key: cord-0016819-w4z62feq authors: Bozkurt, Biykem; Hershberger, Ray E.; Butler, Javed; Grady, Kathleen L.; Heidenreich, Paul A.; Isler, Maria Lizza; Kirklin, James K.; Weintraub, William S. title: 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) date: 2021-03-23 journal: Circ Cardiovasc Qual Outcomes DOI: 10.1161/hcq.0000000000000102 sha: 2cf333fe60fdafac8f1da66db28ba82c90795601 doc_id: 16819 cord_uid: w4z62feq Supplemental Digital Content is available in the text. TOP 10 TAKE-HOME MESSAGES 1 . This document (an update of the 2005 "ACC/AHA Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients With Chronic Heart Failure") presents a clinical lexicon comprising data elements related to heart failure (HF), without differentiation for chronic HF versus acute decompensated HF; inpatient versus outpatient; or medical management with or without palliative care, or hospice. Because HF is a chronic condition, and a patient can experience periodic acute decompensation, the writing committee considered data elements that are pertinent to the full range of care provided to these patients and intended to be useful for all care venues. 2. Data elements for HF risk factors, cardiovascular history, and noncardiovascular health determinants, including COVID-19 infection, are included. 3. Patient assessment with more detailed elements for symptoms, signs and physical exam findings, stages, and functional assessment were updated. 4. Structural and ejection fraction sub-phenotypes were added, including data elements for heart failure with reduced ejection fraction (HFrEF), heart failure with mid-range ejection fraction (HFmEF), and heart failure with preserved ejection fraction (HFpEF). 5 . Data elements related to cause of HF and cardiomyopathy were added, emphasizing the importance of specific diagnoses such as cardiac amyloidosis and peripartum cardiomyopathy. 6. Data elements for noninvasive and invasive diagnostic modalities (echocardiogram, cardiac magnetic resonance imaging, cardiopulmonary exercise testing, left and right heart catheterization) were expanded and updated. 7. Data elements for invasive therapeutic procedures, device therapies, and percutaneous mechanical circulatory support devices were added. 8. Pharmacological treatment options with new classes of medications were updated, and new data elements for new classes of medications were added. 9. Data elements for patient education and counseling on self-care and patient-reported outcome measures were added. 10 . These clinical data standards should be broadly applicable in various settings, including clinical programs such as HF clinics, transitions of care, clinical registries, clinical research, quality performance improvement initiatives, electronic health records and digital health information technology interoperability, public reporting programs, and education/self-care. The American College of Cardiology (ACC) and the American Heart Association (AHA) support their members' goal to improve the prevention and care of cardiovascular diseases through professional education, research, and development of guidelines and standards and by fostering policy that supports optimal patient outcomes. The ACC and AHA recognize the importance of the use of clinical data standards for patient management, assessment of outcomes, and conduct of research, and the importance of defining the processes and outcomes of clinical care, whether in randomized trials, observational studies, registries, or quality improvement initiatives. Hence, clinical data standards strive to define and standardize data relevant to clinical topics in cardiovascular medicine, with the primary goal of assisting data collection by providing a platform of data elements and definitions applicable to various conditions. Broad agreement on a common vocabulary with reliable definitions used by all is vital to pool and/or compare data across studies to promote interoperability of electronic health records (EHRs) and to assess the applicability of research to clinical practice. The increasing national focus on adoption of certified EHRs along with financial incentives for providers to demonstrate "meaningful use" of those EHRs to improve healthcare quality render even more imperative and urgent the need for such definitions and standards. Therefore, the ACC and AHA have undertaken to define and disseminate clinical data standards-sets of standardized data elements and corresponding definitions-to collect data relevant to cardiovascular conditions. The ultimate purpose of clinical data standards is to contribute to the infrastructure necessary to accomplish the ACC's mission of fostering optimal cardiovascular care and disease prevention and the AHA's mission of being a relentless force for a world of longer, healthier lives. The specific goals of clinical data standards are: 1. To establish a consistent, interoperable, and universal clinical vocabulary as a foundation for clinical care and clinical research 2. To facilitate the exchange of data across systems through harmonized, standardized definitions of key data elements 3. To