Minimally invasive valve repair reduces heart failure hospitalizations in patients with severe tricuspid regurgitation: Study

At two years of follow-up, patients with a poorly functioning tricuspid valve in the heart who received the best available medical therapy plus a minimally invasive procedure using a clip to repair the valve were 28% less likely to be hospitalized for recurrent heart failure than similar patients who were initially randomly assigned to medical therapy alone. The study was presented at the American College of Cardiology’s Annual Scientific Session (ACC.25).

“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,” Kar said.

The tricuspid valve, one of four valves in the heart, 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 happens, the heart has to 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.

Currently, the best available medical therapy for tricuspid regurgitation is diuretic medications that reduce fluid buildup in the body but often do not directly treat the mechanical leakage of blood 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 current study reports two-year follow-up results.

A total of 572 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 in the study. A central selection committee of heart specialists oversaw the patients’ medical treatment and confirmed that it was appropriate, Kar said. Half of 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 patients in the TEER group 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 patients in the TEER group, 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 patients in the TEER group 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 the patients in the TEER group, 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.

Reference:

Minimally invasive valve repair reduces heart failure hospitalizations in patients with severe tricuspid regurgitation, American College of Cardiology, Meeting:American College of Cardiology's Annual Scientific Session.