ACC/AHA/ACR/ASE/ASNC/HRS/NASCI/RSNA/SAIP/SCAI/ SCCT/SCMR/SIR 2008 Key Data Elements and Definitions for Cardiac Imaging
A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Clinical Data Standards for Cardiac Imaging)
TABLE OF CONTENTS
2.1. Writing Committee Composition…157
2.2. Relationships with Industry…157
2.3. Review of Literature and Existing Data Definitions…157
2.4. Defining Data Elements…157
2.5. Prioritizing Data Elements…157
2.6. Relation to Other Standards…158
2.7. Consensus Development…158
2.8. Peer Review, Public Review, and Board Approval…158
2.9. Considerations for Cardiac Imaging Clinical Data Standards…158
Cardiac Imaging Clinical Data Standard Elements and Definitions…159
3.3. Study Referral Data…159
3.4. History and Risk Factors…159
3.5. Study Description…159
3.6. Study Findings—Ischemic Heart Disease…161
3.7. Study Findings—LV Function…174
3.8. Study Findings—Cardiac Morphology…175
3.9. Study Findings—Summary…180
Appendix 1: Author Relationships With Industry and Other Entities—ACC/AHA/ACR/ASE/ASNC/HRS/NASCI/RSNA/SAIP/SCAI/SCCT/SCMR/SIR 2008 Key Data Elements and Definitions for Cardiac Imaging…181
Appendix 2: Peer Reviewer Relationships With Industry and Other Entities—ACC/ AHA/ACR/ASE/ASNC/HRS/NASCI/RSNA/SAIP/SCAI/SCCT/SCMR/SIR 2008 Key Data Elements and Definitions for Cardiac Imaging…182
Appendix 3: Table for Visualization of the Coronary Territory…183
Appendix 4: Table for Assessment of Ischemia and Scar Based on 17 Myocardial Segments…184
Appendix 5: Table for the Assessment of Regional Function of the Myocardial Segments…185
Appendix 6: Table for the Assessment of Regional Function of the Myocardial Segments (Contrast Left Ventricular Angiography)…186
The American College of Cardiology (ACC) and the American Heart Association (AHA) support their members’ goal to improve the prevention and care of cardiovascular diseases through professional education, research, development of guidelines and standards, and by fostering policy that supports optimal patient outcomes. The ACC and AHA recognize the importance of the use of clinical data standards for patient management, to assess outcomes, and conduct research, and the importance of defining the processes and outcomes of clinical care, whether in randomized trials, observational studies, registries, or quality improvement initiatives.
Hence, clinical data standards strive to define and standardize data relevant to clinical topics in cardiology, with the primary goal of assisting data collection by providing a platform of data elements and definitions applicable to various conditions. Broad agreement on a common vocabulary with reliable definitions used by all is vital to pool and/or compare data across studies and assess the applicability of research to clinical practice. The growing adoption of electronic medical records renders an even more imperative and urgent need for such definitions and standards. Therefore, the ACC and AHA have undertaken the task of defining and disseminating clinical data standards—sets of standardized data elements and corresponding definitions to collect data relevant to cardiovascular conditions. The ultimate purpose of clinical data standards is to contribute to the infrastructure necessary for accomplishing the ACC/AHA’s mission of fostering optimal cardiovascular care and disease prevention.
The specific goals of clinical data standards are:
to facilitate the establishment of registries and quality improvement programs by providing a list of major variables, outcomes, and definitions;
to optimize the comparison of results and outcomes across registries and studies; and
to become the basis for a standardized medical documentation process, essential for the electronic medical record environment.
