Data presented at PCR London Valves 2024 showed that caval valve implantation (CAVI) with the TricValve® system demonstrates an acceptable safety profile and significant clinical benefits in highly comorbid patients with severe tricuspid regurgitation (TR), according to the TricBicaval registry’s one-year findings.
Severe TR poses a significant clinical challenge, particularly in patients deemed inoperable or unsuitable for conventional tricuspid valve replacement or repair. The TricValve system, a novel percutaneous therapy designed to address severe TR, seeks to eliminate venous backflow, reduce peripheral congestion, and enhance cardiac output. While prior studies suggested improved functional outcomes, real-world evidence was scarce. To bridge this gap, a multicentre registry involving 204 patients across 26 European and one Brazilian hospital was established. Participants had severe symptomatic TR and significant comorbidities, including renal dysfunction (71.1%) and prior pacemaker implantation (34.2%), with a TRI_SCORE, predicted in-hospital mortality, of 23.2%. Additionally, 60.8% of patients had experienced heart failure hospitalisation in the last 12 months.
In the study, the fluoroscopic time was 30 minutes, and intraprocedural success was 96.1%. Key outcomes included an in-hospital mortality rate of 8.3%, and a cardiovascular mortality rate of 15.7%. The most common complication was transient shoulder pain, reported in 47.1% of patients. The analysis also revealed a functional improvement in many patients, with 81.5% of patients were in New York Heart Association Class I or II, compared to 19.8% pre-procedure. Additionally, both the rate of of heart failure hospitalisations, and the mean diuretic doses significantly reduced. This was accompanied by positive right ventricular remodeling and sustained one-year reductions in inferior vena cava pressure. However, slight worsening of RV function was observed in echocardiographic parameters.
The findings indicate that the TricValve offers a viable therapeutic option for patients with severe, symptomatic TR who are ineligible for surgery. Clinicians can expect improvements in functional class, quality of life, and peripheral venous congestion at one-year. Future research should focus on refining patient selection criteria and expanding follow-up durations to establish its role in broader clinical practice.
Reference
Sanchez Recalde A et al. Bicaval TricValve in severe tricuspid regurgitation – One-year outcomes from the Tricbicaval registry. PCR London Valves, 24-26 November, 2024.