure: Effective and cost-effective.
Bandolier 1994, Number 8. Volume 1 Issue 8 http://www.jr2.ox.ac.uk/bandolier/band8/b8-1.html (Type II evidence - economic analyses based on data from randomised controlled trials) ii. Garg R, Yusuf S. Overview of randomised trials of angiotensin converting enzyme inhibitors on mortality and morbidity in patients with heart failure. Journal of the American Medical Association 1995;273:1450-56. In: Database of Reviews of Effectiveness. The Cochrane Library, Issue 4. Oxford: Update Software, 1998 (Type I evidence - systematic review and meta-analysis of 7105 patients in 32 trials comparing ACE inhibitors with placebo) |
| 5.4c.
ACE inhibitors can usually be started safely in primary care
following exclusion of high risk patients requiring
hospitalisationi. (Health gain notation - 1 "beneficial") |
i. Dargie HJ, McMurray JJV.
Diagnosis and management of heart failure. British Medical Journal
1994;308:321-28 (Type V evidence - expert opinion) |
| 5.4d.
There is some evidence that losartan 50mg/day, an angiotensin II
receptor blocker, may be more effective than captopril 50mg
tds in reducing mortality at 48 week follow-up from
congestive cardiac failure (all-cause mortality risk reduction 46%; 95%
CI: 5%, 69%; p=0.035)i. (Health gain notation - 4 "unknown") Caveat: Unexpected finding from a protocol specified secondary endpoint. Further large trials are necessary to confirm these findings and investigate the possibility of a class effect. |
i. Pitt B, Segal
R, Martinez FA, et al, on behalf of ELITE Study Investigators. Randomised
trial of losartan versus captopril in patients over 65 with heart failure
(Evaluation of Losartan In The Elderly study, ELITE). Lancet
1997;349:747-52 (Type II evidence - randomised controlled trial of 722 patients aged over 65 with ejection fraction <40%)
|
| 5.4e.
Diuretics are an effective symptomatic treatment for acute and
chronic heart failure. Their impact on mortality has not been
evaluatedi. (Health gain notation - 1 "beneficial") |
i. Dargie HJ,
McMurray JJV. Diagnosis and management of heart failure. British
Medical Journal 1994;308:321-28 (Type V evidence - expert opinion) |
| 5.4f.
Cardioversion (chemical or electrical) is the preferred management
for patients in atrial fibrillation with left-atrial diameters of
<50mm and less than a one year history, following
anticoagulation and digitilisation to control the heart
ratei. (Health gain notation - 1 "beneficial")
|
i. Konstam M,
Dracup K, Baker D, et al. Heart Failure: Evaluation and Care of
Patients With Left-Ventricular Systolic dysfunction. Clinical
Practice Guideline Number 11 AHCPR. Rockville, MD: Agency for Health
Care Policy and Research and the National Heart, Lung and Blood Institute,
Public Health Service, U.S. Department of Health and Human Services,
1994 http://text.nlm.nih.gov/ftrs/pick?dbName=lvdq&ftrsK=33721&cp=1&t=924604716&collect=ahcpr (Type V evidence - expert opinion and review of randomised controlled trials, non-randomised and observational studies) |
| 5.4g.
Digoxin therapy for patients with heart failure in sinus rhythm is
associated with fewer hospital admissions than placebo (26.8% vs. 34.7%,
risk ratio 0.72; 95% CI: 0.66, 0.79; p<0.001), a borderline reduced
risk of death from worsening heart failure (11.6% vs. 13.2%, risk ratio
0.88; 95% CI: 0.77, 1.01; p=0.06) but no difference in overall mortality
(34.8% vs. 35.1%, risk ratio 0.99; 95% CI: 0.91, 1.07;
p=0.80)i. (Health gain notation - 2 "likely to be beneficial") |
i. The Digitalis
Investigation Group. The effect of digoxin on mortality and morbidity in
patients with heat failure. New England Journal of Medicine
1997;336:525-33 (Type II evidence - randomised controlled trial of 6800 patients in sinus rhythm with ejection fractions <0.45 randomised to digoxin or placebo in addition to diuretics and ACE inhibitors) |
| 5.4h. Ibopamine,a positively inotropic
dopamine agonist, is associated with ventricular arrhythmias and
excess mortalityi. (Health gain notation - 6 "harmful") |
i. Hampton JR,
van Veldhuisen DJ, Kleber FX, et al, for the Second Prospective Randomised
Study of Ibopamine on Mortality and Efficacy (PRIME II) Investigators.
Randomised study of effect of ibopamine on survival in patients with
advanced severe heart failure. Lancet
1997;349:971-77 (Type II evidence - randomised controlled trial of 1906 patients with advanced heart failure randomised to ibopamine or placebo) |
| 5.4i.