The key elements and definitions are a compilation of variables to measure patient management and outcomes for clinical and research purposes as well as for quality improvement in order to standardize the language used to describe cardiovascular diseases and procedures, enhance consistency in cardiology, and increase opportunities for sharing data across data sources. The ACC/AHA Task Force on Clinical Data Standards selects cardiovascular conditions and procedures that will benefit from creating a data standard set. Experts in the subject are selected to examine/consider existing standards and develop a comprehensive, yet not exhaustive, data standard set. When undertaking a data collection effort, only a subset of the elements contained in a clinical data standards listing may be needed or, conversely, users may want to consider whether it may be necessary to collect some elements not listed. For example, in the setting of a randomized clinical trial of a new drug, additional information would likely be required regarding study procedures and drug therapies.
The Health Insurance Portability and Accountability Act (HIPAA) privacy regulations, which went into effect in April 2003, have heightened all practitioners’ awareness of our professional commitment to safeguard our patients’ privacy. The HIPAA privacy regulations (http://www.hhs.gov/ocr/combinedregtext.pdf, page 31) specify which information elements are considered “protected health information.” These elements may not be disclosed to third parties (including registries and research studies) without the patient’s written permission. Protected health information may be included in databases used for health care operations under a data use agreement. Research studies using protected health information must be reviewed by an institutional review board or a privacy board.
We have included identifying information in all clinical data standards to facilitate uniform collection of these elements when appropriate. For example, a longitudinal clinic database may contain these elements, since access is restricted to the patient’s caregivers. On the other hand, registries may not contain protected health information unless specific permission is granted by each patient. These fields are indicated as protected health information in the data standards.
The ACC/AHA Task Force on Clinical Data Standards makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside relationship or a personal, professional, or business interest of a member of the writing panel. Specifically, all members of the writing group were required to submit a disclosure form showing all such relationships that might be perceived as real or potential conflicts of interest. These statements are reviewed by the ACC/AHA Task Force on Clinical Data Standards, reported orally to all members of the writing panel at the first meeting, and updated as changes occur. Writing Committee members’ relationships with industry are listed in Appendix 1. Relationships with industry for official peer reviewers are listed in Appendix 2.
In clinical care, caregivers communicate with each other through a common vocabulary. In an analogous fashion, the integrity of clinical research depends on firm adherence to pre-specified procedures for patient enrollment and follow-up; these procedures are guaranteed through careful attention to definitions enumerated in the study design and case-report forms. When data elements and definitions are standardized across studies, comparison, pooled analysis, and meta-analysis are enabled, thus deepening our understanding of individual studies.
The recent development of quality performance measurement initiatives, particularly those for which comparison of providers is an implicit or explicit aim, has further raised awareness about the importance of data standards. Indeed, a wide audience, including nonmedical professionals such as payers, regulators, and consumers, may draw conclusions about care and outcomes. To understand and compare care patterns and outcomes, the data elements that characterize them must be clearly defined, consistently used, and properly interpreted, now more than ever before.
Véronique L. Roger, MD, MPH, FAHA, FACC
Chair, ACC/AHA Task Force on Clinical Data Standards
Modality and Technique Abbreviations Used in This Document
CACS = Coronary Artery Calcium Score
Cardiac cath = Cardiac Catheterization
CCT = Cardiac Computed Tomography
CCTA =Cardiac Computed Tomographic Angiography
CMR = Cardiac Magnetic Resonance
Echo = Echocardiography
ICA = Invasive Coronary Angiography
LVG = Left Ventriculography
MPI = Myocardial Perfusion Imaging
PET = Positron Emission Tomography
RNA = Radionuclide Angiography
SPECT =Single-Photon Emission Computed Tomography
TEE = Transesophageal Echocardiography
TTE = Transthoracic Echocardiography
Cardiac imaging is an integral part of the evaluation and management of patients with known or suspected heart disease. These techniques offer insight into morphologic features and physiologic functioning of the myocardium, valves, pericardium, coronary arteries, and great vessels. Substantial advances in technology have occurred within the past decade, advancing clinical applications and enhancing diagnostic accuracy.
