The Cardioband tricuspid system significantly reduced tricuspid regurgitation severity, with 59% of patients achieving moderate or less TR at discharge.
Observational (n=61)
None
Yes
Does the Cardioband tricuspid valve reconstruction system improve TR severity and functional status in patients with symptomatic functional tricuspid regurgitation?
The Cardioband tricuspid system effectively reduces TR severity and improves functional status at 30 days in patients with symptomatic severe functional tricuspid regurgitation.
p-value: p=<0.001
BACKGROUND: Severe tricuspid regurgitation (TR) has limited treatment options and is associated with high morbidity and mortality. AIMS: We evaluated the safety and effectiveness of the Cardioband tricuspid valve reconstruction system from the ongoing European single-arm, multicentre, prospective TriBAND post-market clinical follow-up study. METHODS: Eligible patients had chronic symptomatic functional TR despite diuretic therapy and were deemed candidates for transcatheter tricuspid repair by the local Heart Team. RESULTS: Sixty-one patients had ≥severe functional TR. At baseline, 85% of patients were in NYHA Class III-IV, 94% had ≥severe TR (core laboratory-assessed) with 6.8% EuroSCORE II and 53% LVEF. Device success was 96.7%. At discharge, 59% (p<0.001) of patients achieved ≤moderate TR and 78% had at least one grade TR reduction. At 30 days, all-cause mortality and composite MAE rates were 1.6% and 19.7%, respectively; septolateral annular diameter was reduced by 20%, where 69% of patients achieved ≤moderate TR and 85% of patients had at least one grade TR reduction (all p<0.001). Mid-RVEDD, RA volume, and IVC diameter decreased by 10% (p=0.005), 21% (p<0.001), and 11% (p=0.022), respectively; 74% were in NYHA Class I-II (p<0.001) with improvements in overall KCCQ score by 17 points (p<0.001). CONCLUSIONS: In the TriBAND study, the Cardioband tricuspid system demonstrated favourable outcomes at discharge and 30 days in a challenging patient population with symptomatic ≥severe functional TR. Results showed significant reductions in annular diameter and TR severity, accompanied by early evidence of right heart remodelling and improvements in functional status and quality of life.
Nickenig et al. (2021) conducted an observational in Symptomatic functional tricuspid regurgitation (n=61). Cardioband tricuspid valve reconstruction system was evaluated on Reduction in tricuspid regurgitation (TR) severity between baseline and discharge (≤moderate TR achieved) (p=<0.001). The Cardioband tricuspid system significantly reduced tricuspid regurgitation severity, with 59% of patients achieving moderate or less TR at discharge.