acc/aha 2008 guideline update on valvular heart disease ... acc... · practice guideline: focused...

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PRACTICE GUIDELINE: FOCUSED UPDATE ACC/AHA 2008 Guideline Update on Valvular Heart Disease: Focused Update on Infective Endocarditis A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons 2008 Writing Group to Review New Evidence and Update the ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease, Writing on Behalf of the 2006 Valvular Heart Disease Writing Committee Rick A. Nishimura, MD, FACC, FAHA, Chair Blase A. Carabello, MD, FACC, FAHA David P. Faxon, MD, FACC, FAHA Michael D. Freed, MD, FACC, FAHA Bruce W. Lytle, MD, FACC, FAHA Patrick T. O’Gara, MD, FACC, FAHA Robert A. O’Rourke, MD, MACC, FAHA Pravin M. Shah, MD, MACC, FAHA 2006 Writing Committee Members Robert O. Bonow, MD, MACC, FAHA, Chair Blase A. Carabello, MD, FACC, FAHA Kanu Chatterjee, MB, FACC Antonio C. de Leon, JR, MD, FACC, FAHA David P. Faxon, MD, FACC, FAHA Michael D. Freed, MD, FACC, FAHA William H. Gaasch, MD, FACC, FAHA Bruce W. Lytle, MD, FACC, FAHA Rick A. Nishimura, MD, FACC, FAHA Patrick T. O’Gara, MD, FACC, FAHA Robert A. O’Rourke, MD, MACC, FAHA Catherine M. Otto, MD, FACC, FAHA Pravin M. Shah, MD, MACC, FAHA Jack S. Shanewise, MD* *Society of Cardiovascular Anesthesiologists Representative Task Force Members Sidney C. Smith, J R, MD, FACC, FAHA, Chair Alice K. Jacobs, MD, FACC, FAHA, Vice-Chair Christopher E. Buller, MD, FACC Mark A. Creager, MD, FACC, FAHA Steven M. Ettinger, MD, FACC Harlan M. Krumholz, MD, FACC, FAHA Frederick G. Kushner, MD, FACC, FAHA Bruce W. Lytle, MD, FACC, FAHA† Rick A. Nishimura, MD, FACC, FAHA Richard L. Page, MD, FACC, FAHA Lynn G. Tarkington, RN Clyde W. Yancy, JR, MD, FACC, FAHA †Former Task Force member during this writing effort This document is a limited update to the 2006 guideline update and is based on a review of certain evidence, not a full literature review. This document was approved by the American College of Cardiology Foundation Board of Trustees and by the American Heart Association Science Advisory and Coordinating Committee in May 2008. The American College of Cardiology Foundation requests that this document be cited as follows: Nishimura RA, Carabello BA, Faxon DP, Freed MD, Lytle BW, O’Gara PT, O’Rourke RA, Shah PM. ACC/AHA 2008 guideline update on valvular heart disease: focused update on infective endocarditis: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guide- lines. J Am Coll Cardiol 2008;52:676 – 85. This article has been copublished in the August 19, 2008, issue of Circulation. Copies: This document is available on the World Wide Web sites of the Amer- ican College of Cardiology (www.acc.org) and American Heart Association (www. americanheart.org). For copies of this document, please contact Elsevier Inc. Reprint Department, fax (212) 633-3820, e-mail [email protected]. Permissions: Multiple copies, modification, alteration, enhancement, and/or dis- tribution of this document are not permitted without the express permission of the American College of Cardiology Foundation. Please contact Elsevier’s permission department at [email protected]. Journal of the American College of Cardiology Vol. 52, No. 8, 2008 © 2008 by the American College of Cardiology Foundation and the American Heart Association, Inc. ISSN 0735-1097/08/$34.00 Published by Elsevier Inc. doi:10.1016/j.jacc.2008.05.008

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Page 1: ACC/AHA 2008 Guideline Update on Valvular Heart Disease ... ACC... · PRACTICE GUIDELINE: FOCUSED UPDATE ACC/AHA 2008 Guideline Update on Valvular Heart Disease: Focused Update on

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Journal of the American College of Cardiology Vol. 52, No. 8, 2008© 2008 by the American College of Cardiology Foundation and the American Heart Association, Inc. ISSN 0735-1097/08/$34.00P

PRACTICE GUIDELINE: FOCUSED UPDATE

ACC/AHA 2008 Guideline Update on Valvular HeartDisease: Focused Update on Infective EndocarditisA Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines

Endorsed by the Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions,and Society of Thoracic Surgeons

2008 Writing Group to Review New Evidence and Update theACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease,

Writing on Behalf of the 2006 Valvular Heart Disease Writing Committee

ublished by Elsevier Inc. doi:10.1016/j.jacc.2008.05.008

BPRP

Rick A. Nishimura, MD, FACC, FAHA, Chair

Blase A. Carabello, MD, FACC, FAHADavid P. Faxon, MD, FACC, FAHA

his document is a limited update to the 2006 guideline update and is based on aeview of certain evidence, not a full literature review.

