Teacher-directed violence (TDV) by students is a growing concern in Western Australia (WA) with 8,500 students suspended in 2017 for committing TDV. This study investigates the prevalence of TDV reported by WA primary and secondary teachers, as well as the associations between TDV and gender, education sector and Socio-Economic Indexes for Areas (SEFIA) of school locations. Participants included 56 primary and secondary teachers in WA who completed an anonymous survey about their experiences with TDV over the past two years. The results revealed that 67.9% of participants had experienced TDV at least once in the past two years. Furthermore, a significant relationship was detected between TDV and gender, education sector and SEIFA indexes. Combined, this information should direct future research and school policy related to TDV.

SummaryPatients with uncontrolled hypertension are at increased risk of complications during general anaesthesia but the number of patients whose surgery is delayed or cancelled due to hypertension remains unknown. Prospective, regional multicentre service evaluations were performed on consecutive patients undergoing elective surgery before and after the publication of new guidelines from the Association of Anaesthetists and the British Hypertensive Society. The aim was to quantify the number of operations cancelled due to hypertension alone and to assess impact of the guidelines on cancellation rates. In October 2013 (before the publication of the guidelines), 1.37% (95%CI 0.69–2.11%) of patients listed for elective surgery were cancelled solely due to raised blood pressure. This reduced significantly to 0.54% (95%CI 0.20–0.92%, p < 0.001) in 2018. There was a significant reduction in inappropriate cancellations for stage 1 or 2 hypertension from 2013 to 2018 (72 vs. 14, respectively, p < 0.001) in keeping with the recommendations in the guidelines. Furthermore, the number of patients being referred back to primary care for the management of hypertension reduced from 2013 to 2018 (85 vs. 30, respectively, p < 0.001). Our data suggest achievement of three major outcomes: reduced surgical cancellations due to hypertension alone; improved detection of significant hypertension before elective surgery; and reduced referral back to primary care from hospital for hypertension management. To the best of our knowledge, this is the first time the successful implementation of guidelines from the Association of Anaesthetists has been assessed on such a broad scale. Our data indicate that these guidelines have been effectively implemented in both primary and secondary care, which is likely to have made a positive psychosocial, physical and economic impact on patients and the NHS.

For new or updated text, view the 2011 Focused Update and the 2011 Focused Update on Dabigatran. Text supporting unchanged recommendations has not been 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 ACC/AHA Task Force on Practice Guidelines, whose charge is to develop, update, or revise practice guidelines for important cardiovascular diseases and procedures, directs this effort. The Task Force is pleased to have this guideline developed in conjunction with the European Society of Cardiology (ESC). Writing committees are charged with the task of performing an assessment of the evidence and acting as an independent group of authors to develop or update written recommendations for clinical practice. Experts in the subject under consideration have been selected from all 3 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 formal 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 might influence the choice of particular …

HomeCirculationVol. 123, No. 102011 ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Update on Dabigatran) Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplemental MaterialFree AccessResearch ArticlePDF/EPUB2011 ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Update on Dabigatran)A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines L. Samuel Wann, MD, MACC, FAHA, Anne B. Curtis, MD, FACC, FAHA, Kenneth A. Ellenbogen, MD, FACC, FHRS, N.A. Mark EstesIII, MD, FACC, FHRS, Michael D. Ezekowitz, MB, ChB, FACC, Warren M. Jackman, MD, FACC, FHRS, Craig T. January, MD, PhD, FACC, James E. Lowe, MD, FACC, Richard L. Page, MD, FACC, FHRS, FAHA, David J. Slotwiner, MD, FACC, William G. Stevenson, MD, FACC, FHRS, FAHA and Cynthia M. Tracy, MD, FACC L. Samuel WannL. Samuel Wann , Anne B. CurtisAnne B. Curtis , Kenneth A. EllenbogenKenneth A. Ellenbogen , N.A. Mark EstesIIIN.A. Mark EstesIII , Michael D. EzekowitzMichael D. Ezekowitz , Warren M. JackmanWarren M. Jackman , Craig T. JanuaryCraig T. January , James E. LoweJames E. Lowe , Richard L. PageRichard L. Page , David J. SlotwinerDavid J. Slotwiner , William G. StevensonWilliam G. Stevenson and Cynthia M. TracyCynthia M. Tracy Originally published14 Feb 2011https://doi.org/10.1161/CIR.0b013e31820f14c0Circulation. 2011;123:1144–1150Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2011: Previous Version 1 Jacobs Alice K., MD, FACC, FAHAChair, ACCF/AHA Task Force on Practice GuidelinesPreambleA primary challenge in the development of clinical practice guidelines is keeping pace with the stream of new data on which recommendations are based. In an effort to respond promptly to new evidence, the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) Task Force on Practice Guidelines (Task Force) has created a “focused update” process to revise the existing guideline recommendations that are affected by the evolving data or opinion. Before the initiation of this focused approach, periodic updates and revisions of existing guidelines required up to 3 years to complete. Now, however, new evidence will be 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. Evidence will be reviewed at least twice a year, and updates will be initiated on an as-needed basis and completed as quickly as possible while maintaining the rigorous methodology that the ACCF and AHA have developed during their partnership of more than 20 years.These updated guideline recommendations reflect a consensus of expert opinion after a thorough review primarily of late-breaking clinical trials identified through a broad-based vetting process as being important to the relevant patient population, as well as other new data deemed to have an impact on patient care (see Section 1.1, Methodology and Evidence Review, for details). This focused update is not intended to represent an update based on a full literature review from the date of the previous guideline publication. Specific criteria/considerations for inclusion of new data include the following:publication in a peer-reviewed journal;large, randomized, placebo-controlled trial(s);nonrandomized data deemed important on the basis of results affecting current safety and efficacy assumptions;strength/weakness of research methodology and findings;likelihood of additional studies influencing current findings;impact on current and/or likelihood of need to develop new performance measure(s);request(s) and requirement(s) for review and update from the practice community, key stakeholders, and other sources free of relationships with industry or other potential bias;number of previous trials showing consistent results; andneed for consistency with a new guideline or guideline revisions.In analyzing the data and developing the recommendations and supporting text, the focused update writing group used evidence-based methodologies developed by the Task Force that are described elsewhere.1 The committee reviewed and ranked evidence supporting current recommendations with the weight of evidence ranked as Level A if the data were derived from multiple randomized clinical trials or meta-analyses. The committee ranked available evidence as Level B when data were derived from a single randomized trial or nonrandomized studies. Evidence was ranked as Level C when the primary source of the recommendation was consensus opinion, case studies, or standard of care. In the narrative portions of these guidelines, evidence is generally presented in chronological order of development. Studies are identified as observational, retrospective, prospective, or randomized when appropriate. For certain conditions for which inadequate data are available, recommendations are based on expert consensus and clinical experience and ranked as Level C. An example is the use of penicillin for pneumococcal pneumonia, for which there are no randomized trials and treatment is based on clinical experience. When recommendations at Level C are supported by historical clinical data, appropriate references (including clinical reviews) are cited if available. For issues where sparse data are available, a survey of current practice among the clinicians on the writing committee was the basis for Level C recommendations and no references are cited. The schema for classification of recommendation and level of evidence is summarized in Table 1, which also illustrates how the grading system provides an estimate of the size and the certainty of the treatment effect. A new addition to the ACCF/AHA methodology is a separation of the Class III recommendations to delineate whether the recommendation is determined to be of “no benefit” or associated with “harm” to the patient. 