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ISSN: 1524-4539 Copyright © 2008 American Heart Association. All rights reserved. Print ISSN: 0009-7322. Online 72514 Circulation is published by the American Heart Association. 7272 Greenville Avenue, Dallas, TX DOI: 10.1161/CIRCUALTIONAHA.108.189741 2008;117;2820-2840; originally published online May 15, 2008; Circulation Sweeney O.Page, Mark H. Schoenfeld, Michael J. Silka, Lynne Warner Stevenson and Michael Stephen C. Hammill, David L. Hayes, Mark A. Hlatky, L. Kristin Newby, Richard L. Roger A. Freedman, Leonard S. Gettes, A. Marc Gillinov, Gabriel Gregoratos, Andrew E. Epstein, John P. DiMarco, Kenneth A. Ellenbogen, N.A. Mark Estes, III, of Thoracic Surgeons Collaboration With the American Association for Thoracic Surgery and Society Developed inImplantation of Cardiac Pacemakers and Antiarrhythmia Devices): (Writing Committee to Revise the ACC/AHA/NASPE 2002 Guideline Update for Cardiology/American Heart Association Task Force on Practice Guidelines Abnormalities: Executive Summary: A Report of the American College of ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm http://circ.ahajournals.org/cgi/content/full/117/21/2820 located on the World Wide Web at: The online version of this article, along with updated information and services, is http://www.lww.com/reprints Reprints: Information about reprints can be found online at journalpermissions@lww.com 410-528-8550. E-mail: Fax:Kluwer Health, 351 West Camden Street, Baltimore, MD 21202-2436. Phone: 410-528-4050. Permissions: Permissions & Rights Desk, Lippincott Williams & Wilkins, a division of Wolters http://circ.ahajournals.org/subscriptions/ Subscriptions: Information about subscribing to Circulation is online at by on June 7, 2009 circ.ahajournals.orgDownloaded from A R K * † ‡ § T Coo T DiM Sch sum AC T C (my pre kell P Am “Pe ( © C Practice Guideline: Executive SummaryCC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: Executive Summary A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to evise the ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices) Developed in Collaboration With the American Association for Thoracic Surgery and Society of Thoracic Surgeons WRITING COMMITTEE MEMBERS Andrew E. Epstein, MD, FACC, FAHA, FHRS, Chair*; John P. DiMarco, MD, PhD, FACC, FAHA, FHRS*; enneth A. Ellenbogen, MD, FACC, FAHA, FHRS*; N. A. Mark Estes III, MD, FACC, FAHA, FHRS; Roger A. Freedman, MD, FACC, FHRS*; Leonard S. Gettes, MD, FACC, FAHA; A. Marc Gillinov, MD, FACC, FAHA*†; Gabriel Gregoratos, MD, FACC, FAHA; Stephen C. Hammill, MD, FACC, FHRS; David L. Hayes, MD, FACC, FAHA, FHRS*; Mark A. Hlatky, MD, FACC, FAHA; L. Kristin Newby, MD, FACC, FAHA; Richard L. Page, MD, FACC, FAHA, FHRS; Mark H. Schoenfeld, MD, FACC, FAHA, FHRS; Michael J. Silka, MD, FACC; Lynne Warner Stevenson, MD, FACC, FAHA‡; Michael O. Sweeney, MD, FACC* ACC/AHA TASK FORCE MEMBERS Sidney C. Smith, Jr, MD, FACC, FAHA, Chair; Alice K. Jacobs, MD, FACC, FAHA, Vice-Chair; Cynthia D. Adams, RN, PhD, FAHA§; Jeffrey L. Anderson, MD, FACC, FAHA§; Christopher E. Buller, MD, FACC; Mark A. Creager, MD, FACC, FAHA; Steven M. Ettinger, MD, FACC; David P. Faxon, MD, FACC, FAHA§; Jonathan L. Halperin, MD, FACC, FAHA§; Loren F. Hiratzka, MD, FACC, FAHA§; Sharon A. Hunt, MD, FACC, FAHA§; Harlan M. Krumholz, MD, FACC, FAHA; Frederick G. Kushner, MD, FACC, FAHA; Bruce W. Lytle, MD, FACC, FAHA; Rick A. Nishimura, MD, FACC, FAHA; Joseph P. Ornato, MD, FACC, FAHA§; Richard L. Page, MD, FACC, FAHA; Barbara Riegel, DNSc, RN, FAHA§; Lynn G. Tarkington, RN; Clyde W. Yancy, MD, FACC, FAHA Recused from voting on guideline recommendations (see Section 1.2, “Document Review and Approval,” for more detail). American Association for Thoracic Surgery and Society of Thoracic Surgeons official representative. Heart Failure Society of America official representative. Former Task Force member during this writing effort. his document was approved by the American College of Cardiology Foundation Board of Trustees, the American Heart Association Science Advisory and rdinating Committee, and the Heart Rhythm Society Board of Trustees in February 2008. he American College of Cardiology Foundation, American Heart Association, and Heart Rhythm Society request that this document be cited as follows: Epstein AE, arco JP, Ellenbogen KA, Estes NAM III, Freedman RA, Gettes LS, Gillinov AM, Gregoratos G, Hammill SC, Hayes DL, Hlatky MA, Newby LK, Page RL, oenfeld MH, Silka MJ, Stevenson LW, Sweeney MO. ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: executive mary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the C/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices). Circulation. 