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## Complete Summary

#### GUIDELINE TITLE

Prognosis of pulmonary arterial hypertension: ACCP evidence-based
clinical practice guidelines.

#### BIBLIOGRAPHIC SOURCE(S)

McLaughlin VV, Presberg KW, Doyle RL, Abman SH, McCrory DC, Fortin T,
Ahearn G. Prognosis of pulmonary arterial hypertension: ACCP
evidence-based clinical practice guidelines. Chest 2004 Jul;126(1
Suppl):78S-92S. \[45 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15249497)

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

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

### SCOPE

#### DISEASE/CONDITION(S)

Idiopathic pulmonary arterial hypertension

#### GUIDELINE CATEGORY

Evaluation\
Risk Assessment

#### CLINICAL SPECIALTY

Cardiology\
Internal Medicine\
Pulmonary Medicine\
Thoracic Surgery

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

To provide appropriate evidence based recommendations to assess the
prognosis of patients with pulmonary arterial hypertension (PAH).
Specifically, the guideline seeks to answer two questions: what is the
expected survival of patients with PAH, and what are the clinical
factors associated with survival in patients with PAH?

#### TARGET POPULATION

Patients with idiopathic pulmonary arterial hypertension

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Risk Assessment/Prognosis**

Evaluation of:

1.  New York Heart Association functional class

2.  Presence of pericardial effusion

3.  Hemodynamics, including mean right atrial pressure cardiac index,
    mean pulmonary arterial pressure)

4.  Doppler echocardiography right ventricular (RV) (Tei) index

5.  Maximum oxygen consumption

6.  Brain natriuretic peptide levels

7.  Diffusing capacity of the lung for carbon monoxide

8.  Response to medical therapy

9.  Underlying etiologies (e.g., scleroderma, congenital heart disease,
    human immunodeficiency virus infection, portopulmonary hypertension,
    idiopathic pulmonary arterial hypertension)

10. Patient demographics (age, gender, time of onset of symptoms to
    diagnosis)

Applicable testing procedures:

1.  6-minute walk test

2.  Cardiopulmonary exercise test

3.  Electrocardiogram

4.  Doppler echocardiogram

#### MAJOR OUTCOMES CONSIDERED

-   Expected survival in pulmonary arterial hypertension (PAH)

-   Survival in PAH associated with underlying etiology

-   Impact of medical therapy on survival in PAH

-   Survival in children with PAH

-   Clinical factors associated with survival

    -   Demographics

    -   Hemodynamics

    -   Vasodilator responsiveness

    -   Echocardiographic findings

    -   Exercise tolerance

    -   Electrocardiographic findings

    -   New York Heart Association functional class

    -   Serum biomarkers, such as atrial natriuretic peptide, brain
        natriuretic peptide, catecholamines, and uric acid

    -   Pulmonary function

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

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

*Note from National Guideline Clearinghouse (NGC)*: The Center for
Clinical Health Policy Research at Duke University identified and
evaluated evidence on this topic, working with the guideline development
panel to formulate key questions suitable for systematic literature
synthesis.

**Search Strategy**

Computerized searches of the MEDLINE bibliographic database from 1992 to
October 2002 were conducted. The developers searched using the term
*hypertension*, *pulmonary*. The search was limited to articles
concerning human subjects that were published in the English language
and accompanied by an abstract. In addition, the developer searched the
reference lists of included studies, practice guidelines, systematic
reviews, and meta-analyses, and consulted with clinical experts to
identify relevant studies missed by the search strategy or published
before 1992.

**Study Selection**

The developers selected studies that described survival over time and
considered studies among patients with known or suspected idiopathic
pulmonary arterial hypertension (IPAH) or PAH associated with connective
tissue diseases, chronic liver disease with portal hypertension,
congenital heart disease (CHD) and Eisenmenger syndrome, human
immunodeficiency virus (HIV) infection, and chronic thromboembolic
disease. The developers excluded studies of pulmonary hypertension
associated with chronic obstructive pulmonary disease (COPD), other
parenchymal lung disease, high altitude, or cardiac disease (e.g.,
left-heart failure or valvular heart disease) except CHD. They also
excluded studies of neonates and case series with \< 10 subjects.

