TRIPLACE-register: paravalvulaire lekkage na transkatheter-tricuspidalisklepvervanging

BACKGROUND: The clinical efficacy of transcatheter tricuspid valve replacement (TTVR) in abolishing tricuspid regurgitation might be attenuated by the occurrence of paravalvular leak (PVL). OBJECTIVES: The aim of this study was to investigate the incidence, outcomes, and predictors of moderate or severe PVL post-TTVR. METHODS: All eligible patients undergoing TTVR in the multicenter TRIPLACE (Global Multicenter Registry on Transcatheter Tricuspid Valve Replacement) registry were stratified according to predischarge PVL severity. The primary endpoint was the occurrence of moderate or severe PVL post-TTVR. Secondary endpoints were 1-year mortality, 1-year heart failure hospitalization, and post-TTVR NYHA functional class III or IV. Outcomes were analyzed using logistic regression (PVL), Cox regression (mortality), and Gray's test (heart failure). RESULTS: Of 394 TTVR patients, 24 (6.1%) had moderate or severe, 88 (22.3%) mild, and 282 (71.6%) no or trace PVL post-TTVR. Patients with moderate or severe PVL had significantly higher TRI-SCOREs (P < 0.001), lower estimated glomerular filtration rates (P = 0.001), and larger right ventricular and right atrial dimensions (P = 0.002 for both). Patients with moderate or severe PVL post-TTVR had worse 1-month functional class (53% in NYHA functional class III or IV) than those with mild (16%) or no or trace (15%) PVL. The presence of moderate or severe PVL post-TTVR was associated with increased 1-year mortality (39.7%; adjusted HR: 2.6; 95% CI: 1.2-5.7) compared with those with mild (12.6%) or no or trace (10.5%) PVL. A larger right atrial volume (P = 0.02), device malposition (P = 0.0002), and type IV valve morphology (P = 0.01) were independently associated with moderate or severe PVL post-TTVR. CONCLUSIONS: Moderate or greater PVL occurred in 6.1% of patients post-TTVR and was associated with increased 1-year mortality and worse functional status. A larger right atrial volume, device malposition, and type IV valve morphology conferred a higher risk for developing moderate or severe PVL post-TTVR. These findings have important implications for future TTVR design and procedural optimization. (Global Multicenter Registry on Transcatheter Tricuspid Valve Replacement [TRIPLACE]; NCT06033274).