2011 ACCF/AHA guideline for coronary artery bypass graft surgery: Executive summary

The medical profession should play a central role in evaluating the evidence related to drugs, devices, and procedures for the detection, management, and prevention of disease. When properly applied, expert analysis of available data on the benefits and risks of these therapies and procedures can improve the quality of care, optimize patient outcomes, and favorably affect costs by focusing resources on the most effective strategies. An organized and directed approach to a thorough review of evidence has resulted in the production of clinical practice guidelines that assist physicians in selecting the best management strategy for an individual patient. Moreover, clinical practice guidelines can provide a foundation for other applications, such as performance measures, appropriate use criteria, and both quality improvement and clinical decision support tools. The American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) have jointly produced guidelines in the area of cardiovascular disease since 1980. The ACCF/AHA Task Force on Practice Guidelines (Task Force), charged with developing, updating, and revising practice guidelines for cardiovascular diseases and procedures, directs and oversees this effort. Writing committees are charged with regularly reviewing and evaluating all available evidence to develop balanced, patient-centric recommendations for clinical practice. Experts in the subject under consideration are selected by the ACCF and AHA to examine subject-specific data and write guidelines in partnership with representatives from other medical organizations and specialty groups. Writing committees are asked to perform a formal literature review; weigh the strength of evidence for or against particular tests, treatments, or procedures; and include estimates of expected outcomes where such data exist. Patient-specific modifiers, comorbidities, and issues of patient preference that may influence the choice of tests or therapies are considered. When available, information from studies on cost is considered, but data on efficacy and outcomes constitute the primary basis for the recommendations contained herein. In analyzing the data and developing recommendations and supporting text, the writing committee uses evidence-based methodologies developed by the Task Force. 1ACCF/AHA Task Force on Practice GuidelinesMethodologies and Policies from the ACCF/AHA Task Force on Practice Guidelines. http: //assets. cardiosource. com/MethodologyManualforACCAHAWritingCommittees. pdfGoogle Scholar The Class of Recommendation (COR) is an estimate of the size of the treatment effect considering risks versus benefits in addition to evidence and/or agreement that a given treatment or procedure is or is not useful/effective or in some situations may cause harm. The Level of Evidence (LOE) is an estimate of the certainty or precision of the treatment effect. The writing committee reviews and ranks evidence supporting each recommendation with the weight of evidence ranked as LOE A, B, or C according to specific definitions that are included in Table 1. Studies are identified as observational, retrospective, prospective, or randomized where appropriate. For certain conditions for which inadequate data are available, recommendations are based on expert consensus and clinical experience and are ranked as LOE C. When recommendations at LOE C are supported by historical clinical data, appropriate references (including clinical reviews) are cited if available. For issues for which sparse data are available, a survey of current practice among the clinicians on the writing committee is the basis for LOE C recommendations, and no references are cited. The schema for COR and LOE is summarized in Table 1, which also provides suggested phrases for writing recommendations within each COR. A new addition to this methodology is separation of the Class III recommendations to delineate if the recommendation is determined to be of “no benefit” or is 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 or strategy versus another have been added for COR I and IIa, LOE A or B only. Table 1Applying classification of recommendations and level of evidenceA 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. ∗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. †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. Open table in a new tab 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. ∗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. †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. In view of the advances in medical therapy across the spectrum of cardiovascular diseases, the Task Force has designated the term guideline-directed medical therapy (GDMT) to represent optimal medical therapy as defined by ACCF/AHA guideline-recommended therapies (primarily Class I). This new term, GDMT, will be used herein and throughout all future guidelines. Because the ACCF/AHA practice guidelines address patient populations (and healthcare providers) residing in North