ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary Revascularization
2009; Lippincott Williams & Wilkins; Volume: 119; Issue: 9 Linguagem: Inglês
10.1161/circulationaha.108.191768
ISSN1524-4539
AutoresManesh R. Patel, Gregory Dehmer, John W. Hirshfeld, Peter K. Smith, John A. Spertus,
Tópico(s)Cardiac, Anesthesia and Surgical Outcomes
ResumoHomeCirculationVol. 119, No. 9ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary Revascularization Free AccessReview ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplemental MaterialFree AccessReview ArticlePDF/EPUBACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary RevascularizationA Report of the American College of Cardiology Foundation Appropriateness Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, and the American Society of Nuclear Cardiology: Endorsed by the American Society of Echocardiography, the Heart Failure Society of America, and the Society of Cardiovascular Computed Tomography CORONARY REVASCULARIZATION WRITING GROUP Manesh R. Patel, Gregory J. Dehmer, John W. Hirshfeld, Peter K. Smith and John A. Spertus CORONARY REVASCULARIZATION WRITING GROUP , Manesh R. PatelManesh R. Patel , Gregory J. DehmerGregory J. Dehmer , John W. HirshfeldJohn W. Hirshfeld , Peter K. SmithPeter K. Smith and John A. SpertusJohn A. Spertus Originally published8 Jan 2009https://doi.org/10.1161/CIRCULATIONAHA.108.191768Circulation. 2009;119:1330–1352is corrected byCorrectionOther version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 8, 2009: Previous Version 1 Abstract…1331Preface…1331Introduction…1333Methods…1333 Indication Development…1333 Scope of Indications…1333 Panel Selection…1334 Rating Process and Scoring…1334General Assumptions…1334 Table A. CAD Prognostic Index…1334Definitions…1335 Table B. Grading of Angina Pectoris by the Canadian Cardiovascular Society Classification System…1335Abbreviations…1336Results of Ratings…1336Coronary Revascularization Appropriateness Criteria (By Indication)…1336 Table 1. Patients With Acute Coronary Syndromes…1336 Table 2. Patients Without Prior Bypass Surgery…1337 Table 3. Patients With Prior Bypass Surgery (Without Acute Coronary Syndromes)…1340Rating Revascularization Methods…1341 Mode of Revascularization for High Severity of CAD (Indications 60 to 73)…1341 Mortality Risk…1341 Advanced CAD…1341 Table 4. Method of Revascularization: Advanced Coronary Disease, CCS Angina Greater Than or Equal to Class III, and/or Evidence of Intermediate- to High-Risk Findings on Noninvasive Testing…1342Discussion…1341 Clinical Judgment…1341 General Themes in Appropriateness Criteria for Revascularization…1341 Acute Coronary Syndromes…1342 Stable Ischemic Heart Disease Without Prior CABG…1342 Stable Ischemic Heart Disease With Prior CABG…1344 PCI and CABG in Patients With Advanced CAD…1344 Application of Criteria…1345Appendix A: Additional Coronary Revascularization Definitions…1346 Table A1. Clinical Classification of Chest Pain…1346 Table A2. Noninvasive Risk Stratification…1346Appendix B: Additional Methods…1346 Relationships With Industry…1346 Literature Review…1347Appendix C: ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary Revascularization Participants…1347Appendix D: ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Coronary Revascularization Appropriateness Criteria Writing Group, Technical Panel, Task Force, and Indication Reviewers—Relationships With Industry…1349References …1352AbstractThe American College of Cardiology Foundation (ACCF), Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, and the American Association for Thoracic Surgery, along with key specialty and subspecialty societies, conducted an appropriateness review of common clinical scenarios in which coronary revascularization is frequently considered. The clinical scenarios were developed to mimic common situations encountered in everyday practice and included information on symptom status, extent of medical therapy, risk level as assessed by noninvasive testing, and coronary anatomy. Approximately 180 clinical scenarios were developed by a writing committee and scored by a separate technical panel on a scale of 1 to 9. Scores of 7 to 9 indicate that revascularization was considered appropriate and likely to improve health outcomes or survival. Scores of 1 to 3 indicate revascularization was considered inappropriate and unlikely to improve health outcomes or survival. The mid range (4 to 6) indicates a clinical scenario for which the likelihood that coronary revascularization would improve health outcomes or survival was considered uncertain. For the majority of the clinical scenarios, the panel only considered the appropriateness of revascularization irrespective of whether this was accomplished by percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG). In a select subgroup of clinical scenarios in which revascularization is generally considered appropriate, the appropriateness of PCI and