Interventions for valvular disease and heart failure

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

EuroIntervention 2020;15:1506-1513. DOI: 10.4244/EIJ-D-19-00901

Henryk Dreger
Henryk Dreger1,2, MD; Isabel Mattig1, MD; Bernd Hewing1,2,3, MD; Fabian Knebel2,3, MD; Alexander Lauten4, MD; Alexander Lembcke5, MD; Martin Thoenes6, MD; Robert Roehle3,7,8, MSc; Verena Stangl1,2, MD; Ulf Landmesser2,3,4, MD; Herko Grubitzsch9, MD; Karl Stangl1,2, MD; Michael Laule1,3, MD
1. Medizinische Klinik für Kardiologie und Angiologie, Campus Charité Mitte, Charité – Universitätsmedizin Berlin, Berlin, Germany; 2. DZHK (German Centre for Cardiovascular Research), partner site Berlin, Berlin, Germany; 3. Berlin Institute of Health (BIH), Berlin, Germany; 4. Medizinische Klinik für Kardiologie, Campus Benjamin Franklin, Charité – Universitätsmedizin Berlin, Berlin, Germany; 5. Institut für Radiologie, Campus Charité Mitte, Charité – Universitätsmedizin Berlin, Berlin, Germany; 6. Edwards Lifesciences, Nyon, Switzerland; 7. Coordinating Center for Clinical Studies, Charité – Universitätsmedizin Berlin, Germany; 8. Institute of Biometry and Clinical Epidemiology, Charité – Universitätsmedizin Berlin, Germany; 9. Klinik für Kardiovaskuläre Chirurgie, Charité – Universitätsmedizin Berlin, Germany

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.

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