Cedars-Sinai Interventionalists Have Performed More Than 100 Minimally Invasive Tricuspid Valve Replacements, Including the First After Recent FDA Approval

Physicians in the Smidt Heart Institute at Cedars-Sinai have achieved two significant firsts: completing the institute’s 100^th minimally invasive tricuspid valve replacement and performing the first-ever implantation of a new bioprosthetic tricuspid valve following its approval by the U.S. Food and Drug Administration (FDA).

The first 100 minimally invasive tricuspid procedures were done as part of the TRISCEND II clinical trial. The trial studied replacing a malfunctioning tricuspid valve with a bioprosthetic valve to treat patients with tricuspid regurgitation, a condition in which the heart’s tricuspid valve does not close tightly, causing blood to leak backward from the heart into the veins of the body.

The tricuspid valve has historically been the most challenging of the heart’s four valves to treat because of its location in the back of the heart.

“The Smidt Heart Institute is the only institution to have completed this many minimally invasive tricuspid valve replacement procedures, bringing extensive expertise and new options to patients impacted by tricuspid valve disease,” said Eduardo Marbán, MD, PhD, executive director of the Smidt Heart Institute and the Mark S. Siegel Family Foundation Distinguished Professor. “This impressive feat is a testament to our team’s skill in difficult-to-treat valvular conditions.”

Raj Makkar, MD, associate director of the Smidt Heart Institute and vice president of Cardiovascular Innovation and Intervention for Cedars-Sinai, was the principal investigator for the TRISCEND II trial at Cedars-Sinai.

During a minimally invasive tricuspid valve replacement procedure, an interventionalist threads a thin, flexible tube called a catheter through a vein to reach the tricuspid valve. Early results of the trial led to the FDA approving the Edwards EVOQUE Tricuspid Valve Replacement System to treat eligible patients with tricuspid regurgitation.

Makkar led the Smidt Heart Institute team that performed the first EVOQUE implantation following FDA approval and has the most extensive experience globally in this groundbreaking procedure.

“We are proud and humbled to be the first in the U.S. to have implanted the world’s first commercially available transcatheter tricuspid valve,” said Makkar, the Stephen R. Corday, MD, Chair in Interventional Cardiology. “It is moments like this that further our dedication, commitment and passion to the field of interventional cardiology.”

The heart has four valves (aortic, mitral, pulmonic, and tricuspid) that open and close to move blood through the heart and to the rest of the body. If a valve cannot open or close fully it can interfere with blood flow and cause a host of health issues, including heart attack and stroke.

Moderate and severe tricuspid disease is common in the U.S. and affects an estimated 1.6 million people. Some people can manage their valvular heart disease with medications, but others need to have the damaged valve repaired or replaced.

The tricuspid valve is typically replaced during open-heart surgery. In contrast, the catheter-based approach used at Cedars-Sinai involves a tiny incision and patients typically go home the same day.

"The transcatheter tricuspid valve replacement system is a game-changer for patients with tricuspid regurgitation, a condition that has traditionally been overlooked," said Christine M. Albert, MD, MPH, chair of the Department of Cardiology in the Smidt Heart Institute at Cedars-Sinai. “We are proud to be the center with the most experience in transcatheter tricuspid valve replacement, demonstrating our commitment to pioneering new treatments and expanding options for those impacted by tricuspid valve disease.”

For more information, please email heartinstitute@cshs.org