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2012 ACCF/AHA/HRS Focused Update Incorporated Into the ACCF/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities

2012; Lippincott Williams & Wilkins; Volume: 127; Issue: 3 Linguagem: Inglês

10.1161/cir.0b013e318276ce9b

1524-4539

Andrew E. Epstein, John Dimarco, Kenneth A. Ellenbogen, N.A. Mark Estes, Roger A. Freedman, Leonard S. Gettes, A. Marc Gillinov, Gabriel Gregoratos, Stephen C. Hammill, David L. Hayes, Mark A. Hlatky, L. Kristin Newby, Richard L. Page, Mark H. Schoenfeld, Michael J. Silka, Lynne W. Stevenson, Michael O. Sweeney, Cynthia M. Tracy, Andrew E. Epstein, Dawood Darbar, John Dimarco, Sandra B. Dunbar, N.A. Mark Estes, T. Bruce Ferguson, Stephen C. Hammill, Pamela Karasik, Mark S. Link, Joseph E. Marine, Mark H. Schoenfeld, Amit J. Shanker, Michael J. Silka, Lynne W. Stevenson, William G. Stevenson, Paul D. Varosy, Jeffrey L. Anderson, Alice K. Jacobs, Jonathan L. Halperin, Nancy M. Albert, Mark A. Creager, David L. DeMets, Steven M. Ettinger, Robert A. Guyton, Judith S. Hochman, Frederick G. Kushner, E. Magnus Ohman, William G. Stevenson, Clyde W. Yancy,

Cardiac Arrhythmias and Treatments

HomeCirculationVol. 127, No. 32012 ACCF/AHA/HRS Focused Update Incorporated Into the ACCF/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplemental MaterialFree AccessResearch ArticlePDF/EPUB2012 ACCF/AHA/HRS Focused Update Incorporated Into the ACCF/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm AbnormalitiesA Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society Andrew E. Epstein, MD, FACC, FAHA, FHRS, John P. DiMarco, MD, PhD, FACC, FHRS, Kenneth A. Ellenbogen, MD, FACC, FAHA, FHRS, N.A. Mark EstesIII, 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 and Michael O. Sweeney, MD, FACC Cynthia M. Tracy, MD, FACC, FAHA, Andrew E. Epstein, MD, FACC, FAHA, FHRS, Dawood Darbar, MD, FACC, FHRS, John P. DiMarco, MD, PhD, FACC, FHRS, Sandra B. Dunbar, RN, DSN, FAAN, FAHA, N.A. Mark EstesIII, MD, FACC, FAHA, FHRS, T. Bruce FergusonJr, MD, FACC, FAHA, Stephen C. Hammill, MD, FACC, FHRS, Pamela E. Karasik, MD, FACC, FHRS, Mark S. Link, MD, FACC, FHRS, Joseph E. Marine, MD, FACC, FHRS, Mark H. Schoenfeld, MD, FACC, FAHA, FHRS, Amit J. Shanker, MD, FACC, FHRS, Michael J. Silka, MD, FACC, Lynne Warner Stevenson, MD, FACC, William G. Stevenson, MD, FACC, FAHA, FHRS and Paul D. Varosy, MD, FACC, FHRS Jeffrey L. Anderson, MD, FACC, FAHA, Alice K. Jacobs, MD, FACC, FAHA, Jonathan L. Halperin, MD, FACC, FAHA, Nancy M. Albert, PhD, CCNS, CCRN, Mark A. Creager, MD, FACC, FAHA, David DeMets, PhD, Steven M. Ettinger, MD, FACC, Robert A. Guyton, MD, FACC, Judith S. Hochman, MD, FACC, FAHA, Frederick G. Kushner, MD, FACC, FAHA, E. Magnus Ohman, MD, FACC, William Stevenson, MD, FACC, FAHA and Clyde W. Yancy, MD, FACC, FAHA Andrew E. EpsteinAndrew E. Epstein , John P. DiMarcoJohn P. DiMarco , Kenneth A. EllenbogenKenneth A. Ellenbogen , N.A. Mark EstesIIIN.A. Mark EstesIII , Roger A. FreedmanRoger A. Freedman , Leonard S. GettesLeonard S. Gettes , A. Marc GillinovA. Marc Gillinov , Gabriel GregoratosGabriel Gregoratos , Stephen C. HammillStephen C. Hammill , David L. HayesDavid L. Hayes , Mark A. HlatkyMark A. Hlatky , L. Kristin NewbyL. Kristin Newby , Richard L. PageRichard L. Page , Mark H. SchoenfeldMark H. Schoenfeld , Michael J. SilkaMichael J. Silka , Lynne Warner StevensonLynne Warner Stevenson and Michael O. SweeneyMichael O. Sweeney Cynthia M. TracyCynthia M. Tracy , Andrew E. EpsteinAndrew E. Epstein *, Appendix 4, †, ‡, §, ‖, ¶, #, ** , Dawood DarbarDawood Darbar *, Appendix 4, †, ‡, §, ‖, ¶, #, ** , John P. DiMarcoJohn P. DiMarco *, Appendix 4, †, ‡, §, ‖, ¶, #, ** , Sandra B. DunbarSandra B. Dunbar *, Appendix 4, †, ‡, §, ‖, ¶, #, ** , N.A. Mark EstesIIIN.A. Mark EstesIII *, Appendix 4, †, ‡, §, ‖, ¶, #, ** , T. Bruce FergusonJrT. Bruce FergusonJr *, Appendix 4, †, ‡, §, ‖, ¶, #, ** , Stephen C. HammillStephen C. Hammill *, Appendix 4, †, ‡, §, ‖, ¶, #, ** , Pamela E. KarasikPamela E. Karasik *, Appendix 4, †, ‡, §, ‖, ¶, #, ** , Mark S. LinkMark S. Link *, Appendix 4, †, ‡, §, ‖, ¶, #, ** , Joseph E. MarineJoseph E. Marine *, Appendix 4, †, ‡, §, ‖, ¶, #, ** , Mark H. SchoenfeldMark H. Schoenfeld *, Appendix 4, †, ‡, §, ‖, ¶, #, ** , Amit J. ShankerAmit