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Expert Insights From ACC 2022: How New Data in HFrEF Could Influence Your Practice
  • CME

Lee R. Goldberg, MD, MPH, FACC

Professor of Medicine
Division of Cardiovascular Medicine
Department of Medicine
Section Chief, Advanced Heart Failure and Cardiac Transplant
University of Pennsylvania
Philadelphia, Pennsylvania

Lee R. Goldberg, MD, MPH, FACC, has disclosed that he has received funds for research support from Zoll/Respicardia and consultant/advisor/speaker fees from Abbott, VisCardia, and Zoll/Respicardia.

View ClinicalThoughts from this Author

Released: April 20, 2022

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At the 2022 American College of Cardiology Annual Scientific Sessions (ACC 2022), new data that can affect the management of patients with heart failure with reduced ejection fraction (HFrEF) were presented from several trials. In this commentary, I will review key findings and how they could influence your approach. 

SODIUM-HF Trial: Low-Sodium Diet in Heart Failure
For healthcare professionals who treat heart failure, sodium restriction has been something akin to a religion. We have invested a tremendous amount of effort in educating patients on low-sodium diets and in some cases linking their diet choices with their heart failure outcomes.

Data from several clinical trials of various size and rigor have called into question the clinical impact of sodium restriction. Although numerous trials have concluded that high-sodium diets lead to excess heart failure hospitalizations, several other trials have found equivocal results across various dietary sodium levels. This has led to some controversy over which specific lifestyle changes are most valuable for patients. Hence, there was a lot of interest in the SODIUM-HF trial, the largest randomized clinical trial to date to assess sodium restriction in patients with heart failure.

In SODIUM-HF, patients with symptomatic heart failure who were receiving optimal guideline-directed medical therapy (GDMT) were randomized to a strict sodium restriction of 1500 milligrams of sodium per day vs usual care. The primary outcome was a composite of all-cause mortality, cardiovascular hospitalizations, or emergency department (ED) visits within 12 months. Secondary outcomes included safety, quality of life, exercise capacity, and New York Heart Association class. This was a large multicenter trial with sites in Canada, Mexico, Chile, Colombia, Australia, and New Zealand, and there were no inclusion/exclusion criteria around ejection fraction or natriuretic peptide levels.

In the intervention group, participants were provided sample daily menus according to their energy needs. All participants provided 3-day food records at each follow-up visit. Investigators used the food records to assess sodium intake and found that average daily sodium was reduced in the low-sodium arm (1658 mg/day at 12 months) vs the usual care arm (2073 mg/day at 12 months), albeit with significant variability and some overlap. Of note, there was no difference in outcomes stratified by ejection fraction above or below 40%.

There was no statistical difference between groups regarding the composite primary outcome of cardiovascular-related hospitalization, ED visits, or all-cause mortality. However, patients following the low-sodium diet tended to report improved quality of life, especially in physical functioning scores. Moreover, the 6-minute walk distance was numerically larger in the low-sodium group, particularly at 6 months. There were some limitations, including a lower than anticipated event rate and an early stop to the trial.

So, based on these results, should we recommend a low-sodium diet for patients with heart failure? In my opinion, yes, but perhaps not as aggressively as we have in the past. This trial did not assess patients who were starting with a high-sodium diet and transitioning to a low-sodium diet. Participants in the comparator arm were following an approximately 2000-mg/day sodium diet, which is within typical dietary recommendations. Hence, in practice, this trial compared patients with strict levels vs moderate levels of sodium restriction. SODIUM-HF suggests that strict sodium restriction can lead to modest improvements in symptoms and quality of life, but it is likely that there are other interventions that are more important for reducing hospitalizations and improving morbidity and mortality. For example, offering counseling and support for medication adherence and exercise may promote better clinical outcomes. That raises the issue of how best to apply limited resources in terms of education and support for patients. Although very high–sodium diets still may be detrimental to our patients and we should not throw away the sodium mantra completely, I think this data will help us to tailor and temper our advice to patients and perhaps make it more reasonable and more palatable to them overall.

PROMPT-HF Trial: EHR Alerts for GDMT
A major challenge in heart failure management is getting patients on GDMT. Regardless of how strong our science is, how well written our guidelines are, or how well intentioned we are, if patients are not prescribed the right medications and if there is no mechanism to help them adhere, we’re not going to be successful. How do we support healthcare professionals in prescribing the right medications and patients in taking their medicines and following the guidelines? The PROMPT-HF trial evaluated an interesting approach.

