ACCF/SCCT/ACR/AHA/ASE/ASNC/NASCI/SCAI/SCMR 2010 Appropriate Use Criteria for Cardiac Computed Tomography: A Report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, the Society of Cardiovascular Computed Tomography, the American College of Radiology, the American Heart Association, the American Society of Echocardiography, the American Society of Nuclear Cardiology, the North American Society for Cardiovascular Imaging, the Society for Cardiovascular Angiography and Interventions, and the Society for Cardiovascular Magnetic Resonance

Technical Panel

Christopher M. Kramer, MD, FACC, FAHA, Moderator

Allen J. Taylor, MD, FACC, FAHA, Writing Group Liaison

Daniel Berman, MD, FACC§

Alan Brown, MD, FACC, FAHA, FNLA^⁎

Farooq A. Chaudhry, MD, FACC, FAHA, FASE^⁎⁎

Official American Society of Echocardiography Representative;

Ricardo C. Cury, MD§††

Official Society for Cardiovascular Magnetic Resonance Representative;

Milind Y. Desai, MD, FACC††

Andrew J. Einstein, MD, PhD, FACC, FAHA, FASNC†

Antoinette S. Gomes, MD, FAHA, FSIR¶

Robert Harrington, MD, FACC, FAHA, FSCAI^⁎

Udo Hoffmann, MD, MPH#

Rahul Khare, MD‡‡

Official American College of Emergency Physicians Representative;

John Lesser, MD, FACC§

Christopher McGann, MD, FACC§§

Official Heart Rhythm Society Representative;

Alan Rosenberg, MD, FACC∥∥

Official Health Plan Representative;

Robert Schwartz, MD, FACC‡

Marc Shelton, MD, FACC^⁎

Gerald W. Smetana, MD¶¶

Official American College of Physicians Representative

Sidney C. Smith, Jr, MD, FACC, FAHA∥

ACCF Appropriate Use Criteria Task Force

Michael J. Wolk, MD, MACC, Chair

Joseph M. Allen, MA

Steven Bailey, MD, FACC, FSCAI

Pamela S. Douglas, MD, MACC, FAHA, FASE

Robert C. Hendel, MD, FACC, FAHA, FASNC

Christopher M. Kramer, MD, FACC, FAHA

James Min, MD, FACC, FSCCT

Manesh R. Patel, MD, FACC

Leslee Shaw, PhD, FACC, FASNC

Raymond F. Stainback, MD, FACC, FASE

Table of Contents

Abstract

The American College of Cardiology Foundation (ACCF), along with key specialty and subspecialty societies, conducted an appropriate use review of common clinical scenarios where cardiac computed tomography (CCT) is frequently considered. The present document is an update to the original CCT/cardiac magnetic resonance (CMR) appropriateness criteria published in 2006, written to reflect changes in test utilization, to incorporate new clinical data, and to clarify CCT use where omissions or lack of clarity existed in the original criteria (1).

The indications for this review were drawn from common applications or anticipated uses, as well as from current clinical practice guidelines. Ninety-three clinical scenarios were developed by a writing group and scored by a separate technical panel on a scale of 1 to 9 to designate appropriate use, inappropriate use, or uncertain use.

In general, use of CCT angiography for diagnosis and risk assessment in patients with low or intermediate risk or pretest probability for coronary artery disease (CAD) was viewed favorably, whereas testing in high-risk patients, routine repeat testing, and general screening in certain clinical scenarios were viewed less favorably. Use of noncontrast computed tomography (CT) for calcium scoring was rated as appropriate within intermediate- and selected low-risk patients. Appropriate applications of CCT are also within the category of cardiac structural and functional evaluation. It is anticipated that these results will have an impact on physician decision making, performance, and reimbursement policy, and that they will help guide future research.

Preface

In an effort to respond to the need for the rational use of imaging services in the delivery of high-quality care, the ACCF has undertaken a process to determine the appropriate use of cardiovascular imaging for selected patient indications.