This document was approved by the American College of Cardiology Foundationoard of Trustees and by the American Heart Association Science Advisory andoordinating Committee in May 2008.The American College of Cardiology Foundation requests that this document be

ited as follows: Nishimura RA, Carabello BA, Faxon DP, Freed MD, Lytle BW,’Gara PT, O’Rourke RA, Shah PM. ACC/AHA 2008 guideline update on valvular

eart disease: focused update on infective endocarditis: a report of the Americanollege of Cardiology/American Heart Association Task Force on Practice Guide-

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ruce W. Lytle, MD, FACC, FAHAatrick T. O’Gara, MD, FACC, FAHAobert A. O’Rourke, MD, MACC, FAHAravin M. Shah, MD, MACC, FAHA

Michael D. Freed, MD, FACC, FAHA

2006 WritingCommitteeMembers

Robert O. Bonow, MD, MACC, FAHA,Chair

Blase A. Carabello, MD, FACC, FAHAKanu Chatterjee, MB, FACCAntonio C. de Leon, JR, MD, FACC, FAHADavid P. Faxon, MD, FACC, FAHAMichael D. Freed, MD, FACC, FAHAWilliam H. Gaasch, MD, FACC, FAHABruce W. Lytle, MD, FACC, FAHA

Rick A. Nishimura, MD, FACC, FAHAPatrick T. O’Gara, MD, FACC, FAHARobert A. O’Rourke, MD, MACC, FAHACatherine M. Otto, MD, FACC, FAHAPravin M. Shah, MD, MACC, FAHAJack S. Shanewise, MD*

*Society of Cardiovascular Anesthesiologists Representative

Task ForceMembers

Sidney C. Smith, JR, MD, FACC, FAHA, ChairAlice K. Jacobs, MD, FACC, FAHA, Vice-Chair

Christopher E. Buller, MD, FACCMark A. Creager, MD, FACC, FAHASteven M. Ettinger, MD, FACCHarlan M. Krumholz, MD, FACC, FAHA

Frederick G. Kushner, MD, FACC, FAHABruce W. Lytle, MD, FACC, FAHA†Rick A. Nishimura, MD, FACC, FAHARichard L. Page, MD, FACC, FAHALynn G. Tarkington, RNClyde W. Yancy, JR, MD, FACC, FAHA

†Former Task Force member during this writing effort

ines. J Am Coll Cardiol 2008;52:676–85.This article has been copublished in the August 19, 2008, issue of Circulation.Copies: This document is available on the World Wide Web sites of the Amer-

can College of Cardiology (www.acc.org) and American Heart Association (www.mericanheart.org). For copies of this document, please contact Elsevier Inc. Reprintepartment, fax (212) 633-3820, e-mail [email protected]: Multiple copies, modification, alteration, enhancement, and/or dis-

ribution of this document are not permitted without the express permission of themerican College of Cardiology Foundation. Please contact Elsevier’s permissionepartment at [email protected].

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677JACC Vol. 52, No. 8, 2008 Nishimura et al.August 19, 2008:676–85 VHD Focused Update

TABLE OF CONTENTS

reamble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .677

. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .679

1.1. Evidence Review. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .679

1.2. Organization of Committee and RelationshipsWith Industry. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .679

1.3. Review and Approval . . . . . . . . . . . . . . . . . . . . . . . . . . .679

2.3. Endocarditis and Rheumatic FeverProphylaxis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .679

2.3.1. Endocarditis Prophylaxis. . . . . . . . . . . . . . . . . . . . . . . . .6803.1.4.4. AORTIC STENOSIS: MEDICAL THERAPY . . . . . . . . . . . . . . . . . .6823.4.3.1. MITRAL STENOSIS: MEDICAL THERAPY . . . . . . . . . . . . . . . . . .683

3.5.2. Evaluation and Management of the AsymptomaticPatient With Mitral Valve Prolapse. . . . . . . . . . . . . .683

3.5.3. Evaluation and Management of the SymptomaticPatient With Mitral Valve Prolapse . . . . . . . . . . . . .683

. Management of Congenital Valvular Heart Diseasein Adolescents and Young Adults . . . . . . . . . . . . . . . . . . . . .683

6.6.3. Indications for Balloon Valvotomy in PulmonicStenosis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .683

ppendix 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .683

ppendix 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .684

eferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .685

reamble

primary challenge in the development of clinical practiceuidelines is keeping pace with the stream of new data uponhich recommendations are based. In an effort to respondore quickly to new evidence, the American College ofardiology/American Heart Association (ACC/AHA) Taskorce on Practice Guidelines has created a new “focusedpdate” process to revise the existing guideline recommenda-ions that are affected by the evolving data or opinion. Prior tohe initiation of this focused approach, periodic updates andevisions of existing guidelines required up to 3 years toomplete. Now, however, new evidence will be reviewed in anngoing fashion to more efficiently respond to importantcience and treatment trends that could have a major impact onatient outcomes and quality of care. Evidence will be reviewedt least twice a year, and updates will be initiated on an aseeded basis as quickly as possible, while maintaining theigorous methodology that the ACC and AHA have devel-ped during their more than 20 years of partnership.

