Two Florida hospitals are pioneering innovative, minimally invasive treatments for patients suffering from severe tricuspid regurgitation, offering new hope for those previously considered too high-risk for traditional surgical interventions.
Breakthrough Valve Treatments for High-Risk Cardiac Patients
Sarasota Memorial Hospital (SMH) has become one of the first medical centers in the country to implement the newly FDA-approved Evoque Tricuspid Valve Replacement System, while Tampa General Hospital (TGH) recently completed Florida's first TricValve procedure under an FDA Early Feasibility Study.
These developments represent significant advancements for the estimated 1.6 million Americans diagnosed with tricuspid regurgitation, a condition where the tricuspid valve fails to close properly, allowing blood to flow backward into the right atrium. If left untreated, this condition can lead to serious complications including heart failure, pulmonary hypertension, arrhythmias, and liver dysfunction.
Evoque System at Sarasota Memorial Hospital
SMH's heart team, led by interventional cardiologists Drs. Ricardo Yayura, Jeffrey Rossi, and Fabio Lima, has successfully performed transcatheter tricuspid valve replacements (TTVR) on four patients who were considered too high-risk for surgical repair due to age or cardiac anatomy.
"We are very excited to bring this new treatment – and new hope – to people living with serious tricuspid regurgitation in our community," said Dr. Yaryura, medical director of Sarasota Memorial's cardiac catheterization team. "In the past, all we could do for people with severe leakage who were too high risk for surgery was manage their symptoms with medications. But medications often are not enough and over time, the condition can worsen and lead to heart failure or other life-threatening complications."
The Evoque system, developed by Edwards Lifesciences, is the world's first and only approved TTVR system. It received FDA approval in 2024, with the U.S. Centers for Medicare & Medicaid approving reimbursement in March.
Dr. Rossi highlighted the procedure's advantages: "The Evoque TTVR system is a less invasive option that does not require open heart surgery. The procedure typically takes two hours, and most patients recover quickly and are discharged home within two to three days, with significant improvement in symptoms and quality of life."
Patient Success Story
For 94-year-old Bob Fernander, the timing of the FDA approval was life-changing. After suffering from worsening tricuspid regurgitation that severely limited his daily activities and ability to travel, he became SMH's first recipient of the Evoque valve in January.
"I noticed a dramatic difference in just a few days," Fernander reported. "For the first time in a long while, I felt normal." Previously unable to walk ten steps without needing to rest, he has now enrolled in cardiac rehabilitation and is planning several trips, including attending his granddaughter's wedding and a cruise.
TricValve System at Tampa General Hospital
Meanwhile, at Tampa General Hospital, Dr. Hiram Bezerra, director of the TGH Minimally Invasive Valve program, and Dr. Fadi Matar, Interventional Heart Failure program director, completed Florida's first procedure under the FDA Early Feasibility Study for the TricValve System in April 2025.
This procedure is part of the TRICAV 1 clinical study, which aims to evaluate the safety and effectiveness of the TricValve System for patients with severe tricuspid regurgitation who are deemed unsuitable for surgery.
"Cardiac disease remains the leading cause of death in America, with severe tricuspid regurgitation representing a significant, unmet medical need," Dr. Bezerra explained. "Tampa General is committed to constant innovation and assessment of therapeutic options that may provide a benefit over current standard of care treatments for our patients."
How the Procedures Work
Both innovative treatments utilize a catheter-based approach. For the Evoque system, doctors insert a catheter with the valve attached into the femoral vein in the groin area, then guide it through blood vessels until it reaches the diseased tricuspid valve.
The TricValve System takes a slightly different approach, implanting a novel bicaval valve system into the inferior and superior venae cavae (IVC, SVC), the two large veins by which blood returns to the heart's right atrium. This technique reduces the backward blood flow inherent in severe tricuspid regurgitation.
Advancing Cardiac Care Through Research
Tampa General has performed seven TricValve procedures since 2022 under the compassionate use pathway, the highest number for any medical system in the U.S. This work has been supported by the McKibbon Family's donation to the Interventional Cardiology Center of Excellence's Minimally Invasive Valve Program.
Dr. Matar noted, "Tampa General's Heart and Vascular Institute provides world class cardiac care, from simple procedures to groundbreaking interventions, to the Tampa community and beyond. We are grateful for the support of donors who allow us to pursue this work, and proud of our talented team members and world class facilities."
Future Implications
These advancements represent a significant shift in treatment options for patients with tricuspid regurgitation, particularly those who previously had limited or no options due to their high surgical risk. As these technologies continue to develop and gain broader approval, they may transform the standard of care for this challenging cardiac condition.
For the thousands of patients suffering from severe tricuspid regurgitation, these minimally invasive valve treatments offer not just medical improvement but a renewed quality of life—the ability to travel, exercise, and engage in daily activities without the debilitating symptoms that previously limited their lives.
