At The Heart of Innovation: Q&A w/ Cardiovascular Thought Leaders – Nancy Albert, PhD

At The Heart of Innovation: Q&A w/ Cardiovascular Thought Leaders – Nancy Albert, PhD

A powerful female presence in a male-dominated field, Nancy Albert, PhD, CCNS, CHFN, CCRN, NE-BC, FAHA, FCCM, FHFSA, FAAN, is an innovator if there ever was one. The Associate Chief Nursing Officer for Cleveland Clinic’s Office of Nursing Research and Innovation, and a Clinical Nurse Specialist in Cleveland Clinic’s Kaufman Center for Heart Failure in the Heart, Vascular & Thoracic Institute, Dr. Albert balances research and clinical responsibilities like only the caregivers of this enterprise know how. Since her introduction into the organization in 1990 as Nurse Manager of the Coronary ICU, Dr. Albert has become a critical player in understanding and shaping the cardiovascular medicine landscape.

Dr. Albert obtained her numerous degrees and certifications in and around Northeast Ohio, graduating with her PhD in Nursing from Kent State University in 2005. Currently, Dr. Albert is responsible for the management and oversight of all resources, research, and innovation activity conducted within Nursing’s Office of Research and Innovation. Through her leadership, Dr. Albert’s team mentors and coaches nurses as principal and co-investigators in research and evidence-based practice to improve patient outcomes and healthcare provider clinical, education, information technology, and quality efficiency and effectiveness. The team also assists with implementation science, translation of research into practice when warranted, and cultivation of innovative ideas.

Throughout her career, Dr. Albert has been influential in the healthcare industry – actively volunteering on steering committees, workgroups, and task-forces of many national healthcare organizations. She has published more than 350 peer-reviewed articles in nursing and medical journals, written book chapters, and is a national and international presenter. A tenured nurse scientist, she actively conducts studies through her programs of research with multiple themes in heart failure: predictors of improvement in patients’ quality of life and self-care adherence, interventions aimed at reducing hospitalization and mortality, and quality assessment of, and interventions aimed at, improving healthcare provider use of evidence-based heart failure therapies.
Though her role has evolved in her time with the enterprise, Dr. Albert remains a sought after cardiovascular thought leader. Below are some of Dr. Albert’s thoughts as they relate to innovation in the field of cardiovascular medicine – its presence, importance, and best examples at Cleveland Clinic:


Responses have been lightly edited for clarity and length.

Question: We know you wear a few hats, but in your clinical and research roles, what is your cardiac specialty?

Nancy Albert, PhD: I'm a heart failure specialist by background. When I think of my cardiac specialty, the element that stands out is that it's very complex. Patients who have heart failure often have other cardiovascular conditions – it may be atrial fibrillation, coronary artery disease, or valve disease, and patients may also have non-cardiac conditions that make management of their global health tougher to deal with. For example, patients may have diabetes, chronic lung disease, or gout. Or they may have problems that have signs and symptoms that mimic heart failure –anemia, for example, or chronic renal disease. Treating heart failure, in light of other chronic conditions, can be challenging. Providers must recognize when typical heart failure symptoms are getting worse from decompensated heart failure or from other medical conditions.

Over the years, we've been very lucky in that many new drugs and devices have become available to us to treat one form of heart failure- heart failure and reduced ejection fraction (also known as systolic heart failure). In fact, 2015 was a landmark year. I know it's five years ago now, but two new drugs came out on the market for heart failure. At the end of 2019, going into 2020, another new drug was approved, and already in 2021, we’ve seen another drug receive FDA approval.  So again, we are very fortunate that many pharmaceutical companies have stepped up to study and commercialize new therapies that can help improve the lives of patients with heart failure and reduced ejection fraction.

Q: Can you describe some of these drugs more specifically – the mechanisms in which they work and how they're helping heart failure patients in different subsets of the disease?

NA: Drugs that are beneficial in heart failure, were studied and found to be beneficial in certain types of heart failure. For example, tafamidis is a newer drug that is available. Tafamidis is a stabilizer drug for people who have amyloidosis, a condition that can lead to what’s known as Amyloid Transthyretin Cardiomyopathy (ATTR-CM). ATTR-CM is a form of heart failure in which misfolded amyloid protein fibrils cause the heart to be stiff and not pump blood the way it should. So this drug stabilizes the amount of transthyretin (a protein) that enters into heart tissue.  Stabilization of the abnormal protein helps the heart perform better. This drug received FDA approval just a few years ago and is now helping a lot of patients who previously had no medical management specific to their condition. It’s really been a game-changer.
 
After its FDA approval in May 2019, Tafamidis ranked #3 on Cleveland Clinic’s Top 10 Medical Innovations list for 2020. Dubbed ‘Inaugural Treatment for Transthyretin Cardiomyopathy,’ the drug has provided patients an option where there once was none. To read more about this treatment and its placement on the Top 10 list, click here.
 