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/strategy with respect to another for Class I and IIa, Level A or B only have been added.Table 1. Applying Classification of Recommendations and Level of EvidenceTable 1. Applying Classification of Recommendations and Level of Evidence*Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as sex, age, history of diabetes, history of prior myocardial infarction, history of heart failure, and prior aspirin use. A recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Although randomized trials are unavailable, there may be a very clear clinical consensus that a particular test or therapy is useful or effective.†For comparative effectiveness recommendations (Class I and IIa; Level of Evidence: A and B only), studies that support the use of comparator verbs should involve direct comparisons of the treatments or strategies being evaluated.The Task Force makes every effort to avoid actual, potential, or perceived conflicts of interest that may arise as a result of relationships with industry and other entities (RWI) among the writing group. Specifically, all members of the writing group, as well as peer reviewers of the document, are asked to disclose all current relationships and those existing 12 months before initiation of the writing effort. In response to implementation of a newly revised RWI policy approved by the ACC and AHA, it is also required that the writing group chair plus a majority of the writing group (50%) have no relevant RWI. All guideline recommendations require a confidential vote by the writing group and must be approved by a consensus of the members voting. Members who were recused from voting are noted on the title page of this document and in Appendix 1. Members must recuse themselves from voting on any recommendation to which their RWI apply. Any writing group member who develops a new RWI during his or her tenure is required to notify guideline staff in writing. 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. For detailed information about guideline policies and procedures, please refer to the ACCF/AHA methodology and policies manual.1 Authors' and peer reviewers' RWI pertinent to this guideline are disclosed in Appendixes 1 and 2, respectively. In addition, to ensure complete transparency, writing group members' comprehensive disclosure information—including RWI not pertinent to this document—is available online as a supplement to this document. Disclosure information for the Task Force is also available online at www.cardiosource.org/ACC/About-ACC/Leadership/Guidelines-and-Documents-Task-Forces. The work of the writing group was supported exclusively by the ACCF and AHA and Heart Rhythm Society (HRS) without commercial support. Writing group members volunteered their time for this effort.The ACCF/AHA practice guidelines address patient populations (and healthcare providers) residing in North America. As such, drugs that are currently unavailable in North America are discussed in the text without a specific classification of recommendation. For studies performed in large numbers of subjects outside of North America, each writing group reviews the potential impact of different practice patterns and patient populations on the treatment effect and the 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 for the diagnosis, management, and prevention of specific diseases or conditions. These practice guidelines represent a consensus of expert opinion after a thorough review of the available current scientific evidence and are intended to improve patient care. The guidelines attempt to define practices that meet the needs of most patients in most circumstances. The ultimate judgment regarding care of a particular patient must be made by the healthcare provider and patient in light of all the circumstances presented by that patient. Thus, there are circumstances 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 for which additional data are needed to better inform patient care; 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.The recommendations in this focused update will be considered current until they are superseded by another focused update or the full-text guideline is revised. This focused update is published in the Journal of the American College of Cardiology, Circulation, and HeartRhythm as an update to the full-text guideline, and it is also available on the ACC (www.cardiosource.org), AHA (my.americanheart.org), and HRS (www.hrsonline.org) World Wide Web sites. A revised version of the full-text guideline with links to the focused update is e-published in the March 15, 2011, issues of the Journal of the American College of Cardiology and Circulation. For easy reference, this online-only version denotes sections that have been updated.1. Introduction1.1. Methodology and Evidence ReviewThe publication of the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial was considered important enough to prompt a focused update of the ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation.2 To provide clinicians with a comprehensive set of data, whenever deemed appropriate or when published, the absolute risk difference and number needed to treat or harm will be provided in the guideline, along with confidence intervals (CI) and data related to the relative treatment effects such as odds ratio, relative risk (RR), hazard ratio, or incidence rate ratio.Consult the full-text version or executive summary of the ACC/AHA/ESC 2006 Guidelines for the Management of Patients With Atrial Fibrillation for policy on clinical areas not covered by the focused update.2 The individual recommendations in this focused update will be incorporated into future revisions and/or updates of the full-text guideline.1.2. Organization of the Writing CommitteeFor this focused update, all eligible members of the 2006 Atrial Fibrillation Writing Committee were invited to participate; those who agreed (referred to as the 2011 focused update writing group) were required to disclose all RWI relevant to the data under consideration. The HRS was invited to be a partner on this update and provided 3 representatives.1.3. Document Review and ApprovalThis document was reviewed by 2 official reviewers each nominated by the ACCF, AHA, and HRS and 5 individual content reviewers (including members of the ACCF Electrophysiology Committee, the ACCF/AHA Task Force on Performance Measures, and the ACCF/AHA Atrial Fibrillation Data Standards Committee). All information on reviewers' RWI was collected and distributed to the writing committee and is published in this report (Appendix 2).This document was approved for publication by the governing bodies of the ACCF, AHA, and HRS.8. ManagementThis guideline update focuses on the use of dabigatran, a new antithrombotic agent that was recently approved by the US Food and Drug Administration (FDA), for the management of patients with atrial fibrillation (AF).8.1.4.2.5. Recommendation for Use of Oral Direct Thrombin Inhibitor Anticoagulant Agents(See Table 2).Table 2. Recommendation for Emerging Antithrombotic Agents2011 Focused Update RecommendationCommentsClass I1. Dabigatran is useful as an alternative to warfarin for the prevention of stroke and systemic thromboembolism in patients with paroxysmal to permanent AF and risk factors for stroke or systemic embolization who do not have a prosthetic heart valve or hemodynamically significant valve disease, severe renal failure (creatinine clearance <15 mL/min), or advanced liver disease (impaired baseline clotting function).