American heart journal · 2026
Early outcomes of off-label transcatheter tricuspid valve repair/replacement in the STS/ACC TVT registry.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Vekstein Andrew M, Salah Husam M, Stebbins Amanda, Wegermann Zachary, Yankey George Sipa, Kosinski Andrzej, Wang Andrew, Arnold Suzanne, Cohen David, Sorajja Paul, Kaneko Tsuyoshi, Batchelor Wayne, Thourani Vinod, Vemulapalli Sreekanth
Аннотация
BACKGROUND: Transcatheter tricuspid valve interventions (TTVI) have expanded with the recent FDA approval of both replacement transcatheter tricuspid valve replacement (TTVR) and edge-to-edge repair (T-TEER) devices. However, the volume and outcomes of commercial, off-label TTVR and T-TEER procedures are unknown. Herein, we describe institutional volume and patient characteristics for commercial, off-label TTVR and T-TEER procedures in the STS/ACC transcatheter valve therapies (TVT) registry, and assess 30-day and 1-year outcomes, including quality of life.
METHODS: Patients undergoing isolated TTVR or T-TEER for tricuspid regurgitation (TR) without stenosis were identified. The primary outcomes were residual TR severity and change in KCCQ-OS at 30 days. Secondary outcomes included 30-day mortality, vascular/bleeding complications, heart failure readmission, tricuspid reintervention, and 1-year Kaplan-Meier estimated mortality.
RESULTS: A total of 995 tricuspid procedures were performed at 142 sites from January, 2021 to December, 2023, including 238 TTVR (primarily valve-in-valve or valve-in-ring) and 757 T-TEER. 72% of sites performed 5 or fewer procedures, while 4 high-volume centers performed 49, 81, 94, and 120 procedures, respectively. Among TTVR patients (median age 60), 97% had ≤ moderate residual TR at 30 days; 61% had substantial improvement and 14% had moderate improvement in KCCQ-OS. 30-day and 1-year estimated mortality were 3.9% and 19% respectively. Among T-TEER patients (median age 78), 74% had ≤ moderate residual TR; 54% had substantial improvement and 17% moderate improvement in KCCQ-OS. 30-day and 1-year estimated mortality were 3.0% and 18%, respectively.
CONCLUSIONS: Off-label use of transcatheter tricuspid valve interventions was highly variable across institutions, with the majority of institutions performing <5 procedures, while others performed >100. Both T-TEER and TTVR reduced residual TR to ≤ moderate in the majority of cases and were associated with substantial improvements in quality of life.
METHODS: Patients undergoing isolated TTVR or T-TEER for tricuspid regurgitation (TR) without stenosis were identified. The primary outcomes were residual TR severity and change in KCCQ-OS at 30 days. Secondary outcomes included 30-day mortality, vascular/bleeding complications, heart failure readmission, tricuspid reintervention, and 1-year Kaplan-Meier estimated mortality.
RESULTS: A total of 995 tricuspid procedures were performed at 142 sites from January, 2021 to December, 2023, including 238 TTVR (primarily valve-in-valve or valve-in-ring) and 757 T-TEER. 72% of sites performed 5 or fewer procedures, while 4 high-volume centers performed 49, 81, 94, and 120 procedures, respectively. Among TTVR patients (median age 60), 97% had ≤ moderate residual TR at 30 days; 61% had substantial improvement and 14% had moderate improvement in KCCQ-OS. 30-day and 1-year estimated mortality were 3.9% and 19% respectively. Among T-TEER patients (median age 78), 74% had ≤ moderate residual TR; 54% had substantial improvement and 17% moderate improvement in KCCQ-OS. 30-day and 1-year estimated mortality were 3.0% and 18%, respectively.
CONCLUSIONS: Off-label use of transcatheter tricuspid valve interventions was highly variable across institutions, with the majority of institutions performing <5 procedures, while others performed >100. Both T-TEER and TTVR reduced residual TR to ≤ moderate in the majority of cases and were associated with substantial improvements in quality of life.