Appropriate use criteria publications reflect an ongoing effort by the ACCF to critically and systematically create, review, and categorize clinical situations where diagnostic tests and procedures are utilized by physicians caring for patients with cardiovascular diseases. The process is based on current understanding of the technical capabilities of the imaging modalities examined. Although not intended to be entirely comprehensive, the indications are meant to identify common scenarios encompassing the majority of contemporary practice. Given the breadth of information they convey, the indications do not directly correspond to the ninth revision of the International Classification of Diseases(ICD-9) system as these codes do not include clinical information, such as symptom status.

The ACCF believes that careful blending of a broad range of clinical experiences and available evidence-based information will help guide a more efficient and equitable allocation of healthcare resources in cardiovascular imaging. The ultimate objective of appropriate use criteria is to improve patient care and health outcomes in a cost-effective manner but is not intended to ignore ambiguity and nuance intrinsic to clinical decision making. Local parameters, such as the availability or quality of equipment or personnel, may influence the selection of appropriate imaging procedures. Appropriate use criteria thus should not be considered substitutes for sound clinical judgment and practice experience.

The ACCF appropriate use criteria process itself is also evolving. In the current iteration, technical panel members were asked to rate indications for CCT in a manner independent and irrespective of the prior published ACCF ratings for CCT and CMR (1) as well as the prior ACCF ratings for similar diagnostic stress imaging modalities such as cardiac radionuclide imaging (2) or stress echocardiography (3) (see Appendix Afor the definitions of terms used throughout the indication set). Given the iterative nature of the process, readers are counseled not to compare too closely individual appropriate use ratings among modalities rated at different times over the past 2 years. A comparative evaluation of the appropriate use of multiple imaging techniques is currently being undertaken to assess the relative strengths of each modality for various clinical scenarios.

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 CCT 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 Lindsey Law, Starr Webb, and Joseph M. Allen, who continually drove the process forward; and to Allen J. Taylor, MD, the chair of the writing committee for his dedication, insight, and leadership.

Christopher M. Kramer, MD, FACC, FAHA

Moderator, Cardiac Computed Tomography Technical Panel

Michael J. Wolk, MD, MACC

Chair, Appropriate Use Criteria Task Force

1 Introduction

This report addresses the appropriate use of CCT. Improvements in cardiovascular imaging technology and their application, coupled with increasing therapeutic options for cardiovascular disease, have led to an increase in cardiovascular imaging. At the same time, the armamentarium of noninvasive diagnostic tools has expanded with innovations in new contrast agents, molecular radionuclide imaging, perfusion echocardiography, computed tomography for coronary angiography and calcium scoring, and magnetic resonance imaging for myocardial structure and viability. As the field of CCT continues to advance along with other imaging modalities, the healthcare community needs to understand how to best incorporate this technology into daily clinical care.

All prior appropriate use criteria publications from the ACCF and collaborating organizations have reflected an ongoing effort to critically and systematically create, review, and categorize the appropriate use of certain cardiovascular diagnostic tests. The ACCF recognizes the importance of revising these criteria in a timely manner in order to provide the cardiovascular community with the most accurate indications. The present document is the second update to an existing appropriate use criteria document, the “ACCF/ACR/SCCT/SCMR/ASNC/NASCI/SCAI/SIR Appropriateness Criteria for Cardiac Computed Tomography and Cardiac Magnetic Resonance Imaging,” published in 2006 (1). Clinicians, payers, and patients are interested in the specific benefits of CCT. Of importance, inappropriate use of CCT may be potentially harmful to patients and generate unwarranted costs to the health care system, whereas appropriate procedures should likely improve patients' clinical outcomes. This is a critical shift because the intent is for the potential benefits and risks of the treatment to be explicitly considered, rather than the potential usefulness of a diagnostic test as a prelude to further treatment. 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.

2 Methods

The indications included in this review are purposefully broad, and they comprise a wide array of cardiovascular signs and symptoms as well as clinical judgment as to the likelihood of cardiovascular findings.

Further description of the methods used for ranking of the selected clinical indications is outlined in Appendix Band is also found more generally in a previous publication, “ACCF Proposed Method for Evaluating the Appropriateness of Cardiovascular Imaging” (4). Briefly, this process combines evidence-based medicine and practice experience by engaging a technical panel in a modified Delphi exercise. Because the original CCT/CMR criteria document and methods paper was published, several important processes have been put in place to further enhance this process. They include convening a formal writing committee with diverse expertise in imaging, circulating the indications for external review prior to rating by the technical panel, ensuring appropriate balance of the technical panel, a standardized rating package, and creating formal roles for facilitating panel interaction at the face-to-face meeting.

