American Heart Month: New Therapies, Gaps in Heart Failure Management

For American Heart Month, Michael Gillette, PharmD, BCPS, BCCP, clinical pharmacy specialist in cardiology, Michael DeBakey VA Medical Center, discusses recently approved treatments for cardiovascular disease and the future of heart failure management.

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Welcome back to PopHealth Perspectives, a conversation with the Population Health Learning Network where we combine expert commentary and exclusive insight into key issues in population health management and more.

In this episode for American Heart Month, Dr Michael Gillette discusses heart failure management and gaps in care.

Before I get started, I just wanted to state that I have no financial disclosures or conflicts of interest related to this podcast.

My name is Michael Gillette. I'm a clinical pharmacy specialist in cardiology at the Michael DeBakey VA Medical Center here in Houston, Texas. I also serve on the research and development board here. I'm also an instructor at the Baylor College of Medicine, where I lecture on cardiovascular pharmacotherapy.

I earned my pharmacy degree in Nova Southeastern University in South Florida. I then completed 3 years of postgraduate training with the Department of Veterans Affairs. Two of those years were focused specifically in the field of cardiology.

My role here at the VA is multidimensional. My focus is not only on clinical care, but also on cardiovascular research, and then also to provide patient and provider education. I practice in both inpatient and outpatient settings, and this allows me to see a wide spectrum of cardiovascular conditions with varying degrees that further maximize my impact on veteran care.

In honor of American Heart Month, can you discuss the prevalence of heart disease and how the pandemic has impacted this?

Sure. I think most clinicians are aware that heart disease continues to be the #1 cause of death here in the United States. We could refer to it, actually, as the “pre-pandemic pandemic.” To give you some staggering statistics from CDC, as much as 1 person dies every 36 seconds from heart disease, and that accounts for nearly 1 out of every 4 deaths.

In terms of CAD or coronary artery disease, there are over 18 million adults with this condition, but today, I'm going to be focusing on heart failure, which is one potential complication of coronary artery disease. There's estimated to be around 6 million adults here in the United States and almost 1 million cases of heart failure diagnosed annually. Unfortunately, this prevalence is expected to increase further to be around 46% by the year 2030.

In terms of how the pandemic has impacted heart disease,, it's very unfortunate that individuals with heart disease are more likely to become severely ill and potentially even die when they contract COVID-19 illness. Your risk of having a new heart attack is estimated to be anywhere from 3-8 times greater once you catch COVID-19 compared to healthy individuals. COVID-19 has definitely impacted the outlook and prognosis of heart disease.

In addition to heart failure, what are some other complications?

There are many complications that can arise. One of the most important complications that I like to focus on is heart failure. The cost of heart disease in general is overwhelming.

The CDC’s latest estimates were back in 2016 to 2017, and at that time, estimated around $363 billion was spent annually on that condition alone. Out of that, approximately $30 billion was attributed to heart failure management.

Can you tell us about the latest treatments and what gaps exist in the management of heart failure?

Sure. The good news is we are beginning to uncover a lot of new drugs for the management of heart failure. Prior to the release of the PARADIGM-HF trial in 2014, we really hadn't come very far with developing new treatments. There was the SHIFT trial with ivabradine in 2010, which showed a reduction in composite of hospitalizations for worsening heart failure and cardiovascular death, but the reduction was mainly driven by a small reduction in hospitalizations for the worsening heart failure.

However, with the PARADIGM-HF trial which showed a reduction in both mortality and hospitalizations for worsening heart failure, this definitely became a game changer in the management of heart failure.

More recently, the FDA has approved vericiguat in January 2021. This was approved to reduce the risk of cardiovascular death and heart failure hospitalizations as well, but again, this was primarily driven by mass reduction in heart failure hospitalizations has shown in the VICTORIA trial.

Omecamtiv also recently showed a reduction in hospitalizations and urgent care visits for worsening heart failure from the GALACTIC-HF trial. That trial was also published in January 2021, but currently omecamtiv is undergoing an expedited review by the FDA.

This drug is different from the other therapies that we previously used and that it's a myotrope so it increases contractility of the heart, which may be of benefit in patients who are not ideal candidates for the other traditional therapies due to having low or borderline low blood pressure or who have experienced hypotension.

Some of those newer nonpharmacologic therapies include devices that promote cardiac contractility modulation, otherwise known as CCM. The Optimizer Smart system is one such device that was developed by the Impulse Dynamics Group, and they received clinical clearance around March 2019 for use in clinical practice. Unlike pacemakers, though, CCM modulates the heart muscle strength without affecting the heart rate or the action potential, and these could eventually one day be incorporated into pacemakers or ICDs to help further improve clinical outcomes of heart failure.

In terms of the gaps for the management of heart failure, there are currently at least 4 therapies that are considered as the core management of heart failure. This includes sacubitril/valsartan or others that target the angiotensin system, and then your evidence-based beta blockers, your mineralocorticoid receptor antagonists. Then last is the SGLT2 inhibitors.

With the newer agents that I recently mentioned, heart failure management could evolve one day into 5 or 6 or even more medications that form the core management of heart failure. So clinicians, I think, are now beginning to struggle with learning how to start all these different medications. The patients are certainly also going to face difficulties with adherence and compliance with having so many medications onboard. I think this is definitely one area where pharmacists could be instrumental.

Right now, though, we do need more studies to guide when and how all these heart failure regimens should be initiated. Some experts have currently advocated for simultaneous initiation of all 4 core therapies. This approach seems to be getting some momentum. We definitely need more definitive data to guide the appropriate initiation for the core therapies, and then furthermore on how to incorporate the newer agents.

Where do you see the future going in terms of how we're going to manage heart failure?

I discussed a lot about the new treatments, but one area that seems to be expanding is remote monitoring of heart failure. There was especially emphasis on this during the beginning of the COVID-19 pandemic, where a lot of our heart failure patients and other patients with heart conditions were unfortunately unable to present to the hospitals to seek care because of the overwhelming numbers of COVID-19 admissions and the risk of exposure.

Unfortunately, this continues to be a major problem, especially with those with more complex heart failure conditions. With this in mind, I anticipate that there's going to be increased utilization of remote monitoring devices. CardioMEMs is one such example. I also see expansion with regards to implantation of ventricular assist devices.

Given the limitations with available heart donors, implantation of LVADs has remained steady over the past, but based on the latest numbers it was steadily decreasing. We should think about how this would be impacted by the expected increase in the prevalence of heart failure for the future.

Is there anything else you'd to add that we haven't touched on?

One question that comes up a lot is how COVID-19 is going to affect heart failure and patients with heart disease. We really don't have any definitive data on COVID-19 vaccines and whether this will reduce cardiovascular death and more heart failure hospitalizations, but certainly, if patients do not have any contraindications, it's something that we encourage that they discuss with their providers.

It's something that we would recommend that patients would get not only their COVID-19 vaccines, but stay up to date with their flu vaccines and their pneumonia vaccines. Once you get a viral infection like this, this can stress the heart and then potentially put you in the hospital or even result in death.

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