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## Complete Summary

#### GUIDELINE TITLE

Heart failure in adults.

#### BIBLIOGRAPHIC SOURCE(S)

Institute for Clinical Systems Improvement (ICSI). Heart failure in
adults. Bloomington (MN): Institute for Clinical Systems Improvement
(ICSI); 2007 Aug. 119 p. \[217 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Heart failure in adults.
Bloomington (MN): Institute for Clinical Systems Improvement (ICSI);
2005 Jun. 111 p.

### \*\* 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.

-   [August 16, 2007, Coumadin
    (Warfarin)](http://www.fda.gov/medwatch/safety/2007/safety07.htm#Warfarin):
    Updates to the labeling for Coumadin to include pharmacogenomics
    information to explain that people\'s genetic makeup may influence
    how they respond to the drug.

-   [June 8, 2007, Troponin-I
    Immunoassay](http://www.fda.gov/medwatch/safety/2007/safety07.htm#Architect):
    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.

### 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\
 CONTRAINDICATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

-   Heart failure (HF)

-   Acute pulmonary edema

#### GUIDELINE CATEGORY

Counseling\
Diagnosis\
Evaluation\
Management\
Risk Assessment\
Treatment

#### CLINICAL SPECIALTY

Cardiology\
Emergency Medicine\
Family Practice\
Geriatrics\
Internal Medicine

#### INTENDED USERS

Advanced Practice Nurses\
Allied Health Personnel\
Health Care Providers\
Health Plans\
Hospitals\
Managed Care Organizations\
Nurses\
Physician Assistants\
Physicians

#### GUIDELINE OBJECTIVE(S)

-   To decrease the re-admission rate within 30 days of discharge
    following hospitalization for heart failure

-   To optimize the pharmacologic treatment of adult patients with heart
    failure

-   To improve the use of diagnostic testing in order to identify and
    then appropriately treat adult patients with heart failure

-   To improve care of adult heart failure patients by assuring
    comprehensive patient education and follow-up care

#### TARGET POPULATION

Adult patients age 18 and older with suspected heart failure and heart
failure requiring hospitalization

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Diagnosis/Evaluation**

1.  Initial evaluation, including history, cardiac risk factors,
    symptoms, lifestyle issues, and physical examination

2.  Laboratory evaluation, including

    -   Initial evaluation: complete blood count (CBC), prothrombin
        time/international normalized ratio (PT/INR), electrolytes,
        renal function (blood urea nitrogen \[BUN\], creatinine \[Cr\]),
        liver function (aspartate transaminase \[AST\], alanine
        transaminase \[ALT\], alkaline phosphatase, bilirubin, total
        protein (T Prot), albumin), urinalysis, sensitive
        thyroid-stimulating hormone (sTSH)

    -   Inpatient/emergency department evaluation: arterial blood gases,
        tests for myocardial injury (troponin, creatine kinase (CK)/CK
        muscle brain (CKMB), brain natriuretic peptide (BNP)

    -   Evaluation for other causes: ferritin/iron/total iron-binding
        capacity (TIBC)/macrocytic anemias; lipid profile; blood culture
        if endocarditis suspected; lyme serology (if suspect
        bradycardia/heart block); connective tissue disease work up;
        human immunodeficiency virus (HIV)

3.  Assessment of left ventricular functioning by echocardiography or
    radionuclide ventriculography

4.  Electrocardiogram

5.  Chest radiograph

6.  Ischemia evaluation (stress test, angiography) in selected patients

7.  Assessment for causative and precipitating factors of heart failure

8.  Assessment for signs and symptoms requiring emergent management or
    hospitalization

**Treatment/Management**

1.  Hospitalization if indicated

2.  Pharmacologic management including

    -   Beta blockers

    -   Angiotensin-converting enzyme (ACE) inhibitors

    -   Angiotensin II receptor blockers (ARBs)

    -   Diuretics

    -   Aldosterone blocking agents

    -   Inotropes such as dobutamine, dopamine, and milrinone (Note:
        these agents should be restricted to patients needing
        symptomatic relief who are no longer responding to other
        therapies.)

    -   Digoxin

    -   Other vasodilators, such as intravenous nitroglycerin,
        intravenous nitroprusside, nesiritide

    -   Hydralazine/isosorbide dinitrate

    -   Calcium channel blockers

    -   Anti-arrhythmics

    -   Anticoagulants (warfarin)

3.  Non-pharmacologic management including diet (including sodium
    restriction), daily weights, exercise, smoking cessation, coping
    with chronic disease, advanced directives, and end-of-life
    considerations

4.  Ongoing assessment of treatment and evaluation for symptom
    exacerbation

5.  Emergent management including adjusting O~2~, continuous or bilevel
    positive airway pressure

6.  Management of acute pulmonary edema including loop diuretics,
    nitroglycerin or nesiritide

#### MAJOR OUTCOMES CONSIDERED

**Diagnosis**

Sensitivity, specificity, accuracy, and reproducibility of diagnostic
tests

**Treatment**

-   Hospitalization rates

-   Morbidity and mortality

-   Change in function and quality of life

-   Change in symptoms

-   Exercise capacity/tolerance

-   Disease progression

-   Safety of pharmacologic agents

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

A literature search of clinical trials, meta-analysis, and systematic
reviews is performed.

#### 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

Key conclusions (as determined by the work group) are supported by a
conclusion grading worksheet that summarizes the important studies
pertaining to the conclusion. Individual studies are classed according
to the system presented below, and are designated as positive, negative,
or neutral to reflect the study quality.

**Conclusion Grades**:

**Grade I**: The evidence consists of results from studies of strong
design for answering the question addressed. The results are both
clinically important and consistent with minor exceptions at most. The
results are free of any significant doubts about generalizability, bias,
and flaws in research design. Studies with negative results have
sufficiently large samples to have adequate statistical power.

**Grade II**: The evidence consists of results from studies of strong
design for answering the question addressed, but there is some
uncertainty attached to the conclusion because of inconsistencies among
the results from the studies or because of minor doubts about
generalizability, bias, research design flaws, or adequacy of sample
size. Alternatively, the evidence consists solely of results from weaker
designs for the question addressed, but the results have been confirmed
in separate studies and are consistent with minor exceptions at most.

**Grade III**: The evidence consists of results from studies of strong
design for answering the question addressed, but there is substantial
uncertainty attached to the conclusion because of inconsistencies among
the results of different studies or because of serious doubts about
generalizability, bias, research design flaws, or adequacy of sample
size. Alternatively, the evidence consists solely of results from a
limited number of studies of weak design for answering the question
addressed.

**Grade Not Assignable**: There is no evidence available that directly
supports or refutes the conclusion.

**Study Quality Designations**:

The quality of the primary research reports and systematic reviews are
designated in the following ways on the conclusion grading worksheets:

**Positive**: indicates that the report or review has clearly addressed
issues of inclusion/exclusion, bias, generalizability, and data
collection and analysis;

**Negative**: indicates that these issues (inclusion/exclusion, bias,
generalizability, and data collection and analysis) have not been
adequately addressed;

**Neutral**: indicates that the report or review is neither
exceptionally strong nor exceptionally weak;

**Not Applicable**: indicates that the report is not a primary reference
or a systematic review and therefore the quality has not been assessed.

**Evidence Grading System**

A.  **Primary Reports of New Data Collection**:

> Class A: Randomized, controlled trial
>
> Class B: Cohort study
>
> Class C:\
> Non-randomized trial with concurrent or historical controls\
> Case-control study\
> Study of sensitivity and specificity of a diagnostic test\
> Population-based descriptive study
>
> Class D:\
> Cross-sectional study\
> Case series\
> Case report

B.  **Reports that Synthesize or Reflect upon Collections of Primary
    Reports:**

> Class M:\
> Meta-analysis\
> Systematic review\
> Decision analysis\
> Cost-effectiveness analysis
>
> Class R:\
> Consensus statement\
> Consensus report\
> Narrative review
>
> Class X: Medical opinion

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review with Evidence Tables

#### 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

**New Guideline Development Process**

A new guideline, order set, and protocol is developed by a 6- to
12-member work group that includes physicians, nurses, pharmacists,
other healthcare professionals relevant to the topic, along with an
Institute for Clinical Systems Improvement (ICSI) staff facilitator.
Ordinarily, one of the physicians will be the leader. Most work group
members are recruited from ICSI member organizations, but if there is
expertise not represented by ICSI members, 1 or 2 members may be
recruited from medical groups or hospitals outside of ICSI.

The work group will meet for seven to eight three-hour meetings to
develop the guideline. A literature search and review is performed and
the work group members, under the coordination of the ICSI staff
facilitator, develop the algorithm and write the annotations and
footnotes and literature citations.

Once the final draft copy of the guideline is developed, the guideline
goes to the ICSI members for critical review.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

Published cost analyses were reviewed.

#### METHOD OF GUIDELINE VALIDATION

Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

**Critical Review Process**

Every newly developed guideline or a guideline with significant change
is sent to Institute for Clinical Systems Improvement (ICSI) members for
Critical Review. The purpose of critical review is to provide an
opportunity for the clinicians in the member groups to review the
science behind the recommendations and focus on the content of the
guideline. Critical review also provides an opportunity for clinicians
in each group to come to consensus on feedback they wish to give the
work group and to consider changes necessary across systems in their
organization to implement the guideline.

All member organizations are expected to respond to critical review
guidelines. Critical review of guidelines is a criterion for continued
membership within the ICSI.

After the critical review period, the guideline work group reconvenes to
review the comments and make changes, as appropriate. The work group
prepares a written response to all comments.

**Approval**

Each guideline, order set, and protocol is approved by the appropriate
steering committee. There is one steering committee each for
Respiratory, Cardiovascular, Women\'s Health, and Preventive Services.
The Committee for Evidence-based Practice approves guidelines, order
sets, and protocols not associated with a particular category. The
steering committees review and approve each guideline based on the
following:

-   Member comments have been addressed reasonably.

-   There is consensus among all ICSI member organizations on the
    content of the document.

-   To the extent of the knowledge of the reviewer, the scientific
    recommendations within the document are current.

-   Either a critical review has been carried out, or to the extent of
    the knowledge of the reviewer, the changes proposed are sufficiently
    familiar and sufficiently agreed upon by the users that a new round
    of critical review is not needed.

Once the guideline, order set, or protocol has been approved, it is
posted on the ICSI Web site and released to members for use. Guidelines,
order sets, and protocols are reviewed regularly and revised, if
warranted.

**Revision Process of Existing Guidelines**

ICSI scientific documents are revised every 12 to 36 months as indicated
by changes in clinical practice and literature. Every 6 months, ICSI
checks with the work group to determine if there have been changes in
the literature significant enough to cause the document to be revised
earlier than scheduled.

Prior to the work group convening to revise the document, ICSI members
are asked to review the document and submit comments. During revision, a
literature search of clinical trials, meta-analysis, and systematic
reviews is performed and reviewed by the work group. The work group will
meet for 1-2 three-hour meetings to review the literature, respond to
member organization comments, and revise the document as appropriate.

If there are changes or additions to the document that would be
unfamiliar or unacceptable to member organizations, it is sent to
members to review prior to going to the appropriate steering committee
for approval.

**Review and Comment Process**

ICSI members are asked to review and submit comments for every
guideline, order set, and protocol prior to the work group convening to
revise the document.

The purpose of the Review and Comment process is to provide an
opportunity for the clinicians in the member groups to review the
science behind the recommendations and focus on the content of the order
set and protocol. Review and Comment also provides an opportunity for
clinicians in each group to come to consensus on feedback they wish to
give the work group and to consider changes needed across systems in
their organization to implement the guideline.

All member organizations are encouraged to provide feedback on order
sets and protocol, however responding to Review and Comment is not a
criterion for continued membership within ICSI.