facilitate the further development of clinical registries, quality and performance improvement programs, outcomes evaluations, public reporting, and clinical research, including the comparison of results within and across these initiatives The key data elements and definitions are a compilation of variables intended to facilitate the consistent, accurate, and reproducible capture of clinical concepts; standardize the terminology used to describe cardiovascular diseases and procedures; create a data environment conducive to the assessment of patient management and outcomes for quality and performance improvement and clinical and translational research; and increase opportunities for sharing data across disparate data sources. The ACC/AHA Task Force on Clinical Data Standards (Task Force) selects cardiovascular conditions and procedures that will benefit from creation of a clinical data standard set. Experts in the subject area are selected to examine and consider existing standards and develop a comprehensive, yet not exhaustive, data standard set. When undertaking a data collection effort, only a subset of the elements contained in a clinical data standard listing may be needed or, conversely, users may want to consider whether it may be necessary to collect some elements not listed. For example, in the setting of a randomized, clinical trial of a new drug, additional information would likely be required regarding study procedures and drug therapies. Another example is as follows: If the data set is to be used for quality improvement, safety initiatives, or administrative functions, other elements such as Current Procedural Terminology (CPT) codes and International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10-CM) codes, or outcomes may be added. The intent of the Task Force is to standardize the clinical concepts, keeping the focus on the patient and the clinical care, not necessarily on administrative billing or coding concepts, and the clinical concepts selected for development are generally cardiovascular specific, where a standardized terminology already exists. The clinical data standards can therefore serve as a guide for development of administrative data sets, and complementary administrative or quality assurance elements can evolve from these core clinical concepts and elements. Thus, rather than forcing the clinical data standards to harmonize with existing administrative codes, such as ICD-10-CM or CPT codes, we would envision the administrative codes to follow the lead of the clinical data standards. This approach would allow the clinical care to lead standardization of the terminologies in health care. The ACC and AHA recognize that there are other national efforts to establish clinical data standards, and every attempt is made to harmonize newly published standards with existing standards. Writing committees are instructed to consider adopting or adapting existing nationally recognized data standards if the definitions and characteristics are validated, useful, and applicable to the set under development. In addition, the ACC and AHA are committed to continually expanding their portfolio of clinical data standards and will create new standards and update existing ones as needed to maintain their currency and promote harmonization with other standards as health information technology and clinical practice evolve. The Privacy Rule of the Health Insurance Portability and Accountability Act, which went into effect in April 2003, heightened all practitioners' awareness of our professional commitment to safeguard our patients' privacy. The Health Insurance Portability and Accountability Act privacy regulations specify which information elements are considered "protected health information." These elements may not be disclosed to third parties (including registries and research studies) without the patient's written permission. Protected health information may be included in databases used for healthcare operations under a data use agreement. Research studies using protected health information must be reviewed by an institutional review board or a privacy board. We have included identifying information in all clinical data standards to facilitate uniform collection of these elements when appropriate. For example, a longitudinal clinic database may contain these elements because access is restricted to the patient's healthcare providers. In clinical care, healthcare providers communicate with each other through a common vocabulary. In an analogous manner, the integrity of clinical research depends on firm adherence to prespecified procedures for patient enrollment and follow-up; these procedures are guaranteed through careful attention to definitions enumerated in the study design and case report forms. When data elements and definitions are standardized across studies, comparison, pooled analysis, and The Task Force has been spearheading the initiative to standardize the lexicon of cardiovascular medicine to enhance the use of clinical data, improve clinical communication, optimize quality assurance and improvement, assess outcomes, enhance process improvement efforts, and facilitate clinical research, development, and analysis of registries. Because the ACC and AHA are committed to updating existing standards as needed to maintain their currency and promote harmonization with other standards as health information technology and clinical practice evolve, this document is provided as an update of the 2005 ACC/AHA key data elements and definitions for chronic heart failure. 