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Medical research is revolutionizing the evaluation and management of disorders of the heart’s valves, walls and chambers, collectively known as structural heart disease (SHD). But there is still more to learn. Home to one of the top US cardiology programmes, Atlantic Health System conducts dozens of clinical trials every year into diagnostic tools, therapeutic devices and medications for the millions of people suffering from SHD and other complex cardiac conditions. Cardiologist Linda Gillam outlines where the next research breakthroughs may come from.
Linda Gillam, Medical Director of Atlantic Health System’s Cardiovascular Service Line.Credit: Atlantic Health System
SHD is an extremely important and rapidly growing branch of cardiology. These conditions are very common and carry a heavy burden. Because SHD makes the heart work harder to pump blood, or restricts flow through the body, it can lead to many complications — including heart failure, heart attack, stroke, or even sudden death.
What treatments and technologies are you investigating?
Our research portfolio is heavily weighted toward advanced cardiovascular imaging and minimally invasive, catheter-based therapies for forms of SHD that have traditionally been treated with open-heart surgery. We see many opportunities for expansion in these areas, not only in our volume of clinical trials, but also as principal investigators in high-impact work that challenges the status quo.
Since SHD can lead to many serious complications, we are also investigating new approaches to supporting patients who have associated disorders. Our Heart Success Program is for patients with heart failure, and our Cardiovascular Rescue and Recovery Program for those with severe and complicated cardiac issues.
Where will this research have the greatest impact?
With Philippe Géneréux as the principal investigator, we are conducting a clinical trial called PROGRESS that could change treatment protocols for the 2.5 million Americans with aortic stenosis — narrowing of the valve that prevents it from opening fully. Current guidelines recommend valve replacement only if the disease is severe; patients with moderate aortic stenosis are closely monitored by their cardiologists. However, people with moderate aortic stenosis can suffer irreversible heart damage, go into heart failure or die before the guidelines call for treatment. In our study, older adults with moderate aortic stenosis and signs of heart damage or dysfunction receive either standard care or transcatheter aortic valve replacement (TAVR), a minimally invasive FDA-approved procedure.
We have a second study, Early TAVR — also led by Géneréux, to evaluate TAVR in asymptomatic severe aortic stenosis. If TAVR proves to be the way to go in either study, that will result in new guidelines, allowing treatment sooner.
TAVR is a dynamic field. This past September, Géneréux’s Morristown Medical Center team was the first in the United States to use the new FDA-approved SavvyWire — the first sensor-guided TAVR that delivers the valve while also monitoring haemodynamic status.
Which SHD is a high priority for further investigation?
Mitral regurgitation — blood flowing the wrong way through the left heart chambers due to a leaky mitral valve — is top of the list. A few years ago, we did a first-in-human trial of a transcatheter mitral valve replacement device. Now there are more than 20 mitral valve replacement devices in clinical trials, but none has emerged as the clear winner.
There are two broad categories of mitral regurgitation: primary, when the valve itself is the problem; and secondary, when the valves can’t close because of another issue. These groups of patients are treated differently. I served as a principal investigator, our imaging team provided study review, and our structural heart team was one of the highest enrollers in CLASP IID, the first randomized clinical trial to directly compare two transcatheter edge-to-edge repair approaches for primary mitral regurgitation. Results from the trial were published in September and the FDA has approved a new device.
What role is imaging playing in the diagnosis and treatment of SHD?
Until very recently, imaging tools for right-sided heart diseases, such as tricuspid valve regurgitation, were not as well developed as those for left-side diseases. What’s more, imaging was mostly two-dimensional and exclusively with echocardiography. Now we have 3-D approaches with echo, cardiac CT and MRI to illuminate the structure and function of all four valves.
We are also actively exploring the use of AI, for example to help interpret cardiac images and spot areas of concern for cardiologists to review. We expect exponential growth in using AI and machine learning for faster, more accurate and earlier detection of dangerous heart conditions.
What’s ahead for Atlantic Health?
In April 2022, we began offering the first fellowship in the United States for hypertrophic cardiomyopathy (HCM) and sports cardiology, led by Matthew Martinez. HCM is a genetic condition that causes the heart walls to become abnormally thick, and is the leading cause of sudden death in athletes. It’s estimated to affect one in 500 people worldwide, 85% of whom are undiagnosed. There is only one FDA-approved drug to treat certain types of HCM, which must be administered in a tightly controlled environment. We are the only site in New Jersey authorized to administer it. We are also involved in several studies into new drugs for this disease. We see an increasingly important role for subspecialists trained in HCM and sports cardiology to assess the health of athletes. And, of course, we will continue our work in SHD, advanced heart failure and rhythm disorders.