Outcome of Patients With Severe Functional TR According to Medical, Transcatheter or Surgical Treatment - Trial NCT05825898

Timeline & Enrollment

Primary Outcome

Survival at 2 years

Summary

Tricuspid regurgitation (TR) is a public health problem: moderate / severe TR are common,
 especially in ageing populations, and affect 4% of the population 75 years old, totaling
 approximately 1.6 million in the US and 3 million in Europe. TR is associated with an
 increased risk of mortality and morbidity. Contrasting with TR prevalence and the magnitude
 of the problem, the vast majority of patients are medically treated with diuretics to relieve
 their symptoms and a curative surgical treatment for isolated severe TR is seldom performed.
 Reluctance to perform an ITVS can be explained in the one hand by the limited evidence that
 TR correction improves outcomes and on the other hand, ITVS is associated to high observed
 in-hospital mortality rates (≈ 10% remarkably consistent in most series across the
 literature). Severity of the clinical presentation is the main predictor of outcome after
 surgery. The TRI-SCORE, is a dedicated, simple and accurate risk score model to predict
 in-hospital mortality after ITVS that could guide the clinical decision-making process at the
 individual level. Excellent outcomes can be achieved when patients present with low
 TRI-SCORE. These results suggest adopting a more pro-active approach for TV interventions,
 and to intervene earlier in the course of the disease in patients with severe isolated TR,
 irrespective of TR mechanism / etiology, before the occurrence of advanced / irreversible
 consequences such as severe RV dilatation / dysfunction, renal and liver failure, and
 intractable heart failure. Recently transcatheter tricuspid valve interventions (TTVI) have
 emerged recently as a less invasive option to surgery to cure patients with TR.
 
 What is the best treatment between medical, surgical or transcatheter therapy to consider and
 the best timing for each patient are not clearly defined. The aim of the study is to compare
 outcome of patients with significant functional TR according to medical, transcatheter or
 surgical treatment after matching per TRISCORE.

ICD-10 Classifications