Early Outcomes of Real-World Transcatheter Tricuspid Valve Replacement

Abstract

BACKGROUND: Transcatheter tricuspid valve replacement (TTVR) has been recently approved for the treatment of patients with severe tricuspid regurgitation (TR). Real-world evidence regarding the commercial use of TTVR is lacking. OBJECTIVES: The aim of this study was to investigate the real-world safety and efficacy of the EVOQUE TTVR system in patients with severe TR treated at 12 experienced heart valve centers in 5 European countries. METHODS: Consecutive patients treated with the EVOQUE system since approval in Europe (October 2023 to February 2025) were included in this retrospective analysis. Clinical outcomes were assessed at 30-day follow-up. RESULTS: [P < 0.001]; bilirubin 14.2 ± 8.8 μmol/L vs 11.0 ± 9.8 μmol/L [P < 0.001]). Massive or torrential TR at baseline was more common among patients who improved compared with those with stable or worsening NYHA functional class (75 of 98 [76.5%] vs 20 of 40 [50.0%]; P = 0.004). Permanent pacemaker implantation was required in 21 of 111 pacemaker-naive patients (18.9%), in particular those with conduction disturbances at baseline (OR: 4.53; 95% CI: 1.73-11.82; P = 0.002). Moderate or severe right ventricular dysfunction was an independent predictor of clinical failure at 1-month follow-up (OR: 3.60; 95% CI: 1.39-9.32, P = 0.008). CONCLUSIONS: TR elimination following TTVR in a real-world setting was associated with significant symptom and end-organ functional improvement. Patients with massive or torrential TR were more likely to experience functional improvement. Pre-existing conduction disturbances are associated with increased risk for pacemaker implantation, while baseline right ventricular dysfunction is a strong predictor of adverse clinical outcomes.