Early Feasibility Study of the Edwards SAPIEN 3 Transcatheter Heart Valve System With the Edwards Caval Prestent for the Treatment of Reverse Caval Flow in Patients With Severe Tricuspid Regurgitation (TR)

Background and Aims Caval valve implantation has emerged as an alternative to orthotopic valve replacement for patients with severe TR and right heart failure. Current devices are focused primarily on bicaval implantation. The outcomes for patients with (inferior vena cava) IVC implantation only are less clear. The aim of this study was to assess the impact of IVC Caval Valve Implantation on patients with severe TR and heart failure. Methods The RIGHT FLOW trial enrolled patients with severe TR and right heart failure as part of an early feasibility study between November 2021 and December 2022. Results A total of 10 patients were included. The average age of patients was 78.8 ± 6.7 years. Most patients had NYHA class III/IV heart failure symptoms (78.8%). The average overall Kansas City Cardiomyopathy Questionnaire (KCCQ‐OS) score at baseline was 36.9 ± 22.8. Successful device delivery occurred in 9/10 of patients. Post‐implant, there was an increase in right atrial (RA) pressure that returned to baseline at 6 months. Hepatic vein diameter decreased from (13.1 + 3.1 mm at baseline to 8.7 + 3.0 mm at 12 months). Six patients survived to 12 months. Of those patients, all had NYHA Class I/II symptoms. Of patients completing follow‐up, KCCQ‐OS scores increased by 43.4 points at 1‐year. Computer tomography revealed asymptomatic stent fractures in 7 patients. Conclusions Caval valve implantation with the Edwards Caval Prestent system in the IVC only was feasible and safe in patients with severe TR. Patients exhibited a decrease in hepatic vein diameter. There were significant improvements in KCCQ‐OS scores beginning at 30 days that continued out to 1 year. Future design iterations are needed to address stent fractures.