After the Review and Comment period, the work group reconvenes to review
the comments and make changes as appropriate. The work group prepares a
written response to all comments.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

**Note from the National Guideline Clearinghouse (NGC) and the Institute
for Clinical Systems Improvement (ICSI)**: For a description of what has
changed since the previous version of this guidance, refer to [\"Summary
of Changes Report \-- August
2007](http://www.icsi.org/guidelines_and_more/guidelines__order_sets___protocols/cardiovascular/heart_failure_2/heart_failure_in_adults__guideline_.html).\"

The recommendations for the management of heart failure (HF) in adults
are presented in the form of 3 algorithms: [Heart Failure in
Adults](http://www.guideline.gov/algorithm/5972/NGC-5972_1.html),
[Emergent
Management](http://www.guideline.gov/algorithm/5972/NGC-5972_2.html),
and [Acute Pulmonary
Edema](http://www.guideline.gov/algorithm/5972/NGC-5972_3.html) with a
total of 58 components, accompanied by detailed annotations. Clinical
highlights and selected annotations (numbered to correspond with the
algorithm) follow.

Class of evidence (A-D, M, R, X) and conclusion grade (I-III, Not
Assignable) definitions are repeated at the end of the \"Major
Recommendations\" field.

**Clinical Highlights**

-   Evaluate patients presenting with heart failure (HF) for
    exacerbating and underlying causes including coronary artery
    disease, hypertension, valvular disease, and other cardiac and
    non-cardiac causes. (*Annotation #2*)

-   Studies show that the distinction between systolic dysfunction and
    preserved systolic function is important because the choice of
    therapy may be quite different and some therapies for systolic
    dysfunction may be detrimental if used to treat preserved systolic
    function. (*Annotation #2*)

-   After evaluation, diagnosis, and initiation of pharmacologic and
    non-pharmacologic management of heart failure, follow-up in the
    ambulatory setting should focus on optimizing pharmacologic and
    non-pharmacologic therapy and preventing heart failure
    exacerbations. Patient education is central in this effort.
    (*Annotations #13, 14*)

-   Daily weights are critical for managing heart failure and early
    detection of increases in fluid retention. Patients should call
    their provider about a two-pound or greater weight gain overnight or
    a five-pound or greater weight gain in a week. (*Annotation #14*)

-   Unless specific contraindications exist, treat all patients,
    including Class IV patients, with beta-blockers starting with a low
    dose and titrate upward. Do not unnecessarily reduce or discontinue
    beta-blockers in severe or decompensated heart failure. After fluid
    overload and hypotension are corrected and when only one drug can be
    initiated, beta-blockers are preferred. (*Annotation #13*)

-   Treat all patients with left-ventricular systolic dysfunction with
    angiotensin-converting enzyme (ACE) inhibitors (or angiotensin
    receptor blockers \[ARBs\] if intolerant) unless specific
    contraindications exist such as intolerance or adverse reactions to
    ACE inhibitors, serum potassium greater than 5.5 mEq/L, symptomatic
    hypotension, severe renal artery stenosis, or pregnancy. Gradually
    titrate dose up over a two- to three-month period. (*Annotations
    #13*)

-   Consider treatment with aldosterone antagonists for Class III and IV
    heart failure patients with appropriate follow-up. (*Annotation
    #13*)

-   Consider early specialty referral for patients with ischemia or
    those who are refractory despite optimal medical therapy.
    (*Annotation #11*)

-   Brain natriuretic peptide (BNP) and proBNP is useful in the
    diagnosis and prognosis of heart failure in patients with dyspnea of
    unknown etiology. (*Annotation #2*)

[**Heart Failure Algorithm
Annotations**](http://www.guideline.gov/algorithm/5972/NGC-5972_1.html)

1.  **Signs and Symptoms of Heart Failure (Excluding Acute Coronary
    Syndrome)**

> **Signs and Symptoms of Congestion**:

-   Dyspnea

-   Orthopnea

-   Paroxysmal nocturnal dyspnea

-   Cough (recumbent or exertional)

-   Abdominal or epigastric discomfort

-   Abdominal bloating (ascites)

-   Early satiety

-   Hemoptysis, frothy or pink-tinged sputum

-   Pedal/leg swelling

-   Weight gain (rapid)

-   Sleep disturbances (anxiety or air hunger)

-   Chest tightness or discomfort

-   Unexplained confusion, altered mental status, or fatigue

-   Nausea or anorexia

-   Dependent edema

> **Signs and Symptoms of Poor Perfusion/Low Cardiac Output**:

-   Easy fatigability

-   Poor energy level or endurance

-   Decreased exercise tolerance

-   Cachexia

-   Muscle wasting or weakness

-   Nausea or anorexia

-   Early satiety

-   Weight loss, unexplained

-   Malaise

-   Impaired concentration or memory

-   Sleep disturbance

-   Altered mentation (somnolence, confusion)

-   Resting tachycardia

-   Daytime oliguria with recumbent nocturia

-   Cool or vasoconstricted extremities

-   Cheyne-Stokes respiration (with or without apnea)

> See Appendix B in the original guideline document for the New York
> Heart Association (NYHA) Classification and American College of
> Cardiology/American Heart Association (ACC/AHA) Staging System.

2.  **Initial Evaluation**

> **Key Points**:

-   The diagnosis of heart failure should not be a single diagnosis. It
    is important to identify the etiology or precipitating factors as a
    cause of heart failure.

-   It is important to determine whether ventricular dysfunction is
    systolic or diastolic because therapies are quite different. Some
    therapies for systolic dysfunction may even be harmful if used to
    treat preserved systolic function.

-   Ischemia is responsible for the majority of cases of heart failure.
    Two-thirds of systolic heart failure is due to ischemic heart
    disease. Identifying ischemia as a cause of heart failure is
    important, because a majority of these patients would benefit from
    revascularization.

> The purpose of the initial evaluation, whether in the inpatient or
> outpatient setting should be to confirm a diagnosis of heart failure
> and identify an etiology/precipitating factor(s).
>
> Early triage should be performed to determine whether emergent or
> inpatient care is needed. Early identification of acute ischemia as
> the cause of heart failure is important because prompt reversal of
> ischemia may impact outcome.
>
> Consider consultation with cardiology during the initial evaluation
> and any time that it is felt appropriate in the ongoing management of
> HF patients.
>
> **Questions to Determine Severity**:

A.  **History**

> **Presenting Symptoms**:

-   Dyspnea/paroxysmal nocturnal dyspnea (PND)/orthopnea

-   Recent weight gain

-   Chest pain

-   Palpitations

-   Blood loss/causes of anemia

-   Recent fevers/viral infection

-   Cough/sputum production

-   Claudication

-   Exercise tolerance

-   Fatigue

-   Edema/ascites

-   Color changes

> **Past Medical History**:

-   History of congestive heart failure (CHF)

-   History of myocardial infarction (MI)

-   Cardiac risk factors

-   Hypertension/smoking/diabetes/hyperlipidemia

-   History/risk factors for thromboembolic disease

-   History of thyroid dysfunction

-   Recently postpartum

-   History of snoring/sleep apnea

-   Blunt chest injury

-   Rheumatic fever

-   Human immunodeficiency virus (HIV)

-   Bacterial endocarditis

-   Claudication

-   Screen for depression

-   Foreign travel

> **Family History**:

-   Screen for family history of ischemic heart disease, CHF, congenital
    heart disease, risk factors for arteriosclerotic cardiovascular
    disease (ASCVD) and CHF

> **Social History**:

-   Smoking

-   Alcohol use/abuse screen

-   Drug abuse

> **Dietary History**:

-   Salt and daily fluid intake

-   Balanced diet

B.  **Physical Exam**:

    -   Vital signs, including weight and height

    -   Diaphoresis

    -   Diminished peripheral pulse or bruit

    -   Skin color: cyanosis, pallor, jaundice

    -   Lower extremity edema in the absence of venous insufficiency

    -   Elevated jugular venous pressure, positive hepato-jugular reflux

    -   Heart rate: tachycardia, bradycardia/arrhythmias

    -   Left lateral displacement of the point of maximal impulse (PMI)

    -   Heart sounds - S3, S4, murmur

    -   Lungs: labored breathing, rales above the lower 25% of the lung
        that do not clear with cough

    -   Abdomen - large, pulsatile, tender liver or ascites

> ***Evidence supporting this recommendation is of class: R***

C.  **Initial Laboratory Evaluation**:

    -   **Initial**

        -   Complete blood count

        -   Electrolytes (Na^+^, K^+^) and Cl^-^, Bicarbonate, Ca^++,^
            MG^++^ (if on diuretics)

        -   Renal function (blood urea nitrogen \[BUN\], creatinine
            \[Cr\])

        -   Liver function (aspartate transaminase \[AST\], alanine
            transaminase \[ALT\], alkaline phosphatase, bilirubin, total
            protein (T Prot), albumin)

        -   Urinalysis

        -   Sensitive thyroid-stimulating hormone (sTSH)

        -   Prothrombin time/international normalized ratio (PT/INR)

    -   **Inpatient/Emergency Department**

        -   Arterial blood gases

        -   Tests for myocardial injury: troponin, creatine
            kinase/creatine kinase muscle band (MB) (CK/CKMB)

        -   Brain natriuretic peptide (BNP)

    -   **Other Causes**

        -   Ferritin/iron/total iron-binding capacity (TIBC)/macrocytic
            anemias

        -   Lipid profile

        -   Blood culture if endocarditis suspected

        -   Lyme serology (if suspect bradycardia/heart block)

        -   Connective tissue disease work up

        -   HIV

> ***Evidence supporting this recommendation is of class: R***
>
> Refer to the original guideline document for information on ACC/AHA
> heart failure grading.
>
> **Role of Brain Natriuretic Peptide (BNP) in the Diagnosis and
> Management of Heart Failure**
>
> Brain natriuretic peptide (BNP) and ProBNP assays have been found
> useful in the diagnosis of patients with dyspnea of unknown etiology.
> Since BNP and ProBNP concentrations correlate positively with cardiac
> filling pressures, measurement of a low concentration make it unlikely
> that dyspnea is due to cardiac dysfunction.
>
> Refer to the original guideline document for more details on the role
> of BNP in the diagnosis and management of heart failure.
>
> ***Evidence supporting this recommendation is of classes: A, C, D***

D.  **Diagnostic Tests**:

    -   Electrocardiogram

    -   Chest radiograph

    -   Assessment of ventricular function (echocardiogram, radionuclide
        ventriculography)

        -   It is reasonable to reassess ejection fraction (EF) if
            patient is clinically decompensated or after patient has
            been titrated up to target doses of beta-blockers and ACE
            inhibitors.

    -   Ischemia evaluation in patients with coronary artery disease
        (CAD) risk factors (stress test, angiography). Refer to the
        National Guideline Clearinghouse (NGC) summary of the Institute
        for Clinical Systems Improvement (ICSI) guideline [Diagnosis and
        Treatment of Chest Pain and Acute Coronary Syndrome
        (ACS)](http://www.guideline.gov/summary/summary.aspx?doc_id=10227&nbr=005390),
        and [Cardiac Stress Test
        Supplement](http://www.guideline.gov/summary/summary.aspx?doc_id=10810&nbr=005635).

> An electrocardiogram (ECG) and chest radiograph are fundamental parts
> of the initial evaluation for heart failure. In addition, the
> objective evaluation of ventricular performance is also a critical
> part for patients with suspected or known heart failure. Objective
> evaluation of left ventricular (LV) function is necessary because
> Chest x-ray (CXR), ECG, and history and physical examination (H&P)
> often fail to distinguish normal from low EF in patients with heart
> failure.
>
> ***Evidence supporting this recommendation is of classes D, M, R***
>
> Refer to the original guideline document for additional information on
> specific etiologies of ventricular dysfunction, interpretation of
> ventricular function testing, and measurement techniques.

