Outcomes of K-Clip Implantation for Functional Tricuspid Regurgitation Accompanied with Persistent Atrial Fibrillation

Background: Atrial fibrillation (AF) has been identified as a risk factor for functional tricuspid regurgitation (FTR) in the absence of other known etiologies, although limited interventional options are available. K-Clip™, a novel transcatheter tricuspid annuloplasty device, is a clip-based annular plication approach for FTR. To date, no studies have investigated the short-term outcomes of K-Clip™ for patients with severe FTR associated with AF. Therefore, the aim of this study was to explore the feasibility and effectiveness of transcatheter annular repair with K-Clip™ for FTR in patients with persistent AF. Methods: Patients with FTR and persistent AF who underwent transcatheter annular repair with K-Clip™ at nine centers in China during the inclusion period were included (This study derived from Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip™ Transcatheter Annuloplasty System [TriStar study}). Baseline data, imaging results, and follow-up data were collected. Results: All 52 patients (23 men, 74.02 ± 7.03 years) received successful intervention, and the mean operation time and radian exposure were 2.64 ± 1.09 h and 133.33 ± 743.06 mGy, respectively. No death cases and a low major adverse event occurrence rate were reported in 30 days. A significant decrease in FTR was documented, and TR remained severe in only two patients (3.8%). The regurgitation volume decreased significantly, accompanied by a notable reduction in the effective regurgitation orifice area and tricuspid annulus diameter, which subsequently led to the reversal of right heart remodeling. Furthermore, a decrease in pulmonary artery systolic pressure and an increase in cardiac output were documented. Conclusions: Transcatheter annular repair with K-Clip™ showed favorable short-term prognosis and significant improvement in FTR in patients with severe FTR associated with persistent AF. K-Clip™ could be a novel option for that group of patients.