For other new drugs, I’ll go back to 2015 –one agent slows heart rate in patients with heart failure and reduced ejection fraction and a resting heart rate at 70 or more beats per minute. In a healthy heart, we expect a slow heart rate– especially when the heart is at rest, for example, when sitting in a chair, watching TV or filling out a crossword puzzle. In patients with heart failure, when a fast heart rate occurs at rest, it means that hormones are being produced in the body that rev up the heart rate. Those same hormones also lead to worsening of heart failure. Other medications we use to slow this fast heart rate may not work. Ivabradine, the newer agent, is useful therapy to slow the heart rate in patients with heart failure and reduced ejection fraction who have normal sinus rhythm (no atrial fibrillation). It also reduces heart failure hospitalization rates, a sign that the drug is stabilizing the heart failure condition. 

Another really important drug of the last five years is a combination drug called sacubitril/valsartan. Both components of this drug help to widen or vasodilate blood vessels. By making blood vessels wider, the heart doesn't have to work as hard – it's easier for blood to leave the heart and get out to important organs of the body. Importantly, this combination agent decreases the ability of bad hormones to worsen heart failure and also, increases hormones in the blood stream that help to stabilize heart failure. This drug works best in patients with heart failure and ejections fractions that are below the normal range. It performs better than drugs we were previously using to treat heart failure with reduced ejection fraction. By ‘performs better,’ I mean, when used, patients can expect to have a decrease in heart failure hospitalization rates and cardiovascular death.

A drug that was just approved by the FDA for use in heart failure with reduced ejection fraction is called vericiquat. It also widens blood vessels, but it uses the nitric oxide receptor pathway to achieve its actions, which is different from many of the other drugs used in heart failure. It was trialed in patients who had more severe heart failure; some of whom may not tolerate traditional heart failure medication therapies. It also reduced heart failure hospitalization rates and may benefit some patients.

In the United States, there is a drug being reviewed to treat anemia in patients with chronic heart failure. Anemia is more common in adults with kidney function decline. The therapy for anemia is called ferric carboxymaltose. It is an injection given into a vein to increase iron levels. By treating iron deficiency, we can prevent hospitalizations for worsening heart failure. Currently, in the United States, the drug is approved for use in patients with chronic kidney dysfunction. 

And lastly, there is a very interesting drug group called SGLT2 inhibitors. It stands for sodium-glucose co-transporter 2 inhibitors. These drugs increase the amount of glucose leaving the body through your urine. And when glucose leaves the body in the urine, sodium and water are also excreted. This drug was originally developed to treat type 2 diabetes.  In research trials for diabetes, investigators learned that the drug decreased the onset of heart failure and it decreased hospitalization and cardiovascular death. An SGLT2 inhibitor can decrease excess sodium in the blood, thereby preventing fluid overload and distress in the form of shortness of breath or fatigue; both of which are common symptoms. In research trails specifically in patients with heart failure and reduced ejection faction, when an SGLT2 inhibitor was added to other heart failure therapies, there was a 30% risk reduction of being hospitalized for heart failure. That's a big deal, as hospitalization for worsening heart failure is the #1 reason for hospitalization of adults in the United States. A decrease in hospitalization rates keeps our patients healthy and well in their homes. We're starting to see an uptake in use of SGLT2 inhibitors in our patients with heart failure and reduced ejection fraction and are hoping to see new research data on using the agents in patients with heart failure and preserved ejection fraction in the near future – it’s pretty exciting stuff.

Q: This layout of the treatment landscape feeds perfectly into our next question – how have you seen the cardiovascular medicine space develop through time? What is it that’s allowed for the above innovations (research emphasis, increased data collection, improved technology for drug development, etc.)?

NA: When I think about new drug development in heart failure, part of the impetus is that we have a high volume of adults- elderly adults with heart failure who cannot enjoy life to the fullest. When drug companies find a novel target (a hormone, peptide or other mechanism) that can be made into a drug and trialed, they want to do so since we know there are a high number of people in need.  We know heart failure is a condition of aging, and as the United States is growing older, we have a lot of people who are living well into their nineties. Drug companies want to advance healthcare in cardiovascular care – specifically in heart failure care.

A high incidence of heart failure is one factor. A second major factor is frequent re-hospitalization and high mortality as a result of this condition. It’s a huge burden to society. If the drug industry can find the right combination of drugs to help our patients have a better quality of life and better length of life, so they are able to carry out activities of daily living, that's a win-win.
 
When I first got into the field pre-1990s, there were only two drugs available. One was a drug to make you urinate out extra fluid (a diuretic), and the other was to help the heart pump harder. Our newer treatment landscape, that also includes cardiac devices to treat heart failure, gives us new options in managing the condition. We have implantable cardiac devices to help patients’ hearts pump better, and we have ventricular assist devices for patients who are at end-stage heart failure to bridge to a cardiac transplant or keep them from needing one altogether. In the last 4 years, we’ve also had a hemodynamic monitoring device that’s designed to monitor the pressures inside the heart. So even if a patient says they feel fine, we can sometimes see that their pressures are elevated and get treatment on board, even before they develop symptoms of worsening heart failure.

As you can see, we have a lot of treatment pathways in heart failure. And as a result, it has brought more people into the field. Once you see that a medication works, you start asking questions. “What about this? Have we thought about that?” And innovators are developing clever ways to impact heart failure in a really important way.

