Efficacy and Safety of Cardioband in Patients with Tricuspid Regurgitation: Systematic Review and Meta-Analysis of Single-Arm Trials and Observational Studies

Abstract

Background/Objectives: The incidence and prevalence of tricuspid regurgitation (TR) are increasing worldwide. “Traditional” drug therapy with diuretics is often ineffective and the identification of new strategies, including non-pharmacological ones, is an urgent need. The aim of this study was to summarize the results on the efficacy and safety of Cardioband, one of the few approved transcatheter tricuspid valve repair systems, in patients with TR. Methods: Three databases (Medline, Scopus, and CENTRAL) were searched to identify clinical trials and observational studies on the efficacy (primary outcome) and safety (secondary outcome) of Cardioband. A random-effects meta-analysis was performed with R software (version 4.3.3). Survival and freedom from heart failure (HF) hospitalization were estimated with the method of reconstructing individual patient data from Kaplan–Meier curves (IPDfromKM). Results: Eleven studies were included in this systematic review and meta-analysis. Cardioband significantly reduced annulus diameter (−9.31 mm [95% Confidence Interval, CI: −11.47; −7.15]), vena contracta (−6.41 mm [95% CI: −8.34; −4.49]), and effective regurgitant orifice area (EROA) (−0.50 cm2 [95% CI: −0.72; −0.28]) in patients with TR. Cardioband reduced the severity of TR and the extent of heart failure in 91% [95% CI: 85; 97] and 63% [95% CI: 52–75] of patients, respectively. Finally, Cardioband implantation was associated with prolonged survival and freedom from HF hospitalization (80.1% and 57.8% at 24 months, respectively). Conclusions: This study demonstrates that Cardioband implantation leads to cardiac remodeling and mechanical improvements, reduces the severity of TR, and improves quality of life. Therefore, Cardioband is an effective option for the non-pharmacological treatment of TR.