E.  **Assess for Causative and Precipitating Factors**

> Causes of heart failure can be classified as cardiac and non-cardiac.
> Refer to tables 2 and 3 in the original guideline document for the
> salient features of the more common causes.
>
> In patients with heart failure symptoms, it is important to determine
> if they have left or right ventricular systolic dysfunction or
> preserved systolic function. One-third of patients have predominantly
> preserved systolic function, one-third have both systolic and
> diastolic dysfunction and one-third have predominantly systolic
> dysfunction.
>
> Diastolic dysfunction is difficult to measure. Doppler
> echocardiography is currently the method of choice to assess diastolic
> dysfunction. It is, however, technically difficult and requires expert
> interpretation. Furthermore, loading conditions affect mitral inflow
> pulsed-wave Doppler parameters, making the differentiation between
> normal and pseudonormal diastolic dysfunction particularly difficult.
> Therefore, in addition to mitral inflow parameters, pulmonary venous
> (PV) flow Doppler and changes in mitral inflow parameters during
> Valsalva maneuver are commonly used to distinguish pseudonormal from
> normal diastolic function. BNP and proBNP measurements may help in the
> diagnosis of heart failure in patients with preserved EF. About
> two-thirds of patients with heart failure with preserved ejection
> fraction have moderate to severe diastolic dysfunction.
>
> The community prevalence of HF with preserved EF is high, and among
> these patients, most have preserved systolic dysfunction of moderate
> to severe degree. Heart failure with preserved systolic function has
> increased in prevalence over time. Patients with preserved ejection
> fraction are older, are more likely to be women, are less likely to be
> smokers or have a history of MI, and have a lower New York Heart
> Association class, but have similar comorbidities.
>
> Patients with heart failure with preserved systolic function have the
> same or only slightly better rates of survival than those with
> systolic heart failure.
>
> ***Evidence supporting this recommendation is of classes: B, C, R***

3.  **Unstable Signs and Symptoms Requiring Emergent Management?**

> **Unstable symptoms may include**:

-   Dyspnea: at rest/orthopnea (change from baseline), sudden onset of
    shortness of breath (SOB), worsening SOB, exertional dyspnea,
    gasping

-   SaO~2~ less than 90%

-   Coughing up pink/frothy sputum

-   Dizziness or syncope

-   Chest pain

-   Systolic blood pressure (BP) less than 80 to 90 mmHg and symptomatic

-   Evidence of hypoperfusion (cyanosis, decreased level of
    consciousness, etc.)

> **Assess Blood Pressure, Perfusion, and Volume Status**
>
> Refer to Figure 1 in the original guideline document for clinical
> classification of the mode of heart failure.

4.  **Admit to Hospital if Necessary**

> Consider hospitalization in the presence or suspicion of heart failure
> with any of the following findings:

-   Clinical, laboratory, or electrocardiographic evidence of acute
    myocardial ischemia or infarction

-   Severe symptoms of heart failure refractory to outpatient therapy

-   Pulmonary edema or severe respiratory distress

-   Thromboembolic complications requiring interventions

-   Severe complicating medical illness (e.g., pneumonia, renal failure)

-   Management of clinically significant arrhythmias (hemodynamic
    effects)

-   Anasarca (generalized edema)

-   Inadequate social support for safe outpatient management

-   Symptomatic hypotension or syncope

-   Hyperkalemia

> By definition, these patients are Stage C and D, NYHA Class III or IV.
> (See Appendix B in the original guideline document for the New York
> Heart Association Classification and ACC/AHA Staging System.) Heart
> failure should not be the final, stand-alone diagnosis. There should
> always be an associated etiology and/or contributing factor. The
> etiology of heart failure and the presence of exacerbating factors or
> other diseases that may have an important influence on management
> should be carefully considered in all cases.

6.  **Initiate Heart Failure Management**

> **Pharmacologic Management of Heart Failure**:

  -----------------------------------------------------------------------
  **Medication**               **Beneficial Subsets**
  ---------------------------- ------------------------------------------
  **ACE Inhibitors**           **NYHA Class I-IV**

  ACE inhibitors slow disease  
  progression, improve         
  exercise capacity and        
  decrease hospitalization and 
  mortality.\                  
  \[*Conclusion Grade I: See   
  Conclusion Grading Worksheet 
  D - Annotations \# 6 and 13  
  (ACE Inhibitors) in the      
  original guideline           
  document*.\]                 

  **Angiotensin II Receptor    NYHA Class I-IV. Reduce afterload and
  Antagonists**                improve cardiac output. Can be used for
                               patients with ACE inhibitor cough.

  **Hydralazine/Isosorbide     Patients intolerant to ACE inhibitors
  Dinitrate**                  

  **Diuretics**                Fluid overload (edema, ascites, dyspnea,
                               weight gain)

  **Aldosterone Antagonists**  NYHA Class III-IV

  **Digoxin**                  NYHA Class II-IV; patients with atrial
                               fibrillation; patients with S3 gallop,
                               left ventricular (LV) dilatation, high
                               filling pressures

  Digitalis improves symptoms, 
  exercise tolerance, and      
  quality of life, but neither 
  increases nor decreases      
  mortality.\                  
  \[*Conclusion Grade I: See   
  Conclusion Grading Worksheet 
  E - Annotations #6 and 13    
  (Digitalis) in the original  
  guideline document*.\]       

  **Beta-Blockers**            Stable NYHA Class I-IV
  -----------------------------------------------------------------------

> Refer to the original guideline document for information on initial
> daily doses and optimal (target) daily doses.
>
> **Treatment of Systolic Dysfunction**
>
> The cornerstone of treatment is the use of beta-blockers and ACE
> inhibitors. Certain beta-blocking medications have been shown to
> improve clinical symptoms and ventricular function in patients with
> systolic dysfunction.
>
> Beta-blockers decrease hospitalizations and mortality and have
> objective beneficial effect on measures of exercise duration.
> \[*Conclusion Grade I: See Conclusion Grading Worksheet C --
> Annotation #6 and 14 (Beta-blockers and Exercise) in the original
> guideline document*\]
>
> ACE inhibitors prolong life in patients with HF symptoms and EF less
> than 35% and reduce symptom development in asymptomatic patients with
> EF less than 35%.
>
> There is also a mortality benefit in the use of ACE inhibitors in
> patients with recent myocardial infarction and asymptomatic EF less
> than 40%.
>
> ACE inhibitors slow disease progression, improve exercise capacity,
> and decrease hospitalizations and mortality. \[*Conclusion Grade I:
> See Conclusion Grading Worksheet D - Annotations #6 and 13 (ACE
> Inhibitors) in the original guideline document*\]
>
> Refer to the original guideline for additional information on
> treatment of systolic dysfunction.
>
> ***Evidence supporting this recommendation is of classes: A, D***
>
> **Treatment of Heart failure with Preserved Systolic Function**
>
> For the management of preserved systolic function it is particularly
> important to address the underlying etiology. Ischemia and
> hypertension must be optimally controlled. Pericardial disease must be
> specifically treated if present. Control of atrial tachyarrhythmias
> may be of particular importance since these patients need adequate
> time for diastolic filling and they tolerate tachycardias poorly.
> Beta-blockers may be of value to slow the heart rate and allow a
> longer time interval for diastolic filling.
>
> In general, drugs used to treat systolic dysfunction (ACE, ARBs,
> diuretics, beta-blockers) are generally found to be effective in
> patients with heart failure with preserved systolic function.
>
> Diuretics may be helpful to control volume overload and edema. They
> should be used in the lowest dose needed since excessive diuresis may
> cause orthostatic hypotension or prerenal azotemia. Arteriolar
> vasodilators or venodilators should be used with caution as they may
> cause serious hypotension.
>
> Patients with hypertrophic cardiomyopathy should be identified and may
> benefit from genetic counseling. Patients with hypertrophic
> cardiomyopathy may benefit from beta-blockers to slow heart rate. Some
> may benefit from verapamil or disopyramide if beta-blockers are not
> effective. In cases of significant intracavitary pressure gradients,
> dual chamber pacing or septal myectomy surgery may be indicated.
>
> Particular attention must be given to the control of atrial
> tachyarrhythmias. Care should be taken to avoid venodilators and
> arterial vasodilators.
>
> See Annotation #13, \"Pharmacologic Management\" for inpatient
> medications.
>
> ***Evidence supporting this recommendation is of classes: A, C***
>
> For patients with predominant heart failure with preserved systolic
> function:
>
> Treat specific contributing causes:

-   Hypertension (goal is blood pressure of 130/85 mm Hg). See also the
    NGC summary of the ICSI guideline [Hypertension Diagnosis and
    Treatment](http://www.guideline.gov/summary/summary.aspx?doc_id=10225&nbr=005388).

-   Ischemic heart disease

-   Hypertrophic cardiomyopathy - consider referral to subspecialist
    (for verapamil, disopyramide, surgical myectomy, pacemaker)

-   Constrictive pericarditis

> **Pharmacologic Management for Preserved Systolic Function**:

  -----------------------------------------------------------------------
  **Medication**        **Beneficial Subsets**
  --------------------- -------------------------------------------------
  **ACE Inhibitors**    NYHA Class I-IV. Use with caution as they may
                        cause serious hypotension.

  **Angiotensin II      NYHA Class I-IV. Reduce afterload and improve
  Receptor              cardiac output. Can be used for patients with ACE
  Antagonists**         inhibitor cough.

  **Diuretics**         Use with caution to manage fluid retention but
                        not at doses which cause significant orthostatic
                        hypotension or prerenal azotemia.

  **Beta Blockers**     Patients with atrial fibrillation
  -----------------------------------------------------------------------

> See original guideline document for dosing comments.
>
> (See also Annotation #13 for further description of pharmacologic
> management.)

7.  **Coronary Artery Disease (CAD) Known or Suspected and Potential
    Revascularization Candidate?**

> Refer to the NGC summary of the ICSI guideline [Stable Coronary Artery
> Disease](http://www.guideline.gov/summary/summary.aspx?doc_id=10843&nbr=005658).

11. **Consider Specialty Referral/Out of Guideline**

> **Key Points**:

-   Primary care providers should continue to be involved in the
    decision making process when subspecialty consultation and
    management are necessary.

-   Communication between the primary care giver and the cardiologist is
    key and should be encouraged even before the need for a referral in
    order to integrate seamless diagnostic and therapeutic care.

> Once it has been determined that the patient is a candidate for
> revascularization, the next step is angiography performed by a
> cardiologist. Subspecialty consultation will generally involve not
> only performance of the procedure, but also recommendation for further
> management. Primary care providers should continue to be involved in
> the decision-making process. Primary care providers should also be
> familiar with risks associated with various patterns of disease
> distribution seen on angiogram. The decision to proceed with
> revascularization must be determined on an individual basis.
> Consultation should take place among the patient, primary care
> provider, cardiologist, and cardiovascular surgeon to determine the
> most appropriate course of action.
>
> If the results of the angiogram do not show significant CAD or if the
> decision is made not to proceed with revascularization,
> pharmacological management should be continued (see Annotation #13,
> \"Pharmacologic Management\").
>
> Patients with advanced structural heart disease and marked symptoms of
> heart failure at rest despite maximum medical therapy and who require
> specialized interventions are outside of this guideline. These are
> primarily Stage D classed patients.

-   Assumes that all recommendations for Stages A, B, C have been
    maximized, including utilization of neurohormonal inhibitors.

-   Management of fluid status has been aggressively pursued.

-   Accuracy of Stage D diagnosis is confirmed.

-   Any contributing conditions have been identified and treated.

