2011-ACCF-AHA-HRS-Focused-Update-on-the-Management-of-Patients-With-Atrial-Fibrillation

ACCF/AHA/HRS FOCUSED UPDATE 2 P A o 2 L C J M W C 2 V L J A K J L T d S H that this document be cited as follows: Wann LS, Curtis AB, January CT, Ellenbogen KA, Lowe JE, Estes NAM 3rd, Page RL, Ezekowitz MD, S t A o g i 2 A T identifier�3003999 by selecting either the “topic list” link or the “chro- nological list” link (No. KB-0100). To purchase additional reprints, call 1 P lotwiner DJ, Jackman WM, Stevenson WG, Tracy CM, writing on behalf of he 2006 ACC/AHA/ESC Guidelines for the Management of Patients With trial Fibrillation Writing Committee. 2011 ACCF/AHA/HRS focused update n the management of patients with atrial fibrillation (updating the 2006 uideline): a report of the American College of Cardiology Foundation/Amer- can Heart Association Task Force on Practice Guidelines. Heart Rhythm 011;8:157–176. This article has been copublished in the Journal of the merican College of Cardiology and American Heart Association. Copies: his document is available on the World Wide Web sites of the American 843-216-2533 or e-mail kelle.ramsay@wolterskluwer.com. Expert peer re- view of AHA Scientific Statements is conducted at the AHA National Center. For more on AHA statements and guidelines development, visit http://www. americanheart.org/presenter.jhtml?identifier�3023366. Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this doc- ument 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. 011 ACCF/AHA/HRS Focused Update on the Management of atients With Atrial Fibrillation (Updating the 2006 Guideline) Report of the American College of Cardiology Foundation/American Heart Association Task Force n Practice Guidelines 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* *ACCF/AHA Representative. †Recused from voting on Section 8.1.8.3, Recommendations for Dronedarone. ‡HRS Representative. §ACCF/AHA Task Force on Performance Measures Representative. �ACCF/AHA Task Force on Practice Guidelines Liaison. 006 WRITING COMMITTEE MEMBERS alentin Fuster, MD, PhD, FACC, FAHA, FESC, Co-Chair; ars E. Rydén, MD, PhD, FACC, FESC, FAHA, Co-Chair; David S. Cannom, MD, FACC*; ean-Yves Le Heuzey, MD, FESC*; Harry J. Crijns, MD, FACC, FESC¶; James E. Lowe, MD, FACC*; nne B. Curtis, MD, FACC, FAHA*; S. Bertil Olsson, MD, PhD, FESC*; enneth A. Ellenbogen, MD, FACC, FHRS; Eric N. Prystowsky, MD, FACC*; onathan L. Halperin, MD, FACC, FAHA*; Juan Luis Tamargo, MD, FESC*; G. Neal Kay, MD, FACC*; . Samuel Wann, MD, MACC, FAHA, FESC* ¶European Society of Cardiology Representative. his document was approved by the American College of Cardiology Foun- ation Board of Trustees in July 2010, by the American Heart Association cience Advisory and Coordinating Committee in August 2010, and by the eart Rhythm Society in August 2010. The Heart Rhythm Society requests College of Cardiology (www.cardiosource.org), the American Heart As- sociation (my.americanheart.org) and the Hearth Rhythm Society (www. heartrhythmjournal.com) and (www.hrsonline.org). A copy of the docu- ment is also available at http://www.americanheart.org/presenter.jhtml? 547-5271/$ -see front matter © 2011 American College of Cardiology Foundation, the American Heart Association, Inc. and the Heart Rhythm Society. ublished by Elsevier, Inc. All rights reserved. doi:10.1016/j.hrthm.2010.11.047 A A . And N an, M C shner M man W Guyt J Yanc K Rhyth a 176) T P 1 1 1 1 8 8 8 8 8 8 8 8 8 A A and Other Entities............................................................168 Appendix 3. Summary Table ..........................................170 R P A t d r o ( c g e f i h f a p r a p t n s o b p a E i r S i ● ● ● ● strength/weakness of research methodology and findings; ● likelihood of additional studies influencing current find- 1 eferences........................................................................175 reamble primary challenge in the development of clinical prac- ice guidelines is keeping pace with the stream of new ata on which recommendations are based. In an effort to espond promptly to new evidence, the American College f Cardiology Foundation/American Heart Association ACCF/AHA) Task Force on Practice Guidelines has reated a “focused update” process to revise the existing uideline recommendations that are affected by the volving data or opinion. Before the initiation of this ocused approach, periodic updates and revisions of ex- ings; ● 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 poten- tial bias; ● number of previous trials showing consistent results; and ● need for consistency with a new guideline or guideline revisions. In analyzing the data and developing updated recommen- dations