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Complete Summary

GUIDELINE TITLE

Evaluation and management of patients with acute decompensated heart failure: HFSA 2006 comprehensive heart failure practice guideline.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Heart Failure Society of America. Heart Failure Society of America (HFSA) practice guidelines. HFSA guidelines for management of patients with heart failure caused by left ventricular systolic dysfunction--pharmacological approaches. J Card Fail 1999 Dec;5(4):357-82.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s)/intervention(s) for which important revised regulatory and/or warning information has been released.

  • June 8, 2007, Troponin-I Immunoassay: Class I Recall of all lots of the Architect Stat Troponin-I Immunoassay. The assay may report falsely elevated or falsely decreased results at and near a low level, which may impact patient treatment.
  • July 18, 2005, Natrecor (nesiritide): Due to recent questions raised about worsened renal function and mortality, recommendations were made on the appropriate use of the drug and on utilizing educational campaigns for clinicians.
  • May 19, 2005, Natrecor (nesiritide): Revisions to the ADVERSE REACTIONS/Effect on Mortality section of the prescribing information for patients with acutely decompensated congestive heart failure.

COMPLETE SUMMARY CONTENT

 ** REGULATORY ALERT **
 SCOPE
 METHODOLOGY - including Rating Scheme and Cost Analysis
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS
 QUALIFYING STATEMENTS
 IMPLEMENTATION OF THE GUIDELINE
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

SCOPE

DISEASE/CONDITION(S)

Acute decompensated heart failure

GUIDELINE CATEGORY

Evaluation
Management
Treatment

CLINICAL SPECIALTY

Cardiology
Emergency Medicine
Internal Medicine

INTENDED USERS

Advanced Practice Nurses
Pharmacists
Physician Assistants
Physicians

GUIDELINE OBJECTIVE(S)

To provide recommendations for the evaluation and management of patients with acute decompensated heart failure

TARGET POPULATION

Patients with acute decompensated heart failure

INTERVENTIONS AND PRACTICES CONSIDERED

  1. Evaluation of signs and symptoms
  2. Determination of plasma B-type natriuretic peptide (BNP) or N-terminal pro-B-type natriuretic peptide (NT-proBNP) when necessary
  3. Hospital admission, as indicated, and careful monitoring of weight, fluid intake and output, vital signs, signs, symptoms, electrolytes, and renal function
  4. Loop diuretics
  5. Careful observation for the development of renal dysfunction and other side effects
  6. Sodium and fluid restriction, increased doses of loop diuretics, continuous infusion of a loop diuretic, addition of a second type of diuretic orally or intravenously, or ultrafiltration, if needed
  7. Intravenous nitroglycerin, nitroprusside, or nesiritide
  8. Intravenous inotropes
  9. Invasive hemodynamic monitoring in specific patients
  10. Evaluation of admitted patients for precipitating factors
  11. Discharge planning

MAJOR OUTCOMES CONSIDERED

  • Hospitalization rate
  • Survival rate
  • Sensitivity and specificity of diagnostic tests

METHODOLOGY

METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases
Searches of Unpublished Data

DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Databases searched included Medline and Cochrane. In addition, the guideline developers polled experts in specific areas for data.

NUMBER OF SOURCE DOCUMENTS

Not stated

METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Level A: Randomized, Controlled, Clinical Trials
May be assigned based on results of a single trial

Level B: Cohort and Case-Control Studies
Post hoc, subgroup analysis, and meta-analysis
Prospective observational studies or registries

Level C: Expert Opinion
Observational studies – epidemiologic findings
Safety reporting from large-scale use in practice

METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses
Systematic Review

DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

The Heart Failure Society of America (HFSA) Guideline Committee sought resolution of difficult cases through consensus building. Written documents were essential to this process, because they provided the opportunity for feedback from all members of the group. On occasion, consensus of Committee opinion was sufficient to override positive or negative results of almost any form or prior evidence.

RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

"Is recommended": Part of routine care
Exceptions to therapy should be minimized.

"Should be considered": Majority of patients should receive the intervention.
Some discretion in application to individual patients should be allowed.

"May be considered": Individualization of therapy is indicated

"Is not recommended": Therapeutic intervention should not be used

COST ANALYSIS

A formal cost analysis was not performed and published cost analyses were not reviewed.

METHOD OF GUIDELINE VALIDATION

Internal Peer Review

DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The process of moving from ideas of recommendations to a final document includes many stages of evaluation and approval. Every section, once written, had a lead reviewer and 2 additional reviewers. After a rewrite, each section was assigned to another review team, which led to a version reviewed by the Committee as a whole and then the Heart Failure Society of America (HFSA) Executive Council, representing 1 more level of expertise and experience. Out of this process emerged the final document.

