TRILUMINATE Pivotal Trial: A New Dawn for Tricuspid Regurgitation Management?


Take Home Messages
  • Tricuspid regurgitation is prevalent, but isolated surgical interventions have been limited due to unsatisfactory outcomes.
  • The TRILUMINATE Pivotal trial is the first randomised trial comparing percutaneous tricuspid intervention against medical therapy.
  • The TRILUMINATE Pivotal trial showcases tricuspid TEER repair as a promising, effective and safe alternative.
  • Whilst promising, TRILUMINATE’s open-label nature and QoL driven results merit cautious interpretation.

In recent years, tricuspid valve (TV) disease has been under the spotlight.(1) The prevalence of tricuspid regurgitation (TR), primary and secondary, in the community increases with age, representing between 0.55% and 4% in the general population.(2)
Despite the high prevalence of severe TR and its association with poor prognosis, independent of biventricular function, (3) there are limited options with regards to TV interventions and surgeries. (2, 4) Current TR treatment guidelines indicate use of medical therapy to treat symptoms of systemic venous congestion.(5)

In part, this likely stems from previous studies which showed suboptimal outcomes with isolated TV surgeries and an associated 8% in-hospital mortality which increased to 37% for redo-surgeries.(6)

With the recent developments in transcatheter valve interventions and evolution of new devices, percutaneous TV intervention has become an attractive alternative to surgery but there is no evidence regarding its clinical efficacy at reducing mortality or heart failure (HF) hospitalisations in patients with severe symptomatic TR.

The TRILUMINATE PIVOTAL is the first randomised controlled trial (RCT) to evaluate the effectiveness and safety of tricuspid transcatheter edge-to-edge repair (TEER) in patients with symptomatic severe TR. (7).