Two physicians (one with methodologic expertise and one with content
area expertise) reviewed the abstracts of candidate articles and
selected a subset to review in full text. Full-text articles were again
reviewed by two physicians to determine whether they were study reports
or review articles, and were pertinent to the key questions.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus\
Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**Quality of the Evidence**

**Good** = evidence based on good randomized controlled trials or
meta-analyses

**Fair** = evidence based on other controlled trials or randomized
controlled trials with minor flaws

**Low** = evidence based on nonrandomized, case-control, or other
observational studies

**Expert opinion** = evidence based on the consensus of the carefully
selected panel of experts in the topic field. There are no studies that
meet the criteria for inclusion in the literature review.

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

The studies retrieved from the literature search were reviewed and
classified according to primary diagnosis (idiopathic pulmonary arterial
hypertension \[IPAH\] vs. PAH associated with another disease),
treatment strategy, survival rates, risk factors, and type of analysis
done.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Informal Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

An international panel of 19 experts representing five medical experts
was assembled. Representatives from other medical and patient advocacy
associations were also invited to join the panel (including the American
College of Cardiology, American College of Rheumatology, and the
Pulmonary Hypertension Association). These experts convened on several
occasions, including the culminating panel conference in September 2003,
in which they deliberated over the composition of the final
recommendations and grading of the current state of the evidence,
benefits to the patient, and the strength of the recommendations.

Guideline development was led by an executive committee including the
chair, the leader of the methodology support group, and the American
College of Chest Physicians project manager, which supervised the
guideline development process, methodologic issues, panel composition,
structure of the final document, and activities of the writing
committees. Each writing committee, led by a group leader who served as
primary author and editor of that chapter, conferred with the
methodology team on inclusion/exclusion criteria, relevant research
questions, and important literature that was not readily identified.
These individuals continue with their responsibilities to assist in the
development of the implementation tools.

When the evidence was insufficient for evidence-based recommendations,
the panel used informal group consensus techniques to develop
recommendations based on the expert opinion of the panel. With every
member of the panel attending the final conference, the expert-based
opinions are truly representative of geographically diverse and
multispecialty inclusive practice patterns of the complete panel.

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

**Strength of Recommendations**

A = strong recommendation\
B = moderate recommendation\
C = weak recommendation\
D = negative recommendation\
I = no recommendation possible (inconclusive)\
E/A = strong recommendation based on expert opinion only\
E/B = moderate recommendation based on expert opinion only\
E/C = weak recommendation based on expert opinion only\
E/D = negative recommendation based on expert opinion only

**Net Benefit**

Substantial\
Intermediate\
Small/weak\
None\
Conflicting\
Negative

#### COST ANALYSIS

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

#### METHOD OF GUIDELINE VALIDATION

External Peer Review\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The writing groups and the executive committee of the panel extensively
reviewed each chapter during the writing process. The final conference
provided an opportunity for the entire panel to review the latest
drafts. Following final revisions and one final review by the executive
committee, each chapter of the guidelines was reviewed and approved by
the American College of Chest Physicians (ACCP) Health and Science
Policy Committee, the ACCP Pulmonary Vascular NetWork, and then by the
ACCP Board of Regents. The guidelines have not been field tested.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Rating schemes for level of evidence, strength of recommendation, and
net benefit follow the \"Major Recommendations.\"

As the majority of the evidence reviewed in the original guideline
document is applicable to patients with idiopathic pulmonary arterial
hypertension (IPAH), the following recommendations pertain to patients
with IPAH. In most instances, data are insufficient to make
recommendations for patients with pulmonary arterial hypertension (PAH)
due to diagnosis other than IPAH. In patients with IPAH, the following
parameters, as assessed at baseline, may be used to predict a worse
prognosis:

1.  Advanced New York Heart Association functional class (NYHA-FC).
    **Quality of evidence: good; net benefit: substantial; strength of
    recommendation: A**.