CABG individually as the primary mode of revascularization was considered.In general, the use of coronary revascularization for patients with acute coronary syndromes and combinations of significant symptoms and/orischemia was viewed favorably. In contrast, revascularization of asymptomatic patients or patients with low-risk findings on noninvasive testing and minimal medical therapy were viewed less favorably. It is anticipated that these results will have an impact on physician decision making and patient education regarding expected benefits from revascularization and will help guide future research.PrefaceThe publication of appropriateness criteria reflects one of several ongoing efforts by the ACCF and its partners to assist clinicians caring for patients with cardiovascular diseases to deliver high-quality cardiovascular care. The American College of Cardiology (ACC)/American Heart Association (AHA) practice guidelines provide a foundation for summarizing evidence-based cardiovascular care and, when evidence is lacking, provide expert consensus opinion that is approved in review by the ACCF and AHA. However, in many areas, marked variability remains in the use of cardiovascular procedures, raising questions of over- or under-use. One reason for this variability is a paucity of large randomized clinical trials conducted assessing the value of technology for specific patients, including cardiac imaging, catheterization, and coronary revascularization. As such, there are many instances in practice where the guidelines provide no recommendation, or alternatively, a Level C recommendation (expert opinion). For other areas, evidence is available but variability in clinical practice remains. In either case, appropriateness criteria provide practical tools to measure this variability to examine utilization patterns.Appropriateness criteria are developed to serve as a supplement to ACC/AHA guideline documents. Appropriateness criteria are designed to examine the use of diagnostic and therapeutic procedures to support efficient use of medical resources during the pursuit of quality medical care. The process of appropriateness criteria development has been defined previously.1 Briefly, the appropriateness criteria writing group combines specific clinical characteristics to create prototypical patient scenarios. These scenarios are then provided to a separate technical panel for appropriateness rating. The technical panel is created from nominations given by multiple relevant professional societies and provider-led organizations as well as from health policy and payer communities. To preserve objectivity, the technical panels are created so as to not include a majority of individuals whose livelihood is tied to the technology under study.In making its appropriateness determinations, the technical panel is provided with summaries of the relevant evidence from the medical literature and practice guidelines. They are then asked first individually and then collectively to assess the benefits and risks of a test or procedure in the context of the potential benefits to patients' outcomes and an implicit understanding of the associated resource use and costs. After the ranking process, the final appropriateness ratings are summarized using an established rigorous methodology.2Appropriateness criteria are based on current understanding of the technical capabilities and potential patient benefits of the procedures examined. Future evidence development may require these ratings to be updated. The appropriateness criteria are also developed to identify common clinical scenarios—but they cannot possibly include every conceivable clinical situation. Thus, some patients seen in clinical practice are not represented in these appropriateness criteria or have additional extenuating features compared with the clinical scenarios presented. Additionally, although appropriateness criteria indications and ratings are shaped by the practice guidelines, the appropriateness criteria often contain more detailed scenarios than the more generalized situations covered in clinical practice guidelines, and thus, subtle differences between these 2 guidance tools is possible.Finally, appropriateness criteria are intended to assist patients and clinicians, but are not intended to diminish the acknowledged difficulty or uncertainty of clinical decision making and cannot act as substitutes for sound clinical judgment and practice experience. Rather, the aim of these criteria is to allow assessment of utilization patterns for a test or procedure. Comparing utilization patterns across a large subset of provider's patients can allow for an assessment of a provider's management strategies with those of his/her peers. The ACCF and its collaborators believe that an ongoing review of one's practice using these criteria will help guide a more effective, efficient, and equitable allocation of health care resources, and