> Refer to the original guideline document for additional information on
> surgical procedures; left ventricular assist devices; continuous
> infusions of positive inotropic agents such as dobutamine, dopamine,
> or milrinone; hospice; and when to consider referral to subspecialist.
>
> ***Evidence supporting this recommendation is of classes: A, R***

12. **Treat Secondary Causes of HF and Significant Comorbid Conditions
    and Risk Factors**

> Treat as indicated by the particular disease state. Specific treatment
> modalities for secondary causes of HF are considered outside of the
> scope of this guideline. See Table 2: Cardiac Related Causes of HF
> with Reduced Systolic Function and Table 3: Non-Cardiac Related Causes
> in the original guideline document. See also the NGC summary of the
> ICSI guideline [Hypertension Diagnosis and
> Treatment](http://www.guideline.gov/summary/summary.aspx?doc_id=10225&nbr=005388).

13. **Pharmacologic Management**

> **Key Points**:

-   Carvedilol, metoprolol succinate (extended release), and bisoprolol
    have demonstrated reductions in mortality over other generic beta
    blockers for patients with all classes of heart failure.

-   ACE inhibitors should be prescribed for all patients with left
    ventricular systolic dysfunction unless specific contraindications
    exist. An elevated baseline creatinine is not a specific
    contraindication.

-   ACE inhibitors are more effective in decreasing heart failure
    mortality than the isosorbide dinitrate/hydralazine combination.

-   Angiotensin receptor blockers should be considered primarily for
    patients who are intolerant of ACE inhibitors or those receiving
    standard drug therapy (including ACE inhibitors) who continue to
    show clinical deterioration.

-   Routine use of angiotensin receptor blockers with ACE inhibitors and
    aldosterone antagonists cannot be recommended.

-   Diuretics should not be the sole therapy for patients with signs of
    volume overload, and vasoactive drugs should also be considered.

-   Loop diuretics are more effective in severe heart failure than
    thiazide diuretics, and combination therapy with thiazide (or
    thiazide-like medication) and loop diuretic may be used in
    refractory cases of volume overload.

-   Aldosterone blocking agents (spironolactone, eplerenone) reduce
    mortality in patients with Class III-IV heart failure for patients
    on stable doses of digoxin and ACE inhibitors.

-   Currently, the work group recommends that nesiritide be reserved for
    patients with acutely decompensated heart failure who remain volume
    overloaded despite aggressive treatment, display tolerance and/or
    resistance to vasodilators or diuretics, or demonstrate significant
    side-effects to other vasodilators.

-   ACE inhibitors should be prescribed for all patients with left
    ventricular systolic dysfunction unless specific contraindications
    exist. Studies show ACE inhibitors are widely underprescribed.

-   Calcium channel blockers should be used with caution in patients
    with heart failure.

> **Beta-Blockers**

-   When only one drug can be initiated, beta blockers are preferred.

-   Studies strongly support use of certain beta-blockers which have
    demonstrated reductions in mortality (e.g., carvedilol, metoprolol
    succinate \[extended release\], bisoprolol) in patients with Class
    I-IV CHF. Recent data from COMET demonstrated carvedilol to have a
    17% risk reduction in mortality over metoprolol tartrate (immediate
    release).

-   The beta blocker should be started as soon as the patient is stable
    (without fluid overload or hypotension).

-   After appropriate stabilization, it may be safe to start
    beta-blockers in the inpatient setting. Beta-blockers decrease
    hospitalizations and mortality. \[*Conclusion Grade I: See
    Conclusion Grading Worksheet F - Annotation #13 (Beta Blockers and
    Inpatient Setting) in the original guideline document*\]

-   Beta blockers should be started at low initial doses and titrated up
    gradually at rates consistent with those from key studies.

-   Do not unnecessarily reduce or discontinue the dose of beta-blocker.

-   If significant bradycardia/atrioventricular (AV) block occurs with
    use of beta- blockers, the dose may need to be decreased. If
    hypotension or fluid retention occurs, either the dose of
    beta-blocker, ACE inhibitor, or diuretics should be adjusted as
    clinically appropriate.

-   Patients should be informed that positive effects of beta-blockers
    may not be seen until several months after titration to target dose.

-   Beta-blockers have objective beneficial effect on measures of
    exercise duration.

-   Beta-blockers have been shown to decrease mortality and reinfarction
    among patients with compensated HF following acute myocardial
    infarction.

-   Beta-blockers have been shown to improve hemodynamics in patients
    with idiopathic dilated cardiomyopathy.

-   For rate control in tachycardia induced heart failure, the work
    group prefers beta-blockers over other agents.

> ***Evidence supporting this recommendation is of classes: A, M***
>
> **Carvedilol**

-   The COMET trial demonstrated carvedilol to have a 17% risk reduction
    in mortality over metoprolol tartrate.

-   Recommended starting dose for carvedilol is 3.125 mg twice daily for
    two weeks. Dosage can be doubled every two weeks to highest level
    tolerated by patient to maximum 25 mg twice daily (less than 85 kg)
    or 50 mg twice daily (greater than 85 kg). It is suggested that
    after initiation of each new dose, patients should be observed for
    signs of dizziness or lightheadedness. Also consider instructing
    patients to take carvedilol two hours before ACE inhibitors to
    decrease potentiating effects. Carvedilol should be taken with food
    to slow the rate of absorption and reduce the risk of postural
    hypotension.

-   There are now prospective randomized controlled data available for
    carvedilol that have shown a reduction in hospitalization and death
    from heart failure.

> ***Evidence supporting this recommendation is of class: M***
>
> **Metoprolol Succinate**

-   In the MERIT HF study of metoprolol succinate compared to placebo, a
    mortality reduction was shown at one year in patients with NYHA
    Class II-IV heart failure.

-   There are no head-to-head trials comparing carvedilol and metoprolol
    succinate (extended release).

-   Recommended starting dose of metoprolol succinate is 25 mg/once
    daily. In patients with more severe heart failure (NYHA Class III
    or IV) recommended starting dose is 12.5 mg/once daily. The dose may
    then be doubled every two weeks up to the highest tolerated dose or
    up to 200 mg/once daily.

> ***Evidence supporting this recommendation is of classes: A, M***
>
> **Vasodilators**
>
> **ACE Inhibitors**

-   ACE inhibitors are widely underprescribed.

-   ACE inhibitors should be prescribed for all patients with
    left-ventricular systolic dysfunction unless specific
    contraindications exist.

-   Contraindications include:

    -   History of intolerance or adverse reactions to these agents

    -   Serum potassium greater than 5.5 mEq/L

    -   Symptomatic hypotension (unless due to excessive diuresis)

    -   Severe renal artery stenosis

    -   Pregnancy

    -   Cough and rash side effects

-   ACE inhibitors should be prescribed or ARBs if contraindications
    exist.

-   To optimize mortality reductions possible with ACE inhibitors, the
    dose must be titrated to the moderate to high dose range (e.g., 20
    to 40 mg Lisinopril daily). Lower dose therapy has been shown to be
    less effective in reducing mortality.

-   Approach to initiating ACE inhibitor therapy:

    -   Start at a low dose and titrate upward over several weeks to
        targeted moderate to high doses and maximum tolerated dose.

    -   Consider holding one dose of diuretic before giving the first
        dose of ACE inhibitors, particularly in patients with low
        baseline blood pressure.

-   **Hypotension**. Patients should be well hydrated before initiation
    or increase of ACE inhibitors. If the patient develops hypotension
    in the absence of hypovolemia, splitting the dose or switching from
    morning (a.m.) to at-bedtime dosing (in long-acting agents) may be
    helpful. If this is ineffective, the dose should be reduced to the
    highest dose tolerated.

-   Periodically monitor for changes in renal function and potassium as
    well as other electrolytes with these agents, especially when
    titrating doses and when concomitantly administered with other
    agents known to affect electrolytes (diuretics, ACE inhibitors,
    angiotensin blocking agents, aldosterone antagonists).

-   **Renal Insufficiency**. Creatinine should be monitored regularly in
    patients on ACE inhibitors, and more frequently during active
    titration. An increase in serum creatinine of 0.5 mg/dL or more is
    an indication for reassessment of volume status. There is no
    absolute level of creatinine to preclude the use of ACE inhibitors.

-   All ACE inhibitors that have been studied to date in treatment of HF
    have shown benefit. Therefore, simpler dosing regimens may be
    equally effective and less expensive.

-   For patients with asymptomatic or mildly symptomatic decreases in
    left ventricular (LV) systolic performance, use of ACE inhibitors
    has been shown to decrease mortality, progression of HF, and need
    for hospitalization.

-   In the general population, ACE inhibitors are more effective in
    decreasing HF mortality than the isosorbide dinitrate/hydralazine
    combination.

-   In studies demonstrating decreased mortality in HF relatively high
    doses of ACE inhibitors were used.

-   Enalapril 20 mg daily (twice daily dosing)

-   Captopril 100 to 150 mg daily (three times daily dosing)

-   ACE inhibitors slow disease progression, improve exercise capacity,
    and decrease hospitalizations and mortality. \[*Conclusion Grade I:
    See Conclusion Grading Worksheet E- Annotations #6 and 13 (ACE
    Inhibitors) in the original guideline document*\]

> ***Evidence supporting this recommendation is of class: A***
>
> **Angiotensin Receptor Blockers (ARB)**

-   ARBs are to be used if ACE inhibitors are not tolerated.

-   Based on the findings of the series of Candesartan in Heart Failure
    Assessment of Reduction in Mortality and Morbidity (CHARM) studies,
    recommendations to consider adding an angiotensin receptor blocker
    to standard optimized drug therapy for those with systolic
    dysfunction may be supported. An ARB is the preferred alternative to
    hydralazine/isosorbide dinitrate in most patients because of ease of
    use except in renal dysfunction, hyperkalemia, and possibly in
    African-Americans.

-   Specifically, according to the CHARM-Added trial, there is a benefit
    in terms of composite cardiovascular endpoints when adding ARB to a
    regimen of an ACE inhibitor and beta-blockers (triple therapy). This
    observation is consistent overall, with the results of the Val-HeFT
    study. In spite of subgroup analysis from Val-HeFT suggesting that
    the addition of an ARB to the ACE inhibitor and beta-blocker may
    have resulted in a negative effect on both mortality and morbidity,
    the group feels that, based on the findings from the CHARM-Added
    study, the combination of ARBs to an ACE inhibitor and beta-blocker
    regimen is more favored than disfavored at this time.

-   Only valsartan and candesartan are approved for use in patients with
    heart failure.

-   Direct comparison with regards to mortality in patients with HF
    showed no difference between the ARB losartan and captopril.

-   According to the Valsartan In Acute Myocardial Infarction (VALIANT)
    trial, 2003, there is no benefit when adding ARB to ACE inhibitors
    in early post MI patients.

-   Contraindications to ARBs include history of intolerance or adverse
    reactions to serum potassium greater than 5.5 mEq/L, symptomatic
    hypotension (unless due to excessive diuresis), severe renal artery
    stenosis, and pregnancy.

> ***Evidence supporting these recommendations is of class: A***
>
> **Diuretics**

-   Patients with signs of volume overload should be started on a
    diuretic; however, this should not be sole therapy.

-   Severe volume overload, severe renal insufficiency (creatinine
    clearance less than 30 mL/min), or persistent edema despite thiazide
    diuretics are all indications to use a loop diuretic.

-   Combination therapy that combines a thiazide or a thiazide-like
    medication such as metolazone with a loop diuretic may be used in
    refractory cases of volume overload.

-   Periodically monitor for changes in renal function and potassium as
    well as other electrolytes with these agents, especially when
    titrating doses and when concomitantly administered electrolytes
    (diuretics, ACE inhibitors, angiotensin blocking agents, and
    aldosterone antagonists).

-   Excessive diuresis may result in:

    -   Prerenal azotemia

    -   Orthostatic hypotension

    -   Hypokalemia and hypomagnesemia

    -   Inability to achieve optimal dose of ACE inhibitor

    -   Activation of the renin-angiotensin-aldosterone (RAAS) system

-   Fluctuating volume status may necessitate ongoing diuretic
    adjustment that requires frequent monitoring for electrolyte
    imbalances and hypotension.