J. Shanker *, Appendix 4, †, ‡, §, ‖, ¶, #, ** , Michael J. SilkaMichael J. Silka *, Appendix 4, †, ‡, §, ‖, ¶, #, ** , Lynne Warner StevensonLynne Warner Stevenson *, Appendix 4, †, ‡, §, ‖, ¶, #, ** , William G. StevensonWilliam G. Stevenson *, Appendix 4, †, ‡, §, ‖, ¶, #, ** and Paul D. VarosyPaul D. Varosy *, Appendix 4, †, ‡, §, ‖, ¶, #, ** Jeffrey L. AndersonJeffrey L. Anderson , Alice K. JacobsAlice K. Jacobs , Jonathan L. HalperinJonathan L. Halperin , Nancy M. AlbertNancy M. Albert , Mark A. CreagerMark A. Creager , David DeMetsDavid DeMets , Steven M. EttingerSteven M. Ettinger , Robert A. GuytonRobert A. Guyton , Judith S. HochmanJudith S. Hochman , Frederick G. KushnerFrederick G. Kushner , E. Magnus OhmanE. Magnus Ohman , William StevensonWilliam Stevenson and Clyde W. YancyClyde W. Yancy Originally published19 Dec 2012https://doi.org/10.1161/CIR.0b013e318276ce9bCirculation. 2013;127:e283–e352Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2012: Previous Version 1 Table of ContentsPreamble (UPDATED) e2851. Introduction (UPDATED) e2871.1. Organization of Committee e2871.2. Document Review and Approval e2881.3. Methodology and Evidence e2882. Indications for Pacing e2902.1. Pacing for Bradycardia Due to Sinus and Atrioventricular Node Dysfunction e2902.1.1. Sinus Node Dysfunction e2902.1.2. Acquired Atrioventricular Block in Adults e2912.1.3. Chronic Bifascicular Block e2932.1.4. Pacing for Atrioventricular Block Associated With Acute Myocardial Infarction e2942.1.5. Hypersensitive Carotid Sinus Syndrome and Neurocardiogenic Syncope e2952.2. Pacing for Specific Conditions e2962.2.1. Cardiac Transplantation e2972.2.2. Neuromuscular Diseases e2972.2.3. Sleep Apnea Syndrome e2972.2.4. Cardiac Sarcoidosis e2972.3. Prevention and Termination of Arrhythmias by Pacing e2982.3.1. Pacing to Prevent Atrial Arrhythmias e2982.3.2. Long-QT Syndrome e2982.3.3. Atrial Fibrillation (Dual-Site, Dual-Chamber, Alternative Pacing Sites) e2992.4. Pacing for Hemodynamic Indications e2992.4.1. Cardiac Resynchronization Therapy(UPDATED) e2992.4.2. Obstructive Hypertrophic Cardiomyopathy e3032.5. Pacing in Children, Adolescents, and Patients With Congenital Heart Disease e3032.6. Selection of Pacemaker Device e3052.6.1. Major Trials Comparing Atrial or Dual-Chamber Pacing With Ventricular Pacing e3062.6.2. Quality of Life and Functional StatusEnd Points e3062.6.3. Heart Failure End Points e3072.6.4. Atrial Fibrillation End Points e3072.6.5. Stroke or Thromboembolism End Points e3072.6.6. Mortality End Points e3072.6.7. Importance of Minimizing Unnecessary Ventricular Pacing e3092.6.8. Role of Biventricular Pacemakers e3092.7. Optimizing Pacemaker Technology and Cost e3102.8. Pacemaker Follow-Up e3102.8.1. Length of Electrocardiographic Samples for Storage e3112.8.2. Frequency of TranstelephonicMonitoring e3112.8.3. Remote Follow-Up and Monitoring(NEW SECTION) e3123. Indications for Implantable Cardioverter-Defibrillator Therapy e3123.1. Secondary Prevention of Sudden Cardiac Death e3133.1.1. Implantable Cardioverter-Defibrillator Therapy for Secondary Prevention of Cardiac Arrest and Sustained Ventricular Tachycardia e3133.1.2. Specific Disease States and Secondary Prevention of Cardiac Arrest or Sustained Ventricular Tachycardia e3143.1.3. Coronary Artery Disease e3143.1.4. Nonischemic Dilated Cardiomyopathy e3143.1.5. Hypertrophic Cardiomyopathy e3143.1.6. Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy e3153.1.7. Genetic Arrhythmia Syndromes e3153.1.8. Syncope With Inducible Sustained Ventricular Tachycardia e3153.2. Primary Prevention of Sudden Cardiac Death e3153.2.1. Coronary Artery Disease e3153.2.2. Nonischemic Dilated Cardiomyopathy e3163.2.3. Long-QT Syndrome e3173.2.4. Hypertrophic Cardiomyopathy e3173.2.5. Arrhythmogenic Right Ventricular Dysplasia/Cardiomyopathy e3183.2.6. Noncompaction of the Left Ventricle e3183.2.7. Primary Electrical Disease (Idiopathic Ventricular Fibrillation, Short-QT Syndrome, Brugada Syndrome, and Catecholaminergic Polymorphic Ventricular Tachycardia) e3183.2.8. Idiopathic Ventricular Tachycardias e3193.2.9. Advanced Heart Failure and Cardiac Transplantation e3193.3. Implantable Cardioverter-Defibrillators in Children, Adolescents, and Patients With Congenital Heart Disease e3213.3.1. Hypertrophic