Two Clinical Trials, Two Heart Valves

LOS ANGELES (Feb. 26, 2021) — Lisa Stewart doesn’t dwell on the fact that she might be the first in the nation to undergo both mitral and tricuspid valve replacement procedures. She’s too busy counting her blessings.

“Life before and after my procedures is as different as night and day,” Stewart said. “I can walk up stairs. I no longer have to sleep sitting upright and I have newfound energy and zest for each day. I have so much hope now.”

The retired critical care nurse, 61, first came to the Smidt Heart Institute in 2018 for the treatment of mitral valve stenosis, which was also coupled with several other ailments like advanced multiorgan dysfunction. Her collective conditions put her at too high of risk to undergo open heart surgery.

Instead, interventional cardiologist Raj Makkar, MD, vice president of Cardiovascular Innovation and Intervention for Cedars-Sinai and a professor of Cardiology, informed Stewart about a clinical trial involving a transcatheter mitral valve replacement.

“The clinical trial was the best and most promising option for Lisa, who at the time was experiencing poor quality of life and several serious health conditions,” said Makkar.

Her mitral valve was fixed, and Stewart felt better, but then, in 2020, she was diagnosed with right-side heart failure due to severe tricuspid regurgitation. Regurgitation is caused when a valve doesn’t open and close properly, causing blood to build up, which can cause life-threatening conditions like blood clots and heart attack.

To treat it, Stewart enrolled in a second Makkar-led clinical trial and underwent a successful transcatheter tricuspid valve replacement by Makkar.

“Our default philosophy is that no patient is too sick or too complex to merit comprehensive evaluation, treatment and care,” said Makkar. “We have successfully addressed the needs of more than 80% of patients rejected for surgery or intervention elsewhere, adding years to life and life to years.”

World Leader in Complex Heart Valve Fixes 

The Smidt Heart Institute is a world leader in complex heart valve repairs and replacements.

In fact, Cedars-Sinai has performed more transcatheter aortic valve replacements and mitral valve repairs than any other center in the U.S., with outcomes that place Cedars-Sinai among the top-performing programs nationally. It is also one of just a handful of centers in the U.S. that has expertise in minimally invasive, catheter-based procedures for all four heart valves.

While many U.S. medical centers have aortic and mitral valve programs, Cedars-Sinai is one of the few that regularly treats the pulmonary and tricuspid valves, which are located near the back of the heart and are therefore more difficult to reach during a catheter-based procedure.

“We have the unique ability to offer every patient the best of surgical and transcatheter valve reconstruction, absolutely cutting-edge technology, clinical trials and state-of-the-art imaging, surveillance and genetic counseling,” said Eduardo Marbán, MD, PhD, executive director of the Smidt Heart Institute and the Mark S. Siegel Family Foundation Distinguished Professor.

Transcatheter valve procedures are transforming the landscape of care for patients with leaky valves and conditions like heart failure, especially for older and sicker patients who are best helped without open-heart surgery.

“A short decade ago, interventional cardiologists like myself could only treat an aortic valve,” said Makkar, the Stephen R. Corday, MD Chair in Interventional Cardiology. “But today, science at Cedars-Sinai has advanced in such an expedited way that we can successfully treat any valve need, for any patient.”

For Stewart, this expertise, and her choice to enroll in two clinical trials, changed the course of her life—not only extending it, but by improving her overall quality of life.

“I am the data,” said Stewart, when speaking about her participation in clinical research. “Without these innovative clinical trials and procedures, I wouldn’t be here today. I’m grateful to have been part of these life-changing opportunities and thank God each day for the blessings my Cedars-Sinai care teams have given me.”

Read more from the Cedars-Sinai Blog: Options in Treating Mitral Valve Disease