2.  Low 6 -minute walk test (6MWT) distance. **Quality of evidence:
    good; net benefit: substantial; strength of recommendation: A**.

3.  Presence of a pericardial effusion. **Quality of evidence: good; net
    benefit: substantial; strength of recommendation: A**.

4.  Elevated mean right atrial pressure (mRAP). **Quality of evidence:
    fair; net benefit: substantial; strength of recommendation: A**.

5.  Reduced cardiac index (CI). **Quality of evidence: fair; net
    benefit: substantial; strength of recommendation: A**.

6.  Elevated mean pulmonary arterial pressure (mPAP). **Quality of
    evidence: fair; net benefit: intermediate; strength of
    recommendation: B**.

7.  Elevated Doppler Echocardiography right ventricular (RV) (Tei)
    index. **Quality of evidence: low; net benefit: intermediate;
    strength of recommendation: C**.

8.  Low VO~2~max (maximum oxygen consumption) and low peak exercise
    systolic blood pressure (SBP) and diastolic blood pressure (DBP) as
    determined by cardiopulmonary exercise test (CPET). **Quality of
    evidence: low; net benefit: intermediate; strength of
    recommendation: C**.

9.  Electrocardiogram (ECG) findings of increased P-wave amplitude in
    lead II, qR pattern in lead V~1~, and World Health Organization
    criteria for RV hypertrophy. **Quality of evidence: low; net
    benefit: intermediate; strength of recommendation: C**.

10. Elevated brain natriuretic peptide (BNP) (\>180 pg/mL). **Quality of
    evidence: low; net benefit: intermediate; strength of
    recommendation: C**.

11. In patients with IPAH treated with epoprostenol, persistence of
    NYHA-FC III or IV status after at least 3 months of therapy may be
    used to predict a worse prognosis. **Quality of evidence: fair; net
    benefit: substantial; strength of recommendation: A**.

12. In patients with scleroderma-associated PAH, reduced diffusing
    capacity of the lung for carbon monoxide (DLCO) (\<45% of predicted)
    may be used to predict a worse prognosis. **Quality of evidence:
    low; net benefit: small/weak; strength of recommendation: C**.

13. In pediatric patients with IPAH, younger age at diagnosis may be
    used to predict a worse prognosis. **Quality of evidence: low; net
    benefit: small/weak; strength of recommendation: C**.

**[Definitions]{.underline}**

**Quality of the Evidence**

**Good** = evidence based on good randomized controlled trials or
meta-analyses

**Fair** = evidence based on other controlled trials or randomized
controlled trials with minor flaws

**Low** = evidence based on nonrandomized, case-control, or other
observational studies

**Expert opinion** = evidence based on the consensus of the carefully
selected panel of experts in the topic field. There are no studies that
meet the criteria for inclusion in the literature review.

**Strength of Recommendations**

A = strong recommendation\
B = moderate recommendation\
C = weak recommendation\
D = negative recommendation\
I = no recommendation possible (inconclusive)\
E/A = strong recommendation based on expert opinion only\
E/B = moderate recommendation based on expert opinion only\
E/C = weak recommendation based on expert opinion only\
E/D = negative recommendation based on expert opinion only

**Net Benefit**

Substantial\
Intermediate\
Small/weak\
None\
Conflicting\
Negative

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

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

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Assessment of prognosis of patients with pulmonary arterial hypertension
(PAH) is important, as it influences both medical therapy and referral
for transplantation. The guideline provides evidence-based
recommendations to assess the prognosis of these patients.

#### POTENTIAL HARMS

None stated

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   The information provided in the guideline should be used in
    conjunction with clinical judgment. Although the guideline provides
    recommendations that are based on evidence from studies involving
    various populations, the recommendations may not apply to every
    individual patient. It is important for the physician to take into
    consideration the role of patient preferences and the availability
    of local resources.

