Professional Documents
Culture Documents
16, 2021
© 2021 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION
AND THE AMERICAN HEART ASSOCIATION, INC. PUBLISHED BY ELSEVIER
Endorsed by the Heart Failure Society of America, International Society for Heart and Lung
Transplantation, and Society of Thoracic Surgeons
Writing Biykem Bozkurt, MD, PHD, FACC, FAHA, Co-Chair Maria Lizza Isler, MSHIA
Committee Ray E. Hershberger, MD, FACC, FAHA, Co-Chair James K. Kirklin, MD, FACC
Members William S. Weintraub, MD, MACC, FAHA*
Javed Butler, MBBS, MPH, MBA, FACC, FAHA
Kathleen L. Grady, PHD, FAHA
*Task Force Liaison.
Paul A. Heidenreich, MD, FACC, FAHA
ACC/AHA Task Hani Jneid, MD, FACC, FAHA, Chair Nidhi Madan, MD, MPH
Force on Clinical Amgad N. Makaryus, MD, FACC
Data Standards Srinath Adusumalli, MD, MSc, FACCy Gregory M. Marcus, MD, FACC, FAHAy
Sana Al-Khatib, MD, MHS, FACC, FAHAy Paul Muntner, PhD, FAHA
H. Vernon Anderson, MD, FACCy Hitesh Raheja, MDy
Deepak L. Bhatt, MD, MPH, FACC, FAHA Jennifer Rymer, MDy
Biykem Bozkurt, MD, PhD, FACC, FAHAyz Kevin Shah, MD, FACCy
Bruce E. Bray, MD, FACC April W. Simon, RN, MSN
Mauricio G. Cohen, MD, FACC Nadia R. Sutton, MD, MPH, FACC
Monica Colvin, MD, MS, FAHA James E. Tcheng, MD, FACCy
Garth Nigel Graham, MD, FACCy William S. Weintraub, MD, MACC, FAHAz
Nasrien Ibrahim, MD, FACC, FAHA Emily Zeitler, MD, MHS, FACCy
Corrine Y. Jurgens, PhD, RN, ANP, FAHA
David P. Kao, MDy
yFormer Task Force member; current member during the writing effort.
Arnav Kumar, MBBS
zFormer Task Force Chair during this writing effort.
Leo Lopez, MD, FACC, FAHAy
This document was approved by the American College of Cardiology Clinical Policy Approval Committee in October 2020, by the American Heart
Association Science Advisory and Coordinating Committee in September 2020, and by the American Heart Association Executive Committee in
December 2020.
Appendix 4 includes data elements used to describe congenital heart disease obtained from the International Paediatric and Congenital Cardiac Code
(IPCCC) as published by the International Society for Nomenclature of Paediatric and Congenital Heart Disease (ISNPCHD) (http://ipccc.net/).
The American College of Cardiology requests that this document be cited as follows: Bozkurt B, Hershberger RE, Butler J, Grady KL, Heidenreich PA,
Isler ML, Kirklin JK, Weintraub WS. 2021 ACC/AHA key data elements and definitions for heart failure: 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 Heart Failure). J Am Coll
Cardiol. 2021;77:2053–150.
The Comprehensive RWI Data Supplemental Table is available online.
This article is copublished in Circulation: Cardiovascular Quality and Outcomes.
Copies: This document is available on the websites of the American College of Cardiology (www.acc.org) and the American Heart Association
(professional.heart.org). For copies of this document, please contact Elsevier Inc. Reprint Department, fax 212-633-3820, e-mail reprints@elsevier.com.
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.
TABLE OF CONTENTS
1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2056
TOP 10 TAKE-HOME MESSAGES
1.1. Special Considerations . . . . . . . . . . . . . . . . . . . . . 2057
1. This document (an update of the 2005 “ACC/AHA Key
2. METHODOLOGY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2058
Data Elements and Definitions for Measuring the
2.1. Writing Committee Composition . . . . . . . . . . . . . 2058 Clinical Management and Outcomes of Patients With
Chronic Heart Failure”) presents a clinical lexicon
2.2. Relationships With Industry and Other
Entities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2058 comprising data elements related to heart failure (HF),
without differentiation for chronic HF versus acute
2.3. Review of Literature and Existing Data
decompensated HF; inpatient versus outpatient; or
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2058
medical management with or without palliative care,
2.4. Development of Terminology Concepts . . . . . . . 2058 or hospice. Because HF is a chronic condition, and a
2.5. Consensus Development . . . . . . . . . . . . . . . . . . . 2058 patient can experience periodic acute decompensa-
tion, the writing committee considered data elements
2.6. Relation to Other Standards . . . . . . . . . . . . . . . . 2059
that are pertinent to the full range of care provided to
2.7. Peer Review, Public Review, and Board these patients and intended to be useful for all care
Approval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2059 venues.
2. Data elements for HF risk factors, cardiovascular his-
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2059
tory, and noncardiovascular health determinants,
APPENDIX 1 including COVID-19 infection, are included.
Author Relationships With Industry and 3. Patient assessment with more detailed elements for
Other Entities (Relevant) . . . . . . . . . . . . . . . . . . . . . . . 2062 symptoms, signs and physical exam findings, stages,
and functional assessment were updated.
APPENDIX 2 4. Structural and ejection fraction sub-phenotypes
were added, including data elements for heart fail-
Reviewer Relationships With Industry and
Other Entities (Comprehensive) . . . . . . . . . . . . . . . . . 2063 ure with reduced ejection fraction (HFrEF), heart
failure with mid-range ejection fraction (HFmEF),
APPENDIX 3 and heart failure with preserved ejection fraction
Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2065 (HFpEF).
5. Data elements related to cause of HF and cardiomy-
APPENDIX 4 opathy were added, emphasizing the importance of
specific diagnoses such as cardiac amyloidosis and
Medical History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2066
peripartum cardiomyopathy.
6. Data elements for noninvasive and invasive
APPENDIX 5
diagnostic modalities (echocardiogram, cardiac
Patient Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . 2113 magnetic resonance imaging, cardiopulmonary ex-
ercise testing, left and right heart catheterization)
APPENDIX 6 were expanded and updated.
Diagnostic Procedures . . . . . . . . . . . . . . . . . . . . . . . . . 2126 7. Data elements for invasive therapeutic procedures,
device therapies, and percutaneous mechanical cir-
APPENDIX 7 culatory support devices were added.
Invasive Therapeutic Procedures for Heart Failure . . 2135 8. Pharmacological treatment options with new classes
of medications were updated, and new data elements
APPENDIX 8 for new classes of medications were added.
9. Data elements for patient education and counseling
Pharmacological Therapy . . . . . . . . . . . . . . . . . . . . . . . 2140
on self-care and patient-reported outcome measures
were added.
APPENDIX 9
10. These clinical data standards should be broadly
End of Life Management . . . . . . . . . . . . . . . . . . . . . . . 2147 applicable in various settings, including clinical
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JACC VOL. 77, NO. 16, 2021 Bozkurt et al. 2055
APRIL 27, 2021:2053–150 ACC/AHA Heart Failure Data Standards
programs such as HF clinics, transitions of care, clin- 3. To facilitate the further development of clinical regis-
ical registries, clinical research, quality performance tries, quality and performance improvement programs,
improvement initiatives, electronic health records outcomes evaluations, public reporting, and clinical
and digital health information technology interoper- research, including the comparison of results within
ability, public reporting programs, and education/ and across these initiatives
self-care.
The key data elements and definitions are a compila-
tion of variables intended to facilitate the consistent, ac-
curate, and reproducible capture of clinical concepts;
PREAMBLE
standardize the terminology used to describe cardiovas-
cular diseases and procedures; create a data environment
The American College of Cardiology (ACC) and the
conducive to the assessment of patient management and
American Heart Association (AHA) support their mem-
outcomes for quality and performance improvement and
bers’ goal to improve the prevention and care of cardio-
clinical and translational research; and increase oppor-
vascular diseases through professional education,
tunities for sharing data across disparate data sources.
research, and development of guidelines and standards
The ACC/AHA Task Force on Clinical Data Standards (Task
and by fostering policy that supports optimal patient
Force) selects cardiovascular conditions and procedures
outcomes. The ACC and AHA recognize the importance of
that will benefit from creation of a clinical data standard
the use of clinical data standards for patient management,
set. Experts in the subject area are selected to examine
assessment of outcomes, and conduct of research, and the
and consider existing standards and develop a compre-
importance of defining the processes and outcomes of
hensive, yet not exhaustive, data standard set. When
clinical care, whether in randomized trials, observational
undertaking a data collection effort, only a subset of the
studies, registries, or quality improvement initiatives.
elements contained in a clinical data standard listing may
Hence, clinical data standards strive to define and
be needed or, conversely, users may want to consider
standardize data relevant to clinical topics in cardiovas-
whether it may be necessary to collect some elements not
cular medicine, with the primary goal of assisting data
listed. For example, in the setting of a randomized, clin-
collection by providing a platform of data elements and
ical trial of a new drug, additional information would
definitions applicable to various conditions. Broad
likely be required regarding study procedures and drug
agreement on a common vocabulary with reliable defini-
therapies. Another example is as follows: If the data set is
tions used by all is vital to pool and/or compare data
to be used for quality improvement, safety initiatives, or
across studies to promote interoperability of electronic
administrative functions, other elements such as Current
health records (EHRs) and to assess the applicability of
Procedural Terminology (CPT) codes and International
research to clinical practice. The increasing national focus
Statistical Classification of Diseases and Related Health
on adoption of certified EHRs along with financial in-
Problems, 10th revision (ICD-10-CM) codes, or outcomes
centives for providers to demonstrate “meaningful use”
may be added. The intent of the Task Force is to stan-
of those EHRs to improve healthcare quality render even
dardize the clinical concepts, keeping the focus on the
more imperative and urgent the need for such definitions
patient and the clinical care, not necessarily on adminis-
and standards. Therefore, the ACC and AHA have under-
trative billing or coding concepts, and the clinical con-
taken to define and disseminate clinical data standards—
cepts selected for development are generally
sets of standardized data elements and corresponding
cardiovascular specific, where a standardized terminology
definitions—to collect data relevant to cardiovascular
already exists. The clinical data standards can therefore
conditions. The ultimate purpose of clinical data stan-
serve as a guide for development of administrative data
dards is to contribute to the infrastructure necessary to
sets, and complementary administrative or quality
accomplish the ACC’s mission of fostering optimal car-
assurance elements can evolve from these core clinical
diovascular care and disease prevention and the AHA’s
concepts and elements. Thus, rather than forcing the
mission of being a relentless force for a world of longer,
clinical data standards to harmonize with existing
healthier lives.
administrative codes, such as ICD-10-CM or CPT codes, we
The specific goals of clinical data standards are:
would envision the administrative codes to follow the
1. To establish a consistent, interoperable, and universal lead of the clinical data standards. This approach would
clinical vocabulary as a foundation for clinical care and allow the clinical care to lead standardization of the ter-
clinical research minologies in health care.
2. To facilitate the exchange of data across systems The ACC and AHA recognize that there are other na-
through harmonized, standardized definitions of key tional efforts to establish clinical data standards, and
data elements every attempt is made to harmonize newly published
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2056 Bozkurt et al. JACC VOL. 77, NO. 16, 2021
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JACC VOL. 77, NO. 16, 2021 Bozkurt et al. 2057
APRIL 27, 2021:2053–150 ACC/AHA Heart Failure Data Standards
and the total cost of HF care in the United States exceeds The writing committee envisions that the data ele-
$30 billion annually, with over half of these costs spent on ments might be useful in these broad categories:
hospitalizations (15). The mortality rates after hospitali-
n Clinical programs, such as HF clinics, where many cli-
zation for HF remains high, at approximately 20% to 25%
nicians work together to achieve specific goals for the
at 1 year, with similar mortality rates for heart failure with
care and care coordination of patients with HF.
preserved ejection fraction or heart failure with reduced
n Transitions of care, in which patients with HF move
ejection fraction (16).
through different locations and levels of care (i.e.,
The clinical syndrome of HF may result from different
inpatient, outpatient [e.g., home, rehabilitation center,
causes. Thus, despite a common syndrome of HF,
nursing home], palliative care, and hospice) or progress
different etiologies may imply different prognosis and
through different stages of HF (Stages A to D), with
varying treatment strategies, underlining the importance
providers ranging from HF specialists, cardiac trans-
of specific data elements for emphasizing these differ-
plant physicians, home healthcare or palliative care
ences in HF (8). Similarly, the syndrome of HF commonly
providers, and primary care providers.
overlaps with other cardiovascular diseases, such as cor-
n Clinical registries, for ongoing care, prospective
onary artery disease, hypertension, valvular disease, and
epidemiologic and comparative effectiveness research,
primary myocardial disease, which are common causes of
pre- or postmarket analysis for efficacy and safety in
HF. Specifying these data elements for patients with HF is
populations of interest.
important for clinical care, performance improvement,
n Clinical research, particularly prospective randomized
research, and endpoints. Standardized data elements and
clinical trials where eventual pooled analysis or meta-
definitions across studies can help accelerate and facili-
analysis is anticipated.
tate research in HF through dissemination and sharing of
n Quality performance measurement initiatives, provider
relevant information, comparisons, pooled analyses, and
or institutional based or external, retrospective, or
meta-analyses (17).
prospective.
In clinical care, a broad spectrum of clinicians pro-
n Organization and design of electronic medical infor-
vides a continuum of care for patients with HF, ranging
mation initiatives, such as EHRs, pharmacy databases,
from primary care/family medicine providers, HF spe-
computerized decision support, and cloud technologies
cialists and/or cardiologists, cardiac and transplant sur-
incorporating health information.
geons, interventional cardiologists, electrophysiologists,
n Public health policy, healthcare coverage, insurance
advanced practice providers such as nurse practitioners
coverage, and legislation development to provide
and physician assistants, pharmacists, hospitalists,
appropriate and timely care for patients with HF and to
home healthcare providers, palliative care specialists
prevent disparities in HF care.
and nurses, hospice specialists and nurses, social
workers, and cardiac rehabilitation specialists to in- The data element tables are also included as an Excel
vestigators, who must communicate with each other file in the Online Data Supplement.
through a common vocabulary. Care of patients with HF
may take place in specialized clinics delivered by a 1.1. Special Considerations
variety of providers previously mentioned, necessitating Several points are important to recognize regarding the
care coordination comprising common terminology with scope of this document. First, given the magnitude of
a patient-centered approach (18). Furthermore, HF is a additional data elements that cardiac transplantation
chronic problem, and patients are likely to transition and mechanical circulatory support device therapies
through different stages of HF, which requires recogni- would entail, the writing group decided to focus on HF
tion and definition of these states with common termi- and not include cardiac transplantation and mechanical
nology standardized across different providers and circulatory support data elements in detail in this
encounters of care. document.
Similarly, given the recent emphasis on quality per- Second, the data elements were not differentiated for
formance measurement initiatives, particularly those for chronic HF versus acute decompensated HF; or for inpa-
which institutions and providers are compared against tient, outpatient, palliative care, or hospice status,
each other or against benchmarks, and reimbursement because HF is a chronic condition that is not an episodic
strategies and penalties that are attached to such metrics, event, and a patient can transition from one status to the
the necessity for reliable, risk adjustable, and analyzable other through his/her life time. The writing committee
data is gaining more importance for the professional considered data elements pertinent to the full range of
community, as well as for payers, regulators, legislators, care provided to these patients and are intended to be
and consumers (5,19,20). useful for all care venues.