America, drugs that are not currently available in North America are discussed in the text without a specific COR. For studies performed in large numbers of subjects outside North America, each writing committee reviews the potential influence of different practice patterns and patient populations on the treatment effect and relevance to the ACCF/AHA target population to determine whether the findings should inform a specific recommendation. The ACCF/AHA practice guidelines are intended to assist healthcare providers in clinical decision making by describing a range of generally acceptable approaches to the diagnosis, management, and prevention of specific diseases or conditions. The guidelines attempt to define practices that meet the needs of most patients in most circumstances. The ultimate judgment regarding the care of a particular patient must be made by the healthcare provider and patient in light of all the circumstances presented by that patient. As a result, situations may arise for which deviations from these guidelines may be appropriate. Clinical decision making should involve consideration of the quality and availability of expertise in the area where care is provided. When these guidelines are used as the basis for regulatory or payer decisions, the goal should be improvement in quality of care. The Task Force recognizes that situations arise in which additional data are needed to inform patient care more effectively; these areas will be identified within each respective guideline when appropriate. Prescribed courses of treatment in accordance with these recommendations are effective only if followed. Because lack of patient understanding and adherence may adversely affect outcomes, physicians and other healthcare providers should make every effort to engage the patient’s active participation in prescribed medical regimens and lifestyles. In addition, patients should be informed of the risks, benefits, and alternatives to a particular treatment and be involved in shared decision making whenever feasible, particularly for COR IIa and IIb, where the benefit-to-risk ratio may be lower. The Task Force makes every effort to avoid actual, potential, or perceived conflicts of interest that may arise as a result of industry relationships or personal interests among the members of the writing committee. All writing committee members and peer reviewers of the guideline are required to disclose all such current relationships, as well as those existing 12 months previously. In December 2009, the ACCF and AHA implemented a new policy for relationships with industry and other entities (RWI) that requires the writing committee chair plus a minimum of 50% of the writing committee to have no relevant RWI (Appendix 1 for the ACCF/AHA definition of relevance). These statements are reviewed by the Task Force and all members during each conference call and meeting of the writing committee and are updated as changes occur. All guideline recommendations require a confidential vote by the writing committee and must be approved by a consensus of the voting members. Members are not permitted to write, and must rescue themselves from voting on, any recommendation or section to which their RWI apply. Members who recused themselves from voting are indicated in the list of writing committee members, and section recusals are noted in Appendix 1. Authors’ and peer reviewers’ RWI pertinent to this guideline are disclosed in Appendixes 1 and 2, respectively. Additionally, to ensure complete transparency, writing committee members’ comprehensive disclosure information—including RWI not pertinent to this document—is available as an online supplement. Comprehensive disclosure information for the Task Force is also available online at www. cardiosource. org/ACC/About-ACC/Leadership/Guidelines-and-Documents-Task-Forces. aspx. The work of the writing committee was supported exclusively by the ACCF and AHA without commercial support. Writing committee members volunteered their time for this activity. In an effort to maintain relevance at the point of care for practicing physicians, the Task Force continues to oversee an ongoing process improvement initiative. As a result, in response to pilot projects, evidence tables (with references linked to abstracts in PubMed) have been added. In April 2011, the Institute of Medicine released 2 reports: Finding What Works in Health Care: Standards for Systematic Reviews and Clinical Practice Guidelines We Can Trust. 