Zhang Xiaochun, Jin Qinchun, Pan Wenzhi, Li Wei, Guo Yingqiang, Ma Genshan, Pan Cuizhen, Chen Shasha, Zhang Yuan, Zhang Lei, Li Mingfei, Hou Shiqiang, Lam Yat-Yin, Modine Thomas, Lee Alex Pui-Wai, Qian Juying, Zhou Daxin, Ge Junbo
Department of Cardiology, Zhongshan Hospital, Shanghai Institute of Cardiovascular Disease, Fudan University, Shanghai, China; National Clinical Research Center for Interventional Medicine, Shanghai, China.
Shanghai Institution of Cardiovascular Disease, Shanghai Institute of Medical Imaging, Department of Echocardiography, Zhongshan Hospital, Fudan University, Shanghai, China.
Int J Cardiol. 2023 Nov 1;390:131174. doi: 10.1016/j.ijcard.2023.131174. Epub 2023 Jul 12.
Severe TR is associated with impaired prognosis while limited interventional options available. The purpose of this observational first-in-human experience with the K-Clip™ transcatheter tricuspid annular reconstruction system is to investigate its feasibility, safety as well as short-term clinical impact on patients with severe functional tricuspid regurgitation (TR).
In this compassionate-use, prospective, multi-center, single-arm study, 15 patients with severe symptomatic functional TR were treated with the K-Clip™ system and followed up at 30 days after discharge. Feasibility endpoints consisted of safety (major clinical cardiovascular events (MACEs), echocardiographic, clinical and functional endpoints.
All the 15 patients (9 males, 72.67 ± 9.42 years of age) successfully received implants and no MACEs were reported throughout the study at 30 days. Between baseline and 30 days, echocardiography showed remarkable reduction of tricuspid annular circumference and area by 14.30% and 25.96%. Improvement of ≥ + 2 grade and ≥ +3 grade TR was presented in 9/15(60.00%) and 4/15(26.67%) respectively while 10/15(66.67%) of patients had ≤ moderate TR. Clinical evaluation indicated that 86.67% of patients were finally in NYHA functional class I or II (p<0.001) and overall Kansas City Cardiomyopathy Questionnaire score improved from 62.28 ± 18.97 to 77.90 ± 11.70 (p = 0.016).
Our first-in-human results of the transcatheter tricuspid annular reconstruction using the K-Clip™ system demonstrated initial favorable procedural success, acceptable safety and remarkable TR reduction in consistent with significant clinical improvement. Larger-scaled prospective trials with longer follow-up duration are warranted to further determine whether these promising findings could be promoted to a broader population in the long term.
严重三尖瓣反流与预后不良相关，而可用的介入治疗选择有限。本项关于K-Clip™经导管三尖瓣环重建系统的首次人体观察性研究的目的是调查其对严重功能性三尖瓣反流（TR）患者的可行性、安全性以及短期临床影响。
在这项同情用药、前瞻性、多中心、单臂研究中，15例有症状的严重功能性TR患者接受了K-Clip™系统治疗，并在出院后30天进行随访。可行性终点包括安全性（主要临床心血管事件（MACE））、超声心动图、临床和功能终点。
所有15例患者（9例男性，年龄72.67±9.42岁）均成功植入，在30天的整个研究期间未报告MACE。在基线和30天之间，超声心动图显示三尖瓣环周长和面积显著减少，分别减少了14.30%和25.96%。分别有9/15（60.00%）和4/15（26.67%）的患者TR改善≥+2级和≥+3级，而10/15（66.67%）的患者TR≤中度。临床评估表明，86.67%的患者最终处于纽约心脏协会（NYHA）心功能I级或II级（p<0.001），堪萨斯城心肌病问卷总分从62.28±18.97提高到77.90±11.70（p = 0.016）。
我们使用K-Clip™系统进行经导管三尖瓣环重建的首次人体研究结果显示，手术初步取得良好成功，安全性可接受，TR显著减少，同时临床有显著改善。有必要开展规模更大、随访时间更长的前瞻性试验，以进一步确定这些有前景发现能否长期推广到更广泛人群。