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2058 Bozkurt et al. JACC VOL. 77, NO. 16, 2021
Third, the data elements were not differentiated for relationships with industry and other entities pertinent to
new onset incident versus prevalent cases or number of this data standards document are disclosed in Appendixes
encounters, and databases can be built and customized 1 and 2, respectively. In addition, for complete trans-
according to users’ needs to capture such information. parency, the disclosure information of each writing
Fourth, the writing committee would like to alert the committee member—including relationships not perti-
readers to the existence of other documents and guide- nent to this document—is available as a Supplemental
lines with which we tried to harmonize and are likely to Table. The work of the writing committee was supported
complement the content of our document, including the exclusively by the AHA and ACC without commercial
“2020 AHA/ACC Key Data Elements and Definitions for support. Writing committee members volunteered their
Coronary Revascularization” (21), “2019 ACC/AHA/ASE time for this effort. Meetings of the writing committee
Key Data Elements and Definitions for Transthoracic were confidential and attended only by committee
Echocardiography” (22), “2014 ACC/AHA Key Data Ele- members and staff.
ments and Definitions for Cardiovascular Endpoint Events
in Clinical Trials” (23), “2013 ACCF/AHA Guideline for the 2.3. Review of Literature and Existing Data Definitions
Management of Heart Failure” (24), “2017 ACC/AHA/ A substantial body of literature was reviewed to create
HFSA Focused Update of the 2013 ACCF/AHA Guideline this article (1,9,21–24). This information was augmented
for the Management of Heart Failure” (9), Centers for by multiple peer-reviewed references listed in the tables
Medicare & Medicaid Services (https://www.medicare. under the column “Mapping/Source of Definition.”
gov/hospitalcompare/search.html), and The Joint Com-
mission core HF performance measures; meaningful use 2.4. Development of Terminology Concepts
criteria; The Agency for Healthcare Research and Qual- The writing committee aggregated, reviewed, harmo-
ity’s quality indicators for HF; Get With The Guidelines nized, and extended these terms to develop a controlled,
and National Cardiovascular Data Registry CathPCI Reg- semantically interoperable, machine-computable termi-
istry data elements. We made every attempt to use nology set that would be usable, as appropriate, in as
guideline- and evidence-based definitions. broad a number of contexts as possible. As necessary, the
Finally, we did not include data element fields for entry writing committee identified the contexts where indi-
of calculated risk scores, as databases can be programmed vidual terms required differentiation according to their
and customized to calculate risks scores according to the proposed use (i.e., research/regulatory versus clinical care
user’s objective as different risk models can be used for contexts).
different purposes. This publication was developed with the intent that it
The intent of this writing committee was not to be will serve as a common lexicon and base infrastructure
overly prescriptive. that can be used by end users to augment work related to
standardization and healthcare interoperability
2. METHODOLOGY including, but not limited to, structural, administrative,
and technical metadata development. The resulting ap-
2.1. Writing Committee Composition pendixes (Appendixes 4–10) list the data element in the
The Task Force selected the members of the writing first column, followed by a clinical definition of the data
committee. The writing committee consisted of 8 in- element. The allowed responses (“permissible values”)
dividuals with domain expertise in HF, cardiomyopathy, for each data element in the next column are the
cardiovascular disease, outcomes assessment, medical acceptable “answers” for capturing the information. For
informatics, health information management, and data elements with multiple permissible values, a
healthcare services research and delivery. bulleted list of the permissible values is provided in the
row listing the data element, followed by multiple rows
2.2. Relationships With Industry and Other Entities listing each permissible value and corresponding
The Task Force made every effort to avoid actual or po- permissible value definition, as needed. Where possible,
tential conflicts of interest that might arise as a result of clinical definitions (and clinical definitions of the corre-
an outside relationship or a personal, professional, or sponding permissible values) are repeated verbatim as
business interest of any member of the writing commit- authored by the Standardized Data Collection for Car-
tee. Specifically, all members of the writing committee diovascular Trials Initiative (23) or as previously pub-
were required to complete and submit a disclosure form lished in reference documents.
showing all such relationships that could be perceived as
real or potential conflicts of interest. These statements 2.5. Consensus Development
were reviewed by the Task Force and updated when The Task Force established the writing committee per the
changes occurred. Authors’ and peer reviewers’ processes described in the Task Force’s methodology
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JACC VOL. 77, NO. 16, 2021 Bozkurt et al. 2059
APRIL 27, 2021:2053–150 ACC/AHA Heart Failure Data Standards
paper (2).The primary responsibility of the writing com- September 2020, and by the AHA Executive Committee in
mittee was to review and refine the ACC/AHA Key Data December 2020. The writing committee anticipates that
Elements and Definitions for Measuring the Clinical these data standards will require review and updating in
Management and Outcomes of Patients With Chronic the same manner as other published guidelines, perfor-
Heart Failure (1) and develop a harmonized data set for mance measures, and appropriate use criteria. The
coronary revascularization that will provide the attributes writing committee will, therefore, review the set of data
and other informatics formalisms required to attain elements on a periodic basis, starting with the anniver-
interoperability of the terms. The work of the writing sary of publication of the standards, to ascertain whether
committee was accomplished via a series of teleconfer- modifications should be considered.
ence and web conference meetings, along with extensive
email correspondence. The review work was distributed
among subgroups of the writing committee based on in- PRESIDENTS AND STAFF
terest and expertise in the components of the terminology
set. The proceedings of the workgroups were then American College of Cardiology
assembled, resulting in the vocabulary and associated Athena Poppas, MD, FACC, President
descriptive text in Appendixes 4–10. All members Cathleen C. Gates, Chief Executive Officer
reviewed and approved the final vocabulary. John S. Rumsfeld, MD, PhD, FACC, Chief Science Officer
and Chief Innovation Officer
2.6. Relation to Other Standards Lara Slattery, Division Vice President, Clinical Registry
The writing committee reviewed the available published and Accreditation
data standards, including registry data dictionaries from Grace D. Ronan, Team Lead, Clinical Policy Publication
registries, which were specifically developed for HF. Timothy W. Schutt, MA, Clinical Policy Analyst
Relative to published data standards, the writing com- American College of Cardiology/American Heart Association
mittee anticipates that this terminology set will facilitate Abdul R. Abdullah, MD, Director, Guideline Science and
the uniform adoption of these terms, where appropriate, Methodology
by the clinical, clinical and translational research, regu- Kathleen LaPoint, MS, Clinical Healthcare Data Manager
latory, quality and outcomes, and EHR communities. American Heart Association
Mitchell S.V. Elkind, MD, MS, FAAN, FAHA, President
2.7. Peer Review, Public Review, and Board Approval Nancy Brown, Chief Executive Officer
This document was reviewed by official reviewers nomi- Mariell Jessup, MD, FAHA, Chief Science and Medical
nated by ACC and AHA. To increase its applicability Officer
further, the document was posted on the ACC and AHA Radhika Rajgopal Singh, PhD, Vice President, Office of
websites for a 30-day public comment period. This Science, Medicine and Health
document was approved for publication by the ACC Jody Hundley, Production and Operations Manager,
Clinical Policy Approval Committee in October 2020, by Scientific Publications, Office of Science Operations
the AHA Science Advisory and Coordinating Committee in
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report of the American College of Cardiology Foun- data/nhis/earlyrelease/EarlyRelease201803_08.pdf. diovascular Angiography and Interventions. J Am Coll
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2062 Bozkurt et al. JACC VOL. 77, NO. 16, 2021
Institutional,
Organizational,
Ownership/ or Other
Committee Speakers Partnership/ Personal Financial Expert
Member Employment Consultant Bureau Principal Research Benefit Witness
Biykem Bozkurt Baylor College of Medicine—Mary and None None None None None None
(Co-Chair) Gordon Cain Chair Professor of
Medicine and Director, Winters Center
for Heart Failure Research; Michael E.
DeBakey VA Medical Center—Chief,
Cardiology Section
Ray E. Hershberger Ohio State University, Wexner Medical None None None None None None
(Co-Chair) Center—Professor of Medicine,
Cardiovascular Medicine and Human
Genetics, and Director, Division of
Human Genetics
Javed Butler University of Mississippi, Medical None None None None None None
Center—Professor
Kathleen L. Grady Northwestern University—Professor of None None None None None None
Surgery and Medicine, Feinberg School
of Medicine and Northwestern
Memorial Hospital; Bluhm
Cardiovascular
Institute—Administrative Director,
Center for Heart Failure
Ed Havranek* Denver Health Medical Center— None None None None None None
Director of Medicine
Paul A. Heidenreich Stanford University School of None None None None None None
Medicine—Professor of Medicine and
Professor of Health Research and
Policy
Maria Lizza Isler AHA—Interoperability Project Manager None None None None None None
James K. Kirklin University of Alabama at Birmingham— None None None None None None
Professor of Surgery, Division of
Cardiothoracic Surgery and Director,
Kirklin Institute for Research in
Surgical Outcomes (KIRSO)
William S. Weintraub MedStar Heart & Vascular Institute— None None None None None None
Director, Outcomes Research;
Georgetown University—Professor of
Medicine
This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document. These relationships were
reviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarily
reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of $5% of the voting
stock or share of the business entity, or ownership of $$5,000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of
the person’s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are
modest unless otherwise noted. According to the ACC/AHA, a person has a relevant relationship IF: a) the relationship or interest relates to the same or similar subject matter, in-
tellectual property or asset, topic, or issue addressed in the document; or b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the
document, or makes a competing drug or device addressed in the document; or c) the person or a member of the person’s household, has a reasonable potential for financial, professional
or other personal gain or loss as a result of the issues/content addressed in the document.
*Dr. Havranek resigned from the writing committee in February 2019. The writing committee thanks him for his contributions, which were extremely beneficial to the development of
the draft.
ACC indicates American College of Cardiology; AHA, American Heart Association; and VA, Veterans Affairs.
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Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
APRIL 27, 2021:2053–150
Ownership/
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Adam Official Reviewer—AHA Duke University School of Medicine— n Amgen None None n AHA* n NHLBI‡ None
DeVore Assistant Professor of Medicine, Division of n AstraZeneca n Amgen* n PCORI‡
Cardiology; Duke Clinical Research Pharmaceuticals n AstraZeneca* n Intra-Cellular Therapies‡
Institute—Member n Bayer Healthcare n Bayer Healthcare
Pharmaceuticals* Pharmaceuticals
n InnaMed n Intra-Cellular
n LivaNova Therapies
n Mardil Medical n Luitpold
n Novartis* Pharmaceuticals
n Procyrion n Merck & Co.
n scPharmaceuticals n NHLBI*
n Zoll n Novartis*
n PCORI
Gregg C. Official Reviewer—ACC UCLA—Professor of Medicine n Abbott Laboratories* n Novartis* None n Medtronic n ACC/AHA Task Force on None
Fonarow Clinical Policy Approval n Amgen* n NHLBI* Performance Measures†
Committee; Content n CHF Solutions n Novartis* n ACTION Registry GWTG
Reviewer n Edwards Lifesciences Steering Committee Chair†
n Janssen n AHA Consumer Health
n Medtronic Quality Coordinating
n Merck Committee†
n Novartis* n JAMA Cardiology†
n Regeneron n Steering Committee
GWTG†
Corrine Y. Official Reviewer—ACC/ Boston College—Associate Professor; None None None None n HFSA† None
Jurgens AHA Task Force on Data Stony Brook University School of
Standards Nursing—Associate Professor, Emeritus
Daniel J. Official Reviewer—ACC Lifespan Physician Group—Director, None None None None n NIH‡ None
Levine Board of Governors Advanced Heart Failure Program; n Novartis‡
The Warren Alpert Medical School of n Sanofi‡
Brown University—Clinical Associate n St. Jude Medical‡
Professor of Medicine
Kavita Official Reviewer—AHA JHU School of Medicine—Assistant n Novartis n Novartis None n AHA* n Pfizer (King None
Sharma Professor of Medicine; JHU Heart Pharmaceuticals)‡
H. Vernon Content Reviewer University of Texas Health Science n Accreditation for None None None n None None
Anderson Center at Houston McGovern Cardiovascular
Medical School—Professor of Excellence
Medicine, Cardiology n American Medical
Foundation for
Education*
Bozkurt et al.
Maria Rosa Content Reviewer Advocate Heart Institute—Medical n Abbott Laboratories None None n Novartis† n CHF Solutions* None
Costanzo Director, Heart Failure Research; n CHF Solutions n Abbott Laboratories*
Edward Hospital Center for Advanced n Respicardia
Heart Failure—Medical Director
2063
2064
APPENDIX 2. CONTINUED
Ownership/
Speakers Partnership/ Institutional, Organizational,
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Reviewer Representation Employment Consultant Bureau Principal Personal Research or Other Financial Benefit Expert Witness
Akshay Desai Content Reviewer Harvard Medical School—Associate n Abbot Laboratories* None None n Alnylam* n Baim Institute for Clinical n Defendant, cardio-
Professor of Medicine; Brigham and n Alnylam* n AstraZeneca Research* myopathy, 2019
Women’s Hospital—Associate Physician n Amgen* Pharmaceuticals* n TIMI Study Group* n Plaintiff, out-of-
n AstraZeneca n Bayer Healthcare hospital cardiac
Pharmaceuticals* Pharmaceuticals† arrest, 2018
n Biofourmis* n MyoKardia†
n Boehringer Ingel- n Novartis*
heim
Pharmaceuticals
n Boston Scientific*
n Corvidia
Therapeutics*
n DalCor
Pharmaceuticals*
n Merck & Co.
n Novartis*
n Regeneron*
n Relypsa*
Lee Content Reviewer University of Pennsylvania—Professor n Abbott Laboratories None None n Respicardia† None None
Goldberg of Medicine; Vice Chair for Informatics, n Respicardia n NIH
Department of Medicine; Section Chief,
Advanced Heart Failure and Cardiac
Transplant
Nkechinyere Content Reviewer Mayo Clinic—Cardiologist, Department None None None None None None
N. Ijioma of Cardiovascular Medicine
Anuradha Content Reviewer Mount Sinai Health System—Assistant None None None None n Zoll None
Lala- Professor, Medicine, and Population n American Regent‡
Trindade Health Science And Policy; NHLBI n NHLBI‡
Cardiothoracic Surgery Network—Director,
Heart Failure Research
Gurusher Content Reviewer George Washington School of Medicine & None n Pfizer* None None n Abbott Laboratories‡ None
Panjrath Health Sciences—Associate Professor of n HFSA†
Medicine, and Director, Advanced Heart
Failure and Mechanical Circulatory
Support Program
Pamela N. Content Reviewer University of Colorado Anschutz n AHA* None None n NHLBI† None None
Peterson Medical Campus—Professor of
Medicine, Cardiology
APPENDIX 3. ABBREVIATIONS
ACC ¼ American College of Cardiology HFpEF ¼ heart failure with preserved ejection fraction
AHA ¼ American Heart Association HFrEF ¼ heart failure with reduced ejection fraction
CMS ¼ Centers for Medicare & Medicaid Services ICD-10 ¼ International Statistical Classification of Diseases
CPT ¼ Current Procedural Terminology and Related Health Problems, 10th revision
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2066
APPENDIX 4. MEDICAL HISTORY
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Date of event The date an event occurred n Date, in mm/dd/yyyy The format mm/dd/yyyy is commonly
used in the United States. Other formats
used to capture date include dd/mm/
yyyy and yyyy-mm-dd.
Diabetes A metabolic disorder characterized by n Type 1 diabetes NCI Thesaurus Code: C2985 (25) This does not include gestational
abnormally high blood sugar levels due to n Type 2 diabetes American Diabetes Association. diabetes.
diminished production of insulin or insulin n No 2. Classification and diagnosis of
resistance/desensitization. n Unknown diabetes: standards of medical care in
American Diabetes Association criteria for diabetes–2018. Diabetes Care.
diabetes mellitus includes the 2018;41:S13-27. (26)
documentation of the following:
n HbA1c $6.5%; or
n Fasting plasma glucose $126 mg/dL
(7.0 mmol/L); or
n 2-h plasma glucose $200 mg/dL
(11.1 mmol/L) during an oral glucose
tolerance test; or
n In a patient with classic symptoms of
hyperglycemia or hyperglycemic
crisis, a random plasma
glucose $200 mg/dL (11.1 mmol/L)
No No history of diabetes
Unknown
Acutely An emergency condition in which blood n Diabetic ketoacidosis Kitabchi AE, Umpierrez GE, Miles JM,
decompensated glucose level is extremely high n Hyperosmolar hyper- et al. Hyperglycemic crises in adult
diabetes glycemic nonketotic patients with diabetes. Diabetes Care.
syndrome 2009;32:1335-43. (27)
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Diabetes duration Duration since first diagnosis of diabetes n Newly diagnosed American Heart Association. Get With
n <5 y The Guidelines–Heart Failure. Available
n 5–10 y at: https://www.heart.org/en/
n 10 to <20 y professional/quality-improvement/get-
n $20 y with-the-guidelines/get-with-the-
guidelines-heart-failure. Accessed
October 26, 2020. (28)
Diabetes treatment A therapeutic modality used to aid in the n None NCI Thesaurus Code: C99532 (25)
management of an individual’s diabetes n Diet
n Oral
n Insulin
n Noninsulin subcutane-
ous medication
n Unknown
Bozkurt et al.
2067
2068
APPENDIX 4. CONTINUED
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Oral diabetes Types of oral therapeutic medications (Multi-select) Because different oral agents have
medications for diabetes n Metformin differential effects on development of
n Sulfonylurea HF and outcomes in established HF
n Thiazolidinediones patients, we recommend data capture
n GLP-1 agonists separately for each agent.
n DPP-4 inhibitors
n SGLT-2 inhibitors
n Other
n None
n Unknown
Other
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Hypertension Pathological increase in blood pressure n Yes Whelton PK, Carey RM, Aronow WS, et al.
n No 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/
n Unknown APhA/ASH/ASPC/NMA/PCNA guideline
for the prevention, detection, evaluation,
and management of high blood pressure
in adults: executive summary: a report of
the American College of Cardiology/
American Heart Association Task Force
on Clinical Practice Guidelines. J Am Coll
Cardiol. 2018;71:e127-248. (30)
Unknown
Antihypertensive Oral medications taken for n Thiazide or thiazide- Whelton PK, Carey RM, Aronow WS, et al.
medications hypertension type diuretic agents 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/
n ACE inhibitor APhA/ASH/ASPC/NMA/PCNA guideline
n ARB for the prevention, detection, evaluation,
n CCB, dihydropyridine and management of high blood pressure
n CCB, in adults: a report of the American
nondihydropyridine College of Cardiology/American Heart
n Secondary agent(s) Association Task Force on Clinical
n No Practice Guidelines. J Am Coll Cardiol.
n Unknown 2018;71:e127-248. (30)
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
No
White coat n
Patient has white coat hypertension, which Yes Whelton PK, Carey RM, Aronow WS, et al. The white coat effect is usually
hypertension is characterized by elevated n No 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/ considered clinically significant when
office blood pressure but normal readings n Unknown APhA/ASH/ASPC/NMA/PCNA guideline office systolic and diastolic blood
when measured outside for the prevention, detection, evaluation, pressures are >20/10 mm Hg higher than
the office with either ambulatory and management of high blood pressure home blood pressure monitoring or
blood pressure monitoring in adults: a report of the American ambulatory blood pressure monitoring
or home blood pressure College of Cardiology/American Heart systolic and diastolic blood pressures.
monitoring. Association Task Force on Clinical
Practice Guidelines. J Am Coll Cardiol.
