What’s New in HFrEF Treatment: ACC Consensus Guidance

The American College of Cardiology has published a new update to its consensus decision pathway for the treatment of heart failure with reduced ejection fraction (HFrEF).

Chair of the consensus document Writing Committee Thomas M. Maddox, MD, explained to theheart.org | Medscape Cardiology that this new Decision Pathway provides a practical, streamlined update to frontline clinicians treating patients with heart failure and incorporates evidence from the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure.

The authors said that the treatment of heart failure can feel overwhelming, and many opportunities to improve patient outcomes are being missed.

“While the AHA/ACC/HFSA Guidelines are wonderful in that they collate all the latest scientific evidence, they don’t speak as much to the practicalities of delivering the care. This is what this Decision Pathway document comes in — it is designed to help frontline clinicians with the practical reality of managing these patients,” Maddox, who is director of the Healthcare Innovation Lab at BJC HealthCare and the Washington University School of Medicine in St Louis, Missouri, commented.

The document, “Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment: Answers to 10 Pivotal Issues About Heart Failure With Reduced Ejection Fraction,” was published online on March 8 in the Journal of the American College of Cardiology.

The authors provided guidance on introducing the numerous evidence-based therapies now available for HFrEF, improving adherence, overcoming treatment barriers, acknowledging contraindications and situations for which few data exist, affording expensive therapies, treating special cohorts, and making the transition to palliative care.

Rather than focusing on extensive text, the document provided practical tips, tables, and figures to make clear the steps, tools, and provisos needed to treat patients with heart failure successfully and expeditiously, they added.

Maddox reported that there are three main updated areas of advice on the treatment of heart failure in the new document.

Valsartan/Sacubitril First Line

One of the major changes involves an elevation for the status of the angiotensin receptor-neprilysin inhibitor (ARNI), Entresto (valsartan/sacubitril).

“It is now clear that this agent is superior to ACE-inhibitors or angiotensin receptor blockers in terms of reducing heart failure hospitalization and death, whereas previously it was seen as somewhat equivalent,” Maddox said. “So, barring a contraindication or another problem with getting the medication, this agent should be one of the first line medicines for all patients with heart failure and a reduced ejection fraction.”

Dual Sodium-Glucose Cotransporter 1/2 (SGLT1/2) Inhibitor

A second update involves the addition of sotagliflozin (a dual inhibitor of both SGLT1 and SGLT2) to the SGLT2 inhibitors as another first-line medication for patients with heart failure and reduced ejection fraction.

“We now have evidence that both SGLT2 and SGLT1 inhibitors are beneficial in reducing heart failure hospitalization and death. Previously we only had evidence on SGLT2 inhibitors — dapagliflozin and empagliflozin. Sotagliflozin is a newer agent, which inhibits both SGLT1 and SGLT2, and it turns out that inhibiting both are beneficial in heart failure. So, this gives us a third med in this category,” Maddox noted.

Rapid Initiation of the Four Pillars of Therapy

The document stated that more data have emerged recently to support early and rapid initiation and titration of the “four pillars” of medical therapy in heart failure to maximize the benefits of patient-reported outcomes and reduction in hospitalizations and mortality.

The four pillars of therapy are ARNI, a beta-blocker, a mineralocorticoid antagonist, and an SGLT inhibitor.

As an example, four-class medication initiation reduced the hazard of cardiovascular death or hospital admission for heart failure significantly (hazard ratio, 0.38) compared with therapy with just an angiotensin-converting enzyme inhibitor/angiotensin receptor blocker plus a beta-blocker, the document reported.

“What we realize now is that the more quickly we can get patients on all four of these drug classes and escalate to target doses or maximally tolerated doses ideally within 3 months, the better the outcome,” Maddox said.

“Unfortunately, right now there is very incomplete realization and recognition of that in clinical practice. So, we are trying to highlight the importance of this to encourage clinicians to be more aggressive in making this happen.”

“In all patients with heart failure and reduced ejection fraction, getting them on all four of these medicines as quickly as possible will give the best outcome. We’ve seen evidence in support of this from several broad population trials,” he added. “There are times when they can’t take all four but we should do our best to get there.”

