Tricuspid valve repair with the Cardioband system: two-year outcomes of the multicentre, prospective TRI-REPAIR study

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.

Conflict of interest statement

G. Nickenig, R.S. von Bardeleben, U. Schäfer, S. Baldus, M. Montorfano, and F. Deuschl have received speakers’ honoraria as well as travel and grant support from Edwards Lifesciences. E. Agricola and R. Schüler have received speakers’ honoraria from Edwards Lifesciences. F. Deuschl, S.H. Deo, S. Gilmore, and T. Feldman are employees of Edwards Lifesciences. R.T. Hahn reports speaker honoraria from Baylis Medical, Edwards Lifesciences and Medtronic, consulting for Abbott Structural, Edwards Lifesciences, Medtronic, Navigate and Philips Healthcare, and being the Chief Scientific Officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. The other authors have no conflicts of interest to declare.

Figures

Figure 1

Transcatheter Cardioband Tricuspid Valve Reconstruction System. Cardioband tricuspid implant along the adjusted tricuspid valve annulus. Image provided by Edwards Lifesciences with permission.

Figure 2

Patient disposition diagram. ¶One device-related. *Died between one and two years.

Figure 3

Reduction in septolateral annular diameter and tricuspid regurgitation severity for the Cardioband Tricuspid Valve Reconstruction System. A) Significant reduction in end-diastolic septolateral annular diameter. B) Mild/moderate TR was present in 24% of patients at baseline, 63% at one year (p=0.007) and 72% at two years (p=0.016). Paired Student’s t-test for continuous variables or the Wilcoxon signed-rank test for categorical variables. aBaseline vs discharge (n=22), baseline vs one year (n=17) or baseline vs two years (n=12). bBaseline vs discharge (n=20), baseline vs one year (n=15) or baseline vs two years (n=10). The figure reports all available data, i.e., unpaired. The p-values were calculated from paired data reflected in the figure legend.

Figure 4

Clinical and functional improvements from baseline to two years for the Cardioband Tricuspid Valve Reconstruction System. A) New York Heart Association (NYHA) functional Class I-II was increased to 82% at two years. B) Oedema grade ++ or worse, classified by pitted oedema grades, was reduced to 6% at two years. C) Six-minute walk distance increased to 309±119 metres at two years. D) Kansas City Cardiomyopathy Questionnaire (KCCQ) scores increased to 63±26 points at two years. Paired Student’s t-test for continuous variables or the Wilcoxon signed-rank test for categorical variables. aBaseline vs one year (n=23) or baseline vs two years (n=17). bBaseline vs one year (n=23) or baseline vs two years (n=17). cBaseline vs one year (n=19) or baseline vs two years (n=12). dBaseline vs one year (n=23) or baseline vs two years (n=20). The figure reports all available data, i.e., unpaired. The p-values were calculated from paired data reflected in the figure legend.

Figure 5

Two-year survival and hospitalisation Kaplan-Meier curves. A) The KM estimate of survival at two years was 73%. B) The KM estimate of freedom from heart failure hospitalisation at two years was 56%.