The panel first rated indications independently. In rating these criteria, the Cardiac Computed Tomography Appropriate Use Criteria Technical Panel was asked to assess whether the use of the test for each indication is appropriate, uncertain, or inappropriate as defined in the following text.

An appropriate imaging study is one in which the expected incremental information, combined with clinical judgment, exceeds the expected negative consequences^⁎

Negative consequences include the risks of the procedure (radiation or contrast exposure) and the downstream impact of poor test performance such as delay in diagnosis (false negatives) or inappropriate diagnosis (false positives).

The technical panel scores each indication as follows:

• Score 7 to 9

• Appropriate test for specific indication (test isgenerally acceptable and isa reasonable approach for the indication).

• Score 4 to 6

• Uncertain for specific indication (test maybe generally acceptable and maybe a reasonable approach for the indication). (Uncertainty also implies that more research and/or patient information is needed to classify the indication definitively.)

• Score 1 to 3

• Inappropriate test for specific indication (test is notgenerally acceptable and is nota reasonable approach for the indication).

Then the panel was convened for a face-to-face meeting for discussion of each indication. At this meeting, panel members were provided with their scores and a blinded summary of their peers' scores. After the consensus meeting, panel members were then asked to independently provide their final scores for each indication. Following the second round ratings, a supplemental rating process was conducted for a revised set of criteria for preoperative testing (31 to 38) and the clinical scenario of prior revascularization (40 to 41). Although these categories had been considered within the original 2 rounds of rating, the clinical scenarios were rewritten to more closely mirror prior documents, and the balloting was repeated.

The contributors acknowledge that the division of these scores into 3 categories of appropriate use is somewhat arbitrary and that the numeric designations should be viewed as a continuum. The contributors also recognize diversity in clinical opinion for particular clinical scenarios. Scores in the intermediate level of appropriate use should therefore be labeled uncertain, as critical patient or research data may be lacking or discordant. This designation should be a prompt to the field to carry out definitive research, whenever possible. It is anticipated that the appropriate use criteria reports will require updates as further data are generated and information from the implementation of the criteria is accumulated.

To avoid bias in the scoring process, the technical panel deliberately was not comprised solely of specialists in the particular procedure under evaluation. Specialists, 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 guidelines and key references, to the technical panel. Panel members were not provided explicit cost information to help determine their appropriate use ratings, but they were asked to implicitly consider cost as an additional factor in their evaluation of appropriate use.

The level of agreement among panel members, as defined by RAND (5), was analyzed for each indication based on the BIOMED rule for a panel of 14 to 16 (a simplified RAND method for determining disagreement). Per the BIOMED definition, agreementwas defined as an indication where 4 or fewer panel members ratings fell outside the 3-point region containing the median score. Disagreementwas defined as a situation where at least 5 panel members 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 (IPR) compared with the interpercentile range adjusted for symmetry (IPRAS). This information was used by the moderator to guide the panel's discussion by highlighting areas of differences among the panel members. There was also a third category for indications that were not classified in either the agreement or disagreement categories. Any indication having disagreement was categorized as uncertain regardless of the final median score. Indications that met neither definition for agreement or disagreement are in a third, unlabeled, category.

3 General Assumptions

All indications were considered with the following important assumptions for CCT:

4 Definitions

A complete set of definitions of terms used throughout the indication set is listed in Appendix A. These definitions were provided and discussed with the technical panel prior to ratings of indications.

Ischemic Equivalent Chest Pain Syndrome, Anginal Equivalent, or Ischemic Electrocardiographic Abnormalities:Any constellation of clinical findings that is clinically judged to be consistent with obstructive CAD. Examples of such findings include, but are not limited to, chest pain, chest tightness, burning, shoulder pain, jaw pain, and new electrocardiographic abnormalities suggestive of ischemic heart disease. Nonchest pain symptoms, such as dyspnea or worsening effort tolerance that are felt to be consistent with CAD may also be considered to be an anginal equivalent.

