Angellotti, DomenicoDomenicoAngellottiMattig, IsabelIsabelMattigSamim, DaryoushDaryoushSamimGoebel, BjörnBjörnGoebelJantsch, CharlotteCharlotteJantschRubinic, BarbaraBarbaraRubinicRuf, TobiasTobiasRufGeisler, TobiasTobiasGeislerKessler, MirjamMirjamKesslerAdam, MattiMattiAdamStolz, LukasLukasStolzDannenberg, VariusVariusDannenbergKassar, MohammadMohammadKassar0000-0002-7576-2224Stathogiannis, KonstantinosKonstantinosStathogiannisCesario, VincenzoVincenzoCesarioDumonteil, NicolasNicolasDumonteilChrissoheris, MichaelMichaelChrissoherisSpargias, KonstantinosKonstantinosSpargiasBaldus, StephanStephanBaldusRottbauer, WolfgangWolfgangRottbauerGerçek, MuhammedMuhammedGerçekBartko, Philippe MPhilippe MBartkoLapp, HaraldHaraldLappDreger, HenrykHenrykDregerHausleiter, JörgJörgHausleiterLurz, PhilippPhilippLurzWindecker, StephanStephanWindeckerRudolph, VolkerVolkerRudolphPraz, FabienFabienPraz2025-06-262025-06-262025-08-11https://boris-portal.unibe.ch/handle/20.500.12422/212453Background 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.enpostmarketreal worldstructuraltranscatheter tricuspid valve implantationtranscatheter tricuspid valve replacementtricuspid regurgitationtricuspid valvevalvular heart diseasearticle10.48620/887734056010710.1016/j.jcin.2025.06.002