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Complete Summary

GUIDELINE TITLE

The role of endomyocardial biopsy in the management of cardiovascular disease. A scientific statement from the American Heart Association, the American College of Cardiology, and the European Society of Cardiology.

BIBLIOGRAPHIC SOURCE(S)

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
 IMPLEMENTATION OF THE GUIDELINE
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

SCOPE

DISEASE/CONDITION(S)

Cardiovascular disease

  • Heart failure
  • Cardiomyopathy
  • Cardiac tumors
  • Ventricular arrhythmias
  • Atrial fibrillation

GUIDELINE CATEGORY

Assessment of Therapeutic Effectiveness
Diagnosis
Management

CLINICAL SPECIALTY

Cardiology
Pathology
Pediatrics

INTENDED USERS

Physicians

GUIDELINE OBJECTIVE(S)

  • To define the current role of endomyocardial biopsy (EMB) in the management of cardiovascular disease
  • To provide an understanding of the range of acceptable approaches for the use of EMB while recognizing that individual patient care decisions depend on factors not well reflected in the published literature, such as local availability of specialized facilities, cardiovascular pathology expertise, and operator experience

TARGET POPULATION

Adult and pediatric patients with cardiovascular diseases requiring endomyocardial biopsy

INTERVENTIONS AND PRACTICES CONSIDERED

Endomyocardial biopsy

MAJOR OUTCOMES CONSIDERED

Sensitivity and specificity of endomyocardial biopsy

METHODOLOGY

METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

The recommendations contained in the present joint Scientific Statement are derived from a comprehensive review of the published literature on specific cardiomyopathies, arrhythmias, and cardiac tumors and are categorized according to presenting clinical syndrome rather than pathologically confirmed disease.

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

Levels of Evidence

Level A (highest): Multiple randomized clinical trials.

Level B (intermediate): Limited number of randomized trial, nonrandomized studies, and registries

Level C (lowest): Primarily expert consensus.

METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review

DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

To define the current role of EMB in the management of cardiovascular disease, a multidisciplinary group of experts in cardiomyopathies and cardiovascular pathology was convened by the American Heart Association (AHA), the American College of Cardiology (ACC), and the European Society of Cardiology (ESC). The present Writing Group was charged with reviewing the published literature on the role of EMB in cardiovascular diseases, summarizing this information, and making useful recommendations for clinical practice with classifications of recommendations and levels of evidence.

The Writing Group identified 14 clinical scenarios in which the incremental diagnostic, prognostic, and therapeutic value of EMB could be estimated and compared with the procedural risks.

RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Classification of Recommendations

Class I: Conditions for which there is evidence or there is general agreement that a given procedure is beneficial, useful, and effective

Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment

Class IIa: Conditions for which the weight of evidence/opinion is in favor of usefulness/efficacy

Class IIb: Conditions for which usefulness/efficacy is less well established by evidence/opinion

Class III: Conditions for which there is evidence and/or general agreement that a procedure/treatment is not useful/effective and in some cases may be harmful.

COST ANALYSIS

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

METHOD OF GUIDELINE VALIDATION

Peer Review

DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

This document was approved by the American Heart Association Science Advisory and Coordinating Committee on July 2, 2007; the American College of Cardiology Foundation Board of Trustees on May 21, 2007; and the European Society of Cardiology Committee for Practice Guidelines on April 3, 2007.

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Endomyocardial biopsy (EMB) should be performed in the setting of unexplained, new-onset heart failure of <2 weeks' duration associated with a normal-sized or dilated left ventricle in addition to hemodynamic compromise. Class of Recommendation I, Level of Evidence B.

EMB should be performed in the setting of unexplained new-onset heart failure of 2 weeks' to 3 months' duration associated with a dilated left ventricle and new ventricular arrhythmias, Mobitz type II second- or third-degree atrioventricular (AV) heart block, or failure to respond to usual care within 1 to 2 weeks. Class of Recommendation I, Level of Evidence B.

EMB is reasonable in the clinical setting of unexplained heart failure of >3 months' duration associated with a dilated left ventricle and new ventricular arrhythmias, Mobitz type II second- or third-degree AV heart block, or failure to respond to usual care within 1 to 2 weeks. Class of Recommendation IIa, Level of Evidence C.

EMB is reasonable in the setting of unexplained heart failure associated with a dilated cardiomyopathy (DCM) of any duration that is associated with suspected allergic reaction in addition to eosinophilia. Class of Recommendation IIa, Level of Evidence C.

EMB is reasonable in the setting of unexplained heart failure associated with suspected anthracycline cardiomyopathy. Class of Recommendation IIa, Level of Evidence C.

EMB is reasonable in the setting of heart failure associated with unexplained restrictive cardiomyopathy. Class of Recommendation IIa, Level of Evidence C.