Cardiomyopathy e3233.4. Limitations and Other Considerations e3233.4.1. Impact on Quality of Life (Inappropriate Shocks) e3233.4.2. Surgical Needs e3233.4.3. Patient Longevity and Comorbidities e3243.4.4. Terminal Care e3253.5. Cost-Effectiveness of Implantable Cardioverter-Defibrillator Therapy e3263.6. Selection of ImplantableCardioverter-Defibrillator Generators e3263.7. Implantable Cardioverter-Defibrillator Follow-Up e3273.7.1. Elements of Implantable Cardioverter-Defibrillator Follow-Up e3283.7.2. Focus on Heart Failure After First Appropriate Implantable Cardioverter-Defibrillator Therapy e3284. Areas in Need of Further Research e329References (UPDATED) e329Appendix 1. 2008 Author Relationships With Industry and Other Entities (Relevant) e343Appendix 2. 2008 Reviewer Relationships With Industry and Other Entities (Relevant) e345Appendix 3. Abbreviations List (UPDATED) e347Appendix 4. 2012 Author Relationships With Industry and Other Entities (Relevant) (NEW) e348Appendix 5. 2012 Reviewer Relationships WithIndustry and Other Entities (NEW) e350Appendix 6. 2012 Indications for CRT Therapy–Algorithm (NEW) e352Preamble (UPDATED)It is important that the medical profession play a significant role in critically evaluating the use of diagnostic procedures and therapies as they are introduced and tested in the detection, management, or prevention of disease states. Rigorous and expert analysis of the available data documenting absolute and relative benefits and risks of those procedures and therapies can produce helpful guidelines that improve the effectiveness of care, optimize patient outcomes, and favorably affect the overall cost of care by focusing resources on the most effective strategies.The American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) have jointly engaged in the production of such guidelines in the area of cardiovascular disease since 1980. The ACCF/AHA Task Force on Practice Guidelines (Task Force), whose charge is to develop, update, or revise practice guidelines for important cardiovascular diseases and procedures, directs this effort. Writing committees are charged with the task of performing an assessment of the evidence and acting as an independent group of authors to develop, update, or revise written recommendations for clinical practice.Experts in the subject under consideration have been selected from both organizations to examine subject-specific data and write guidelines. The process includes additional representatives from other medical practitioner and specialty groups when appropriate. Writing committees are specifically charged to perform a literature review, weigh the strength of evidence for or against a particular treatment or procedure, and include estimates of expected health outcomes where data exist. Patient-specific modifiers, comorbidities, and issues of patient preference that may influence the choice of particular tests or therapies are considered, as well as frequency of follow-up and cost-effectiveness. When available, information from studies on cost will be considered; however, review of data on efficacy and clinical outcomes will constitute the primary basis for preparing recommendations in these guidelines.The guidelines will be reviewed annually by the Task Force. Each guideline is considered current unless it is updated, revised, or a published addendum declares it out of date and no longer official ACCF/AHA policy. Keeping pace with the stream of new data and evolving evidence on which guideline recommendations are based is an ongoing challenge to timely development of clinical practice guidelines. In an effort to respond promptly to new evidence, the Task Force has created a "focused update" process to revise the existing guideline recommendations that are affected by evolving data or opinion. New evidence is reviewed in an ongoing fashion to more efficiently respond to important science and treatment trends that could have a major impact on patient outcomes and quality of care.The 2012 focused update was prompted following a thorough review of late-breaking clinical trials presented at national and international meetings, in addition to other new published data deemed to have an impact on patient care (Section 1.3, "Methodology and Evidence"). Through a broad-based