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

The strength of evidence (A, B, C) and strength of recommendations are defined at the end of the "Major Recommendations" field.

  • The diagnosis of decompensated heart failure (HF) should be based primarily on signs and symptoms. (Strength of Evidence = C)

    When the diagnosis is uncertain, determination of plasma B-type natriuretic peptide (BNP) or N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration should be considered in patients being evaluated for dyspnea who have signs and symptoms compatible with HF. (Strength of Evidence = A)

    The natriuretic peptide concentration should not be interpreted in isolation, but in the context of all available clinical data bearing on the diagnosis of HF.

  • Hospital admission is recommended for patients presenting with acute decompensated heart failure (ADHF) when the clinical circumstances listed in Table 12.1(section a), below, are present. Patients presenting with ADHF should be considered for hospital admission when the clinical circumstances listed in Table 12.1(section b), below, are present. (Strength of Evidence = C)

Table 12.1: Recommendations for Hospitalizing Patients Presenting with ADHF

Recommendation Clinical Circumstances
(a) Hospitalization Recommended Evidence of severely decompensated HF, including:
  • Hypotension
  • Worsening renal function
  • Altered mentation
Dyspnea at rest
  • Typically reflected by resting tachypnea
  • Less commonly reflected by oxygen saturation <90%
Hemodynamically significant arrhythmia
  • Including new onset of rapid atrial fibrillation
Acute coronary syndromes
(b) Hospitalization Should be Considered Worsened congestion
  • Even without dyspnea
  • Typically reflected by a weight gain of >5 kg
Signs and symptoms of pulmonary or systemic congestion
  • Even in the absence of weight gain
Major electrolyte disturbance

Associated comorbid conditions
  • Pneumonia
  • Pulmonary embolus
  • Diabetic ketoacidosis
  • Symptoms suggestive of transient ischemic accident or stroke
Repeated implantable cardioverter defibrillators (ICD) firings

Previously undiagnosed HF with signs and symptoms of systemic or pulmonary congestion

Table 12.2: Signs and Symptoms of Congestion in HF

  Pulmonary Systemic
Symptoms Dyspnea Edema
Orthopnea Abdominal (or hepatic) swelling and pain
Paroxysmal nocturnal dyspnea (PND)  
Signs Rales Edema
Wheezing Elevated jugular venous pressure (JVP)
Pleural effusion Hepatic enlargement and tenderness
Hypoxemia Ascites
Third heart sound (left-sided)* Third heart sound (right-sided)*
Worsening mitral regurgitation Worsening tricuspid regurgitation
Hepatojugular reflux

* May occur without congestion

  • It is recommended that patients admitted with ADHF be treated to achieve the goals listed in the Table 12.3, below. (Strength of Evidence = C)

Table 12.3: Treatment Goals for Patients Admitted for ADHF

  • Improve symptoms, especially congestion and low-output symptoms
  • Optimize volume status
  • Identify etiology (see Table 4.6 in the National Guideline Clearinghouse (NGC) summary of the Heart Failure Society of American (HFSA) guideline Evaluation of Patients for Ventricular Dysfunction and Heart Failure)
  • Identify precipitating factors
  • Optimize chronic oral therapy
  • Minimize side effects
  • Identify patients who might benefit from revascularization
  • Educate patients concerning medications and self assessment of HF
  • Consider and, where possible, initiate a disease management program
  • Patients admitted with ADHF should be carefully monitored. It is recommended that the items listed in Table 12.4, below, be assessed at the stated frequencies. (Strength of Evidence = C)

Table 12.4: Monitoring Recommendations for Patients Hospitalized With ADHF

Frequency Value Specifics
At least daily Weight Determine after voiding in the morning
Account for possible increased food intake due to improved appetite
At least daily Fluid intake and output  
More than daily Vital signs Including orthostatic blood pressure
At least daily Signs Edema
Ascites
Pulmonary rales
Hepatomegaly
Increased jugular venous pressure (JVP)
Hepatojugular reflux
Liver tenderness
At least daily Symptoms Orthopnea
Paroxysmal nocturnal dyspnea (PND)
Nocturnal cough
Dyspnea
Fatigue
At least daily Electrolytes Potassium
Sodium
At least daily Renal function Blood urea nitrogen (BUN)
Serum creatinine*

See background section in the original guideline document for additional recommendations on laboratory evaluations.

  • Routine and frequent laboratory tests recommended in ADHF are shown in Table 12.5, below.