(3) (Level of Evidence: B)New recommendationDabigatran etexilate is a prodrug that is rapidly converted to the active direct thrombin (factor IIa) inhibitor dabigatran. This conversion is independent of cytochrome P-450, making drug-drug and drug-diet interactions less likely. Dabigatran is predominantly excreted via a renal pathway. Dabigatran was evaluated in a large, open-label, randomized trial (RE-LY) in which it was compared with warfarin (goal international normalized ratio [INR] 2.0 to 3.0) in 18 113 patients with nonvalvular AF.3 Dabigatran was administered in fixed doses without laboratory monitoring of anticoagulation intensity. Eligible participants had at least 1 risk factor for stroke (previous stroke or transient ischemic attack or systemic embolism, left ventricular ejection fraction <40% or symptomatic heart failure [New York Heart Association class II or higher in the last 6 months], hypertension, age ≥75 years, or age 65 to 74 years with either diabetes mellitus or coronary artery disease). Exclusion criteria in RE-LY included a prosthetic heart valve or hemodynamically significant valvular heart disease, disabling or recent stroke, recent or pending surgery, recent or known bleeding disorders, uncontrolled hypertension, need for anticoagulation of disorders other than AF, planned ablation or surgery for AF, reversible causes of AF, severe renal dysfunction (creatinine clearance <30 mL/min), active liver disease, or pregnancy. Two doses of dabigatran (110 mg and 150 mg twice daily) were evaluated. The mean age of participants was 71 years, 63.6% were male, half had prior long-term therapy with vitamin K antagonists, and the mean CHADS2 (Congestive heart failure, Hypertension, Age, Diabetes, prior Stroke) risk prediction score was 2.1. The primary outcome was all stroke (ischemic or hemorrhagic) or systemic embolism; safety outcomes included bleeding, liver dysfunction, and other adverse events.Results of the RE-LY trial were published in 2009.3 Rates for the primary outcome of all stroke (ischemic or hemorrhagic) or systemic embolism were 1.71% per year in the warfarin group. Dabigatran etexilate, 150 mg twice daily, reduced the rate by 34% (to 1.11% per year; P<0.001 for superiority; RR: 0.65; 95% CI: 0.52 to 0.81), and at this dose there was no increase in major bleeding.3 Dabigatran etexilate, 110 mg twice daily, was also associated with a rate of stroke and systemic embolism (1.54% per year) that was noninferior to warfarin (P<0.001 for noninferiority; RR with dabigatran: 0.90; 95% CI: 0.74 to 1.10), and at this dose there was a 20% reduction in major bleeding risk compared with warfarin (P=0.003 for superiority). Rates of major bleeding were 3.57% per year for patients taking warfarin, 2.87% per year for those on dabigatran 110 mg twice daily (P=0.003), and 3.32% per year for those on dabigatran 150 mg twice daily (P=0.32). In the warfarin group, INR values were within the target range 64.4% of the time.4In addition, the results showed other secondary benefits and adverse outcomes. For safety, both doses showed a reduction in life-threatening, intracranial, and total bleeding, including lower rates of intracerebral hemorrhage with both 150 mg and 110 mg twice-daily doses (from 0.38% per year in the warfarin group to 0.12% per year with dabigatran 110 mg twice daily [P<0.001] and 0.10% per year with dabigatran 150 mg twice daily [P<0.001]). Dyspepsia occurred more frequently with dabigatran (11.8% and 11.3% of patients in the low-dose [110 mg] and high-dose [150 mg] groups, respectively) compared to warfarin (5.8% of patients). Also, myocardial infarction was more frequent with dabigatran and occurred at rates of 0.82% (RR: 1.29; 95% CI: 0.96 to 1.75; P=0.09) and 0.81% (RR: 1.27; 95% CI: 0.94 to 1.71; P=0.12) with dabigatran 110 mg and 150 mg twice daily, respectively, and 0.64% with warfarin.3,4 Increased3 or decreased5 rates of myocardial infarction have been reported with other oral thrombin inhibitors in different patient populations; however, the increase in myocardial infarction seen in RE-LY was not statistically significant in the dabigatran groups.4 In RE-LY, dabigatran did not cause hepatotoxicity.3 Drug discontinuation rates were slightly higher in the dabigatran groups compared with warfarin. There was no difference in mortality with dabigatran compared with warfarin. Both dabigatran doses appeared to be noninferior to warfarin with respect to the primary efficacy outcome of stroke or systemic embolism. In addition, the 150-mg twice–daily dose was superior to warfarin with respect to stroke or systemic embolism, and the 110-mg twice–daily dose was superior to warfarin with respect to major bleeding. There is no specific antidote for dabigatran, which has a half-life of 12 to 17 hours. Supportive therapy for severe hemorrhage may include transfusions of fresh-frozen plasma, packed red blood cells, or surgical intervention if appropriate.Because of the twice-daily dosing and greater risk of nonhemorrhagic side effects with dabigatran, patients already taking warfarin with excellent INR control may have little to gain by switching to dabigatran. Selection of patients with AF and at least 1 additional risk factor for stroke who could benefit from treatment with dabigatran as opposed to warfarin should consider individual clinical features, including the ability to comply with twice-daily dosing, availability of an anticoagulation management program to sustain routine monitoring of INR, patient preferences, cost, and other factors.6Dabigatran etexilate was approved by the FDA on October 19, 2010, for marketing in the United States for the prevention of stroke and systemic embolism in patients with nonvalvular AF. A dose of 150 mg twice daily was approved for patients with a creatinine clearance >30 mL/min, whereas in patients with severe renal insufficiency (creatinine clearance 15 to 30 mL/min) the approved dose is 75 mg twice daily, a dose currently marketed in the European Union but not evaluated in the RE-LY trial. There are no dosing recommendations for patients with creatinine clearance <15 mL/min or patients on dialysis. The 110-mg twice–daily dose used in the RE-LY trial did not receive FDA approval. The approval requires distribution of a medication guide with each prescription that details the risk of serious bleeding in patients receiving dabigatran in this open-label (or “unblinded”) trial.7 Dabigatran is the first new oral anticoagulant to become available for clinical use in >50 years.StaffAmerican College of Cardiology FoundationJohn C. Lewin, MD, Chief Executive OfficerJanet Wright, MD, FACC, Senior Vice President, Science and QualityCharlene May, Senior Director, Science and Clinical PolicyLisa Bradfield, CAE, Director, Science and Clinical PolicySue Keller, BSN, MPH, Senior Specialist, Evidence-Based MedicineErin A. Barrett, MPS, Senior Specialist, Science and Clinical PolicyBeth Denton, Specialist, Science and Clinical PolicyAmerican Heart AssociationNancy Brown, Chief Executive OfficerRose Marie Robertson, MD, FAHA, Chief Science OfficerGayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice President, Office of Science OperationsMark D. Stewart, MPH, Science and Medicine Advisor, Office of Science OperationsFootnotes2006 WRITING COMMITTEE MEMBERSValentin Fuster, MD, PhD, FACC, FAHA, FESC, Co-Chair; Lars E. Rydén, MD, PhD, FACC, FESC, FAHA, Co-Chair; David S. Cannom, MD, FACC; Harry J. Crijns, MD, FACC, FESC; Anne B. Curtis, MD, FACC, FAHA; Kenneth A. Ellenbogen, MD, FACC, FHRS†; Jonathan L. Halperin, MD, FACC, FAHA; G. Neal Kay, MD, FACC; Jean-Yves Le Heuzey, MD, FESC; James E. Lowe, MD, FACC; S. Bertil Olsson, MD, PhD, FESC; Eric N. Prystowsky, MD, FACC; Juan Luis Tamargo, MD, FESC; L. Samuel Wann, MD, MACC, FAHA, FESCACCF/AHA TASK FORCE MEMBERSAlice K. Jacobs, MD, FACC, FAHA, Chair; Jeffrey L. Anderson, MD, FACC, FAHA, Chair-Elect; Nancy Albert, PhD, CCNS, CCRN, FAHA; Mark A. Creager, MD, FACC, FAHA; Steven M. Ettinger, MD, FACC; Robert A. Guyton, MD, FACC; Jonathan L. Halperin, MD, FACC, FAHA; Judith S. Hochman, MD, FACC, FAHA; Frederick G. Kushner, MD, FACC, FAHA; Erik Magnus Ohman, MD, FACC; William G. Stevenson, MD, FACC, FAHA; Clyde W. Yancy, MD, FACC, FAHAThis document was approved by the American College of Cardiology Foundation Board of Trustees, the American Heart Association Science Advisory and Coordinating Committee, and the Heart Rhythm Society in January 2011.The online-only Data Supplement is available with this article at http://circ.ahajournals.org/cgi/content/full/CIR.0b013e31820f14c0/DC1.The American Heart Association requests that this document be cited as follows: Wann LS, Curtis AB, Ellenbogen KA, Estes NAM 3rd, Ezekowitz MD, Jackman WM, January CT, Lowe JE, Page RL, Slotwiner DJ, Stevenson WG, Tracy CM, writing on behalf of the 2006 ACC/AHA/ESC Guidelines for the Management of Patients With Atrial Fibrillation Writing Committee. 