The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Treatment of Severe TRIcuspid Regurgitation in Patients with Advanced Heart Failure with CAval Vein Implantation of the Edwards Sapien XT VALve (TRICAVAL): a controlled prospective randomized trial

DOI: 10.4244/EIJ-D-19-00901

1. Charite - Universitätsmedizin Berlin, Cardiology and Angiology, Berlin, Germany
2. Medizinische Klinik für Kardiologie und Angiologie, Campus Charité Mitte, Charité – Universitätsmedizin Berlin, Germany
3. Medizinische Klinik für Kardiologie und Angiologie, Campus Charité Mitte, Charité – Universitätsmedizin Berlin, Germany; DZHK (German Centre for Cardiovascular Research), partner site Berlin, Germany; Berlin Institute of Health (BIH), Berlin, Germany
4. Medizinische Klinik für Kardiologie, Campus Benjamin Franklin, Charité – Universitätsmedizin Berlin, Germany
5. Institut für Radiologie, Campus Charité Mitte, Charité – Universitätsmedizin Berlin, Germany
6. Edwards Lifesciences, Nyon, Switzerland
7. Berlin Institute of Health (BIH), Berlin, Germany; Coordinating Center for Clinical Studies, Charité – Universitätsmedizin Berlin, Germany; Institute of Biometry and Clinical Epidemiology, Charité – Universitätsmedizin Berlin, Germany
8. Medizinische Klinik für Kardiologie und Angiologie, Campus Charité Mitte, Charité – Universitätsmedizin Berlin, Germany; DZHK (German Centre for Cardiovascular Research), partner site Berlin, Germany
9. DZHK (German Centre for Cardiovascular Research), partner site Berlin, Germany; Berlin Institute of Health (BIH), Berlin, Germany; Medizinische Klinik für Kardiologie, Campus Benjamin Franklin, Charité – Universitätsmedizin Berlin, Germany
10. Klinik für Kardiovaskuläre Chirurgie, Charité – Universitätsmedizin Berlin, Germany
11. Medizinische Klinik für Kardiologie und Angiologie, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, Germany; DZHK (German Centre for Cardiovascular Research), partner site Berlin, Germany, GERMANY
12. Medizinische Klinik für Kardiologie und Angiologie, Campus Charité Mitte, Charité – Universitätsmedizin Berlin, Germany; Berlin Institute of Health (BIH), Berlin, Germany
13. Schlafmedizinisches Zentrum, Universitätsmedizin Essen, Ruhrlandklinik, Essen, 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: 28 patients were randomized to OMT (n = 14) or CAVI (n = 14). Primary endpoint was maximal oxygen uptake at the three months follow-up. Secondary endpoints included six-minute walk test, NYHA class, NT-proBNP levels, right heart function, unscheduled heart failure hospitalization, 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 randomization. Maximal oxygen uptake did not change significantly in both groups 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, dyspnea, and quality of life after three months. However, there were no statistically significant differences in the secondary endpoints between both 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 hemorrhage.

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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