2016 ACC/AHA/HFSA Focused Update on New Pharmacological Therapy for Heart Failure: An Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America
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Table of Contents
7.3. Stage C e285
7.3.2. Pharmacological Treatment for Stage C HF With Reduced Ejection Fraction: Recommendations e285
126.96.36.199. Renin-Angiotensin System Inhibition With Angiotensin-Converting Enzyme Inhibitor or Angiotensin Receptor Blocker or ARNI: Recommendations e285
188.8.131.52. Ivabradine: Recommendation e287
Appendix 1. Author Relationships With Industry and Other Entities (Relevant) e289
Appendix 2. Reviewer Relationships With Industry and Other Entities (Comprehensive) e291
Incorporation of new study results, medications, or devices that merit modification of existing clinical practice guideline recommendations, or the addition of new recommendations, is critical to ensuring that guidelines reflect current knowledge, available treatment options, and optimum medical care. To keep pace with evolving evidence, the American College of Cardiology (ACC)/American Heart Association (AHA) Task Force on Clinical Practice Guidelines (“Task Force”) has issued this focused update to reassess guideline recommendations on the basis of recently published study data. This update has been subject to rigorous, multilevel review and approval, similar to the full guidelines. For specific focused update criteria and additional methodological details, please see the ACC/AHA guideline methodology manual.1
Processes have evolved over time in response to published reports from the Institute of Medicine2,3 and ACC/AHA mandates,4–7 leading to adoption of a “knowledge byte” format. This process entails delineation of a recommendation addressing a specific clinical question, followed by concise text (ideally <250 words) and hyperlinked to supportive evidence. This approach better accommodates time constraints on busy clinicians, facilitates easier access to recommendations via electronic search engines and other evolving technology, and supports the evolution of guidelines as “living documents” that can be dynamically updated as needed.
Guideline-Directed Evaluation and Management
The term guideline-directed evaluation and management (GDEM) refers to care defined mainly by ACC/AHA Class I recommendations. For these and all recommended drug treatment regimens, the reader should confirm dosage with product insert material and carefully evaluate for contraindications and interactions. Recommendations are limited to treatments, drugs, and devices approved for clinical use in the United States.
Class of Recommendation and Level of Evidence
The Class of Recommendation (COR) and Level of Evidence (LOE) are derived independently of each other according to established criteria. The COR indicates the strength of recommendation, encompassing the estimated magnitude and certainty of benefit of a clinical action in proportion to risk. The LOE rates the quality of scientific evidence supporting the intervention on the basis of the type, quantity, and consistency of data from clinical trials and other sources (Table 1). Recommendations in this focused update reflect the new 2015 COR/LOE system, in which LOE B and C are subcategorized for the purpose of increased granularity.1,5,8
Relationships With Industry and Other Entities
The ACC and AHA exclusively sponsor the work of guideline writing committees without commercial support, and members volunteer time for this activity. Selected organizations and professional societies with related interests and expertise are invited to participate as partners or collaborators. The Task Force makes every effort to avoid actual, potential, or perceived conflicts of interest that might arise through relationships with industry or other entities (RWI). All writing committee members and reviewers are required to fully disclose current industry relationships or personal interests, beginning 12 months before initiation of the writing effort. Management of RWI involves selecting a balanced writing committee and requires that both the chair and a majority of writing committee members have no relevant RWI (see Appendix 1 for the definition of relevance). Members are restricted with regard to writing or voting on sections to which RWI apply. Members of the writing committee who recused themselves from voting are indicated and specific section recusals are noted in Appendix 1. In addition, for transparency, members’ comprehensive disclosure information is available as an Online Supplement, and reviewers’ RWI disclosures are included in Appendix 2. Comprehensive disclosure information for the Task Force is also available at http://www.acc.org/guidelines/about-guidelines-and-clinical-documents/guidelines-and-documents-task-forces. The Task Force strives to avoid bias by selecting experts from a broad array of backgrounds representing different geographic regions, genders, ethnicities, intellectual perspectives, and scopes of clinical activities.
Guidelines provide recommendations applicable to patients with or at risk of developing cardiovascular disease. The focus is on medical practice in the United States, but guidelines developed in collaboration with other organizations may have a broader target. Although guidelines may be used to inform regulatory or payer decisions, the intent is to improve quality of care and align with patients’ interests. The guidelines are reviewed annually by the Task Force and are official policy of the ACC and AHA. Each guideline is considered current unless and until it is updated, revised, or superseded by a published addendum.
