This transcript has been edited for clarity.
Ileana L. Piña, MD, MPH: Hello. I'm Ileana Piña. I am a clinical professor of medicine at Central Michigan University, and this is my blog. I'm really pleased today to have with me a good friend, Andrew Coats, who is the current president of the Heart Failure Association (HFA) of the European Society of Cardiology (ESC), which just had their meeting. It was very exciting — part virtual, part in-person. Andrew had been the dean of the medical school, and he's now the dean of the College of Physicians and spends his time in between Australia and the United Kingdom, which is a long way to travel each time.
Thank you for joining me. My first question is, tell the audience a little bit about the HFA and who you are.
Andrew J.S. Coats, MA, DM, DSc, MBA: Great to be with you, and fantastic you're doing the blog. The HFA is the major heart failure grouping around the European countries. As you know, ESC is a composite of a lot of national societies. It's actually got 47 country members. Of course, countries in Europe, some of them are quite small but some of them are very big. So the ESC actually straddles everywhere from the west of Ireland through to near the Japanese coast in Vladivostok, the other end of Russia, in terms of the affiliated countries, and it covers some of North Africa. It's a very large geographical footprint, and the ESC has about 110,000 members for all of cardiology. But there are a number of associations, which are subspecialist groups that have a degree of functional independence, and HFA is one of those. So, we're not an independent legal entity, but we are a specialist group of heart failure physicians, as well as nurses and allied health personnel, from the countries affiliated with the ESC.
Piña: The Heart Failure Society of America (HFSA) is probably the most similar to yours. What projects have you done together now with HFSA?
Universal Definition of Heart Failure
Coats: HFA and HFSA — a bit of a mouthful to say — are increasingly doing work together, and it's a very pleasing collaboration. We actually have a three-way partnership, with our two organizations and also the Japanese Heart Failure Society, where we meet once a year and work on a particular issue and that leads to a position paper. We're into our third year, and we've done one on endomyocardial biopsies and an important one that I know you're very active in, and that's the universal definition of heart failure paper.
Piña: How do you think that that universal definition of heart failure is different from what the others have been? I mean, we've been hearing about the inability of the heart to pump, blah, blah, blah... What is so different about this document?
Coats: Well, Ileana, some say there's nothing new in the world; everything that's to be said has been said. We felt it was necessary to look at this again because there were some very august definitions by some of the founding fathers of heart failure cardiology, but they weren't really practical in the sense that it wasn't very democratic. If you weren't a heart failure specialist, it was difficult to interpret parts of the definition, such as, "The circulation was not adequate to supply the metabolic needs of the tissue at rest or exercise." How would a bedside doctor be able to assess that? We tried to make it usable by a number of specialties — doctors who look after patients with heart failure and just want a checklist to say, this is probably heart failure and this probably isn't.
Piña: What was your position in that paper about biomarkers, particularly the natriuretic peptides?
Coats: I was pushing very hard — a lot of us were — to raise the status of the natriuretic peptides, particularly N-terminal pro–B-type natriuretic peptide (BNP), to become a very important part of the diagnosis. We chose not to go as far as to say that heart failure was elevated N-terminal proBNP in the setting of a clinical picture. We said it was one of the important ways you could document that it was heart failure. We wanted signs and symptoms of heart failure and objective abnormality of cardiac function supported by documentary evidence of congestion, which could be evidenced in a number of ways, one of which was elevated N-terminal pro-BNP or other natriuretic peptides.
Stage B Heart Failure and Differences Across the Pond
Piña: I think the group that has been listening to my blog has heard me talk about the stages of heart failure as well. But I think that you guys took stage B, which used to be just "the heart doesn't look so hot, but the patient looks fine," and you've extended that. So, what's different about stage B?
Coats: That was tricky, without telling stories out of school. It was one of the issues that was difficult to untangle because it was a difference across the pond, across the Atlantic, between the ACC/AHA (American College of Cardiology/American Heart Association) stages of heart failure that goes back to risk factors and the European perspective that heart failure is a symptomatic condition. We didn't want to say that just purely having a risk factor, such as hypertension, was heart failure. It's a bit like saying that a smoker has cancer. We ended up with what I think is a really good staging system to say that there's four stages of progression. The first two stages are "at risk for heart failure," which is having risk factors, and the second one is pre–heart failure. In a number of conditions, we have this precondition; it means that there's already something happening that tells you that heart failure is going to happen.
Piña: And that you've got to intervene; you've got to do something about it. We just drafted an editorial on the paper from the regulatory point of view. We look at whatever comes in on a protocol or on a study, and that's what we use, whether it's a drug defining it. We don't have our own universal definition, but we take what the professional societies say. The AHA and the ACC have drafted their heart failure guidelines, and they're out for review. Do you have any thoughts about whether they are going to agree with yours? I'm surprised it wasn't endorsed — it's probably all political.
Coats: It is political. We all know guidelines are shrouded in secrecy, quite appropriately. So, the HFA ESC guideline is due to come out September, but we revealed some of the recommendations for our drug treatment at our recent meeting. As part of that process, there were feelers put out as to what the American guidelines would say around definitions of the ejection fraction subtypes like heart failure with what we're now calling "mid-range ejection fraction." No one wanted to do something that was going in the opposite direction to the other major group. We just wanted to check that there was comfort in numbers.
Drug Therapy Includes SGLT2 Inhibitors
Piña: It's really been secrecy. We all suspect that the SGLT2s will be added to the foundational therapies. Everybody kind of agrees.
Coats: The Canadians got in first, and the update to the European guidelines (the bits that have been released) have sodium glucose cotransporter 2 (SGLT2) inhibitors up there as one of the four main foundational therapies. The other trend we're seeing is that it's no longer a rigid order — step 1, step 2, step 3, step 4. Instead, it's a destination; you want all four steps, and now let's talk about how you get there.
Piña: And clinicians may have to pick their own pathway to get there, but getting to that goal is better to say it that way than saying, "You have to uptitrate." Well, I'm uptitrating to what? And which drug do I uptitrate first? Those have all been questions.
Andrew, thank you so much for speaking with us and being my guest. It's always terrific. I want the audience to take a look at HFA online. They're going to be able to register, and they can see some of the talks. And do read this universal definition of heart failure. I think you'll find it very well written; it's very easy to read. I think you'll find it very helpful.
This is Ileana Piña signing off. Thank you for being with me today. Have a great day.
Ileana L. Piña, MD, MPH, is a heart failure and cardiac transplantation expert. She serves as an advisor/consultant to the FDA's Center for Devices and Radiological Health and has been a volunteer for the American Heart Association since 1982. Originally from Havana, Cuba, she is passionate about enrolling more women and minorities in clinical trials. She also enjoys cooking and taking spin classes.
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Cite this: Ileana L. Piña, Andrew J.S. Coats. Can We Agree on a Universal Definition of Heart Failure? - Medscape - Jul 22, 2021.