K夹经导管三尖瓣环成形系统治疗重度功能性三尖瓣反流患者的中期结果
Mid-Term Outcomes of K-Clip Transcatheter Tricuspid Annuloplasty System in Patients With Severe Functional Tricuspid Regurgitation.
作者信息
Xu Hongfei, Chen Miao, Wang Zhen, Huo Jingyuan, Li Jing, He Fengpu, Husanova Firyuza, Li Haoyang, Zhou Daxin, Zhang Xiaochun, Liu Xianbao, Song Guangyuan, Li Jie, Luo Jianfang, Guo Yingqiang, Mou Yun, Yuan Shuai, Tao Tingting, Wu Shengjun, Teng Peng, Ni Yiming, Ma Liang, Pan Xiangbin, Ge Junbo, Lee Alex Pui-Wai, Li Weidong
机构信息
Department of Cardiovascular Surgery, The First Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, China.
Echocardiography and Vascular Ultrasound Center, The First Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, China.
出版信息
JACC Cardiovasc Interv. 2024 Dec 9;17(23):2796-2807. doi: 10.1016/j.jcin.2024.10.007.
BACKGROUND
Conservative treatments for tricuspid regurgitation (TR) frequently yield suboptimal outcomes. Transcatheter interventions provide a new therapeutic avenue, with ongoing assessments of safety and effectiveness.
OBJECTIVES
The TriStar (Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip™ Transcatheter Annuloplasty System) study investigated 1-year outcomes of the K-Clip transcatheter tricuspid annuloplasty system in treating patients with severe functional TR.
METHODS
Patients with TR grade ≥4, resistant to medical management, were enrolled and selected by core laboratory evaluation. Oversight by a data and safety monitoring board and event adjudication by a clinical events committee occurred. Assessments at 30 days, 6 months, and 1 year included echocardiographic data, clinical symptoms, quality of life, study endpoints, and major adverse events.
RESULTS
A total of 96 patients (mean age 72.6 years, 59.4% women) were included, with a 97.9% implantation success rate. One-year outcomes showed 5.2% all-cause mortality, a 19.8% composite major adverse event rate, and no device-related reinterventions. TR decreased by ≥1 grade in 94.2%, and by ≥2 grades in 87.2% of patients. Kaplan-Meier estimates demonstrated 94.7% ± 2.3% survival and 90.4% ± 3.0% freedom from heart failure rehospitalization. NYHA functional class significantly improved (P < 0.001), with 97.7% reaching functional class I or II. The 6-minute walk distance improved by 42.8 m (P < 0.001), and Kansas City Cardiomyopathy Questionnaire score increased by 7.0 points (P < 0.001).
CONCLUSIONS
The K-Clip transcatheter tricuspid annuloplasty system showed high procedural success, a favorable safety profile, sustained TR reduction, and marked improvements in clinical outcomes and quality of life at 1 year. (Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip™ Transcatheter Annuloplasty System [TriStar]; NCT05173233).
背景
三尖瓣反流（TR）的保守治疗效果往往欠佳。经导管介入治疗提供了一种新的治疗途径，目前正在对其安全性和有效性进行评估。
目的
TriStar（使用K-Clip™经导管瓣环成形系统治疗三尖瓣反流的验证性临床研究）研究调查了K-Clip经导管三尖瓣瓣环成形系统治疗重度功能性TR患者的1年结局。
方法
纳入TR分级≥4级且药物治疗无效的患者，并通过核心实验室评估进行筛选。由数据和安全监测委员会进行监督，并由临床事件委员会进行事件判定。在30天、6个月和1年时的评估包括超声心动图数据、临床症状、生活质量、研究终点和主要不良事件。
结果
共纳入96例患者（平均年龄72.6岁，女性占59.4%），植入成功率为97.9%。1年结局显示全因死亡率为5.2%，复合主要不良事件发生率为19.8%，且无与器械相关的再次干预。94.2%的患者TR降低≥1级，87.2%的患者TR降低≥2级。Kaplan-Meier估计显示生存率为94.7%±2.3%，无心力衰竭再住院率为90.4%±3.0%。纽约心脏协会（NYHA）心功能分级显著改善（P<0.001），97.7%的患者达到I级或II级心功能。6分钟步行距离增加了42.8米（P<0.001），堪萨斯城心肌病问卷评分增加了7.0分（P<0.001）。
结论
K-Clip经导管三尖瓣瓣环成形系统显示出较高的手术成功率、良好的安全性、持续的TR降低，以及1年时临床结局和生活质量的显著改善。（使用K-Clip™经导管瓣环成形系统治疗三尖瓣反流的验证性临床研究[TriStar]；NCT05173233）
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