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.
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?
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.
Absolute Event Rate: -1% vs -0.1%
p-value: p=0.4995
AIMS: The aim of our study was to compare the impact of implantation of a balloon-expandable transcatheter valve into the inferior vena cava (CAVI) on exercise capacity with optimal medical therapy (OMT) in patients with severe tricuspid regurgitation (TR) and high surgical risk. METHODS AND RESULTS: Twenty-eight patients were randomised to OMT (n=14) or CAVI (n=14). The primary endpoint was maximal oxygen uptake at the three-month follow-up. Secondary endpoints included six-minute walk test, NYHA class, NT-proBNP levels, right heart function, unscheduled heart failure hospitalisation, and quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Patients underwent follow-up examinations one, three, six, and twelve months after randomisation. Maximal oxygen uptake did not change significantly in either group after three months and there was no difference between the OMT and CAVI groups (-0.1±1.8 ml∙kg-1∙min-1 vs -1.0±1.6 ml∙kg-1∙min-1, p=0.4995). Compared to baseline, CAVI improved NYHA class, dyspnoea, and quality of life after three months. However, there were no statistically significant differences in the secondary endpoints between the groups. Four periprocedural complications occurred after CAVI, resulting in open heart surgery. Four patients in the OMT group and eight patients (including four after conversion to surgery) in the CAVI group died from right heart failure, sepsis or haemorrhage. CONCLUSIONS: CAVI did not result in a superior functional outcome compared to OMT. Due to an unexpectedly high rate of valve dislocations, the study was stopped for safety reasons.
Dreger et al. (Wed,) conducted a 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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