FATE-register: mislukte transkatheter-tricuspidalisreparatie (T-TEER)

BACKGROUND: Tricuspid regurgitation (TR) is linked to significant morbidity and mortality. Tricuspid transcatheter edge-to-edge repair (T-TEER) provides a less invasive option for high-risk patients, but real-world data on device failure mechanisms and outcomes remain limited. OBJECTIVES: The aim of this study was to investigate the incidence, management, and outcomes of T-TEER device-related failures due to loss of leaflet insertion, single-leaflet device attachment, or device embolization, offering insights into these adverse events. METHODS: The retrospective, multicenter FATE (Failed Tricuspid Transcatheter Edge-to-Edge) registry identified all device-related failures associated with moderate or greater residual or recurrent TR among 2,278 consecutive T-TEER procedures performed at 31 centers from 2017 to 2024. Failure mechanisms were classified by multiparametric echocardiography. Coprimary endpoints were the incidence and management of device-related failure and the composite of death or heart failure rehospitalization. RESULTS: Among 2,278 T-TEER procedures, 123 device-related failures (5.4%) were identified (loss of leaflet insertion, 24%; single-leaflet device attachment, 75%; embolization, 1%), mostly diagnosed early and associated with severe or greater TR in 73%. Management was medical therapy in 54% and reintervention in 46%. Reintervention achieved greater TR reduction and right atrial reverse remodeling than medical therapy, but over a median follow-up period of 255 days, the composite of death or heart failure rehospitalization remained frequent (38.2%) and did not differ between strategies. Higher TRI-SCORE, acute kidney injury, and greater discharge TR severity independently predicted adverse outcomes. CONCLUSIONS: Device-related failure after T-TEER is uncommon but clinically relevant. Reintervention achieves greater TR reduction and right atrial reverse remodeling than medical therapy, but events remain similar between both strategies.