Author + information
- Published online June 24, 2019.
- Writing Committee Members,
- Pamela S. Douglas, MD, MACC, FAHA, FASE, Chair,
- Blase A. Carabello, MD, FACC,
- Roberto M. Lang, MD, FACC, FAHA, FASE,
- Leo Lopez, MD, FACC, FAHA, FASE,
- Patricia A. Pellikka, MD, FACC, FAHA, FASE,
- Michael H. Picard, MD, FACC, FAHA, FASE,
- James D. Thomas, MD, FACC, FASE,
- Paul Varghese, MD, FACC,
- Tracy Y. Wang, MD, MHS, MSc, FACC, FAHA,
- Neil J. Weissman, MD, FACC, FASE and
- Rebecca Wilgus, RN, MSN
ACC/AHA Task Force on Clinical Data Standards Members
Biykem Bozkurt, MD, FACC, FAHA, Chair
Hani Jneid, MD, FACC, FAHA, Chair-Elect
Sana M. Al-Khatib, MD, FACC, FAHA
H. Vernon Anderson, MD, FACC, FAHA
Lauren Gilstrap, MD∗
Grant N. Graham, MD∗
Gail K. Jones, MD∗
David Kao, MD∗
Leo Lopez, MD, FACC, FAHA, FASE∗
Greg Marcus, MD, FACC, FAHA∗
Jennifer Rymer, MD∗
James E. Tcheng, MD, FACC
Table of Contents
1. Introduction ▪
2. Methodology ▪
2.1. Writing Committee Composition ▪
2.2. Relationships With Industry and Other Entities ▪
2.3. Review of Literature and Existing Data Definitions ▪
2.4. Consensus Development ▪
2.5. Relation to Other Standards ▪
2.6. Peer Review, Public Review, and Board Approval ▪
3. Data Elements and Definitions ▪
3.1. Left and Right Heart Structures ▪
3.2. Left and Right Heart Function ▪
3.3. Aorta ▪
3.4. Right Heart Hemodynamics and Pulmonary Artery ▪
3.5. Congenital Heart Disease ▪
3.6. Heart Valves ▪
4. Informatics of Controlled Vocabularies ▪
Author Relationships With Industry and Other Entities (Relevant) ▪
Reviewer Relationships With Industry and Other Entities ▪
Left and Right Heart Structures ▪
Left and Right Heart Function ▪
Right Heart Hemodynamics and Pulmonary Artery ▪
Congenital Heart Disease ▪
Heart Valves ▪
The American College of Cardiology (ACC) and the American Heart Association (AHA) support their members’ goal to improve the care of patients with cardiovascular disease through professional education, research, and development of guidelines and standards and by fostering policies that support optimal patient outcomes. The ACC and AHA recognize the importance of the use of clinical data standards for patient management, assessment of outcomes, and conduct of research, and the importance of defining the processes and outcomes of clinical care, whether in randomized trials, observational studies, registries, or quality-improvement initiatives.
Clinical data standards strive to define and standardize data relevant to clinical concepts, with the primary goal of facilitating uniform data collection by providing a platform of clinical terms with corresponding definitions and data elements. Broad agreement on a common vocabulary with reliable definitions used by all is vital to pool and/or compare data across clinical trials to promote interoperability with electronic health records and to assess the applicability of research to clinical practice. The ultimate purpose of clinical data standards is to contribute to the infrastructure necessary to accomplish the ACC’s mission of fostering optimal cardiovascular care and disease prevention and the AHA’s mission of being a relentless force for a world of longer, healthier lives.