Table 12.5: Laboratory Evaluation for Patients With ADHF

Routinely Electrolytes
BUN and creatinine
Blood glucose
Troponin
Complete blood count
International normalized ratio (INR) if using Coumadin
Oxygen saturation
Frequently BNP or NT-proBNP
Liver function tests
Urinalysis
D-dimer
Arterial blood gases

Table 12.7: Discharge Criteria for Patients With HF

Recommended for all HF Patients
Should be considered for patients with advanced HF or recurrent admissions for HF
  • Oral medication regimen stable for 24 hours
  • No intravenous vasodilator or inotropic agent for 24 hours
  • Ambulation before discharge to assess functional capacity after therapy
  • Plans for postdischarge management (scale present in home, visiting nurse or telephone follow up generally no longer than 3 days after discharge)
  • Referral for disease management
  • Discharge planning is recommended as part of the management of patients with ADHF. Discharge planning should address the following issues:
    • Details regarding medication, dietary sodium restriction, and recommended activity level
    • Follow-up by phone or clinic visit early after discharge to reassess volume status
    • Medication and dietary compliance
    • Monitoring of body weight, electrolytes and renal function
    • Consideration of referral for formal disease management (Strength of Evidence = C)

Definitions:

Strength of Evidence

Level A: Randomized, Controlled, Clinical Trials
May be assigned based on results of a single trial

Level B: Cohort and Case-Control Studies
Post hoc, subgroup analysis, and meta-analysis
Prospective observational studies or registries

Level C: Expert Opinion
Observational studies – epidemiologic findings
Safety reporting from large-scale use in practice

Strength of Recommendations

"Is recommended": Part of routine care
Exceptions to therapy should be minimized.

"Should be considered": Majority of patients should receive the intervention.
Some discretion in application to individual patients should be allowed.

"May be considered": Individualization of therapy is indicated

"Is not recommended": Therapeutic intervention should not be used

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations").

The recommendations are supported by randomized controlled clinical trials, cohort and case-control studies, and expert opinion.

BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

POTENTIAL BENEFITS

Accurate evaluation and appropriate management of patients with acute decompensated heart failure

POTENTIAL HARMS

  • High-dose diuretic therapy is a marker for increased mortality during hospitalization for heart failure (HF), as it is in chronic HF. Whether this is a direct adverse effect of diuretics or a reflection of the severity of the HF is unclear. However, complications of diuretic therapy that could result in poor outcomes include electrolyte disturbance, hypotension, and volume depletion. Treatments that effectively relieve symptoms in patients with acute decompensated heart failure (ADHF), such as diuretics, vasodilators, and inodilators, can be associated with significant short- and even long-term adverse effects on renal function.
  • Troponin release has been documented during hospitalization for ADHF. These findings suggest that myocyte loss from necrosis and apoptosis may be accelerated in patients admitted with acute decompensated heart failure. Mechanisms potentially accounting for cell death are still being determined but may include neurohormonal activation and pharmacologic therapy. Medications that increase myocardial oxygen demand have the potential to induce ischemia and may damage hibernating but viable myocardium, especially in patients with ischemic heart disease. Experimental data indicate that dobutamine can cause necrosis in hibernating myocardium. One outcome study comparing dobutamine to levosimendan suggested greater risk in patients randomized to dobutamine.
  • Administration of intravenous furosemide has been associated with neurohormonal activation, which may result in worsening of hemodynamics secondary to vasoconstriction in the early stages of therapy.
  • Despite beneficial effects in acute HF, diuretics may be associated with a variety of adverse effects that often require alterations in their use or the use of concomitant medications. Patients treated with diuretics should be monitored carefully for excessive urine output, development of hypotension, and reductions in serum potassium, magnesium, and renal function. Serial determinations of creatinine and blood urea nitrogen (BUN) are particularly important when these side effects are present or anticipated. Diuretic therapy must be highly individualized based on the degree of fluid overload present and the degree of volume loss produced to minimize these side effects. (See the original guideline document for further details about hypokalemia, hypotension, neurohormonal activation, and other side effects of diuretics.)
  • The adverse effects of nitroglycerin therapy include headache and symptomatic hypotension. Hypotension is more likely when preload is low, which may occur as filling pressures decline in response to diuretic therapy.
  • The potential side effects of nesiritide include hypotension, headache, and worsening renal function. The risk of hypotension appears to be dose dependent and was less frequent in the Vasodilator in the Management of Acute Heart Failure (VMAC) study than in earlier trials that used higher maintenance doses. The incidence of symptomatic hypotension in the VMAC trial was similar in patients treated with nitroglycerin versus nesiritide. Because of the longer effective half-life of nesiritide, hypotension may last longer with nesiritide than with nitroglycerin. The risk of hypotension appears to be reduced in the absence of volume depletion, so correct assessment of fluid status will help to minimize this side effect. If rapid onset of hemodynamic effect is not needed, the bolus dose of nesiritide can be omitted, which may lessen the risk of symptomatic hypotension, although this strategy has not been tested in controlled trials. Headache is not a common side effect and only infrequently is severe enough to warrant discontinuation of the drug.