2008;117:2820–2840. his article has been copublished in the May 27, 2008, issue of the Journal of the American College of Cardiology and the June 2008 issue of Heart Rhythm. opies: This document is available on the World Wide Web sites of the American College of Cardiology (www.acc.org), the American Heart Association .americanheart.org), and the Heart Rhythm Society (www.hrsonline.org). A copy of the statement is also available at http://www.americanheart.org/ senter.jhtml?identifier�3003999 by selecting either the “topic list” link or the “chronological list” link. To purchase additional reprints, call 843-216-2533 or e-mail e.ramsay@wolterskluwer.com. ermissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the erican Heart Association. Instructions for obtaining permission are located at http://www.americanheart.org/presenter.jhtml?identifier�4431. A link to the Practice Guideline: Executive Summary rmission Request Form” appears on the right side of the page. Circulation. 2008;117:2820-2840.) 2008 by the American College of Cardiology Foundation, the American Heart Association, Inc, and the Heart Rhythm Society. irculation is available at http://circ.ahajournals.org DOI: 10.1161/CIRCUALTIONAHA.108.189741 2820 by on June 7, 2009 circ.ahajournals.orgDownloaded from Pre 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Re Ap Ap Ind Ap It rol an de oro ab an eff ab the an en car Ca wh gu du the act or sel da rep gro ch str pro wh an of fre ab ho wi tio ev co rel Sp pe dis pe co pre rel me or wr me the wr by me mi ind wi wi pro ge me Cl Epstein et al ACC/AHA/HRS Guidelines for Device-Based Therapy: Executive Summary 2821 TABLE OF CONTENTS amble . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2821 . Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2822 1.1. Organization of Committee . . . . . . . . . . . . . . . . . . . . . .2822 1.2. Document Review and Approval . . . . . . . . . . . . . . . .2822 1.3. Methodology and Evidence . . . . . . . . . . . . . . . . . . . . . .2822 . Recommendations for Permanent Pacing in Sinus Node Dysfunction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2824 . Recommendations for Acquired Atrioventricular Block in Adults . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2825 . Recommendations for Permanent Pacing in Chronic Bifascicular Block . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2827 . Recommendations for Permanent Pacing After the Acute Phase of Myocardial Infarction . . . . . . . . . . . . . . .2828 . Recommendations for Permanent Pacing in Hypersensitive Carotid Sinus Syndrome and Neurocar- diogenic Syncope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2828 . Recommendations for Pacing After Cardiac Transplantation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2828 . Recommendations for Permanent Pacemakers That Automatically Detect and Pace to Terminate Tachycardias . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2828 . Recommendations for Pacing to Prevent Tachycardia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2829 . Recommendation for Pacing to Prevent Atrial Fibrillation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2829 . Recommendations for Cardiac Resynchronization Therapy in Patients With Severe Systolic Heart Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2829 . Recommendations for Pacing in Patients With Hypertrophic Cardiomyopathy . . . . . . . . . . . . . . . . . . . . . . .2829 . Recommendations for Permanent Pacing in Children, Adolescents, and Patients With Congenital Heart Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2830 . Recommendations for Implantable Cardioverter- Defibrillators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2830 . Recommendations for Implantable Cardioverter- Defibrillators in Pediatric Patients and Patients With Congenital Heart Disease. . . . . . . . . . . . . . . . . . . . . . . . . . . . .2832 ferences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2832 pendix 1. Author Relationships With Industry . . . . . . .2836 pendix 2. Peer Reviewer Relationships With ustry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2838 pendix 3. Abbreviations List . . . . . . . . . . . . . . . . . . . . . . . . . .2840 Preamble is important that the medical profession play a significant e in critically evaluating the use of diagnostic procedures d therapies as they are introduced and tested in the tection, management, or prevention of disease states. Rig- us and expert analysis of the available data documenting solute and relative benefits and risks of those procedures d therapies can produce helpful guidelines that improve the ectiveness of care, optimize