Q: Following this thread of innovation, tell us a little about your other role at Cleveland Clinic – Associate Chief Nursing Officer for the Office of Nursing Research and Innovation.

NA: I am steeped in research in heart failure. Many of my projects are born out of meeting and discussing life events with patients. When patients started saying to me, “I'm not getting up and leaving my house anymore because I'm afraid to go outside with COVID-19,” or, “I know I'm eating all the wrong foods because I don't want to keep going to the food store when things get stale or moldy” I began getting ideas of new research that is needed. These patients are buying canned soup, breads, potato chips, frozen pizzas, etc. They know some foods are too high in sodium (salt) content and can make their heart failure worse, but they may be struggling to live in a pandemic environment.

That led me to consider a research study to observe the self-care practices of our patients living in this COVID-19 environment. We are conducting survey research and reviewing medical records for outcomes.  We’ve enrolled 992 patients with heart failure. On February 22, we’ll start sending out follow-up surveys to see if their quality of life has changed. We're trying to learn more about our patients to develop interventions to offset our current pandemic situation.

We have another research study involving an SGLT2 inhibitor, the sodium-glucose co-transporter two inhibitors that I talked about earlier, in our patients with cardiovascular diseases and diabetes. After reviewing the literature, we learned that there is very little data on quality of life. We know patients are less likely to be in the hospital on the therapy, but that doesn't mean they feel better when they're living their daily lives at home. Through our research, we will better understand how patients on SGLT2 inhibitors with diabetes and cardiovascular disease respond to quality of life questions compared to patients who are on another diabetic agent.

In another research study we just completed, we had an innovative intervention. One of our information technology personnel developed an idea to use an interactive card, like a greeting card, to give information to patients when they're leaving the hospital. Information like discharge instructions. Her idea came about because her mother was hospitalized with heart failure. When her mother got home, she asked her, “What did they tell you at discharge?” And her mother's response was, “I don't know. I don't remember” – which was understandably concerning and the inspiration for more informed instructions. Since her idea involved my field of research and innovation interest, I worked collaboratively with her and our CC Innovations team to develop the self-care communication that would be used in a card at discharge to help patients with heart failure.

In a randomized controlled trial, we gave the card to one-half of patients and the other half received discharge instructions that they would normally get from their physician, other provider or nurse. Then we followed study patients for six months to learn if the rate of healthcare outcomes differed between groups. We learned that patients who received the card with the special heart failure instructions actually had fewer emergency department visits, hospitalizations, and deaths as a composite outcome early after hospital discharge. Regardless if they paid attention to the physical activity, diet, medication or general information button content, patients who received the card did something a little bit different in their daily care routines that allowed them to have better outcomes than those with usual care discharge instruction. We are preparing to implement this card at Cleveland Clinic so we can help more patients ultimately feel better and live longer.
 
The MyROAD® (My Recorded On-Demand Audio Discharge Instructions) card was developed through collaboration with greeting card company, American Greetings, and the Innovation at Cleveland Clinic team. To view full study results, click here. For a product demonstration, click here.
 
Q: What are your predictions for the future of cardiac care? What are you hoping to see, and what’s required for those results?

NA: When I think about predictions for the future of cardiovascular care, there's a couple of different elements to consider. We know patients are home 99% of the time. Only 1% of the time, they are in the hospital or the doctor’s office for regular checkups/because they’re feeling worse. So if they're home most of the time, we need to develop s innovations that help patients understand their condition and keeps them as healthy as possible. Whether it be identifying behaviors that can worsen their condition, so patients know to turn themselves around, or monitoring symptoms to allow for earlier intervention, our goal should be to decrease the burden of heart failure-- to decrease hospitalization rates and ultimately, the rate of death from the condition. Sine each adult patient is an individual, with different physical characteristics, environment, biology/genetics, lifestyle, etc., we need to develop tools that help us to be able to give the right care at the right time to patients who will receive the best outcomes. The term often used is precision medicine. This goal is important, since targeted therapy is often less expensive and can lead to improved clinical outcomes, but it will take some time to achieve this future state. 

The other big issue that we're seeing in the United States, and likely Europe as well, is that the heart failure management landscape has gotten so complex for care providers. It may be difficult for healthcare providers to keep up with the literature on new medication and device therapies and understand their practical uses. We’ve gone from having only two drugs available to treat heart failure to ten classes of drugs – a lot for cardiologist, family practice, internal medicine, or advanced practice providers keep current in.

When initiating treatment, many heart failure drug therapies require a stepped approach – meaning we start out at a low dose and every two weeks, we increase the dose with the goal of getting to the dose used in large trials that showed benefit. If patients don't understand the value of an office visit, their medications may never get to the right dose, and they may ultimately miss out on the true benefits of the therapy. So one of the things I hope to see in the future for cardiovascular care is a novel way to ensure that our patients are not only on the right treatment, but they are on the right dose of the right treatment. In other words, we need to optimize medical therapies so that our patients are actually getting the best care possible – no matter who they're treated by or where they live.

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