Many options for imaging the heart and adjacent structures are available such as, echocardiography, single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI), positron emission tomography (PET), cardiac magnetic resonance (CMR), cardiac computed tomography (CCT), invasive coronary angiography (ICA), and left ventriculography (LVG). Major specialty societies, such as the ACC, the AHA, the Radiological Society of North American (RSNA), and the American College of Radiology (ACR) have demonstrated leadership in promoting research and written guidelines and practice standards for the performance of cardiac imaging. In many cases, each modality has developed rather independently and has strong advocacy by dedicated clinicians/researchers and their own subspecialty societies, including the American Society of Nuclear Cardiology (ASNC), the American Society of Echocardiography (ASE), the Society for Atherosclerosis Imaging and Prevention (SAIP), the Society for Cardiovascular Computed Tomography (SCCT), the Society for Cardiovascular Magnetic Resonance (SCMR), the Society for Cardiovascular Angiography and Interventions (SCAI), the Society of Interventional Radiology (SIR), the North American Society for Cardiovascular Imaging (NASCI), and the Heart Rhythm Society (HRS).
Cardiac imaging is included in patient decision-making and is often referenced in guidelines and other data standards. However, differing definitions abound, leading to misunderstanding and confusion. Furthermore, structured reporting is becoming commonplace and imaging data fields are increasingly being used within registries and clinical databases. The ACC has led a multisocietal effort that culiminated in the development of a document that recommends the use of structured reporting for cardiovascular imaging as an essential component of improved cardiovascular health care;1 that article is being published simultaneously with these data standards. These two writing efforts were coordinated with each other and underscore the importance for capturing and reporting clear, consistent and complete information for patients undergoing cardiovascular imaging.
The ACC/AHA Clinical Data Standards Task Force was approached about assembling a committee to harmonize cardiac imaging definitions that have been developed by many organizations and committees, in a fashion similar to the existing clinical data standards for electrophysiology, ischemic heart disease, and heart failure. The need for data standardization in cardiac imaging was highlighted at a “Think Tank” meeting sponsored by Duke University and the ACC.2 The development of common data elements was felt to be a priority that would lead to the development of important quality metrics in imaging. A follow-up ad hoc group was formed as part of a subcommittee of the ACC Cardiovascular Imaging Collaborative Committee with a focus on quality in imaging and developed a working draft of data standards, which was used as a starting point for the Writing Committee.
2.1. Writing Committee Composition
The ACC/AHA Task Force on Clinical Data Standards selected members for the Writing Committee to Develop Clinical Data Standards for Cardiac Imaging (Writing Committee). The Writing Committee consisted of 15 members who are well versed in structured reporting initiatives, as well as active in the various disciplines of cardiac imaging, including invasive contrast angiography, CCT, CMT, nuclear cardiology, and echocardiography. All organizations listed on the masthead nominated individuals to comprise the makeup of the Writing Committee.
2.2. Relationships With Industry
The ACC/AHA Task Force on Clinical Data Standards makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside relationship or a personal, professional, or business interest of a member of the writing panel. Specifically, all members of the writing group were required to complete and submit a disclosure form showing all such relationships that might be perceived as real or potential conflicts of interest. These statements are reviewed by the ACC/AHA Task Force on Clinical Data Standards and are updated when changes occur. Please see Appendix 1 for the Writing Committee relationships with industry.