2018;71:e127-248. (30)
Dyslipidemia History of dyslipidemia, most n Yes NCI Thesaurus Code: C80385 (25)
commonly hyperlipidemia, that was n No Grundy SM, Stone NJ, Bailey AL, et al. 2018
diagnosed and/or treated by a n Unknown AHA/ACC/AACVPR/AAPA/ABC/ACPM/
healthcare provider. Criteria include ADA/AGS/APhA/ASPC/NLA/PCNA
documentation of the following: guideline on the management of blood
n Total cholesterol >200 mg/dL (5.18 cholesterol: a report of the American
mmol/L); or College of Cardiology/American Heart
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Metabolic syndrome Presence of at least 3 of the following: n Yes Arnett DK, Blumenthal RS, Albert MA,
n Increased waist circumference n No et al. 2019 ACC/AHA guideline on the
(by ethnically appropriate cutpoints) n Unknown primary prevention of cardiovascular
n Elevated triglycerides (>150 mg/dL, disease: a report of the American College
nonfasting) or drug treatment for of Cardiology/American Heart
elevated triglycerides Association Task Force on Clinical
n Elevated blood pressure, or antihy- Practice Guidelines. J Am Coll Cardiol.
pertensive drug treatment in a pa- 2019;74:e177-232. (32)
tient with a history of hypertension Alberti KG, Eckel RH, Grundy SM, et al.
n Elevated glucose (fasting Harmonizing the metabolic syndrome: a
glucose $100 mg/dL), or drug joint interim statement of the
treatment for elevated glucose International Diabetes Federation Task
n Low HDL cholesterol (<40 mg/dL in Force on Epidemiology and Prevention;
men; <50 mg/dL in women), or drug National Heart, Lung, and Blood
treatment for low HDL cholesterol Institute; American Heart Association;
World Heart Federation; International
Atherosclerosis Society; and
International Association for the Study of
Obesity. Circulation. 2009;120:1640-5.
(33)
Tobacco use Current or previous use of any combustible n Current everyday user Barua RS, Rigotti NA, Benowitz NL, et al.
tobacco product (e.g., cigarettes, cigars, n Current some day user 2018 ACC expert consensus decision
and pipes) or heated tobacco product n Current user, frequency pathway on tobacco cessation treatment:
captured as smoking status unknown a report of the American College of
n Former user Cardiology Task Force on Clinical Expert
n Never user Consensus Documents. J Am Coll Cardiol.
n User, current status 2018;72:3332-65. (34)
unknown NCDR CathPCI Registry Coder’s Data
n Unknown Dictionary v5.0 (element #4625) (35)
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Current everyday user As defined in the NHIS, a person who reports The only permissible value definition, as
currently smoking tobacco every day and has shown, currently available is for
smoked at least 100 cigarettes (5 packs) in his cigarette smoking. There are no
or her lifetime (36). current definitions for cigar, pipe, or
heated tobacco product use.
Current some day user As defined in the NHIS, a person who reports
currently smoking tobacco on some days (nondaily
smoker) and has smoked at least 100 cigarettes (5
packs) in his or her lifetime (36).
Current user, frequency The patient smokes tobacco, but the frequency is
unknown unknown.
User, current status The patient smokes tobacco, but the frequency is
unknown unknown.
Tobacco type The type of tobacco product n Cigarettes NCDR CathPCI Registry Coder’s Data
the patient uses n Cigars Dictionary v5.0 (element #4626) (35)
n Pipe Barua RS, Rigotti NA, Benowitz NL, et al.
n Heated tobacco 2018 ACC expert consensus decision
products pathway on tobacco cessation treatment:
n Other smokeless to- a report of the American College of
bacco products Cardiology Task Force on Clinical Expert
Consensus Documents. J Am Coll Cardiol.
2018;72:3332-65. (34)
Cigarettes
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Quantity of Quantification of lifetime tobacco n Numerical, pack-years NCI Thesaurus Code: C73993 (25) One pack-year is defined as smoking 20
cigarettes exposure defined as number of cigarettes cigarettes/d for 1 y.
smoked smoked/day (pack-years)
Exposure to The IOM defines secondhand smoke as a n Current ongoing Institute of Medicine Committee on
secondhand complex mixture that is made up of gases exposure Secondhand Smoke Exposure and Acute
smoke and particles and includes smoke from n Recent past exposure Coronary Events. Secondhand Smoke
burning cigarettes, cigars, and pipe (<1 y) Exposure and Cardiovascular Effects:
tobacco (sidestream smoke) and exhaled n Remote past exposure Making Sense of the Evidence.
mainstream smoke. This includes aged (>1 y) Washington, DC: National Academies
smoke that lingers after smoking ceases. Press (US); 2010. (37)
Use of electronic Use of electronic cigarettes (e-cigarettes), n Yes Barua RS, Rigotti NA, Benowitz NL, et al. Electronic nicotine delivery systems
nicotine delivery which are battery-operated devices that n No 2018 ACC expert consensus decision generate an aerosol (but not smoke) that
system heat a liquid containing nicotine, n Unknown pathway on tobacco cessation treatment: the user inhales. Users’ exposure to
propylene glycol, and/or vegetable a report of the American College of nicotine and other chemicals in the
glycerin and flavorants to generate an Cardiology Task Force on Clinical Expert aerosol depends on factors such as the
aerosol that the user inhales (i.e., vaping), Consensus Documents. J Am Coll Cardiol. type of device, the components of the e-
or heat-not-burn tobacco products, which 2018;72:3332-65. (34) liquid, and on how the devices are used.
are tobacco products that heat tobacco to
a lower temperature than required for
combustion
Alcohol Consumption of liquids containing ethanol n None NCI Thesaurus Code: C16273 (25) A standard drink is equal to 14.0 g (0.6
consumption n #1 alcoholic drinks/wk Centers for Disease Control and Prevention oz) of pure alcohol. Generally, this
n 2–7 alcoholic drinks/wk Fact Sheets - Alcohol use and your amount of pure alcohol is found in
n $8 alcoholic drinks/wk health. Available at: https://www.cdc. n 12 oz of beer (5% alcohol content)
n Unknown gov/alcohol/fact-sheets/alcohol-use. n 8 oz of malt liquor (7% alcohol
htm. Accessed October 26, 2020. (38) content)
n 5 oz of wine (12% alcohol content)
n 1.5 oz or a “shot” of 80-proof (40%
alcohol content) distilled spirits or
liquor (e.g., gin, rum, vodka,
whiskey) (38)
Bozkurt et al.
2073
2074
APPENDIX 4. CONTINUED
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Alcohol dependency Chronic disease in which a person craves n Yes NCI Thesaurus Code: C93040 (25)
drinks that contain alcohol and is unable to n No
control his or her drinking n Unknown
Treatment for Documented treatment for alcohol n Yes
alcohol dependency n No
dependency n Unknown
Alcoholic cardiomyopathy A dilated cardiomyopathy that is associated with NCI Thesaurus Code: C53653 (25)
consumption of large amounts of alcohol over a
period of years
Alcoholic hepatitis Acute or chronic degenerative and inflammatory NCI Thesaurus Code: C34684 (25)
lesion of the liver due to alcohol abuse. Depending
on its severity, the inflammatory lesion may be
reversible or potentially progress to liver cirrhosis.
Alcoholic cirrhosis A disorder of the liver characterized by the NCI Thesaurus Code: C34782 (25)
presence of fibrotic scar tissue instead of healthy
liver tissue. This condition is attributed to excessive
consumption of alcoholic beverages.
Wernicke–Korsakoff A syndrome caused by thiamine deficiency. It NCI Thesaurus Code: C35764 (25)
syndrome usually occurs in alcoholics and is characterized by
confusion, ataxia, and ophthalmoplegia.
Illicit drug use Documented history of current, recent, or n Current user Because laws regarding marijuana vary
remote use of any illicit drug (e.g., cocaine, n Recent user (within 1 y by state, marijuana use is excluded from
methamphetamine, heroin) or controlled but not current) consideration for this data element and
substance, or misuse of prescription drugs n Former user (>1 y) listed separately.
n No
n Unknown
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
NSAID A pharmacological agent that is not a steroid and NCI Thesaurus Code: C257 (25)
has potential anti-inflammatory, analgesic,
antipyretic, and antiplatelet activities. Most NSAIDs
act by inhibiting the conversion of arachidonic acid
to the precursors of prostaglandin and
thromboxane by cyclooxygenase enzymes.
Other potentially
cardiotoxic chemotherapy
agents
Exposure to The use of synthetic or naturally occurring n Yes
cardiotoxic chemicals for the n No
chemotherapy treatment of diseases. n Unknown
Although this term is used to describe
any therapy involving the use of chemical-
based agents, it is particularly used to
refer to the use of chemical-based agents
to treat cancer.
Chemotherapy may also include agents
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Cardiotoxic Synthetic or naturally occurring chemicals n Anthracycline NCI Thesaurus Code: C15632 (25)
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Anthracycline antibiotics Includes anthracycline, daunorubicin, doxorubicin, NCI Thesaurus Codes: C1594, C1583,
epirubicin, idarubicin C456, C62028, C562 (25)
Alkylating agents For example, cyclophosphamide NCI Thesaurus Code: C405 (25)
Bozkurt et al.
n Left breast
n Right breast
n Other potentially car-
diotoxic chemotherapy
agents
2077
Chest The anterior side of the thorax from the neck to the NCI Thesaurus Code: C25389 (25)
abdomen
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Left breast The hemispheric projection, including the NCI Thesaurus Code: C47855 (25)
mammary gland, located on the anterior
portion of the chest, lateral to the midline, on the
side of the body to the west when facing north
Right breast The hemispheric projection, including the NCI Thesaurus Code: C47856 (25)
mammary gland, located on the anterior portion of
the chest, lateral to the midline, on the side of the
body to the east when facing north
Other
Family history of Family history of sudden cardiac death, n Yes NCI Thesaurus Code: C50911 (25)
sudden cardiac defined as natural death due to cardiac n No
death causes, heralded by abrupt loss of n Unknown
consciousness in first-degree relatives
(parents, siblings, children). The time and
mode of death are unexpected even
though preexisting heart disease may have
been known to be present. Sudden death
without obvious cause is considered
sudden cardiac death. Age at time of
sudden cardiac death and cause, if known,
may be specified.
Family history of History of having any first-degree relatives n Yes Cannon CP, Brindis RG, Chaitman BR,
premature CAD (parents, siblings, children) who have had n No et al. 2013 ACCF/AHA key data elements
any of the following conditions at age <55 n Unknown and definitions for measuring the clinical
y for male relatives or <65 y for female management and outcomes of patients
relatives: with acute coronary syndromes and
n AMI coronary artery disease: a report of the
n Sudden cardiac death without American College of Cardiology
obvious cause Foundation/American Heart Association
n CABG surgery Task Force on Clinical Data Standards
n PCI (Writing Committee to Develop Acute
Coronary Syndromes and Coronary
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Ventricular arrhythmia Irregular heartbeat resulting from a pathological NCI Thesaurus Code: C26924 (25)
process in the cardiac ventricles
Conduction disorder A disorder affecting the conduction system that NCI Thesaurus Code: C78245 (25)
sends electrical signals in the myocardium
None
Unknown
Dilated cardiomyopathy Dilated, poorly contracting left ventricle in absence Bozkurt B, Colvin M, Cook J, et al.
of coronary artery disease Current diagnostic and treatment
strategies for specific dilated
cardiomyopathies: a scientific
statement from the American Heart
Association. Circulation.
2016;134:e579-646. (8)
Bozkurt et al.
that primarily encode components of
the sarcomere.
2079
2080
APPENDIX 4. CONTINUED
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Fabry disease An X-linked lysosomal storage disorder NCI Thesaurus Code: C84701 (25)
characterized by deficiency of the enzyme alpha-
galactosidase A, which results in the accumulation
of glycolipids in the blood vessels and tissues. Signs
and symptoms include hypertension,
cardiomyopathy, angiokeratomas, neuropathy,
hypohidrosis, keratopathy, proteinuria, and renal
failure.
No
Unknown
Family history of Family history of known hereditary n Yes (if yes, specify or-
amyloidosis amyloidosis, often affecting the liver, gan involvement and, if
nerves, heart, and kidneys. Many genetic known, mutation type)
defects are implicated. For example, n No
hereditary form of transthyretin can n Unknown
be the cause.
ACE indicates angiotensin-converting enzyme; AMI, acute myocardial infarction; ARB, angiotensin II receptor blocker; ARVC, arrhythmogenic right ventricular cardiomyopathy; ARVD, arrhythmogenic right ventricular dysplasia; CABG, coronary artery
bypass grafting; CCB, calcium channel blocker; CUI, concept unique identifier; DPP-4, dipeptidyl peptidase-4; FDA, US Food and Drug Administration; GLP-1, glucagon-like peptide-1; HbA1c, hemoglobin A1c; HCM, hypertrophic cardiomyopathy; HDL,
high-density lipoprotein; HF, heart failure; IOM, Institute of Medicine; LDL, low-density lipoprotein; mm/dd/yyyy, month/day/year; NCI, National Cancer Institute; NHIS, National Health Interview Survey; NSAID, nonsteroidal anti-inflammatory drug; PCI,
percutaneous coronary intervention; PPAR-gamma, peroxisome proliferator-activated receptor-gamma; SGLT-2, sodium-glucose cotransporter-2; and UMLS, Unified Medical Language System.
Permissible Value
Downloaded for Adina Braha (braha.adina@umft.ro) at University of Medicine and Pharmacy Victor Babes Timisoara from ClinicalKey.com by
Data Element Data Element Definition Permissible Values Definitions Mapping/Source of Definition Additional Notes
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HF HF is a complex clinical syndrome that n Yes Yancy CW, Jessup M, Bozkurt B, et al. 2013 There is no single diagnostic test for HF
results from any structural or functional n No ACCF/AHA guideline for the management because it is largely a clinical diagnosis
impairment of ventricular filling or n Unknown of heart failure: a report of the American based on a careful history and physical
ejection of blood. The cardinal College of Cardiology Foundation/ examination. A low EF alone, without
manifestations of HF are dyspnea and American Heart Association Task Force on clinical evidence of HF does
fatigue, which may limit exercise Practice Guidelines. J Am Coll Cardiol. not qualify as HF.
tolerance and cause or lead to fluid 2013;62:e147-239. (24) HF subtypes are specified
retention, which may lead to pulmonary in Appendix 6.
and/or splanchnic congestion and/or
peripheral edema. Some patients have
exercise intolerance but little evidence
of fluid retention, whereas others
complain primarily of edema, dyspnea,
or fatigue. Because some patients
present without signs or symptoms of
volume overload, the term HF is
preferred over congestive HF. Provider
documentation or report of a former
diagnosis of HF before a care encounter,
or a previous hospital admission with a
diagnosis of HF, is considered evidence
of HF history.
Typical angina 1) Substernal chest discomfort with a n Yes Fihn SD, Gardin JM, Abrams J, et al. 2012
characteristic quality and duration that n No ACCF/AHA/ACP/AATS/PCNA/SCAI/STS
is 2) provoked by exertion or emotional n Unknown guideline for the diagnosis and management
stress and 3) relieved by rest or of patients with stable ischemic heart
nitroglycerin. disease: a report of the American College of
Cardiology Foundation/American Heart
Association Task Force on Practice
Guidelines, and the American College of
Physicians, American Association for
Thoracic Surgery, Preventive Cardiovascular
Nurses Association, Society for
Cardiovascular Angiography and
Interventions, and Society of
Thoracic Surgeons. J Am Coll Cardiol.
2013;61:e78-140. (41)
Bozkurt et al.
American College of Physicians, American
Association for Thoracic Surgery,
Preventive Cardiovascular Nurses
Association, Society for Cardiovascular
Angiography and Interventions, and
Society of Thoracic Surgeons. J Am Coll
Cardiol. 2013;61:e78-140. (41)
2081
Continued on the next page
2082
APPENDIX 4. CONTINUED
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Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Data Element Data Element Definition Permissible Values Definitions Mapping/Source of Definition Additional Notes
Anginal equivalent Symptom such as dyspnea, n Yes Anderson JL, Adams CD, Antman EM, et al. Anginal equivalents are considered
diaphoresis, nausea, extreme fatigue, n No 2012 ACCF/AHA focused update symptoms of myocardial ischemia.
ventricular arrhythmias, or pain at a n Unknown incorporated into the ACCF/AHA 2007 For high cardiac risk determination,
site other than the chest, occurring in a guidelines for the management of patients please refer to 2013 ACC/AHA Guideline
patient at high cardiac risk. Anginal with unstable angina/non–ST-elevation on the Assessment of Cardiovascular
equivalents have the same importance myocardial infarction: a report of the Risk. ACC/AHA ASCVD Risk Calculator
as angina pectoris. American College of Cardiology http://www.cvriskcalculator.com/
Foundation/American Heart Association
Task Force on Practice Guidelines. J Am
Coll Cardiol. 2013;61:e179-347. (42)
Angina grade Grade symptoms or signs in patients n Class 0 Campeau L. The Canadian Cardiovascular Both preprocedure and postprocedure
with suspected or presumed stable n Class I Society grading of angina pectoris timing Canadian Cardiovascular Society
angina (or angina equivalent) n Class II revisited 30 years later. Can J Cardiol. class can be collected.
according to the Canadian n Class III 2002;18:371-9. (43)
Cardiovascular Society grading scale n Class IV
n Unknown
Class 0 Asymptomatic
Permissible Value
Data Element Data Element Definition Permissible Values Definitions Mapping/Source of Definition Additional Notes
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Previous myocardial Any MI occurrence between birth and n Yes Presence of any 1 of the following criteria
infarction arrival at this facility, excludes AMI n No that meets the diagnosis of previous MI:
n Uncertain n Pathological Q waves with or without
symptoms in the absence of non-
ischemic causes.
n Imaging evidence of a region of loss
of myocardium that is thinned and/or
fails to contract, in the absence of
nonischemic cause.