and supporting text, the focused update writing group used evidence-based methodologies developed by the CCF/AHA TASK FORCE MEMBERS lice K. Jacobs, MD, FACC, FAHA, Chair; Jeffrey L ancy Albert, PhD, CCNS, CCRN; Judith S. Hochm hristopher E. Buller, MD, FACC#; Frederick G. Ku ark A. Creager, MD, FACC, FAHA; Erik Magnus Oh illiam G. Stevenson, MD, FACC, FAHA; Robert A. onathan L. Halperin, MD, FACC, FAHA; Clyde W. #Former Task Force member during this writing effort. EYWORDS AHA Scientific Statements; Atrial fibrillation; Rate control; gents; Thromboembolism; Catheter ablation (Heart Rhythm 2011;8:157– ABLE OF CONTENTS reamble ..........................................................................158 . Introduction ................................................................161 .1. Methodology and Evidence Review.......................161 .2. Organization of the Writing Committee ................161 .3. Document Review and Approval ...........................161 . Management ...............................................................161 .1.3. Rate Control During Atrial Fibrillation...............161 .1.4.2.4. Recommendation for Combining Anticoagu- lant With Antiplatelet Therapy (New Section).............162 .1.4.2.5. Emerging and Investigational Antithrombotic Agents ...............................................................................163 .1.4.3. Nonpharmacologic Approaches to Prevention of Thromboembolism .......................................................163 .1.8.3. Recommendations for Dronedarone for the Pre- vention of Recurrent Atrial Fibrillation (New Section)....163 .3. Maintenance of Sinus Rhythm ...............................164 .3.1. Recommendations for Therapy............................164 .3.1.4. Catheter-Based Ablation Therapy for Atrial Fi- brillation (New Section) ..................................................164 ppendix 1. Author Relationships With Industry and Other Entities ...................................................................167 ppendix 2. Peer Reviewer Relationships With Industry 58 sting guidelines required up to 3 years to complete. Now, owever, new evidence will be reviewed in an ongoing A d erson, MD, FACC, FAHA, Chair-Elect; D, FACC, FAHA; , MD, FACC, FAHA; , MD, FACC; Steven M. Ettinger, MD, FACC; on, MD, FACC; Lynn G. Tarkington, RN#; y, MD, FACC, FAHA m control; Anticoagulant therapy; Antiplatelet therapy; Antithrombotic ashion to more efficiently respond to important science nd treatment trends that could have a major impact on atient outcomes and quality of care. Evidence will be eviewed at least twice a year, and updates will be initi- ted on an as-needed basis and completed as quickly as ossible while maintaining the rigorous methodology that he ACCF and AHA have developed during their part- ership of more than 20 years. These updated guideline recommendations reflect a con- ensus of expert opinion after a thorough review primarily f late-breaking clinical trials identified through a broad- ased vetting process as being important to the relevant atient population, as well as other new data deemed to have n impact on patient care (see Section 1.1, Methodology and vidence Review, for details). This focused update is not ntended to represent an update based on a full literature eview from the date of the previous guideline publication. pecific criteria/considerations for inclusion of new data nclude 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; Heart Rhythm, Vol 8, No 1, January 2011 CCF/AHA Task Force on Practice Guidelines that are escribed elsewhere.1 The Task Force on Practice Guide- l c i g a r i o p t ( r b a w t s R R s F c u g A r A p d d s G A T p m a g w u i d m c d n w c c d d r a a s e m m d d a a c r s a w e m a o r a o s i o I p A i s s r a r m o a d t d p c p v s w a a p t f h s e 159Wann et al Guideline Focused Update: Atrial Fibrillation ines makes every effort to avoid actual, potential, or per- eived conflicts of interest that may arise as a result of ndustry relationships or personal interests among the writing roup. Specifically, all members of the writing group, as well s peer reviewers of the document, are asked to disclose ALL elevant relationships and those existing 12 months before nitiation of the writing effort. In response to implementation f a new relationship with industry and other entities (RWI) olicy approved by the ACC and AHA, it is also required that he writing group chair plus a majority of the writing group 50%) have no relevant RWI. All guideline recommendations equire a confidential vote by the writing group members efore and after external review of the document and must be pproved by a