vetting process, the studies included are identified as being important to the relevant patient population. The focused update is not intended to be based on a complete literature review from the date of the previous guideline publication but rather to include pivotal new evidence that may affect changes to current recommendations. See the 2012 focused update for the complete preamble and evidence review period.1In analyzing the data and developing recommendations and supporting text, the focused update writing group uses evidence-based methodologies developed by the Task Force.1a The Class of Recommendation (COR) is an estimate of the size of the treatment effect, with consideration given to risks versus benefits, as well as evidence and/or agreement that a given treatment or procedure is or is not useful/effective and in some situations may cause harm. The Level of Evidence (LOE) is an estimate of the certainty or precision of the treatment effect. The writing group reviews and ranks evidence supporting each recommendation, with the weight of evidence ranked as LOE A, B, or C, according to specific definitions that are included in Table 1. Studies are identified as observational, retrospective, prospective, or randomized, as appropriate. For certain conditions for which inadequate data are available, recommendations are based on expert consensus and clinical experience and are ranked as LOE C. When recommendations at LOE C are supported by historical clinical data, appropriate references (including clinical reviews) are cited if available. For issues for which sparse data are available, a survey of current practice among the clinicians members of the writing group is the basis for LOE C recommendations, and no references are cited. The schema for COR and LOE is summarized in Table 1, which also provides suggested phrases for writing recommendations within each COR. A new addition to this methodology for the 2012 focused update is separation of the Class III recommendations to delineate whether the recommendation is determined to be of "no benefit" or is associated with "harm" to the patient. (This version of the COR/LOE table was used for development of the 2012 Focused Update and is included in the current document.1) In addition, in view of the increasing number of comparative effectiveness studies, comparator verbs and suggested phrases for writing recommendations for the comparative effectiveness of one treatment or strategy versus another have been added for COR I and IIa, LOE A or B only.Table 1. Applying Classification of Recommendations and Level of EvidenceTable 1. Applying Classification of Recommendations and Level of EvidenceTable 2. Choice of Pacemaker Generator in Selected Indications for PacingPacemaker GeneratorSinus Node DysfunctionAtrioventricular BlockNeurally Mediated Syncope or Carotid Sinus HypersensitivitySingle-chamber atrial pacemakerNo suspected abnormality of atrioventricular conduction and not at increased risk for future atrioventricular blockNot appropriateNot appropriateMaintenance of atrioventricular synchrony during pacing desiredSingle-chamber ventricular pacemakerMaintenance of atrioventricular synchrony during pacing not necessaryChronic atrial fibrillation or other atrial tachyarrhythmia or maintenance of atrioventricular synchrony during pacing not necessaryChronic atrial fibrillation or other atrial tachyarrhythmiaRate response available if desiredRate response available if desiredRate response available if desiredDual-chamber pacemakerAtrioventricular synchrony during pacing desiredRate response available if desiredSinus mechanism presentSuspected abnormality of atrioventricular conduction or increased risk for future atrioventricular blockAtrioventricular synchrony during pacing desiredRate response available if desiredRate response available if desiredAtrial pacing desiredRate response available if desiredSingle-lead, atrial-sensing ventricular pacemakerNot appropriateDesire to limit the number of pacemaker leadsNot appropriateIn view of the advances in medical therapy across the spectrum of cardiovascular diseases, the Task Force has designated the term guideline-directed medical therapy (GDMT) to represent optimal medical therapy as defined by ACCF/AHA guideline (primarily Class I)–recommended