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (update on dabigatran): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2011;123:1144–1150.This article is copublished in the Journal of the American College of Cardiology and HeartRhythm.Copies: This document is available on the World Wide Web sites of the American College of Cardiology (www.cardiosource.org), the American Heart Association (my.americanheart.org), and the Heart Rhythm Society (www.hrsonline.org). A copy of the document is also available at http://www.americanheart.org/presenter.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 kelle.[email protected]com.Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American Heart Association. Instructions for obtaining permission are located at http://www.americanheart.org/presenter.jhtml?identifier=4431. A link to the “Permission Request Form” appears on the right side of the page.References1. ACCF/AHA Task Force on Practice Guidelines. Methodologies and Policies from the ACCF/AHA Task Force on Practice Guidelines. Available at: http://assets.cardiosource.com/Methodology_Manual_for_ACC_AHA_Writing_Committees.pdf and http://circ.ahajournals.org/manual/.Last update July 20, 2010. Accessed January 3, 2011Google Scholar2. Fuster V, Ryden LE, Cannom DS, et al. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation). Circulation. 2006; 114:e257–e354LinkGoogle Scholar3. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009; 361:1139–51CrossrefMedlineGoogle Scholar4. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010; 363:1875–6CrossrefMedlineGoogle Scholar5. Wallentin L, Wilcox RG, Weaver WD, et al. Oral ximelagatran for secondary prophylaxis after myocardial infarction: the ESTEEM randomised controlled trial. Lancet. 2003; 362:789–97CrossrefMedlineGoogle Scholar6. Gage BF. Can we rely on RE-LY?N Engl J Med. 2009; 361:1200–2CrossrefMedlineGoogle Scholar7. Dabigatran medication guide.Available at: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Pradaxa/Patient+Info/PradaxaMedGuide.pdf.Last update November 23, 2010. Accessed January 3, 2011.Google ScholarAppendixesTable A1. Appendix 1. Author Relationships With Industry and Other Entities—2011 ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Update on Dabigatran)Committee MemberEmploymentConsultantSpeaker's BureauOwnership/ Partnership/PrincipalPersonal ResearchInstitutional, Organizational, or Other Financial BenefitExpert WitnessL. Samuel Wann, ChairWisconsin Heart and Vascular Clinics–Chairman, Department of Cardiovascular MedicineNoneNoneNoneNoneNoneNoneAnne B. CurtisUniversity at Buffalo–Charles and Mary Bauer Professor and Chair, Department of MedicineNoneNoneNoneNoneNoneNoneKenneth A. EllenbogenVirginia Commonwealth University Medical Center–Director, Clinical Electrophysiology LaboratoryNoneNoneNoneNoneEditor-in-chief, AfibProfessional.orgmNoneN.A. Mark Estes III†New England Cardiac Arrhythmia Center, Tufts Medical Center–Director; Tufts University School of Medicine, Division of Cardiology–Professor of MedicineNoneBoehringer IngelheimMedtronicmNoneNoneNoneNoneMichael D. Ezekowitz†Lankenau Institute for Medical Research–Vice President; Jefferson Medical College– ProfessorARYx Therapeutics*AstraZenecaBoehringer Ingelheim*Bristol-Myers SquibbmDaiichi SankyomMedtronicmPortola Pharmaceuticals*Boehringer IngelheimNoneARYx TherapeuticsBoehringer Ingelheim*Daiichi SankyoPortola Pharmaceuticals*NoneNoneWarren M. JackmanHeart Rhythm Institute, University of Oklahoma Health Sciences Center–G.L. Cross Research Professor Emeritus of Medicine (Cardiology)NoneNoneNoneNoneNoneNoneCraig T. JanuaryUniversity of Wisconsin, Madison–Professor of Medicine, Departments of Medicine (Division of Cardiovascular Medicine) and PhysiologyNoneNoneNoneNoneNoneNoneJames E. LoweDuke University HospitalNoneNoneNoneNoneNoneNoneRichard L. PageUniversity of Wisconsin, Madison–Professor of Medicine and Chairman of the Department of MedicineNoneNoneNoneNoneNoneNoneDavid J. Slotwiner†North Shore, Long Island Jewish Health Care System–Associate Director, Electrophysiology LaboratoryNoneNoneNoneBoehringer Ingelheim*NoneNoneWilliam G. StevensonBrigham and Women's Hospital, Cardiovascular Division–Director, Clinical Cardiac Electrophysiology ProgramNoneNoneNoneNoneNoneNoneCynthia M. TracyGeorge Washington University Medical Center–Associate Director, Division of Cardiology; George Washington University Hospital– Director, Cardiac ServicesNoneNoneNoneNoneNoneNoneThis table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document. These relationships were reviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarily reflect relationships with industry at the time of

2011;57;1330-1337; originally published online Feb 14, 2011; J. Am. Coll. Cardiol. Richard L. Page, David J. Slotwiner, William G. Stevenson, and Cynthia M. Tracy Michael D. Ezekowitz, Warren M. Jackman, Craig T. January, James E. Lowe, L. Samuel Wann, Anne B. Curtis, Kenneth A. Ellenbogen, N.A. Mark Estes, III, on Practice Guidelines of Cardiology Foundation Foundation/American Heart Association Task Force Atrial Fibrillation (Update on Dabigatran): A Report of the American College 2011 ACCF/AHA/HRS Focused Update on the Management of Patients With This information is current as of March 11, 2012 http://content.onlinejacc.org/cgi/content/full/57/11/1330 located on the World Wide Web at: The online version of this article, along with updated information and services, is

HomeCirculationVol. 123, No. 12011 ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Updating the 2006 Guideline) Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessResearch ArticlePDF/EPUB2011 ACCF/AHA/HRS Focused Update on the Management of Patients With Atrial Fibrillation (Updating the 2006 Guideline)A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines 2011 Writing Group Members L. Samuel Wann, MD, MACC, FAHA, Anne B. Curtis, MD, FACC, FAHA, Craig T. January, MD, PhD, FACC, Kenneth A. Ellenbogen, MD, FACC, FHRS, James E. Lowe, MD, FACC, N.A. Mark EstesIII, MD, FACC, FHRS, Richard L. Page, MD, FACC, FHRS, Michael D. Ezekowitz, MB, ChB, FACC, David J. Slotwiner, MD, FACC, Warren M. Jackman, MD, FACC, FHRS, William G. Stevenson, MD, FACC, FAHA and Cynthia M. Tracy, MD, FACC 2011 Writing Group Members , L. Samuel WannL. Samuel Wann , Anne B. CurtisAnne B. Curtis , Craig T. JanuaryCraig T. January , Kenneth A. EllenbogenKenneth A. Ellenbogen , James E. LoweJames E. Lowe , N.A. Mark EstesIIIN.A. Mark EstesIII , Richard L. PageRichard L. Page , Michael D. EzekowitzMichael D. Ezekowitz , David J. SlotwinerDavid J. Slotwiner , Warren M. JackmanWarren M. Jackman , William G. StevensonWilliam G. Stevenson and Cynthia M. TracyCynthia M. Tracy Originally published20 Dec 2010https://doi.org/10.1161/CIR.0b013e3181fa3cf4Circulation. 