-   In patients refractory to furosemide, a combination of oral or
    intravenous (IV) thiazide diuretics to block the distal tubules
    followed one hour later by a loop diuretic may be beneficial in
    achieving diuresis.

-   Diuretic effectiveness may be increased by 1 to 2 hours of bed rest
    (supine position) after taking diuretics.

-   Hyponatremia is an indication for fluid restriction in a
    volume-overloaded patient and a decrease in diuretic in a
    volume-depleted patient.

-   Hyperkalemia may be the result of too much potassium
    supplementation, potassium-sparing diuretics, digoxin toxicity, ACE
    inhibitor or ARB use, or renal insufficiency.

-   Hypomagnesemia often accompanies hypokalemia. If high doses of
    diuretic are used, serum magnesium levels should be checked
    regularly and oral supplementation given as indicated.
    Hypomagnesemia may prevent correction of hypokalemia.

-   Orthostatic hypotension may indicate overdiuresis in the absence of
    congestive symptoms and may be accompanied by an increased blood
    urea nitrogen (BUN) to creatinine ratio. If volume depletion is not
    present, intolerance of the ACE inhibitor is likely (see \"ACE
    Inhibitors\" earlier in this annotation).

> ***Evidence supporting these recommendations is of classes: A, C, D***
>
> **Aldosterone Blocking Agents**
>
> **Spironolactone**

-   A multi-center, randomized clinical trial showed a reduction in
    mortality among patients with Class III-IV HF who were treated with
    spironolactone 25 to 50 mg per day. These patients were already on
    stable doses of digoxin and ACE inhibitors. In the Randomized
    Aldactone Evaluation Study (RALES), 25 mg per day of spironolactone
    was found to decrease morbidity and mortality. The mechanism is felt
    to be due to inhibition of aldosterone effects on myocardial cell
    death. Hyperkalemia is a side effect of spironolactone and potassium
    levels should be checked three to seven days after starting the
    drug.

> **Eplerenone**

-   Eplerenone, a selective aldosterone antagonist with fewer endocrine
    side effects than spironolactone, was evaluated in the Eplerenone
    Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival
    Study (EPHESUS) trial. It was used in study subjects who had a
    myocardial infarction 3 to 14 days prior and had a left ventricular
    ejection fraction (LVEF) less than 40% with evidence of HF (in 90%)
    and/or diabetes mellitus. Patients with a plasma creatinine greater
    than 2.5 mg/dL or potassium over 5 mEq/L were excluded. The starting
    dose was 25 mg/day, increased to 50 mg/day after four weeks. There
    was a significant lower rate of all-cause mortality (14.4%) due to
    reduction in cardiovascular mortality, reduction in sudden cardiac
    death, decreased mortality and hospitalizations for HF. Most
    patients in this trial (unlike RALES) were on an ACE Inhibitor, A2
    blocker and a beta-blocker

-   The mean left ventricular ejection fraction (LVEF) in EPHESUS was
    33% (compared to 25% in RALES), suggesting that patients with less
    severe heart failure than seen in the RALES trial, might benefit
    from aldosterone antagonism. The NYHA class in the EPHESUS trial
    could not be established as most patients had an MI two weeks prior
    to enrollment.

-   The current recommendation would be to use spironolactone for
    patients who fulfill the RALES criteria (current or recent NYHA
    class IV HF, class III HF with patient being in class IV HF in the
    past 6 months, preserved renal function, or reduced potassium
    concentration). Eplerenone could be used for patients who have had a
    recent MI, LVEF less than 40%, and symptomatic HF and/or diabetes as
    a pharmacologic alternative to spironolactone with less risk of
    gynecomastia. However, the cost and lack of outcome studies in the
    heart failure area would be a limiting factor.

> ***Evidence supporting these recommendations is of class: A***
>
> **Inotropes**
>
> The inotropes -- dobutamine, dopamine, and milrinone -- have failed to
> demonstrate the ability to improve mortality in the treatment of
> severe decompensated heart failure. A review of the literature has in
> fact shown an increase in mortality with the use of these agents.
> \[*Conclusion Grade I: See Conclusion Grading Worksheet G - Annotation
> #13 (Inotropes) in the original guideline document*\]. The use of
> these inotropes should therefore be restricted to those patients
> needing symptomatic relief who are no longer responding to other
> therapies. \[*Conclusion Grade III: See Conclusion Grading Worksheet
> G - Annotation #13 (Inotropes) in the original guideline document*\]
> As palliative treatment in select patients, the available data
> supports continuous infusion over repetitive intermittent infusion.
>
> **Digoxin**

-   Digoxin is a useful drug in heart failure patients with atrial
    fibrillation with a rapid ventricular response.

-   Digoxin in combination with ACE inhibitors has been shown to be of
    benefit in regard to hospitalization heart failure patients.

-   The initiation of digoxin in asymptomatic heart failure patients
    still remains unsupported by clinical trials.

-   Loading doses are generally not needed and steady state generally
    takes one week to reach (longer in patients with renal impairment).

-   Serum levels of 0.7 to 1.5 ng/mL are considered therapeutic. Serum
    levels do not always correlate to symptoms of digoxin toxicity.

-   Monitor for symptoms of toxicity (nausea, confusion, visual
    disturbance, anorexia), reduction of renal function, or conduction
    abnormality.

-   To avoid digitalis toxicity, care should be used to use lower doses
    in the elderly and those with renal impairment, check digitalis
    level in one to two weeks after start of therapy in elderly or
    renal-impaired patients, and beware of drug interactions with new
    medications.

-   In subjects in normal sinus rhythm with preserved systolic function
    (PSF) and mild to moderate heart failure symptoms on optimal
    therapy, digoxin had no effect on the endpoints of all-cause or
    cardiovascular mortality or hospitalization.

-   Post hoc retrospective analysis of mortality statistics regarding
    the use of digoxin in heart failure indicate that the drug may
    actually increase mortality in women when compared to placebo. There
    are no randomized, prospective studies to confirm gender-based
    differences, but practitioners may want to consider this information
    when prescribing digoxin to women. If digoxin therapy is to be
    continued in women, it may be reasonable to recommend that lower
    dosing (0.125 mg per day) should be used and lower serum levels (1.0
    or less) should be maintained.

> ***Evidence supporting this recommendation is of class: A***
>
> **Other Vasodilators**

-   Alpha-adrenergic blockers (prazosin, terazosin) have not
    demonstrated survival or functional benefit in the treatment of HF

> ***Evidence supporting this recommendation is of class: A***
>
> **Nitroglycerin (Intravenous)**

-   Food and Drug Administration (FDA) Indication: Intravenous
    nitroglycerin is indicated for the treatment of heart failure in
    patients with concomitant acute myocardial infarction.

-   Non-FDA indication: Nitroglycerin can be used to treat pulmonary
    edema.

-   Following acute MI, early parenteral nitrate therapy has been
    documented to result in a lower incidence of new heart failure.
    Intravenous nitroglycerin is the only dosage form approved in the
    U.S. for use in heart failure associated with acute myocardial
    infarction, although sublingual, transmucosal, and transdermal
    dosage forms have been used for both acute and chronic symptomatic
    control.

-   Nitroglycerin is normally reserved for patients whose cardiac index
    is adequate but pulmonary wedge pressure is elevated (greater than
    18 mm Hg). A combination of diuretics and nitroglycerin or nitrates
    is effective in lowering pulmonary capillary wedge pressure.

-   In one study versus nitroprusside, results supported a preference
    for nitroglycerin over nitroprusside for the treatment of heart
    failure and/or acute hypertension complicating acute myocardial
    infarction.

-   Severe hypotension, particularly with upright posture, may occur
    even with small doses of nitroglycerin. The drug, therefore, should
    be used with caution in subjects who may have volume depletion from
    diuretic therapy or in patients who have low systolic blood pressure
    (e.g., below 90 mm Hg).

-   Paradoxical bradycardia and increased angina pectoris may accompany
    nitroglycerin-induced hypotension. Nitrate therapy may aggravate the
    angina caused by hypertrophic cardiomyopathy.

-   Tolerance to this drug and cross-tolerance to continuous use of
    other nitrates may occur within days.

> ***Evidence supporting this recommendation is of classes: A, M, R***
>
> **Nitroprusside (Intravenous)**

-   Nitroprusside is FDA indicated for the treatment of acute congestive
    heart failure.

-   Nitroprusside has been shown to cause significant and sustained
    symptomatic improvement in severe, refractory heart failure due to a
    variety of causes. However, in acute MI patients with subsequent
    left ventricular failure, the use of nitroprusside has been
    associated with an increase in mortality. Due to this study and the
    well-known propensity for nitroprusside to induce a \"coronary steal
    syndrome,\" it is recommended to avoid use of nitroprusside in
    patients experiencing ischemia.

> ***Evidence supporting this recommendation is of classes: A, D, R***
>
> **Nesiritide**

-   Nesiritide is FDA approved for the intravenous treatment of patients
    with acutely decompensated heart failure who have dyspnea at rest or
    with minimal activity.

-   In patients hospitalized with decompensated heart failure,
    nesiritide was shown to improve hemodynamic function and clinical
    status. When added to standard care in patients hospitalized with
    acutely decompensated heart failure, one study confirmed that
    nesiritide significantly reduced pulmonary capillary wedge pressure
    more than nitroglycerin or placebo. These effects were sustained for
    at least 24 hours.

-   In comparison with dobutamine, nesiritide causes significantly fewer
    heart rate variances, tachycardia, premature ventricular beats,
    repetitive beats, and neurohormonal activation. In comparison to
    dobutamine, nesiritide is associated with a shorter treatment
    course, the use of fewer additional parenteral agents, a lower
    hospitalization rate, and a significantly lower mortality rate at
    six months.

-   Compared with noninotrope-based control therapy, nesiritide may be
    associated with an increased risk of death after treatment for
    acutely decompensated heart failure. Until further studies can be
    done, it is the opinion of this group that other vasodilators and/or
    diuretics be attempted prior to a trial of nesiritide.

-   If nesiritide is to be used, the best candidates for therapy are
    patients with decompensated heart failure who have clinical evidence
    of fluid overload and/or raised central venous pressure.

-   There is little experience with infusions of nesiritide for more
    than 48 hours.

-   In patients with severe heart failure whose renal function may
    depend on the activity of the renin-angiotensin-aldosterone system,
    treatment with nesiritide may be associated with azotemia.

> ***Evidence supporting this recommendation is of classes: A, R***
>
> **Hydralazine/Isosorbide Dinitrate**

-   Hydralazine/isosorbide dinitrate may be considered as a therapeutic
    option in those patients experiencing hyperkalemia or renal
    insufficiency secondary to ACE inhibitor, and possibly ARB usage.

-   There is favorable evidence for the use of a fixed dose of
    hydralazine + isosorbide dinitrate in African-Americans with Class
    III and IV heart failure.

-   If higher doses of ACE inhibitors or ARBs are not tolerated despite
    euvolemia, a lower dose should be continued and/or a trial of
    hydralazine/isosorbide dinitrate instituted.

-   Hydralazine combined with isosorbide dinitrate has been shown to
    reduce mortality and increase exercise tolerance in patients with
    symptomatic HF.

> ***Evidence supporting this recommendation is of class: A***
>
> **Calcium Channel Blockers**

-   Diltiazem, nifedipine, and verapamil have been associated with
    adverse outcomes in patients with diminished LV function and should
    be avoided.

-   Among the calcium antagonists, amlodipine seems less likely to
    worsen non-ischemic heart failure. The Prospective Randomized
    Amlodipine Survival Evaluation (PRAISE) study demonstrated no
    adverse effects on survival or cardiac morbidity when amlodipine was
    added to patients with Class II or III heart failure with EF less
    than 30% and in whom an ACE inhibitor, digoxin and diuretics were
    already being used.