Atherosclerotic 10-y risk of ASCVD for primary n Numeric, % American College of Cardiology. ASCVD
cardiovascular prevention patients (those without Risk Estimator Plus. Available at: http://
disease risk ASCVD) tools.acc.org/ASCVD-Risk-Estimator-Plus/
#!/calculate/estimate/. Accessed October
26, 2020. (44)
AMI The term AMI should be used when n Type 1: Spontaneous Thygesen K, Alpert JS, Jaffe AS, et al.
there is acute myocardial injury with n Type 2: Ischemic imbalance Fourth universal definition of myocardial
clinical evidence of acute myocardial n Type 3: Death, no biomarkers infarction (2018). J Am Coll Cardiol.
ischemia and with detection of a rise n Type 4a: PCI-related 2018;72:2231-64. (45)
and/or fall of cTn values with at least 1 n Type 4b: Stent thrombosis
value above the 99th percentile URL n Type 4c: PCI restenosis
and at least 1 of the following: n Type 5: CABG-related
n Symptoms of myocardial n Unknown
ischemia;
n New ischemic changes on the
ECG;
n Development of pathological Q
waves;
n Imaging evidence of new loss of
myocardium or new regional wall
motion abnormality in a pattern
consistent with an ischemic
cause;
n Identification of a coronary
thrombus by angiography or au-
topsy (not for type 2 or 3 MIs).
Bozkurt et al.
2083
APPENDIX 4. CONTINUED
2084
B. Cardiovascular History (Continued)
Data Element Data Element Definition Permissible Values Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Type 1: Spontaneous Spontaneous clinical syndrome related to cTn—I or T—is the preferred biomarker. If a
atherosclerotic plaque rupture, cTn assay is unavailable, the best
ulceration, fissuring, erosion, or alternative is CK-MB. $1 coronary
dissection, with resulting intraluminal artery may be involved.
thrombus and leading to decreased Note: This definition does not require a
myocardial blood flow or distal platelet severe underlying coronary stenosis.
emboli with ensuing myocyte necrosis. Typically, some degree of CAD is found
This classification requires a detection by angiography, but less frequently
of a rise and/or fall of cardiac there may be nonobstructive or no
biomarker values (preferably cTn) with coronary artery disease. The term
at least 1 value >99th percentile of the “myocardial infarction with
URL and at least 1 of the following: nonobstructed coronary arteries
n Symptoms of myocardial ischemia (MINOCA)” is often used to describe
n New or presumed new significant this clinical finding. In some patients,
ST-segment T wave changes or new acute myocarditis may also present with
LBBB on the ECG acute myocardial injury and/or
n Development of pathological Q ST-segment changes (45).
waves on the ECG
n Imaging evidence of new loss of
myocardium or new regional wall
motion abnormality
n Identification of an intracoronary
thrombus by angiography or autopsy.
Type 2: Ischemic Spontaneous clinical syndrome where a cTn—I or T—is the preferred biomarker. If a
imbalance condition other than coronary artery cTn assay is unavailable, the best
disease contributes to an imbalance alternative is CK-MB.
between myocardial oxygen supply
and/or demand (e.g., coronary
endothelial dysfunction, coronary
artery spasm, coronary embolism,
tachy-/bradyarrhythmias, anemia,
respiratory failure, hypotension, and
hypertension with or without LVH).
This classification requires a) detection
of a rise and/or fall of cardiac
biomarker values (preferably cTn) with
at least 1 value >99th percentile of
the URL, and b) at least 1 of the
following:
n Symptoms of myocardial ischemia
n New or presumed new significant ST-
segment T wave changes or new
LBBB on the ECG
n Development of pathological Q
Permissible Value
Data Element Data Element Definition Permissible Values Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Type 4b: Stent thrombosis MI associated with stent thrombosis as cTn—I or T—is the preferred biomarker.
detected by coronary angiography or at If a cTn assay is unavailable, the
autopsy, where symptoms suggestive of best alternative is CK-MB.
myocardial ischemia are present, and with
a rise and/or fall of cardiac biomarkers
values, with at least 1 value >99th
percentile of the URL
Type 4c: PCI restenosis Spontaneous clinical syndrome occurring cTn—I or T—is the preferred biomarker. If a
>48 h after PCI, with elevation of cTn assay is unavailable, the best
Bozkurt et al.
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2085
2086
APPENDIX 4. CONTINUED
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Permissible Value
Data Element Data Element Definition Permissible Values Definitions Mapping/Source of Definition Additional Notes
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None .
Other
Previous CABG CABG surgery before the current n Yes Timeframe does NOT include current
surgery admission n No admission.
n Unknown
Bozkurt et al.
Not applicable
Unknown A proper value is applicable but not
known.
2087
2088
APPENDIX 4. CONTINUED
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Data Element Data Element Definition Permissible Values Definitions Mapping/Source of Definition Additional Notes
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Date of previous The date of the most recent CABG n Date, in mm/dd/yyyy
CABG done on patient n Unknown
CAD CAD is present as documented by n Yes Hillis LD, Smith PK, Anderson JL, et al. 2011
invasive coronary angiography at any n No ACCF/AHA guideline for coronary artery
time before the current admission. n Unknown bypass graft surgery: a report of the
Additional acceptable evidence American College of Cardiology
documenting the presence of CAD Foundation/American Heart Association
includes: 1) presence of a previous MI Task Force on Practice Guidelines. J Am
with Q-waves and/or fixed perfusion Coll Cardiol. 2011;58:e123-210. (46)
defect, 2) history of previous Levine GN, Bates ER, Blankenship JC, et al.
revascularization procedure (either PCI 2011 ACCF/AHA/SCAI guideline for
or CABG), and 3) coronary CT percutaneous coronary intervention: a
angiography showing obstructive report of the American College of
coronary stenoses and other Cardiology Foundation/American Heart
noninvasive imaging studies showing Association Task Force on Practice
findings diagnostic of CAD. Guidelines and the Society for
Cardiovascular Angiography and
Interventions. J Am Coll Cardiol.
2011;58:e44-122. (47)
No
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Ischemic stroke An episode of neurological dysfunction Sacco RL, Kasner SE, Broderick JP, et al. An Hemorrhage may be a consequence of
caused by focal cerebral, spinal, or updated definition of stroke for the 21st ischemic stroke. In this situation, the
retinal infarction. (Note: Evidence of century: a statement for healthcare stroke is an ischemic stroke with
CNS infarction is defined above.) professionals from the American hemorrhagic transformation.
Definition of silent CNS infarction: Heart Association/American The newer definitions as described
imaging or neuropathological Stroke Association. Stroke. by Hicks KA et al. have been included
evidence of CNS infarction, 2013;44:2064-89. (48) wherever possible.
without a history of Hicks KA, Mahaffey KW, Mehran R, et al.
acute neurological dysfunction 2017 Cardiovascular and stroke
attributable to the lesion. endpoint definitions for clinical trials.
Circulation. 2018;137:961-72. (49)
TIA Transient episode of neurological Hicks KA, Mahaffey KW, Mehran R, et al. The distinction between a TIA and ischemic
dysfunction caused by focal or global 2017 Cardiovascular and stroke endpoint stroke is the presence of infarction. The
brain, spinal cord, or retinal ischemia definitions for clinical trials. Circulation. unifying concept driving the definition is
without acute infarction 2018;137:961-72. (49) that stroke is a marker of potentially
Sacco RL, Kasner SE, Broderick JP, et al. An disabling vascular brain injury.
updated definition of stroke for the 21st The duration of $24 h has been
century: a statement for healthcare used as an operational definition of
professionals from the American Heart persisting symptoms of stroke rather
Association/American Stroke Association. than TIA, based mostly on consensual
Stroke. 2013;44:2064-89. (48) practice rather than objective evidence.
Noninvasive or invasive arterial Noninvasive or invasive arterial imaging Cannon CP, Brindis RG, Chaitman BR, et al.
imaging test test demonstrating $50% stenosis of any 2013 ACCF/AHA key data elements and
of the major extracranial or intracranial definitions for measuring the clinical
vessels to the brain. Examples include management and outcomes of patients
carotid Doppler ultrasound and contrast with acute coronary syndromes and
angiography. coronary artery disease: a report of the
American College of Cardiology
Foundation/American Heart Association
Task Force on Clinical Data Standards
(Writing Committee to Develop Acute
Coronary Syndromes and Coronary Artery
Disease Clinical Data Standards). J Am Coll
Cardiol. 2013;61:992-1025. (40)
Previous cervical or cerebral artery History of cervical or cerebral artery Cannon CP, Brindis RG, Chaitman BR, et al.
Bozkurt et al.
Coronary Syndromes and Coronary Artery
Disease Clinical Data Standards). J Am Coll
Cardiol. 2013;61:992-1025. (40)
None
Unknown A proper value is applicable but not
known.
2089
Continued on the next page
2090
APPENDIX 4. CONTINUED
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Stroke An episode of neurological dysfunction n Yes Hicks KA, Mahaffey KW, Mehran R, et al.
caused by focal cerebral, spinal, or n No 2017 Cardiovascular and stroke endpoint
retinal infarction. In the absence of n Unknown definitions for clinical trials. Circulation.
pathological, imaging, or other 2018;137:961-72. (49)
objective evidence of ischemic injury in Sacco RL, Kasner SE, Broderick JP, et al. An
a defined vascular distribution, clinical updated definition of stroke for the 21st
evidence of symptoms persisting $24 century: a statement for healthcare
h or until death, with other etiologies professionals from the American Heart
excluded. Association/American Stroke Association.
Stroke. 2013;44:2064-89. (48)
Type of stroke Categories of stroke n Ischemic NCDR CathPCI Registry Coder’s Data
n Hemorrhagic Dictionary Supplement v5.0 (data
n Undetermined element #9001) (50)
n Unknown Sacco RL, Kasner SE, Broderick JP, et al. An
updated definition of stroke for the 21st
century: a statement for healthcare
professionals from the American Heart
Association/American Stroke Association.
Stroke. 2013;44:2064-89. (48)
Ischemic An episode of neurological dysfunction Sacco RL, Kasner SE, Broderick JP, et al. Hemorrhage may be a consequence of
caused by focal cerebral, spinal, or An updated definition of stroke for ischemic stroke. In this situation, the
retinal infarction. (Note: Evidence of the 21st century: a statement for stroke is an ischemic stroke with
CNS infarction is defined above.) healthcare professionals from the hemorrhagic transformation and not a
Definition of silent CNS infarction: American Heart Association/ hemorrhagic stroke.
imaging or neuropathological evidence American Stroke Association. If ischemic stroke, list most likely
of CNS infarction without a history of Stroke. 2013;44:2064-89. (48) etiologies:
acute neurological dysfunction n Large artery atherosclerosis of the
attributable to the lesion. extracranial vessels (e.g., carotid)
n Large artery atherosclerosis of the
intracranial vessels (e.g., middle ce-
rebral artery stenosis)
n Cardioembolism
n Small vessel occlusion (lacunar)
n Ischemic stroke of other determined
cause (e.g., arterial dissection)
Large artery atherosclerosis of the extra-
cranial vessels (e.g., carotid)
Hemorrhagic Rapidly developing clinical signs of Sacco RL, Kasner SE, Broderick JP, et al. An Subdural hematomas are intracranial
neurological dysfunction attributable to a updated definition of stroke for the 21st hemorrhagic events and not strokes.
focal collection of blood within the brain century: a statement for healthcare
parenchyma, ventricular system, or professionals from the American Heart
bleeding into the subarachnoid space, that Association/American Stroke Association.
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Cerebrovascular Time period between last documented n Recent STS Risk Calculator(51)
event timing cerebrovascular event (TIA or stroke) n Remote
and presentation n Unknown
Recent #2 wk
Remote >2 wk
PAD Diagnosis of PAD, which includes lower n Yes Cannon CP, Brindis RG, Chaitman BR, et al.
extremity from iliac to tibialis and n No 2013 ACCF/AHA key data elements and
upper extremity with subclavian and n Unknown definitions for measuring the clinical
brachial vessels but excludes renal management and outcomes of patients
(kidney), coronary, cerebral, and with acute coronary syndromes and
mesenteric vessels and aneurysms. The coronary artery disease: a report of the
criteria for the diagnosis of PAD American College of Cardiology
include: Foundation/American Heart Association
n Claudication on exertion that is Task Force on Clinical Data Standards
relieved by rest (Writing Committee to Develop Acute
n Positive noninvasive test (e.g., Coronary Syndromes and Coronary Artery
ankle-brachial index #0.9, Disease Clinical Data Standards). J Am Coll
ultrasonography, MRI, or CT Cardiol. 2013;61:992-1025. (40)
scanning of >50% diameter Creager MA, Belkin M, Bluth EI, et al. 2012
stenosis in any peripheral artery ACCF/AHA/ACR/SCAI/SIR/STS/SVM/SVN/
[i.e., subclavian, femoral, iliac]) SVS key data elements and definitions for
or angiographic imaging peripheral atherosclerotic vascular disease:
n Vascular reconstruction, bypass a report of the American College of
surgery, or percutaneous revas- Cardiology Foundation/American Heart
cularization in the arteries of the Association Task Force on Clinical Data
lower and upper extremities Standards (Writing Committee to Develop
n Amputation for severe arterial Clinical Data Standards for Peripheral
vascular insufficiency. Atherosclerotic Vascular Disease). J Am
Coll Cardiol. 2012;59:294-357. (52)
Previous pacemaker Non-ICD pacemaker implantation, n Yes NCI Thesaurus Code: C94198 (25) Device type (pacemaker, cardiac
implantation before the current encounter, usually n No chamber(s) involved, and year of
(non-ICD) indicated for abnormality of electrical n Unknown implantation may be helpful
Bozkurt et al.
2091
2092
APPENDIX 4. CONTINUED
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Previous ICD: a battery-powered electrical n ICD Cannon CP, Brindis RG, Chaitman BR, et al. Information about the type of device
implantation of impulse generator implanted in n No 2013 ACCF/AHA key data elements and (pacemaker, biventricular/
an ICD patients at risk of sudden cardiac death n Unknown definitions for measuring the clinical resynchronization/
to detect cardiac arrhythmia and management and outcomes of patients CRT, implantable cardioverter-
correct it, usually with antitachycardia with acute coronary syndromes and defibrillator, combination), cardiac
pacing and then by delivering a jolt of coronary artery disease: a report of the chamber(s) involved, and year of
electricity, implanted before the American College of Cardiology implantation may be helpful.
current encounter Foundation/American Heart Association
Task Force on Clinical Data Standards
(Writing Committee to Develop Acute
Coronary Syndromes and Coronary Artery
Disease Clinical Data Standards). J Am Coll
Cardiol. 2013;61:992-1025. (40)
No No ICD history
Unknown
ICD shock The patient received an ICD shock. n Yes, shock appropriate
n Yes, shock inappropriate
n Yes, shock appropriateness
unknown
n No
n Unknown
Previous Patient has history of implantation of n CRT or CRT-P
cardiac CRT device before the current n CRT-D, CRT with ICD
resynchronization encounter. A CRT device is a n No
therapy biventricular pacemaker that sends n Unknown
electrical signals to both ventricles
that resynchronizes the heart
chambers and helps it pump more
effectively. It may or may not have an
atrial pacing wire.
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No
Unknown
Atrial fibrillation History of atrial fibrillation, which is an n Paroxysmal NCI Thesaurus Code: C80391 (25)
abnormal heart rhythm characterized n Persistent January CT, Wann LS, Alpert JS, et al. 2014
by rapid and irregular beating of the n Permanent AHA/ACC/HRS guideline for the
atrial chambers of the heart n No management of patients with atrial
n Unknown fibrillation: a report of the American
College of Cardiology/American
Heart Association Task Force on
practice guidelines and the Heart
Rhythm Society. J Am Coll Cardiol.
2014;64:e1-76. (53)
No
Unknown
Atrial flutter History of atrial flutter, which is a well- n Paroxysmal NCI Thesaurus Code: C51224 (25)
organized but overly rapid contraction n Persistent
of the atrium of the heart (usually at a n Permanent
rate of 250–350 contractions/min) n No
Bozkurt et al.
n Unknown
2093
Continued on the next page
2094
APPENDIX 4. CONTINUED
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Sick sinus syndrome A constellation of signs and symptoms NCI Thesaurus Code: C62244 (25)
which may include syncope, fatigue,
dizziness, and alternating periods of
bradycardia and atrial tachycardia, which is
caused by sinoatrial node and/or AV nodal
dysfunction
Paroxysmal supraventricular An electrocardiographic finding of episodic NCI Thesaurus Code: C34901 (25)
tachycardia supraventricular tachycardia with abrupt
onset and termination
History of History of rhythm abnormalities n Frequent PVCs Specify documentation source (e.g., Holter,
ventricular arising from the ventricles n Nonsustained ventricular event recorder, ICD, pacemaker).
arrhythmias tachycardia
n Sustained ventricular
tachycardia
n Ventricular fibrillation
Nonsustained ventricular Nonsustained ventricular tachycardia is a NCI Thesaurus Code: C71053 (25)
tachycardia type of ventricular tachycardia that stops
on its own within 30 s.