The specific goals of clinical data standards are:
1. To establish a consistent, interoperable, and universal clinical vocabulary as a foundation for both clinical care and clinical research, including clinical trials
2. To promote the ubiquitous use of electronic health records and facilitate the exchange of data across systems through harmonized, standardized definitions of key data elements
3. To facilitate the further development of clinical registries, quality- and performance-improvement programs, outcomes evaluations, and clinical research, including the comparison of results within and across these initiatives
The key elements and definitions are intended to facilitate the consistent, accurate, and reproducible capture of clinical concepts; standardize the terminology used to describe cardiovascular diseases and procedures; create a data environment conducive to the assessment of patient management and outcomes for quality and performance improvement and clinical and translational research; and increase opportunities for sharing data across disparate data sources. The ACC/AHA Task Force on Clinical Data Standards (Task Force) selects cardiovascular conditions and procedures that will benefit from creation of a standard dataset. Subject matter experts are selected to examine/consider existing standards and develop a comprehensive, yet not exhaustive, standard dataset. When undertaking a data collection effort, only a subset of the elements contained in a clinical data standard 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 ACC and AHA recognize that there are other national efforts to establish clinical data standards, and every attempt is made to harmonize newly published standards with existing standards. Writing committees are instructed to consider adopting or adapting existing nationally and internationally recognized data standards if the definitions and characteristics are useful and applicable to the set under development. In addition, the ACC and AHA are committed to continually expanding their portfolio of data standards and will create new standards and update existing standards as needed to maintain their currency and promote harmonization with other standards as health information technology and clinical practice evolve.
The Health Insurance Portability and Accountability Act privacy regulations, which went into effect in April 2003, have heightened all practitioners’ awareness of our professional commitment to safeguard our patients’ privacy. The Health Insurance Portability and Accountability Act privacy regulations (1) 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 healthcare 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 because access is restricted to the patient’s caregivers. Conversely, 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.
In clinical care, caregivers communicate with each other through a common vocabulary. In an analogous manner, the integrity of clinical research depends on firm adherence to prespecified procedures for patient enrollment and follow-up; these procedures are guaranteed through careful attention to definitions enumerated in the study protocol, case report forms, and clinical event committee charters. 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 the 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.
Biykem Bozkurt, MD, FACC, FAHA
Chair, ACC/AHA Task Force on Clinical Data Standards
Echocardiography is an integral and valued part of the evaluation and management of patients with known or suspected heart disease. It offers 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. Although many options for imaging the heart and adjacent structures are available in addition to echocardiography, echocardiography is by far the most commonly performed imaging examination, and this field has demonstrated leadership in promoting research and in establishing guidelines and practice standards for the performance of echocardiographic imaging. Indeed, these existing guidelines and standards documents formed the basis for the data elements enumerated here; this document has purposefully avoided creating new standards. Echocardiography is included in patient decision-making and is often referenced in guidelines and other data standards. However, differing definitions of echocardiographic parameters abound, potentially leading to misunderstanding and confusion, and remains a robust barrier to the structured reporting required for clinical interoperability, clinical research, registries, and clinical databases (2). The ACC, AHA, and the American Society of Echocardiography (ASE) have joined forces to lead the multisocietal effort that has culminated in the development of this document, which provides a critical platform for structured reporting for echocardiographic imaging. The development of common data elements is also anticipated to further the development of important quality metrics and support quality improvement efforts in echocardiography (3).
2.1 Writing Committee Composition
The Task Force selected members of the writing committee jointly with ASE. The writing committee consisted of 11 individuals with domain expertise in cardiovascular medicine, echocardiography, clinical research, epidemiology, outcomes assessment, medical informatics, health information management, and healthcare services research and delivery.
2.2 Relationships With Industry and Other Entities
The Task Force makes every effort to avoid actual or potential conflicts of interest that might arise as a result of an outside relationship or a personal, professional, or business interest of any member of the writing committee. Specifically, all members of the writing committee are required to complete and submit a disclosure form showing all such relationships that could be perceived as real or potential conflicts of interest. These statements are reviewed by the Task Force and updated when changes occur. Authors’ and peer reviewers’ relationships with industry and other entities pertinent to this data standards document are disclosed in Appendixes 1 and 2, respectively. In addition, for complete transparency, the disclosure information of each Writing Committee member—including relationships not pertinent to this document—is available as an online supplement. The work of the Writing Committee was supported exclusively by the ACC and AHA without commercial support and was closely assisted by the ASE. Writing committee members volunteered their time for this effort. Meetings of the writing committee were confidential and attended only by committee members and staff.
