Background: Transcatheter tricuspid valve edge-to-edge repair (T-TEER) is associated with significant reduction of tricuspid regurgitation (TR) and clinical improvement in patients with severe TR. While the procedure can be technically challenging, especially in patients with complex anatomies, the impact of operator and site experience on clinical outcomes is largely unknown.
Objectives: This study aimed at assessing the association between site experience and clinical outcomes in patients undergoing T-TEER in clinical practice.
Methods: The study included patients from the PASTE registry (NCT05328284) who underwent T-TEER for significant TR from 2019 to 2023 at 16 heart valve centers across Europe. Study endpoints included TR reduction and clinical success, defined as acceptable device performance in the absence of serious adverse events including hospitalization for heart failure, tricuspid valve reintervention, and improvement in clinical status.
Results: The study included a total of 1059 patients (mean age 79 ± 9 years; 53% female, 84% NYHA functional class ≥ III, mean TRI-SCORE 6 ± 2 points). TR was severe (3+), massive (4+) and torrential (5+) in 41%, 35% and 20% of patients, respectively. Complex anatomies with large coaptation gaps >8 mm and multi-leaflet morphologies were present in 24% and 43% of patients. The mean number of T-TEER procedures per year and site was 21. Post-procedural TR reduction to grade <2+ was similar in sites with lower (≤20 annually T-TEER procedures: 84% TR <2+ at discharge) or higher experience (>20 annually T-TEER procedures: 88% TR <2+ at discharge, p = 0.085). However, complication rates with early single-leaflet device attachment (SLDA) were lower in sites with higher experience (early SLDA 3%), when compared to sites with lower experience (early SLDA 6%, p < 0.05). Furthermore, clinical success rate at 1 year was superior with increasing site experience (higher experience: 55%, lower experience: 44%, p < 0.01).
Conclusions: Increasing experience was associated with lower complications and higher clinical success rates following T-TEER. Thus, all TR patients undergoing tricuspid interventions should be transferred to high-volume heart valve centers specialized in the treatment of TR.