Abstract
Due to progressive abdominal-venous congestion severe tricuspid regurgitation (TR) is a common cause of cardiorenal and cardiohepatic syndrome. We initiated the TRICAVAL study to compare interventional valve implantation into the inferior vena cava (CAVI) versus optimal medical therapy (OMT) in severe TR. In the present subanalysis, we aimed to evaluate the effects of CAVI on clinical signs of congestion, renal and hepatic function. TRICAVAL was an investigator-initiated, randomized trial. Twenty-eight patients with severe TR were randomized to OMT or CAVI using an Edwards Sapien XT valve. Probands who completed the 3-month follow-up (CAVI [n = 8], OMT [n = 10]) were evaluated by medical history, clinical examination, and laboratory testing at baseline, 3 and 12 months. After 3 months, the CAVI group exhibited a significant reduction of body weight (from 80.7 [69.0–87.7] kg to 75.5 [63.8–84.6] kg, p < 0.05) and abdominal circumference (from 101.5 ± 13.8 cm to 96.3 ± 15.4 cm, p ≤ 0.01) and a trend to lower doses of diuretics compared to OMT. Renal and hepatic function parameters did not change significantly. Within a short-term follow-up, CAVI led to an improvement of clinical signs of venous congestion and a non-significant reduction of diuretic doses compared to OMT.
Highlights
Due to progressive abdominal-venous congestion severe tricuspid regurgitation (TR) is a common cause of cardiorenal and cardiohepatic syndrome
On the assumption that a singular implantation of an Edwards Sapien XT valve into the inferior vena cava in patients with severe TR leads to an improvement of abdominal-venous congestion, the TRICAVAL trial (Treatment of Severe Secondary Tricuspid Regurgitation in Patients with Advance Heart Failure with Caval Vein Implantation of the Edwards Sapien XT Valve, NCT02387697) was initiated[19]
At 3-month FUP, the CAVI group exhibited a significantly lower body weight and reduced abdominal circumference compared to baseline (Table 2; Figs. 2, 3), while in the optimal medical therapy (OMT) group both parameters remained unchanged
Summary
Due to progressive abdominal-venous congestion severe tricuspid regurgitation (TR) is a common cause of cardiorenal and cardiohepatic syndrome. We initiated the TRICAVAL study to compare interventional valve implantation into the inferior vena cava (CAVI) versus optimal medical therapy (OMT) in severe TR. First-in-human studies and a case series investigated the effects of bioprosthetic valve implantation into the inferior vena cava or in both—inferior and superior vena cava[15,16,17,18] These studies suggested an improvement of symptoms of right heart failure[15,16] and a reduction of venous congestion[15,16,17,18]. On the assumption that a singular implantation of an Edwards Sapien XT valve into the inferior vena cava in patients with severe TR leads to an improvement of abdominal-venous congestion, the TRICAVAL trial (Treatment of Severe Secondary Tricuspid Regurgitation in Patients with Advance Heart Failure with Caval Vein Implantation of the Edwards Sapien XT Valve, NCT02387697) was initiated[19]. Aimed to evaluate the effect of CAVI on clinical signs of congestion as well as on renal and hepatic function parameters
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