Incidence, Clinical Implications, and Predictors of Paravalvular Leak Following Transcatheter Tricuspid Valve Replacement: The TRIPLACE Registry.
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Scotti Andrea, Latib Azeem, Filtz Annalisa, Sturla Matteo, Zahr Firas, Boone Robert, Kodali Susheel, Tchétché Didier, De Backer Ole, Coisne Augustin, Ludwig Sebastian, Garcia Santiago A, Stolz Lukas, Loureiro Rodrigo Estevez, Adam Matti, De Marco Federico, Ho Edwin C, Cheung Anson, Biroli Matteo, Patrascu Alexandru, Alnasser Sami, Chadderdon Scott, Lulic Davorka, Bartkowiak Joanna, Echarte-Morales Julio, Sievert Horst, Byrne Timothy, Maisano Francesco, Frerker Christian, Dumonteil Nicolas, Oliva Omar A, Rudolph Tanja K, Rudolph Felix, Guddeti Raviteja, Bakhtadze Beka, Krishnaswamy Amar, Kapadia Samir R, Portillo Juan Del, Rodés-Cabau Josep, Schofer Niklas, Cruz-Gonzalez Ignacio, Granada Juan, Hausleiter Jörg, Hahn Rebecca T, Modine Thomas, Fam Neil, Puri Rishi
Аннотация
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).