2.3. Review of Literature and Existing Data Definitions
These imaging standards are intended to provide data elements that parallel and complement existing data fields as previously reported in ACC and AHA documents, along with those used as fields within existing registries, such as those developed by the ACC National Cardiovascular Data Registry (NCDR).3 We also reviewed the ACC/AHA Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients with Chronic Heart Failure,4 the ACC/AHA Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients with Atrial Fibrillation,5 the ACC/AHA/HRS 2006 Key Data Elements and Definitions for Electrophysiological Studies and Procedures,6 and the American College of Cardiology Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients with Acute Coronary Syndromes.7
2.4. Defining Data Elements
The core elements and definitions were originally drafted by a group of imaging specialists formed after the first Duke/ACC Think Tank meeting, whose proceedings were published 1 year later.2 The Writing Committee then gathered many other candidate data elements gleaned from other sources. As the Writing Committee developed definitions, they were encouraged to write definitions broad enough to be applicable in a variety of data collection settings, but specific enough that the data elements can be uniformly interpreted. Some elements will require an additional level of specificity by the end-user for implementation which is beyond the scope of the Writing Committee. Data definitions were linked whenever possible to the evidence-based national guidelines. To ensure consistency across ACC/AHA clinical data standards, writers used an existing ACC/AHA definition verbatim unless there was a reason related to cardiac imaging to change that definition. The Writing Committee chose not to develop an all-inclusive list of every possible data element that may be used for all cardiac imaging techniques. Rather, the Writing Committee focused its attention on common elements that cross modality boundaries. It is anticipated that modality-specific data definitions and elements will need further delineation, likely by subspecialty society organizations and groups. The purpose of this document is to attempt to harmonize as many common data fields as possible. These data elements were constructed primarily for use with the adult cardiac patient. Therefore, these elements are not designed for pediatric cardiology or those adults with congenital heart disease.
2.5. Prioritizing Data Elements
Once the Writing Committee reviewed the draft submitted as a working manuscript by the Think Tank Group, a focused group of data elements and definitions was developed. The group was most interested in common data elements which transcended an individual imaging modality. Of the data elements included within this paper, items were identified as:
Recommended for all imaging studies;
Recommended for a specific modality or modalities;
Optional, meaning a worthwhile data element but not necessarily required in all instances;
Derived, meaning that this field would be calculated based on previously entered information, negating the need to specifically obtain this information.
These descriptors were felt to help identify the most important data elements for database and registry construction.
2.6. Relation to Other Standards
The Writing Committee reviewed other standards including those developed for heart failure, atrial fibrillation, electrophysiology, and acute coronary syndromes, as previously noted. Although other groups have used imaging within their disciplines and have definitions based on imaging parameters, the Writing Committee felt that it was the responsibility of this multimodality group to provide a uniform standard that may be adopted by other data standards groups for their imaging parameters. It was felt that this Writing Committee possessed key levels of expertise needed to address this issue in a consistent fashion. It is hoped that these definitions will be used in subsequent revisions of the data standards for heart failure, atrial fibrillation, electrophysiology, and acute coronary syndromes, in order to maintain consistency.
2.7. Consensus Development
These ACC/AHA data standards, like others, are team-developed written documents and are based on the judgments of experts within cardiovascular imaging. The Writing Committee met more than 10 times, by telephone and in person, over the course of 5 months to define and refine the data elements. Throughout the process, consensus was developed through extensive in-person discussion, teleconferences, and e-mails. Minority opinions are expressed in the discussion of the elements when differences existed.
2.8. Peer Review, Public Review, and Board Approval
The set of imaging standards and definitions was independently reviewed by official appointees from the ACC, AHA, ACR, ASE, ASNC, HRS, NASCI, RSNA, SAIP, SCAI, SCCT, SCMR, and SIR, as well as the ACC/AHA Data Standards Task Force. To increase its applicability, this document was posted on the ACC and ACR Website for a 30-day public comment period from April 14, 2008, through May 14, 2008. The document was then approved by all sponsoring organizations.
The Writing Committee anticipates these data standards will require review and updating, just as with guidelines, performance measures, and appropriateness criteria. At the anniversary of the data standards publication, the Writing Committee will review the data standards to ascertain whether or not modifications should be considered.
2.9. Considerations for Cardiac Imaging Clinical Data Standards
The Writing Committee anticipates that the cardiac imaging data standards will prove useful in several settings:
Clinical Programs, where providers and health plans work in concert to achieve optimal utilization of cardiac imaging procedures. Data standards will assist in the development of structured reporting systems, organizing and designing of electronic medical information systems including clinical databasing, and decision support tools.