5 Abbreviations

ACS = acute coronary syndrome

CABG = coronary artery bypass grafting surgery

CAD = coronary artery disease

CCS = coronary calcium score

CHD = coronary heart disease

CT = computed tomography

CTA = computed tomographic angiography

ECG = electrocardiogram

HF = heart failure

MET = estimated metabolic equivalent of exercise

MI = myocardial infarction

PCI = percutaneous coronary intervention

6 Results of Ratings

The final ratings for CCT (Tables 1 to 7) are listed by indication sequentially as obtained from second round rating sheets submitted by each panel member. The final score reflects the median score of the 17 panel members and has been labeled according to the 3 appropriate use categories of appropriate, uncertain, and inappropriate. Tables 8 to 10present the indications by these categories. Algorithm Figures 1 to 10describe the application of criteria as presented in these tables.

A majority of ratings were in agreement as defined in the preceding text, including 66% of appropriate and 55% of inappropriate indications. In contrast, only 7% of indications rated as uncertain showed agreement, indicating greater diversity of opinion on these indications. Only 2 of the 93 indications (Indications 1 [low] and 15 [low], both of which were rated as uncertain), were statistically classified as being in disagreement. Because these indications were already placed in the uncertain category, no changes were required to reflect disagreement.

7 Cardiac Computed Tomography Appropriate Use Criteria (By Indication)

8 Cardiac Computed Tomography Appropriate Use Criteria (By Appropriate Use Criteria)

9 Discussion

Appropriate use criteria define common patient subgroups where expert opinion and the available medical evidence are combined to assess the net benefit of a test or procedure, in this instance CCT. The intent of these criteria is to guide the rational use of the procedure, namely avoidance of either under- or overutilization, and thereby lead to more optimal healthcare delivery and justifiable healthcare expenditures.

This document is an update to the original appropriateness criteria for CCT published in 2006 (1), written to reflect changes in test utilization in the context of rapidly developing technical and clinical applications and within the conceptual framework of dynamic appropriate use criteria development. Several aspects of the present document are noteworthy, including careful alignment to and, where possible, definition oflanguage in the radionuclide imaging appropriate use criteria (2) to enhance integration into comparable decision support tools and performance metrics. The underlying assumptions for the document are intended to broadly reflect the present community standards of technology and performance of the technique with an emphasis on adherence to imaging guidelines, patient safety, and laboratory quality and accreditation.

The clinical scenarios included in this report were designed to reflect the most common and important potential applications for CCT imaging. After the initial writing by the writing group, extensive review from external editors, and then ranking by the technical panel itself, the result is a set of scenarios that define patient-specific applications. The appropriate use criteria in this report provide a consensus judgment of whether it is reasonable to use CCT imaging for the particular clinical scenario described, such as those 93 indications listed in this document. These criteria are expected to be useful for clinicians, healthcare facilities, and third-party payers engaged in the delivery of cardiovascular imaging services. Although numerous, the indications are commonly divided among subclasses of patient CHD risk or pretest probability of CAD, as such characteristics are important considerations within the test performance characteristics. In total, 35 of 93 indications were judged to be appropriate, and 58 were judged to be either inappropriate or uncertain. It is important to note however, that an understanding of pretest patient characteristics is an important determinant of the appropriate use ratings. Few categories are uniform in the ratings for all patient characteristics.