Beta-blocker therapy provides symptomatic benefit in patients with
heart failurei, and there is evidence for a reduction in
all-cause mortality; odds ratio 0.69; 95% CI: 0.54, 0.89;
p=0.0035ii. Sub-group analyses found a beneficial effect of
lower mortality only in patients receiving vasodilator beta blockers
compared to patients not treated with a beta blocker. (Health gain notation - 2 "likely to be beneficial") Caveat: Methodological issues limit the validity of the meta-analysisii. Cause-specific mortality was not available from primary studies due to small size, un-specified primary mortality outcomes and short duration (mean 13 months) of follow-up. Criteria for the selection or assessment of the relevance and validity of the primary studies were not specified. Large scale, long-term randomised controlled mortality trials are required to determine more reliably the size of effects of treatment on survival and the sub-groups of patients with heart failure likely to benefit. |
i. Cleland JG,
Bristow MR, Erdmann E, Remme WJ, Swedberg K, Waagstein F. Beta-blocking
agents in heart failure. Should they be used and how? European Heart
Journal 1996;17:1629-39 (Type II evidence - narrative review of randomised controlled trials) ii. Doughty RN, Rodgers A, Sharpe N, MacMahon S. Effects of beta-blocker therapy on mortality in patients with heart failure: a systematic overview of randomised controlled trials. European Heart Journal 1997;18:560-65. In: Database of Reviews of Effectiveness. The Cochrane Library, Issue 4. Oxford: Update Software, 1998 (Type I evidence - systematic review and meta-analysis of 3141 patients in 24 randomised controlled trials) |
| 5.4j. Phosphodiesterase inhibitors are associated
with a non-significant increased mortality at minimum follow-up of three
months in patients with chronic heart failure. Analysis of
studies excluding vesnarinone found a significant increase in mortality of
41% (95% CI: 11%, 79%)i. (Health gain notation - 6 "likely to be harmful") |
i. Nony P,
Boissel JP, Lievre M, et al. Evaluation of the effect of phosphodiesterase
inhibitors on mortality in chronic heart failure patients: a
meta-analysis. European Journal of Clinical Pharmocology
1994;46:191-96. In: Database of Reviews of Effectiveness.
The Cochrane Library, Issue 4. Oxford: Update Software,
1998 (Type I evidence - systematic review of 2732 patients in 13 randomised controlled trials) |
| 5.4k.
There is no good evidence for or against the effectiveness of
anticoagulation in preventing stroke, arterial or pulmonary embolus
in patients with heart failure in sinus rhythm without a history of
thrombus or embolii. (Health gain notation - 4 "unknown") Caveat: No clinical trials were located. Evidence from seven small studies of benefits conflicts with no evidence of benefits in two larger studies. Full anticoagulation was found to increase the risk of major bleeding. |
i. Baker DW,
Wright RF. Management of heart failure IV: anticoagulation for patients
with heart failure due to left ventricular systolic dysfunction.
Journal of the American Medical Association
1994;272:1614-18. In: Database of Reviews of Effectiveness.
The Cochrane Library, Issue 4. Oxford: Update Software,
1998 (Type IV evidence - narrative review of nine observational studies examining effectiveness of anticoagulation; five studies examined risk of major bleeding associated with anticoagulation) |
| 5.5 Surgical management | |
| 5.5a.
Coronary artery bypass grafting improves survival and functional
outcome (improvement in ejection fraction) in males with moderate to
severe heart failure and concomitant limiting angina with a likely
mortality reduction of between 30% and 50%. There is insufficient evidence
of benefit for women, for men without angina, or of benefit from
angioplastyi. (Health gain notation - 2 "likely to be beneficial") Caveat: Conclusions based on the three highest quality primary studies, one showing no difference and one compromised by un-adjusted baseline differences. The mortality reduction may differ from the 30% to 50% reported. |
i. Baker DW,
Jones RJ, Hodges J, Massie B M, Konstam MA, Rose EA. Management of heart
failure III: the role of revascularisation in the treatment of patients
with moderate or severe left ventricular systolic dysfunction. Journal
of the American Medical Association 1994;272:1528-34. In:
Database of Reviews of Effectiveness. The Cochrane Library,
Issue 4. Oxford: Update Software, 1998 (Type IV evidence - narrative review of 2691 patients (80% male) with moderate to severe left ventricular dysfunction in eight cohort studies of CABG vs. medical treatment) |
| 5.5b.
Cardiac transplantation should be considered in patients severely
limited by heart failure despite aggressive medical therapy in whom
revascularisation is unlikely to be
beneficiali. (Health gain notation - 3 "trade-off between beneficial and adverse effects") |
i. Konstam M,
Dracup K, Baker D, et al. Heart Failure: Evaluation and Care of
Patients With Left-Ventricular Systolic dysfunction. Clinical
Practice Guideline Number 11 AHCPR. Rockville, MD: Agency for Health
Care Policy and Research and the National Heart, Lung and Blood Institute,
Public Health Service, U.S. Department of Health and Human Services,
1994 http://text.nlm.nih.gov/ftrs/pick?dbName=lvdq&ftrsK=33721&cp=1&t=924604716&collect=ahcpr (Type V evidence - expert opinion) |
| 5.5c.
There is currently insufficient evidence that cardiomyoplasty is an
effective treatment for patients with advanced heart
failurei. (Health gain notation - 4 "unknown") Caveat: Cardiomyoplasty is potentially a lower cost alternative to cardiac transplantation: few patients have been studied world wide. |
i. Cowley D.
Cardiomyoplasty. Canberra: Australian Institute of Health and Welfare
1992. In: Health Technology Assessment: author abstracts. The
Cochrane Library, Issue 4. Oxford: Update Software,
1998 (Type V evidence - expert opinion)
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Dr Alison Weightman, Protocol Enhancement Project, Duthie Library, UWCM, Cardiff CF4 4XN. e-mail: weightmanal@cardiff.ac.uk