These updated guideline recommendations reflect a con-ensus of expert opinion after a thorough review primarily ofate-breaking clinical trials identified through a broad-based

etting process as important to the relevant patient popu- r

ation, and of other new data deemed to have an impact onatient care (see Section 1.1 “Evidence Review” for detailsegarding this focused update). It is important to note thathis focused update is not intended to represent an updateased on a full literature review from the date of therevious guideline publication. Specific criteria/considera-ions for inclusion of new data include:

Publication in a peer-reviewed journalLarge randomized, placebo-controlled trial(s)Nonrandomized data deemed important on the basis ofresults impacting current safety and efficacy assumptionsStrength/weakness of research methodology and findingsLikelihood of additional studies influencing current findingsImpact on current performance measure(s) and/or like-lihood of need to develop new performance measure(s)Requests and requirements for review and update from thepractice community, key stakeholders, and other sourcesfree of relationships with industry or other potential biasNumber of previous trials showing consistent resultsNeed for consistency with a new guideline or guidelinerevision

In analyzing the data and developing updated recommen-ations and supporting text, the focused update writingroup used evidence-based methodologies developed by theCC/AHA Task Force on Practice Guidelines, which areescribed elsewhere (1).The schema for class of recommendation and level of

vidence is summarized in Table 1, which also illustratesow the grading system provides an estimate of the size ofhe treatment effect and an estimate of the certainty of thereatment effect. Note that a recommendation with Level ofvidence B or C does not imply that the recommendation

s weak. Many important clinical questions addressed inuidelines do not lend themselves to clinical trials. Althoughandomized trials may not be available, there may be a verylear clinical consensus that a particular test or therapy isseful and effective. Both the class of recommendation andevel of evidence listed in the focused updates are based ononsideration of the evidence reviewed in previous iterationsf the guideline as well as the focused update. Of note, themplications of older studies that have informed recommen-ations but have not been repeated in contemporary settingsre carefully considered.

The ACC/AHA practice guidelines address patient pop-lations (and health care providers) residing in Northmerica. As such, drugs that are not currently available inorth America are discussed in the text without a specific

lass of recommendation. For studies performed in largeumbers of subjects outside of North America, each writingommittee reviews the potential impact of different practiceatterns and patient populations on the treatment effect andn the relevance to the ACC/AHA target population toetermine whether the findings should inform a specific

ecommendation.
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678 Nishimura et al. JACC Vol. 52, No. 8, 2008VHD Focused Update August 19, 2008:676–85

The ACC/AHA practice guidelines are intended to assistealth care providers in clinical decision making by describ-

ng a range of generally acceptable approaches for theiagnosis, management, and prevention of specific diseasesr conditions. The guidelines attempt to define practiceshat meet the needs of most patients in most circumstances.he ultimate judgment regarding care of a particular patientust be made by the health care provider and patient in

ight of all the circumstances presented by that patient.hus, there are circumstances in which deviations from

able 1. Applying Classification of Recommendations and Leve

hese guidelines may be appropriate. Clinical decision mak- t

ng should consider the quality and availability of expertisen the area where care is provided. These guidelines may besed as the basis for regulatory or payer decisions, but theltimate goal is quality of care and serving the patient’s bestnterests.

Prescribed courses of treatment in accordance with theseecommendations are only effective if they are followed byhe patient. Because lack of patient adherence may adverselyffect treatment outcomes, health care providers shouldake every effort to engage the patient in active participa-

vidence

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ion with prescribed treatment.

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679JACC Vol. 52, No. 8, 2008 Nishimura et al.August 19, 2008:676–85 VHD Focused Update

The ACC/AHA Task Force on Practice Guidelines makesvery effort to avoid any actual, potential, or perceived conflictf interest arising from industry relationships or personalnterests of a writing committee member. All writing commit-ee members and peer reviewers were required to provideisclosure statements of all such relationships pertaining to therials and other evidence under consideration (see Appendixesand 2). Final recommendations were balloted to all writing

ommittee members. Writing committee members with sig-ificant (greater than $10 000) relevant relationships with

ndustry were required to recuse themselves from voting onhat recommendation. Writing committee members who didot participate are not listed as authors of this focused update.With the exception of the recommendations presented

ere, the full guideline remains current. Only the recom-endations from the affected section(s) of the full guideline

re included in this focused update. For easy reference, allecommendations from any section of a guideline impactedy a change are presented with notation as to whether theyemain current, are new, or have been modified. Whenvidence impacts recommendations in more than 1 set ofuidelines, those guidelines are updated concurrently.

The recommendations in this focused update will be con-idered current until they are superseded by another focusedpdate or the full-text guidelines are revised. This focusedpdate is published in the August 19, 2008, issue of the Journalf the American College of Cardiology and the August 19, 2008,ssue of Circulation as an update to the full-text guideline, ands also posted on the ACC (www.acc.org) and AHA (www.mericanheart.org) Web sites. A revised version of the 2006ull-text guideline that incorporates the focused update isvailable on the respective Web sites (2). For easy reference,his online-only version denotes sections that have been up-ated.

Sidney C. Smith, Jr, MD, FACC, FAHAChair, ACC/AHA Task Force on Practice Guidelines

Alice K. Jacobs, MD, FACC, FAHAVice-Chair, ACC/AHA Task Force on Practice Guidelines

. Introduction

.1. Evidence Review

ate-breaking clinical trials presented at the 2005 and 2006nnual scientific meetings of the ACC, AHA, and Europeanociety of Cardiology, as well as selected other data publisheduring the same time period, were reviewed by the standinguideline writing committee along with the parent task forcend other experts to identify those trials and other key data thatay impact guideline recommendations. On the basis of the

riteria/considerations noted above, recent trial data and otherlinical data were considered when deciding whether there wasvidence important enough to prompt an update of theCC/AHA 2006 Guidelines for the Management of Patients

ith Valvular Heart Disease (3). e

This focused update of the ACC/AHA 2006 Guidelines forhe Management of Patients With Valvular Heart Diseasepotlights the 2007 AHA guidelines for infective endocarditisrophylaxis (4). Only recommendations related to infectivendocarditis have been revised. Individual recommendationspdated in the present focused update will be incorporated intouture revisions and/or updates of the full-text guidelines.olicy on clinical areas not covered by the present focusedpdate can be found in the 2008 Focused Update Incorporatednto the ACC/AHA 2006 Guidelines for the Management ofatients With Valvular Heart Disease (2).