> ***Evidence supporting these recommendations is of class: A***
>
> **Antiarrhythmics**

-   The role of prophylactic antiarrhythmic drug therapy to prevent
    sudden cardiac death in patients with cardiomyopathy, HF, and
    asymptomatic ventricular ectopic activity (ventricular premature
    beats \[VPBs\] or non-sustained ventricular tachycardia \[NSVT\]) is
    probably not recommended. These drugs are less likely to suppress
    ventricular arrhythmias in patients with HF and may be associated
    with life-threatening complications such as proarrhythmia, which is
    more likely in HF, and worsening of left ventricular function.

-   Nearly all antiarrhythmic agents can exert clinically significant
    negative inotropic effects, which may limit the utility and safety
    of these drugs in patients with left ventricular dysfunction.

-   Only amiodarone and dofetilide have been shown to be mortality
    neutral when treating arrhythmias in patients with heart failure.

-   The recent publication of the results of the Sudden Cardiac Death in
    Heart Failure Trial (SCD-HeFT), demonstrated that in patients with
    NYHA Class II or Class III CHF and LVEF of 35 percent or less,
    amiodarone had no favorable effect on survival, despite the use of
    appropriate dosage and reasonable compliance rates over longer
    periods than in other placebo controlled trials. Whereas
    single-lead, shock-only instantaneous cardiac death (ICD) therapy
    reduces overall mortality and the relative risk of death by 23
    percent, resulting in an absolute reduction of 7.2 percentage points
    at five years among patients with CHF who received state-of-the-art
    background medical therapy, and the benefit did not vary according
    to the cause of CHF.

-   In the Multicenter Automatic Defibrillator Implantation Trial 2
    (MADIT 2), a study of patients who had had a myocardial infarction,
    and in the Antiarrhythmics Versus Implantable Defibrillators (AVID)
    study, a secondary prevention trial, the worse the ejection
    fraction, the greater the benefit of ICD therapy. In the
    Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation
    (DEFINITE) trial, patients in NYHA Class III derived the largest
    survival benefit from ICD therapy.

> ***Evidence supporting this recommendation is of class: A***
>
> **Anticoagulants**

-   Anticoagulation with warfarin is indicated in heart failure (HF)
    patients with atrial fibrillation mechanical heart valves, or in
    patients with impaired systolic function (i.e., ejection fraction
    \[EF\] less than 20%) and prior thromboemboli and left ventricular
    mural thrombi. No studies to date have shown a significant
    difference in major outcomes with patients taking warfarin.

-   Emboli due to ventricular thrombi in patients with chronic
    congestive failure are uncommon and occur most frequently in
    patients with very low ejection fractions (less than 20%).

-   Patients with atrial fibrillation and heart failure are at high risk
    for thromboemboli.

> Refer to the NGC summary of the ICSI guideline [Antithrombotic Therapy
> Supplement](http://www.guideline.gov/summary/summary.aspx?doc_id=11529&nbr=005971).
>
> ***Evidence supporting these recommendations is of classes: A, B***

14. **Non-Pharmacologic Management**

> **Key Points**:

-   Dietary indiscretion is the most common cause of exacerbation of
    heart failure.

-   Sodium restriction alone may provide substantial benefits for heart
    failure patients. Dietary counseling is important for patients to
    learn the need for fluid balance management, avoiding excess sodium
    and/or water intake. Referral to a dietitian should be considered
    for patients with comorbid conditions or repeat episodes of edema.

-   Daily weights are important for managing heart failure and early
    detection of increases in fluid retention. Patients should call
    their provider for a two-pound or greater weight gain over night or
    a five-pound or greater weight gain in a week.

-   Simplifying medication regimes as much as possible should be
    explored. All medications, including over the counter (OTC)
    medications should be reviewed at each visit.

-   Major depression is common in patients hospitalized with heart
    failure and is independently associated with a poor prognosis.
    Additionally, depression is independently associated with a
    substantial increased risk of heart failure in older patients with
    isolated systolic hypertension.

-   Consider utilizing a heart failure clinic or case management for
    patients with medical problems or at high risk for
    re-hospitalization.

> Patient education for early symptom recognition and counseling about
> their disease process should be initiated at this time. See the Other
> Resources Available section in the original guideline document for Web
> sites and tools to assist the provider and patient with
> non-pharmacologic management of heart failure.
>
> Refer to the original guideline documents for additional information
> on dietary recommendations, daily weights, medication regimens,
> exercise and activity guidelines, smoking cessation, coping with
> chronic diseases, advanced directives, and end-of-life considerations.

15. **Symptom Control Satisfactory?**

    -   Consider reassessment of ventricular function (echocardiography
        or radionuclide ventriculography) if the symptoms persist
        despite changes in pharmacologic management or if symptoms
        markedly change.

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16. **Ongoing Assessment of Response to Treatment and Evaluation for
    Symptom Exacerbation**

    -   After initial evaluation and diagnosis, follow-up of HF patients
        in the ambulatory setting should focus on optimizing
        pharmacologic therapy and prevention of HF exacerbations.

    -   Patient education should be ongoing and consistently reinforced,
        and family members should be a part of this process whenever
        possible. Symptoms of worsening heart failure should be
        explained, and patients should be advised to contact their
        provider or nurse if these symptoms develop.

    -   Patients should be advised to call their provider for a greater
        or equal two pounds/day weight gain or five or more pounds/week.

    -   Also refer to Appendix A in the original guideline document,
        \"Strategies to Address Adherence to Treatment Plan.\"

> **Accessibility**
>
> Intimidation by or frustration with large health care systems and
> social isolation are factors that distance patients from their health
> care providers. A patient\'s failure to maintain this contact, as well
> as inadequate patient education, contribute to poor patient compliance
> and high hospital admission and readmission rates in this population.

-   To prevent HF exacerbation, efforts and resources should be directed
    toward early intervention in the form of increased accessibility to
    care and education aimed at symptom recognition and treatment plan
    adherence.

-   Frequently, patients wait until they are in crisis before seeking
    medical assistance, bypassing the provider\'s office and going
    straight to the emergency department (ED). Limited hours and
    limited/untrained staff at providers\' offices have been cited as
    reasons patients seek acute care with worsening symptoms of heart
    failure.

-   Case managers and HF clinics may be effective strategies to avert ED
    visits and hospitalizations by providing patients with a contact
    person who is familiar with their care to expedite treatment
    alternatives. This contact person, usually a nurse, is available to
    answer questions and clarify instructions, potentially increasing
    treatment plan compliance. The nurse should have adequate ancillary
    support services available (e.g., social workers, dietary, etc.)

-   Time between visits is important for the patient to formulate
    questions and assimilate the previously presented information.
    Family members and care givers should also be involved in education
    to support the patient\'s efforts.

> ***Evidence supporting these recommendations is of classes: A, R***

[**Emergent Management Algorithm
Annotations**](http://www.guideline.gov/algorithm/5972/NGC-5972_2.html)

18. **Initial Patient Assessment**

    -   History

    -   Physical

> **Notes**:

-   Patients with decompensated aortic stenosis should not receive
    vasodilator agents (vs. mitral regurgitation patients that benefit
    greatly).

-   Patients with jugular venous distension from right ventricular
    infarct may require a fluid challenge.

-   Patients with low cardiac output and peripheral vasoconstriction
    have unreliable noninvasive blood pressure measures.

-   Digoxin, as an inotrope, is not useful in the acute management of
    decompensated heart failure (may be used to control atrial
    fibrillation).

> **Differential Diagnosis**:

-   Chronic obstructive lung disease

-   Asthma exacerbation

-   Volume overload (iatrogenic)

-   Chordae rupture

-   Acute coronary syndrome

-   Pulmonary embolism

-   Sepsis

-   Severe pneumonia

-   Anaphylaxis

-   Takotsubo cardiomyopathy

21. **Initiate O~2~ Therapy, Start IV, Order Labs, Chest X-Ray and
    Electrocardiogram (ECG). Consider Echocardiogram (ECHO)**

    A.  **Initial Laboratory Assessment**:

        -   Complete blood count (CBC)

        -   Electrolytes (Na^+^, K^+^)

        -   Renal function (blood urea nitrogen \[BUN\], creatinine)

        -   Magnesium (if on diuretics)

        -   Calcium

        -   Urinalysis

        -   Digoxin level (if on digoxin)

        -   Prothrombin time/international normalized ratio (PT/INR) if
            on coumadin

        -   Cardiac markers (creatine kinase muscle band \[CKMB\],
            troponin)

        -   Glucose

        -   BNP (if the diagnosis is uncertain)

        -   Blood gases (may be indicated if the patient is hypoxic, has
            underlying lung disease, or has persistent respiratory
            distress)

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    B.  **ECG and continuous rhythm monitoring: Recommended in all
        cases.**

    C.  **Imaging: A chest x-ray is recommended in all cases.**

        -   An emergent echocardiogram is indicated for the patient who
            is not improving with initial interventions.

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23. **Adjust O~2~ Delivery/Consider Continuous Positive Airway Pressure
    (CPAP)/Bilevel PAP (BiPAP)/Intubation**

> Non-invasive ventilatory support has been proven effective and may
> reduce the need for intubation. Continuous positive airway pressures
> (CPAP) and bilevel positive airway pressure are both effective airway
> supports. Bilevel use is controversial in patients with acute MI.
>
> ***Evidence supporting these recommendations is of class: R***

[**Acute Pulmonary Edema
Algorithm**](http://www.guideline.gov/algorithm/5972/NGC-5972_3.html)

41. **Volume Overload?**

> Patients with persistent volume overload may be candidates for
> continuous IV diuretics, ultrafiltration, or hemodialysis (all out of
> guideline).

43. **Loop Diuretic: IV Bolus, Consider IV Infusion**

    -   Furosemide is the most commonly used loop diuretic, with the
        dose adjusted upward if the patient is currently on oral doses.
        Diuretic effect occurs in 30 minutes with peak effect in one to
        two hours.

    -   Torsemide or Bumetanide IV is an alternative loop diuretic.

> The pharmacologic characteristics of all loop diuretics are similar.
> Therefore, a lack of response to adequate doses of one loop diuretic
> mitigates against the administration of another loop diuretic;
> instead, combinations of diuretics with different mechanisms of action
> should be given.
>
> In patients who have poor responses to intermittent doses of a loop
> diuretic, a continuous intravenous infusion can be tried. If an
> effective amount of the diuretic is maintained at the site of action
> at all times, a small but clinically important increase in the
> response may occur. There are other reasons to consider giving a
> continuous infusion of a loop diuretic. It may be easier for nursing
> staff to give a continuous infusion than intermittent bolus
> intravenous doses. In addition, with a continuous infusion, decisions
> about the timing of doses of an additional diuretic are simplified.
> Finally, by closely monitoring urinary output, one can unambiguously
> determine whether the added drug was beneficial.
>
> Another strategy to enhance the response to a loop diuretic is to add
> an oral or IV thiazide diuretic. Metolazone is frequently given in the
> United States, whereas other thiazides are given elsewhere. The
> pharmacologic characteristics of metolazone are similar to those of
> other thiazides. Some formulations of the drug are absorbed poorly and
> slowly, and it has a long elimination half-life (about two days).
> Thus, metolazone accumulates over a period of about 10 days. Other
> thiazides have the same synergistic effects when combined with a loop
> diuretic. Since the absorption of other thiazides, such as
> hydrochlorothiazide, is more rapid and predictable, they may be
> preferable to metolazone.
>
> ***Evidence supporting this recommendation is of classes: A, D, R***

44. **Nitroglycerin Sublingual (SL) or Drip**

> Concurrent with diuretic therapy is the initiation of vasodilators

-   Nitroglycerin, 0.4 mg sublingual or paste.

> Many patients will improve symptomatically with the \"first-line
> therapy\" and may be transferred to an observation unit or inpatient
> bed.
>
> Patients who are not improving will need more aggressive treatment:

-   Begin nitroglycerin infusion at 10 to 20 micrograms/minute (min) and
    increase by 10 to 20 mcg/min every 3 to 5 min to achieve desired
    effect. The maximum dose is 300 micrograms/min.

