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

<b>Background:</b> 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...

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Main Authors: Da-Wei Lin, Ling-Wei Zou, Jia-Xin Miao, Jia-Ning Fan, Min-Fang Meng, Yi-Ming Qi, Zhi Zhan, Wen-Zhi Pan, Da-Xin Zhou, Xiao-Chun Zhang, Jun-Bo Ge
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Language:English
Published: MDPI AG 2025-02-01
Series:Journal of Cardiovascular Development and Disease
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Online Access:https://www.mdpi.com/2308-3425/12/2/55
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author Da-Wei Lin
Ling-Wei Zou
Jia-Xin Miao
Jia-Ning Fan
Min-Fang Meng
Yi-Ming Qi
Zhi Zhan
Wen-Zhi Pan
Da-Xin Zhou
Xiao-Chun Zhang
Jun-Bo Ge
author_facet Da-Wei Lin
Ling-Wei Zou
Jia-Xin Miao
Jia-Ning Fan
Min-Fang Meng
Yi-Ming Qi
Zhi Zhan
Wen-Zhi Pan
Da-Xin Zhou
Xiao-Chun Zhang
Jun-Bo Ge
author_sort Da-Wei Lin
collection DOAJ
description <b>Background:</b> 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. <b>Methods:</b> 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. <b>Results:</b> 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. <b>Conclusions:</b> 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.
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spelling doaj-art-e90d01e9a26a4b0990ee95f158a9fc622025-08-20T02:44:42ZengMDPI AGJournal of Cardiovascular Development and Disease2308-34252025-02-011225510.3390/jcdd12020055Outcomes of K-Clip Implantation for Functional Tricuspid Regurgitation Accompanied with Persistent Atrial FibrillationDa-Wei Lin0Ling-Wei Zou1Jia-Xin Miao2Jia-Ning Fan3Min-Fang Meng4Yi-Ming Qi5Zhi Zhan6Wen-Zhi Pan7Da-Xin Zhou8Xiao-Chun Zhang9Jun-Bo Ge10Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, ChinaDepartment of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, ChinaDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, ChinaDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, ChinaDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, ChinaDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, ChinaDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, ChinaDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, ChinaDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, ChinaDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, ChinaDepartment of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, China<b>Background:</b> 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. <b>Methods:</b> 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. <b>Results:</b> 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. <b>Conclusions:</b> 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.https://www.mdpi.com/2308-3425/12/2/55transcatheter annular repairK-Clip™functional tricuspid regurgitationatrial fibrillation
spellingShingle Da-Wei Lin
Ling-Wei Zou
Jia-Xin Miao
Jia-Ning Fan
Min-Fang Meng
Yi-Ming Qi
Zhi Zhan
Wen-Zhi Pan
Da-Xin Zhou
Xiao-Chun Zhang
Jun-Bo Ge
Outcomes of K-Clip Implantation for Functional Tricuspid Regurgitation Accompanied with Persistent Atrial Fibrillation
Journal of Cardiovascular Development and Disease
transcatheter annular repair
K-Clip™
functional tricuspid regurgitation
atrial fibrillation
title Outcomes of K-Clip Implantation for Functional Tricuspid Regurgitation Accompanied with Persistent Atrial Fibrillation
title_full Outcomes of K-Clip Implantation for Functional Tricuspid Regurgitation Accompanied with Persistent Atrial Fibrillation
title_fullStr Outcomes of K-Clip Implantation for Functional Tricuspid Regurgitation Accompanied with Persistent Atrial Fibrillation
title_full_unstemmed Outcomes of K-Clip Implantation for Functional Tricuspid Regurgitation Accompanied with Persistent Atrial Fibrillation
title_short Outcomes of K-Clip Implantation for Functional Tricuspid Regurgitation Accompanied with Persistent Atrial Fibrillation
title_sort outcomes of k clip implantation for functional tricuspid regurgitation accompanied with persistent atrial fibrillation
topic transcatheter annular repair
K-Clip™
functional tricuspid regurgitation
atrial fibrillation
url https://www.mdpi.com/2308-3425/12/2/55
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