1 The goal of this publication is to provide new data elements consistent with practice guidelines and updated terminology and attributes in compliance with current methodology of the Task Force 2 and current policies of the ACC and AHA regarding harmonization of data across organizations and disciplines. Heart failure (HF) data standards are of critical importance to clinical providers, investigators, administrators, healthcare services and institutions, regulators, legislators, and payers more than ever as a result of: 1) increasing prevalence and burden of HF 3, 4 ; 2) increased focus on performance metrics for HF 5 ; 3) increasing need for large data sets to examine comparative effectiveness and safety of treatment strategies in real world patients 6 ; 4) increased recognition of healthcare disparities that require understanding of patient, healthcare delivery, and system variables 7 ; 5) growing need for new effective preventive and treatment strategies in HF targeted for different stages or types of HF 8 ; subgroups of interest and comorbidities requiring better classification and documentation of patient and treatment variables; 6) need for improved communication and for shared decision-making and transitions of care between different levels of care and providers 9,10 ; 7) development of models for prediction of therapeutic benefit and outcomes 11 ; 8) universally understandable data for individualization of therapies and management strategies for patients with complex HF by different providers; and 9) development and conduct of future registries, at both hospital and national levels, by providing a list of major variables, outcomes, and definitions. Approximately 6.2 million persons ≥20 years of age in the United States have HF, with approximately 1 million new HF cases diagnosed annually, and the prevalence continues to rise. 3, 12 Despite improvements in age-adjusted HF-related survival rates between 2000 and 2012, there has been a recent increase in mortality rates for all age and sex subgroups. 12-14 HF remains as the primary diagnosis in >1 million hospitalizations annually, and the total cost of HF care in the United States exceeds $30 billion annually, with over half of these costs spent on hospitalizations. 15 The mortality rates after hospitalization for HF remains high, at approximately 20% to 25% at 1 year, with similar mortality rates for heart failure with preserved ejection fraction or heart failure with reduced ejection fraction. 16 The clinical syndrome of HF may result from different causes. Thus, despite a common syndrome of HF, different etiologies may imply different prognosis and varying treatment strategies, underlining the importance of specific data elements for emphasizing these differences in HF. 8 Similarly, the syndrome of HF commonly overlaps with other cardiovascular diseases, such as coronary artery disease, hypertension, valvular disease, and primary myocardial disease, which are common causes of HF. Specifying these data elements for patients with HF is important for clinical care, performance improvement, research, and endpoints. Standardized data elements and definitions across studies can help accelerate and facilitate research in HF through dissemination and sharing of relevant information, comparisons, pooled analyses, and meta-analyses. 17 In clinical care, a broad spectrum of clinicians provides a continuum of care for patients with HF, ranging from primary care/family medicine providers, HF specialists and/or cardiologists, cardiac and transplant surgeons, interventional cardiologists, electrophysiologists, advanced practice providers such as nurse practitioners and physician assistants, pharmacists, hospitalists, home healthcare providers, palliative care specialists and nurses, hospice specialists and nurses, social workers, and cardiac rehabilitation specialists to investigators, who must communicate with each other through a common vocabulary. Care of patients with HF may take place in specialized clinics delivered by a variety of providers previously mentioned, necessitating care coordination comprising common terminology with a patient-centered approach. 18 Furthermore, HF is a chronic problem, and patients are likely to transition through different stages of HF, which requires recognition and definition of these states with common terminology standardized across different providers and encounters of care. Similarly, given the recent emphasis on quality performance measurement initiatives, particularly those for which institutions and providers are compared against each other or against benchmarks, and reimbursement strategies and penalties that are attached to such metrics, the necessity for reliable, risk adjustable, and analyzable data is gaining more importance for the professional community, as well as for payers, regulators, legislators, and consumers. 