Q&A: New universal definition, classification of HF ‘clinically relevant and simple’
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In March, three societies announced a new universal definition and classification of HF designed to standardize language and practices around the definition and classification of HF.
The Heart Failure Society of America, the Heart Failure Association of the European Society of Cardiology and the Japanese Heart Failure Society undertook the effort to make HF terminology and practices clearer for patients and providers, according to a press release issued by the societies. The document has been endorsed by the Canadian Heart Failure Society, the Heart Failure Association of India, the Cardiac Society of Australia and New Zealand, and the Chinese Heart Failure Association.
“Definitions of HF have lacked standardization among clinicians, investigators, administrators, health care services, institutions, legislators and payers, as well as patients and caregivers. The new Universal Definition and Classification of Heart Failure provides a definition that is clinically relevant and simple but conceptually comprehensive,” the writing committee wrote.
Healio spoke to Biykem Bozkurt, MD, PhD, The Mary and Gordon Cain Chair and Professor of Medicine and director of the Winters Center for Heart Failure Research at Baylor College of Medicine, the immediate past president of HFSA and the chair of the writing committee, about the new definition and classifications.
Healio: What are the limitations of the current HF definitions and classifications?
Bozkurt: Current HF definitions vary. The textbook definition usually covers a patient with advanced HF in the context of the heart not being able to meet the metabolic demands of the body. Unfortunately, the textbook definition of HF was not generalizable to the large population of HF.
This was utilized predominantly in research in academic venues, but in practice, the HF syndrome definition varied between societies and organizations, and therefore it was clear to us that there needed to be a standardization across different societies for the syndrome of HF.
Healio: Why did the societies decide to design new definitions and classifications?
Bozkurt: The reason we thought that it was critical for us to come up with a universal standardized official HF definition was because despite advances in guideline-directed medical therapies, the uptake of evidence-based treatment strategy in the real-world population was stagnant, not improving in the last 2 decades, according to recent data from real-world registries.
The use of treatment strategies such as ACE inhibitors, beta-blockers, angiotensin receptor blockers and mineralocorticoid receptor antagonists has not improved in the last 20 years, despite evidence of improvement in survival with these lifesaving medications.
Part of the reason was lack of recognition of HF in the community, by clinicians and patients, lack of standardization of definition across scientific societies and the complexity of nonstandardized diagnoses in electronic health records and administrative systems.
The academic definitions such as the heart’s inability to meet the metabolic demands, although accurate for a certain subgroup of patients with advanced HF, were not applicable or measurable in most patients with HF.
Differences between societies and academic institutions created confusion and complexity. We also recognized the need for a standard definition to enhance the clinician’s ability to prevent and treat HF effectively. The lack of improvement in use of lifesaving medications underlines the importance of a systematic change, which entailed a standard definition that was sensitive but also specific enough to identify the population.
We also recognized the need to revise the stages with intent to make the stages clearer to nonspecialists and to patients.
We thought that gaps could be addressed first by standardization of terminology and that it would be clear to the clinician what HF is, objectively documented and sufficiently captured in the system for it to be appropriately treated.
The other reason is the different stakeholders — clinicians, researchers, investigators, health care services legislators and payers — also need to have a uniform definition for them to appropriately utilize the accurate diagnosis for their targeted objectives.
Performance measures, for example, target appropriate treatment strategies for HF. If HF is not documented in a standardized manner, then we will not be able to monitor the performance improvement strategies across institutions.
The same thing is important from the payers’ and administrators’ perspective; to make sure that the right types of treatment strategies are covered for the right type of patient.
Healio: What are the major changes regarding the definition of HF?
Bozkurt: The new universal definition of HF defines HF as a clinical syndrome with current or prior symptoms and/or signs caused by structural and/or functional cardiac abnormalities and corroborated by at least one of the following: elevated natriuretic peptide levels or objective evidence of cardiogenic pulmonary or systemic congestion.
Healio: What are the major changes regarding classification of HF?
Bozkurt: There is an important change in terminology.
Traditionally, the American Heart Association classification categorized stages of HF as stages: A, B, C or D. But the nomenclature, although understandable by academicians and specialists, was not easily translatable to patients and nonspecialists.
Whereas we are aware, from the cancer perspective, that the patient would understand what pre-cancer means.
So, we changed stage A terminology to at risk for HF.
We call that stage at risk for HF for individuals who are at risk, but without current symptoms or signs and without any structural cardiac abnormalities.
So, patients with high BP, diabetes, CAD, obesity or known exposure to cardiac toxicity would be individuals at risk for future HF.
We changed the nomenclature of stage B to pre-HF.