.2. Organization of Committee and Relationshipsith Industry

or this focused update, all members of the 2006 Valvulareart Disease Writing Committee were invited to partici-

ate; those who agreed (referred to as the 2008 Focusedpdate Writing Group) were required to disclose all rela-

ionships with industry relevant to the data under consid-ration (1). Each recommendation required a confidentialote by the writing group members before and after externaleview of the document. Any writing group member with aignificant (greater than $10 000) relationship with industryelevant to the recommendation was recused from voting onhat recommendation.

.3. Review and Approval

his document was reviewed by 2 external reviewers nomi-ated by the ACC and 2 external reviewers nominated by theHA, as well as 3 reviewers from the ACC Foundation’s

ACCF) Congenital Heart Disease and Pediatric Committee,reviewers from the ACCF Cardiovascular Surgery Commit-

ee, 5 reviewers from the AHA Heart Failure and Transplantommittee, and 3 reviewers from the Rheumatic Fever,ndocarditis, and Kawasaki Disease Committee. All informa-

ion about reviewers’ relationships with industry was collectednd distributed to the writing committee and is published inhis document (see Appendix 2 for details).

This document was approved for publication by theoverning bodies of the ACCF and the AHA and endorsedy the Society of Cardiovascular Anesthesiologists, theociety for Cardiovascular Angiography and Interventions,nd the Society of Thoracic Surgeons.

.3. Endocarditis and Rheumatic Fever Prophylaxis

his focused update deals exclusively with the changes inecommendations for antibiotic prophylaxis against infectivendocarditis in patients with valvular heart disease (VHD).reatment considerations in patients with congenital heartisease (CHD) or implanted cardiac devices are reviewed inetail in other publications (5) and the upcoming ACC/AHAuideline for the management of adult patients with CHD.or an in-depth review of the rationale for the recommendedhanges in the approach to patients with VHD, the reader iseferred to the AHA guidelines on prevention of infective

ndocarditis published online in April 2007 (4).
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.3.1. Endocarditis Prophylaxis

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nfective endocarditis is a serious illness associated withignificant morbidity and mortality. Its prevention by theppropriate administration of antibiotics before a procedurexpected to produce bacteremia merits serious consider-tion. Experimental studies have suggested that endothelialamage leads to platelet and fibrin deposition and theormation of nonbacterial thrombotic endocardial lesions.

able 2. Updates to Section 2.3.1. Endocarditis Prophylaxis

2006 VHD Guideline Recommendations 2008 VH

Class I

. Prophylaxis against infective endocarditis isrecommended for the following patients:• Patients with prosthetic heart valves and patients with

a history of infective endocarditis. (Level of Evidence: C)• Patients who have complex cyanotic congenital heart

disease (e.g., single-ventricle states, transposition ofthe great arteries, tetralogy of Fallot). (Level ofEvidence: C)

• Patients with surgically constructed systemicpulmonary shunts or conduits. (Level of Evidence: C)

• Patients with congenital cardiac valve malformations,particularly those with bicuspid aortic valves, andpatients with acquired valvular dysfunction (e.g.,rheumatic heart disease). (Level of Evidence: C)

• Patients who have undergone valve repair. (Level ofEvidence: C)

• Patients who have hypertrophic cardiomyopathy whenthere is latent or resting obstruction. (Level of Evidence: C)

• Patients with MVP and auscultatory evidence ofvalvular regurgitation and/or thickened leaflets onechocardiography.* (Level of Evidence: C)

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. Prophylaxis against infective endocarditis is notrecommended for the following patients:• Patients with isolated secundum atrial septal defect.

(Level of Evidence: C)• Patients 6 or more months after successful surgical or

percutaneous repair of atrial septal defect, ventricularseptal defect, or patent ductus arteriosus. (Level ofEvidence: C)

• Patients with MVP without MR or thickened leaflets onechocardiography.* (Level of Evidence: C)

• Patients with physiological, functional, or innocentheart murmurs, including patients with aortic valvesclerosis as defined by focal areas of increasedechogenicity and thickening of the leaflets withoutrestriction of motion and a peak velocity less than2.0 m per second. (Level of Evidence: C)

• Patients with echocardiographic evidence of physiologicMR in the absence of a murmur and with structurallynormal valves. (Level of Evidence: C)

• Patients with echocardiographic evidence ofphysiological TR and/or pulmonary regurgitation in theabsence of a murmur and with structurally normalvalves. (Level of Evidence: C)

1. Prophylaxisrecommentransesophesophagogabsence of

This footnote is obsolete. Please see 2006 VHD Guideline (3) for footnote text.MR indicates mitral regurgitation; MVP, mitral valve prolapse; and TR, tricuspid regurgitation.

