Minimally Invasive Valve Repair Reduces Hospitalizations in Severe Tricuspid Regurgitation Patients
Posted on 01 Apr 2025
The tricuspid valve is one of the four heart valves, responsible for regulating blood flow from the right atrium (the heart's upper-right chamber) to the right ventricle (the lower-right chamber). Tricuspid regurgitation occurs when the valve fails to close properly, causing blood to flow backward into the right atrium. This forces the heart to work harder to pump blood efficiently. Individuals with severe tricuspid regurgitation often experience symptoms like fatigue, shortness of breath, liver enlargement, kidney failure, and fluid buildup in areas such as the abdomen, legs, ankles, or feet. Currently, the most effective treatment for this condition is diuretic medications, which help reduce fluid accumulation but do not directly address the mechanical leakage of blood through the valve. A new study has revealed that patients with a poorly functioning tricuspid valve who received the best available medical therapy alongside a minimally invasive procedure using a clip to repair the valve had a 28% lower likelihood of being hospitalized for recurrent heart failure compared to patients who were initially treated with medical therapy alone.
The TRILUMINATE Pivotal trial aimed to determine whether patients at intermediate or higher risk for complications from tricuspid valve surgery would benefit from adding transcatheter edge-to-edge repair (TEER) using the TriClip device made by Abbott (Abbott Park, IL, USA). This minimally invasive procedure involves using a catheter (a flexible tube) to place one or more small clips on the tricuspid valve leaflets to prevent blood from leaking into the right atrium. In the randomized controlled trial, patients were randomly assigned to receive either the TEER procedure and medical therapy or medical therapy alone. The study enrolled patients who were highly likely to experience a reduction in tricuspid regurgitation to a moderate level or less. The two-year follow-up results of this study have been published. A total of 572 patients (mean age 78 years, 60% women) from five countries (United States, Canada, Germany, Italy, and Spain) were included in the study. All participants had severe tricuspid regurgitation, with 55.1% suffering from severe heart failure symptoms despite receiving optimal medical therapy, 50% showing "torrential" tricuspid regurgitation (the highest severity), and 23.8% having been hospitalized for heart failure in the previous year.
Throughout the study, all patients continued their prescribed medications for tricuspid regurgitation and heart failure, with a central committee of heart specialists overseeing their treatment to ensure its appropriateness. Half of the participants (the TEER group) were randomly assigned to receive the TriClip device, while the other half (the control group) did not undergo the procedure. The primary endpoint of the study was a composite of death from any cause, tricuspid valve surgery, hospitalization for heart failure, and quality of life improvement at one year. Secondary endpoints at two years included recurrent hospitalizations for heart failure and freedom from death or the need for tricuspid valve surgery or another valve-repair procedure. At the two-year mark, 77.6% of the patients in the TEER group were alive and free from the need for tricuspid valve surgery or another valve-repair procedure, compared to 29.3% of the control patients. This difference was primarily due to the control patients "crossing over" to receive the TriClip treatment after one year, if their symptoms remained severe. By the two-year analysis, 60% of the control group had crossed over to receive the TriClip device.
The annual rate of recurrent heart failure hospitalizations was 0.19 per patient in the TEER group, compared to 0.26 in the control group. This difference was statistically significant, representing a 28% reduction in the risk of recurrent heart failure hospitalization for patients receiving the TriClip compared to the controls. The number of deaths and the number of patients requiring tricuspid valve surgery during the two-year period were similar between both groups. Additionally, no patients in the TEER group experienced blood clots or required blood-thinning medication due to the device. By the end of the two-year follow-up, 84% of patients in the TEER group had their tricuspid regurgitation reduced to moderate or less severity, compared to just 21% in the control group who remained on medical therapy alone. Patients will continue to be monitored for a total of five years to assess the long-term effectiveness, safety, and durability of the TEER device. The study was presented at the American College of Cardiology’s Annual Scientific Session (ACC.25) and was also simultaneously published in Circulation.
“At two years, transcatheter edge-to-edge repair (TEER) for the treatment of symptomatic, severe tricuspid regurgitation appears to be safe, significantly reduced symptom severity and decreased the rate of recurrent hospitalization for heart failure compared with medical therapy alone,” said Saibal Kar, MD, program director for cardiovascular disease fellowship at Los Robles Health System in California, National Physician Leader, Interventional Cardiology, HCA Healthcare USA and first author of the study. “This is the first and largest prospective randomized controlled trial to compare transcatheter device therapy plus medical therapy with medical therapy alone for severe tricuspid regurgitation, and these results represent the longest follow-up to date.”
