This transcript has been edited for clarity.
Hello. I'm Ileana Piña. I have recently taken a position at Thomas Jefferson University in Philadelphia. This is my blog.
I wanted to spend a little time today talking about the heart failure guidelines. We have been waiting for the American College of Cardiology/American Heart Association, and now Heart Failure Society of America, guidelines. All three organizations have collaborated here.
It also takes into consideration the definitions of heart failure that were published in the Journal of Cardiac Failure, which is the journal of the Heart Failure Society of America. That was published over a year ago, and I think it set the stage for these guidelines.
Certainly, the Europeans published their guidelines in the summer of 2021 at about the same time as the European Society of Cardiology (ESC) meeting.
We've all been wondering: Is it going to be the same, or are there any differences?
SGLT2 Inhibitors and ARNI
The ESC guidelines already included the sodium-glucose co-transporter 2 (SGLT2) inhibitors, and we had a consensus statement from the American College of Cardiology showing the benefits of the SGLT2 inhibitors and including them in the basis of care.
This is essentially one of the things that is now in these new guidelines, and that's the so-called pillars of care, which are made up of four individual drugs. Certainly, the SGLT2 inhibitors —not defined as one drug vs another one, it's not empagliflozin or dapagliflozin, but it's looked at as a drug class. The beta-blockers, which are not going to disappear — the same beta-blockers that I have talked to you about on this blog. The mineralocorticoid receptor antagonists, which would be the third drug, and then the fourth drug, the renin-angiotensin system (RAS) inhibitors.
What is different is that they have moved the angiotensin receptor-neprilysin inhibitor (ARNI) further up, even though if you look closely, it's a class 1A indication along with the angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs). They're calling the ARNI "preferred," and they're saying very specifically it's for New York Heart Association (NYHA_ class II-III disease because that is where the PARADIGM-HF trial sat.
This past year, there was another small trial of very advanced heart failure where the drug did not meet its specified endpoint. They're moving class III and IV disease to the standard RAS inhibition, so that's a little bit different. As clinicians, I want you to read it. There's an executive summary that is much easier to read.
The other thing that I am very happy about is that they really emphasize team care, and I think that's a stronger point than has been made before. Team care is necessary to take care of the sick patients that are very complicated.
HFpEF and HFmrEF
They have also looked at heart failure with preserved ejection fraction (HFpEF). Very interestingly, as I expected they emphasize the same things as in the previous guidelines about HFpEF — for example, treat blood pressure. Make sure the blood pressure is reduced. If the patient has any signs of ischemia, deal with that, look for it, and work it up. How about arrhythmias? Work up and see if there are, in fact, arrhythmias. All these peripheral things to HFpEF are really important.
Then they talk about, for example, in the PARAGON-HF trial, where HFpEF was defined, but in those with an ejection fraction above 57%, the ARNI drug seemed to have actually an opposite hazard ratio.
Then they mentioned the SGLT2 inhibitors. Right now, the only one that we really have solid data on is empagliflozin in the EMPEROR-Preserved trial, which had a very dramatic reduction in the primary endpoint, but not mortality — mostly heart failure hospitalization and repeated heart failure hospitalization. There were wins on both fronts and some improvement in health status as well.
There is a substudy of sotagliflozin, and that may be what they included because they've made it a class 2A recommendation for the SGLT2 inhibitors in HFpEF. Again, it's giving us something that we didn't have before. Very similar to the previous guidelines, they have kept the 2B recommendation for spironolactone. There is an explanation in there about the TOPCAT trial, where the benefits were seen at the lower range of ejection fraction, not at the higher range.
Everything leads us to keep thinking about this group that appears to be different, and they're spending a lot of time in these guidelines about heart failure with mid-range ejection fraction (HFmrEF), which the Europeans initially described as middle-range EF. To me, clinically, these patients behave like they have heart failure with reduced ejection fraction (HFrEF), and it means an ejection fraction somewhere between 40% and 49% or 41% and 49%, so it's sitting in that middle range. They do make some distinctions about what to do. I really recommend that you read in the executive summary.
Value of Care
I want to finish off with a different idea in the guidelines. They now are talking about value. I think that was put in there because, in the United States, Medicare is moving to payment for value, payment for quality, and payment for better outcomes. They are describing that, for example, a drug may be expensive, but the value in terms of reduction in hospitalization or reductions in death is high up there on the scale. That's a brand-new section.
Finally, they still talk about iron deficiency and why it's so important to work up iron deficiency. They mention sleep apnea. They mention hypertension, as well as all the things that were in the previous 2013 guidelines and then the 2017 guidelines.
We've been waiting for this. The executive summary is very well put together. The tables are easy to read, and you can put this in your office and take a look at it. In general, you need to get the patients who have HFrEF on the four drugs, and those are the pillars of care that we really need to follow. Everything else may be a little bit here and a little bit there. Think about the SGLT2 inhibitors as well, besides doing all the other ancillary things that we need to do.
This is Ileana Piña. Thank you for joining me today, and I hope to talk more about this in the future. 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. Key Points From the New Heart Failure Guidelines - Medscape - May 04, 2022.