Physicians treating heart failure should strive to build a working relationship with their patients to better ease symptoms with a sometimes complex array of medications and other treatment options, according to heart failure experts.
“Explain to the patients the importance of being on the medications, and try to get a buy in,” said Estefania Oliveros, MD, FACP, a cardiologist and assistant professor of medicine at Temple University's Lewis Katz School of Medicine in Philadelphia. “You are trying to tackle so many pathways and it's already a complicated [patient] population to guide through it. But the truth is that just using one medication, one single pathway, or even two may not be enough.”
Slightly more than 6 million American adults live with heart failure, and the rate is increasing as the population ages, according to data published Feb. 23 in Circulation. Associated costs from treatment and lost work add up to over $30 billion annually, according to federal data.
Dr. Oliveros served on an American College of Cardiology (ACC) writing committee that recently published an updated decision pathway for treating patients with reduced ejection fraction, diagnosed in roughly half of heart failure patients. The pathway, which covered 10 management issues and was published Feb. 16 by the Journal of the American College of Cardiology, provides the latest guidance for treatments that have emerged since the ACC's prior 2017 pathway. For instance, it recommends that sacubitril/valsartan—an angiotensin-receptor blocker/neprilysin inhibitor combo, dubbed ARNI—be considered as first-line treatment in newly diagnosed patients.
For nonhospitalized patients who have been newly diagnosed, the overarching goal is to prescribe and adjust the medication regimen every two weeks to reach target doses within three to six months, the authors wrote in the 2021 decision pathway. Achieving that benchmark represents a steep challenge not just for physicians, but also for patients who may be scared and still adjusting to their diagnosis, Dr. Oliveros said.
“You have to make sure that they don't feel lonely in the process, because I think it's a lot to overcome,” Dr. Oliveros said. She tells her patients that she will add medications bit by bit with the goal of helping them feel better and keeping them out of the hospital.
But she also assures them that if a medication has troubling side effects, “We can always scale back. Giving them that option, so that they don't feel like they are trapped, they feel like it's a collaboration,” she said.
Either a beta-blocker or an inhibitor of the renin-angiotensin system—ARNI, angiotensin-converting enzyme (ACE) inhibitor, or angiotensin-receptor blocker (ARB)—should be prescribed in new-onset heart failure, according to the 2021 ACC pathway. In some cases, both types of drug can be started at the same time, the authors wrote.
Sacubitril/valsartan, first approved by the FDA in 2015, has increasingly reshaped the treatment of patients newly diagnosed with reduced ejection fraction, said Brent Lampert, DO, a cardiologist and an associate professor of clinical medicine at Ohio State University Wexner Medical Center in Columbus.
“It is really becoming the standard of care, the first-line therapy in place of an ACE inhibitor or an angiotensin-receptor blocker,” said Dr. Lampert, noting that cost remains an issue for some patients.
Among other medication-related recommendations, according to an ACC summary detailing key takeaways from the new pathway, are the following:
- A patient's renal function and potassium should be checked within one to two weeks of starting an ARNI, ACE inhibitor, or ARB, as well as when the dose is increased.
- After a beta-blocker and angiotensin antagonist are started, the addition of an aldosterone antagonist should be considered, along with monitoring the patient's electrolytes.
- Consider also prescribing a sodium-glucose cotransporter-2 (SGLT-2) inhibitor for patients with New York Heart Association class II-IV heart failure, regardless of whether they've been diagnosed with diabetes.
- For Black patients with persistent symptoms despite other medication treatment, consider adding hydralazine and isosorbide dinitrate.
Despite evidence-based guidelines dating back years, though, “heart failure guideline-directed therapy has not improved,” said Biykem Bozkurt, MD, PhD, a professor of medicine and the Mary and Gordon Cain Chair in cardiology at Baylor College of Medicine in Houston. Population-based heart failure registries show that the prescribing of beta-blockers, ACE inhibitors, ARBs, and mineralocorticoid receptor antagonists has not increased over nearly two decades, according to data in an editorial that Dr. Bozkurt authored, published May 21, 2019, in the Journal of the American College of Cardiology.
The editorial cited various factors for explaining the treatment gap, including side effects, lack of adherence, and cost issues on the patient side. But it also listed some physician-related contributions, including inertia, complex titration protocols, and inadequate follow-up.
“Please do not discontinue the treatment due to transient rise in creatinine or minor fluctuations in blood pressure without symptoms,” she said. “If the treatment needs to be interrupted due to a variety of comorbidities or complications, please resume as soon as possible. We are seeing tons of medications being stopped and never resumed.”
If the issue is a medication's side effects, consider switching medications rather than avoiding the drug class entirely, said David Smith, MD, a cardiologist and clinical assistant professor at Yale School of Medicine in New Haven, Conn. For instance, if patients who are prescribed carvedilol struggle with dizziness, asthma, or fatigue, that does not mean they cannot tolerate all beta-blockers, he said, noting that those symptoms may be due to the complete blockade of alpha and beta receptors. Switching to another beta-blocker, such as metoprolol or bisoprolol, may more selectively target the heart and reduce symptoms, he said.
Convincing insurers to cover some medications, including sacubitril/valsartan or isosorbide dinitrate/hydralazine hydrochloride, also can be difficult, Dr. Smith said. He noted that for Black patients, the highest-risk demographic for hospitalization and death from heart failure with reduced ejection fraction, insurance coverage of guideline-directed fixed-dose isosorbide/hydralazine rather than generic off-label substitutions requires heavy documentation, including functional status. To forestall denials of heart failure medications, both the primary care physician and the cardiologist should document everything from patients' functional status and number of hospitalizations to what medications they have been taking and for how long, he said.
