Early Outcomes of Real-World Transcatheter Tricuspid Valve Replacement
- PMID: 40560107
- DOI: 10.1016/j.jcin.2025.06.002
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.
Keywords: postmarket; real world; structural; transcatheter tricuspid valve implantation; transcatheter tricuspid valve replacement; tricuspid regurgitation; tricuspid valve; valvular heart disease.
Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Funding Support and Author Disclosures Dr Angellotti has received a research grant from the CardioPath PhD program. Dr Samim has received funding for an online course from Edwards Lifesciences. Dr Kessler has received speaker honoraria from Abbott Laboratories and Edwards Lifesciences. Dr Adam has received fees from Abbott Laboratories, Boston Scientific, Edwards Lifesciences, JenaValve Technology, Medtronic, and Meril. Dr Stolz has received speaker honoraria from Edwards Lifesciences. Dr Gerçek has received funding from Ruhr University Bochum (advanced clinician scientist) and consulting fees from Edwards Lifesciences. Dr Dumonteil has received consultancy fees from Abbott Laboratories, Ancora Heart, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Bartko has been a proctor and speaker for Abbott Laboratories and Edwards Lifesciences. Dr Hausleiter has received research support and speaker honoraria from Edwards Lifesciences. Dr Lurz has received institutional grants from Edwards Lifesciences and honoraria from Innoventrics. Dr Windecker has received research, travel, and/or educational grants to the institution from Abbott Laboratories, Abiomed, Alnylam, Amicus Therapeutics, Amgen, AstraZeneca, Bayer, B. Braun, BioAnalytica, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cordis Medical, CorFlow Therapeutics, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Fumedica, GE Healthcare, Guerbet, IACULIS, Inari Medical, Janssen AI, Johnson & Johnson, MedAlliance, Medtronic, Merck Sharp & Dohme, Neovii Pharmaceutica, Neutromedics, Novartis, Novo Nordisk, OM Pharma, Optimapharm, Orchestra BioMed, Pfizer, Philips, Sanofi, Servier, Shockwave Medical, Siemens Healthcare, Sinomed, Sahajanand Medical Technologies, Vascular Medical, and V-Wave; serves as advisory board member and/or member of the steering or executive groups of trials funded by Abbott Laboratories, Amgen, Abiomed, Edwards Lifesciences, EnCarda, Medtronic, Novartis, and Sinomed, with payments to the institution but no personal payments; is a member of the steering or executive committee groups of several investigator-initiated trials that receive funding from industry, without impact on his personal remuneration. Dr Praz has received travel expenses from Edwards Lifesciences, Abbott Vascular, Medira, Siemens Healthineers, and InQB8 Medical Technologies; and has received a research grant to the institution from Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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