n the presence of bacteremia, organisms may adhere to p

hese lesions and multiply within the platelet-fibrin com-lex, leading to an infective vegetation. Valvular and con-enital abnormalities, especially those associated with high-elocity jets, can result in endothelial damage, platelet-fibrineposition, and a predisposition to bacterial colonization.ince 1955, the AHA has made recommendations forrevention of infective endocarditis with antimicrobial pro-

used Update Recommendations Comments

Class IIa

nst infective endocarditis ise following patients at highest risk

omes from infective endocarditis whorocedures that involve manipulation

l tissue or the periapical region ofion of the oral mucosa (4):prosthetic cardiac valves or prostheticfor cardiac valve repair. (Level of

previous infective endocarditis. (Level)CHD. (Level of Evidence: B)cyanotic CHD, including palliativeconduits. (Level of Evidence: B)repaired congenital heart defect

th prosthetic material or device,ced by surgery or by catheter, during the first 6 months after the(Level of Evidence: B)HD with residual defects at the site orthe site of a prosthetic patch orevice (both of which inhibit

ization). (Level of Evidence: B)lant recipients with valve

due to a structurally abnormal valve.nce: C)

Modified recommendation(changed class ofrecommendation from I to IIa,changed text). There are no ClassI recommendations for infectiveendocarditis prophylaxis.

I

st infective endocarditis is notr nondental procedures (such asechocardiogram,uodenoscopy, or colonoscopy) in theinfection. (Level of Evidence: B) (4)

Modified recommendation(changed text)

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enitourinary (GU) procedures in patients at risk for itsevelopment. However, many authorities and societies, asell as the conclusions of published studies, have questioned

he efficacy of antimicrobial prophylaxis in most situations.On the basis of these concerns, a writing group was

ppointed by the AHA for their expertise in prevention andreatment of infective endocarditis, with liaison membersepresenting the American Dental Association, the Infec-ious Disease Society of America, and the American Acad-my of Pediatrics. The writing group reviewed the relevantiterature regarding procedure-related bacteremia and infec-ive endocarditis, in vitro susceptibility data of the mostommon organisms that cause infective endocarditis, resultsf prophylactic studies of animal models of infective endo-arditis, and both retrospective and prospective studies ofrevention of infective endocarditis. As a result, majorhanges were made in the recommendations for prophylaxisgainst infective endocarditis.

The major changes in the updated recommendationsncluded the following:

The committee concluded that only an extremely smallnumber of cases of infective endocarditis may be preventedby antibiotic prophylaxis for dental procedures even if suchprophylactic therapy were 100 percent effective.Infective endocarditis prophylaxis for dental proceduresis reasonable only for patients with underlying cardiacconditions associated with the highest risk of adverseoutcome from infective endocarditis.For patients with these underlying cardiac conditions,prophylaxis is reasonable for all dental procedures thatinvolve manipulation of either gingival tissue or theperiapical region of teeth or perforation of oral mucosa.Prophylaxis is not recommended solely on the basis ofan increased lifetime risk of acquisition of infectiveendocarditis.Administration of antibiotics solely to prevent endocar-ditis is not recommended for patients who undergo a GUor GI tract procedure.

The rationale for these revisions is based on theollowing:

Infective endocarditis is more likely to result from fre-quent exposure to random bacteremias associated withdaily activities than from bacteremia caused by a dental,GI tract, or GU procedure.Prophylaxis may prevent an exceedingly small number ofcases of infective endocarditis (if any) in individuals whoundergo a dental, GI tract, or GU procedure.The risk of antibiotic-associated adverse effects exceedsthe benefit (if any) from prophylactic antibiotic therapy.Maintenance of optimal oral health and hygiene mayreduce the incidence of bacteremia from daily ac-tivities and is more important than prophylactic antibi-otics for a dental procedure to reduce the risk of infective

endocarditis.

2

The AHA Prevention of Infective Endocarditis Commit-ee recommended that prophylaxis be given only to aigh-risk group of patients before dental procedures that

nvolve manipulation of either gingival tissue or the peri-pical region of the teeth or perforation of oral mucosaTables 2 to 4). High-risk patients were defined as thoseatients with underlying cardiac conditions associated withhe highest risk of adverse outcome from infective endocar-itis, not necessarily those with an increased lifetime risk ofcquisition of infective endocarditis. Prophylaxis is noonger recommended for prevention of endocarditis forrocedures that involve the respiratory tract unless therocedure is performed in a high-risk patient and involvesncision of the respiratory tract mucosa, such as tonsillec-omy and adenoidectomy. Prophylaxis is no longer recom-ended for prevention of infective endocarditis for GI orU procedures, including diagnostic esophagogastroduode-

oscopy or colonoscopy (Table 2). However, in high-riskatients with infections of the GI or GU tract, it iseasonable to administer antibiotic therapy to preventound infection or sepsis. For high-risk patients undergo-

ng elective cystoscopy or other urinary tract manipulationho have enterococcal urinary tract infection or coloniza-

ion, antibiotic therapy to eradicate enterococci from therine before the procedure is reasonable.These changes are a significant departure from the past

HA (7) and European Society of Cardiology (8) recom-endations for prevention of infective endocarditis and may

iolate longstanding expectations in practice patterns ofatients and health care providers. However, the writingommittee for these updated guidelines consists of expertsn the field of infective endocarditis; input was also obtainedrom experts not affiliated with the writing group. All datao date were reviewed thoroughly, and the current recom-endations reflect analysis of all relevant literature. Thisultidisciplinary team of experts emphasizes that previously

ublished guidelines for the prevention of endocarditisontained ambiguities and inconsistencies and relied moren opinion than on data. The writing committee delineates

able 3. Endocarditis Prophylaxis for Dental Procedures*

Reasonable Not Recommended

ndocarditis prophylaxis isreasonable for patientswith the highest risk ofadverse outcomes whoundergo dentalprocedures that involvemanipulation of eithergingival tissue or theperiapical region ofteeth or perforation ofthe oral mucosa.