5, 19, 20 The writing committee envisions that the data elements might be useful in these broad categories: • Clinical programs, such as HF clinics, where many clinicians work together to achieve specific goals for the care and care coordination of patients with HF. • Transitions of care, in which patients with HF move through different locations and levels of care (ie, inpatient, outpatient [eg, home, rehabilitation center, nursing home], palliative care, and hospice) or progress through different stages of HF (Stages A to D), with providers ranging from HF specialists, cardiac transplant physicians, home healthcare or palliative care providers, and primary care providers. • Clinical registries, for ongoing care, prospective epidemiologic and comparative effectiveness research, pre-or postmarket analysis for efficacy and safety in populations of interest. • Clinical research, particularly prospective randomized clinical trials where eventual pooled analysis or meta-analysis is anticipated. • Quality performance measurement initiatives, provider or institutional based or external, retrospective, or prospective. • Organization and design of electronic medical information initiatives, such as EHRs, pharmacy databases, computerized decision support, and cloud technologies incorporating health information. • Public health policy, healthcare coverage, insurance coverage, and legislation development to provide appropriate and timely care for patients with HF and to prevent disparities in HF care. The data element tables are also included as an Excel file in the Online Data Supplement. Several points are important to recognize regarding the scope of this document. First, given the magnitude of additional data elements that cardiac transplantation and mechanical circulatory support device therapies would entail, the writing group decided to focus on HF and not include cardiac transplantation and mechanical circulatory support data elements in detail in this document. Second, the data elements were not differentiated for chronic HF versus acute decompensated HF; or for inpatient, outpatient, palliative care, or hospice status, because HF is a chronic condition that is not an episodic event, and a patient can transition from one status to the other through his/her life time. The writing committee considered data elements pertinent to the full range of care provided to these patients and are intended to be useful for all care venues. Third, the data elements were not differentiated for new onset incident versus prevalent cases or number of encounters, and databases can be built and customized according to users' needs to capture such information. Fourth, the writing committee would like to alert the readers to the existence of other documents and guidelines with which we tried to harmonize and are likely to complement the content of our document, including the "2020 AHA/ACC Key Data Elements and Definitions for Coronary Revascularization," 21 Finally, we did not include data element fields for entry of calculated risk scores, as databases can be programmed and customized to calculate risks scores according to the user's objective as different risk models can be used for different purposes. The intent of this writing committee was not to be overly prescriptive. The Task Force selected the members of the writing committee. The writing committee consisted of 8 individuals with domain expertise in HF, cardiomyopathy, cardiovascular disease, outcomes assessment, medical informatics, health information management, and healthcare services research and delivery. The Task Force made every effort to avoid actual or potential conflicts of interest that might arise as a result of an outside relationship or a personal, professional, or business interest of any member of the writing committee. Specifically, all members of the writing committee were required to complete and submit a disclosure form showing all such relationships that could be perceived as real or potential conflicts of interest. These statements were reviewed by the Task Force and updated when changes occurred. Authors' and peer reviewers' relationships with industry and other entities pertinent to this data standards document are disclosed in Appendixes 1 and 2, respectively. In addition, for complete transparency, the disclosure information of each writing committee member-including relationships not pertinent to this document-is available as a Supplemental Table. The work of the writing committee was supported exclusively by the AHA and ACC without commercial support. Writing committee members volunteered their time for this effort. Meetings of the writing committee were confidential and attended only by committee members and staff. A substantial body of literature was reviewed to create this article. 