February 1, 2021Open Access
Tricuspid valve repair with the Cardioband system: two-year outcomes of the multicentre, prospective TRI-REPAIR study
Key Result
Tricuspid valve repair with the Cardioband system resulted in 72% of patients having ≤moderate TR grade at two years (p=0.016) and 82% in NYHA Class I-II (p=0.002).
Structured PICO
Does tricuspid valve repair with the Cardioband system improve clinical, functional, and echocardiographic outcomes in patients with symptomatic, ≥moderate functional TR who are inoperable?
P
Population
30 patients with symptomatic, ≥moderate functional tricuspid regurgitation deemed inoperable due to unacceptable surgical risk, followed for up to two years.
I
Intervention
Tricuspid valve repair with the Cardioband tricuspid valve reconstruction system
O
Outcome
One- and two-year clinical, functional, and echocardiographic outcomes
The Cardioband tricuspid system provides sustained reduction in annular diameter and TR severity at two years, alongside improvements in functional status and quality of life in inoperable patients with ≥moderate functional TR.
Main Result
p-value: p=0.016
Abstract
AIMS: Tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. We report one- and two-year outcomes of the Cardioband tricuspid valve reconstruction system in the treatment of ≥moderate functional TR in the TRI-REPAIR study. METHODS AND RESULTS: Thirty patients were enrolled in this single-arm, multicentre, prospective study. Patients were evaluated as having ≥moderate, symptomatic functional TR and deemed inoperable due to unacceptable surgical risk. Clinical, functional, and echocardiographic data were prospectively collected up to two years (mean duration 604±227 days). At baseline, 83% were in NYHA Class III-IV, and the mean LVEF was 58%. Technical success was 100%. At two years, there were eight deaths. Echocardiography showed a significant reduction in septolateral annular diameter of 16% (p=0.006) and 72% of patients (p=0.016) with ≤moderate TR grade; 82% of patients were in NYHA Class I-II (p=0.002). Six-minute walk distance and KCCQ score improved by 73 m (p=0.058) and 14 points (p=0.046), respectively. CONCLUSIONS: These results demonstrate that the Cardioband tricuspid system showed favourable results in patients with symptomatic, ≥moderate functional TR. Annular reduction and TR severity reduction remained significant and sustained at two years. Patients experienced improvements in quality of life and exercise capacity. ClinicalTrials.gov Identifier: NCT02981953.