Key result
Caval vein implantation did not improve maximal oxygen uptake compared to optimal medical therapy at 3 months (-1.0 vs -0.1 ml/kg/min, p=0.4995) and the study was stopped for safety reasons.
Why the study?
The study aimed to compare the impact of inferior vena cava valve implantation versus optimal medical therapy on exercise capacity in patients with severe tricuspid regurgitation and high surgical risk.
Does caval vein implantation of a transcatheter valve improve maximal oxygen uptake in patients with severe tricuspid regurgitation and advanced heart failure compared to optimal medical therapy?
RCT (n=28)
randomised
Does caval vein implantation of a transcatheter valve improve maximal oxygen uptake in patients with severe tricuspid regurgitation and advanced heart failure compared to optimal medical therapy?
Absolute Event Rate: -1% vs -0.1%
p-value: p=0.4995
Caval vein implantation of a transcatheter valve for severe tricuspid regurgitation did not improve exercise capacity and was associated with significant safety concerns, including valve dislocations and periprocedural complications.
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CAVI failed to improve exercise capacity over OMT in severe TR; challenges caval valve implantation and leaves open safer transcatheter strategies.
Dreger et al. (2020) conducted an RCT in Severe tricuspid regurgitation and high surgical risk (n=28). Caval vein implantation (CAVI) vs. Optimal medical therapy (OMT) was evaluated on Maximal oxygen uptake at the three-month follow-up (p=0.4995). Caval vein implantation did not improve maximal oxygen uptake compared to optimal medical therapy at 3 months (-1.0 vs -0.1 ml/kg/min, p=0.4995) and the study was stopped for safety reasons.
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