1, 9, [21] [22] [23] [24] This information was augmented by multiple peer-reviewed references listed in the tables under the column "Mapping/Source of Definition." The writing committee aggregated, reviewed, harmonized, and extended these terms to develop a controlled, semantically interoperable, machine-computable terminology set that would be usable, as appropriate, in as broad a number of contexts as possible. As necessary, the writing committee identified the contexts where individual terms required differentiation according to their proposed use (ie, research/regulatory versus clinical care contexts). This publication was developed with the intent that it will serve as a common lexicon and base infrastructure that can be used by end users to augment work related to standardization and healthcare interoperability including, but not limited to, structural, administrative, and technical metadata development. The resulting appendixes (Appendixes 4-10) list the data element in the first column, followed by a clinical definition of the data element. The allowed responses ("permissible values") for each data element in the next column are the acceptable "answers" for capturing the information. For data elements with multiple permissible values, a bulleted list of the permissible values is provided in the row listing the data element, followed by multiple rows listing each permissible value and corresponding permissible value definition, as needed. Where possible, clinical definitions (and clinical definitions of the corresponding permissible values) are repeated verbatim as authored by the Standardized Data Collection for Cardiovascular Trials Initiative 23 or as previously published in reference documents. The Task Force established the writing committee per the processes described in the Task Force's methodology paper. 2 The primary responsibility of the writing committee was to review and refine the "ACC/AHA Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients With Chronic Heart Failure" 1 and develop a harmonized data set for coronary revascularization that will provide the attributes and other informatics formalisms required to attain interoperability of the terms. The work of the writing committee was accomplished via a series of teleconference and web conference meetings, along with extensive email correspondence. The review work was distributed among subgroups of the writing committee based on interest and expertise in the components of the terminology set. The proceedings of the workgroups were then assembled, resulting in the vocabulary and associated descriptive text in Appendixes 4-10. All members reviewed and approved the final vocabulary. The writing committee reviewed the available published data standards, including registry data dictionaries from registries, which were specifically developed for HF. Relative to published data standards, the writing committee anticipates that this terminology set will facilitate the uniform adoption of these terms, where appropriate, by the clinical, clinical and translational research, regulatory, quality and outcomes, and EHR communities. This document was reviewed by official reviewers nominated by ACC and AHA. To increase its applicability further, the document was posted on the ACC and AHA websites for a 30-day public comment period. This document was approved for publication by the ACC Clinical Policy Approval Committee in October 2020, by the AHA Science Advisory and Coordinating Committee in September 2020, and by the AHA Executive Committee in December 2020. The writing committee anticipates that these data standards will require review and updating in the same manner as other published guidelines, performance measures, and appropriate use criteria. The writing committee will, therefore, review the set of data elements on a periodic basis, starting with the anniversary of publication of the standards, to ascertain whether modifications should be considered. 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 ≥$5000 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, intellectual 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. Current user, frequency unknown The patient smokes tobacco, but the frequency is unknown. (Continued ) Mapping/Source of Definition Former user As defined in the NHIS, a person who does not currently smoke tobacco but has smoked at least 100 cigarettes in his or her lifetime. Because relapse to smoking occurs frequently after quitting, long-term abstinence is often operationally defined as 6 mo of abstinence. Abstinence from smoking for at least 7 d in a row is the criterion often required in clinical studies for an individual to be considered a former smoker in the short term. Never user A person who has not smoked tobacco regularly and does not now smoke every day or some days. NHIS defines never smoker as an individual who has not smoked 100 cigarettes (5 packs) in his or her lifetime. 