Baptist Health Miami Cardiac & Vascular Institute First in Florida to Repair Heart Valve with Newly Approved Device

Baptist Health Miami Cardiac & Vascular Institute has taken a leading role in national clinical trials that have led to pivotal advances in treating or replacing heart valves. The Institute’s latest milestone involves the first procedure in Florida, and the sixth nationwide, to repair a defective heart valve – the tricuspid valve -- by implanting a new device just approved by the U.S. Food and Drug Administration (FDA).

An 86-year-old woman underwent the minimally invasive procedure at the Institute to clip together a portion of the leaflets – or flaps of tissue – of her tricuspid valve. The FDA-approved TriClip essentially prevents the severe and potentially deadly condition known as tricuspid regurgitation (TR) – which is when blood flow through the tricuspid valve leaks in the wrong direction.

The heart has four valves — the aortic, mitral, pulmonary and tricuspid — that enables blood to flow in the right direction. When at least one of them doesn’t open or close correctly, a person is diagnosed with heart valve disease. The tricuspid valve controls blood as it flows from the heart's right atrium to the right ventricle. TR occurs when the valve doesn't close properly, causing a leak and allowing blood to flow backward in the heart.

The first procedure in Florida with the TriClip was led by Ramon Quesada, M.D., director of Interventional & Structural Cardiac Innovations and director of Cardiac Research at the Institute. He explains that patients with TR are classified as having mild, moderate, severe, massive, or torrential TR.

Ramon Quesada, M.D., director of Interventional & Structural Cardiac Innovations and director of Cardiac Research at Baptist Health Miami Cardiac & Vascular Institute.

“The first procedure went beautifully,” said Dr. Quesada. “She had significant TR. Her condition went from massive to trace, which is near normal. The patient is doing great. She went home the following day and it was an excellent result.”

TriClip’s Minimally Invasive Procedure

Delivered through a vein in the leg, TriClip's TEER (Transcatheter edge-to-edge repair) technology works by clipping together a portion of the valve’s leaflets to repair the tricuspid valve and help restore proper blood flow. Most patients need only one day in the hospital before they recover and can return home.

“This procedure is definitely all catheter-based, meaning that it's minimally invasive,” said Dr. Quesada. “We go through the femoral vein, and then advance the clip and steer it down into the tricuspid valve in right atrium. And then we advance the TriClip below the valve, and then we secure it. All of that is guided by real-time imaging.”

TR can force the heart to work much harder, causing debilitating symptoms such as fatigue and shortness of breath. When left untreated, TR can lead to atrial fibrillation, the most common form of irregular heartbeat, heart failure, and ultimately, an early death. For those who continue to have symptoms or persistent TR -- despite drug therapies -- and are not considered good candidates for surgery. TriClip is likely the best option to improve the patient’s quality of life within days after the minimally invasive procedures, explains Dr. Quesada.

The Institute’s Leading Role in the TriClip Trial

Dr. Quesada and his team at Miami Cardiac & Vascular Institute took a leading role in the U.S. clinical trial that led to the FDA’s recent approval of the TriClip. The goal of the so-named Triluminate Trial was to determine the safety and effectiveness of the TriClip device in symptomatic patients with severe TR who were at “intermediate or greater estimated risk” if they undergo traditional tricuspid valve surgery.

The tricuspid is sometimes referred to as “the forgotten valve” because surgeons years ago had issues with its complexity, said Dr. Quesada. Before the development of such devices as the TriClip, the prevailing thought was to focus on mitral valve regurgitation..

Most patients previously were treated for mitral valve issues – but surgeons noticed that many of them also suffered from severe TR. Adds Dr. Quesada: “The mortality of those patients with severe insufficiency was significantly high.”

“The Triluminate trial came along when we knew we needed to have a device that is dedicated to the tricuspid valve. And that's why the TriClip device was designed, and we had a trial comparing it to approved medical therapy, which normally involves diuretics (blood thinners). The results of the trial were incredibly positive because the TriClip procedure improved the quality of life of the vast majority of patients.”

With the Institute’s involvement, the trial’s results were excellent. The TriClip’s minimally invasive procedure improved tricuspid regurgitation to moderate or less severity in 87 percent of patients. “Reduction in tricuspid regurgitation was associated with improvements in symptoms, functional status, and quality of life,” states the American College of Cardiology. 

The ‘Cutting Edge of Innovation’

“Clinical research is vital,” said Dr. Quesada. “The Institute prides itself on being a quality care center in cardiovascular care. Being part of the latest research and on the cutting edge of innovation is extremely important to provide the best care for our patients.”

For years, the Institute’s research team has taken part in numerous national trials that have advanced the use of devices and valve replacement, including a now common procedure to replace the aortic valve via a minimally invasive procedure called TAVR, or “transcatheter aortic valve replacement.”

The FDA previously approved the use of a separate device to repair the mitral valve -- the MitraClip -- to treat patients who have severe and difficult-to-treat heart failure. The PASCAL (Precision Transcatheter Valve Repair System) implant was approved in 2022. The implant clips the two flaps together to reduce MR, or the backflow of blood through the mitral valve. PASCAL is the latest implant to help patients with serious mitral valve issues.

“These innovations cannot happen without the research team effort at the Institute,” said Dr. Quesada. “This effort requires a lot of specialists. All these patients that were part of the Triluminate trial went through very rigorous investigation and protocols.”

Learn more about heart valve disease treatment, diagnosis, risk factors and symptoms.