Sustained ventricular tachycardia Sustained ventricular tachycardia is a NCI Thesaurus Code: C71052 (25)
ventricular rhythm faster than 100 bpm
lasting at least 30 s or requiring
termination earlier due to hemodynamic
instability. VT is defined as a wide complex
tachycardia (QRS $120 ms) that originates
from 1 of the ventricles and is not caused
by aberrant conduction of supraventricular
arrhythmias.
Ventricular fibrillation An electrocardiographic finding of a rapid NCI Thesaurus Code: C50799 (25)
grossly irregular ventricular rhythm with
marked variability in the QRS cycle length,
morphology, and amplitude. The rate is
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Data Element Data Element Definition Permissible Values Definitions Mapping/Source of Definition Additional Notes
Brugada syndrome ventricular An electrocardiographic finding of a NCI Thesaurus Code: C71059 (25)
arrhythmia pattern of right bundle branch block and
ST-segment elevation within
electrocardiogram leads V1–V3. This
pattern emerges as a result of a defect in
ion channel genes, resulting in atypical
electrophysiological activity in the right
ventricle and a propensity for malignant
tachyarrhythmias.
Bozkurt et al.
a delta wave.
2095
2096
APPENDIX 4. CONTINUED
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Sudden unsuspected death Sudden unexplained death syndrome Veerakul G, Nademanee K. What is the
syndrome (young Asian males) describes the death of apparently sudden death syndrome in
healthy individuals—usually young Southeast Asian males? Cardiol Rev.
Southeast Asian men—in whom 2000;8:90-5. (55)
postmortem examination does not
reveal the cause of death. The victims
are in apparently good health and
usually die at night while sleeping. They
die within minutes after the onset of
agonal respiration. Patients who have
been resuscitated were found to have
ventricular fibrillation and inducible
polymorphic ventricular tachycardia in
the electrophysiological laboratory.
AV nodal reentry tachycardia An electrocardiographic finding of a NCI Thesaurus Code: C35058 (25)
(AVNRT) supraventricular tachycardia due to reentry
along a circuit contained within the AV node
RV outflow tract ventricular An electrocardiographic finding of NCI Thesaurus Code: C71064 (25)
tachycardia ventricular tachycardia originating in the
right ventricular outflow tract
Bundle branch-mediated Bundle branch re-entrant ventricular NCI Thesaurus Code: C71062 (25)
ventricular tachycardia tachycardia: an electrocardiographic
finding of ventricular tachycardia
incorporating both bundle branches into
the reentry circuit
Persistent Persistent or chronic tachycardia with n Yes NCI Thesaurus Code: C38029 (25)
tachycardia heart rate >100 bpm, defined as the n No
one occurring in >10% of cardiac n Unknown
rhythm during 24 h. It may begin at
any age, persisting months or years. If
the mechanism of arrhythmia is not
sinus, tachycardia-induced
cardiomyopathy may result.
History of rheumatic History of rheumatic fever, an n Yes NCI Thesaurus Code: C34984 (25)
valvular disease inflammatory disease that can involve n No
the heart, joints, skin, and brain that n Unknown
develops after a streptococcal throat
infection, resulting in carditis
and valvular disease. It can manifest
with pericarditis, heart murmur,
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Other (specify)
Patent arterial duct (patent ductus A congenital cardiovascular finding in IPCCC 09.27.21
Bozkurt et al.
which there is a hole or pathway between
the ventricular chambers
2097
2098
APPENDIX 4. CONTINUED
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Other
Repair of congenital Procedure was performed to treat a n Yes (if yes, specify type of
cardiac lesion congenital cardiac lesion repair)
AMI indicates acute myocardial infarction; ASCVD, atherosclerotic cardiovascular disease; AV, atrioventricular; bpm, beats per minute; CABG, coronary artery bypass grafting; CAD, coronary artery disease; CK-MB, creatine kinase MB; CNS, central
nervous system; CRT, cardiac resynchronization therapy; CRT-D, cardiac resynchronization therapy defibrillator; CRT-P, cardiac resynchronization therapy pacemaker; CT, computed tomography; cTn, cardiac troponin; ECG, echocardiography; EF, ejection
fraction; HF, heart failure; ICD, implantable cardioverter-defibrillator; IPCCC, International Paediatric and Congenital Cardiac Code; LBBB, left bundle branch block; left ventricular hypertrophy; MI, myocardial infarction; mm/dd/yyyy, month/day/year;
MRI, magnetic resonance imaging; NCI, National Cancer Institute; PAD, peripheral artery disease; PCI, percutaneous coronary intervention; PVC, premature ventricular contraction; RV, right ventricular; STS, Society of Thoracic Surgeons; TIA, transient
ischemic attack; and URL, upper reference limit.
APPENDIX 4. CONTINUED
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Data Element Data Element Definition Permissible Values Definitions Mapping/Source of Definition Additional Notes
History of asthma A respiratory condition marked by n Yes Patients with onset of asthma in
spasms in the bronchi of the lungs, n No adulthood, asthma diagnosis should
causing difficulty in breathing. It usually n Unknown precede HF diagnosis by $5 y or have
results from an allergic reaction or other documented pulmonary function test
forms of hypersensitivity. evidence of reversible bronchospasm.
History of chronic Chronic obstructive pulmonary n Yes NCI Thesaurus Codes: C3199,
lung disease disease: a chronic and progressive lung n No C26722, C3348 (25)
disorder characterized by the loss of n Unknown
elasticity of the bronchial tree and the
air sacs, destruction of the air sacs
wall, thickening of the bronchial wall,
and mucus accumulation in the
bronchial tree, resulting in the
disruption of the air flow in the
bronchial airways. Signs and symptoms
include shortness of breath, wheezing,
productive cough, and chest tightness.
Includes chronic obstructive bronchitis
and is usually treated with inhaled or
oral pharmacological therapy (e.g.,
beta-adrenergic agonist, anti-
inflammatory agent, leukotriene
receptor antagonist, or steroid).
Bozkurt et al.
renal function) of the following:
n Increase in serum creatinine
by $0.3 mg/dL.
n Decline in estimated GFR by
>20%
2099
2100
APPENDIX 4. CONTINUED
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Peritoneal dialysis Dialysis fluid being introduced into and NCI Thesaurus Code: C15297 (25)
removed from the peritoneal cavity as
either a continuous or an intermittent
procedure
No
Unknown
History of dementia History of dementia, loss of n Yes NCI Thesaurus Codes: C4786,
intellectual abilities interfering with an n No C4786 (25)
individual’s social and occupational n Unknown
functions. Causes include Alzheimer’s
disease, brain injuries, brain tumors,
and cerebrovascular disorders.
History of History of treated depression, or n Yes NCI Thesaurus Code: C2982 (25)
depression currently taking antidepressant n No
medication. Note if past or present n Unknown
episode has required or is currently
requiring drug treatment or
electroconvulsive therapy.
History of A blockage of the airway, usually when n Yes American Heart Association. Get With
obstructive sleep the soft tissue in the back of the throat n No The Guidelines–Heart Failure. Available
apnea collapses during sleep n Unknown at: https://www.heart.org/en/
professional/quality-improvement/
get-with-the-guidelines/get-with-the-
guidelines-heart-failure. Accessed
October 26, 2020. (28)
History of chronic Disease of the liver that lasts >6 mo. It n Yes
liver disease consists of a wide range of liver n No
pathologies that include chronic n Unknown
hepatitis and liver cirrhosis.
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Yes Presence of chronic liver disease such NCI Thesaurus Codes: C82978,
as chronic hepatitis, an active C2951 (25)
inflammatory process affecting the
liver for >6 mo or cirrhosis, which
is a disorder characterized by
replacement of the liver
parenchyma with fibrous tissue and
regenerative nodules, usually
caused by alcoholism, hepatitis B,
hepatitis C, or nonalcoholic fatty
liver disease. Complications include
development of ascites,
esophageal varices, coagulopathy,
and encephalopathy.
No
Unknown
History of systemic SLE is an autoimmune disease with n Yes NCI Thesaurus Code: C3201 (25)
lupus autoantibodies targeted against skin, n No
erythematosus heart, lungs, kidneys, joints, and n Unknown
nervous system resulting in organ
damage, arthritis, and skin disorders.
SLE is marked by many different
symptoms; however, not every
patient with SLE has all of
the symptoms.
History of Rheumatoid arthritis is a chronic n Yes NCI Thesaurus Code: C2884 (25)
rheumatoid systemic disease, primarily of the n No
arthritis joints, marked by inflammatory n Unknown
changes in the synovial membranes
and articular structures, widespread
fibrinoid degeneration of the collagen
fibers in mesenchymal tissues, and by
atrophy and rarefaction of bony
structures. Cause is unknown, but
autoimmune mechanisms have been
Bozkurt et al.
lungs, gastrointestinal tract, and
kidneys.
2101
APPENDIX 4. CONTINUED
2102
C. Noncardiovascular History (Continued)
Data Element Data Element Definition Permissible Values Definitions Mapping/Source of Definition Additional Notes
n
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
History of muscular Muscular dystrophy is a group of n Yes NCI Thesaurus Code: C84910 (25) This condition may lead to advanced
dystrophy inherited progressive muscle disorders n No HF and heart transplant in
characterized by muscle weakness and n Unknown appropriately selected patients.
eventual death of the muscle tissues.
Some may be associated with
cardiomyopathy.
Hyperthyroidism Overactivity of the thyroid gland NCI Thesaurus Code: C3123 (25)
resulting in overproduction of
thyroid hormone and increased
metabolic rate. Causes include
diffuse hyperplasia of the thyroid
gland (Graves’ disease), single
nodule in the thyroid gland, and
thyroiditis. The symptoms are related
to the increased metabolic rate and
include weight loss, fatigue, heat
intolerance, excessive sweating,
diarrhea, tachycardia, insomnia,
muscle weakness, and tremor.
Hypothyroidism A condition in which the production of NCI Thesaurus Code: C26800 (25)
None
Unknown
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Unknown
History of ATTR ATTR amyloidosis is a form of systemic n Hereditary ATTR
amyloidosis amyloidosis caused by amyloid amyloidosis
deposits made up of a protein n Acquired (nonhereditary)
called TTR. ATTR amyloidosis can be or wild-type ATTR
either hereditary or acquired amyloidosis
(nonhereditary). n No
Bozkurt et al.
n Unknown
2103
APPENDIX 4. CONTINUED
2104
C. Noncardiovascular History (Continued)
Data Element Data Element Definition Permissible Values Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
No
Unknown
History of HIV Infection and seropositivity status with n HIV seropositive HIV can be associated with
HIV, a retrovirus that causes AIDS n AIDS cardiomyopathy and pulmonary
n HIV negative arterial hypertension.
n Unknown
AIDS A syndrome resulting from the NCI Thesaurus Code: C2851 (25)
acquired deficiency of cellular
immunity caused by HIV. It is
characterized by the reduction of the
helper T-lymphocytes in the peripheral
blood and the lymph nodes. Symptoms
include generalized lymphadenopathy,
fever, weight loss, and chronic
diarrhea. Patients with AIDS are
especially susceptible to opportunistic
infections and the development of
malignant neoplasms.
HIV negative
Unknown
Acute COVID-19 COVID-19 is an infectious disease n Confirmed COVID-19
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Confirmed COVID-19 infection Confirmed diagnosis of the COVID-19 World Health Organization. COVID-19 COVID-19 testing is usually done by
as documented by the provider, coding in ICD-10. Available at: RT-PCR testing. The role of
with a clinical presentation https://www.who.int/ convalescent antibodies is evolving
supportive of the COVID-19 classifications/icd/COVID-19- and needs further validation for
infection or documentation of a coding-icd10.pdf?ua¼1. Accessed specificity and sensitivity for
positive COVID-19 test result, or a October 26, 2020. (56) COVID-19 infection.
presumptive positive COVID-19
test result
Suspected COVID-19 infection If the provider documents "suspected," World Health Organization. COVID-19
"possible," "probable," or coding in ICD-10. Available at: https://
“inconclusive” COVID-19 infection but www.who.int/classifications/icd/
not confirmed by a COVID-19 test COVID-19-coding-icd10.pdf?ua¼1.
Accessed October 26, 2020. (56)
Asymptomatic COVID-19 Incidental diagnosis of COVID-19 in an World Health Organization. COVID-19 COVID-19 testing is usually done by
infection asymptomatic patient with the finding coding in ICD-10. Available at: https:// RT-PCR testing. The role of
of a positive COVID-19 test during www.who.int/classifications/icd/ convalescent antibodies is evolving
screening COVID-19-coding-icd10.pdf?ua¼1. and needs further validation for
Accessed October 26, 2020. (56) specificity and sensitivity for COVID-19
infection.
No
Unknown
Exposure to COVID- Exposure to someone who is confirmed n Yes World Health Organization. COVID-19
19 or suspected to have COVID-19, and n No coding in ICD-10. Available at: https://
the exposed individual either tests n Unknown www.who.int/classifications/icd/
negative or the test results are COVID-19-coding-icd10.pdf?ua¼1.
unknown Accessed October 26, 2020. (56)
Previous COVID-19 Patient had COVID-19 infection >14 n Yes Patients usually would have tested
infection d ago and has recovered. n No positive by RT-PCR during the acute
n Unknown infection, and if repeat testing
obtained, recovery is usually defined
after 2 negative RT-PCR tests. The role
of convalescent antibodies (IgM and
IgG) is evolving and needs further
Bozkurt et al.
Date of COVID-19 The date the COVID-19 hospitalization Date, in mm/dd/yyyy
hospitalization occurred
2105
APPENDIX 4. CONTINUED
2106
C. Noncardiovascular History (Continued)
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Acute myocardial injury due to Acute myocardial injury diagnosed with Hendren NS, Drazner MH, Bozkurt B,
COVID-19 without elevation in cardiac troponin and/or et al. Description and proposed
cardiomyopathy, without with cardiac imaging such as management of the acute COVID-
coronary obstruction or cardiac MRI, without any evidence 19 cardiovascular syndrome.
acute coronary syndrome of decline in LVEF, with no Circulation. 2020;141:1903-14. (57)
evidence of obstructive coronary
artery disease or without clinical or
electrocardiographic evidence of
acute coronary syndrome
presentation during acute COVID-
19 infection
Acute myocardial injury due to Acute myocardial injury diagnosed with Hendren NS, Drazner MH, Bozkurt B,
COVID-19 with left ventricular elevation in cardiac troponin and/or et al. Description and proposed
cardiomyopathy without acute with cardiac imaging such as cardiac management of the acute COVID-19
coronary syndrome or coronary MRI, with evidence of a decline in cardiovascular syndrome. Circulation.
obstruction LVEF, with no evidence of obstructive 2020;141:1903-14. (57)
coronary artery disease or without
clinical or electrocardiographic
evidence of acute coronary syndrome
presentation during acute COVID-19
infection
Acute myocardial injury due to Acute myocardial injury diagnosed with Hendren NS, Drazner MH, Bozkurt B,
COVID-19 with RV elevation in cardiac troponin and/or et al. Description and proposed
cardiomyopathy without acute with cardiac imaging such as cardiac management of the acute COVID-19
coronary syndrome MRI, with evidence of a decline in RV cardiovascular syndrome. Circulation.
function, with no evidence of 2020;141:1903-14. (57)
obstructive coronary artery disease or
without clinical or electrocardiographic
evidence of acute coronary syndrome
presentation during acute COVID-19
infection
Acute myocardial injury with Acute myocardial injury diagnosed with Hendren NS, Drazner MH, Bozkurt B,
COVID-19 with acute coronary elevation in cardiac troponin, along et al. Description and proposed
syndrome with clinical presentation suggestive of management of the acute COVID-19
acute coronary syndrome with chest cardiovascular syndrome. Circulation.
Persistent sinus tachycardia Persistent sinus tachycardia with Hendren NS, Drazner MH, Bozkurt B,
with acute COVID-19 infection COVID-19 infection that cannot be et al. Description and proposed
explained by the degree of hypoxia, management of the acute COVID-19
hypotension, fever, or anemia during cardiovascular syndrome. Circulation.
acute COVID-19 infection 2020;141:1903-14. (57)
Ventricular arrhythmia with PVCs, ventricular tachycardia, or Hendren NS, Drazner MH, Bozkurt B,
Bozkurt et al.
acute COVID-19 infection ventricular fibrillation during acute et al. Description and proposed
COVID-19 infection management of the acute COVID-19
cardiovascular syndrome. Circulation.
2020;141:1903-14. (57)
2107
APPENDIX 4. CONTINUED
2108
C. Noncardiovascular History (Continued)
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Atrial tachyarrhythmia with Atrial flutter or atrial fibrillation during Hendren NS, Drazner MH, Bozkurt B,
acute COVID-19 infection acute COVID-19 infection et al. Description and proposed
management of the acute COVID-
19 cardiovascular syndrome.