-   The American College of Chest Physicians (ACCP) is sensitive to
    concerns that nationally and/or internationally developed guidelines
    are not always applicable in local settings. Further, guideline
    recommendations are just that, recommendations not dictates. In
    treating patients, individual circumstances, preferences, and
    resources do play a role in the course of treatment at every
    decision level. Although the science behind evidence-based medicine
    is rigorous, there are always exceptions. The recommendations are
    intended to guide healthcare decisions. These recommendations can be
    adapted to be applicable at various levels.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

Implementation tools have been developed, including a quick reference
guide in print and personal digital assistant format, and educational
slide presentations for physicians and other health-care practitioners.

#### IMPLEMENTATION TOOLS

Patient Resources\
Personal Digital Assistant (PDA) Downloads\
Quick Reference Guides/Physician Guides\
Resources\
Slide Presentation\
Tool Kits

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

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

#### IOM CARE NEED

Living with Illness

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

McLaughlin VV, Presberg KW, Doyle RL, Abman SH, McCrory DC, Fortin T,
Ahearn G. Prognosis of pulmonary arterial hypertension: ACCP
evidence-based clinical practice guidelines. Chest 2004 Jul;126(1
Suppl):78S-92S. \[45 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15249497)

#### ADAPTATION

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

#### DATE RELEASED

2004 Jul

#### GUIDELINE DEVELOPER(S)

American College of Chest Physicians - Medical Specialty Society

#### SOURCE(S) OF FUNDING

Funding for both the evidence reviews and guideline development was
provided through an unrestricted educational grant from GlaxoSmithKline,
Texas Biotechnology Corporation, and Actelion Pharmaceuticals US.
Representatives from these companies were not granted right of review,
nor were they allowed participation in any portion of the guideline
development.

#### GUIDELINE COMMITTEE

American College of Chest Physicians (ACCP) Expert Panel on Pulmonary
Artery Hypertension

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Primary Authors*: Vallerie V. McLaughlin, MD, FCCP, Rush Presbyterian
St. Luke\'s Hospital, Chicago, IL; Kenneth W. Presberg, MD, FCCP,
Medical College of Wisconsin, Milwaukee, WI; Ramona L. Doyle, MD, FCCP,
Stanford University, Palo Alto, CA; Steven H. Abman, MD, Children\'s
Hospital, Denver, CO; Douglas C. McCrory, MD, MHSc, Duke University
Medical Center, Durham, NC; Terry Fortin, MD, Duke University Medical
Center, Durham, NC; Gregory Ahearn, MD, Duke University Medical Center,
Durham, NC

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

The following participants have disclosed information regarding
potential or real conflicts of interest and commitment:

Steven H. Abman, MD: scientific advisory board for INO Therapeutics;
consultant for Pfizer.

Charles W. Atwood, Jr., MD, FCCP: research support from Respironics,
Inc.

David B. Badesch, MD, FCCP: consultant or Speaker\'s Bureau for Glaxo
Wellcome/GlaxoSmithKline, Actelion, InterMune, Encysive, Myogen,
Astra-Merck, Astra-Zeneca, Exhale Therapeutics/CoTherix, Forrest Labs,
INO Therapeutics, Berlex; research support from Glaxo
Wellcome/GlaxoSmithKline, United Therapeutics, Boehringer Ingelheim,
Actelion, Encysive, ICOS/Texas Biotechnologies/Encysive, Myogen, INO
Therapeutics, Scleroderma Foundation, National Institutes of Health,
National Heart, Lung, and Blood Institute, United Therapeutics, Pfizer,
American Lung Association.

Robyn J. Barst, MD: consultant and research support from Actelion,
Encysive, Exhale Therapeutics, INO, Myogen, United Therapeutics, Pfizer
GlaxoSmithKline; unrestricted education grants from GlaxoSmithKline,
Encysive, Actelion.