Clinical Research, including prospective registries and randomized controlled trials. Meta-analyses will be particularly strengthened by the use of standardized data for key variables.
Quality Assessment/Performance Measurement: data standards will especially facilitate interpretation for nonmedical users, including payers, regulators, and consumers.
There is a clear need for a uniform digital standard for all imaging and clinical data (eg, electronic health records and lab results). These data elements for cardiac imaging are an important step towards this goal.
Although this set of imaging data standards is not specifically designed to be a precursor to an imaging registry, it is clear that the data definitions may be used as fields for such a registry or incorporated as data elements within registries focused on specific diseases, such as for heart failure or ischemic heart disease. Additionally, it is hoped that these standards will be used for definition within the information technology community to standardize textual cardiac imaging data and to be incorporated within structured reporting programs. An ongoing dialogue with key groups, including Digital Imaging and Communications in Medicine (DICOM) and Integrating the Healthcare Enterprise (IHE), will ensure data harmonization and uniformity.
The Writing Committee discussed the overall philosophy of these standards at great length, including whether or not to develop comprehensive or focused data elements. As multiple modalities were included within this standard, it was decided to include key elements only and those in which there was overlap among modalities.
It is anticipated that these standards will not be comprehensive enough for all needs, and additional elements may need to be created for modality-specific findings. This multimodality data standards document, however, aims to define elements which cross modality barriers. The emphasis for this effort was on harmonization among the imaging modalities whenever possible, such as when defining ischemia or ventricular function.
A modular approach to the use of these imaging data standards should be considered. Certain data definitions are applicable only to an indication, such as detection of ischemia. As such, only the imaging methods of stress echocardiography, stress SPECT MPI, and stress CMR would need to define the presence, absence, and extent of ischemia. Likewise if no intracardiac shunting were detected, then completion of fields defining the presence of a patent foramen ovale or ventricular septal defect would not be required.
Whenever feasible, the Writing Committee attempted to incorporate existing definitions into this document. For example, data elements involving identification of the patient or physician have already been published and replicated within this document. Likewise, defining hypertension or heart failure have been previously described and are beyond the scope of this paper. However, other publications have already included definitions of image-related data which the Writing Committee felt were either inaccurate or not optimally described, and it is the hope of this group that the standards defined in the current document will be used in future, revised versions of other guidelines and data standards.
Two categories of data elements deserve special mention. The Writing Committee firmly supports standardization of nomenclature for left ventricular (LV) segmentation, which was initially supported by all imaging modalities8 but not universally adopted. Rather than describe imaging abnormalities with use of regions or territories that are defined within a specific modality, the 17-segment model was felt to reflect a reasonable, previously published standard, which should be supported. The size of the abnormality can then be defined by the number of segments affected. A second area of intense discussion involved defining LV function and ejection fraction determination. Once again the Writing Committee emphasized the unique opportunity to help clarify LV function, which has many definitions depending on the imaging modality and method of analysis. The composition of this group representing all key organizations associated with cardiac imaging permitted a unique opportunity for resolving this “tower of Babel.”
3. Cardiac Imaging Clinical Data Standard Elements and Definitions
There are a total of 6 administrative elements: site ID, site of service, cardiac imaging service, accreditation status, accreditation entity, and insurance payer. Ideally, the information from these elements could be provided to the registry once, at the time of site registration, and associated with the site ID, thus decreasing the number of elements requiring data entry at the time of recruitment. Recruitment sites would include a wide variety of facilities: private practice settings, academic centers, both in-patient and outpatient facilities, and emergency departments. As such, a specific institution might have several site IDs, one for each provided service, as patients may be entered into the registry from different departments providing the different services described.
The insurance payer element was included to be certain that patients of all payer status were included in studies equitably, especially those funded federally. The inclusion of this data was not to in any way suggest that cardiac imaging patients should be screened on the basis of ability to pay.