2.3 Review of Literature and Existing Data Definitions
A series of reference publications provided the foundation for the cardiovascular imaging data element concepts identified by the writing committee of the ACC (www.acc.org), the AHA (professional.heart.org), and the ASE (http://asecho.org/guidelines/guidelines-standards/). Many of these documents are referenced in the tables below. In general, we did not include text, diagrams, measurement cutpoints, and other content that is redundant to these standards. Importantly, we avoided changing existing standards whenever possible, as well as not repeating them unnecessarily so as to limit the length of this document.
2.4 Consensus Development
The Task Force established the writing committee in March 2015, per the processes described in the Task Force’s methodology paper (4). The work of the writing committee was accomplished via a series of teleconferences and web conferences, along with extensive email correspondence. The review work was distributed among subgroups of the writing committee on the basis of their interest and expertise in the components of the terminology set. The proceedings of the workgroups were then assembled, resulting in the vocabulary and associated descriptive prose in Appendixes 3 to 8. All members reviewed and approved the final vocabulary.
2.5 Relation to Other Standards
The writing committee reviewed the unpublished work of the U.S. Food and Drug Administration Cardiovascular Imaging Data Standards workgroup along with available published data standards and clinical guidelines. Current echocardiography guidelines from the ASE and other societies were also instrumental in defining the data elements within this document. A particularly important source document was the 2008 multisociety data elements document for cardiac imaging (5).
The writing committee anticipates that this transthoracic echocardiography (TTE) vocabulary will facilitate the uniform adoption of these terms, where appropriate, by the clinical care, clinical and translational research, regulatory, quality and outcomes, and electronic health records communities.
2.6 Peer Review, Public Review, and Board Approval
The “2019 ACC/AHA/ASE Key Data Elements and Definitions for Transthoracic Echocardiography” was reviewed by official reviewers nominated by ACC, AHA, and ASE. To increase its applicability further, the document was posted on the ACC, AHA, and ASE websites for a 30-day public comment period. This document was approved by the ACC Clinical Policy Approval Committee, by the AHA Science Advisory and Coordinating Committee, and by the ASE Board of Directors in January 2019, and by the AHA Executive Committee in March 2019. The writing committee anticipates that these data standards will require review and updating in the same manner as other published guidelines, performance measures, and appropriate use criteria. The writing committee will therefore review the set of data elements periodically, starting with the anniversary of publication of the standards, to ascertain whether modifications should be considered.
3 Data Elements and Definitions
This TTE data element set contains a broad range of data elements for adult and pediatric echocardiography. The use case for these data elements include supporting regulatory reporting of TTE data, clinical reporting, and ongoing efforts to harmonize electronic medical records and improve interoperability. As such, the organizational framework for these data elements is a TTE case report form or clinical report, with similar section headings that draw on the data elements in the Appendixes. It is not intended to represent all possible TTE reports.
The following assumptions and conventions were used in the preparation of the TTE data elements and should be considered in their application.
1. Interpretations are assumed to be made by a qualified imager on the basis of findings in the imaging study, rather than other components of the history or physical. The ASE and ACC provide recommendations regarding professional training and competency.
2. Reference ranges are specifically not provided for qualitative data elements because they are available through national standards documents to define qualitative categories and are referenced in Appendixes.
3. Reference ranges are also not provided for quantitative data elements (numbers), which are represented by “Float” as the permissible values. The intent of a quantitative data element is to collect the actual value. The assertion of a reference range implies interpretation and as such potentially influences measurement of the actual value. Interpretations of quantitative values are specific to each implementation and as such are beyond scope of this set of standard data elements.