ultimately, better patient outcomes.In developing these appropriateness criteria for coronary revascularization, the technical panel was asked to assess whether coronary revascularization for each indication was appropriate, uncertain, or inappropriate using the following definition of appropriateness:Coronary revascularization is appropriate when the expected benefits, in terms of survival or health outcomes (symptoms, functional status, and/or quality of life) exceed the expected negative consequences of the procedure.The technical panel scored each indication on a scale from 1 to 9 as follows:Appropriate: Score 7 to 9Appropriate for the indication provided, meaning coronary revascularization is generally acceptable and is a reasonable approach for the indication and is likely to improve the patients' health outcomes or survival.Uncertain: Score 4 to 6Uncertain for the indication provided, meaning coronary revascularization may be acceptable and may be a reasonable approach for the indication but with uncertainty implying that more research and/or patient information is needed to further classify the indication.Inappropriate: Score 1 to 3Inappropriate for the indication provided, meaning coronary revascularization is not generally acceptable and is not a reasonable approach for the indication and is unlikely to improve the patients' health outcomes or survival.It is acknowledged that grouping these scores into 3 categories is somewhat arbitrary and that the numeric designations should be viewed as a continuum. Since some diversity in clinical opinions for particular clinical scenarios will exist or available research is limited or conflicting, scores in the intermediate level of appropriateness are labeled "uncertain." This identifies the need for targeted investigations to clarify the best therapy in these circumstances. It is anticipated that these appropriateness criteria will require updates as further data are generated and information from the implementation of these criteria accumulates.To prevent bias in the scoring process, the technical panel was deliberately comprised of physicians with varying perspectives on coronary revascularization and not comprised solely of experts (eg, interventional cardiologists or cardiovascular surgeons) in the particular procedure under evaluation. Such experts, while offering important clinical and technical insights, might have a natural tendency to rate the indications within their specialty as more appropriate than nonspecialists. In addition, care was taken in providing objective, nonbiased information, including national practice guidelines and a broad range of key references, to the technical panel.We are grateful to the technical panel, a professional group with a wide range of skills and insights, for their thoughtful and thorough deliberation of the merits of coronary revascularization for various indications. In addition to our thanks to the technical panel for their dedicated work and review, we would like to offer special thanks to the many individuals who provided a careful review of the draft indications: to Peggy Christiansen, the ACCF librarian, for her comprehensive literature searches; to Karen Caruth, who continually drove the process forward; to Lindsey Law and Kennedy Elliott, who helped map these criteria with existing ACC/AHA practice guidelines; and to Manesh Patel, MD, the chair of the writing committee, for his dedication, insight and leadership.Frederick A. Masoudi, MD, MSPH, FACCModerator, Coronary Revascularization Technical PanelRalph G. Brindis, MD, MPH, FACC, FSCAIChair, Appropriateness Criteria Task ForceIntroductionThis report addresses the appropriateness of coronary revascularization. The increasing prevalence of coronary artery disease (CAD), advances in surgical and percutaneous techniques for revascularization as well as concomitant medical therapy for CAD, and the costs of revascularization have resulted in heightened interest regarding the appropriateness of coronary revascularization. Clinicians, payers, and patients are interested in the specific benefits of revascularization. Importantly, inappropriate use of revascularization may be potentially harmful to patients and generate unwarranted costs to the health care system, whereas appropriate procedures should likely improve patients' clinical outcomes.All prior appropriateness criteria publications from the ACCF and collaborating organizations have reflected an ongoing effort to critically and systematically create, review, and categorize the appropriateness of certain cardiovascular diagnostic tests. This document presents the first attempt to develop appropriateness criteria for therapeutic procedures: in this case, 2 distinct approaches to coronary artery revascularization. This is an important shift to the explicit consideration of the potential benefits and risks of a therapeutic procedure. This document presents the results of this effort, but