consensus of the members voting. Members ho were recused from voting are noted on the title page of his document and in Appendix 1. Members must recuse them- elves from voting on any recommendations to which their WI apply. Any writing group member who develops a new WI during his or her tenure is required to notify guideline taff in writing. These statements are reviewed by the Task orce on Practice Guidelines and all members during each onference call and/or meeting of the writing group and are pdated as changes occur. For detailed information about uideline policies and procedures, please refer to the ACCF/ HA methodology and policies manual.1 Authors’ and peer eviewers’ RWI pertinent to this guideline are disclosed in ppendixes 1 and 2, respectively. Additionally, to ensure com- lete transparency, writing group members’ comprehensive isclosure information—including RWI not pertinent to this ocument—are available online as a data supplement. Disclo- ure information for the ACCF/AHA Task Force on Practice uidelines is available online at www.cardiosource.org/ CC/About-ACC/Leadership/Guidelines-and-Documents- ask-Forces.aspx and at www.americanheart.org/ resenter.html?identifier�3039684. Writing committee embers who chose not to participate are not listed as uthors of this focused update. The work of the writing roup was supported exclusively by the ACCF and AHA ithout commercial support. Writing group members vol- nteered their time for this effort. The committee reviewed and ranked evidence support- ng current recommendations, with the weight of evi- ence ranked as Level A if the data were derived from ultiple randomized clinical trials or meta-analyses. The ommittee ranked available evidence as Level B when ata were derived from a single randomized trial or onrandomized studies. Evidence was ranked as Level C hen the primary source of the recommendation was onsensus opinion of experts, case studies, or standard of are. In the narrative portions of these guidelines, evi- ence is generally presented in chronological order of evelopment. Studies are identified as observational, ret- ospective, prospective, or randomized where appropri- te. For certain conditions for which inadequate data are vailable, recommendations are based on expert consen- us and clinical experience and ranked as Level C. An s g xample is the use of penicillin for pneumococcal pneu- onia, where there are no randomized trials and treat- ent is based on clinical experience. When recommen- ations at Level C are supported by historical clinical ata, appropriate references (including clinical reviews) re cited if available. For issues where sparse data are vailable, a survey of current practice among the clini- ians on the writing committee was the basis for Level C ecommendations and no references are cited. The chema for Classification of Recommendations (COR) nd Level of Evidence (LOE) is summarized in Table 1, hich also illustrates how the grading system provides an stimate of the size of the treatment effect and an esti- ate of the certainty of the treatment effect. A new ddition to the ACCF/AHA methodology is a separation f the Class III recommendations to delineate whether the ecommendation is determined to be of “no benefit” or ssociated with “harm” to the patient. In addition, in view f the increasing number of comparative effectiveness tudies, comparator verbs and suggested phrases for writ- ng recommendations for the comparative effectiveness f one treatment/strategy with respect to another for COR and IIa, LOE A or B only have been added. The ACCF/AHA practice guidelines address patient opulations (and healthcare providers) residing in North merica. As such, drugs that are not currently available n North America are discussed in the text without a pecific COR. For studies performed in large numbers of ubjects outside of North America, each writing group eviews the potential impact of different practice patterns nd patient populations on the treatment effect and the elevance to the ACCF/AHA target population to deter- ine whether the findings should inform a specific rec- mmendation. The ACCF/AHA practice guidelines are intended to ssist healthcare providers in clinical decision making by escribing a range of generally acceptable approaches for he diagnosis, management, and prevention of specific iseases or conditions. The guidelines attempt to define ractices that meet the needs of most patients in most ircumstances. The ultimate judgment regarding care of a articular patient must be made by the healthcare pro- ider and patient in light of all the circumstances pre- ented by that patient. Thus, there are circumstances in hich deviations