Richard N. Channick, MD, FCCP: research support from Actelion, Pfizer,
Myogen, United Therapeutics; consultant and Speaker´s Bureau for
Actelion.

Ramona L. Doyle, MD, FCCP: Speaker\'s Bureau for Actelion; clinical
research for Actelion, Myogen, United Therapeutics.

David D. Gutterman, MD, FCCP: stock options with Johnson & Johnson;
relative who is a Vice-President at GlaxoSmithKline.

James E. Loyd, MD, FCCP: relationships with GlaxoSmithKline, United
Therapeutics, Actelion, ICOS/Texas Biotechnology, Westat, PRA
International, Pfizer, Exhale Therapeutics.

Michael D. McGoon, MD: past research support from Glaxo Wellcome, United
Therapeutics, Actelion; research support from Texas Biotech/Encysive,
Myogen, Pfizer, Medtronic.

Vallerie V. McLaughlin, MD, FCCP: consultant for Actelion, United
Therapeutics, Exhale Therapeutics; Speaker\'s Bureau for Actelion;
research funding from Actelion, United Therapeutics, Pfizer,
Encysive/Texas Biotechnologies, Glaxo Wellcome, Exhale Therapeutics,
Myogen.

Stuart Rich, MD: research funding from Actelion, Pfizer, United
Therapeutics, Encysive, Myogen; consultant for Actelion, Pfizer, United
Therapeutics, GlaxoSmithKline.

Lewis J. Rubin, MD, FCCP: consultant for Actelion, Myogen, Schering,
Exhale Therapeutics, United Therapeutics, Pfizer, Celgene; investigator
for Actelion, Myogen, Exhale, Pfizer, Celgene; no stock holdings or
other ownerships or positions.

Gerald Simonneau, MD: consultant and investigator for Glaxo Wellcome,
Pfizer, Actelion, Schering, Myogen, United Therapeutics.

Virginia D. Steen, MD: relationships with Arthritis Foundation,
Scleroderma Foundation, Actelion.

Fredrick M. Wigley, MD: research funding from Biogen, Pfizer, Actelion;
consultant to Genzyme.

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available to subscribers of [Chest - The
Cardiopulmonary and Critical Care
Journal](http://www.chestjournal.org/).

Print copies: Available from the American College of Chest Physicians,
Products and Registration Division, 3300 Dundee Road, Northbrook IL
60062-2348.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

Background Articles

-   Rubin, LJ. Diagnosis and management of pulmonary arterial
    hypertension: ACCP evidence-based clinical practice guidelines.
    Introduction. Chest 2004 Jul;126(1 Suppl):7S-10S.

-   Rubin LJ. Diagnosis and management of pulmonary arterial
    hypertension: ACCP evidence-based clinical practice guidelines.
    Executive summary. Chest 2004 Jul;126(1 Suppl):4S-6S.

-   McCrory DC, Lewis SZ. Methodology and grading for pulmonary
    hypertension evidence review and guideline development. Chest 2004
    Jul;126(1 Suppl):11S-13S.

Electronic copies: Available to subscribers of [Chest - The
Cardiopulmonary and Critical Care
Journal](http://www.chestjournal.org/).

Print copies: Available from the American College of Chest Physicians,
Products and Registration Division, 3300 Dundee Road, Northbrook IL
60062-2348.

Additional implementation tools are available:

-   Clinical Resource: Pulmonary Arterial Hypertension. Northbrook, IL.
    ACCP, 2004.

Ordering information is available from the [American College of Chest
Physicians (ACCP) Web
site](http://www.chestnet.org/education/hsp/products/index.php).

#### PATIENT RESOURCES

The following is available:

-   A patient\'s guide to pulmonary hypertension. In: Clinical resource:
    pulmonary arterial hypertension. Northbrook (IL): American College
    of Chest Physicians (ACCP). 2004.

Ordering information is available from the [American College of Chest
Physicians (ACCP) Web
site](http://www.chestnet.org/education/hsp/products/index.php).

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 August 30, 2004.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions.

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

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008