35 User, current status unknown The patient smokes tobacco, but the frequency is unknown. Unknown A proper value is applicable but not known. A synthetic steroid hormone that resembles testosterone in promoting the growth of muscle. Such hormones are used medicinally to treat some forms of weight loss and (illegally) by some athletes and others to enhance physical performance. An agent that relieves congestion of mucous membranes, such as pseudoephedrine, phenylephrine Ephedrine Ephedrine is a crystalline alkaloid drug obtained from ephedra causing constriction of the blood vessels and widening of the bronchial passages. Ephedra is an herb also known as ma huang, which contains the stimulant ephedrine. It is closely related to compounds found in the drugs pseudoephedrine and phenylpropanolamine. It was promoted for weight loss. The FDA banned supplements with ephedra after the herb was linked to serious cardiovascular side effects. (Continued ) April 2021 497 NSAID A pharmacological agent that is not a steroid and 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 (specify) Exposure to cardiotoxic chemotherapy The use of synthetic or naturally occurring chemicals for the treatment of diseases. 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 that enhance immune function or alter hormonal activity. Patient has history of implantation of CRT device before the current encounter. A CRT device is a biventricular pacemaker that sends 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. CRT or CRT-P Cardiac resynchronization therapy (CRT or CRT-P). A CRT device is a biventricular pacemaker that sends 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. CRT-P has the pacing function in addition to resynchronization but does not entail defibrillator function. Year of occurrence of and precipitant for acute kidney injury may be specified. History of dialysis Dialysis is the process of removing excess water, solutes, and toxins from the blood in people whose kidneys can no longer perform these functions naturally. This is referred to as renal replacement therapy. May also be called cytokine storm syndrome Patient has received a vaccine for SARS-CoV-2. We are working with the presumption a safe and effective vaccine will be 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 erythematosus; TNF, tumor necrosis factor; and TTR, transthyretin. Syncope Sudden loss of consciousness not related to anesthesia, with spontaneous recovery noted by patient or observer. Patients losing consciousness before an ICD discharge will be considered to have syncope. Acute pulmonary edema Rapid progression or acute onset of pulmonary edema causing significant hypoxemia and/or need for mechanical ventilation American Heart Association. Get With The Guidelines-Heart Failure. Available at: https://www.heart. org/en/professional/ quality-improvement/ get-with-the-guidelines/ get-with-the-guidelinesheart-failure. Accessed October 26, 2020. 28 Pulmonary congestion Progressive symptoms of dyspnea on exertion, orthopnea, paroxysmal nocturnal dyspnea, peripheral edema, or other HF symptoms, usually but not always 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. American Heart Association. Get With The Guidelines-Heart Failure. Available at: https://www.heart. org/en/professional/ quality-improvement/ get-with-the-guidelines/ get-with-the-guidelinesheart-failure. Accessed October 26, 2020. 28 HF indicates heart failure; and ICD, implantable cardioverter-defibrillator. A right ventricular assist device pumps blood from right ventricle or right atrium into pulmonary artery and to the lungs. A biventricular assist device is a mechanical device that supports both right and left ventricles. A total artificial heart is a pump that is surgically installed to provide circulation and replace both heart ventricles, as well as heart valves, that are diseased or damaged. Cardiac transplantation performed A heart transplant is an operation in which a failing, diseased heart is replaced with a healthier donor heart. VA-ECMO Extracorporeal membrane oxygenation. In VA-ECMO, a venous cannula is usually placed in the right or left common femoral vein for extraction, and an arterial cannula is usually placed into the right or left femoral artery for infusion, with an oxygenator between the extraction and infusion cannulae. TandemHeart provides ventricular support via a left atrial-tofemoral artery bypass system comprising a transseptal cannula, arterial cannulae, and a centrifugal blood pump. The inflow cannula aspirates oxygenated blood from the left atrium. Blood is then pumped into the femoral artery. Microaxial flow pump (eg, Impella) A microaxial flow pump provides temporary ventricular support by pulling blood from the left ventricle through an inlet area near the tip and expels blood into the ascending aorta. 