from these guidelines may be appropri- te. Clinical decision making should consider the quality nd availability of expertise in the area where care is rovided. Prescribed courses of treatment in accordance with hese recommendations are effective only if they are ollowed. Because lack of patient understanding and ad- erence may adversely affect treatment outcomes, phy- icians and other healthcare providers should make every ffort to engage the patient’s active participation in pre- cribed medical regimens and lifestyles. When these uidelines are used as the basis for regulatory or payer d c h r t e a n h d a T f evide o r t s 1 ecisions, the goal should be improvement in quality of are aligned with the patient’s best interest. With the exception of the recommendations presented ere, the full-text guideline remains current. Only the ecommendations from the affected section(s) of the full- ext guideline are included in this focused update. For asy reference, all recommendations from any section of guideline affected by a change are presented with otation as to whether they remain current, are new, or ave been modified. When evidence affects recommen- able 1 Applying classification of recommendation and level o *Data available from clinical trials or registries about the usefulness/effi f prior myocardial infarction, history of heart failure, and prior aspirin ecommendation is weak. Many important clinical questions addressed in rials are not available, there may be a very clear clinical consensus that †For comparative effectiveness recommendations (Class I and IIa; Lev hould involve direct comparisons of the treatments or strategies being e 60 ations in more than 1 set of guidelines, those guidelines re updated concurrently. The recommendations in this focused update will be con- idered current until they are superseded by another focused pdate or the full-text guidelines are revised. This focused pdate is published in the December 28, 2010/January 4, 2011, ssue of the Journal of the American College of Cardiology, he January 4, 2011, issue of Circulation, and the December 010 issue of HeartRhythm as an update to the full-text guide- ine,2 and it is available on the ACC (www.cardiosource.org), HA (my.americanheart.org), and Heart Rhythm Society hrsonline.org) World Wide Web sites. nce different subpopulations, such as gender, age, history of diabetes, history recommendation with Level of Evidence B or C does not imply that the elines do not lend themselves to clinical trials. Even though randomized ular test or therapy is useful or effective. idence A and B only), studies that support the use of comparator verbs d. Heart Rhythm, Vol 8, No 1, January 2011 s u u i t 2 l A ( cacy in use. A the guid a partic el of Ev valuate Alice K. Jacobs, MD, FACC, FAHA Chair, ACCF/AHA Task Force on Practice Guidelines 1 1 L s e r g P a t a c t o w a t t t ( r a A P n m f 1 F F t W t w r 1 T n S m A t v t p e c 8 T d h s a d r t o m i 8 C t c r a m t o m p n p r h e o l s b C i a e v t r 1 g T fi 2 C 1 W Introduction .1 Methodology and Evidence Review ate-breaking clinical trials presented at the 2009 annual cientific meetings of the ACC, AHA, and European Soci- ty of Cardiology (ESC), as well as selected other data eported through April 2010, were reviewed by the standing uideline writing committee along with the Task Force on ractice Guidelines and other experts to identify those trials nd other key data that may impact guideline recommenda- ions. On the basis of the criteria/considerations noted bove, recent trial data and other clinical information were onsidered important enough to prompt a focused update of he ACC/AHA/ESC 2006 Guidelines for the Management f Patients with Atrial Fibrillation.2 To provide clinicians with a comprehensive set of data, henever deemed appropriate or when published in the rticle, data from the clinical trial will be used to calculate he absolute risk difference (ARD) and number needed to reat (NNT) or harm (NNH); data related to the relative reatment effects will also be provided, such as odds ratio OR), relative risk (RR), hazard ratio (HR), or incidence rate atio (IRR) along with confidence interval (CI) when avail- ble. Consult the full-text version or executive summary of the CC/AHA/ESC 2006 Guidelines for the Management of atients with Atrial Fibrillation2 for policy on clinical areas ot covered by the focused update. The individual recom- endations in this focused update will be incorporated into uture revisions and/or updates of the full-text guideline. .2 Organization of the Writing Committee or this focused update, all members of the 2006 Atrial ibrillation Writing Committee were invited to particip