2011;123:104–123is corrected byCorrectionOther version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2010: Previous Version 1 Jacobs Alice K., MD, FACC, FAHAPreambleA primary challenge in the development of clinical practice guidelines is keeping pace with the stream of new data on which recommendations are based. In an effort to respond promptly to new evidence, the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) Task Force on Practice Guidelines has created a "focused update" process to revise the existing guideline recommendations that are affected by the evolving data or opinion. Before the initiation of this focused approach, periodic updates and revisions of existing guidelines required up to 3 years to complete. Now, however, new evidence will be 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. Evidence will be reviewed at least twice a year, and updates will be initiated on an as-needed basis and completed as quickly as possible while maintaining the rigorous methodology that the ACCF and AHA have developed during their partnership of more than 20 years.These updated guideline recommendations reflect a consensus of expert opinion after a thorough review primarily of late-breaking clinical trials identified through a broad-based vetting process as being important to the relevant patient population, as well as other new data deemed to have an impact on patient care (see Section 1.1, Methodology and Evidence Review, for details). This focused update is not intended to represent an update based on a full literature review from the date of the previous guideline publication. Specific criteria/considerations for inclusion of new data include the following: publication in a peer-reviewed journal;large, randomized, placebo-controlled trial(s);nonrandomized data deemed important on the basis of results affecting current safety and efficacy assumptions;strength/weakness of research methodology and findings;likelihood of additional studies influencing current findings;impact on current and/or likelihood of need to develop new performance measure(s);request(s) and requirement(s) for review and update from the practice community, key stakeholders, and other sources free of relationships with industry or other potential bias;number of previous trials showing consistent results; andneed for consistency with a new guideline or guideline revisions.In analyzing the data and developing updated recommendations and supporting text, the focused update writing group used evidence-based methodologies developed by the ACCF/AHA Task Force on Practice Guidelines that are described elsewhere.1 The Task Force on Practice Guidelines 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 writing group. Specifically, all members of the writing group, as well as peer reviewers of the document, are asked to disclose ALL relevant relationships and those existing 12 months before initiation of the writing effort. In response to implementation of a new relationship with industry and other entities (RWI) policy approved by the ACC and AHA, it is also required that the writing group chair plus a majority of the writing group (50%) have no relevant RWI. All guideline recommendations require a confidential vote by the writing group members before and after external review of the document and must be approved by a consensus of the members voting. Members who were recused from voting are noted on the title page of this document and in Appendix 1. Members must recuse themselves from voting on any recommendations to which their RWI apply. Any writing group member who develops a new RWI during his or her tenure is required to notify guideline staff in writing. These statements are reviewed by the Task Force on Practice Guidelines and all members during each conference call and/or meeting of the writing group and are updated as changes occur. For detailed information about guideline policies and procedures, please refer to the ACCF/AHA methodology and policies manual.1 Authors' and peer reviewers' RWI pertinent to this guideline are disclosed in Appendixes 1 and 2, respectively. Additionally, to ensure complete transparency, writing group members' comprehensive disclosure information—including RWI not pertinent to this document—are available online as a data supplement. Disclosure information for the ACCF/AHA Task Force on Practice Guidelines is available online at www.cardiosource.org/ACC/About-ACC/Leadership/Guidelines-and-Documents-Task-Forces.aspx and at www.americanheart.org/presenter.html?identifier=3039684. Writing committee members who chose not to participate are not listed as authors of this focused update. The work of the writing group was supported exclusively by the ACCF and AHA without commercial support. Writing group members volunteered their time for this effort.The committee reviewed and ranked evidence supporting current recommendations, with the weight of evidence ranked as Level A if the data were derived from multiple randomized clinical trials or meta-analyses. The committee ranked available evidence as Level B when data were derived from a single randomized trial or nonrandomized studies. Evidence was ranked as Level C when the primary source of the recommendation was consensus opinion of experts, case studies, or standard of care. In the narrative portions of these guidelines, evidence is generally presented in chronological order of development. Studies are identified as observational, retrospective, prospective, or randomized where appropriate. For certain conditions for which inadequate data are available, recommendations are based on expert consensus and clinical experience and ranked as Level C. An example is the use of penicillin for pneumococcal pneumonia, where there are no randomized trials and treatment is based on clinical experience. When recommendations at Level C are supported by historical clinical data, appropriate references (including clinical reviews) are cited if available. For issues where sparse data are available, a survey of current practice among the clinicians on the writing committee was the basis for Level C recommendations and no references are cited. The schema for Classification of Recommendations (COR) and Level of Evidence (LOE) is summarized inTable 1, which also illustrates how the grading system provides an estimate of the size of the treatment effect and an estimate of the certainty of the treatment effect. A new addition to the ACCF/AHA methodology is a separation of the Class III recommendations to delineate whether the recommendation is determined to be of "no benefit" or associated with "harm" to the patient. 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/strategy with respect to another for COR I and IIa, LOE A or B only have been added.Table 1. Applying Classification of Recommendation and Level of EvidenceTable 1. Applying Classification of Recommendation and Level of Evidence*Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as gender, age, history of diabetes, history of prior myocardial infarction, history of heart failure, and prior aspirin use. A recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Even though randomized trials are not available, there may be a very clear clinical consensus that a particular test or therapy is useful or effective.†For comparative effectiveness recommendations (Class I and IIa; Level of Evidence A and B only), studies that support the use of comparator verbs should involve direct comparisons of the treatments or strategies being evaluated.The ACCF/AHA practice guidelines address patient populations (and healthcare providers) residing in North America. As such, 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 of North America, each writing group reviews the potential impact of different practice patterns and patient populations on the treatment effect and the 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 for 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 regarding care of a particular patient must be made by the healthcare provider and patient in light of all the circumstances presented by that patient. Thus, there are circumstances 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.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 treatment outcomes, physicians and other healthcare providers should make every effort to engage the patient's active participation in prescribed medical regimens and lifestyles. When these guidelines are used as the basis for regulatory or payer decisions, the goal should be improvement in quality of care aligned with the patient's best interest.With the exception of the recommendations presented here, the full-text guideline remains current. Only the recommendations from the affected section(s) of the full-text guideline are included in this focused update. For easy reference, all recommendations from any section of a guideline affected by a change are presented with notation as to whether they remain current, are new, or have been modified. When evidence affects recommendations in more than 1 set of guidelines, those guidelines are updated concurrently.The recommendations in this focused update will be considered current until they are superseded by another focused update or the full-text guidelines are revised. This focused update is published in the December 28, 2010/January 4, 2011, issue of the Journal of the American College of Cardiology, the January 4, 2011, issue of Circulation, and the December 2010 issue of HeartRhythm as an update to the full-text guideline,2 and it is available on the ACC (http://www.cardiosource.org), AHA (my.americanheart.org), and Heart Rhythm Society (hrsonline.org) World Wide Web sites.Alice K. Jacobs, MD, FACC, FAHA Chair, ACCF/AHA Task Force on Practice Guidelines1. Introduction1.1. Methodology and Evidence ReviewLate-breaking clinical trials presented at the 2009 annual scientific meetings of the ACC, AHA, and European Society of Cardiology (ESC), as well as selected other data reported through April 2010, were reviewed by the standing guideline writing committee along with the Task Force on Practice Guidelines and other experts to identify those trials and other key data that may impact guideline recommendations. On the basis of the criteria/considerations noted above, recent trial data and other clinical information were considered important enough to prompt a focused update of the ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation.2To provide clinicians with a comprehensive set of data, whenever deemed appropriate or when published in the article, data from the clinical trial will be used to calculate the absolute risk difference (ARD) and number needed to treat (NNT) or harm (NNH); data related to the relative treatment effects will also be provided, such as odds ratio (OR), relative risk (RR), hazard ratio (HR), or incidence rate ratio (IRR) along with confidence interval (CI) when available.Consult the full-text version or executive summary of the ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation2 for policy on clinical areas not covered by the focused update. The individual recommendations in this focused update will be incorporated into future revisions and/or updates of the full-text guideline.1.2. Organization of the Writing CommitteeFor this focused update, all members of the 2006 Atrial Fibrillation Writing Committee were invited to participate; those who agreed (referred to as the 2011 Focused Update Writing Group) were required to disclose all RWI relevant to the data under consideration. The Heart Rhythm Society was invited to be a partner on this update and provided 3 representatives.1.3. Document Review and ApprovalThis document was reviewed by 2 official reviewers each nominated by the ACCF, the AHA, the Heart Rhythm Society, and 25 individual content reviewers (including members of the ACCF Electrophysiology Committee, the Atrial Fibrillation Performance Measures Committee, and the Atrial Fibrillation Data Standards Committee). All reviewer RWI information was collected and distributed to the writing committee and is published in this report (Appendix 2).This document was approved for publication by the governing bodies of the ACCF, AHA, and Heart Rhythm Society.8. ManagementThis guideline update focuses on several areas in which new data on management of patients with atrial fibrillation (AF) have become available, including a) recommendations for strict versus lenient heart rate control, b) combined use of antiplatelet and anticoagulant therapy, and c) use of dronedarone. Recommendations are not made for use of dabigatran, a new antithrombotic agent which was not approved by the US Food and Drug Administration (FDA) at the time of organizational approval of this document, or for the Watchman device for occlusion of the left atrial appendage which is investigational pending FDA approval.8.1.3. Rate Control During Atrial FibrillationCRITERIA FOR RATE CONTROL. In patients with AF, the ventricular rate may accelerate excessively during exercise even when it is well controlled at rest (Table 2). Rate reduction, allowing adequate time for ventricular filling and avoiding rate-related ischemia, may result in improved hemodynamics. Therefore, evaluating the heart rate response to submaximal or maximal exercise or to monitor the rate over an extended period (eg, by 24-hour Holter recording) may be an option. In addition, rate variability during AF provides information about the status of the autonomic nervous system that may have independent prognostic implications.4–7 Parameters for optimal rate control in AF remain controversial. The definition of adequate rate control has been based primarily on short-term hemodynamic benefits and has not been well studied with respect to regularity or irregularity of the ventricular response to AF, quality of life, symptoms, or development of cardiomyopathy. No standard method for assessment of heart rate control has been established to guide management of patients with AF. Criteria for rate control vary with patient age but usually involve achieving ventricular rates between 60 and 80 bpm at rest and between 90 and 115 bpm during moderate exercise. For the AFFIRM (Atrial Fibrillation Follow-up Investigation of Rhythm Management) study, adequate control was defined as an average heart rate of up to 80 bpm at rest and either an average rate of up to 100 bpm over at least 18 hours of ambulatory Holter monitoring with no rate greater than 100% of the maximum age-adjusted predicted exercise heart rate or a maximum heart rate of 110 bpm during a 6-minute walk test.8Table 2. Recommendation for Rate Control During Atrial Fibrillation2011 Focused Update RecommendationCommentsClass III–No Benefit1. Treatment to achieve strict rate control of heart rate (<80 bpm at rest or <110 bpm during a 6-minute walk) is not beneficial compared to achieving a resting heart rate <110 bpm in patients with persistent AF who have stable ventricular function (left ventricular ejection fraction >0.40) and no or acceptable symptoms related to the arrhythmia, though uncontrolled tachycardia may over time be associated with a reversible decline in ventricular performance.3(Level of Evidence: B)New recommendationThe potential benefits of strict (resting heart rate <80 bpm, heart rate <110 bpm during moderate exercise) versus lenient (resting heart rate <110 bpm) rate control were addressed in the RACE II (Rate Control Efficacy in Permanent Atrial Fibrillation) trial of 614 patients with permanent AF.3 AF was treated with a variety of atrioventricular (AV) nodal blocking agents to control heart rate.3 Primary endpoints were death from cardiovascular causes, hospitalization for heart failure, stroke, systemic embolism, bleeding, and life-threatening arrhythmias. The 3-year estimated cumulative incidence of the primary outcome was 12.9% in the lenient-control group and 14.9% in the strict-control group (Appendix 3), with an absolute difference between lenient control and strict control of −2.0 percentage points (90% CI, −7.6 to 3.5; P<0.001) and HR of 0.84 (90% CI, 0.58 to 1.21; P=0.001 for the prespecified noninferiority margin). Symptoms were also similar in both groups. All patients included in the study were ambulatory and relatively young (mean age, 68 years), predominantly male, and may have been healthier and less symptomatic than many patients encountered in clinical practice. Long-term effects of a more rapid heart rate response to AF on ventricular function were not studied. If a lenient rate control strategy is chosen for patients with persistent AF who have stable ventricular function (left ventricular [LV] ejection fraction >0.40) and or no acceptable symptoms related to AF, LV function should be monitored.The RACE II study reported only a total of 81 composite events in 614 patients and was not adequately powered to make conclusive comments on whether there were or were not clinically relevant differences in clinical outcomes between strict- and lenient-rate control.3 Nevertheless, strict targeting of treatment to achieve an arbitrary heart rate seems unnecessary. The RACE II study shows that lenient-rate control <110 bpm is not inferior to strict-rate control <80 bpm. As lenient-rate control is generally more convenient, requiring fewer outpatient visits and examinations, lenient-rate control may be adopted as a reasonable strategy in patients with permanent AF.The Atrial Fibrillation and Congestive Heart Failure Trial compared the benefits of rhythm control with rate control in a randomized, multicenter trial of 1376 patients with AF and congestive heart failure.9 AF was defined as 1 episode of AF lasting at least 6 hours or requiring cardioversion within the preceding 6 months or an episode lasting for at least 10 minutes within the previous 6 months and previous cardioversion. Congestive heart failure was defined as an ejection fraction of ≤35% and symptomatic New York Heart Association (NYHA) class II or IV heart failure within the previous 6 months, or an ejection fraction