Credit: Original article published here.
TRILUMINATE Pivotal trial 12-month outcomes showed significant improvement in quality of life with tricuspid transcatheter edge-to-edge repair (T-TEER) in patients deemed to have intermediate-high risk for surgery. The results of this first randomized controlled trial that was conducted in such a population were also remarkable with the favorable safety profile of this device.
Tricuspid regurgitation (TR) is a prevalent condition that is associated with increased mortality and poor quality-of-life. While the optimal timing of intervention and best strategy remain unclear, many individuals benefit from conservative management with diuresis along with treatment of contributing underlying factors. The importance of a multidisciplinary team discussion is crucial for assessment of need for surgical and transcatheter interventions in patients with refractory TR despite optimal medical therapy.
The 2023 American College of Cardiology Scientific Sessions highlighted the full gamut of emerging interventions such as edge-to-edge repair, spacer, coronary sinus cinch, annuloplasty, direct annular plication and transcatheter valve replacement. Despite this growing interest and novel strategies, lack of randomized-controlled trials that study their benefits continues to be an issue.
With this backdrop, the 12-month outcomes of TRILUMINATE Pivotal trial were presented at ACC23. TRILUMINATE Pivotal trial is a randomized clinical trial that evaluates tricuspid transcatheter edge-to-edge repair (T-TEER) with the TriClip Transcatheter Tricuspid Valve Repair system (Abbott Structural Heart) in patients with severe symptomatic TR who are at intermediate to high risk for surgery. According to study results, in 87% of patients who underwent TriClip therapy, TR was reduced to moderate or less. While there was no significant difference in mortality and heart failure hospitalizations, there was significant improvement in quality of life in the device arm. Interestingly, improvement in quality of life was associated with improvement of TR severity to moderate or less. 30-day major adverse event rate was reported as 1.7% with cardiovascular mortality rate of 0.6% which suggests a reassuring safety profile.
Late-breaking Clinical Trials Deep Dive Session at ACC23 featured the TRILUMINATE Pivotal trial. In his talk, Dr. Patrick O’Gara highlighted the favorable safety profile and consistency of the results with 6-month and 12-month outcomes of prior single arm studies. He also drew attention to the carefully selected patient population through a committee that predicted which patient would benefit most from the intervention and posed the question if this population was generalizable. Moreover, including the quality of life in the primary end-points of the study as a patient measured outcome brought up the concern for confounding by placebo effect.
Overall, the trial fell short of proving benefit for hard clinical end-points of mortality and heart failure although a longer term follow-up will be helpful to adjudicate chronic effects of T-TEER therapy. Still, improving quality of life is an important patient-centered goal that serves as the main target for many accepted procedures. As demonstrated by sham-controlled trials like ORBITA for coronary interventions in stable angina, there is potential for a potent positive placebo effect on subjective outcomes just by virtue of performing a procedure. While the open-label nature of TRILUMINATE Pivotal trial lends itself vulnerable to such a placebo effect for a subjective quality of life outcome, a dose response relationship between the degree of quality of life improvement and extent of TR improvement likely indicates a true symptomatic benefit.
ACC23 hosted compelling discussions about the historically ‘forgotten’ or ‘not studied’ valve. With the promising results of TRILUMINATE Pivotal trial, there seems to be an exciting acceleration in evidence-based data about transcatheter interventions of the tricuspid valve on the horizon.
Dr. Nazli Okumus is a cardiology fellow at Allegheny Health Network and served as a CardioNerds Conference Scholar for the American College of Cardiology 2023 Scientific Sessions.