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; NYHA, New York Heart Association; VAD, ventricular assist device; and VA-ECMO, veno-arterial extracorporeal membrane oxygenation. ACC/AHA key data elements and definitions for measuring the clinical management and outcomes of patients with chronic heart failure: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Heart Failure Clinical Data Standards) ACC/AHA 2013 methodology for developing clinical data standards: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards Heart disease and stroke statistics-2019 update: a report from the Forecasting the future of cardiovascular disease in the United States: a policy statement from the ACCF/AHA/AMA-PCPI 2011 performance measures for adults with heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures and the American Medical Association-Physician Consortium for Performance Improvement Priorities for comparative effectiveness reviews in cardiovascular disease Disparities in heart failure care: now is the time to focus on health care delivery Former Task Force member; current member during the writing effort. †Former Task Force Chair during this writing effort Description and proposed management of the acute COVID-19 cardiovascular syndrome. Circulation COVID-19 and thrombotic or thromboembolic disease: implications for prevention, antithrombotic therapy, and follow-up Pulmonary embolism in patients with COVID-19: awareness of an increased prevalence Large-vessel stroke as a presenting feature of Covid-19 in the young Clinical characteristics of coronavirus disease 2019 in China Covid-19 in immune-mediated inflammatory diseases-case series from New York COVID-19 and the cardiovascular system: implications for risk assessment, diagnosis, and treatment options COVID-19 and its implications for thrombosis and anticoagulation Rhabdomyolysis as potential late complication associated with COVID-19 Neurologic manifestations of hospitalized patients with coronavirus disease 2019 in Wuhan, China COVID-19). Symptoms of coronavirus Pneumococcal vaccination Gastrointestinal and liver issues in heart failure Cognitive change in heart failure: a systematic review A standardized definition of ischemic cardiomyopathy for use in clinical research Predicted values for clinical exercise testing Principles of Exercise Testing and Interpretation: Including Pathophysiology and Clinical Applications AHA/ACC Key Data Elements and Definitions for Coronary Revascularization AHA/ACC key data elements 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) Valve surgery performed Refer to the 2020 AHA/ACC key data elements and definitions for coronary revascularization: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards 21 follow-up visit Documentation of follow-up evaluation for patients with established HF should include date of next follow-up visit • Patient history • Functional status • Current symptoms • Physical examination • Laboratory or other tests Patient referral Patient referred to other care: • HF specialty clinic • HF transitional care by advanced practice to home, between healthcare practitioners and settings as their condition and care needs change during the course of a chronic or acute illness • Home health care • HF nurse case manager • Hospice or palliative care • Home telemonitoring • Ambulatory cardiac telemetric monitoring (eg, mobile cardiac outpatient telemetry) heart failure CRT or CRT-P CRT device is a biventricular pacemaker that sends 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. CRT-P has the pacing function in addition to resynchronization but does not entail defibrillator function.CRT-D, CRT with ICD CRT-D also incorporates the additional function of an ICD, to quickly terminate an abnormally fast, life-threatening heart rhythm.His bundle pacing A transvenous pacemaker system that can produce normal physiological ventricular activation with a lead positioned on the His bundle No Unknown CRT indicates cardiac resynchronization therapy; CRT-D, cardiac resynchronization therapy defibrillator; CRT-P, cardiac resynchronization therapy pacemaker; and ICD, implantable cardioverter-defibrillator. April 2021 562 Milrinone Milrinone is a phosphodiesterase 3 inhibitor that works to increase the heart's contractility and decrease pulmonary vascular resistance. Dobutamine is a direct-acting inotropic agent whose primary activity results from stimulation of the beta receptors of the heart while producing comparatively mild chronotropic, hypertensive, arrhythmogenic, and vasodilative effects. Norepinephrine is a sympathomimetic amine that increases blood pressure and enhances ventricular contractility. Epinephrine, when injected into an intravenous fluid solution, increases blood pressure, coronary artery pressure, thereby promoting increased coronary blood flow and ventricular contractility. Dopamine at low doses acts through the sympathetic nervous system to increase heart muscle contraction force and heart rate, thereby increasing cardiac output and blood pressure; at higher doses, causes vasoconstriction that further increases blood pressure.Other None Intravenous vasodilators, medicines that dilate blood vessels, are administered.Nitroglycerin belongs to the group of medicines called nitrates. It works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its workload. Nitroprusside is a strong vasodilator that works by relaxing the muscles in blood vessels, and results in reduction in systemic vascular resistance. 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; PPARalpha, peroxisome proliferator-activated receptor-alpha; and SGLT-2, sodium-glucose cotransporter-2.