Tricuspid Transcatheter Edge-to-Edge Repair Plus Optimized Medical Therapy efficacious in Severe Symptomatic Tricuspid Regurgitation: Study

Individuals with tricuspid
regurgitation often experience reduced quality of life and poor survival rates
due to decreased cardiac output and frequent manifestations of heart failure.
Owing to the history of regurgitation, surgery is rarely performed, which
leaves the option of medical management. Previous research has shown that
Tricuspid transcatheter edge-to-edge repair (T-TEER) has emerged as a safe and
effective therapy for reducing tricuspid regurgitation. As it has demonstrated
the benefits of lowering the regurgitation rates and improving quality of life,
researchers from France conducted a study to evaluate T-TEER combined with
optimized medical therapy (OMT) vs OMT alone in patients with severe,
symptomatic tricuspid regurgitation.

An investigator-initiated
prospective, randomized clinical trial was carried out at 24 centers in France
and Belgium. Patients were randomized 1:1 to receive T-TEER + OMT or OMT alone.
The primary outcome was a composite clinical endpoint at 1 year comprising a
change in New York Heart Association class (NYHA), change in patient global
assessment (PGA), or occurrence of major cardiovascular events. Tricuspid
regurgitation severity was the first of 6 secondary outcomes evaluated in a
hierarchical closed-testing procedure. This included the Kansas City
Cardiomyopathy Questionnaire (KCCQ) score, patient global assessment, and a
composite outcome of all-cause death, tricuspid valve surgery, KCCQ score
improvement, or time to hospitalization for heart failure.

Findings:

• Of 300 enrolled patients (mean age, 78 [SD, 6]
  years, 63.7% women), 152 were allocated to T-TEER + OMT and 148 to OMT alone.
• At 1 year, 109 patients (74.1%) in the
  T-TEER + OMT group had an improved composite score compared with 58 patients
  (40.6%) in the OMT-alone group.
• Massive or torrential tricuspid regurgitation
  was found in 6.8% of patients in the T-TEER + OMT group and 53.5% of those in
  the OMT-alone group (P < .001).
• Mean overall KCCQ summary score at 1 year was
  69.9 (SD, 25.5) for the T-TEER + OMT group and 55.4 (SD, 28.8) for the
  OMT-alone group (P < .001).
• The win ratio for the composite secondary
  outcome was 2.06 (95% CI, 1.38-3.08) (P < .001).

Thus, the study concluded that the
combination of T-TEER + OMT enhanced composite clinical outcomes like the NYHA
class, PGA, and major cardiovascular events in 1 year. This has significantly
reduced tricuspid regurgitation and hence can be used as an effective
intervention option for treating it.

Further reading: Donal E, Dreyfus
J, Leurent G, et al. Transcatheter Edge-to-Edge Repair for Severe Isolated
Tricuspid Regurgitation: The Tri.Fr Randomized Clinical Trial. JAMA. Published
online November 27, 2024. doi:10.1001/jama.2024.21189.