patient outcomes, and favor- av Th circ.ahajournals.Downloaded from ly affect the overall cost of care by focusing resources on most effective strategies. The American College of Cardiology Foundation (ACCF) d the American Heart Association (AHA) have jointly gaged in the production of such guidelines in the area of diovascular disease since 1980. The American College of rdiology (ACC)/AHA Task Force on Practice Guidelines, ose charge is to develop, update, or revise practice idelines for important cardiovascular diseases and proce- res, directs this effort. Writing committees are charged with task of performing an assessment of the evidence and ing as an independent group of authors to develop, update, revise written recommendations for clinical practice. Experts in the subject under consideration have been ected from both organizations to examine subject-specific ta and write guidelines. The process includes additional resentatives from other medical practitioner and specialty ups when appropriate. Writing committees are specifically arged to perform a formal literature review, weigh the ength of evidence for or against a particular treatment or cedure, and include estimates of expected health outcomes ere data exist. Patient-specific modifiers and comorbidities d issues of patient preference that may influence the choice particular tests or therapies are considered, as well as quency of follow-up and cost-effectiveness. When avail- le, information from studies on cost will be considered; wever, review of data on efficacy and clinical outcomes ll constitute the primary basis for preparing recommenda- ns in these guidelines. The ACC/AHA Task Force on Practice Guidelines makes ery effort to avoid any actual, potential, or perceived nflicts of interest that may arise as a result of an industry ationship or personal interest of the writing committee. ecifically, all members of the writing committee, as well as er reviewers of the document, were asked to provide closure statements of all such relationships that may be rceived as real or potential conflicts of interest. Writing mmittee members are also strongly encouraged to declare a vious relationship with industry that may be perceived as evant to guideline development. If a writing committee mber develops a new relationship with industry during his her tenure, he or she is required to notify guideline staff in iting. The continued participation of the writing committee mber will be reviewed. These statements are reviewed by parent task force, reported orally to all members of the iting committee at each meeting, and updated and reviewed the writing committee as changes occur. Please refer to the thodology manual for ACC/AHA guideline writing com- ttees for further description of the relationships with ustry policy.1 See Appendix 1 for author relationships th industry and Appendix 2 for peer reviewer relationships th industry that are pertinent to this guideline. These practice guidelines are intended to assist health care viders in clinical decision making by describing a range of nerally acceptable approaches for the diagnosis, manage- nt, and prevention of specific diseases or conditions. inical decision making should consider the quality and ailability of expertise in the area where care is provided. ese guidelines attempt to define practices that meet the by on June 7, 2009 org ne lin aft ev reg Pre rec Be ad he pa me dec pat a p the pat gu AH ere wi rec the 20 Rh iss AC an sit av 1.1 Th Im De 19 ne rep his ma be tha ad ev tac lin rhy ex sen ici Th As Am 1.2 Th na ad ha ad the inc ha AH (no ind wh Al wr req rel da wr 1.3 Th po co co Ad the an are ing ran ran ind Le nu nu no Ev ex the ge Stu spe for av ex we Le pn tria C en av 2822 Circulation May 27, 2008 eds of most patients in most circumstances. These guide- e recommendations reflect a consensus of expert opinion er a thorough review of the available current scientific idence and are intended to improve patient care. Patient adherence to prescribed and agreed upon medical imens and lifestyles is an important aspect of treatment. scribed courses of treatment in accordance with these ommendations will only be effective if they are followed. cause lack of patient understanding and adherence may versely affect treatment outcomes, physicians and other alth care providers should make every effort to engage the tient in active participation with prescribed medical regi- ns and lifestyles. If these guidelines are used as the basis for regulatory or payer isions, the ultimate goal is quality of care and serving the ient’s best interests. The ultimate judgment regarding care of articular patient must be made by the health care provider