-   This work group recommends the upward titration of nitroglycerin
    before converting to nesiritide.

> Alternative dosing protocols exist which may provide a greater safety
> margin, such as:
>
> IV: non-PVC tubing, 5 mcg/min, initial titration should be in 5
> mcg/min increments at intervals of 3 to 5 min guided by patient
> response; if no response is seen at 20 mcg/min, incremental increases
> of 10 and 20 mcg/min may be used; PVC tubing, initial dose 25 mcg/min
> IV
>
> Additional note: some intensive care units (ICUs) and EDs are now
> titrating in mcg/kg/min.
>
> A patient who continues to exhibit signs and symptoms of volume
> overload despite aggressive loop diuretics and IV nitroglycerin may be
> a candidate for nesiritide.
>
> Nesiritide reduces pulmonary capillary wedge pressure and improves
> dyspnea in patients with acute decompensated heart failure. Compared
> with dobutamine, ventricular arrhythmias and cardiac arrest occurred
> less frequently with nesiritide. Nesiritide can cause symptomatic
> hypotension comparable to nitroglycerin; however, the duration of
> symptomatic hypotension with nesiritide is longer (2.2 hours versus
> 0.7 hours).

-   Nesiritide 2 mcg IV bolus, then 0.01 mcg/kg/min IV infusion.

-   Nesiritide, a natriuretic peptide, has been tested in combination
    with diuretics but not with IV nitroglycerin. The safety profile is
    favorable in comparison with the phosphodiesterase inhibitors (e.g.,
    milrinone) or the adrenergic inotropes (e.g., dobutamine).

> The experience with nesiritide to date has been limited, in comparison
> with the other two drugs.
>
> ***Evidence supporting this recommendation is of classes: A, R***

46. **Stabilized?**

> Patients who stabilize may be admitted to an observation unit or
> monitored hospital bed.
>
> Unstable criteria include:

-   Unstable vital signs

-   ECG or serum markers of myocardial ischemia

-   Decompensation (concomitant end-organ hypoperfusion, volume
    overload, and systemic vasoconstriction)

-   Requiring continuous vasoactive medication (e.g., nitroglycerin,
    nitroprusside, dobutamine, or milrinone) to stabilize hemodynamics

-   Non-sustained ventricular tachycardia not caused by electrolyte
    imbalance

-   Acute mental status abnormality

-   Severe electrolyte imbalances

48. **Emergency Department (ED) Observation or Short Stay Admission?**

> Some heart failure patients may be managed in a short stay or
> observation unit. A short stay for diagnosis, intensive therapy, and
> education has demonstrated advantages. Institutions that utilize
> observation units will need to have selection criteria and observation
> protocols to achieve optimal results.
>
> Peacock and Albert provide a framework for the use of observation
> units in the management of heart failure patients. Observation units
> provide a cost-effective alternative to hospitalization for select
> patients.
>
> ***Evidence supporting this recommendation is of class: R***

**Definitions**:

**Conclusion Grades**:

**Grade I**: The evidence consists of results from studies of strong
design for answering the question addressed. The results are both
clinically important and consistent with minor exceptions at most. The
results are free of any significant doubts about generalizability, bias,
and flaws in research design. Studies with negative results have
sufficiently large samples to have adequate statistical power.

**Grade II**: The evidence consists of results from studies of strong
design for answering the question addressed, but there is some
uncertainty attached to the conclusion because of inconsistencies among
the results from the studies or because of minor doubts about
generalizability, bias, research design flaws, or adequacy of sample
size. Alternatively, the evidence consists solely of results from weaker
designs for the question addressed, but the results have been confirmed
in separate studies and are consistent with minor exceptions at most.

**Grade III**: The evidence consists of results from studies of strong
design for answering the question addressed, but there is substantial
uncertainty attached to the conclusion because of inconsistencies among
the results of different studies or because of serious doubts about
generalizability, bias, research design flaws, or adequacy of sample
size. Alternatively, the evidence consists solely of results from a
limited number of studies of weak design for answering the question
addressed.

**Grade Not Assignable**: There is no evidence available that directly
supports or refutes the conclusion.

**Classes of Research Reports**:

A.  **Primary Reports of New Data Collection**:

> Class A: Randomized, controlled trial
>
> Class B: Cohort study
>
> Class C:\
> Non-randomized trial with concurrent or historical controls\
> Case-control study\
> Study of sensitivity and specificity of a diagnostic test\
> Population-based descriptive study
>
> Class D:\
> Cross-sectional study\
> Case series\
> Case report

B.  **Reports that Synthesize or Reflect upon Collections of Primary
    Reports:**

> Class M:\
> Meta-analysis\
> Systematic review\
> Decision analysis\
> Cost-effectiveness analysis
>
> Class R:\
> Consensus statement\
> Consensus report\
> Narrative review
>
> Class X: Medical opinion

#### CLINICAL ALGORITHM(S)

Detailed and annotated clinical algorithms are provided for:

-   [Heart Failure in
    Adults](http://www.guideline.gov/algorithm/5972/NGC-5972_1.html)

-   [Emergent
    Management](http://www.guideline.gov/algorithm/5972/NGC-5972_2.html)

-   [Acute Pulmonary
    Edema](http://www.guideline.gov/algorithm/5972/NGC-5972_3.html)

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is classified for selected
recommendations (see \"Major Recommendations\").

In addition, key conclusions contained in the Work Group\'s algorithm
are supported by a grading worksheet that summarizes the important
studies pertaining to the conclusion. The type and quality of the
evidence supporting these key recommendations (i.e., choice among
alternative therapeutic approaches) is graded for each study.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

-   Accurate diagnosis of heart failure (HF) through improved use of
    diagnostic testing

-   Appropriate treatment and management of patients with HF

#### POTENTIAL HARMS

Adverse events associated with medications

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

Contraindications to *angiotensin-converting enzyme (ACE) inhibitors*
include:

-   History of intolerance or adverse reactions to these agents

-   Serum potassium greater than 5.5 mEq/L

-   Symptomatic hypotension (unless due to excessive diuresis)

-   Severe renal artery stenosis

-   Pregnancy

-   Cough and rash side effects

Contraindications to *angiotensin receptor blockers (ARBs)* include:

-   History of intolerance or adverse reactions to these agents

-   Serum potassium greater than 5.5 mEq/L,

-   Symptomatic hypotension (unless due to excessive diuresis)

-   Severe renal artery stenosis

-   Pregnancy

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   This health care guideline is designed to assist clinicians by
    providing an analytical framework for the evaluation and treatment
    of patients, and is not intended either to replace a clinician\'s
    judgment or to establish a protocol for all patients with a
    particular condition. A guideline will rarely establish the only
    approach to a problem.

-   This health care guideline should not be construed as medical advice
    or medical opinion related to any specific facts or circumstances.
    Patients are urged to consult a health care professional regarding
    their own situation and any specific medical questions they may
    have. In addition, patients should seek assistance from a health
    care professional in interpreting this ICSI Health Care Guidelines
    and applying it in your individual case.

-   The acute pulmonary edema (APE) guideline surfaces areas of weak or
    absent evidence for some traditional therapies. Per Felker et al.,
    \"the syndrome of decompensated heart failure remains poorly defined
    and vastly understudied. Few high-quality epidemiologic studies,
    randomized controlled trials, or published guidelines are available
    to guide the management of this complex disease. In addition, there
    is no consensus definition of the clinical problem that it presents,
    no agreed-upon nomenclature to describe its clinical features, and
    no recognized classification scheme for its patient population; all
    of which has contributed to the lack of therapeutic development in
    this critical arena of cardiovascular disease.\"

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

Once a guideline is approved for general implementation, a medical group
can choose to concentrate on the implementation of that guideline. An
action group is formed when a topic is selected as an initiative. In
addition to the action group goals and measures, each medical group sets
specific goals they plan to achieve in improving patient care based on
the particular guideline(s). Each medical group shares its experiences
and supporting measurement results within the action group. This sharing
facilitates a collaborative learning environment. Action group learnings
are also documented and shared with interested medical groups within the
collaborative.

Currently, action groups may focus on one guideline or a set of
guidelines such as hypertension, lipid treatment, and tobacco cessation.

Detailed measurement strategies are presented in the original guideline
document to help close the gap between clinical practice and the
guideline recommendations. Summaries of the measures are provided in the
National Quality Measures Clearinghouse (NQMC).

**Key Implementation Recommendations**

The following system changes were identified by the guideline work group
as key strategies for health care systems to incorporate in support of
the implementation of this guideline.

1.  Develop a process that will allow primary care to identify patients
    who have been re-admitted to the hospital with a diagnosis of heart
    failure.

2.  Emphasize patient self-management strategies. These may include
    heart failure education and other actions designed to sustain
    engagement of patients with their heart failure care.

3.  Develop a process to provide education to the patient and/or
    caregiver in the area of:

    -   Diet

    -   Weight monitoring (to include: provider should be contacted
        about a two-pound or greater weight gain overnight or a
        five-pound or greater weight gain during the week)

    -   Activity level

    -   Medications

    -   The importance of follow-up appointments

    -   What to do if symptoms worsen

4.  Develop a process for timely, early specialty referral for patients
    with ischemia or those who are refractory despite optimal medical
    therapy.

#### IMPLEMENTATION TOOLS

Chart Documentation/Checklists/Forms\
Clinical Algorithm\
Patient Resources\
Pocket Guide/Reference Cards\
Quality Measures

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

#### RELATED NQMC MEASURES

-   [Heart failure in adults: percentage of adult patients with a
    primary diagnosis of heart failure who are readmitted for heart
    failure within 30 days of
    discharge.](http://www.qualitymeasures.ahrq.gov/summary/summary.aspx?ss=1&doc_id=11560)

-   [Heart failure in adults: percentage of adult patients with a
    primary diagnosis of heart failure who have LVSD and who do not have
    contraindications to taking both ACEI and ARBs, who are prescribed
    an ACEI or an ARB at hospital
    discharge.](http://www.qualitymeasures.ahrq.gov/summary/summary.aspx?ss=1&doc_id=11561)

-   [Heart failure in adults: percentage of adult patients with a
    primary diagnosis of heart failure who have LVSD and who do not have
    a contraindication to taking beta-blockers, who are prescribed
    beta-blocker therapy at hospital
    discharge.](http://www.qualitymeasures.ahrq.gov/summary/summary.aspx?ss=1&doc_id=11562)

-   [Heart failure in adults: percentage of adult patients with a
    primary diagnosis of heart failure with documentation in the
    hospital record that LVS function was evaluated before arrival,
    during hospitalization, or is planned for after
    discharge.](http://www.qualitymeasures.ahrq.gov/summary/summary.aspx?ss=1&doc_id=11564)

-   [Heart failure in adults: percentage of adult patients with a
    primary diagnosis of heart failure discharged home with written
    instructions or educational material given to the patient or his or
    her caregiver at discharge or during the hospital stay, addressing
    all of the following: activity level, diet, discharge medications,
    follow-up appointment, weight monitoring, and what to do if symptoms
    worsen.](http://www.qualitymeasures.ahrq.gov/summary/summary.aspx?ss=1&doc_id=11565)

-   [Heart failure in adults: percentage of adult patients with a
    primary diagnosis of heart failure who have used tobacco anytime
    during the year prior to hospital arrival and who are given smoking
    cessation advice or counseling during the hospital stay or at
    discharge.](http://www.qualitymeasures.ahrq.gov/summary/summary.aspx?ss=1&doc_id=11566)

-   [Heart failure in adults: percentage of adult heart failure patients
    who have ever had LVSD and were prescribed or were taking an ACEI or
    ARB within the last 12 months of the clinic visit, or who have
    contradictions to taking both ACEI or an ARB (primary care and
    outpatient
    cardiology).](http://www.qualitymeasures.ahrq.gov/summary/summary.aspx?ss=1&doc_id=11569)