QUALIFYING STATEMENTS

QUALIFYING STATEMENTS

It must be recognized that the evidence supporting recommendations is based largely on population responses that may not always apply to individuals within the population. Therefore, data may support overall benefit of 1 treatment over another but cannot exclude that some individuals within the population may respond better to the other treatment. Thus guidelines can best serve as evidence-based recommendations for management, not as mandates for management in every patient. Furthermore, it must be recognized that trial data on which recommendations are based have often been carried out with background therapy not comparable to therapy in current use. Therefore, physician decisions regarding the management of individual patients may not always precisely match the recommendations. A knowledgeable physician who integrates the guidelines with pharmacologic and physiologic insight and knowledge of the individual being treated should provide the best patient management.

IMPLEMENTATION OF THE GUIDELINE

DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

IMPLEMENTATION TOOLS

Pocket Guide/Reference Cards
Slide Presentation

For information about availability, see the "Availability of Companion Documents" and "Patient Resources" fields below.

INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

IOM CARE NEED

Living with Illness

IOM DOMAIN

Effectiveness

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

1999 (revised 2006 Feb)

GUIDELINE DEVELOPER(S)

Heart Failure Society of America, Inc - Disease Specific Society

SOURCE(S) OF FUNDING

Heart Failure Society of America, Inc

GUIDELINE COMMITTEE

Comprehensive Heart Failure Practice Guideline Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Committee Members: Kirkwood F. Adams, Jr, MD (Co-Chair); JoAnn Lindenfeld, MD (Co-Chair); J. Malcolm O. Arnold, MD; David W. Baker, MD; Denise H. Barnard, MD; Kenneth Lee Baughman, MD; John P. Boehmer, MD; Prakash Deedwania, MD; Sandra B. Dunbar, RN, DSN; Uri Elkayam, MD; Mihai Gheorghiade, MD; Jonathan G. Howlett, MD; Marvin A. Konstam, MD; Marvin W. Kronenberg, MD; Barry M. Massie, MD; Mandeep R. Mehra, MD; Alan B. Miller, MD; Debra K. Moser, RN, DNSc; J. Herbert Patterson, PharmD; Richard J. Rodeheffer, MD; Jonathan Sackner-Bernstein, MD; Marc A. Silver, MD; Randall C. Starling, MD, MPH; Lynne Warner Stevenson, MD; Lynne E. Wagoner, MD

HFSA Executive Council: Gary S. Francis, MD, President; Michael R. Bristow, MD, PhD; Jay N. Cohn, MD; Wilson S. Colucci, MD; Barry H. Greenberg, MD; Thomas Force, MD; Harlan M. Krumholz, MD; Peter P. Liu, MD; Douglas L. Mann, MD; Ileana L. Piña, MD; Susan J. Pressler, RN, DNS; Hani N. Sabbah, PhD; Clyde W. Yancy, MD

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Committee members and reviewers from the Executive Council received no direct financial support from the Heart Failure Society of America (HFSA) or any other source for the development of the guideline. Administrative support was provided by the Heart Failure Society of America staff, and the writing of the document was performed on a volunteer basis by the Committee. Financial relationships that might represent conflicts of interest were collected for all members of the Guideline Committee and of the Executive Council, who were asked to disclose potential conflicts and recuse themselves from discussions when necessary. Current relationships are shown in Table 1.5 of the "Development and Implementation" companion document (see the "Availability of Companion Documents" field).

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Heart Failure Society of America. Heart Failure Society of America (HFSA) practice guidelines. HFSA guidelines for management of patients with heart failure caused by left ventricular systolic dysfunction--pharmacological approaches. J Card Fail 1999 Dec;5(4):357-82.

GUIDELINE AVAILABILITY

Electronic copies: Available from the Heart Failure Society of America, Inc. Web site.

Print copies: Available from the Heart Failure Society of America, Inc., Court International - Suite 240 S, 2550 University Avenue West, Saint Paul, Minnesota 55114; Phone: (651) 642-1633

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

The following is also available:

  • Heart Failure Society of America. Pocket guide. HFSA 2006 comprehensive heart failure practice guideline.

Electronic copies: Not available at this time.

Print copies: Available from the Heart Failure Society of America, Inc., Court International - Suite 240 South, 2550 University Avenue West, Saint Paul, Minnesota 55114; Phone: (651) 642-1633

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI on July 31, 2006. The information was verified by the guideline developer on August 10, 2006. This summary was updated by ECRI Institute on July 12, 2007 following the U.S. Food and Drug Administration (FDA) advisory on Troponin-1 Immunoassay.

COPYRIGHT STATEMENT

DISCLAIMER

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