First-in-man Experience of a New Transcatheter Edge-to-edge Repair System Neoblazar in Patients With Severe Tricuspid Regurgitation  

作　　者：Xiang Chen Da Zhu Maolong Su Xu Chen Pianpian Yan Hongmei Wen Bin Wang Nianguo Dong Xiangbin Pan Yan Wang 

机构地区：[1]Department of Cardiology,Xiamen Cardiovascular Hospital of Xiamen University,Xiamen,Fujian 361004,China [2]Department of Cardiac Surgery,Fuwai Yunnan Cardiovascular Hospital,Kunming,Yunnan 650102,China [3]Department of Cardiac Surgery,Wuhan Union Hospital,Tongji Medical College,Huazhong University of Science and Technology University,Wuhan,Hubei 430022,China

出　　处：《Cardiology Discovery》2024年第2期160-166,共7页心血管病探索（英文）

基　　金：National Key Researchand Development Program(2022YFC2503400);Yunnan Provincial Clinical Research Center for Cardiovascular Diseases(202302AA310045).

摘　　要：objective:Severe tricuspid regurgitation frequently leads to increased mortality and a poor prognosis.Transcatheter edge-to-edge repair(TEER)for tricuspid valve regurgitation has been reported as a safe alternative to traditional open-heart surgery.This study endeavors to assess the efficacy and safety of a newly designed Neoblazar TEER system in this high-risk population.Methods:This investigation was structured as a prospective,single-arm,first-in-man trial in China(ClinicalTrials.gov number:NCT05497141).From August 2022 to October 2022,patients with severe tricuspid regurgitation were enrolled from 3 centers(Xiamen Cardiovascular Hospital,Fuwai Yunnan Cardiovascular Hospital,and Wuhan Union Hospital).The primary endpoint was achieving a minimum 1-grade reduction in tricuspid regurgitation at the 6-month post-TEER intervention,in addition to the pertinent New York Heart Association class.Scheduled echocardiographic evaluations were conducted at the following distinct intervals:baseline,discharge,1 month,and 6 months post-TEER intervention.Results:A total of 10 patients were enrolled in the study.Immediately after the TEER procedure with the Neoblazar system,massive tricuspid regurgitation(grade 5+)at baseline decreased to moderate-severe tricuspid regurgitation(grade 3+)in 2 patients and the optimal tricuspid regurgitation reduction(severe tricuspid regurgitation(grade 4+)to mild tricuspid regurgitation(grade 1+)were achieved in 6 patients.After 6 months of follow-up,tricuspid regurgitation reduction was found to be durable in all enrolled patients,among whom at least 1 grade of tricuspid regurgitation reduction was sustained,even without reintervention.Consistently,the New York Heart Association class among these subjects significantly improved,with the percentage of patients categorized as class I-ll increasing from 0/10 at baseline to 5/10 after 1 month(P=0.015)and 8/10 after 6 months(P<0.001).Conclusion:Tricuspid TEER with the newly designed Neoblazar system appears to be a feasible and safe alternative in

关 键 词：Tricuspid valve insufficiency Transcatheter edge-to-edge repair Heart failure 

分 类 号：R654.2[医药卫生—外科学] R318[医药卫生—临床医学]