The HIPAA privacy regulations specify which elements are considered “protected health information (PHI).” These elements may not be disclosed to third parties (including registries and research studies) without the patient’s written permission. PHI may be included in databases used for health care operations under a data use agreement. Research studies using PHI must be reviewed by an institutional review board or a privacy board. PHI will then need to be uncoupled from any identifying information. One possible method of doing this is to generate a unique numerical identifier (ie, 1-way hash number)9,10 computer generated by immutable patient statistics. Cross-linkage of data regarding various imaging procedures is essential for evaluation of possibly redundant and serial testing, but the means to accomplish this task are beyond the scope of this project and the charge of the Writing Committee.
3.3. Study Referral Data
It is important to capture the referral source data for purposes of studying trends in referral patterns over time and to determine the utilization of cardiac imaging. The use of the National Physician Identifier (NPI) was chosen to uniquely and longitudinally track referral physician, particularly in longstanding studies and in the case of physicians that change geographic or institutional venues. The Referral Physician Specialty element was designed to capture the most likely specialty groups to be referring patients for cardiac imaging studies; the level of granularity for this element was discussed at length, and the final decision was to include a representative list, rather than a comprehensive all-inclusive list of likely physician referrers.
3.4. History and Risk Factors
Information about a patient’s medical history and risk factors obtained prior to an imaging test is important for quality performance measurement, clinical research, and clinical care. Presence of cardiac risk factors or symptoms may impact interpretation of findings and are necessary to track the appropriate use of imaging tests. Medical history may impact the imaging test chosen or alter the technical approach of an imaging test in an effort to maximize diagnostic yield. Medical history is also critical to ensure the safety of an imaging test, as it may reveal absolute or relative contraindications to an imaging modality or agents used in performance of an imaging test.
The medical history and risk factors data elements chosen for inclusion in this document are intended to reproduce standard elements in other data standard documents and to adhere to current consensus guidelines on the classification of disease states whenever possible. In addition, elements were constructed with the specific purpose of tracking applications of relevant Appropriateness Criteria and Consensus Practice Guidelines in which imaging tests are prominent (eg, Perioperative Guidelines for Noncardiac Surgery11). Some of the elements in this area may be derived from others using standard risk-factor calculation tools. The Writing Committee recognizes that all historical information included may not be routinely available for all imaging tests and that more detailed information may be necessary/routine prior to specific imaging tests or for specific indications.
3.5. Study Description
The study description includes a categorical designation of the imaging modality employed. The specific physician involved in the interpretation of the study should be noted, along with his/her credentials. Subsequent elements further describe the details of the method used to perform the examination. This generally includes technical elements of image acquisition specific to the modality, use of an imaging agent, ie, contrast or radionuclide, and, if stress testing was performed, the method of stress testing. The primary and secondary indications for the study are also included in this section.
3.6. Study Findings—Ischemic Heart Disease
Commonly recognized confounding factors in the baseline electrocardiographic recording, including Q waves, abnormal rhythm, ST-segment depression, and evidence of ventricular pacing or conduction abnormalities, should be noted due to their potential negative impact on the interpretability of the ECG recording during any subsequent stress testing for inducible ischemia.
For any exercise stress testing performed, the number of metabolic equivalent tasks (a.k.a. METS) may be noted to reflect exercise capacity. A recording of the nature of any induced chest pain, along with the maximum amount of ST-segment depression, should be recorded.
Changes in both heart rate (HR) and in blood pressure (BP) components, from baseline to maximum, should be noted to reflect the physiologic response to any stress testing performed. Achievement of at least 85% of maximum predicted HR is to be used to assess adequacy of the stress, and together, achieved HR and achieved BP, permit calculation of the double product. HR recovery from peak exercise may be used to further assess physiologic response to stress.
