TY - JOUR JO - EuroIntervention TI - Treatment of Severe TRIcuspid Regurgitation in Patients with Advanced Heart Failure with CAval Vein Implantation of the Edwards Sapien XT VALve (TRICAVAL): a randomised controlled trial AB - <p><strong>Aims:</strong> 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.</p> <p><strong>Methods and results:</strong> 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 (&minus;0.1&plusmn;1.8 ml∙kg<sup>&minus;1</sup>∙min<sup>&minus;1</sup> vs &minus;1.0&plusmn;1.6 ml∙kg<sup>&minus;1</sup>∙min<sup>&minus;1</sup>, 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.</p> <p><strong>Conclusions:</strong> 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.</p> AU - Dreger Henryk AU - Mattig Isabel AU - Hewing Bernd AU - Knebel Fabian AU - Lauten Alexander AU - Lembcke Alexander AU - Thoenes Martin AU - Roehle Robert AU - Stangl Verena AU - Landmesser Ulf AU - Grubitzsch Herko AU - Stangl Karl AU - Laule Michael VL - 15 IS - 17 Y1 - 17/04/2020 Y1 - 2020 DOI - 10.4244/EIJ-D-19-00901 SP - 1506 EP - 1513 KW - dyspnoea KW - femoral KW - tricuspid disease KW - ttvr PB - Europa Digital & Publishing SE - Interventions for valvular disease and heart failure UR - https://eurointervention.pcronline.com/article/treatment-of-severe-tricuspid-regurgitation-in-patients-with-advanced-heart-failure-with-caval-vein-implantation-of-the-edwards-sapien-xt-valve-tricavala-controlled-prospective-randomized-trial SN - 1774-024X ER -