PROMPT-HF was an implementation study asking whether electronic health record (EHR)-based alerts could improve the use of GDMT in patients with HFrEF. In the study, 100 providers from a single academic center were randomized to EHR-based alerts or usual care. The alerts prompted providers to review patient characteristics and individualized GDMT recommendations and provided links to order any missing medications. The primary outcome was the proportion of patients with an increase in the number of GDMT drug classes prescribed within 30 days. Secondary outcomes explored increases in dosing of current GDMT medications, filling of prescriptions, and total costs for healthcare, hospitalizations, ED visits, and death.

Among 1310 patients with HFrEF enrolled on the study, the investigators reported a significant increase in the number of GDMT drug classes in the intervention group vs control (25.7% vs 18.7%; absolute risk reduction: 1.41; 95% CI: 1.03-1.93; P = .03). Moreover, the intervention group had significantly more dose increases or new drug classes initiated than the control group (36.2% vs 26.2%; absolute risk reduction: 1.39; 95% CI: 1.08-1.79; P = .01). There were no differences in 30-day rates of hospitalizations or ED visits.

Many healthcare professionals balk at the idea of pop-up alerts or best-practice alerts in the EHR. Some view them as counterproductive and link them to fatigue and burnout among healthcare professionals and see a limited benefit for patients. But in PROMPT-HF, the alerts were well received, with 80% of providers reporting that they were helpful. Having a clinical trial demonstrate that the alerts led to a difference in GDMT is reassuring and perhaps overcomes some of the negative aspects of pop-up alerts in the EHR.

A caveat of this study was that all the healthcare professionals were at a single academic center. It is unclear whether this intervention would scale to nonacademic practices or other settings with different EHR systems. Nonetheless, I am reassured by this study that an EHR intervention is feasible. Does it change clinical practice in and of itself? No. But if it helps more patients receive GDMT, then we would expect to get closer to the outcomes seen in clinical trials of those therapies.

As heart failure guidelines have grown more complex with an expanding toolbox of drugs and rising costs for care, it is increasingly important that we find solutions for helping healthcare professionals to implement the best practices. PROMPT-HF provides an intriguing strategy for addressing the implementation challenge of an increasingly intricate management approach.

DIAMOND: Patiromer for Hyperkalemia in Heart Failure
Another common implementation challenge of GDMT in patients with heart failure is managing adverse events to help keep them on effective therapies. Hyperkalemia is a common adverse event in patients receiving renin–angiotensin–aldosterone system inhibitors, which is worrisome to cardiologists because of the risk of arrythmias and other complications. At ACC 2022, we saw new data from the DIAMOND trial evaluating the efficacy of patiromer to prevent increases in serum potassium in patients with HFrEF and a history of hyperkalemia.

The DIAMOND investigators demonstrated that patients who were randomized to receive patiromer had significantly decreased levels in serum potassium vs the control group and were better able to tolerate heart failure medications—in particular, mineralocorticoid antagonists. These findings give us a useful strategy to help patients who previously were unable to access the significant morbidity and mortality benefits of GDMT.

Adding patiromer for those at risk of hyperkalemia is a nuanced approach to maximizing benefits and minimizing risk. It is not a first-line drug, but for a patient in whom hyperkalemia is the barrier to GDMT, I might consider patiromer. It’s another arrow in our quiver.

EMPULSE: Empagliflozin in Acute Heart Failure
At ACC 2022, sodium-glucose cotransporter 2 (SGLT2) inhibitors were in the spotlight. New data have further underscored their utility in all forms of heart failure, and the drug class was promoted in the newest heart failure guidelines from the American Heart Association/ACC/Heart Failure Society of America to be recommended for patients with HFrEF regardless of the presence of diabetes, as well as for patients with heart failure with preserved ejection fraction and heart failure with mildly reduced ejection fraction.

Adding to the momentum, the randomized phase III EMPULSE trial showed that starting empagliflozin in the hospital led to greater clinical benefit at 90 days vs placebo in patients with acute decompensated heart failure, regardless of ejection fraction or the presence of diabetes. This included improvements in mortality, heart failure hospitalizations, symptoms, and quality of life.

Of importance, EMPULSE demonstrated that starting the drug early during an acute exacerbation may translate into early benefit—as soon as 15 days—for patients in terms of morbidity and quality of life. That’s incredibly impactful for patients and adds another brick on the layer of support that this class of drugs provides. In addition, no safety issues were identified with starting empagliflozin in the hospital during an acute heart failure exacerbation. It is exciting to see the evolution of SGLT2 inhibitors in heart failure. EMPULSE validated what we have seen in previous clinical trials of SGLT2 inhibitors, which is very reassuring.

Your Thoughts?
Which new data in HFrEF from ACC 2022 will most likely influence your practice? Answer the polling question and join the conversation by posting a comment.

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