Circulation. 2020;141:1903-14. (57)
Asystole with COVID-19 Asystole during acute COVID-19 Hendren NS, Drazner MH, Bozkurt B,
infection infection et al. Description and proposed
management of the acute COVID-19
cardiovascular syndrome. Circulation.
2020;141:1903-14. (57)
Pericarditis/pericardial effusion Pericardial fluid accumulation and/or Hendren NS, Drazner MH, Bozkurt B,
with COVID-19 pericarditis during acute COVID-19 et al. Description and proposed
infection management of the acute COVID-19
cardiovascular syndrome. Circulation.
2020;141:1903-14. (57)
DVT with acute COVID-19 Thrombosis formation within deep Bikdeli B, Madhavan MV, Jimenez D,
infection veins during acute COVID-19 infection et al. COVID-19 and thrombotic or
thromboembolic disease: implications
for prevention, antithrombotic
therapy, and follow-up. J Am Coll
Cardiol. 2020;75:2950-73. (58)
Pulmonary embolus with Thrombus formation or lodging in an Poissy J, Goutay J, Caplan M, et al.
COVID-19 infection artery in the lung during acute COVID- Pulmonary embolism in patients with
19 infection COVID-19: awareness of an
increased prevalence. Circulation.
2020;142:184-6. (59)
Sudden cardiac death with Unexpected death caused by sudden Hendren NS, Drazner MH, Bozkurt B,
COVID-19 infection cardiac arrest with asystole, ventricular et al. Description and proposed
tachycardia, or ventricular fibrillation management of the acute COVID-19
during acute COVID-19 infection cardiovascular syndrome. Circulation.
2020;141:1903-14. (57)
Cardiogenic shock with COVID- Low cardiac index (<2.2 L/min/m2) Hendren NS, Drazner MH, Bozkurt B, COVID-19 infection may result in septic
19 infection accompanied with hypotension and/or et al. Description and proposed or vasodilatory shock. If there is
impaired tissue perfusion during acute management of the acute COVID-19 cardiac involvement with inability of
Permissible Value
Data Element Data Element Definition Permissible Values Definitions Mapping/Source of Definition Additional Notes
Stroke with COVID-19 infection Acute interruption or reduction of Oxley TJ, Mocco J, Majidi S, et al.
blood supply to brain, preventing Large-vessel stroke as a presenting
brain tissue from getting oxygen feature of Covid-19 in the young. N
and nutrients during acute COVID- Engl J Med. 2020;382:e60. (60)
19 infection
None
Unknown
COVID-19 n ARDS with COVID-19
noncardio- infection
vascular n Pneumonia with COVID-19
complications infection
n Cytokine surge syndrome
with COVID-19
infection
n Acute kidney injury with
COVID-19 infection
n Acute liver failure with
COVID-19 infection
n Disseminated intravascular
coagulation with COVID-19
infection
n Rhabdomyolysis with
COVID-19 infection
n Seizures and/or
encephalopathy with
COVID-19 infection
n Loss of smell
and/or taste
with COVID-19
infection
n Other
Bozkurt et al.
2109
APPENDIX 4. CONTINUED
2110
C. Noncardiovascular History (Continued)
Data Element Data Element Definition Permissible Values Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
ARDS with COVID-19 infection Respiratory failure of sudden (acute) Guan WJ, Ni ZY, Hu Y, et al. Clinical
onset due to the rapid characteristics of coronavirus
accumulation of fluid in the lungs disease 2019 in China. N Engl J
(pulmonary edema) after an abrupt Med. 2020;382:1708-20. (61)
increase in the permeability of the
normal barrier between the
capillaries and alveoli in COVID-19
infection
Pneumonia with COVID-19 Acute COVID-19 infection accompanied Guan WJ, Ni ZY, Hu Y, et al. Clinical
infection with symptoms, signs of pneumonia, characteristics of coronavirus disease
and pulmonary consolidation by 2019 in China. N Engl J Med.
imaging 2020;382:1708-20. (61)
Cytokine surge syndrome with Systemic inflammatory response Haberman R, Axelrad J, Chen A, et al. May also be called cytokine storm
COVID-19 infection syndrome triggered in the setting of Covid-19 in immune-mediated syndrome
acute COVID-19 infection usually inflammatory diseases–case series
manifested by marked elevations in from New York. N Engl J Med.
ferritin, C-reactive protein, 2020;283:85-8. (62)
proinflammatory cytokines such as IL-
6, IL-1, or TNF, accompanied with end-
organ damage in liver, kidney, and
other organs during COVID-19
infection
Acute kidney injury with COVID- Abrupt reduction in kidney function Guan WJ, Ni ZY, Hu Y, et al. Clinical
19 infection based on an elevation in serum characteristics of coronavirus disease
creatinine level, a reduction in urine 2019 in China. N Engl J Med.
output, the need for renal replacement 2020;382:1708-20. (61)
therapy (dialysis), or a combination of
these during acute COVID-19 infection
Acute liver failure with COVID- Loss of liver function rapidly during Guan WJ, Ni ZY, Hu Y, et al. Clinical
19 infection acute COVID-19 infection, usually characteristics of coronavirus disease
manifested by rise in liver enzymes 2019 in China. N Engl J Med.
2020;382:1708-20. (61)
Disseminated intravascular Abnormalities in blood clotting and a Guzik TJ, Mohiddin SA, Dimarco A,
coagulation with COVID-19 condition in which blood clots form et al. COVID-19 and the cardiovascular
infection throughout the body, blocking small system: implications for risk
blood vessels during acute COVID-19 assessment, diagnosis, and treatment
infection options. Cardiovasc Res.
2020;116:1666-87. (63)
Connors JM, Levy JH. COVID-19 and its
implications for thrombosis and
anticoagulation. Blood.
Permissible Value
Data Element Data Element Definition Permissible Values Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Seizures and/or encephalopathy Convulsions, sensory, cognitive Mao L, Jin H, Wang M, et al. Neurologic
with COVID-19 infection disturbances, or loss of manifestations of hospitalized
consciousness resulting from patients with coronavirus disease
abnormal electrical discharges in 2019 in Wuhan, China. JAMA
the brain during acute COVID-19 Neurol. 2020;77:683-90. (66)
infection
Loss of smell and/or taste Loss of or impairment of olfactory and Centers for Disease Control and
(anosmia and/or ageusia) with gustatory function during COVID-19 Prevention. Coronavirus Disease 2019
COVID-19 infection infection (COVID-19) Symptoms. Available at:
https://www.cdc.gov/coronavirus/201
9-ncov/symptoms-testing/symptoms.
html. Accessed October 26, 2020. (67)
Other
None
Unknown
History of hepatitis B A viral infection caused by the hepatitis n Positive, fully treated
infection B virus n Positive, partially treated
n Positive, untreated
n Negative
n Unknown
History of hepatitis C A viral infection caused by the hepatitis n Positive, fully treated
infection C virus n Positive, partially treated
n Positive, untreated
n Negative
n Unknown
Bozkurt et al.
lymphadenopathy, cardiomyopathy,
and arrhythmias.
2111
APPENDIX 4. CONTINUED
2112
C. Noncardiovascular History (Continued)
Permissible Value
Data Element Data Element Definition Permissible Values Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Pneumococcal Pneumococcal vaccines are vaccines n Up to date with pneumo- Centers for Disease Control and
immunization against the bacterium Streptococcus coccal conjugate vaccina- Prevention. Pneumococcal Disease.
pneumoniae. tion (PCV13) Pneumococcal Vaccination. Available
n Up to date with pneumo- at: https://www.cdc.gov/
coccal polysaccharide vac- pneumococcal/vaccination.html.
cine (PPSV23) Accessed October 26, 2020. (68)
n Not up to date with PCV13
n Not up to date with
PPSV23
n Unknown
SARS-CoV-2 Patient has received a vaccine for n Yes We are working with the presumption a
immunization SARS-CoV-2. n No safe and effective vaccine will be
n Unknown developed for COVID-19
AIDS indicates acquired immunodeficiency syndrome; AL, amyloid light-chain; ARDS, acute respiratory distress syndrome; ATTR, transthyretin amyloidosis; CKD, chronic kidney disease; COVID-19, coronavirus disease 2019; DVT, deep vein thrombosis;
ECG, echocardiography; ECMO, extracorporeal membrane oxygenation; ED, emergency department; GFR, glomerular filtration rate; HF, heart failure; HIV, human immunodeficiency virus; ICD-10, International Statistical Classification of Diseases and
Related Health Problems, 10th revision; ICU, intensive care unit; IgG, immunoglobulin G; IgM, immunoglobulin M; IL-1, interleukin-1; IL-6, interleukin-6; LVEF, left ventricular ejection fraction; mm/dd/yyyy, month/day/year; MRI, magnetic resonance
imaging; NCI, National Cancer Institute; PVC, premature ventricular contractions; RT-PCR, reverse transcription-polymerase chain reaction; RV, right ventricular; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; SLE, systemic lupus er-
ythematosus; TNF, tumor necrosis factor; and TTR, transthyretin.
Permissible
Value
Data Element Data Element Definition Permissible Values Definitions Mapping/Source of Definition Additional Notes
Activities that elicit Indicate degree of activity required to elicit n Difficulty breathing while recumbent
dyspnea on dyspnea symptom. n Running or other sport (specify sport)
exertion n Walking up an incline (specify
distance)
n Walking on a flat surface (specify
distance)
n Stopping to rest while dressing
n Standing (specify length of time)
n Other activity (e.g., shopping or
housework; specify)
Orthopnea Difficulty breathing while recumbent. n Yes Recurrent supine cough with
Patient describes uncomfortable n No other known cause may be an
awareness of breathing while in a n Unknown orthopnea equivalent.
supine position, usually accompanied
with positioning with $2–3 pillows or
in a chair or recliner to maintain
comfortable breathing during sleep.
Bozkurt et al.
Time frame of Time frame over which weight n Numeric, d, wk, or mo
weight gain or change occurred
weight loss
Fatigue Unusual tiredness and inability n Yes
to perform usual activities n No
2113
APPENDIX 5. CONTINUED
2114
A. Current Symptoms and Signs: Clinical Symptoms (Continued)
Permissible
Value
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Data Element Data Element Definition Permissible Values Definitions Mapping/Source of Definition Additional Notes
n Unknown
Gastrointestinal Patient experiences gastrointestinal n Anorexia Yancy CW, Jessup M, Bozkurt B, et al. 2013
symptoms symptoms. n Early satiety ACCF/AHA guideline for the management of heart failure:
n Abdominal pain a report of the American College of Cardiology
n Ascites Foundation/American Heart Association Task Force on practice
n Other guidelines. J Am Coll Cardiol. 2013;62:e147-239. (24)
n No Sundaram V, Fang JC. Gastrointestinal and liver
n Unknown issues in heart failure. Circulation. 2016;133:1696-703. (69)
Cognitive decline Decline in cognitive function such as n Yes Hajduk AM, Kiefe CI, Person SD, et al. Cognitive change in
memory, attention, executive function, or n No heart failure: a systematic review. Circ Cardiovasc
psychomotor speed n Unknown Qual Outcomes. 2013;6:451-60. (70)
Acute pulmonary Rapid progression or acute onset of n Yes American Heart Association. Get With The Guidelines–Heart
edema pulmonary edema causing significant n No Failure. Available at: https://www.heart.org/en/professional/quality-
hypoxemia and/or need for mechanical n Unknown improvement/get-with-the-guidelines/get-with-the-guidelines-heart-
ventilation failure. Accessed October 26, 2020. (28)
Pulmonary Progressive symptoms of dyspnea on n Yes American Heart Association. Get With The Guidelines–Heart Failure.
congestion exertion, orthopnea, paroxysmal nocturnal n No Available at: https://www.heart.org/en/professional/quality-
dyspnea, peripheral edema, or other HF n Unknown improvement/get-with-the-guidelines/get-with-the-guidelines-heart-
symptoms, usually but not always failure. Accessed October 26, 2020. (28)
accompanied by weight gain. Rales may be
heard on examination, and usually there is
evidence of elevated ventricular filling
pressures (may be evidenced by natriuretic
peptide levels, invasive or noninvasive
hemodynamic assessment, or by Doppler
imaging by echocardiography), and mild to
moderate pulmonary congestion/edema on
chest x-ray. This category should not
include patients with fulminant acute
pulmonary edema/significant hypoxemia
potentially requiring intubation.
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Heart rate Heart rate recorded closest to the time n Numeric, bpm
of presentation to the healthcare n Unknown
facility and/or on discharge (for
inpatient)
Regular heart rhythm Normal heart rate range for adults is 60–
100 bpm; however, this may vary from
person to person.
Systolic blood The blood pressure during the n Numeric, mm Hg NCI Thesaurus Code: C25298 (25)
pressure contraction of the left ventricle of the n Unknown
heart. Value recorded closest to the
time of presentation to the healthcare
facility.
Diastolic blood The blood pressure after the n Numeric, mm Hg NCI Thesaurus Code: C25299 (25)
pressure contraction of the heart while the n Unknown
chambers of the heart refill with blood.
Value recorded closest to the time of
presentation to the healthcare facility.
Jugular venous The estimated height of the mean n Numeric, cm Yancy CW, Jessup M, Bozkurt B,
pressure jugular venous waveform above the n Unknown et al. 2013 ACCF/AHA guideline for
right atrium, measured at a 45-degree the management of heart failure: a
angle. When expressed in cm without report of the American College of
further description, the number should Cardiology Foundation/American
be recorded as written. When it is Heart Association Task Force on
expressed as cm above the sternal Practice Guidelines. J Am Coll
angle, 5 cm should be added to the Cardiol. 2013;62:e147-239. (24)
number recorded.
Jugular venous Increased pressure of the superior vena n Yes Yancy CW, Jessup M, Bozkurt B,
distension cava causing the jugular vein to bulge, n No et al. 2013 ACCF/AHA guideline for
making it visualized at a level of the n Unknown the management of heart failure: a
Bozkurt et al.
Continued on the next page
2115
APPENDIX 5. CONTINUED
2116
B. Current Symptoms and Signs: Physical Examination (Continued)
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
n
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Third heart sound Presence of a third (mid-diastolic) n Yes Yancy CW, Jessup M, Bozkurt B,
(S3) heart sound n No et al. 2013 ACCF/AHA guideline for
n Unknown the management of heart failure: a
report of the American College of
Cardiology Foundation/American
Heart Association Task Force on
practice guidelines. J Am Coll
Cardiol. 2013;62:e147-239. (24)
Fourth heart sound Presence of a fourth (late-diastolic) n Yes Yancy CW, Jessup M, Bozkurt B,
(S4) heart sound n No et al. 2013 ACCF/AHA guideline for
n Unknown the management of heart failure: a
report of the American College of
Cardiology Foundation/American
Heart Association Task Force on
practice guidelines. J Am Coll
Cardiol. 2013;62:e147-239. (24)
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Wheezing Abnormal breath sounds characterized by a NCI Thesaurus Code: End-expiratory wheezes may indicate bronchospasm.
high-pitched, whistling sounds during C78718 (25)
breathing
Pleural friction rub An abnormal lung sound that is caused by NCI Thesaurus Code:
inflammation of the pleural layer of the C26860 (25)
lungs rubbing together. Pleural friction rub
is heard on inspiration and expiration and
sounds like a low-pitch harsh/grating noise.
Other findings
Ascites Intra-abdominal fluid accumulation as n Yes Abdominal ultrasound may also reflect presence of
determined by physical examination n No ascites.
n Unknown
Bozkurt et al.
bpm indicates beats per minute; and NCI, National Cancer Institute.
2117
APPENDIX 5. CONTINUED
2118
C. Summary Assessment: Heart Failure Stages, Functional Assessment
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Stage of HF Presence or absence of a HF stage by n None Yancy CW, Jessup M, Bozkurt B, et al.
ACCF/AHA criteria n Stage A 2013 ACCF/AHA guideline for the
n Stage B management of heart failure: a report
n Stage C of the American College of Cardiology
n Stage D Foundation/American Heart
Association Task Force on Practice
Guidelines. J Am Coll Cardiol.
2013;62:e147-239. (24)
None
New York Heart NYHA class as reported by a n None Yancy CW, Jessup M, Bozkurt B, et al.
Association class healthcare provider n Class I 2013 ACCF/AHA guideline for the
n Class II management of heart failure: a report
n Class III of the American College of Cardiology
n Class IV Foundation/American Heart
Association Task Force on Practice
Guidelines. J Am Coll Cardiol.
2013;62:e147-239. (24)
None
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
n
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
HF with reduced EF HFrEF is also referred to as Yes Yancy CW, Jessup M, Bozkurt B, et al.
systolic HF or cardiomyopathy. n No 2013 ACCF/AHA guideline for the
HF in a patient with documented n Unknown management of heart failure: a report
LVEF of #40%. of the American College of Cardiology
Foundation/American Heart
Association Task Force on Practice
Guidelines. J Am Coll Cardiol.
2013;62:e147-239. (24)
HF with preserved EF HFpEF is HF in a patient with n Yes Yancy CW, Jessup M, Bozkurt B, et al.
documented n No 2013 ACCF/AHA guideline for the
LVEF of $50% n Unknown management of heart failure: a report
of the American College of Cardiology
Foundation/American Heart
Association Task Force on Practice
Guidelines. J Am Coll Cardiol.