For some patients, the biggest hurdle boils down to pill burden, whether that is due to cost or logistics or both, Dr. Lampert said. It's not unusual for patients to be taking three to five heart failure medications along with medications for diabetes, high blood pressure, and other diseases.
In those cases, Dr. Lampert will try to meet patients halfway by prioritizing their heart failure medications. “I'd rather have them take one of their medicines I know that's good all of the time and be compliant with it,” he said, “than pat myself on the back for prescribing three medicines but they don't take any of them.”
Clinical guidance for heart failure tends to focus on patients with reduced ejection fraction because that's the population in whom most of the research has been conducted, said Barry Greenberg, MD, director of the advanced heart failure treatment program at the University of California San Diego Health. However, there has been “decreasing certainty” in recent years regarding how to classify patients between the two major types—reduced ejection or preserved heart failure—and it's becoming clear that more than ejection fraction should be used to guide treatment, he said.
Broadly speaking, management of patients with preserved ejection fraction involves treating the related risk factors and symptoms, such as hypertension or congestion, Dr. Greenberg said. In February, the FDA opened the door to prescribing sacubitril/valsartan to a wider pool of patients, including those with preserved ejection fraction, he said. Federal officials updated the drug's label, stating that the drug's benefits are most evident in patients with a below-normal ejection fraction, but did not specify any number, he said.
“What that means in practice is that when you get a patient with heart failure, ejection fraction is not the only factor that is a determinant of whether you use an ARNI or not,” Dr. Greenberg said. “It is a factor.” While the lower the ejection fraction the more likely the drug will help, there's some research indicating that a patient with a mildly reduced ejection fraction of 40% to 49% or even higher is likely to benefit as well, he said.
Given the challenges involved in treating patients with mildly reduced ejection fraction, Dr. Greenberg suggests considering referral to consultation with a heart failure specialist. “Because for that group, the guidelines are largely silent,” he said.
Another group to refer out for additional guidance, Dr. Greenberg added, are those whose ejection fraction has returned to normal. “Determining whether or not these patients have fully recovered or are in remission remains a little bit unclear to most clinicians,” he said.
Both Dr. Greenberg and Dr. Bozkurt highlighted the findings of a small randomized trial, published Jan. 5, 2019, in The Lancet, involving 51 patients who appeared to have recovered from heart failure. They were split into two groups, one of which continued with medication and the second of which began withdrawing from it. Within the first six months, 44% of those randomly assigned to treatment withdrawal relapsed, whereas none did in the treatment group.
Therefore, physicians should not refer to “recovered heart failure,” Dr. Bozkurt stressed. Instead, they should describe those patients as having “heart failure in remission,” she said.
Worsening heart failure
The COVID-19 pandemic's rapid shift to telemedicine has highlighted the potent role it could play moving forward in helping patients more rapidly reach their targeted medication regimen within six months, Dr. Oliveros said.
Rather than scheduling in-office appointments every few months, which may delay medication titration adjustments, a mix of virtual visits, phone calls, and text messages can be used in between, she noted. Patients can monitor their weight and blood pressure, as well as any symptoms, and report back to a clinician on the physician team, she said.
“The paradigm of COVID is that it's allowing us to understand the benefits of telemedicine,” Dr. Oliveros said. “It allows us to go up on medication regimens faster and in a safe manner.”
As physicians care for these patients, they should also strive to distinguish signs of worsening heart failure from other medical conditions, which can be difficult at times, Dr. Smith said. For instance, he said, “Remember that a heart failure exacerbation either can come from or contribute to sleep apnea.”
To identify worsening heart failure, physicians can ask a patient two key questions, Dr. Smith said: “Do you wake up from sleep short of breath?” and “Can you lay down flat to go to sleep, or do you need multiple pillows?”
The latest ACC decision pathway includes the acronym I-NEED-HELP to guide physicians when a patient's condition might be worsening and he or she should be referred to a heart failure specialist, a list that includes edema despite escalating diuretics and New York Heart Association class IIIB/IV heart failure or persistently elevated natriuretic peptides.
For primary care physicians, a more shorthand way to assess if patients may be slipping from stage C to stage D heart failure is if they have been hospitalized more than once within a six-month stretch without an obvious precipitating cause, such as not taking their medications, Dr. Greenberg said. Another flag for a heart specialist referral would be a notable decline in a patient's ability to perform typical activities without any discernible cause, he said.
“I find that in some of these cases you can readjust their medications and get them back to where they were before,” Dr. Greenberg said. “But it's not easy, and you need to have a fair amount of experience in this area.”
Faster detection of worsening heart failure also enables patients to be referred for advanced therapies, such as a left ventricular assist device (LVAD) or a heart transplant, before they have developed other organ damage or increasing frailty that may exclude those options, Dr. Greenberg said.
As heart failure progresses and treatments change, physicians should check in periodically with patients about their quality-of-life goals, and not wait until nearer the end of life, Dr. Lampert said.
Dr. Lampert prefers to use decision aids (he cites as an example those developed by the Colorado Program for Patient Centered Decisions) to plainly lay out the potential risks and benefits of aggressive treatment, such as getting an LVAD. He also tries to be frank when treatment options have run out and his focus will be more on easing the patient's symptoms for as long as possible.
“I used to avoid those conversations; they're hard,” Dr. Lampert said. “But I don't think you do anyone a service to be evasive. I think there is a way to have those conversations without crushing hope and spirit. That is hard, and I think it takes practice.”