2Institute of MedicineFinding What Works in Health Care: Standards for Systematic Reviews. The National Academies Press, Washington, DC2011Google Scholar, 3Institute of MedicineClinical Practice Guidelines We Can Trust. The National Academies Press, Washington, DC2011Google Scholar It is noteworthy that the ACCF/AHA guidelines are cited as being compliant with many of the proposed standards. A thorough review of these reports and of our current methodology is under way, with further enhancements anticipated. The recommendations in this guideline are considered current until they are superseded by a focused update or the full-text guideline is revised. Guidelines are official policy of both the ACCF and AHA. Alice K. Jacobs, MD, FACC, FAHA, Chair, ACCF/AHA Task Force on Practice Guidelines Whenever possible, the recommendations listed in this document are evidence based. Articles reviewed in this guideline revision covered evidence from the past 10 years through January 2011, as well as selected other references through April 2011. Searches were limited to studies, reviews, and evidence conducted in human subjects that were published in English. Key search words included but were not limited to: analgesia, anastomotic techniques, antiplatelet agents, automated proximal clampless anastomosis device, asymptomatic ischemia, Cardica C-port, cost effectiveness, depressed left ventricular (LV) function, distal anastomotic techniques, direct proximal anastomosis on aorta, distal anastomotic devices, emergency coronary artery bypass graft (CABG) and ST-elevation myocardial infarction (STEMI), heart failure, interrupted sutures, LV systolic dysfunction, magnetic connectors, PAS-Port automated proximal clampless anastomotic device, patency, proximal connectors, renal disease, sequential anastomosis, sternotomy, symmetry connector, symptomatic ischemia, proximal connectors, sequential anastomosis, T grafts, thoracotomy, U-clips, Ventrica Magnetic Vascular Port system, Y grafts. Additionally, the committee reviewed documents related to the subject matter previously published by the ACCF and AHA. References selected and published in this document are representative but not all-inclusive. The guideline is focused on the safe, appropriate, and efficacious performance of CABG. The STEMI, percutaneous coronary intervention (PCI), and CABG guidelines were written concurrently, with additional collaboration from the Stable Ischemic Heart Disease (SIHD) guideline writing committee. This allowed greater collaboration among the different writing committees on topics such as PCI in STEMI and revascularization strategies in patients with coronary artery disease (CAD) (including unprotected left main PCI, multivessel disease revascularization, and hybrid procedures). In accordance with the direction of the Task Force and feedback from readers, in this iteration of the guideline, the amount of text has been shortened, and emphasis has been placed on summary statements rather than detailed discussion of numerous individual trials. Online supplemental evidence and summary tables have been created to document the studies and data considered for new or changed guideline recommendations. Because the executive summary contains only the recommendations, the reader is encouraged to consult the full-text guideline4Hillis L. D. Smith P. K. Anderson J. L. et al. 2011 ACCF/AHA guideline for coronary artery bypass graft surgery: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2011; (published online before print November 7, 2011, doi: 10. 1016/j. jacc. 2011. 08. 009. Accessed November 7, 2011) Google Scholar for additional detail on the recommendations and guidance on the care of the patient undergoing CABG. The committee was composed of acknowledged experts in CABG, interventional cardiology, general cardiology, and cardiovascular anesthesiology. The committee included representatives from the ACCF, AHA, American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and Society of Thoracic Surgeons (STS). This document was reviewed by 2 official reviewers, each nominated by both the ACCF and the AHA, as well as 1 reviewer each from the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and STS, as well as members from the ACCF/AHA Task Force on Data Standards, ACCF/AHA Task Force on Performance Measures, ACCF Surgeons’ Scientific Council, ACCF Interventional Scientific Council, and Southern Thoracic Surgical Association. All information on reviewers’ RWIs was distributed to the writing committee and is published in this document (Appendix 2. This document was approved for publication by the governing bodies of the ACCF and the AHA and endorsed by the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and STS. Class I1. Anesthetic management directed toward early postoperative extubation and accelerated recovery of low- to medium-risk patients undergoing uncomplicated CABG is recommended. 5Hawkes CA, Dhileepan S, Foxcroft D. Early extubation for adult cardiac surgical patients. Cochrane Database Syst Rev. 2003;CD003587-10. 1002/14651858. CD003587. Google Scholar, 6Myles P. S. Daly D. J. Djaiani G. et al. A systematic review of the safety and effectiveness of fast-track cardiac anesthesia. Anesthesiology. 2003; 99: 982-987Crossref PubMed Scopus (22) Google Scholar, 7van Mastrigt G. A. Maessen J. G. Heijmans J. et al. Does fast-track treatment lead to a decrease of intensive care unit and hospital length of stay in coronary artery bypass patients? A meta-regression of randomized clinical trials. Crit Care Med. 2006; 34: 1624-1634Crossref PubMed Scopus (18) Google Scholar (Level of Evidence: B) 2. 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