https://doi.org/10.1007/s00392-025-02625-4
1Universitätsmedizin der Johannes Gutenberg-Universität Mainz Zentrum für Kardiologie Mainz, Deutschland; 2IRCCS San Raffaele Milano, Italien; 3Hopital Haut Leveque Bordeaux, Frankreich; 4LMU Klinikum der Universität München Medizinische Klinik und Poliklinik I München, Deutschland; 5Changhai Hospital Shanghai, China; 6Fuwai Hospital Beijing, Deutschland; 7Cardiovascular Research Foundation New York, USA
Background
Tricuspid regurgitation (TR) is a common valvular disease, associated with significant morbidity and mortality. Both transcatheter tricuspid edge-to-edge repair (T-TEER) and transcatheter tricuspid valve replacement (TTVR) have shown to improve symptoms and quality of life of TR patients more than optimal medical therapy. However, the clinical implications of a repair versus replacement strategy, including the impact of residual TR, are unknown. Aim of this study is to compare short- and mid-term outcomes of T-TEER and TTVR with the Lux-Valve Plus trans-jugular system in symptomatic high-risk TR patients.
Methods
We included 1939 patients who underwent isolated T-TEER (from the international, multicenter EuroTR registry) and 96 patients who underwent TTVR with the LuX-Valve Plus system (from the TRAVEL II study). 2:1 propensity score-matching (PSM) was performed to balance covariates. Both unmatched and matched cohorts were compared in terms of procedural outcomes and the composite of all-cause mortality or heart failure hospitalization (HFH) at 1 year.
Results
Pts in the T-TEER cohort were older (79 ± 7 vs 71 ± 9 years, p<0.001), had more pre-operative comorbidities (previous myocardial infarction 11% vs 1%, p=0.003; COPD 18% vs 5%, p=0.002; previous stroke 11% vs 3%, p=0.019) and a more advanced stage of right heart failure (RHF) (RV-end diastolic area 27 ± 13 mm vs 23 ± 8 mm, p<0.001; TAPSE 17.1 ± 4.6 vs 17.9 ± 3.7 mm, p=0.05; any clinical sign of RHF 71.5% vs 44.8%, p<0.001; NTproBNP 4722 ± 874 vs 1011 ± 877, p<0.001). However, TTVR patients had more often history of previous cardiac surgery (41% vs 29%, p=0.023) and this was reflected in a higher pre-operative STS score (9 ± 4 vs 7.5 ± 7, p=0.002).
TR at discharge was moderate or less in 99% of the LuX patients vs 81% of the T-TEER ones (p<0.01), and this difference remained significant at 1-year (95% of the LuX group free from TR>2 vs 71.2% of the T-TEER group; p<0.001). In the unmatched cohorts, the composite outcome of mortality or HFH at one year occurred in 21.4% of the T-TEER group vs 3.1% of the TTVR group (p<0.001).
After PSM, 47 LuX patients were compared with 97 T-TEER control.
In the matched cohorts, TTVR was still associated with a more significant TR reduction at one year (97.8% of pts with TR<3 in the LuX group vs 71.2% in the T-TEER one, p=0.001), but this difference did neither affect the occurrence of the composite outcome (13.4% in the T-TEER cohort vs 8.7% in the TTVR cohort, p=0.8) nor the severity of symptoms at follow-up (p=ns for both NYHA status and 6-minutes walking test). These results were confirmed by the Inverse-probability-of-treatment weighting (IPTW) analysis, that showed a non-significant association between treatment choice and the composite outcome (p=0.5).
Conclusions
In high-risk patients with significant TR, TTVR is associated with a more consistent and durable TR reduction compared to TEER. However, this does not affect one-year outcomes in the matched cohorts.