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Institute First in Florida, 5th in Nation to Perform TriClip™ Procedure Following FDA Approval

Ramon Quesada, M.D., FACP, FAACN, FCSAI

Tricuspid regurgitation (TR) affects approximately 1.6 million Americans annually. However, treatment options for this difficult-to-reach valve have lagged behind those for other types of valve disease.

Now, doctors at Baptist Health Miami Cardiac & Vascular Institute are offering a newly approved device to treat TR. Called TriClip™ and manufactured by Abbott, the device — and the minimally invasive approach to placing it on the tricuspid valve — brings new hope to people with severe TR symptoms.

Ramon Quesada, M.D., FACP, FAACN, FCSAI, director of interventional and structural cardiac innovations and director of cardiac research for Baptist Health Miami Cardiac & Vascular Institute, has studied heart valve disease treatment options for the last 15 years. On April 12, just 10 days after approval by the Food and Drug Administration (FDA), he became the first in Florida and fifth in the nation to perform the TriClip procedure outside of a clinical trial.

“The tricuspid valve has been the ‘forgotten valve,’” Dr. Quesada says. “There’s long been a need for a device dedicated to tricuspid valve repair. TriClip is a new treatment option that can significantly improve the quality of life for people suffering from the fatigue, shortness of breath and swelling associated with TR.”

The procedure also can reduce patients’ reliance on certain medications, including diuretics.

How TriClip works

TriClip is a transcatheter edge-to-edge repair (TEER) system of the tricuspid valve.

During the TriClip procedure, surgeons use image guidance to thread a catheter through the femoral vein into the right atrium. They then advance the TriClip down to and below the tricuspid valve, maneuvering the device to grasp the valve and clip together its leaflets.

Who is eligible for TriClip?

TriClip is available to people with TR who don’t have reduced symptoms with medical therapy or those who cannot undergo open heart surgery.

To determine eligibility for TriClip, surgeons review a patient’s anatomy using imaging tests. They use these images to determine whether or not they can reach and grasp the tricuspid valve.

TriClip patients must be able to tolerate general anesthesia.

Because TR is often present in patients with mitral valve disease, Dr. Quesada says it is beneficial to evaluate people with mitral valve disease for tricuspid valve regurgitation.

“TR symptoms take time to develop,” Dr. Quesada says. “By the time they emerge, it could be too late to expect a good long-term outcome. It’s important that we detect TR early and consider repairing the tricuspid valve during other valve repair procedures.”

Turning research into therapies

Early research into mitral valve repair led to TriClip’s development. Baptist Health Miami Cardiac & Vascular Institute participated in the EVEREST trial, a study that resulted in the 2013 approval of a device to treat mitral valve regurgitation.

“We learned that patients who underwent mitral valve repair had worse outcomes when they also had severe tricuspid regurgitation,” Dr. Quesada says. “We knew we had to do something about the tricuspid valve, but we also knew how difficult it was for surgeons to access. So, we began studying the off-label use of mitral valve repair technologies to treat the tricuspid valve.”

Promising results from that work formed the foundation for the TRILUMINATE Pivotal trial — a worldwide study that led to the FDA’s approval of TriClip.

Dr. Quesada, also a clinical associate professor of medicine at the Herbert Wertheim School of Medicine at Florida International University, oversaw Baptist Health Miami Cardiac & Vascular Institute’s participation in TRILUMINATE Pivotal.

“This work has opened a whole new field for tricuspid valve repair,” Dr. Quesada says. “And this is just the first step. There’s more to come, which is great for patients and their quality of life.”

For more information visit Baptist Health Miami Cardiac & Vascular Institute.

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