therapies. This new term, GDMT, is incorporated into the 2012 focused update and will be used throughout all future guidelines.Because the ACCF/AHA practice guidelines address patient populations (and healthcare providers) residing in North America, drugs that are not currently available in North America are discussed in the text without a specific COR. For studies performed in large numbers of subjects outside North America, each writing group reviews the potential impact of different practice patterns and patient populations on the treatment effect and relevance to the ACCF/AHA target population to determine whether the findings should inform a specific recommendation.The ACCF/AHA practice guidelines are intended to assist healthcare providers in clinical decision making by describing a range of generally acceptable approaches to the diagnosis, management, and prevention of specific diseases or conditions. The guidelines attempt to define practices that meet the needs of most patients in most circumstances. The ultimate judgment about care of a particular patient must be made by the healthcare provider and patient in light of all the circumstances presented by that patient. As a result, situations may arise in which deviations from these guidelines may be appropriate. Clinical decision making should consider the quality and availability of expertise in the area where care is provided. When these guidelines are used as the basis for regulatory or payer decisions, the goal should be improvement in quality of care. The Task Force recognizes that situations arise in which additional data are needed to inform patient care more effectively; these areas will be identified within each respective guideline when appropriate.Prescribed courses of treatment in accordance with these recommendations are effective only if they are followed. Because lack of patient understanding and adherence may adversely affect outcomes, physicians and other healthcare providers should make every effort to engage the patient's active participation in prescribed medical regimens and lifestyles. In addition, patients should be informed of the risks, benefits, and alternatives to a particular treatment and should be involved in shared decision making whenever feasible, particularly for COR IIa and IIb, for which the benefit-to-risk ratio may be lower.The Task Force makes every effort to avoid actual, potential, or perceived conflicts of interest that may arise as a result of industry relationships or personal interests among the members of the writing group. All writing group members and peer reviewers of the guideline are required to disclose all current healthcare–related relationships, including those existing 12 months before initiation of the writing effort.For the 2008 guidelines, all members of the writing committee, as well as peer reviewers of the document, were asked to provide disclosure statements of all such relationships that may be perceived as real or potential conflicts of interest. Writing committee members are also strongly encouraged to declare a previous relationship with industry that may be perceived as relevant to guideline development.In December 2009, the ACCF and AHA implemented a new policy for relationships with industry and other entities (RWI) that requires the writing group chair plus a minimum of 50% of the writing group to have no relevant RWI (Appendix 4 includes the ACCF/AHA definition of relevance). These statements are reviewed by the Task Force and all members during each conference call and/or meeting of the writing group and are updated as changes occur. All guideline recommendations require a confidential vote by the writing group and must be approved by a consensus of the voting members. Members may not draft or vote on any text or recommendations pertaining to their RWI. The 2012 members who recused themselves from voting are indicated in the list of writing group members, and specific section recusals are noted in Appendix 4. 