Regardless of the measure of myocardial ischemia induced by stress testing (evoked hypoperfusion or ventricular dysfunction) and/or the measure of post-infarct myocardial scarring (nonreversible hypoperfusion or ventricular dysfunction versus contrast-delineated necrosis/scar visualization), myocardial abnormalities (normal versus scar versus ischemia versus mixed) and their severity are to be addressed using a standard 17-segment LV description.7 This permits a unified approach to study categorization, irrespective of the stress imaging modality. It is, however, recognized that there can be significant patient-to-patient variability in the relationship between an LV myocardial segment and the supplying coronary artery. It is also understood that not all segments may be visualized for all studies or modalities given that certain techniques, such as single-plane contrast ventriculography, would not allow for it. The severity of the abnormality is to be graded as mild, moderate, or severe; the definition of the severity is modality-dependent and beyond the scope of this multimodality Writing Committee. Subspecialty organizations, however, are encouraged to assign properties to each category in the near future. The delineation of the size of the abnormality is based on the number/location of the involved segments. It is assumed that if a segment has an abnormality, even if the complete segment is not completely involved, it will be categorized as being abnormal. A geographically distinct second abnormality may also be described.
When imaging of the coronary artery lumen is involved, the assessment of diameter percent stenosis by coronary distribution should be described according to a standard 6-element description. For an example of a table for visualization of the coronary territory, which includes the 6-segment scheme, see Appendix 3.
3.7. Study Findings—LV Function
The description of LV function was divided into systolic and diastolic components. The definition of diastolic dysfunction was left broad in acknowledgment of differences in capabilities of the various imaging modalities to investigate the diastolic phase. Expansion of this category would be desirable for certain modalities, especially echocardiography.
It was acknowledged that determination of systolic function, although pivotal to patient care, occurs with significant variability between the modalities. It is well appreciated that each imaging modality has a unique range of normal values for quantitative ejection fraction determination. Even within modalities, different quantitative methods may yield disparate results, with differences in ejection fraction units, at times, approaching 10 absolute units.
Although there was great discussion about the overall goal and potential impact of describing LV systolic function, the majority of the panel felt that uniformity should be attempted, and the final consensus was that, as a required data element, this section incorporates only 4 categories for systolic function: normal, mildly reduced, moderately reduced, and severely reduced. It was also agreed that a range of quantitative values should be elucidated for differing degrees of LV dysfunction. For purposes of reporting a specific value, the mid point of the range may be used, such that moderate LV dysfunction would be reported as 35%.
The quantitative value for ejection fraction was recommended to be reported as an optional item. The measured quantitative ejection fraction could be reported as a specific value (eg, 64%) or a 5% range (eg, 30% to 35%). The mid point of the range would be used for data collection/storage. It was noted that, overall, the precision on this measure is poor, as is its reproducibility for some modalities; however, the error range for this measurement is implicit. Although the quality of the images is critical, other factors, including volume status, arrhythmias, and conduction disturbances, all lead to variability. Differing methodological approaches (eg, count-based, 3-dimensional count-based) further increase variability. When reported as a numerical value, the imaging modality and method of analysis (visual, quantitative) should be specified.
The Writing Committee felt that a standard for LV function must be established, although cognizant of the controversies and challenges. One option for future research may be the use of a regression analysis, whereby a given ejection fraction obtained using a specific method could be converted into a “universal ejection fraction,” thereby eliminating modality-specific differences in ranges of dysfunction. However, at the current time, the category of LV function was felt to be the most useful parameter, with modality-specific definitions contained within each category.
To attain consistency between methods, regional systolic function is defined using the 17-segment scheme. Broad categories of hypokinesis, akinesis, and dyskinesis are recommended to describe regional dysfunction.16 The panel recognized that differentiation among these wall motion categories may be difficult and subjective, and that the clinical relevance between akinesis and dyskinesis may not be high. However, it was agreed that additional layers of granularity for hypokinetic regions was likely not useful. For reporting purposes, if global hypokinesis is present, scoring for each segment should be performed.