and patient in light of all of the circumstances presented by that ient. There are circumstances in which deviations from these idelines are appropriate. The guidelines will be reviewed annually by the ACC/ A Task Force on Practice Guidelines and will be consid- d current unless they are updated, revised, or sunsetted and thdrawn from distribution. The executive summary and ommendations are published in the May 27, 2008, issue of Journal of the American College of Cardiology, May 27, 08, issue of Circulation, and the June 2008 issue of Heart ythm. The full-text guidelines are e-published in the same ue of the journals noted above, as well as posted on the C (www.acc.org), AHA (http://my.americanheart.org), d Heart Rhythm Society (HRS) (www.hrsonline.org) Web es. Copies of the full-text and the executive summary are ailable from each organization. Sidney C. Smith, Jr, MD, FACC, FAHA Chair, ACC/AHA Task Force on Practice Guidelines 1. Introduction . Organization of Committee is revision of the “ACC/AHA/NASPE Guidelines for plantation of Cardiac Pacemakers and Antiarrhythmia vices” updates the previous versions published in 1984, 91, 1998, and 2002. Revision of the statement was deemed cessary for multiple reasons: 1) Major studies have been orted that have advanced our knowledge of the natural tory of bradyarrhythmias and tachyarrhythmias, which y be treated optimally with device therapy; 2) there have en tremendous changes in the management of heart failure t involve both drug and device therapy; and 3) major vances in the technology of devices to treat, delay, and en prevent morbidity and mortality from bradyarrhythmias, hyarrhythmias, and heart failure have occurred. The committee to revise the “ACC/AHA/NASPE Guide- es for Implantation of Cardiac Pacemakers and Antiar- thmia Devices” was composed of physicians who are perts in the areas of device therapy and follow-up and ior clinicians skilled in cardiovascular care, internal med- ne, cardiovascular surgery, ethics, and socioeconomics. e committee included representatives of the American co spa circ.ahajournals.Downloaded from sociation for Thoracic Surgery, Heart Failure Society of erica, and Society of Thoracic Surgeons. . Document Review and Approval e document was reviewed by 2 official reviewers nomi- ted by each of the ACC, AHA, and HRS and by 11 ditional peer reviewers. Of the total 17 peer reviewers, 10 d no significant relevant relationships with industry. In dition, this document has been reviewed and approved by governing bodies of the ACC, AHA, and HRS, which lude 19 ACC Board of Trustees members (none of whom d any significant relevant relationships with industry), 15 A Science Advisory Coordinating Committee members ne of whom had any significant relevant relationships with ustry), and 14 HRS Board of Trustees members (6 of om had no significant relevant relationships with industry). l guideline recommendations underwent a formal, blinded iting committee vote. Writing committee members were uired to recuse themselves if they had a significant evant relationship with industry. The guideline recommen- tions were unanimously approved by all members of the iting committee who were eligible to vote. . Methodology and Evidence e recommendations listed in this document are, whenever ssible, evidence based. An extensive literature survey was nducted and limited to studies, reviews, and other evidence nducted in human subjects and published in English. ditionally, the committee reviewed documents related to subject matter previously published by the ACC, AHA, d HRS. References selected and published in this document representative and not all-inclusive. The committee reviewed and ranked evidence support- current recommendations, with the weight of evidence ked as Level A if the data were derived from multiple domized clinical trials that involved a large number of ividuals. The committee ranked available evidence as vel B when data were derived either from a limited mber of trials that involved a comparatively small mber of patients or from well-designed data analyses of nrandomized studies or observational data registries. idence was ranked as Level C when the consensus of perts was the primary source of the recommendation. In narrative portions of these guidelines, evidence is nerally presented in chronological order of development. dies are identified as observational, randomized, pro- ctive, or retrospective. The committee emphasizes that certain conditions for which no other therapy is ailable, the indications for device therapy are based on pert consensus and years of clinical experience and are thus ll supported, even though the evidence was ranked as vel C. An analog