2013;62:e147-239. (24)
Dilated cardiomyopathy Dilated, poorly contracting left ventricle. Yancy CW, Jessup M, Bozkurt B, et al.
Usually implies depressed LVEF 2013 ACCF/AHA guideline for the
(LVEF <40 %). management of heart failure: a
Bozkurt et al.
heart. It can be with or without LV Foundation/American Heart
outflow obstruction. Association Task Force on Practice
Guidelines. J Am Coll Cardiol.
2013;62:e147-239. (24)
2119
APPENDIX 5. CONTINUED
2120
C. Summary Assessment: Heart Failure Stages, Functional (Continued)
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Restrictive cardiomyopathy A rare form of heart muscle disease that is Yancy CW, Jessup M, Bozkurt B, et al.
characterized by restrictive filling of the 2013 ACCF/AHA guideline for the
ventricles. In this disease the contractile management of heart failure: a
function (squeeze) of the heart and wall report of the American College of
thicknesses are usually normal, but the Cardiology Foundation/American
relaxation or filling phase of the heart is Heart Association Task Force on
very abnormal. Practice Guidelines. J Am Coll
Cardiol. 2013;62:e147-239. (24)
No
Unknown
Cause of dilated Causes of dilated cardiomyopathy, (Multi-select) Bozkurt B, Colvin M, Cook J, et al.
cardiomyopathy resulting in the abnormality of the n Ischemic cardiomyopathy Current diagnostic and treatment
heart muscle n Nonischemic cardiomyopathy strategies for specific dilated
n Unknown cardiomyopathies: a scientific
statement from the American Heart
Association. Circulation.
2016;134:e579-646. (8)
Ischemic cardiomyopathy Ischemic cardiomyopathy is a type of Bozkurt B, Colvin M, Cook J, et al. Ischemic cause of HF usually develops in the
cardiomyopathy caused by significant Current diagnostic and treatment setting of significant $1 coronary artery
coronary artery disease. Typically, strategies for specific dilated disease with $75% stenosis and/or in
patients with ischemic cardiomyopathy cardiomyopathies: a scientific patients with history of myocardial infarction,
have extensive coronary artery disease statement from the American Heart history of coronary revascularization. It can
with significant ischemic burden, or Association. Circulation. be a result of irreversible loss of myocardium
history of myocardial infarction. 2016;134:e579-646. (8) due to previous myocardial infarction, or
Felker GM, Shaw LK, O’Connor CM. A ischemic but still viable myocardium.
standardized definition of ischemic
cardiomyopathy for use in clinical
research. J Am Coll Cardiol.
2002;39:210-8. (71)
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
n
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Cause of Causes of nonischemic dilated Idiopathic dilated Bozkurt B, Colvin M, Cook J, et al.
nonischemic cardiomyopathy, resulting in the cardiomyopathy Current diagnostic and treatment
cardiomyopathy abnormality of the heart muscle n Familial dilated strategies for specific dilated
cardiomyopathy cardiomyopathies: a scientific
n Chemotherapy-induced statement from the American Heart
dilated cardiomyopathy Association. Circulation.
n Tachycardia-induced dilated 2016;134:e579-646. (8)
cardiomyopathy
n Diabetic dilated
cardiomyopathy
n Infection-related dilated
cardiomyopathy
n Thyroid disease-mediated
dilated cardiomyopathy
n Toxin-mediated dilated
cardiomyopathy
n Infiltrative heart disease-
related dilated
cardiomyopathy
n Nutritional deficiency-
related cardiomyopathy
n Stress-induced
cardiomyopathy
n Systemic autoimmune
disease-related
cardiomyopathy
n Peripartum cardiomyopathy
n Dilated cardiomyopathy due
to hypertensive heart disease
n Other
n Unknown
Idiopathic dilated cardiomyopathy Primary myocardial disease of unknown Bozkurt B, Colvin M, Cook J, et al.
cause characterized by LV or Current diagnostic and treatment
biventricular dilatation and impaired strategies for specific dilated
myocardial contractility cardiomyopathies: a scientific
statement from the American Heart
Association. Circulation.
Familial dilated cardiomyopathy Familial dilated cardiomyopathy is a Bozkurt B, Colvin M, Cook J, et al.
hereditary disease, presenting as dilated Current diagnostic and treatment
cardiomyopathy. strategies for specific dilated
cardiomyopathies: a scientific
statement from the American Heart
Association. Circulation.
2016;134:e579-646. (8)
Bozkurt et al.
Chemotherapy-induced dilated Dilated cardiomyopathy that develops after Bozkurt B, Colvin M, Cook J, et al. For further information regarding cardiotoxic
cardiomyopathy exposure to cardiotoxic chemotherapy Current diagnostic and treatment chemotherapy agent and dose, please refer to
agents strategies for specific dilated Appendix 4.
cardiomyopathies: a scientific
statement from the American Heart
Association. Circulation.
2016;134:e579-646. (8)
2121
Continued on the next page
APPENDIX 5. CONTINUED
2122
C. Summary Assessment: Heart Failure Stages, Functional (Continued)
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
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Tachycardia-induced dilated Dilated cardiomyopathy that is caused by Bozkurt B, Colvin M, Cook J, et al. For specific tachyarrhythmias, please refer to
cardiomyopathy sustained increased heart rate. It is Current diagnostic and treatment Appendix 4B.
usually reversible. strategies for specific dilated
cardiomyopathies: a scientific
statement from the American Heart
Association. Circulation.
2016;134:e579-646. (8)
Diabetic dilated cardiomyopathy Dilated cardiomyopathy attributed to Bozkurt B, Colvin M, Cook J, et al. Usually seen in patients with long-standing or
diabetes, in the absence of significant Current diagnostic and treatment uncontrolled diabetes
obstructive CAD or other causes of strategies for specific dilated
cardiomyopathy cardiomyopathies: a scientific
statement from the American Heart
Association. Circulation.
2016;134:e579-646. (8)
Infection-related dilated Dilated cardiomyopathy related to Bozkurt B, Colvin M, Cook J, et al. Common infectious causes include viral
cardiomyopathy infections known to or suspected to cause Current diagnostic and treatment myocarditis due to CMV, Coxsackie, other
myocardial injury and/or myocarditis strategies for specific dilated enteroviruses, parvovirus B19, herpes virus 6,
cardiomyopathies: a scientific HIV, SARS-CoV-2, rubella, and others.
statement from the American Heart Bacterial causes may include poststreptococcal
Association. Circulation. disease. Protozoal causes can include
2016;134:e579-646. (8) Chagas disease caused by the parasite
Trypanosoma cruzi.
Thyroid disease-mediated dilated Dilated cardiomyopathy attributed to Bozkurt B, Colvin M, Cook J, et al.
cardiomyopathy uncontrolled hyperthyroidism or severe Current diagnostic and treatment
hypothyroidism strategies for specific dilated
cardiomyopathies: a scientific
statement from the American Heart
Association. Circulation.
2016;134:e579-646. (8)
Toxin-mediated dilated Dilated cardiomyopathy attributed to Bozkurt B, Colvin M, Cook J, et al. Alcoholism is associated with development of
cardiomyopathy excessive alcohol intake, or illicit drug or Current diagnostic and treatment dilated cardiomyopathy. Illicit drugs that are
substance abuse, or cardiotoxic drug or strategies for specific dilated cardiotoxic and that have been implicated in the
chemical exposure cardiomyopathies: a scientific development of dilated cardiomyopathy include
statement from the American Heart cocaine, amphetamine, methamphetamine,
Association. Circulation. methylphenidate, dextroamphetamine, ecstasy,
2016;134:e579-646. (8) bath salts, and synthetic cathinones. Other
myocardial toxins include cobalt,
phenothiazines, clozapine, ephedrine, carbon
monoxide, lead, lithium, methysergide,
pseudoephedrine, ephedrine, cobalt, anabolic
steroids, hydroxychloroquine, catecholamines,
and high doses of pseudoephedrine or
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Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Infiltrative heart disease-related Dilated cardiomyopathy that develops in Bozkurt B, Colvin M, Cook J, et al. Patients with infiltrative cardiomyopathies, if
dilated cardiomyopathy advanced stages of infiltrative Current diagnostic and treatment diagnosed early, have restrictive
cardiomyopathies such as cardiac strategies for specific dilated cardiomyopathy phenotype. In advanced
amyloidosis, hemochromatosis, cardiomyopathies: a scientific stages, infiltrative cardiomyopathies may
sarcoidosis statement from the American Heart progress to a dilated cardiomyopathy form.
Association. Circulation.
2016;134:e579-646. (8)
Nutritional deficiency-related Dilated cardiomyopathy attributed to Bozkurt B, Colvin M, Cook J, et al. Usually seen in extreme deficiencies, and some
cardiomyopathy nutritional deficiencies such as thiamine, Current diagnostic and treatment can be related to genetic causes.
carnitine, selenium deficiency strategies for specific dilated
cardiomyopathies: a scientific
statement from the American Heart
Association. Circulation.
2016;134:e579-646. (8)
Stress-induced cardiomyopathy Stress-induced cardiomyopathy is Bozkurt B, Colvin M, Cook J, et al. Other commonly used terminology is Tako-tsubo
characterized by acute, usually reversible Current diagnostic and treatment cardiomyopathy. Most patients have a clinical
LV dysfunction in the absence of significant strategies for specific dilated presentation similar to that of acute coronary
CAD, usually triggered by acute emotional cardiomyopathies: a scientific syndrome and may have transiently elevated
or physical stress. statement from the American Heart cardiac enzymes such as cardiac troponin.
Association. Circulation. Although apical ballooning is seen in most
2016;134:e579-e646. (8) (termed as Tako-tsubo cardiomyopathy), other
diverse ventricular contraction patterns have
been defined by cardiovascular imaging.
Systemic autoimmune disease- Dilated cardiomyopathy attributed to Bozkurt B, Colvin M, Cook J, et al. Systemic autoimmune diseases commonly
related cardiomyopathy existing systemic autoimmune diseases Current diagnostic and treatment associated with dilated cardiomyopathy include
strategies for specific dilated systemic lupus erythematosus, dermatomyositis,
cardiomyopathies: a scientific rheumatoid arthritis, scleroderma, and
statement from the American Heart polyarteritis nodosa.
Association. Circulation.
2016;134:e579-646. (8)
Peripartum cardiomyopathy HF caused by systolic dysfunction Bozkurt B, Colvin M, Cook J, et al. It can present during other times during
presenting usually during the last month of Current diagnostic and treatment pregnancy and early postpartum. Multiparity,
pregnancy or in the first 5 mo postpartum strategies for specific dilated advanced maternal age, obesity, and
cardiomyopathies: a scientific hypertension are some of the risk factors for
statement from the American Heart peripartum cardiomyopathy.
Dilated cardiomyopathy due to HF with reduced EF and dilated chambers, Other commonly used terminology includes
hypertensive heart disease seen in patients with long-standing hypertensive dilated cardiomyopathy. The classic
uncontrolled hypertension, usually paradigm of hypertensive heart disease involves
accompanied with LV hypertrophy concentric LV hypertrophy. As the disease
progresses, the left ventricle dilates, and LVEF
declines in what is described as a “burned out”
left ventricle.
Bozkurt et al.
Other
2123
APPENDIX 5. CONTINUED
2124
C. Summary Assessment: Heart Failure Stages, Functional (Continued)
Health status Health status of patient at the time of n 5-Point Likert Scale
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
5-Point Likert Scale A psychometric scale commonly used in NCI Thesaurus Code: C85429 (25)
questionnaires where a respondent is
asked to evaluate an opinion according
to subjective or objective criteria, by
rating their level of agreement or
disagreement with a statement
Visual Analog Scale A pain scale marked off like a ruler from NCI Thesaurus Code: C21120 (25)
0 to 10 on which the patient marks the
current level of pain experienced
SF-36 or SF-12 SF-36: A question survey for measuring NCI Thesaurus Codes: C20078,
health status and outcomes from the C20079 (25)
patient’s point of view. Designed for use in
surveys of general and specific populations,
health policy evaluations, and clinical
practice and research. Measures limitations
in physical activities due to health
problems, bodily pain, general health
perceptions, vitality, mental health, etc.
SF-12: A 12-question subset of the SF-36.
Designed to be administered in a shorter
time.
PHQ-2 The PHQ-2 consists of the first 2 questions
from the PHQ-9. Patients who screen
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Other
ACCF indicates American College of Cardiology Foundation; AHA, American Heart Association; CAD, coronary artery disease; CMV, Cytomegalovirus; DSM-IV, Diagnostic and Statistical Manual of Mental Disorders, fourth edition; EF, ejection fraction; HCM,
hypertrophic cardiomyopathy; HF, heart failure; HFmEF, heart failure with mid-range ejection fraction; HFpEF, heart failure with preserved ejection fraction; HFrEF, heart failure with reduced ejection fraction; HFrecovEF, heart failure with recovered
ejection fraction; HIV, human immunodeficiency virus; LV, left ventricular; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; PHQ-2, Patient Health Questionnaire-2; PHQ-9, Patient Health Questionnaire-9; S3, third heart sound;
S4, fourth heart sound; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; SF-12, 12-item Short Form Health Survey; and SF-36, 36-item Short Form Health Survey.
Radionuclide ventriculography A multigated acquisition scan and a form of radionuclide NCI Thesaurus Code:
imaging that provides a comprehensive look at blood C38073 (25)
flow and the function of the lower chambers of the
heart ventricles.
MRI Imaging that uses radiofrequency waves and a strong NCI Thesaurus Code:
field rather than x-rays to provide amazingly clear and C16809 (25)
detailed pictures of internal organs and tissues. The
technique is valuable for the diagnosis of many
pathologic conditions, including cancer, heart and
vascular disease, stroke, and joint and musculoskeletal
disorders.
Echocardiography A test that uses high-frequency sound waves NCI Thesaurus Code:
(ultrasound) to create an image of the heart. C16525 (25)
Contrast left ventriculography Radiography of the ventricles of the heart after injection
of a contrast medium
Other
Radionuclide Cardiac blood pool imaging (first n LVEF: percentage (range:
ventriculography pass or gated equilibrium) with or 5%–90%) for left ventricle
without stress n RVEF: percentage (range:
5%–90%) for right ventricle
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Echocardiography data Refer to the 2019 ACC/AHA/ASE Douglas PS, Carabello BA, Lang RM,
elements Key Data Elements and Definitions et al. 2019 ACC/AHA/ASE key data
for Transthoracic elements and definitions for
Echocardiography. transthoracic echocardiography: 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
Transthoracic Echocardiography) and the
American Society of Echocardiography.
J Am Coll Cardiol. 2019; 74:
403-69. (22)
Bozkurt et al.
electrical conduction system.
Presence of abnormal $0.03 s in width and $1 mm [0.1 mV] in depth in at
Q waves least 2 contiguous leads
2127
2128
APPENDIX 6. CONTINUED
QRS duration, in ms
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QTc interval The time interval between the start of the Q wave and NCI Thesaurus Code: C100391 (25)
the end of the T wave in the cardiac cycle as corrected
with a nonspecified correction formula
Heart block An electrocardiographic finding of blocked cardiac NCI Thesaurus Code: C34665 (25)
electrical impulses along the fibers normally responsible
for impulse conduction
Pulmonary vascular redistribution, Pulmonary edema: accumulation of fluid in the lung NCI Thesaurus Code: C26868 (25)
pulmonary congestion, or tissues causing disturbance of the gas exchange that
pulmonary edema may lead to respiratory failure. It is caused by direct
injury to the lung parenchyma or congestive HF.
Cardiomegaly, chamber Abnormal enlargement of the heart NCI Thesaurus Code: C61453 (25)
enlargement
Pleural effusion(s) Increased amounts of fluid within the pleural cavity. NCI Thesaurus Code: C3331 (25)
Symptoms include shortness of breath, cough, and chest
pain. It is usually caused by lung infections, congestive
HF, pleural and lung tumors, connective tissue
disorders, and trauma.
No abnormalities related to HF
Myocardial perfusion Refer to the 2020 AHA/ACC Key Dehmer GJ, Badhwar V, Bermudez EA,
imaging Data Elements and Definitions for et al. 2020 AHA/ACC key data elements
Coronary Revascularization. and definitions for coronary
revascularization: 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 Coronary
Revascularization). J Am Coll Cardiol.
2020;75:1975-2088. (21)
Coronary angiography Refer to the 2020 AHA/ACC Key Dehmer GJ, Badhwar V, Bermudez EA,
Data Elements and Definitions for et al. 2020 AHA/ACC key data elements
Coronary Revascularization. and definitions for coronary
Left heart Refer to the 2020 AHA/ACC Key Dehmer GJ, Badhwar V, Bermudez EA, Important variables for HF
catheterization Data Elements and Definitions for et al. 2020 AHA/ACC key data include LV end-diastolic pressure
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Coronary Revascularization. elements and definitions for coronary (mm Hg) and left
revascularization: a report of the ventriculography EF.
American College of Cardiology/
American Heart Association Task Force
on Clinical Data Standards (Writing
Committee to Develop Clinical Data
Standards for Coronary
Revascularization). J Am Coll
Cardiol, 2020;75:1975-2088. (21)
Bozkurt et al.