-   [Heart failure in adults: percentage of adult heart failure patients
    who have ever had LVSD and were prescribed or were on beta-blocker
    therapy within the last 12 months of the clinic visit or who have a
    contraindication to taking beta-blockers (primary care and
    outpatient
    cardiology).](http://www.qualitymeasures.ahrq.gov/summary/summary.aspx?ss=1&doc_id=11571)

-   [Heart failure in adults: percentage of adult heart failure patients
    who have ever had LVSD and met the following (for which they are
    eligible) at their last clinic visit: prescribed or were taking
    ACEI/ARB, prescribed or were on beta blocker therapy, non-smoker
    (primary care and outpatient
    cardiology).](http://www.qualitymeasures.ahrq.gov/summary/summary.aspx?ss=1&doc_id=11572)

-   [Heart failure in adults: percentage of adult heart failure patients
    with documentation that LVS function was evaluated or will be
    evaluated (primary care and outpatient
    cardiology).](http://www.qualitymeasures.ahrq.gov/summary/summary.aspx?ss=1&doc_id=11573)

-   [Heart failure in adults: percentage of adult heart failure patients
    to whom (or to their caregivers) written or verbal instructions or
    educational material are given during the clinic visit, addressing
    one or more of the following: activity level, diet, medications,
    follow-up appointment, weight monitoring, and what to do if symptoms
    worsen (primary care and outpatient
    cardiology).](http://www.qualitymeasures.ahrq.gov/summary/summary.aspx?ss=1&doc_id=11574)

-   [Heart failure in adults: percentage of adult heart failure patients
    who have used tobacco anytime during the previous year and who were
    given smoking cessation advice or counseling at the last clinic
    visit (primary care and outpatient
    cardiology).](http://www.qualitymeasures.ahrq.gov/summary/summary.aspx?ss=1&doc_id=11575)

-   [Heart failure in adults: percentage of adult heart failure patients
    who have not used tobacco anytime during the previous year (primary
    care and outpatient
    cardiology).](http://www.qualitymeasures.ahrq.gov/summary/summary.aspx?ss=1&doc_id=11576)

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness

#### IOM DOMAIN

Effectiveness\
Patient-centeredness\
Timeliness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Institute for Clinical Systems Improvement (ICSI). Heart failure in
adults. Bloomington (MN): Institute for Clinical Systems Improvement
(ICSI); 2007 Aug. 119 p. \[217 references\]

#### ADAPTATION

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

#### DATE RELEASED

1997 Oct (revised 2007 Aug)

#### GUIDELINE DEVELOPER(S)

Institute for Clinical Systems Improvement - Private Nonprofit
Organization

#### GUIDELINE DEVELOPER COMMENT

Organizations participating in the Institute for Clinical Systems
Improvement (ICSI): Affiliated Community Medical Centers, Allina Medical
Clinic, Altru Health System, Aspen Medical Group, Avera Health,
CentraCare, Columbia Park Medical Group, Community-University Health
Care Center, Dakota Clinic, ENT Specialty Care, Fairview Health
Services, Family HealthServices Minnesota, Family Practice Medical
Center, Gateway Family Health Clinic, Gillette Children\'s Specialty
Healthcare, Grand Itasca Clinic and Hospital, HealthEast Care System,
HealthPartners Central Minnesota Clinics, HealthPartners Medical Group
and Clinics, Hutchinson Area Health Care, Hutchinson Medical Center,
Lakeview Clinic, Mayo Clinic, Mercy Hospital and Health Care Center,
MeritCare, Mille Lacs Health System, Minnesota Gastroenterology,
Montevideo Clinic, North Clinic, North Memorial Care System, North
Suburban Family Physicians, Northwest Family Physicians, Olmsted Medical
Center, Park Nicollet Health Services, Pilot City Health Center, Quello
Clinic, Ridgeview Medical Center, River Falls Medical Clinic, Saint
Mary\'s/Duluth Clinic Health System, St. Paul Heart Clinic, Sioux Valley
Hospitals and Health System, Southside Community Health Services,
Stillwater Medical Group, SuperiorHealth Medical Group, University of
Minnesota Physicians, Winona Clinic, Ltd., Winona Health

ICSI, 8009 34th Avenue South, Suite 1200, Bloomington, MN 55425;
telephone, (952) 814-7060; fax, (952) 858-9675; e-mail:
<icsi.info@icsi.org>; Web site: [www.icsi.org](http://www.icsi.org/).

#### SOURCE(S) OF FUNDING

The following Minnesota health plans provide direct financial support:
Blue Cross and Blue Shield of Minnesota, HealthPartners, Medica,
Metropolitan Health Plan, PreferredOne, and UCare Minnesota. In-kind
support is provided by the Institute for Clinical Systems Improvement\'s
(ICSI) members.

#### GUIDELINE COMMITTEE

Cardiovascular Steering Committee (CVSC)

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Work Group Members*: Stephen Kopecky, MD (Work Group Leader) (Mayo
Clinic) (Cardiology); Rufino Festin, MD (Park Nicollet Health Services)
(Cardiology); Peter Smars, MD (Mayo Clinic) (Emergency Medicine);
Mohammad T. Fareed, MD (Avera Health) (Family practice); Ashok Ojha, MD
(Hutchinson Medical Center) (Internal Medicine); Mary Jo Macklem, RN
(Park Nicollet Health Services) (Nursing); Joshua E. Breeding, PharmD,
BCPS (Fairview University Medical Center) (Pharmacy); Robert Straka,
PharmD (University of Minnesota Physicians) (Pharmacy); Angela Turner,
Pa-C (Park Nicollet Health Services) (Physician Assistant); Penny
Fredrickson (Institute for Clinical Systems Improvement) (Measurement
Advisor); Ann-Marie Evenson, BS, RHIT (Institute for Clinical Systems
Improvement) (Facilitator)

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

In the interest of full disclosure, Institute for Clinical Systems
Improvement (ICSI) has adopted the policy of revealing relationships
work group members have with companies that sell products or services
that are relevant to this guideline topic. The reader should not assume
that these financial interests will have an adverse impact on the
content of the guideline, but they are noted here to fully inform
readers. Readers of the guideline may assume that only work group
members listed below have potential conflict of interest to disclose.

Joshua Breeding, PharmD has consulted with Scios.

Robert Straka, PharmD has received research support from Abbott Labs. He
has also received honoraria for speaking from Astra Zeneca, Pfizer, and
Abbott.

Stephen L. Kopecky, MD is a consultant for and has received honoraria
from Glaxo SmithKline and is on the advisory board for BioPhysical.

No other work group members have potential conflicts of interest to
disclose.

ICSI\'s conflict of interest policy and procedures are available for
review on ICSI\'s website at [www.icsi.org](http://www.icsi.org/).

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Heart failure in adults.
Bloomington (MN): Institute for Clinical Systems Improvement (ICSI);
2005 Jun. 111 p.

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [Institute for Clinical Systems
Improvement (ICSI) Web
site](http://www.icsi.org/guidelines_and_more/guidelines__order_sets___protocols/).

Print copies: Available from ICSI, 8009 34th Avenue South, Suite 1200,
Bloomington, MN 55425; telephone, (952) 814-7060; fax, (952) 858-9675;
Web site: [www.icsi.org](http://www.icsi.org/); e-mail:
<icsi.info@icsi.org>.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   Heart failure in adults. Executive summary. Bloomington (MN):
    Institute for Clinical Systems Improvement, 2007 Aug. 2 p.
    Electronic copies: Available from the [Institute for Clinical
    Systems Improvement (ICSI) Web
    site](http://www.icsi.org/guidelines_and_more/guidelines__order_sets___protocols/cardiovascular/heart_failure_2/heart_failure_in_adults__guideline_.html).

-   ICSI pocket guidelines. April 2006 edition. Bloomington (MN):
    Institute for Clinical Systems Improvement, 2006. 298 p.

A measurement tool worksheet for recording patient\'s ACE inhibitor use
is available in the [original guideline
document](http://www.icsi.org/guidelines_and_more/guidelines__order_sets___protocols/cardiovascular/heart_failure_2/heart_failure_in_adults__guideline_.html).

Print copies: Available from ICSI, 8009 34th Avenue South, Suite 1200,
Bloomington, MN 55425; telephone, (952) 814-7060; fax, (952) 858-9675;
Web site: [www.icsi.org](http://www.icsi.org/); e-mail:
<icsi.info@icsi.org>.

#### PATIENT RESOURCES

The following is available:

-   Heart failure in adults. Bloomington (MN): Institute for Clinical
    Systems Improvement, 2007 Oct. 55 p.

Electronic copies: Available from the [Institute for Clinical Systems
Improvement (ICSI) Web
site](http://www.icsi.org/guidelines_and_more/guidelines__order_sets___protocols/for_patients_families/heart_failure_in_adults__for_patients___families__22592.html).

Please note: This patient information is intended to provide health
professionals with information to share with their patients to help them
better understand their health and their diagnosed disorders. By
providing access to this patient information, it is not the intention of
NGC to provide specific medical advice for particular patients. Rather
we urge patients and their representatives to review this material and
then to consult with a licensed health professional for evaluation of
treatment options suitable for them as well as for diagnosis and answers
to their personal medical questions. This patient information has been
derived and prepared from a guideline for health care professionals
included on NGC by the authors or publishers of that original guideline.
The patient information is not reviewed by NGC to establish whether or
not it accurately reflects the original guideline\'s content.

#### NGC STATUS

This NGC summary was completed by ECRI on October 9, 2002. The
information was verified by the guideline developer on October 21, 2002.
This summary was updated by ECRI on April 1, 2004, July 27, 2004,
September 16, 2005, and October 5, 2006. This summary was updated by
ECRI on March 6, 2007 following the U.S. Food and Drug Administration
(FDA) advisory on Coumadin (warfarin sodium). 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. This summary
was updated by ECRI Institute on September 7, 2007 following the revised
U.S. Food and Drug Administration (FDA) advisory on Coumadin (warfarin).
This NGC summary was updated by ECRI Institute on December 13, 2007.

#### COPYRIGHT STATEMENT

This NGC summary (abstracted Institute for Clinical Systems Improvement
\[ICSI\] Guideline) is based on the original guideline, which is subject
to the guideline developer\'s copyright restrictions.

The abstracted ICSI Guidelines contained in this Web site may be
downloaded by any individual or organization. If the abstracted ICSI
Guidelines are downloaded by an individual, the individual may not
distribute copies to third parties.

If the abstracted ICSI Guidelines are downloaded by an organization,
copies may be distributed to the organization\'s employees but may not
be distributed outside of the organization without the prior written
consent of the Institute for Clinical Systems Improvement, Inc.

All other copyright rights in the abstracted ICSI Guidelines are
reserved by the Institute for Clinical Systems Improvement, Inc. The
Institute for Clinical Systems Improvement, Inc. assumes no liability
for any adaptations or revisions or modifications made to the abstracts
of the ICSI Guidelines.

### DISCLAIMER

#### NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce,
approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced
under the auspices of medical specialty societies, relevant professional
associations, public or private organizations, other government
agencies, health care organizations or plans, and similar entities.

Guidelines represented on the NGC Web site are submitted by guideline
developers, and are screened solely to determine that they meet the NGC
Inclusion Criteria which may be found at
<http://www.guideline.gov/about/inclusion.aspx> .

NGC, AHRQ, and its contractor ECRI Institute make no warranties
concerning the content or clinical efficacy or effectiveness of the
clinical practice guidelines and related materials represented on this
site. Moreover, the views and opinions of developers or authors of
guidelines represented on this site do not necessarily state or reflect
those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or
hosting of guidelines in NGC may not be used for advertising or
commercial endorsement purposes.

Readers with questions regarding guideline content are directed to
contact the guideline developer.

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Date Modified: 11/10/2008