4. Data elements for individual measurements (i.e., regurgitant jet area, valve gradients and area) may be presented individually as well as overarching data elements that can provide an integrated impression of the severity of cardiac valve regurgitation and cardiac valve stenosis. This allows compliance with the recommendations that the assessment of cardiac valve regurgitation and cardiac valve stenosis be performed as an overall assessment integrating all available data. Thus, these assessments are represented as a single qualitative stenosis or regurgitation data element for each valve (mitral regurgitation severity; mitral stenosis severity).
5. Every effort was made to maximize the information conveyed by each data element. As such, whenever possible, “indicator” elements (e.g., presence or absence) were combined with grade of severity, type or location elements by adding permissible values of “none,” “unknown,” and either “present, unable to characterize further” or “indeterminate” to the more specific, descriptive severity, type or location permissible values.
7. “Qualitative” and “quantitative” were used in the data element name only when these were the only term that differentiated 2 elements.
8. Words that reflect data type were used in the data element name (i.e., diameter is always a numeric value; severity is always a qualitative value; “size” is usually qualitative but can be quantitative, so the definition of the size data elements describes the intended value).
9. Definition of clinical concepts associated with a specific data element follow the data element definition. For example, the definition for “annular calcification” follows the definition for “annular calcification severity.”
10. Clinical concepts used in the definitions of multiple data elements are not defined in this document. Although a common understanding of the meaning of these concepts is necessary to accurately and consistently report data for the elements where these concepts are used, this document assumes that the reader is familiar with general cardiovascular terminology (e.g., diastole and systole).
11. The data elements are meant to include those options chosen by most laboratories but not to prescribe their use. For example, the permissible values for valvular regurgitation include trace, mild, mild-to-moderate, moderate, moderate-to-severe and severe descriptors, but most laboratories will use a subset of these (e.g., mild, moderate, severe). In this sense, the data elements should be thought of as a vocabulary: only those words that accurately convey the intended meaning in a given setting should be used.
12. Whenever possible, we used the standard 17-segment left ventricular model; however, we acknowledge that there are implementations that use other segmentation schema, including a 16-segment model and those that divide the apex in 6 segments.
13. Standard terms, such as “body surface area,” are defined here because they are included in other data elements documents and are outside the scope of this one.
The tables in Appendixes 3 to 8 contain data elements addressing left and right heart structures, left and right heart function, aorta and pulmonary artery, right heart hemodynamics, congenital heart disease, and heart valves. In each table, data elements are listed and defined. Permissible values for each element and the definition of each are provided, along with references to current guidelines and standards documents, when available.
3.1 Left and Right Heart Structures
Appendix 3 provides the qualitative data elements and measurements that are typically available for assessment of cardiac chamber sizes, wall thickness, and geometry. It has sections (in this order) on left atrium, right atrium, left ventricle, and right ventricle. Qualitative assessments are noted in relationship to normal values, as codified in the appropriate, referenced guideline and standards document(s).
3.2 Left and Right Heart Function
Appendix 4 provides the data elements and measurements that are typically available for assessment of left ventricular global systolic function, including ejection fraction, stroke volume, cardiac output, right ventricular systolic function, and left ventricular diastolic function. Also included are data elements for segmental wall motion abnormality, global systolic longitudinal strain, diastolic function, and dyssynchrony. The appendix also has a section on right ventricular systolic function. Qualitative assessments are noted in relationship to normal values, as codified in the appropriate, referenced guideline and standards document(s).
Appendix 5 provides the data elements and measurements that are typically available for assessment of the aorta. This includes measurements of various portions of the aorta including sinuses of valsalva, ascending aorta, transverse arch, descending thoracic, and abdominal aorta. It also defines and characterizes aortic pathology including dissection, coarctation of the aorta, aortic aneurysm, and thoracic aortic aneurysm. Qualitative assessments are noted in relationship to normal values, as codified in the appropriate, referenced guideline and standards document(s).