EMB is reasonable in the setting of suspected cardiac tumors, with the exception of typical myxomas. Class of Recommendation IIa, Level of Evidence C.

EMB is reasonable in the setting of unexplained cardiomyopathy in children. Class of Recommendation IIa, Level of Evidence C.

EMB may be considered in the setting of unexplained, new-onset heart failure of 2 weeks' to 3 months' duration associated with a dilated left ventricle, without new ventricular arrhythmias or Mobitz type II second- or third-degree AV heart block, that responds to usual care within 1 to 2 weeks. Class of Recommendation IIb, Level of Evidence B.

EMB may be considered in the setting of unexplained heart failure of >3 months' duration associated with a dilated left ventricle, without new ventricular arrhythmias or Mobitz type II second- or third-degree AV heart block, that responds to usual care within 1 to 2 weeks. Class of Recommendation IIb, Level of Evidence C.

EMB may be considered in the setting of heart failure associated with unexplained hypertrophic cardiomyopathy (HCM). Class of Recommendation IIb, Level of Evidence C.

EMB may be considered in the setting of suspected arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C). Class of Recommendation IIb, Level of Evidence C.

EMB may be considered in the setting of unexplained ventricular arrhythmias. Class of Recommendation IIb, Level of Evidence C.

EMB should not be performed in the setting of unexplained atrial fibrillation. Class of Recommendation III, Level of Evidence C.

Definitions:

Levels of Evidence

Level A (highest): Multiple randomized clinical trials.

Level B (intermediate): Limited number of randomized trials, nonrandomized studies, and registries

Level C (lowest): Primarily expert consensus.

Classification of Recommendations

Class I: Conditions for which there is evidence or there is general agreement that a given procedure is beneficial, useful, and effective

Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/efficacy of a procedure or treatment

Class IIa: Conditions for which the weight of evidence/opinion is in favor of usefulness/efficacy

Class IIb: Conditions for which usefulness/efficacy is less well established by evidence/opinion

Class III: Conditions for which there is evidence and/or general agreement that a procedure/treatment is not useful/effective and in some cases may be harmful.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is specifically stated for each recommendation (see 'Major Recommendations' field).

BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

POTENTIAL BENEFITS

Appropriate use of endomyocardial biopsy in the diagnosis of cardiovascular disease

POTENTIAL HARMS

  • The risks of endomyocardial biopsy (EMB) may be divided into those that are acute and those that are delayed. Immediate risks of biopsy include perforation with pericardial tamponade, ventricular or supraventricular arrhythmias, heart block, pneumothorax, puncture of central arteries, pulmonary embolization, nerve paresis, venous hematoma, damage to the tricuspid valve, and creation of arterial venous fistula within the heart. The risks of EMB likely vary with the experience of the operator, clinical status of the patient, presence or absence of left bundle-branch block, access site, and possibly bioptome. The use of a long sheath that crosses the tricuspid valve may decrease the risk of bioptome-induced tricuspid valve trauma. Delayed complications include access site bleeding, damage to the tricuspid valve, pericardial tamponade, and deep venous thrombosis. Most complications are known from case reports, and therefore the precise frequency of these events is not known.
  • The death rate associated with EMB is a result of perforation with pericardial tamponade. Patients with increased right ventricular systolic pressures, bleeding diathesis, recent receipt of heparin, or right ventricular enlargement seem to be at higher risk.

IMPLEMENTATION OF THE GUIDELINE

DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

IOM CARE NEED

Getting Better
Living with Illness

IOM DOMAIN

Effectiveness
Safety

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

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

DATE RELEASED

2007 Nov 6

GUIDELINE DEVELOPER(S)

American College of Cardiology Foundation - Medical Specialty Society
American Heart Association - Professional Association
European Society of Cardiology - Medical Specialty Society

SOURCE(S) OF FUNDING

American Heart Association

GUIDELINE COMMITTEE

Writing Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Committee Members: Leslie T. Cooper, MD, FAHA, FACC; Kenneth L. Baughman, MD, FAHA, FACC; Arthur M. Feldman, MD, PhD, FAHA, FACC; Andrea Frustaci, MD; Mariell Jessup, MD, FAHA, FACC; Uwe Kuhl, MD; Glenn N. Levine, MD, FAHA, FACC; Jagat Narula, MD, PhD, FAHA; Randall C. Starling, MD, MPH; Jeffrey Towbin, MD, FAHA, FACC; Renu Virmani, MD, FACC

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

The American Heart Association makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside relationship or a personal, professional, or business interest of a member of the writing panel. Specifically, all members of the writing group are required to complete and submit a Disclosure Questionnaire showing all such relationships that might be perceived as real or potential conflicts of interest.

