Off-Label Transcatheter Tricuspid Valve Interventions Demonstrate Reduced Residual TR, Improved QOL | NCDR Study

Off-label use of transcatheter tricuspid valve interventions varied greatly across institutions; however, in the majority of tricuspid transcatheter edge-to-edge repair (T-TEER) and transcatheter tricuspid valve replacement (TTVR) cases analyzed, these interventions reduced residual tricuspid regurgitation (TR) to at least moderate severity, and patients saw improved quality of life (QOL), according to a study published in the American Heart Journal.

Andrew M. Vekstein, MD, et al., used data from the STS/ACC TVT Registry, investigating the volume and variation of off-label transcatheter tricuspid valve interventions as well as 30-day and one-year outcomes. They included 995 procedures (238 TTVR and 757 T-TEER) from 142 sites performed between January 2021 and December 2023. The study's primary outcomes were residual TR severity and change in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS) at 30 days.

Overall, 72% of sites performed five or less procedures while sites with the highest volume performed over 100 procedures. In patients who underwent TTVR, moderate or better residual TR was observed in 97% of cases and 61% had substantial improvement in KCCQ-OS. In patients who underwent T-TEER, moderate or better residual TR was achieved in 74% of cases and 54% had substantial improvement in KCCQ-OS.

"Notably, there was no significant association between residual TR grade and change in KCCQ-OS, suggesting that factors beyond echocardiographic TR severity may influence symptomatic benefit," write the authors.

A secondary outcome of 30-day and one-year estimated mortality was also explored: 3% and 18%, respectively. Compared with risk for surgical tricuspid interventions reported by the Society of Thoracic Surgeons, 30-day mortality was lower for transcatheter procedures. "This indirect comparison of mortality is suboptimal for high quality comparative effective studies," note the authors. "However, any prospective, randomized comparison of surgical TVR/TVr vs. transcatheter TVR/TVr would necessarily be limited to patients with acceptable surgical risk and appropriate anatomy."

They add that "given the differences in operative risk profiles, but also potential differences in echocardiographic results, a combination of prospective studies and carefully designed and executed observational analyses may be needed to address questions of comparative effectiveness."




Keywords: National Cardiovascular Data Registries, STS/ACC TVT Registry, Tricuspid Valve, Off-Label Use, Tricuspid Valve Insufficiency, Quality of Life, Registries


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