Appropriate use criteria represent the first component of the chain of quality recommendations for cardiovascular imaging (15). In addition to appropriate use, patient safety also should be considered when ordering coronary computed tomographic angiography (CTA), as it should be when ordering any cardiac imaging test. A consideration of the appropriate balance of using radiation dose reduction techniques to minimize radiation exposure while preserving image quality and the related benefits of imaging for a specific patient should be undertaken. This issue is discussed in more depth in a 2010 expert consensus document on coronary CTA (16). The present document greatly expands the number of potential clinical scenarios in comparison to the original 2006 document. The clinical scenarios include acute and chronic chest pain, testing in symptomatic and asymptomatic patients, heart failure, preoperative risk assessment before both cardiac and noncardiac surgery, testing in the setting of prior test results (exercise testing, stress imaging procedures, coronary calcium scores, and repeat testing), prior revascularization, and the evaluation of cardiac structure and function. Although these criteria are intended to provide guidance for patients and clinicians, they are not intended to serve as substitutes for sound clinical judgment and practice experience. The writing group recognizes that many patients encountered in clinical practice may not be represented in these appropriate use criteria or may have extenuating features when compared with the clinical scenarios presented. Although the appropriate use ratings reflect critical medical literature as well as expert consensus, physicians and other stakeholders should understand the role of clinical judgment in determining whether to order a test for an individual patient. Additionally, uncertain indications often require individual physician judgment and understanding of the patient to better determine the usefulness of a test for a particular scenario. As such, the ranking of an indication as uncertain (4 to 6) should not be viewed as limiting the use of CCT imaging for such patients. It should be emphasized that the technical panel was instructed that the uncertain designation was still designed to be considered as a “reimbursable” category.

These ratings are intended to evaluate the appropriate use of specific patient scenarios to determine overall patterns of careregarding CCT. In situations where there is substantial variation between the appropriate use rating and what the clinician believes is the best recommendation for the patient, further considerations or actions, such as a second opinion, may be appropriate. Moreover, it is not anticipated that all physicians or facilities will have 100% of their CCT procedures deemed appropriate. However, related to the overall patterns of care, if the national average of appropriate and uncertain ratings is 80%, for example, and a physician or facility has a 40% rate of inappropriate procedures, further examination of the patterns of care may be warranted and helpful. Implementation of these criteria is highly encouraged through provider education, as it is anticipated that increasing emphasis by laboratory accreditation bodies and other organizations focused on provider quality will apply.

Appendix A Additional Cardiac Computed Tomography Definitions

Angina:As defined by the ACC/AHA Guidelines on Exercise Testing (9)

Acute Coronary Syndrome:As defined by the ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction, patients with an acute coronary syndrome include those whose clinical presentations cover the following range of diagnoses: unstable angina, MI without ST-elevation (NSTEMI), and myocardial infarction with ST-elevation (STEMI) (18).

Evaluating Perioperative Risk for Noncardiac Surgery

METHOD FOR DETERMINING PERIOPERATIVE RISK

Review Figure A1, “Stepwise Approach to Perioperative Cardiac Assessment,” from the ACC/AHA 2009 Perioperative Guidelines (19). Based on the algorithm, once it is determined that the patient does not require urgent surgery, the clinician should determine the patient's active cardiac conditions and/or perioperative risk predictors—see definitions in the following text. If any active cardiac conditions (Table A1)and/or major risk predictors (Table A2) are present, Figure A1suggests consideration of coronary angiography and postponing or canceling noncardiac surgery. Once perioperative risk predictors are assessed based on the algorithm, then the surgical risk and patient's functional status should be used to establish the need for noninvasive testing.

ECG—Uninterpretable:Refers to electrocardiograms with resting ST-segment depression (≥0.10 mV), complete left bundle-branch block, pre-excitation (Wolff-Parkinson-White syndrome), or paced rhythm.

Able to Exercise:Able to complete a diagnostic exercise treadmill examination.

Appendix B Additional Methods

See the Methods section for a description of panel selection, indication development, scope of indications, and rating process.

Appendix C ACCF/SCCT/ACR/AHA/ASE/ASNC/NASCI/SCAI/SCMR 2010 Appropriate Use Criteria for Cardiac Computed Tomography Participants

Appendix D ACCF/SCCT/ACR/AHA/ASE/ASNC/NASCI/SCAI/SCMR 2010 Cardiac Computed Tomography Appropriate use Criteria Writing Group, Technical Panel, Task Force, and Indication Reviewers—Relationships with Industry and Other Entities (in Alphabetical Order)

Staff

American College of Cardiology Foundation

John C. Lewin, MD, Chief Executive Officer

Joseph M. Allen, MA, Director, TRIP (Translating Research Into Practice)

Lindsey Law, MHS, Senior Specialist, Appropriate Use Criteria

Starr Webb, MPH, Senior Specialist, Appropriate Use Criteria

Erin A. Barrett, MPS, Senior Specialist, Science and Clinical Policy

Footnotes