Writing Group Disclosures

Writing Group Member Employment Research Grant Other Research Support Speakers' Bureau/
Honoraria
Expert Witness Ownership Interest Consultant/
Advisory Board
Other
Leslie T. Cooper Mayo Clinic None None None None None None None
Kenneth L. Baughman Brigham and Women's Hospital NIH† None None None None None None
Arthur Feldman Thomas Jefferson University Hospital None None None None None None None
Andrea Frustaci La Sapienza University None None None None None None None
Mariell Jessup University of Pennsylvania None None AstraZeneca*; Medtronic*; ACORN*; GlaxoSmithKline* None None ACORN*; Medtronic*; GlaxoSmithKline*; Ventracor* None
Uwe Kuhl Charite University None None None None None None None
Glenn N. Levine Baylor College of Medicine None None Sanofi-Aventis*; Medicines Company* None None None None
Jagat Narula University of California, Irvine None None GlaxoSmithKline† None None None None
Randall C. Starling Cleveland Clinic Foundation NIH† Novartis*; Orquis*; Johnson & Johnson* None None None Acorn Cardiovascular Inc*; Cardiomems*; Myocor*; Medtronic*; World Heart* None
Jeffrey Towbin Baylor College of Medicine None None None None None None None
Renu Virmani CV Path None None None None None Medtronic†; Guidant†; Abbott Laboratories†; W.L. Gore†; CryoVascular Systems, Inc†; Volcano Therapeutics Inc†; Precient Medical†; Medicon†; Cardiomind, Inc†; Direct Flow† None

This table represents the relationships of writing group members that may be perceived as actual or reasonably perceived conflicts of interest as reported on the Disclosure Questionnaire, which all members of the writing group are required to complete and submit. A relationship is considered to be "significant" if (a) the person receives $10,000 or more during any 12-month period, or 5% or more of the person's gross income; or (b) the person owns 5% or more of the voting stock or share of the entity, or owns $10,000 or more of the fair market value of the entity. A relationship is considered to be "modest" if it is less than "significant" under the preceding definition.

*Modest

†Significant

Reviewer Disclosures

Reviewer Employment Research Grant Other Research Support Speakers' Bureau Expert Witness Ownership Interest Consultant/
Advisory Board
Other
Mazen Abu-Fadel Ponca City Medical Center None None None None None None None
Jeffrey Anderson LDS Hospital None None None None None None None
Eloisa Arbustini I.R.C.C.S. Policlinico San Matteo, Pavia, Italy None None None None None None None
Eric Bates University of Michigan None None None None None None None
Fred Bove Temple University Penn Dept of Health None None None None Insight Telehealth Systems* None
Rihal Charanjit Mayo Clinic None None None None None None None
G. William Dec Massachusetts General Hospital None None None None None None None
Jose Diez Baylor College of Medicine None None None None None Sanofi-Aventis* None
Mark Eisenberg McGill University None None None None None None None
Gerasimos Filippatos Evangelismos Hospital, Athens, Greece None None None None None None None
Robert Harrington Duke University None None None None None None None
Mark Hlatky Stanford University None None None None None None None
Maryl Johnson University of Wisconsin None None None None None None None
Jay Mason Covance Central Diagnostics None None None None None None None
Walter Paulus VU University Medical Center, Netherlands None None None None None None None
Richard Schofield University of Florida None None AstraZeneca*; AtCor Medical*; Novartis*; Pfizer*; Scios* None None Pfizer* None
Udo Sechtem Robert-Bosch- Medical Center, Stuttgart, Germany None None None None None None None
Ajay Shah King's College London None None None None None None None
Samuel J. Shubrooks, Jr Beth Israel Deaconess Medical Center None None None None None None None

This table represents the relationships of reviewers that may be perceived as actual or reasonably perceived conflicts of interest as reported on the Disclosure Questionnaire, which all reviewers are required to complete and submit. A relationship is considered to be "significant" if (a) the person receives $10,000 or more during any 12-month period, or 5% or more of the person's gross income; or (b) the person owns 5% or more of the voting stock or share of the entity, or owns $10,000 or more of the fair market value of the entity. A relationship is considered to be "modest" if it is less than "significant" under the preceding definition.

*Modest

†Significant

ENDORSER(S)

Heart Failure Society of America, Inc - Disease Specific Society

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

Electronic copies: Available from the American Heart Association Web site, the American College of Cardiology (ACC) Web site, and from the European Society of Cardiology Web site.

Print copies: Available from the American Heart Association, Public Information, 7272 Greenville Ave, Dallas, TX 75231-4596; Phone: 800-242-8721

AVAILABILITY OF COMPANION DOCUMENTS

None available

PATIENT RESOURCES

None available

NGC STATUS

This summary was completed by ECRI Institute on December 24, 2008.

COPYRIGHT STATEMENT

DISCLAIMER

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