Endocarditis prophylaxis is notrecommended for:• Routine anesthetic injections through

noninfected tissue• Dental radiographs• Placement or removal of

prosthodontic or orthodonticappliances

• Adjustment of orthodontic appliances• Placement of orthodontic brackets• Shedding of deciduous teeth• Bleeding from trauma to the lips or

oral mucosa

This table corresponds to Table 6 in the 2008 Focused Update Incorporated Into the ACC/AHA

006 Guidelines for the Management of Valvular Heart Disease (2).Adapted with permission (6).
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682 Nishimura et al. JACC Vol. 52, No. 8, 2008VHD Focused Update August 19, 2008:676–85

he reasons with which evolutionary refinement in thepproach to infective endocarditis prophylaxis can be justi-ed. In determining which patients receive prophylaxis,here is a clear focus on the risk of adverse outcomes afternfective endocarditis rather than the lifetime risk of acqui-ition of infective endocarditis. The current recommenda-ions result in greater clarity for patients, health careroviders, and consulting professionals.Other international societies have published recommen-

ations and guidelines for the prevention of infective endo-arditis. New recommendations from the British Society forntimicrobial Chemotherapy are similar to the currentHA recommendations for prophylaxis before dental pro-

edures. The British Society for Antimicrobial Chemother-py did differ in continuing to recommend prophylaxis forigh-risk patients before GI or GU procedures associatedith bacteremia or endocarditis (9).Therefore, Class IIa indications for prophylaxis against

nfective endocarditis are reasonable for VHD patients atighest risk for adverse outcomes from infective endocardi-is before dental procedures that involve manipulation ofither gingival tissue. This high-risk group includes: 1)atients with a prosthetic heart valve or prosthetic materialsed for valve repair, 2) patients with a past history ofnfective endocarditis, and 3) patients with cardiac valvu-opathy after cardiac transplantation, as well as 4) specificatients with CHD (Table 2). Patients with innocenturmurs and those patients who have abnormal echocar-

iographic findings without an audible murmur shouldefinitely not be given prophylaxis for infective endocarditis.nfective endocarditis prophylaxis is not necessary for non-ental procedures that do not penetrate the mucosa, such asransesophageal echocardiography, diagnostic bronchos-opy, esophagogastroscopy, or colonoscopy, in the absence

able 4. Regimens for a Dental Procedure*

Situation

ral A

nable to take oral medication A

O

C

llergic to penicillins or ampicillin—oral C

O

C

O

A

llergic to penicillins or ampicillin and unable to take oral medication C

O

C

This table corresponds to Table 7 in the 2008 Focused Update Incorporated Into the ACCecond-generation oral cephalosporin in equivalent adult or pediatric dosage. ‡Cephalosporins sr ampicillin.IM indicates intramuscular; and IV, intravenous.

f active infection. a

The committee recognizes that decades of previousecommendations for patients with most forms of VHDnd other conditions have been abruptly changed by theew AHA guidelines (4). Because this may cause con-ternation among patients, clinicians should be availableo discuss the rationale for these new changes with theiratients, including the lack of scientific evidence toemonstrate a proven benefit for infective endocarditisrophylaxis. In select circumstances, the committee alsonderstands that some clinicians and some patients maytill feel more comfortable continuing with prophylaxisor infective endocarditis, particularly for those withicuspid aortic valve or coarctation of the aorta, severeitral valve prolapse, or hypertrophic obstructive cardio-yopathy. In those settings, the clinician should deter-ine that the risks associated with antibiotics are low

efore continuing a prophylaxis regimen. Over time, andith continuing education, the committee anticipates

ncreasing acceptance of the new guidelines among bothrovider and patient communities.A multicenter randomized, controlled trial has never been

erformed to evaluate the efficacy of infective endocarditisrophylaxis in patients who undergo dental, GI, or GUrocedures. On the basis of these new recommendations,ewer patients will receive infective endocarditis prophylaxis.t is hoped that the revised recommendations will stimulateroperly designed prospective studies on the prevention ofnfective endocarditis.

Tables 5 and 8 of the 2006 Valvular Heart Diseaseuideline (3) are now obsolete. Please disregard these tables.

.1.4.4. AORTIC STENOSIS: MEDICAL THERAPY

ntibiotic prophylaxis is no longer indicated in patients with

Regimen: Single Dose 30 to 60 minBefore Procedure

Agent Adults Children

cillin 2 g 50 mg/kg

illin 2 g IM or IV 50 mg/kg IM or IV

lin or ceftriaxone 1 g IM or IV 50 mg/kg IM or IV

lexin†‡ 2 g 50 mg/kg

mycin 600 mg 20 mg/kg

mycin or clarithromycin 500 mg 15 mg/kg

lin or ceftriaxone‡ 1 g IM or IV 50 mg/kg IM or IV

mycin 600 mg IM or IV 20 mg/kg IM or IV

006 Guidelines for the Management of Valvular Heart Disease (2). †Or use other first- orot be used in an individual with a history of anaphylaxis, angioedema, or urticaria with penicillins

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683JACC Vol. 52, No. 8, 2008 Nishimura et al.August 19, 2008:676–85 VHD Focused Update

.4.3.1. MITRAL STENOSIS: MEDICAL THERAPY

ntibiotic prophylaxis is no longer indicated in patients withitral stenosis for prevention of infective endocarditis.

