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 The study included 176 patients (mean age 77.8 years, 72.0% women, median TRI-SCORE 5 points [IQR: 2 points]). At a median follow-up time of 30 days (IQR: 2 days), severe or greater TR was reduced to mild or none in 126 of 128 patients (98.4%; P < 0.001). NYHA functional class improved from 20.2% (28 of 138) class I or II at baseline to 79.7% (110 of 138; P) at 1 month (P < 0.001), with signs of improved hepatorenal function (estimated glomerular filtration rate 47.0 ± 19.9 mL/min/1.73 m2 vs 53.7 ± 23.3 mL/min/1.73 m2 [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.