it is critical to understand the background and scope of this document before interpreting the rating tables.MethodsBriefly, this process combines evidence-based medicine, guidelines, and practice experience by engaging a technical panel in a modified Delphi exercise as previously described by RAND.2Indication DevelopmentThe writing group for the coronary revascularization indications was comprised of members from the relevant professional societies including both practicing interventional cardiologists and a cardiothoracic surgeon. Recognizing variability in many patient factors, local practice patterns, and a lack of data comparing PCI with CABG in all possible clinical scenarios, the technical panel was asked to rate the majority of clinical indications only for the appropriateness of revascularization and not to distinguish between the specific modes of revascularization (i.e., PCI versus CABG). In addition, the writing group identified indications for patients with advanced coronary disease and symptoms, where revascularization is generally considered to be appropriate. In this section, PCI and CABG were independently evaluated for appropriateness.Once the indications were drafted, reviewers from all participating collaborators and stakeholders, including cardiovascular and surgical societies, provided feedback regarding the clinical indications for coronary revascularization. These comments led to substantial improvements and changes in the clinical scenarios.Scope of IndicationsThe indications contained in this report are purposefully broad and intended to represent the most common patient scenarios for which coronary revascularization is considered. The development of these clinical scenarios re-emphasized to the writing group the complexity of the decision-making process for revascularization and the number of variables that inform this decision. The writing group estimated that over 4,000 separate clinical scenarios would be required to incorporate all permutations of these variables. However, providing that level of granularity to this framework would be cumbersome and likely degrade the purpose of these criteria. As this was not a viable option, the indications were developed considering the following common variables: a. The clinical presentation (eg, acute coronary syndrome, stable angina, and so on);b. Severity of angina (asymptomatic, Canadian Cardiovascular Society [CCS] Class I, II, III, or IV);c. Extent of ischemia on noninvasive testing and the presence or absence of other prognostic factors, such as congestive heart failure (CHF), depressed left ventricular function, or diabetes;d. Extent of medical therapy; ande. Extent of anatomic disease (1-, 2-, 3-vessel disease, with or without proximal left anterior descending artery [LAD] or left main coronary disease).The clinical indications developed include coronary anatomy, as this is the focus of much of the previous literature on coronary revascularization. However, the writing group recognizes that for everyday patient care, symptom status, ischemic burden, and level of medical therapy often play a critical role in decision making even before the coronary anatomy has been defined by angiography.Please note that the indications focus on revascularization, percutaneous or surgical, and therefore do not address diagnostic catheterization or coronary angiography. Additionally, the clinical scenarios presented are not inclusive of every possible clinical situation. For example, the use of coronary revascularization for patients with multivessel disease including 1 or more occluded vessels and clinical symptoms or ischemia was not included as a separate indication since other variations of multivessel disease are present.Panel SelectionStakeholders were given the opportunity to participate in the appropriateness criteria process by submitting nominees from their organizations through a call for nominations announced in the summer of 2006. From this list of nominees, the task force and writing group selected technical panel members to ensure an appropriate balance with respect to expertise. The 17-member technical panel was composed of 4 interventional cardiologists, 4 cardiovascular surgeons, 8 members representing cardiologists, other physicians who treat patients with cardiovascular disease, health outcome researchers, and 1 medical officer from a health plan.Rating Process and ScoringThe panel members first rated indications independently. Then the panel met for a discussion of each indication. After the face-to-face discussion, panel members then independently provided their final scores for each indication. Each panel member had equal weight in producing the final result for the indications and was not forced into consensus. For each indication, the median numerical score was determined.At the face-to-face meeting, each panelist received a personalized rating form that indicated his/her rating for each