For additional information pertaining to the methodology for grading evidence, assessment of benefit and harm, shared decision making between the patient and clinician, structure of evidence tables and summaries, standardized terminology for articulating recommendations, organizational involvement, peer review, and policies regarding periodic assessment and updating of guideline documents, we encourage readers to consult the ACC/AHA guideline methodology manual.1
Jonathan L. Halperin, MD, FACC, FAHA
Chair, ACC/AHA Task Force on Clinical Practice Guidelines
The ACC, the AHA, and the Heart Failure Society of America (HFSA) recognize that the introduction of effective new therapies that potentially affect a large number of patients presents both opportunities and challenges. The introduction of an angiotensin receptor–neprilysin inhibitor (ARNI) (valsartan/sacubitril) and a sinoatrial node modulator (ivabradine), when applied judiciously, complements established pharmacological and device-based therapies and represents a milestone in the evolution of care for patients with heart failure (HF). Accordingly, the writing committees of the “2016 ACC/AHA/HFSA Focused Update on New Pharmacological Therapy for Heart Failure” and the “2016 ESC Guideline on the Diagnosis and Treatment of Acute and Chronic Heart Failure” concurrently developed recommendations for the incorporation of these therapies into clinical practice. Working independently, each writing committee surveyed the evidence, arrived at similar conclusions, and constructed similar, but not identical, recommendations. Given the concordance, the respective organizations simultaneously issued aligned recommendations on the use of these new treatments to minimize confusion and improve the care of patients with HF.
Members of the ACC/AHA/HFSA writing committee without relevant RWI voted on the final recommendations. These were subjected to external peer review by 25 official, organizational, and content reviewers before approval by the Task Force and the leadership of the ACC, AHA, and HFSA, as well as endorsement by the American College of Chest Physicians and the International Society for Heart and Lung Transplantation. The statements issued by the European Society of Cardiology writing committee went through a similarly rigorous process of external review before endorsement by the societal leadership.
No single clinical trial answers all pertinent questions, nor can trial results be perfectly replicated in clinical practice. Several critical questions remain unanswered, and further experience in both ongoing trials and clinical therapeutics may require modification of these initial recommendations. On the basis of the currently available evidence, however, the recommendations that follow reflect our assessment of how best to proceed today.
7.3. Stage C
7.3.2. Pharmacological Treatment for Stage C HF With Reduced Ejection Fraction: Recommendations
184.108.40.206. Renin-Angiotensin System Inhibition With Angiotensin-Converting Enzyme Inhibitor or Angiotensin Receptor Blocker or ARNI: Recommendations
See the Online Data Supplement for evidence supporting these recommendations.
220.127.116.11. Ivabradine: Recommendation
See the Online Data Supplement for evidence supporting this recommendation.
The remainder of the “2016 ACC/AHA/HFSA Focused Update on the Management of Heart Failure: An Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure” will be forthcoming.
ACC/AHA TASK FORCE MEMBERS
Jonathan L. Halperin, MD, FACC, FAHA, Chair
Glenn N. Levine, MD, FACC, FAHA, Chair-Elect
Sana M. Al-Khatib, MD, MHS, FACC, FAHA
Kim K. Birtcher, PharmD, MS, AACC
Biykem Bozkurt, MD, PhD, FACC, FAHA
Ralph G. Brindis, MD, MPH, MACC
Joaquin E. Cigarroa, MD, FACC
Lesley H. Curtis, PhD, FAHA
Lee A. Fleisher, MD, FACC, FAHA
Federico Gentile, MD, FACC
Samuel Gidding, MD, FAHA
Mark A. Hlatky, MD, FACC
John Ikonomidis, MD, PhD, FAHA
José Joglar, MD, FACC, FAHA
Susan J. Pressler, PhD, RN, FAHA
Duminda N. Wijeysundera, MD, PhD
Presidents and Staff
American College of Cardiology
Richard A. Chazal, MD, FACC, President
Shalom Jacobovitz, Chief Executive Officer
William J. Oetgen, MD, MBA, FACC, Executive Vice President, Science, Education, Quality, and Publications
Amelia Scholtz, PhD, Publications Manager, Science, Education, Quality, and Publishing
American College of Cardiology/American Heart Association
Melanie Stephens-Lyman, MSc, Director, Guideline Operations and Strategy
Lisa Bradfield, CAE, Director, Guideline Methodology and Policy
Abdul R. Abdullah, MD, Associate Science and Medicine Advisor
Morgane Cibotti-Sun, MPH, Project Manager, Clinical Practice Guidelines
American Heart Association
Mark A. Creager, MD, FACC, FAHA, President
Nancy Brown, Chief Executive Officer
Rose Marie Robertson, MD, FAHA, Chief Science and Medical Officer
Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice President, Office of Science Operations
Comilla Sasson, MD, PhD, FACEP, Vice President, Science and Medicine
Jody Hundley, Production Manager, Scientific Publications, Office of Science Operations
Developed in Collaboration With the American College of Chest Physicians and International Society for Heart and Lung Transplantation
ACC/AHA Task Force Members, see page e287
↵* Writing committee members are required to recuse themselves from voting on sections to which their specific relationships with industry may apply; see Appendix 1 for detailed information. †ACC/AHA Task Force on Clinical Practice Guidelines Liaison. ‡ACC/AHA Representative. §ACP Representative. ‖ISHLT Representative. ¶HFSA Representative. #CHEST Representative. **ACC/AHA Task Force on Performance Measures Representative. ††AAFP Representative.
