If you or a loved one has been diagnosed with severe tricuspid regurgitation (TR)—a condition where the heart’s right-sided valve doesn’t close properly, causing blood to flow backward — you know the fatigue, swelling, and breathlessness that define the disease. For decades, the options were limited to medical management or high-risk open-heart surgery.
Ramon Quesada, M.D.,
Today, thanks to revolutionary minimally invasive procedures, that outlook is changing dramatically. Baptist Health Miami Cardiac & Vascular Institute has again reinforced its role as a national leader in this transformation, being one of the first health systems in Florida to offer both of the cutting-edge technologies approved by the U.S. Food and Drug Administration (FDA) that are reshaping how this complex condition is treated.
Baptist Health provides both tricuspid valve treatment and replacement options: the T-TEER repair procedure (using the TriClip device studied extensively by the Institute in the TRILUMINATE trial) and the T-TVR replacement procedure (using the recently FDA-approved Evoque system).
Miami Cardiac & Vascular Institute was part of the T-TEER trial and registry before FDA approval, and was one of the top five U.S. health centers that was presented as part of “late breaking trials” at TCT 2025 (Transcatheter Cardiovascular Therapeutics), a major conference for interventional cardiology held in October in San Francisco.
The Institute has performed hundreds of tricuspid valve repairs. Moreover, since January of this year the Institute completed three tricuspid valve replacements using the Evoque system – and all three patients are over the age of 85 and doing very well. This unique position provides patients in the region with a rare range of minimally invasive treatment options tailored to their specific needs.
“We were one of the first in this space of tricuspid valve interventions in Florida,” explains Ramon Quesada, M.D., director of Interventional & Structural Cardiac Innovations and director of Cardiac Research at Baptist Health Miami Cardiac & Vascular Institute. “We started nearly nine years ago with tricuspid valve repair with the TriClip device. ”
The Problem with the ‘Forgotten Valve’
The tricuspid valve, often called the "forgotten valve" because research has historically focused on the left side of the heart, plays a crucial role in regulating blood flow. When it leaks severely, the right side of the heart struggles, leading to fluid buildup in the abdomen and legs and frequent hospitalizations for heart failure. The standard medical treatments could manage symptoms, but not fix the underlying structural problem.
Now, two distinct minimally invasive solutions exist: Transcatheter Tricuspid Edge-to-Edge Repair (T-TEER) and Transcatheter Tricuspid Valve Replacement (T-TVR). The team at the Institute has been at the forefront of both, thanks to a commitment to research and innovation led by physicians such as Dr. Quesada.
“You have to be really selective, because the enemy is in the details,” explains Dr. Quesada. “We have to plan properly. We have very exhaustive evaluation with a multidisciplinary approach on all ends. And that makes the success of this therapy reproducible — and helps more patients.”
Pioneering Repair: The TRILUMINATE Trial and the TriClip Device
Baptist Health South Florida’s initial involvement in bringing these therapies to market began with the rigorous clinical trials that paved the way for FDA approval.
Dr. Quesada served as a key principal investigator for the U.S. arm of the pivotal TRILUMINATE trial.
This landmark trial evaluated the safety and effectiveness of the TriClip device — a technology designed to repair the native tricuspid valve without surgery. During a T-TEER procedure, doctors guide a thin tube (catheter) through a vein in the leg to the heart. A small clip is then used to grasp the edges of the leaking valve leaflets, helping them close more tightly and reducing the backflow of blood.
The results from the TRILUMINATE trial were impressive. The latest long-term data (up to three years) confirm that the procedure is not only safe but provides lasting benefits. Patients experienced significant improvements in their quality of life, increased physical capacity (measured by how far they could walk), and critically, a 28 percent reduction in the rate of hospitalizations for heart failure compared to medication alone.
Miami Cardiac & Vascular Institute’s participation in this foundational trial meant that patients in South Florida had early access to this life-changing technology, long before it was commercially available nationwide.
The Next Frontier: T-TVR and the Evoque System
While T-TEER is an excellent option for many patients, it is not suitable for everyone, particularly those with highly complex or damaged valve anatomy. The next leap forward came with T-TVR, the complete replacement of the valve via catheter.
This therapy was studied in the separate TRISCEND II trial, which led to the FDA approval of the Evoque TTVR system. In January 2025, Baptist Health became one of the first centers in the nation to commercially implant the Evoque valve after its approval.
This achievement highlights a significant milestone: Baptist Health is one of a few health systems in Florida equipped to offer the full spectrum of advanced tricuspid valve interventions.
The Advantage of Choice: Tailored Treatment Plans
The true benefit for the patient lies in having both T-TEER (TriClip) and T-TVR (Evoque) available under one roof at Miami Cardiac & Vascular Institute.
"Having these two innovative tools allows us to provide a comprehensive, patient-centered approach," notes Dr. Quesada. "Not every patient is a candidate for repair, and not every patient is a candidate for replacement. Our expertise gained through years of clinical trials means we can precisely match the right technology to the individual patient’s anatomy and condition."
This ability to tailor treatment plans ensures that physicians can select the procedure that offers the best possible outcome for each unique case, maximizing effectiveness and minimizing risk.
For patients suffering from the debilitating effects of severe tricuspid regurgitation, the progress in minimally invasive heart valve therapies represents a new chapter in cardiac care. Through their leading role in national clinical trials and rapid adoption of cutting-edge technology, Dr. Quesada and the Miami Cardiac & Vascular Institute teams are solidifying their reputation as pioneers.
“The most important thing is to be on the cutting edge of technology through clinical research and to be able to help our patients,” Dr. Quesada said.