And those are individuals without current or prior symptoms or signs of HF but with evidence of either structural heart disease or abnormal cardiac function. Or they may have a marker such as elevated natriuretic peptide levels or elevated cardiac troponin, especially in the setting of exposure to cardiac toxins.
In this stage, other than the name change, pre-HF, the addition of biomarkers are new criteria for definition of pre-HF or stage B HF.
We also changed the terminology for stage C to HF — which is symptomatic HF — and finally stage D to advanced HF.
Healio: How might these changes impact the jobs of HF specialists?
Bozkurt: The standardization in the syndrome definition of HF with the requirement for the objective criteria will make it easy specific and sensitive to appropriately and accurately diagnose HF.
This would mean patients coming in with volume overload from a competing diagnosis such as advanced kidney disease would not be misdiagnosed as HF.
Individuals with evidence of symptoms and signs and these objective findings would not be missed, and would not be misdiagnosed as not having HF.
The changes add sensitivity and specificity to the diagnosis.
In terms of phases, it allows the clinicians to translate things in a more practical manner to the patients and alert the patient that they are in a HF stage.
We also have specific treatment strategies that are critically important to prevent HF in the pre-HF stage in addition to treatment of HF. The new changes would make it clear to the patient as to why they need to be managed or treated with certain medications for prevention of HF when they are in the pre-HF status.
The third area that is new in this document is the standardization of classification of ejection fraction. We have four categories: HF with reduced EF, with LVEF less than or equal to 40%; HF with mildly reduced EF, with EF between 41% and 49%; HF with preserved EF, with EF greater or equal to 50%; and the final category of HF with improved EF, for those with a baseline EF less than or equal to 40% but with at least a 10-point increase from baseline and the second measurement being greater or equal to 40%.
EF categorization is important to target appropriate evidence-based guideline-directed therapies.
However, we did not want to create misperception by using terminology such as recovered, because we do know that in these individuals with improvement in EF, continuation of lifesaving therapies is critical for the patient to not have a further decline upon cessation of therapy.
With these new classifications of EF, we think that the appropriate guidelines directed at medical therapies would be easier and clearer to implement in patients with the indication.
Healio: How might these changes lead to improvement of care in patients with HF?
Bozkurt: Standardization of terminologies and diagnostic criteria allows timely recognition and enhanced optimization of therapies in a timely manner.
There would not be any confusion or complexity as a barrier for the clinicians to recognize HF, as an indication to treat or prevent.
The other component is because the new system is more practical and easier to understand, the patients may understand the indications, be more compliant and be more willing to initiate or continue lifesaving therapies.
Finally, from the systems of care perspective, it would be easier to capture the appropriateness of care and performance measures and it would be very apparent at the system level whether care is standardized and is adherent to the current guidelines.
From the patient perspective as well as the systems of care, standardization of terminologies will help with uniformity in optimized care delivery.
Healio: What must be done to implement these changes in clinical practice?
Bozkurt: We envision a necessity for wide dissemination of the definition and classifications used in this document to all clinicians and all learners in health care practice. We must also disseminate the terminology to our patients. for their own self-directed care.
The other components that need to happen are a variety of administrative implementations. For example: ICD-10 codes or other derivatives of how we capture pre-HF, advanced HF or HF with mildly reduced EF in practice will need to align with these terminologies.
It will be critical for the ICD-10 codes to harmonize with the definitions so it would be easier for the clinician to be able to document it and for it also to be captured in the disease categories. In the clinical practice, it will also be important for all stakeholders and multidisciplinary care members to be aware of the new terminologies and document it so that the communication across the platform or across the continuum of care would be clear to all involved. These stakeholders range from the primary care providers to hospitalists, specialists, case managers, social workers, pharmacists, nurses, social workers and advanced practitioners.
Healio: Is there anything else you would like to mention?
Bozkurt: The document also addresses clinical trajectory terminologies.
We recommend using the terminology of persistent HF instead of stable HF because even in the setting of stable HF, there are many opportunities to optimize therapies that would prevent further worsening and/or deterioration or adverse outcomes.
We also recommend using HF in remission rather than recovered HF for patients who had resolution of their symptoms and/or cardiac dysfunction, because HF relapses in a significant proportion.
Improvement usually does not mean the HF is cured. It is very rare that there is a true full recovery with a reversible course in a setting of HF once HF symptoms and signs ensue. Therefore, we would like to alert the clinicians to use persistent HF rather than stable HF and to use HF in remission rather then recovered HF.
For more information:
Biykem Bozkurt, MD, PhD, can be reached at bbozkurt@bcm.edu.
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