of ≤25%. Rhythm control included cardioversion and antiarrhythmic therapy, primarily using amiodarone, repeat cardioversion if needed, and possible referral for nonpharmacologic therapy. Rate control was achieved primarily using beta blockers with digitalis to achieve a target heart rate of <80 bpm at rest or <110 bpm during a 6-minute walk test. No difference was found in the primary endpoint of death from cardiovascular causes with a mean follow-up of 37 months. One hundred eighty-two (27%) in the rhythm-control group died compared with 175 (25%) in the rate-control group (HR 1.06; 95% CI, 0.86 to 1.30; P=0.59) by log rank test. Secondary outcomes, including death from any cause, worsening heart failure, stroke, and composite and death from cardiovascular causes, were also similar in both groups. Patients treated with rhythm control were more likely to be hospitalized than those treated with rate control.9 This trial showed no benefit for use of a routine strategy of rhythm control in patients with AF and systolic heart failure compared with a strategy of rate control.8.1.4.2.4. Recommendation for Combining Anticoagulant With Antiplatelet Therapy (New Section)Multiple studies have demonstrated that oral anticoagulation with warfarin is effective for prevention of thromboembolism in AF patients (Table 3).2,11–16 Aspirin (ASA) offers only modest protection against stroke for AF patients.13,17–23 Adjusted-dose oral anticoagulation is more efficacious than ASA for prevention of stroke in patients with AF.2,24 Recent studies have assessed the thienopyridine antiplatelet agent clopidogrel with ASA for stroke prevention in AF patients.10,25Table 3. Recommendation for Combining Anticoagulant With Antiplatelet Therapy2011 Focused Update RecommendationCommentsClass IIb1. The addition of clopidogrel to aspirin (ASA) to reduce the risk of major vascular events, including stroke, might be considered in patients with AF in whom oral anticoagulation with warfarin is considered unsuitable due to patient preference or the physician's assessment of the patient's ability to safely sustain anticoagulation.10(Level of Evidence: B)New recommendationThe ACTIVE-W (Atrial Fibrillation Clopidogrel Trial with Irbesartan for Prevention of Vascular Events) trial25 compared clopidogrel plus ASA with oral anticoagulation therapy with warfarin for prevention of vascular events in AF patients with an average of 2 stroke risk factors. The primary outcome was first occurrence of stroke, noncentral nervous system systemic embolism, myocardial infarction (MI), or vascular death. There were 165 primary events in patients receiving oral anticoagulation therapy (annual risk 3.93%) and 234 in those receiving clopidogrel plus ASA (annual risk 5.60%; RR 1.44; [95% CI, 1.18 to 1.76; P=0.0003; NNT 47]). Although rates of hemorrhage were similar between the 2 groups, significantly greater minor and total bleeds occurred with clopidogrel and ASA than with oral anticoagulation therapy. Major hemorrhages (severe and fatal) occurred in 2.42% of patients treated with clopidogrel plus ASA and in 2.21% of those treated with oral anticoagulation (RR 1.10; 95% CI, 0.83 to 1.45; P=0.53). Total hemorrhagic complications occurred in 15.40% of patients treated with clopidogrel plus ASA and in 13.21% of those treated with oral anticoagulation (RR 1.21; 95% CI, 1.08 to 1.35; P=0.001). The total adverse outcome (primary outcome and major bleeds) was 316 in clopidogrel and ASA and 229 in oral anticoagulation (RR 1.41; 95% CI, 1.19 to 1.67; P<0.001). Oral anticoagulation therapy with warfarin proved superior to clopidogrel plus ASA for prevention of vascular events in AF patients. Treatment with clopidogrel plus ASA was associated with bleeding risk similar to treatment with warfarin.The ACTIVE-A (Effect of Clopidogrel Added to Aspirin in Patients with Atrial Fibrillation) trial assessed whether the addition of clopidogrel to ASA would reduce the risk of vascular events in AF patients who were considered unsuitable for therapy with oral anticoagulation with warfarin10 (Appendix 3). Patients were deemed "unsuitable" for oral anticoagulation due to a specific risk of bleeding (22.9%), patient preference (26%), or physician preference (49.7%). The primary outcome was the composite of stroke, MI, noncentral nervous system systemic embolism, or death from vascular causes. At 3.6 years of follow-up, major vascular events had occurred in 832 patients receiving ASA plus clopidogrel (6.8% per year) and in 924 patients receiving ASA plus placebo (7.6% per year) (RR with clopidogrel 0.89; 95% CI, 0.81 to 0.98; P=0.01). The difference was primarily due to a reduction in the rate of stroke with clopidogrel. Stroke occurred in 296 patients receiving ASA plus clopidogrel (2.4% per year) and in 408 patients receiving placebo (3.3% per year; RR 0.72; 95% CI, 0.62 to 0.83; P<0.001). MI occurred in 90 patients receiving clopidogrel (0.7% per year) and in 115 patients receiving placebo (0.9% per year) (RR 0.78; 95% CI, 0.59 to 1.03; P=0.08). Major bleeding occurred in 251 patients receiving ASA plus clopidogrel (2.0% per year) and in 162 patients receiving ASA plus placebo (1.3% per year; RR 1.57; 95% CI, 1.29 to 1.92; P<0.001). In AF patients for whom oral anticoagulation with warfarin was considered unsuitable, the addition of clopidogrel to ASA reduced the risk of major vascular events, especially stroke, and increased the risk of major hemorrhage.The combined use of dual-antiplatelet therapy with both clopidogrel and ASA plus anticoagulation with warfarin (triple therapy) has been suggested as a strategy for treatment and prevention of complications of 2 or more coexisting conditions such as AF, mechanical valve prosthesis, or the presence of a drug-eluting coronary stent.26 This strategy is associated with an increase in bleeding complications that might range from mild or moderate to severe or life threatening. No prospective randomized trials have been reported addressing this important clinical issue.8.1.4.2.5. Emerging and Investigational Antithrombotic AgentsThe RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial of dabigatran,27 a prodrug that is rapidly converted to an active direct thrombin inhibitor independent of the cytochrome P-450, was reviewed by the 2011 Focused Update Writing Group, but recommendations about its use are not included in this focused update because dabigatran was not approved for clinical use by the FDA at the time of organizational approval.8.1.4.3. Nonpharmacologic Approaches to Prevention of ThromboembolismThe 2011 Focused Update Writing Group considered the Watchman device for atrial appendage closure in its deliberations in anticipation of FDA approval of this device.28 Because the FDA has not approved clinical use of the Watchman device pending the results of additional ongoing trials, the writing group's deliberations and recommendations regarding the Watchman device are not included in the final version of this focused update. A future guideline writing committee will address this and other evolving areas in the management of AF.8.1.8.3. Recommendations for Dronedarone for the Prevention of Recurrent Atrial Fibrillation (New Section)Dronedarone is similar to amiodarone but lacks an iodine moiety. Its multiple electrophysiologic actions include sympatholytic effects as well as inhibition of the L-type calcium current, the inward sodium current, and multiple potassium currents (Table 4).31 Two randomized trials (EURIDIS [European Trial In Atrial Fibrillation or Flutter Patients Receiving Dronedarone for the Maintenance of Sinus Rhythm] and ADONIS [American-Australian-African Trial With Dronedarone in Atrial Fibrillation or Flutter Patients for the Maintenance of Sinus Rhythm]) found that dronedarone prolongs the time to recurrence of AF (Appendix 3).32,33 In patients with persistent AF, DAFNE (Dronedarone Atrial FibrillatioN study after Electrical Cardioversion) showed that administration of dronedarone converted only 5.8% to sinus rhythm (3.1% converted with placebo) and did not improve the acute success of electrical cardioversion.33 Dronedarone slows the ventricular rate in AF by an average of 11 to 13 bpm.33,34 Incidence of spontaneous conversion to sinus rhythm was dose related (ie, 800, 1200, and 1600 mg). The conversion ratio was 5.8% (800 mg), 8.2% (1200 mg), and 14.2% (1600 mg), but the incidence of successful electrical cardioversion was not statistically different between groups (800 mg=77.3%; 1200 mg=87.9%; and 1600 mg=76.6% versus 73.0% in the placebo group).33Table 4. Recommendations for Use of Dronedarone in Atrial Fibrillation2011 Focused Update Recommendati