3.4 Right Heart Hemodynamics and Pulmonary Artery
Appendix 6 provides the data elements and parameters that are typically available for the right heart hemodynamics and pulmonary artery assessments. These elements should describe quantitative assessments of relevant structures (e.g., the inferior vena cava diameter) that are used to assess hemodynamics (e.g., the inferior vena cava) and related functional assessments, such as measurement of right ventricular systolic pressure derived by using the tricuspid regurgitation jet velocity. Together, these anatomic sizes and functional assessments, when compared with normal values, as codified in the appropriate, referenced guideline and standards document(s), will allow assessment to identify pathologically elevated right-sided pressures.
3.5 Congenital Heart Disease
Appendix 7 provides the data elements, definitions, and permissible values related to some of the more common congenital heart diseases, although these lesions represent only a fraction of all the congenital cardiovascular malformations encountered in clinical practice. In addition, there is wide variability in presentation for each lesion because of equally wide variability in associated morphology and physiology, often resulting in heterogeneous nomenclature and definitions across the spectrum of congenital heart diseases. In an effort to bridge these frequently competing classification systems, the International Society for Nomenclature of Pediatric and Congenital Heart Disease developed the International Pediatric and Congenital Cardiac Code (http://www.ipccc.net/), a comprehensive list of congenital cardiovascular malformations that contains >1,000 diagnostic terms related to pediatric and congenital cardiac disease and cross-maps the terms from the most commonly used nomenclature systems into a single coding structure. From this list, the International Society for Nomenclature of Pediatric and Congenital Heart Disease identified a subset of 319 congenital heart disease terms that were incorporated into the 11th revision of the International Classification of Diseases (ICD-11) of the World Health Organization, and the terms, definitions, synonyms, and associated commentaries (6). Several common congenital heart diseases are listed in the other tables, most notably aortic coarctation (Appendix 5) and bicuspid aortic valve (listed under CDE “Number of Cusps” in Appendix 8).
3.6 Heart Valves
Appendix 8 contains the data elements needed to describe and quantify valvular heart disease. The actual quantitative methods are not described in detail but should be performed using the methods put forth in the appropriate guidelines from ACC and ASE. Normal values for qualitative and quantitative measures are as codified in the appropriate, referenced guideline and standards document(s). The tables are organized into sections on valve structure, cusp/leaflet motion, regurgitation, and stenosis.
4 Informatics of Controlled Vocabularies
The ACC/AHA/ASE key data elements for TTE were identified and described per the informatics principles articulated in the “ACC/AHA 2013 Methodology for Developing Clinical Data Standards” (4). Each data element represents the smallest clinically meaningful unit of information (4). Each data element is identified with a label and definition of the data element, along with the values that are allowed (permissible values) as responses to describe the state of the data element. Where unique to echocardiography, definitions of the permissible values were also defined. Every effort was made to ensure the data element definitions and the permissible value definitions were clinically precise and unambiguous. The permissible values comprising a value set are intended to be mutually exclusive. As such, the data elements are positioned for representation in the “Clinical Data Interchange Standards Consortium Study Data Tabulation Model Cardiovascular Therapeutic Area User Guide” and “Clinical Data Interchange Standards Consortium” controlled terminology, for formal development in controlled vocabularies such as Logical Observation Identifiers Names and Codes, and for representation in metadata repositories such as the National Cancer Institute Enterprise Vocabulary Server. This approach positions the terms as semantically interoperable common data elements, supports linkages with national distributed research platforms, and facilitates the uniform adoption by the clinical, regulatory, quality, and health information technology communities.