.5.2. Evaluation and Management of the Asymptom-tic Patient With Mitral Valve Prolapse

ntibiotic prophylaxis is no longer indicated in all patients withitral valve prolapse for prevention of infective endocarditis.

.5.3. Evaluation and Management of the Symptomaticatient With Mitral Valve Prolapse

ntibiotic prophylaxis is no longer indicated in all patients withitral valve prolapse for prevention of infective endocarditis.

. Management of Congenital Valvular Heartisease in Adolescents and Young Adults

ntibiotic prophylaxis is no longer indicated in the adolescentnd young adult with native heart valve disease for prevention

f infective endocarditis. K

.6.3. Indications for Balloon Valvotomy inulmonic Stenosis

ntibiotic prophylaxis is no longer indicated in the adolescentnd young adult with native heart valve disease for preventionf infective endocarditis.

taff

merican College of Cardiology Foundationohn C. Lewin, MD, Chief Executive Officerharlene May, Senior Director, Science and Clinical Policyisa Bradfield, Associate Director, ACC/AHA Guidelinesark D. Stewart, MPH, Associate Director, Evidence-

ased Medicineennedy Elliott, Specialist, ACC/AHA Guidelinesrin A. Barrett, Senior Specialist, Science and Clinical Policy

merican Heart Association. Cass Wheeler, Chief Executive Officerayle R. Whitman, RN, PhD, FAAN, FAHA, Viceresident, Office of Science Operations

athryn A. Taubert, PhD, FAHA, Senior Science Advisor

PPENDIX 1. AUTHOR RELATIONSHIPS WITH INDUSTRY—ACC/AHA 2008 GUIDELINE UPDATE ON VALVULAREART DISEASE: FOCUSED UPDATE ON INFECTIVE ENDOCARDITIS WRITING COMMITTEE

Committee Member Consultant

Speakers’Bureau/Honoraria

Ownership/Partnership/

Principal Research

Institutional,Organizational, or

Other Financial Benefit Expert Witness

r. Rick A. Nishimura None None None None None None

r. Blase A. Carabello None None None None None None

r. David P. Faxon ● Boston Scientific● Bristol-Myers Squibb● GlaxoSmithKline● Johnson & Johnson

None None None None None

r. Michael D. Freed None None None None None None

r. Bruce W. Lytle None None None None None None

r. Patrick T. O’Gara None None None None None None

r. Robert A. O’Rourke None None None None None None

r. Pravin M. Shah ● Edwards LifeSciences None None None None None

his table represents the relationships of committee members with industry that were reported orally at the initial writing committee meeting and updated in conjunction with all meetings and conferencealls of the writing committee during the document development process. It does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significantnterest in a business if the interest represents ownership of 5% or more of the voting stock or share of the business entity, or ownership of $10 000 or more of the fair market value of the businessntity; or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. A relationship is considered to be modest if it is less than significantnder the preceding definition. Relationships in this table are modest unless otherwise noted.

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AV

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684 Nishimura et al. JACC Vol. 52, No. 8, 2008VHD Focused Update August 19, 2008:676–85

PPENDIX 2. PEER REVIEWER RELATIONSHIPS WITH INDUSTRY—ACC/AHA 2008 GUIDELINE UPDATE ONALVULAR HEART DISEASE: FOCUSED UPDATE ON INFECTIVE ENDOCARDITIS

Peer Reviewer* Representation Consultant

Speakers’Bureau/Honoraria

Ownership/Partnership/

Principal Research

Institutional,Organizational, orOther Financial

BenefitExpert

Witness

r. Ann F. Bolger ● Official AHA Reviewer None None None None None None

r. Paul L. Douglass ● Official Reviewer—ACCF Board ofTrustees

● Aventis● Merck● Novartis

● BayerHealthcare

● Bristol-MyersSquibb

● Pfizer

None None None None

r. Timothy J. Gardner ● Official AHA Reviewer None None None None None None

r. Chittur A. Sivaram ● Official Reviewer—ACCF Board ofGovernors

None None None None None None

r. David Aguilar ● Content Reviewer—AHA Heart Failure &TransplantCommittee

None None None None None None

r. Larry M. Baddour ● Content Reviewer—AHA RheumaticFever, Endocarditis, &Kawasaki DiseaseCommittee

● AmericanCollege ofPhysicians

● Enturia● UpToDate

None None None None None

r. Louis I. Bezold ● Content Reviewer—ACC Congenital HeartDisease & PediatricCommittee

None None None None None None

r. Robert O. Bonow ● Content Reviewer—2006 WritingCommittee Chair

None None None None None None

r. A. Michael Borkon ● Content Reviewer—ACC CardiovascularSurgery Committee

None None None None None None

r. Jeffrey A. Feinstein ● Content Reviewer—ACC Congenital HeartDisease & PediatricCommittee

