Patients with a poorly functioning tricuspid heart valve who received the best available medical therapy and underwent a minimally invasive procedure to repair the valve with a clip were 28% less likely to be hospitalized for recurrent heart failure after two years than similar patients who received medical therapy alone, according to recent study data.

“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, M.D., program director for cardiovascular disease fellowship at Los Robles Health System in California, National Physician Leader, Interventional Cardiology, HCA Healthcare USA and the study’s first author. “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.”

One of four heart valves, the tricuspid valve controls 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 leaks, allowing blood to flow back into the right atrium. When this occurs, the heart must work harder to pump blood effectively. Patients with severe tricuspid regurgitation frequently have symptoms such as severe fatigue and shortness of breath, an enlarged liver, kidney failure, and fluid accumulation in the abdomen, legs, ankles or feet.

The best available medical therapy for tricuspid regurgitation currently is diuretic medications that reduce fluid buildup in the body but often do not directly treat the blood leaking through the tricuspid valve, Kar said.

The TRILUMINATE Pivotal trial was designed to determine whether patients at intermediate or greater risk for complications from tricuspid valve surgery would benefit from medical therapy plus TEER using a TriClip device, a minimally invasive procedure in which a catheter (a long flexible tube) is used to place one or more tiny clips on the tricuspid valve leaflets to prevent blood from leaking back into the right atrium.

In this randomized controlled trial, patients were randomly assigned to receive TEER and medical therapy or medical therapy alone. Patients deemed highly likely to achieve a reduction in tricuspid regurgitation to moderate or less were enrolled. The study reports two-year follow-up results.

Five hundred seventy-two patients (mean age 78 years, 60% women) in five countries (United States, Canada, Germany, Italy, and Spain) were enrolled in the randomized trial. All patients had severe tricuspid regurgitation; 55.1% had severe heart failure symptoms despite receiving the best available medical therapy; 50% had tricuspid regurgitation rated as “torrential” (the highest level of severity on a five-level scale); and 23.8% had been hospitalized for heart failure within the previous year.

All patients continued to take their medications for tricuspid regurgitation and heart failure while enrolled in the study. A central selection committee of heart specialists supervised the patients’ medical treatment and confirmed that it was appropriate, Kar said. Half the patients (the TEER group) were randomly assigned to have the TriClip device placed in the tricuspid valve. The other half did not undergo this procedure and served as a control group.

The study’s primary endpoint was a composite of death from any cause or tricuspid valve surgery, hospitalization for heart failure, and quality of life improvement at one year. Two-year secondary endpoints were recurrent hospitalizations for heart failure and freedom from death due to any cause or the need for tricuspid valve surgery or another valve repair procedure.

At two years, 77.6% of TEER group patients were alive and free from the need for tricuspid valve surgery or another valve repair procedure, compared with 29.3% of control patients. This difference was driven by many of the control patients “crossing over” to receive TriClip treatment once eligible after one year of follow up and if their symptoms remained severe, Karr said. At the two-year analysis, 60% of control patients had crossed over and been treated with the TriClip device,

The rate of recurrent hospitalizations for heart failure per patient each year was 0.19 for TEER group patients, compared with 0.26 in the control group. This difference was statistically significant and associated with a 28% reduction in the risk of recurrent hospitalization for heart failure at two years for patients who received the TriClip compared with controls, Kar said.

The number of patient deaths and the number of patients who needed tricuspid valve surgery during the two-year follow-up period was similar in both groups. No TEER group patients experienced blood clots or needed treatment with blood-thinning medications specifically due to the device, Kar said. At two years, tricuspid regurgitation severity was moderate or less for 84% of TEER group patients, compared with 21% in the control group that remained on medical therapy alone.

The patients will be followed for a total of five years to evaluate the continued effectiveness, safety and durability of the TEER device, he said.

A limitation of the study is that it was unblinded, meaning both patients and their clinicians knew who had received TEER and who had not, Kar said. However, experts independent of the study sponsor assessed the hospitalizations, deaths and other adverse events that occurred in the study. In addition, the study findings are limited to patients with tricuspid regurgitation features deemed more amenable to a reduction in regurgitation to moderate or less.

The study was funded by Abbott, the TriClip device manufacturer. The company also participated in site selection, trial management, and data collection and analyses.

This study appears online in Circulation.