2008 and 2012 authors' and peer reviewers' RWI pertinent to this guideline are disclosed in Appendixes 1, 2, 4, and 5, respectively. Additionally, to ensure complete transparency, writing group members' comprehensive disclosure information—including RWI not pertinent to this document—is available as an online supplement. Comprehensive disclosure information for the Task Force is also available online at http://cardiosource.org/ACC/About-ACC/Who-We-Are/Leadership/Guidelines-and-Documents-Task-Forces.aspx. The work of the 2012 writing group is supported exclusively by the ACCF, AHA, and the Heart Rhythm Society (HRS) without commercial support. Writing group members volunteered their time for this activity. Guidelines are official policy of both the ACCF and AHA.In April 2011, the Institute of Medicine released 2 reports: Finding What Works in Health Care: Standards for Systematic Reviews and Clinical Practice Guidelines We Can Trust.1b,1c It is noteworthy that the ACCF/AHA practice guidelines were cited as being compliant with many of the standards that were proposed. A thorough review of these reports and our current methodology is under way, with further enhancements anticipated.The current document is a republication of the "ACCF/AHA/HRS 2008 Guidelines for DeviceBased Therapy of Cardiac Rhythm Abnormalities"1d, revised to incorporate updated recommendations and text from the 2012 Focused Update.1 For easy reference, this online-only version denotes sections that have been updated.Jeffrey L. Anderson, MD, FACC, FAHAChair, ACCF/AHA Task Force on Practice Guidelines1. Introduction (UPDATED)1.1. Organization of CommitteeThis 2008 revision of the ACCF/AHA/HRS Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities (formally named "ACC/AHA/NASPE Guidelines for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices") updates the previous versions published in 1984, 1991, 1998, and 2002. Revision of the statement was deemed necessary for multiple reasons: 1) Major studies have been reported that have advanced our knowledge of the natural history of bradyarrhythmias and tachyarrhythmias, which may be treated optimally with device therapy; 2) there have been tremendous changes in the management of heart failure that involve both drug and device therapy; and 3) major advances in the technology of devices to treat, delay, and even prevent morbidity and mortality from bradyarrhythmias, tachyarrhythmias, and heart failure have occurred. The writing committee was composed of physicians who are experts in the areas of device therapy and follow-up and senior clinicians skilled in cardiovascular care, internal medicine, cardiovascular surgery, ethics, and socioeconomics. The committee included representatives of the American Association for Thoracic Surgery, Heart Failure Society of America, and Society of Thoracic Surgeons.For the 2012 focused update, selected members of the 2008 Device-Based Therapy (DBT) Writing Committee were invited to participate on the basis of areas of expertise, requirements for committee rotation, and the current RWI policy; those who agreed are referred to as the 2012 Focused Update Writing Group. The HRS was invited to be a partner on this focused update and has provided representation. The writing group also included representatives from the American Association for Thoracic Surgery, Heart Failure Society of America, and Society of Thoracic Surgeons.1.2. Document Review and ApprovalThe 2008 Guideline document was reviewed by 2 official reviewers nominated by each of the ACC, AHA, and HRS and by 11 additional peer reviewers. Of the total 17 peer reviewers, 10 had no significant relevant relationships with industry. In addition, this document has been reviewed and approved by the governing bodies of the ACC, AHA, and HRS, which include 19 ACC Board of Trustees members (none of whom had any significant relevant relationships with industry), 15 AHA Science Advisory Coordinating Committee members (none of whom had any significant relevant relationships with industry), and 14 HRS Board of Trustees members (6 of whom had no significant relevant relationships with industry). All guideline recommendations underwent a formal, blinded writing committee vote. Writing committee members were required to recuse themselves if they had a significant relevant relationship with industry. The guideline recommendations were unanimously approved by all members of the writing committee who were eligible to vote. The section "Pacing in Children and Adolescents" was reviewed by additional reviewers with special expertise in