indication and the distribution of deidentified ratings of other members of the panel. In addition, the moderator received a summary rating form with similar information (including panelist identification), along with other statistics reflecting the level of agreement among panel members. The level of agreement among panelists, as defined by RAND, was analyzed for each indication based on the BIOMED rule for a panel of 14 to 16 (a simplified RAND method for determining disagreement).2 Per the BIOMED definition, agreement was defined as an indication where 4 or fewer panelists' ratings fell outside the 3-point region containing the median score. Disagreement was defined as a situation where at least 5 panelists' ratings fell in both the appropriate and the inappropriate categories. Because the panel had 17 representatives, which exceeded the 16 addressed in this rule, an additional level of agreement analysis as described by RAND was performed that examines the interpercentile range compared to interpercentile range adjusted for symmetry.2 This information was used by the moderator to guide the panel's discussion by highlighting areas of differences among the panelists.General AssumptionsSpecific assumptions are provided that were considered by the technical panel in rating the relevant clinical indications for the appropriateness of revascularization: Each clinical indication includes the patient's clinical status/symptom complex, ischemic burden by noninvasive functional testing when presented, burden of coronary atherosclerosis as determined by angiography, and intensity of medical therapy in the determination of the appropriateness of coronary revascularization.Assume coronary angiography has been performed when these findings are presented in the clinical indications. The panel should rate the appropriateness of revascularization based upon the clinical features and coronary findings, and not the appropriateness of diagnostic coronary angiography.Assume left main coronary artery stenosis (greater than or equal to 50% luminal diameter narrowing) or proximal LAD stenosis (greater than or equal to 70% luminal diameter narrowing) is not present unless specifically noted. Assume no other significant coronary artery stenoses are present except those noted in the clinical scenario.The clinical scenarios should be rated based on the published literature regarding the risks and benefits of percutaneous and surgical coronary revascularization. Note that specific patient groups not well represented in the literature are not presented in the current clinical scenarios. However, the writing group recognizes that decisions about coronary artery revascularization in such patients are frequently required. Examples of such patients include those with end-stage renal disease or advanced age.Clinical outcome is related to the extent of coronary artery disease3 (Table A). Based on this observation and clinical guideline recommendations regarding "borderline" angiographic stenoses (50% to 60%) in epicardial (non-left main) locations, a significant coronary stenosis for the purpose of the clinical scenarios is defined as: Table A. CAD Prognostic IndexExtent of CADPrognostic Weight (0–100)5-Year Survival Rate (%)**Assuming medical treatment only. CAD indicates coronary artery disease; LAD, left anterior descending coronary artery. From Califf RM, Armstrong PW, Carver JR, et al. Task Force 5. Stratification of patients into high-, medium-, and low-risk subgroups for purposes of risk factor management. J Am Coll Cardiol. 1996;27:964–1047.41-vessel disease, 75%2393>1-vessel disease, 50% to 74%23931-vessel disease, ≥95%32912-vessel disease37882-vessel disease, both ≥95%42861-vessel disease, ≥95% proximal LAD48832-vessel disease, ≥95% LAD48832-vessel disease, ≥95% proximal LAD56793-vessel disease56793-vessel disease, ≥95% in at least 163733-vessel disease, 75% proximal LAD67673-vessel disease, ≥95% proximal LAD7459 greater than or equal to 70% luminal diameter narrowing, by visual assessment, of an epicardial stenosis measured in the "worst view" angiographic projection. greater than or equal to 50% luminal diameter narrowing, by visual assessment, of a left main stenosis measured in the "worst view" angiographic projection.All patients are receiving standard care, including guideline-based risk-factor modification for primary or secondary prevention in cardiovascular patients unless specifically noted.5–9Despite the best efforts of the clinician, all patients may not achieve target goals for risk-factor modification. However, a plan of care to address risk factors is assumed to be occurring in patients represented in the indications. For patients with chronic stable angina, the writing group recognizes that there is a wide variance in the medical therapy for angina. The specific definition of maximal anti-ischemic medical therapy is presented in the definition section.Operators performing percutaneous