Background: CT coronary angiography (CTA) is highly accurate in excluding anatomically significant coronary artery disease (CAD). Adenosine stress CT myocardial perfusion imaging (CTP) is a novel imaging modality for detection of myocardial ischemia.Purpose: To evaluate the feasibility and accuracy of combined CTA/CTP in assessment of stable symptomatic patients with suspected CAD using fractional flow reserve (FFR) as reference standard.Methods: Seventeen consecutive patients (10 male; mean age = 63.2; 51 vessels) with chest pain and suspected CAD were investigated using CTA, CTP and FFR. Adenosine stress CTP was undertaken 20 minutes after CTA, both acquired using 320-row detector CT and prospective ECG-gating. Images for CTA and CTP were assessed by consensus between two blinded observers. Scan parameters were documented. FFR ≤ 0.8 indicated hemodynamically significant stenoses (FFRSS).Results: CTA and CTP were successfully acquired in all patients at mean heart rate of 51.5 ± 7.4 bpm and 69.9 ± 7.4 bpm. This was achieved after metoprolol administration (mean oral dose = 55.9 ± 31.3 mg; mean intravenous dose = 15.7 ± 11.4 mg) and required 120 ml of iodinated-contrast. Mean radiation dose of CTA and CTP was 5.6 ± 3.9 mSv and 4.2 ± 1.9 mSv. Duration spent in the CT department and scanner was 131.4 ± 30.8 min and 44.1 ± 5.6 min. Per patient and per vessel diagnostic accuracy, sensitivity and specificity were 100% and 96%, 100% and 85.7% and 100% and 97.7% respectively.Conclusion: Combined CTA/CTP using 320-slice CT and prospective-ECG gating can be conveniently performed with an acceptable radiation dose and high degree of accuracy compared against FFR, in stable symptomatic patients with suspected coronary artery disease. Background: CT coronary angiography (CTA) is highly accurate in excluding anatomically significant coronary artery disease (CAD). Adenosine stress CT myocardial perfusion imaging (CTP) is a novel imaging modality for detection of myocardial ischemia. Purpose: To evaluate the feasibility and accuracy of combined CTA/CTP in assessment of stable symptomatic patients with suspected CAD using fractional flow reserve (FFR) as reference standard. Methods: Seventeen consecutive patients (10 male; mean age = 63.2; 51 vessels) with chest pain and suspected CAD were investigated using CTA, CTP and FFR. Adenosine stress CTP was undertaken 20 minutes after CTA, both acquired using 320-row detector CT and prospective ECG-gating. Images for CTA and CTP were assessed by consensus between two blinded observers. Scan parameters were documented. FFR ≤ 0.8 indicated hemodynamically significant stenoses (FFRSS). Results: CTA and CTP were successfully acquired in all patients at mean heart rate of 51.5 ± 7.4 bpm and 69.9 ± 7.4 bpm. This was achieved after metoprolol administration (mean oral dose = 55.9 ± 31.3 mg; mean intravenous dose = 15.7 ± 11.4 mg) and required 120 ml of iodinated-contrast. Mean radiation dose of CTA and CTP was 5.6 ± 3.9 mSv and 4.2 ± 1.9 mSv. Duration spent in the CT department and scanner was 131.4 ± 30.8 min and 44.1 ± 5.6 min. Per patient and per vessel diagnostic accuracy, sensitivity and specificity were 100% and 96%, 100% and 85.7% and 100% and 97.7% respectively. Conclusion: Combined CTA/CTP using 320-slice CT and prospective-ECG gating can be conveniently performed with an acceptable radiation dose and high degree of accuracy compared against FFR, in stable symptomatic patients with suspected coronary artery disease.

This conclusion presents some closing thoughts on the concepts covered in the preceding chapters of this book. The book argues that the critical criminologists of the 1970s were well aware of racism’s potential as a source of both unity and division among the white working class. It also argues that an adequate understanding of racist crime demands a model of the human subject informed by the empirical evidence that demonstrates that racist mindsets are rarely all-encompassing, absolute, and immutable. The book discusses the relation to both the “community cohesion” and the “respect” agendas that successive governments have failed to understand the needs of young people while treating them as either vehicles for, or targets of, doomed policy initiatives. It shows how the promise of “social inclusion” made to the young British Pakistani men interviewed remained unfulfilled, and how they, their families, and …

011 WRITING GROUP MEMBERS . Samuel Wann, MD, MACC, FAHA*, Chair; Anne B. Curtis, MD, FACC, FAHA*†; raig T. January, MD, PhD, FACC*†; Kenneth A. Ellenbogen, MD, FACC, FHRS†‡; ames E. Lowe, MD, FACC*; N.A. Mark Estes III, MD, FACC, FHRS§; Richard L. Page, MD, FACC, FHRS‡; ichael D. Ezekowitz, MB, ChB, FACC*; David J. Slotwiner, MD, FACC‡; arren M. Jackman, MD, FACC, FHRS*; William G. Stevenson, MD, FACC, FAHA ; ynthia M. Tracy, MD, FACC*

Background Survival after coronary artery bypass graft surgery (CABG)andmedical therapy inpatients withcoro- naryartery disease (CAD)hasbeenstudied inbothrandom- ized trials andobservational treatment comparisons. Overthe pastdecade, theuseofcoronary angioplasty (PTCA)has increased dramatically, without guidance fromeither random- izedtrials orprospective observational comparisons. The purpose ofthis study wastodescribe thesurvival experience of a large prospective cohort ofCAD patients treated with

BACKGROUND:The development of laser-assisted extraction techniques for chronically implanted pacemaker and defibrillator leads has reduced the need for open surgical removal. Reports of the mortality from laser-assisted extraction range from 1.9% to 3.4%. The purpose of this study was to determine the rate of major cardiovascular injury and emphasize the need for cardiothoracic surgical participation in this procedure.METHODS:A retrospective cohort study was performed of 112 consecutive laser-assisted lead extractions at a single university medical center during a 6-year period. Patient and lead characteristics were analyzed as well as indications, outcomes, and major complications.RESULTS:Successful lead extraction was accomplished in 103 (92%) of the 112 patients. Elective sternotomy after failure of laser-assisted lead removal was successfully performed in 4 patients. Emergent surgical intervention was required in 4 patients for caval perforation (n = 2), subclavian vein injury (n = 1), or right atrial injury (n = 1). Three of the 4 patients requiring emergent intervention died, for an overall series mortality of 2.6%. In July of 2006, a policy of cardiothoracic surgeon presence during the laser-assisted extraction was instituted. Since that time, there has been one emergent sternotomy and one elective sternotomy for lead removal with no procedure-related deaths.CONCLUSIONS:Despite recent advances in laser technology for the removal of pacemaker and defibrillator leads, the potential for major cardiovascular injury and death remains. Involvement of the cardiothoracic surgeon in both the preoperative decision-making process as well as the laser-assisted lead extraction is critical to prevent or emergently treat any major complications.

Purpose: An unusual case of superior vena cava (SVC) syndrome caused by an infected right atrial-SVC junction thrombus may be diagnosed using transesophageal echocardiography. Clinical features: A 59-yr-old male with end-stage renal disease requiring hemodialysis presented with fungemia and later developed facial and bilateral upper extremity edema. Transesophageal echocardiography revealed subtotal occlusion of the SVC at its junction with the right atrium. The mass was surgically removed with cardiopulmonary bypass support. Pathological examination of the mass confirmed the presence of a large fungal colony of Candida species mixed in the thrombus. The patient’s signs and symptoms of SVC obstruction resolved, and he was discharged from the hospital four weeks later in stable condition. Conclusion: Although usually caused by extrinsic tumour compression, SVC syndrome can result from intravascular caval obstruction. This etiology should also be considered in the differential diagnosis, particularly in patients with intravascular devices. Transesophageal echocardiography is a valuable diagnostic tool in these cases.