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© 2025 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

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.

Details

Title
Outcomes of K-Clip Implantation for Functional Tricuspid Regurgitation Accompanied with Persistent Atrial Fibrillation
Author
Da-Wei, Lin 1 ; Ling-Wei, Zou 2 ; Jia-Xin Miao 1 ; Jia-Ning, Fan 1   VIAFID ORCID Logo  ; Min-Fang, Meng 3   VIAFID ORCID Logo  ; Yi-Ming, Qi 1 ; Zhan, Zhi 1 ; Wen-Zhi Pan 1 ; Da-Xin, Zhou 1 ; Xiao-Chun, Zhang 1 ; Jun-Bo Ge 1 

 Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, China; [email protected] (D.-W.L.); [email protected] (J.-X.M.); [email protected] (J.-N.F.); [email protected] (M.-F.M.); [email protected] (Y.-M.Q.); [email protected] (Z.Z.); [email protected] (W.-Z.P.); [email protected] (J.-B.G.); National Clinical Research Center for Interventional Medicine, Shanghai 200433, China 
 Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China; [email protected] 
 Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, China; [email protected] (D.-W.L.); [email protected] (J.-X.M.); [email protected] (J.-N.F.); [email protected] (M.-F.M.); [email protected] (Y.-M.Q.); [email protected] (Z.Z.); [email protected] (W.-Z.P.); [email protected] (J.-B.G.); Department of Echocardiography, Zhongshan Hospital, Fudan University, Shanghai 200032, China 
First page
55
Publication year
2025
Publication date
2025
Publisher
MDPI AG
e-ISSN
23083425
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
3171060469
Copyright
© 2025 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.