or surgical revascularization have appropriate clinical training and experience and have satisfactory outcomes as assessed by quality assurance monitoring.10–12Revascularization by either percutaneous or surgical methods is performed in a manner consistent with established standards of care.10–12In the clinical scenarios, no unusual extenuating circumstances exist (such as inability to comply with antiplatelet agents, do not resuscitate status, patient unwilling to consider revascularization, technically not feasible to perform revascularization, or comorbidities likely to markedly increase procedural risk substantially), unless specifically noted.DefinitionsA complete set of definitions of terms used throughout the indication set are listed in Appendix A. These definitions were provided and discussed with the technical panel prior to ratings of indications.Maximal Anti-Ischemic Medical TherapyAs previously stated, the indications assume that patients are receiving risk-factor modification according to guideline-based recommendations. For the purposes of the clinical scenarios presented, maximal antianginal medical therapy is defined as the use of at least 2 classes of therapies to reduce anginal symptoms.Stress Testing and Risk of Findings on Noninvasive TestingStress testing is commonly used for both diagnosis and risk stratification of patients with coronary artery disease. Using criteria defined for traditional exercise stress tests13: Low-risk stress test findings: associated with a cardiac mortality of less than 1% per year;Intermediate-risk stress test findings: associated with a 1% to 3% per year cardiac mortality;High-risk stress test findings: associated with a greater than 3% per year cardiac mortality.Examples of findings from noninvasive studies and their associated level of risk for cardiac mortality are presented in Table A2.12 As noted in the footnote to this table, for certain low-risk findings, there may be additional findings that alter the assessment of risk, but these relationships have not been well studied. Implicit in these risk definitions is a measure of the amount of myocardium at risk, or ischemic myocardium. For the purpose of the clinical indications for coronary revascularization, stress test findings are presented by these risk criteria. For patients without stress test findings, please refer to the note below on invasive methods of determining hemodynamic significance. Assume that when prior testing (including an imaging procedure) is referenced in an indication, the testing was performed correctly and with sufficient quality so as to produce a meaningful and accurate result within the limits of the test performance.For the purposes of the clinical indications in this document, patients with both typical and atypical angina are classified by the feature of the CCS grading system presented in Patients with noncardiac chest pain should be considered to be asymptomatic. Table B. Table B. Grading of Angina Pectoris by the Canadian Cardiovascular Society Classification SystemFrom Campeau L. Grading of angina pectoris [letter]. Circulation. 1976;54:522–3.14 Copyright 1976 American Heart Association, Inc. Reprinted with permission.Class IOrdinary physical activity does not cause angina, such as walking, climbing stairs. Angina (occurs) with strenuous, rapid, or prolonged exertion at work or recreation.Class IISlight limitation of ordinary activity. Angina occurs on walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals or in cold, or in wind, or under emotional stress, or only during the few hours after awakening. Angina occurs on walking more than 2 blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal condition.Class IIIMarked limitations of ordinary physical activity. Angina occurs on walking 1 to 2 blocks on the level and climbing 1 flight of stairs in normal conditions and at a normal pace.Class IVInability to carry on any physical activity without discomfort—anginal symptoms may be present at rest.High-Risk Features for Short-Term Risk of Death or Nonfatal MI for UA/NSTEMI15At least 1 of the following: History: accelerating tempo of ischemic symptoms in preceding 48 hoursCharacter of pain: prolonged ongoing (greater than 20 minutes) rest painClinical findings ○ Pulmonary edema, most likely due to ischemia ○ New or worsening mitral regurgitation murmur ○ S3 or new/worsening rales ○ Hypotension, bradycardia, tachycardia ○ Age greater than 75 yearsElectrocardiogram ○ Angina at rest with transient ST-segment changes greater than 0.5 mm ○ Bundle-branch block, new or presumed new ○ Sustained ventricular tachycardiaCardiac marker ○ Elevated cardiac troponin T, troponin I, or creatine kinase-MB (eg, troponin T or I greater than 0.1 ng per mL)AbbreviationsCABG = coronary artery bypass graftingCAD = coronary artery diseaseCCS = Canadian Cardiovascular SocietyCCT = cardiac computed tomog
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