Practical Considerations

Maddox pointed out that the Consensus Document is also trying to account for practical realities and barriers to heart failure treatment.

“When we think about these recommendations — and evidence that getting patients on all these medicines is valuable, we also focus on the fact that there are three major barriers that can get in the way of this and how to think about overcoming those barriers,” he said.

The barriers are comorbidities/side effects of medications, costs of the medicines, and systems of care that are needed to ensure patients can be treated with multiple medications in a timely fashion.

In terms of comorbidities/side effects, Maddox explained that patients with heart failure are generally older and are likely to have other comorbidities. “The more medicines we give, the more likely we are to run into side effects. So, we have produced some guidance on how to monitor for adverse effects and ways to mitigate these effects so the guideline recommended therapies can be continued without creating new harms.”

He gave the example of mineralocorticoid antagonists, which can sometimes elevate potassium levels, particularly if there is some underlying kidney disease, so clinicians are advised to recommend a low-potassium diet for these patients or the use of potassium binding agents that will also lower the amount of potassium in the blood stream; in this way, patients are able to continue the mineralocorticoid antagonist.

On costs, Maddox noted that the valsartan/sacubitril combination drug and SGLT inhibitors are new medicines and are expensive.

“They can be prohibitively expensive for patients who have suboptimal pharmacy benefits or who are uninsured.”

The Consensus Document therefore provided some guidance on ways to identify rebate programs, access insurance, and find different pathways to obtaining those drugs at a more reasonable price. It also advocated for policy changes to allow these medicines to be more accessible to more people.

More Use of Digital Tools

On the issue of systems of care, Maddox noted that the preexisting model of delivering care, which almost always involves the patient coming into the doctor’s office, invokes a high burden on both the system and most especially, the patient.

“Patients do not want to come back and forth to the doctor’s office multiple times in a few weeks. This is often a nonstarter, particularly for patients with busy lives,” he commented.

The Consensus Document advised more use of digital tools to provide remote care and contact with patients including sensors that can measure variables such as heart rate and blood pressure and video appointments.

“We are still working out what are the right models of care and how they can be performed safely and how they can be funded. But I think at the end of the day, this will give us more practical ways of getting people on multiple heart failure medicines and monitoring them safely without causing an undue burden for them logistically,” Maddox said.

He pointed out that there are a record number of medicines now available to treat heart failure, and while this is welcome, many of these patients are also on multiple other medications for other comorbidities as well.

“If you start giving patients seven, eight, or nine different medicines that they have to take every day, sometimes multiple times a day — that’s complicated medically, logistically, and financially. The potential for interaction and complications increases with every additional medication.”

Maddox also noted that patients have limits on how many medications they will accept. “It really helps if we have an engaged patient who has a good relationship with the care team to try to develop the right treatment plan that is going to meet their needs and give them the best possible health outcomes.”

It can take many visits to get the patient on all these medications and then up-titrate to target doses.

“We try and do a couple of things in each appointment. Often, we tend to start one or maybe two drugs at a time at a relatively low dose to avoid side effects, so we can be talking about 12-16 different encounters in total,” he said.

He recommended making a plan and the use of new technologies to manage each incremental step.

A Team Approach

Another issue that is discussed in the document is the use of a healthcare team to manage all the necessary appointments.

“It is no longer practical that one person can be the engineer for all this. It should be a team effort,” Maddox stated.

Responsibilities can be allocated across physicians, nurses, pharmacists, and even case managers, so that the team can take more of a population approach and develop a system to get patients on the multiple medications as quickly as possible.

“While this can still be quite a big burden for the patient, we need to figure out a system to make this as palatable as possible for them. Practices need to tailor this themselves according to what resources they have,” he added.

While most new patients will be routed to cardiologists to start their treatment plans, once on their initial medications and these have been up titrated to target levels, they should be able to be managed by primary care doctors, who will have the most holistic view of the patient and their other comorbidities, Maddox advised.

“Following this guidance should lead to more patients receiving evidence-based care which leads to better health outcomes, but delivered in a practical way that fits with their life reality and logistical needs,” he concluded.