pediatric electrophysiology. The committee thanks all the reviewers for their comments. Many of their suggestions were incorporated into the final document.The 2012 focused update was reviewed by 2 official reviewers each nominated by the ACCF, AHA, and HRS, as well as 1 reviewer each from the American Association for Thoracic Surgery, Heart Failure Society of America, and Society of Thoracic Surgeons, and 21 individual content reviewers. All information on reviewers' RWI was collected and distributed to the writing group and is published in this document (Appendix 5). The 2012 focused update was approved for publication by the governing bodies of the ACCF, AHA, and HRS and was endorsed by the American Association for Thoracic Surgery, Heart Failure Society of America, and Society of Thoracic Surgeons.1.3. Methodology and EvidenceThe recommendations listed in this document are, whenever possible, evidence based. An extensive literature survey was conducted that led to the incorporation of 595 references. Searches were limited to studies, reviews, and other evidence conducted in human subjects and published in English. Key search words included but were not limited to antiarrhythmic, antibradycardia, atrial fibrillation, bradyarrhythmia, cardiac, CRT, defibrillator, device therapy, devices, dual chamber, heart, heart failure, ICD, implantable defibrillator, device implantation, long-QT syndrome, medical therapy, pacemaker, pacing, quality-of-life, resynchronization, rhythm, sinus node dysfunction, sleep apnea, sudden cardiac death, syncope, tachyarrhythmia, terminal care, and transplantation. Additionally, the committee reviewed documents related to the subject matter previously published by the ACC, AHA, and HRS. References selected and published in this document are representative and not all-inclusive.The focus of the 2008 guidelines is the appropriate use of heart pacing devices (eg, pacemakers for bradyarrhythmias and heart failure management, cardiac resynchronization, and implantable cardioverter-defibrillators [ICDs]), not the treatment of cardiac arrhythmias. The fact that the use of a device for treatment of a particular condition is listed as a Class I indication (beneficial, useful, and effective) does not preclude the use of other therapeutic modalities that may be equally effective. As with all clinical practice guidelines, the recommendations in this document focus on treatment of an average patient with a specific disorder and may be modified by patient comorbidities, limitation of life expectancy because of coexisting diseases, and other situations that only the primary treating physician may evaluate appropriately.These guidelines include sections on selection of pacemakers and ICDs, optimization of technology, cost, and follow-up of implanted devices. Although the section on follow-up is relatively brief, its importance cannot be overemphasized: First, optimal results from an implanted device can be obtained only if the device is adjusted to changing clinical conditions; second, recent advisories and recalls serve as warnings that devices are not infallible, and failure of electronics, batteries, and leads can occur.2,3The committee considered including a section on extraction of failed/unused leads, a topic of current interest, but elected not to do so in the absence of convincing evidence to support specific criteria for timing and methods of lead extraction. A policy statement on lead extraction from the North American Society of Pacing and Electrophysiology (now the HRS) provides information on this topic.4 Similarly, the issue of when to discontinue long-term cardiac pacing or defibrillator therapy has not been studied sufficiently to allow formulation of appropriate guidelines5; however, the question is of such importance that this topic is addressed to emphasize the importance of patient-family-physician discussion and ethical principles.The text that accompanies the listed indications should be read carefully, because it includes the rationale and supporting evidence for many of the indications, and in several instances, it includes a discussion of alternative acceptable therapies. Many of the indications are modified by the term "potentially reversible." This term is used to indicate abnormal pathophysio