Early outcomes of off-label transcatheter tricuspid valve repair/replacement in the STS/ACC TVT registry

Abstract

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.