The American Heart Association requests that this document be cited as follows: Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos G, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2016 ACC/AHA/HFSA focused update on new pharmacological therapy for heart failure: an update of the 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. 2016;134:e282–e293. DOI: 10.1161/CIR.0000000000000435.
This document was approved by the American College of Cardiology Board of Trustees and Executive Committee, the American Heart Association Science Advisory and Coordinating Committee and Executive Committee, and the Heart Failure Society of America Executive Committee in April 2016.
The Comprehensive RWI Data Supplement table is available with this article at http://circ.ahajournals.org/lookup/suppl/doi:10.1161/CIR.0000000000000435/-/DC1.
The Data Supplement is available with this article at http://circ.ahajournals.org/lookup/suppl/doi:10.1161/CIR.0000000000000435/-/DC2.
This article has been copublished in the Journal of the American College of Cardiology and the Journal of Cardiac Failure.
Copies: This document is available on the World Wide Web sites of the American College of Cardiology (www.acc.org), the American Heart Association (professional.heart.org), and the Heart Failure Society of America (www.hfsa.org). A copy of the document is available at http://professional.heart.org/statements by using either “Search for Guidelines & Statements” or the “Browse by Topic” area. To purchase additional reprints, call 843-216-2533 or e-mail .
Expert peer review of AHA Scientific Statements is conducted by the AHA Office of Science Operations. For more on AHA statements and guidelines development, visit http://professional.heart.org/statements. Select the “Guidelines & Statements” drop-down menu, then click “Publication Development.”
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.heart.org/HEARTORG/General/Copyright-Permission-Guidelines_UCM_300404_Article.jsp. A link to the “Copyright Permissions Request Form” appears on the right side of the page.
Circulation is available at http://circ.ahajournals.org.
- © 2016 by the American College of Cardiology Foundation, the American Heart Association, Inc., and the Heart Failure Society of America.
- 1.↵ACCF/AHA Task Force on Practice Guidelines. Methodology Manual 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://my.americanheart.org/idc/groups/ahamah-public/@wcm/@sop/documents/downloadable/ucm_319826.pdf. 2010; American College of Cardiology and American Heart Association. Accessed April 7, 2016.
- 2.↵Committee on Standards for Developing Trustworthy Clinical Practice Guidelines, Institute of Medicine (US). Clinical Practice Guidelines We Can Trust. Washington, DC: National Academies Press; 2011.
- 3.↵Committee on Standards for Systematic Reviews of Comparative Effectiveness Research, Institute of Medicine (US). Finding What Works in Health Care: Standards for Systematic Reviews. Washington, DC: National Academies Press; 2011.
- Jacobs AK,
- Kushner FG,
- Ettinger SM,
- et al
- Jacobs AK,
- Anderson JL,
- Halperin JL
- Anderson JL,
- Heidenreich PA,
- Barnett PG,
- et al
- Arnett DK,
- Goodman RA,
- Halperin JL,
- et al
- Halperin JL,
- Levine GN,
- Al-Khatib SM,
- et al
- Packer M,
- Poole-Wilson PA,
- Armstrong PW,
- et al
- Køber L,
- Torp-Pedersen C,
- Carlsen JE,
- et al
- Packer M,
- Fowler MB,
- Roecker EB,
- et al
- Yancy CW,
- Jessup M,
- Bozkurt B,
- et al
- Eschalier R,
- McMurray JJV,
- Swedberg K,
- et al
- Yusuf S,
- Teo K,
- Anderson C,
- et al
- 29.Entresto [package insert]. Hanover, NJ: Novartis Pharmaceuticals Corporation; 2015.
- Packer M,
- Califf RM,
- Konstam MA,
- et al
- Kostis JB,
- Packer M,
- Black HR,
- et al
- Vardeny O,
- Miller R,
- Solomon SD
- Braunwald E