Spotlight on Advancements in Mitral Valve Repair, Research

You may not know Carol Barr, but in the future, she could save your life. 

Barr’s death at 39 from sudden cardiac arrest was caused by mitral valve prolapse—a heart valve defect that can affect the heart’s ability to pump blood. It can, in some cases, lead to death. 

Now, thanks to the cardiovascular advances in research and Opportunities Legacy (CAROL) Act—legislation named in honor of Barr that allocates funding through the National Heart, Lung, and Blood Institute to study heart valve disease and risk factors that may lead to sudden cardiac arrest—the lives of millions of Americans with the condition could be saved. 

The Smidt Heart Institute recently received CAROL Act funding to study the connection between ventricular arrhythmias—abnormal heartbeats that start in the heart’s two lower chambers—and an elevated risk of sudden cardiac death in patients with mitral valve disease. 

This sub-study of the National Institutes of Health-sponsored PRIMARY clinical trial is led by Smidt Heart Institute cardiologist and Chair of the Department of Cardiology Christine Albert, MD, MPH. Albert, the Lee and Harold Kapelovitz Distinguished Chair in Cardiology at the Smidt Heart Institute and past president of the Heart Rhythm Society, is noted for her pioneering contributions to cardiac electrophysiology research. 

The PRIMARY trial is directed by Joanna Chikwe, MD, chair of the Department of Cardiac Surgery at Cedars-Sinai. The randomized trial--across 60 sites in six countries--compares transcatheter edge-to-edge mitral repair (using a clip) to surgical repair for patients with severe mitral regurgitation caused by mitral valve prolapse. 

The PRIMARY trial is co-chaired by interventional cardiologist Raj Makkar, MD, Cedars-Sinai’s vice president of Cardiovascular Innovation and Intervention, associate director of the Smidt Heart Institute and a professor of Cardiology in the Department of Cardiology. 

To kick off Heart Month, the Cedars-Sinai Newsroom sat down with Chikwe and Makkar--experts in robotic and minimally invasive surgical techniques and transcatheter edge-to-edge repair--to discuss mitral valve disease and advancements in treatment approaches.   

What should we know about mitral valve disease and treatment? 

Chikwe: The symptoms—rapid heartbeat, fatigue, cough and shortness of breath—are subtle and can be difficult to detect. Many patients don’t have any symptoms and have no idea there is a problem with their heart. The condition is often discovered when physicians pick up on a heart murmur during a routine physical exam or when the patient is receiving care for something else. Untreated, it can sometimes lead to sudden and unexpected death, as was the case with Carol Barr. In the past, heart surgeons corrected a faulty mitral valve by replacing it with an artificial one during open-heart surgery. But today, we can repair, rather than replace, the valve through minimally invasive, low-risk, extremely safe and effective surgery or by using a clip.  

What makes the Smidt Heart Institute’s mitral valve program unique? 

Chikwe: We combine the highest levels of surgical, nonsurgical and imaging expertise available in the U.S. Few centers are strong in both surgery and transcatheter repair, and very few match our level of experience and results with transcatheter and robotic mitral repair. Patients come to us from all over the U.S. and overseas for our expertise. 

Makkar: Also, patients have earlier access to the most innovative treatments because we are often leading clinical trials and using new devices and novel approaches. We treat the most complex patient cases. And we help people who have had misdiagnoses elsewhere or who may have been told they needed a different procedure than we might recommend. We can help inform the patient’s decision-making by presenting all their options and discussing what might work best for them. This individualized approach is unique. 

What excites you about the future of heart valve disease study? 

Makkar: The PRIMARY trial is very exciting. Because the mitral valve represents a challenging frontier between surgical and nonsurgical treatment options, I believe the results, whichever way the evidence shows, will transform patient care. If a transcatheter approach turns out to be better for patients long term, that might give another option to patients who currently don’t have access to it. Alternatively, trial results may demonstrate that minimally invasive surgery is by far the safest and most effective way to treat mitral valve prolapse. 

Chikwe: I completely agree with Dr. Makkar around excitement about the PRIMARY trial’s potential to transform future mitral valve patient care. He mentioned that it is essential for a discussion between the heart team and a patient deciding between surgery or interventional approaches. We need randomized clinical trials with robust evidence to help us better inform these important decisions. 

What does it mean for the PRIMARY trial to receive additional funding as a result of the CAROL Act? 

Chikwe: It reflects Cedars-Sinai’s unique expertise in arrhythmia management, imaging and treatment for mitral valve conditions. To be at the forefront of an effort to get to the bottom of why people with mitral prolapse may die suddenly and unexpectedly, even when they’re quite young, as Carol Barr was, is particularly impactful. Without the additional funding, we wouldn’t have the opportunity to better understand how to identify people at high risk of mitral valve disease and how to help prevent a potentially catastrophic outcome.   

Makkar: Cedars-Sinai’s pioneering mitral valve program has been further validated thanks to this additional funding, and that is significant. Although the CAROL Act was born from tragedy, our goal is to prevent similar tragedies in the future through new discoveries that could one day improve outcomes for many people, perhaps even beyond those with mitral prolapse.