2129
APPENDIX 6. CONTINUED
2130
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
CPO, watts Cardiac power is the product of simultaneously Resting CPO is measured in watts
measured cardiac output (or index) and mean arterial using the following formula:
blood pressure. By coupling both pressure and flow cardiac output (L/min) mean
domains of the cardiovascular system, it is a measure of arterial pressure divided by 451.
cardiac pumping.
Cardiac index, L/min/m2 Hemodynamic parameter that relates the cardiac output
to body surface area
Pulmonary vascular resistance, Resistance offered by the pulmonary circulation to the Pulmonary vascular resistance is
Wood units, or dynes/s/cm flow of blood from the right ventricle calculated as (mean PA pressure
minus mean pulmonary capillary
wedge pressure) divided by
cardiac output.
Systemic vascular resistance, The resistance offered by the systemic circulation Systemic vascular resistance is
dynes/s/cm2 calculated as the systemic mean
arterial blood pressure minus right
arterial pressure divided by cardiac
output.
Cardiopulmonary Findings of cardiopulmonary n Maximal or submaximal Peak VO2 max refers to the highest
exercise testing exercise testing, which provides (symptom limited) test value of VO2 attained on a
assessment of the integrative n Workload achieved particular exercise test. Max VO2
exercise responses involving the refers to the highest value of VO2
pulmonary, cardiovascular, that is deemed attainable by an
hematopoietic, individual. Despite this difference,
neuropsychological, and skeletal peak VO2 and max VO2 are often
muscle systems mistakenly used interchangeably.
Submaximal exercise tests can be
used to measure VO2 peak and/or
estimate VO2 max.
Maximal or submaximal
(symptom limited) test
Percent predicted VO2 Peak oxygen consumption n Numeric Hansen JE, Sue DY, Wasserman K.
max calculated according to the Predicted values for clinical exercise
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Ventilatory efficiency Ventilatory efficiency, defined n Numeric (VE/VCO2 slope) can be calculated
(VE/VCO2 slope) as the slope of the linear as 863/(1–VD/VT)(PaCO2), where
relationship between VD is dead space, VT is tidal
ventilation and CO2 output. volume, and PaCO2 is arterial CO2
tension.
Bozkurt et al.
2131
APPENDIX 6. CONTINUED
2132
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
electrocardiographic n AV block
monitoring n Mean heart rate, bpm
n Minimum heart rate, bpm
n Maximum heart rate, bpm
n Number of ventricular
extrasystoles
n Nonsustained ventricular
tachycardia
n Sustained ventricular
tachycardia
n Sinus pause
n Heart rate variability
n Atrial fibrillation
Duration of continuous ambulatory Time during which the monitor is recording the heart’s
electrocardiographic electrical signals
monitoring, h
Mean heart rate, bpm Mean heart rate for patient in atrial fibrillation during
continuous ambulatory electrocardiographic monitoring
Minimum heart rate, bpm Minimum heart rate for patient in atrial fibrillation during
continuous ambulatory electrocardiographic monitoring
Maximum heart rate, bpm Maximum heart rate for patient in atrial fibrillation
during continuous ambulatory electrocardiographic
monitoring
Reported measurements Measurements from implanted n PA systolic pressure, mm Hg May need to specify baseline data,
from implantable pulmonary artery remote n PA diastolic pressure, mm Hg specific dates of measurements
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Left atrial pressure, mm Hg Left atrial pressure from left atrial sensor
Monitoring of volume Detection of volume accumulation n Present Examples include OptiVol system,
accumulation and/or or increased filling pressures by n Absent MultiSENSE system
increased filling measurement of intrathoracic n Unknown
pressures by indirect impedance or by multisensory
measurements from algorithm
ICD or CRT-D
Noninvasive remote Devices, applications, or wearables n Home durable devices for
monitoring of that provide noninvasive remote remote monitoring of physi-
physiological measurement and monitoring of ological parameters
parameters physiological parameters n Wearable devices or apps on
smartphones for remote
monitoring of physiological
parameters
n None
Bozkurt et al.
2133
2134
APPENDIX 6. CONTINUED
Home durable devices for remote Durable devices and platforms that measure blood
monitoring of physiological pressure, heart rate, weight, or oxygen saturation
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None
AV indicates atrioventricular; bpm, beats per minute; CPO, cardiac power output; CRT-D, cardiac resynchronization therapy defibrillator; EF, ejection fraction; HF, heart failure; ICD, implantable cardioverter-defibrillator; ICU, intensive care unit; LBBB, left
bundle branch block; LV, left ventricular; LVEF, left ventricular ejection fraction; MRI, magnetic resonance imaging; NCI, National Cancer Institute; PA, pulmonary artery; PAPI, pulmonary artery pressure index; PCWP, pulmonary capillary wedge pressure;
RA, right atrial; RBBB, right bundle branch block; RVEF, right ventricular ejection fraction; VAT, ventilatory anaerobic threshold; VCO2, carbon dioxide output; VO2, oxygen consumption; and VO2 max, maximal oxygen uptake.
A. Surgical Procedures
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Coronary revascularization Refer to the 2020 AHA/ACC Key Data Dehmer GJ, Badhwar V, Bermudez EA, et al. 2020
surgery Elements and Definitions for Coronary AHA/ACC key data elements and definitions for
Revascularization. coronary revascularization: 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
Coronary Revascularization). J Am Coll Cardiol.
2020;75:1975-2088. (21)
Valve surgery performed Please refer to the 2020 AHA/ACC Key n Yes Dehmer GJ, Badhwar V, Bermudez EA, et al. 2020
Data Elements and Definitions for n No AHA/ACC key data elements and definitions for
Coronary Revascularization. n Unknown coronary revascularization: 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
Coronary Revascularization). J Am Coll Cardiol.
2020;75:1975-2088. (21)
Left ventricular assist device A left ventricular assist device May be pulsatile or nonpulsatile flow
pumps blood from left devices. Examples include
ventricle to the rest of the Heartware LVAS and HeartMate III.
body.
Bozkurt et al.
damaged.
None
2135
APPENDIX 7. CONTINUED
2136
B. Electrophysiological Procedures
Mapping/Source
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Data Element Data Element Definition Permissible Values Permissible Value Definitions of Definition Additional Notes
Implantation of an A battery-powered electrical impulse generator n ICD Cannon CP, Brindis RG, Chaitman BR, et al. 2013 Information about the
ICD performed implanted in patients at risk of sudden cardiac death n No ACCF/AHA key data elements and definitions for type of device
to detect cardiac arrhythmia and correct it with n Unknown measuring the clinical management and outcomes (pacemaker,
antitachycardia pacing and then by delivering a jolt of of patients with acute coronary syndromes and biventricular/
electricity, implanted during current encounter coronary artery disease: a report of the American resynchronization/
College of Cardiology Foundation/American Heart CRT, ICD,
Association Task Force on Clinical Data Standards combination), cardiac
(Writing Committee to Develop Acute Coronary chamber(s) involved,
Syndromes and Coronary Artery Disease and year of
Clinical Data Standards). J Am Coll Cardiol. implantation may
2013;61:992-1025. (40) be helpful.
No No ICD history
Unknown
Mapping/Source
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Data Element Data Element Definition Permissible Values Permissible Value Definitions of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Multisite pacing
No
Unknown
CRT indicates cardiac resynchronization therapy; CRT-D, cardiac resynchronization therapy defibrillator; CRT-P, cardiac resynchronization therapy pacemaker; and ICD, implantable cardioverter-defibrillator.
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
PCI Refer to the 2020 AHA/ACC Key Data n Yes Dehmer GJ, Badhwar V, Bermudez EA, et al. 2020
Elements and Definitions for Coronary n No AHA/ACC key data elements and definitions for
Revascularization. n Unknown coronary revascularization: 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
Coronary Revascularization). J Am Coll Cardiol.
2020; 75:1975-2088. (21)
Bozkurt et al.
Other
HF indicates heart failure; MR, mitral regurgitation; PCI, percutaneous coronary intervention; TAVR, transcatheter aortic valve replacement; and TMV, transcatheter mitral valve.
2137
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APPENDIX 7. CONTINUED
Mapping/Source of
Data Element Data Element Definition Permissible Values Permissible Value Definitions Definition Additional Notes
IABP Intra-aortic balloon pump: A medical device that NCI Thesaurus Code:
increases myocardial oxygen perfusion while at C100087 (25)
the same time increasing cardiac output
None
Unknown
Mechanical ventilatory Mechanical ventilation, or assisted n Mechanical ventilation
support ventilation, is the medical term for n CPAP
artificial ventilation where mechanical n BiPAP
means are used to assist or replace n Adaptive servo-ventilation
spontaneous breathing. n None
Mapping/Source of
Data Element Data Element Definition Permissible Values Permissible Value Definitions Definition Additional Notes
Adaptive servo-ventilation Positive airway pressure therapy in which air In patients with NYHA class II–IV HFrEF
pressure target is adjusted according to the and central sleep apnea, adaptive servo-
patient’s breathing patterns ventilation causes harm. (9)
None
BiPAP indicates bilevel positive airway pressure; CPAP, continuous positive airway pressure; CRT, cardiac resynchronization therapy; HF, heart failure; HFrEF, heart failure with reduced ejection fraction; IABP, intra-aortic balloon counterpulsation; MCS,
mechanical circulatory support; NCI, National Cancer Institute; VAD, ventricular assist device; and VA-ECMO, veno-arterial extracorporeal membrane oxygenation.
Mapping/Source of
Data Element Data Element Definition Permissible Values Permissible Value Definitions Definition Additional Notes
Loop diuretic Patient has been prescribed a loop diuretic such as n Yes
furosemide, torsemide, or bumetanide. n No
n Unknown
Total daily dose of loop Total daily dose of loop diuretic n Numeric, furosemide
diuretic equivalents
Total daily dose of other Total daily dose of other thiazide-like diuretic n Numeric, mg/d
thiazide-like diuretic
Total daily dose of Total daily dose of mineralocorticoid receptor n Numeric, mg/d
aldosterone inhibitor antagonist or aldosterone inhibitor such as
spironolactone or eplerenone
ACE inhibitor medication Patient has been prescribed an ACE inhibitor, which n Yes NCI Thesaurus Code:
is a substance that inhibits ACE, an enzyme that n No C247 (25)
catalyzes the conversion of angiotensin I to n Unknown
angiotensin II. Inhibition of ACE results in a
reduction in angiotensin II and angiotensin II-
induced aldosterone secretion, causing vasodilation
and natriuresis.
Total daily dose of ACE Total daily dose of ACE inhibitor n Numeric, mg/d
inhibitor
ARB medication Patient has been prescribed an ARB medication, n Yes NCI Thesaurus Code:
which is a class of agents that act by selectively n No C66930 (25)
inhibiting angiotensin II receptor activation in the n Unknown
renin-angiotensin-aldosterone system. ARBs bind to
and block the activation of AT1 receptors, thereby
Mapping/Source of
Data Element Data Element Definition Permissible Values Permissible Value Definitions Definition Additional Notes
Total daily dose of ARB Total daily dose of ARB n Numeric, mg/d
Total daily dose of ARNi Total daily dose of ARNi n Numeric, mg/d
Beta-adrenergic Patient has been prescribed a guideline-directed n Bisoprolol Yancy CW, Jessup M,
antagonist (beta beta-adrenergic antagonist (beta blocker) n Carvedilol Bozkurt B, et al. 2013
blocker) medication medication for the indication of HF with reduced EF. n Metoprolol succinate ACCF/AHA guideline for
n Other the management of heart
n No failure: a report of the
n Unknown American College of
Cardiology Foundation/
American Heart
Association Task Force on
Practice Guidelines. J Am
Coll Cardiol.
2013;63:e147-239. (24)
Total daily dose of beta Total daily dose of beta-blocker medication n Numeric, mg/d
blocker
Digoxin Patient has been prescribed digoxin, a medication n Yes NCI Thesaurus Code:
isolated from digitalis, a substance that enhances n No C28990 (25)
cardiac contractility. n Unknown
Bozkurt et al.
2141
2142
APPENDIX 8. CONTINUED
Mapping/Source of
Data Element Data Element Definition Permissible Values Permissible Value Definitions Definition Additional Notes
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Total daily dose of oral Total daily dose of nitrate n Numeric, mg/d
nitrate therapy
Total daily dose of Total daily dose of hydralazine/isosorbide dinitrate n Numeric, mg/d
hydralazine/
isosorbide dinitrate
combination
Other
None
Mapping/Source of
Data Element Data Element Definition Permissible Values Permissible Value Definitions Definition Additional Notes
None
Unknown
Intravenous iron infusion A procedure in which iron is delivered to the body n Yes
intravenously n No
n Unknown
Oxygen therapy Patient has been prescribed oxygen by nasal n Yes (if yes, specify L/min)
cannulae or chronic use. n No
n Unknown
Bozkurt et al.
2143
2144
APPENDIX 8. CONTINUED
Mapping/Source of
Data Element Data Element Definition Permissible Values Permissible Value Definitions Definition Additional Notes
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No
Unknown
Total daily dose of SGLT- Total daily dose of SGLT-2 inhibitor n Numeric, mg/d
2 inhibitor
Mapping/Source of
Data Element Data Element Definition Permissible Values Permissible Value Definitions Definition Additional Notes
Bile acid sequestrant The bile acid sequestrants are a group of resins used
to bind certain components of bile in the
gastrointestinal tract. They disrupt the
enterohepatic circulation of bile acids by combining
with bile constituents and preventing their
reabsorption from the gut.
Other
Unknown
Bozkurt et al.
aspirin
P2Y12 inhibitor Patient has been prescribed a nonaspirin P2Y12 n Yes
inhibitor such as clopidogrel, ticagrelor, or prasugrel n No
as an antiplatelet agent. n Unknown
2145
2146
APPENDIX 8. CONTINUED
Mapping/Source of
Data Element Data Element Definition Permissible Values Permissible Value Definitions Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Total daily dose of P2Y12 Total daily dose of P2Y12 inhibitor n Numeric, mg/d
inhibitor
Total daily dose of DOAC Total daily dose of DOAC n Numeric, mg/d
Data Element Data Element Definition Permissible Values Permissible Value Definitions Mapping/Source of Definition Additional Notes
Elsevier on June 16, 2021. For personal use only. No other uses without permission. Copyright ©2021. Elsevier Inc. All rights reserved.
Medication Medication that causes an allergic n Name of medication Specify allergic reaction and date.
causing allergy reaction in the patient
Medication causing side effect Medication that causes a side n Name of medication Specify side effect and date.
effect in the patient. Date of side
effect and/or medication
discontinuation may be specified.
ACE indicates angiotensin-converting enzyme; ARB, angiotensin receptor blocker; ARNi, angiotensin receptor blocker with neprilysin inhibitor, AT1, angiotensin II type 1; DOAC, direct oral anticoagulant; EF, ejection fraction; HDL, high-density lipoprotein;
HF, heart failure; INR, international normalized ratio; IV, intravenous; LDL, low-density lipoprotein; NCI, National Cancer Institute; NSAID, nonsteroidal anti-inflammatory drug; PCSK-9, proprotein convertase subtilisin/kexin type 9; PPAR-alpha,
peroxisome proliferator-activated receptor-alpha; and SGLT-2, sodium-glucose cotransporter-2.
Advance care planning Documentation of discussion carried out with n Yes Advance directive is defined as documentation in the medical
Bozkurt et al.
physician’s assistant that records a patient’s n Unknown
treatment preferences
2147
2148 Bozkurt et al. JACC VOL. 77, NO. 16, 2021
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JACC VOL. 77, NO. 16, 2021 Bozkurt et al. 2149
APRIL 27, 2021:2053–150 ACC/AHA Heart Failure Data Standards
Permissible Mapping/
Value Source of Additional
Data Element Data Element Definition Permissible Values Definitions Definition Notes
Weight counseling May include any or all of the following n Verbal/written instructions
elements: regarding how to monitor/record
daily weight
n Target weight
n Instructions on using a scale
n Instructions on what to do when
weight increases, including parame-
ters for seeking immediate help
n Written weight record
n Daily self-assessment for edema
n Counseling regarding fluid
restriction
Diet counseling pertinent Advice given or discussion carried out with the n Sodium restriction
to lowering patient and/or family regarding diet counseling. n Fluid restriction
cardiovascular risk May include: n Other (specify)
Counseling about alcohol Advice given or discussion carried out with the n Yes
abstinence/ patient and/or family regarding the importance n No
restriction of abstaining from or reducing intake of alcohol n Unknown
Counseling about illicit Advice given or discussion carried out with the n Yes
drug abuse patient and/or family regarding the importance n No
of abstaining from illicit drug use n Unknown
Activity counseling Advice given or discussion carried out with the n Yes
patient and/or family regarding activity level n No
and restrictions in activity, and/or exercise n Unknown
recommendations
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2150 Bozkurt et al. JACC VOL. 77, NO. 16, 2021
Permissible Mapping/
Value Source of Additional
Data Element Data Element Definition Permissible Values Definitions Definition Notes
Smoking cessation Advice given or discussion carried out with the n Counseling (may be basic or
counseling patient (by healthcare provider or other advanced)
personnel) regarding the importance of n Written materials
stopping smoking. May include: n Referral to smoking cessation
program
n Nicotine replacement therapy
Immunization counseling Advice given or discussion carried out with the n Yes
patient and/or family regarding the importance n No
of obtaining influenza and pneumococcal n Unknown
immunizations
Permissible
Value Mapping/Source Additional
Data Element Data Element Definition Permissible Values Definitions of Definition Notes
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