3.8. Study Findings—Cardiac Morphology
In the reporting of cardiac morphology, presentation of 3-dimensional volumetric data in regards to LV end-diastolic and -systolic volumes, LV mass, and ejection fraction is optimal. In the absence of 3-dimensional data, calculations of volumetric data from geometric assumptionsfrom 2-dimensional data sets can be substituted. Alternatively, 2-dimensional measures of chamber sizes and wall thicknesses could be reported.
Assessment of severity of valvular regurgitation and stenosis should follow current ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease.17
American College of Cardiology Foundation
John C. Lewin, MD, Chief Executive Officer
Charlene May, Senior Director, Science and Clinical Policy
Tilithia McBride, Associate Director, Performance Measurement Policy
Dawn R. Phoubandith, MSW, Associate Director, Science and Clinical Policy
Maria Lizza D. Isler, BSMT, Specialist, Clinical Data Standards
Dan Roman, Specialist, Healthcare Technology
Erin A. Barrett, Senior Specialist, Science and Clinical Policy
American Heart Association
M. Cass Wheeler, Chief Executive Officer
Rose Marie Robertson, MD, FACC, FAHA, Chief Science Officer
Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice President, Office of Science Operations
TASK FORCE MEMBERS
Véronique L. Roger, MD, MPH, FAHA, FACC, Chair; Paul Heidendreich, MD, FACC∥∥;
Robert C. Hendel, MD, FACC, FAHA, FASNC; Martin B. Leon, MD, FACC;
Eric D. Peterson, MD, MPH, FACC, FAHA; Pamela N. Peterson, MD, FAHA;
William S. Weintraub, MD, MPH, FACC
↵* Society for Atherosclerosis Imaging and Prevention Official Representative.
↵† Society of Interventional Radiology Official Representative.
↵‡ Society for Cardiovascular Angiography and Interventions Official Representative.
↵§ American Society of Echocardiography Official Representative.
↵∥ Heart Rhythm Society Official Representative.
↵¶ Society for Cardiovascular Magnetic Resonance Official Representative.
↵# North American Society for Cardiovascular Imaging Official Representative.
↵** American Society of Nuclear Cardiology Official Representative.
↵†† Society of Cardiovascular Computed Tomography Official.
↵‡‡ Radiological Society of North America Official Representative.
↵§§ American College of Radiology Official Representative.
↵∥∥ Former Task Force Chair during this writing effort.
↵¶¶ Former Task Force Member during this writing effort.
This document was approved by the American College of Cardiology Foundation Board of Trustees in September 2008, the American Heart Association Science Advisory and Coordinating Committee in September 2008, the American College of Radiology Board in October 2008, the American Society of Echocardiography Board of Directors in October 2008, the American Society of Nuclear Cardiology in October 2008, the Heart Rhythm Society Board of Trustees in October 2008, the North American Society for Cardiovascular Imaging in October 2008, the Radiological Society of North American Board in October 2008, the Society for Atherosclerotic Imaging and Prevention Board in October 2008, the Society for Cardiovascular Angiography and Interventions in October 2008, the Society of Cardiovascular Computed Tomography Board in October 2008, the Society for Cardiovascular Magnetic Resonance Board in October 2008, and the Society for Interventional Radiology in October 2008.
The American Heart Association requests that this document be cited as follows: Hendel RC, Budoff MJ, Cardella JF, Chambers CE, Dent JM, Fitzgerald DM, Hodgson JM, Klodas E, Kramer CM, Stillman AE, Tilkemeier PL, Ward RP, Weigold WG, White RD, Woodard PK. ACC/AHA/ACR/ASE/ASNC/HRS/NASCI/RSNA/SAIP/SCAI/SCCT/SCMR/SIR 2008 key data elements and definitions for cardiac imaging: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Clinical Data Standards for Cardiac Imaging). Circulation. 2009;119:154–186.
This article has been copublished in the Journal of the American College of Cardiology.
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