None None None None None None

r. Gary S. Francis ● Content Reviewer—AHA Heart Failure &TransplantCommittee

● BoehringerIngelheim

● Johnson &Johnson

● NitroMed● Novartis● Otsuka

None None ● NationalInstitutes ofHealth†

● Pfizer†

None None

r. Wayne L. Miller ● Content Reviewer—AHA Heart Failure &TransplantCommittee

None None None None None None

r. Judith E. Mitchell ● Content Reviewer—AHA Heart Failure &TransplantCommittee

● Astellas● GlaxoSmithKline● NitroMed

None None None None None

r. John B. O’Connell ● Content Reviewer—AHA Heart Failure &TransplantCommittee

None None None None None None

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685JACC Vol. 52, No. 8, 2008 Nishimura et al.August 19, 2008:676–85 VHD Focused Update

Peer Reviewer* Representation Consultant

Speakers’Bureau/Honoraria

Ownership/Partnership/

Principal Research

Institutional,Organizational, orOther Financial

BenefitExpert

Witness

r. Geoffrey L. Rosenthal ● Content Reviewer—ACC Congenital HeartDisease & PediatricCommittee

None None None None None None

r. Anne Rowley ● Content Reviewer—AHA RheumaticFever, Endocarditis, &Kawasaki DiseaseCommittee

None None None None None None

r. Hartzell V. Schaff ● Content Reviewer—ACC CardiovascularSurgery Committee

None None None ● AtriCure● Bolton Medical● Jarvik Heart● Medtronic● Sorin Group/Carbomedics

● St. Jude● Thoratec● W.L. Gore andAssociates

● Sorin Group†● St. Jude†

None

r. Kathryn A. Taubert ● Content Reviewer—AHA RheumaticFever, Endocarditis, &Kawasaki DiseaseCommittee

None None None None None None

his table represents the relationships with industry that were disclosed at the time of peer review. It does not necessarily reflect relationships with industry at the time of publication. A person is deemedo have a significant interest in a business if the interest represents ownership of 5% or more of the voting stock or share of the business entity, or ownership of $10 000 or more of the fair marketalue of the business entity; or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. A relationship is considered to be modest if it

s less than significant under the preceding definition. Relationships in this table are modest unless otherwise noted.

than $1

5

6

7

8

9

*Names are listed in alphabetical order within each category of review. †Significant (greater

EFERENCES

. ACC/AHA Task Force on Practice Guidelines. Manual for ACC/AHA Guideline Writing Committees: Methodologies and Policiesfrom the ACC/AHA Task Force on Practice Guidelines. Available at:http://www.acc.org/qualityandscience/clinical/manual/pdfs/methodology.pdf and http://circ.ahajournals.org/manual/. Accessed June 2007.

. Bonow RO, Carabello BA, Chatterjee K, et al. 2008 focused updateincorporated into the ACC/AHA 2006 guidelines for the managementof patients with valvular heart disease: a report of the American Collegeof Cardiology/American Heart Association Task Force on PracticeGuidelines (Writing Committee to Develop Guidelines for the Man-agement of Patients With Valvular Heart Disease). J Am Coll Cardiol.2008;52:e1–142.

. Bonow RO, Carabello BA, Chatterjee K, et al. ACC/AHA 2006guidelines for the management of patients with valvular heart disease: areport of the American College of Cardiology/American Heart Asso-ciation Task Force on Practice Guidelines (Writing Committee toRevise the 1998 guidelines for the management of patients with valvularheart disease) developed in collaboration with the Society of Cardio-vascular Anesthesiologists endorsed by the Society for CardiovascularAngiography and Interventions and the Society of Thoracic Surgeons.J Am Coll Cardiol. 2006;48:e1–148.

. Wilson W, Taubert KA, Gewitz M, et al. Prevention of infectiveendocarditis: guidelines from the American Heart Association: a guide-line from the American Heart Association Rheumatic Fever, Endocar-

ditis, and Kawasaki Disease Committee, Council on Cardiovascular

Kh

0 000) relationship.

Disease in the Young, and the Council on Clinical Cardiology, Councilon Cardiovascular Surgery and Anesthesia, and the Quality of Care andOutcomes Research Interdisciplinary Working Group. Circulation.2007;116:1736–54.

. Baddour LM, Bettmann MA, Bolger AF, et al. Nonvalvular cardiovas-cular device-related infections. Circulation. 2003;108:2015–31.

. Dajani AS, Taubert KA, Wilson W, et al. Prevention of bacterialendocarditis: recommendations by the American Heart Association.Circulation. 1997;96:358–66.

. Baddour LM, Wilson WR, Bayer AS, et al. Infective endocarditis:diagnosis, antimicrobial therapy, and management of complications: astatement for healthcare professionals from the Committee on Rheu-matic Fever, Endocarditis, and Kawasaki Disease, Council on Cardio-vascular Disease in the Young, and the Councils on Clinical Cardiology,Stroke, and Cardiovascular Surgery and Anesthesia, American HeartAssociation: endorsed by the Infectious Diseases Society of America.Circulation. 2005;111:e394–434.

. Horstkotte D, Follath F, Gutschik E, et al. Guidelines on prevention,diagnosis and treatment of infective endocarditis executive summary;the task force on infective endocarditis of the European Society ofCardiology. Eur Heart J. 2004;25:267–76.

. Gould FK, Elliott TS, Foweraker J, et al. Guidelines for the preventionof endocarditis: report of the Working Party of the British Society forAntimicrobial Chemotherapy. J Antimicrob Chemother. 2006;57:1035–42.

ey Words: ACC/AHA practice guideline y focused update y valvulareart disease y infective endocarditis y prophylaxis.