- Sorajja P. et al. (2023). Transcatheter Repair for Patients with Tricuspid Regurgitation. N Engl J Med. 2023 Mar 4.
- Hell M.M. et al. (2022). Moderne Therapieoptionen der Trikuspidalklappeninsuffizienz. Kardiologe 16, 38–45 (2022)
Tricuspid regurgitation is the second most common valvular heart disease. The majority (about 85%) of TI patients have secondary TI. The pathomechanism of secondary TI is based on dilatation of the right ventricle and the tricuspid valve annulus. This leads to dysfunctional leaflet coaptation. The result is pathological regurgitation during the systolic phase of the heartbeat. In more than 50% of patients, left-side heart diseases are present, resulting in secondary TI. This includes pathological changes in the aortic and mitral valves.2
Severe tricuspid regurgitation is a disease associated with significant morbidity and reduction in quality of life. Until recently, insufficient awareness of this condition in everyday clinical practice had far-reaching consequences for this vulnerable patient group: the lack of awareness of the condition resulted in many cases in irreversible damage to the right ventricle.
Reduction of tricuspid regurgitation may be associated with a decrease in symptoms and an improvement in clinical outcomes. In our study, an improvement in quality of life and a reduction in tricuspid regurgitation was achieved. The Pivotal TRILUMINATE study is a prospective, randomised trial of percutaneous tricuspid valve repair (TEER) for severe tricuspid regurgitation, published in the New England Journal of Medicine (DOI: 10.1056/NEJMoa2300525). This multicentre study was conducted at a total of 65 centres in Europe, the USA and Canada. Patients with symptomatic severe tricuspid regurgitation were divided into 2 groups in a 1:1 ratio: The TEER group or the control group. The primary endpoint of the study consisted of the following:
Quality of life was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The scale of the KCCQ score started at 0 and ended at 100. The safety aspects of TEER and the severity of tricuspid regurgitation were also recorded and evaluated.1
The requirement for study participation was the presence of symptomatic, severe tricuspid regurgitation. This was proven by echocardiography. Severe was defined as New York Heart Association (NYHA) functional class II, III or IVa. Further prerequisites were:
A total of 350 patients took part in the Pivotal TRILUMINATE study. The average age of the patients was 78 years. The female gender predominated with 54.9%. There were no differences between the two groups with regard to the incidence of death, the need for tricuspid valve surgery, and the hospitalisation rate due to heart failure. There was a significant difference (p<0.001) in quality of life: The KCCQ score for quality of life changed by an average (± SD) of 12.3 ± 1.8 points in the TEER group.
In the control group, however, only a change of 0.6 ± 1.8 points was measurable. A clear difference was also observed with regard to tricuspid regurgitation. Tricuspid TEER reduced the severity of tricuspid regurgitation. After 30 days, 87.0% of patients in the TEER group and only 4.8% of patients in the control group had tricuspid regurgitation of moderate or less severity (p<0.001). In the TEER group, 98.3% of patients had been free of serious adverse events at 30 days. Tricuspid TEER is thus a safe method.1