Lin Da-Wei, Zou Ling-Wei, Miao Jia-Xin, Fan Jia-Ning, Meng Min-Fang, Qi Yi-Ming, Zhan Zhi, Pan Wen-Zhi, Zhou Da-Xin, Zhang Xiao-Chun, Ge Jun-Bo
Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
National Clinical Research Center for Interventional Medicine, Shanghai 200433, China.
J Cardiovasc Dev Dis. 2025 Feb 3;12(2):55. doi: 10.3390/jcdd12020055.
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. 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. 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. 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.
心房颤动（AF）已被确定为在无其他已知病因情况下功能性三尖瓣反流（FTR）的一个危险因素，尽管可用的干预选项有限。K-Clip™是一种新型经导管三尖瓣环成形装置，是一种用于FTR的基于夹子的环缩术方法。迄今为止，尚无研究调查K-Clip™用于伴有AF的严重FTR患者的短期结局。因此，本研究的目的是探讨使用K-Clip™进行经导管环修复治疗持续性AF患者FTR的可行性和有效性。纳入了纳入期内在中国9个中心接受K-Clip™经导管环修复的FTR和持续性AF患者（本研究源自K-Clip™经导管环成形系统治疗三尖瓣反流的验证性临床研究[TriStar研究]）。收集了基线数据、影像学结果和随访数据。所有52例患者（23例男性，年龄74.02±7.03岁）均成功接受干预，平均手术时间和辐射暴露分别为2.64±1.09小时和133.33±743.06毫戈瑞。30天内未报告死亡病例且主要不良事件发生率较低。记录到FTR显著降低，仅2例患者（3.8%）的三尖瓣反流（TR）仍为重度。反流容积显著降低，同时有效反流口面积和三尖瓣环直径明显减小，随后导致右心重塑逆转。此外，记录到肺动脉收缩压降低和心输出量增加。使用K-Clip™进行经导管环修复显示出良好的短期预后，且伴有持续性AF的严重FTR患者的FTR有显著改善。K-Clip™可能是该组患者的一种新选择。