American College of Cardiology
C. Michael Valentine, MD, FACC, President
Timothy W. Attebery, MBA, FACHE, Chief Executive Officer
William J. Oetgen, MD, MBA, FACC, Executive Vice President, Science, Education, Quality, and Publishing
Lara Slattery, Division Vice President, Clinical Registry and Accreditation
Amelia Scholtz, PhD, Publications Manager, Science, Education, Quality, and Publishing
American College of Cardiology/American Heart Association
Abdul R. Abdullah, MD, Senior Manager, Guideline Science
Kathleen LaPoint, MS, Clinical Healthcare Data Manager
American Heart Association
Ivor J. Benjamin, MD, FAHA, President
Nancy Brown, Chief Executive Officer
Mariell Jessup, MD, FAHA, Chief Science and Medicine Officer
Rose Marie Robertson, MD, FAHA, Deputy Chief Science and Medical Officer
Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice President, Office of Science Operations
Radhika Rajgopal Singh, PhD, Director, Science and Medicine, Office of Science Operations
Jody Hundley, Production and Operations Manager, Scientific Publications, Office of Science Operations
American Society of Echocardiography
Jonathan R. Lindner, MD, FASE, President
Robin Wiegerink, MNPL, Chief Executive Officer
Andrea M. Van Hoever, MSGH, Deputy Director
Appendix 1 Author Relationships With Industry and Other Entities (Relevant)—2019 ACC/AHA/ASE Key Data Elements and Definitions for Transthoracic Echocardiography
Appendix 2 Reviewer Relationships With Industry and Other Entities—2019 ACC/AHA/ASE Key Data Elements and Definitions for Transthoracic Echocardiography
Appendix 3 Left and Right Heart Structures
Appendix 4 Left and Right Heart Function
Appendix 7 Congenital Heart Disease
Note: This is an incomplete presentation of the data elements used to describe congenital heart disease. All definitions (unless otherwise stated) are obtained from the International Pediatric and Congenital Cardiac Code (IPCCC) as published by the International Society for Nomenclature of Pediatric and Congenital Heart Disease (ISNPCHD) (http://www.ipccc.net/). The IPCCC number for each lesion is listed in the Source column. For a more complete listing of congenital heart diseases, please see the ISNPCHD website (http://www.ipccc.net/) and 2017 publication (20).
Appendix 8 Heart Valves
↵∗ Former Task Force member; current member during the writing effort.
↵† Former Task Force Chair; current chair during the writing effort.
This document was approved by the American College of Cardiology Clinical Policy Approval Committee, the American Heart Association Science Advisory and Coordinating Committee, and the American Society of Echocardiography Board of Directors in January 2019, and by the American Heart Association Executive Committee in March 2019.
The American College of Cardiology requests that this document be cited as follows: Douglas PS, Carabello BA, Lang RM, Lopez L, Pellikka PA, Picard MH, Thomas JD, Varghese P, Wang TY, Weissman NJ, Wilgus R. 2019 ACC/AHA/ASE key data elements and definitions for transthoracic echocardiography: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards) and the American Society of Echocardiography. J Am Coll Cardiol 2019;xx:xx-xx.
The Comprehensive RWI Data Supplement table is available at http://jaccjacc.acc.org/Clinical_Document/TTE_DS_Author_Comprehensive_RWI_Table_4.3.2019.pdf.
This article is copublished in Circulation: Cardiovascular Imaging and the Journal of the American Society of Echocardiography.
Copies: This document is available on the websites of the American College of Cardiology (www.acc.org), the American Heart Association (professional.heart.org), and the American Society of Echocardiography (http://asecho.org). For copies of this document, please contact Elsevier Inc. Reprint Department, fax 212-633-3820, e-mail .
Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American College of Cardiology. Instructions for obtaining permission are located at https://www.elsevier.com/about/policies/copyright/permissions.
- 2019 American Heart Association, Inc., and the American College of Cardiology Foundation
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- Table of Contents
- 1 Introduction
- 2 Methodology
- 3 Data Elements and Definitions
- 4 Informatics of Controlled Vocabularies
- Appendix 1 Author Relationships With Industry and Other Entities (Relevant)—2019 ACC/AHA/ASE Key Data Elements and Definitions for Transthoracic Echocardiography
- Appendix 2 Reviewer Relationships With Industry and Other Entities—2019 ACC/AHA/ASE Key Data Elements and Definitions for Transthoracic Echocardiography
- Appendix 3 Left and Right Heart Structures
- Appendix 4 Left and Right Heart Function
- Appendix 5 Aorta
- Appendix 6 Right Heart Hemodynamics and Pulmonary Artery
- Appendix 7 Congenital Heart Disease
- Appendix 8 Heart Valves