Edge-to-edge repair for tricuspid regurgitation: 1-year follow-up and clinical implications from the TR-Interventional Study.

Abstract

Aims: Tricuspid regurgitation affects 7% of the population, with moderate-to-severe tricuspid regurgitation contributing to up to 12% of heart failure-related hospitalizations. Traditional treatments have several limitations, prompting the exploration of innovative interventions. Our study aims to investigate the efficacy and clinical outcomes following transcatheter edge-to-edge repair (TEER) in patients with severe, symptomatic tricuspid regurgitation through a 1-year follow-up.

Methods: The TR-Interventional study (TRIS) is a prospective, single-arm study conducted at the Fondazione Policlinico Universitario Campus Bio-Medico. From March 2021 to December 2023, we enrolled 44 symptomatic patients with at least severe tricuspid regurgitation referred for tricuspid TEER with the TriClip System.

Results: The study cohort had a mean age of 78.3 ± 7 years with a median TRISCORE 5.4% (interquartile range 3.5-9.0). Significant reduction in tricuspid regurgitation grade occurred immediately after the procedure with durable results at 30 days and 1-year follow-up (P < 0.001). The primary efficacy endpoint, which assesses the successful implantation and performance of the device at 30 days, was attained in 82.9% of patients. The secondary efficacy endpoint, evaluating the stability of tricuspid regurgitation reduction at 12 months, was achieved in 82.3% of patients. The NYHA Functional Class and KCCQ scores significantly improved from baseline to 1 year (P < 0.05; P < 0.0001). Echocardiographic assessments reveal sustained positive right ventricle remodeling throughout the 1-year follow-up period.

Conclusion: Evidence from the TRIS study confirms that tricuspid TEER is a valuable and effective therapeutic option in contemporary practice. The lasting reduction in tricuspid regurgitation at 1 year is associated with sustained clinical benefits and reverse structural remodeling of the right ventricle.