Huan Liu1, Ye Yang1, Wenshuo Wang1, Da Zhu2, Lai Wei3, Kefang Guo4, Weipeng Zhao5, Xue Yang6, Liming Zhu1, Yingqiang Guo2, Wei Wang7, Chunsheng Wang1. 1. Department of Cardiovascular Surgery, Shanghai Cardiovascular Institution and Zhongshan Hospital, Fudan University, Shanghai, China. 2. Department of Cardiac Surgery, West China Hospital, Sichuan University, Chengdu, China. 3. Department of Cardiovascular Surgery, Shanghai Cardiovascular Institution and Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: wl_heartsurgeon@126.com. 4. Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, China. 5. Department of Echocardiography, Shanghai Cardiovascular Institution and Zhongshan Hospital, Fudan University, Shanghai, China. 6. Department of Medical Imaging, Zhongshan Hospital, Fudan University, Shanghai, China. 7. Department of Cardiac Surgery, Fuwai Cardiovascular Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Abstract
OBJECTIVE: To report on the Chinese multicenter study of the J-Valve transcatheter heart valve for treatment of predominant aortic regurgitation. METHODS: Transapical transcatheter aortic valve replacement with the J-Valve for treating high-risk severe aortic regurgitation was performed in 43 patients in 3 Chinese centers. The study was registered with the Chinese Clinical Trial Registry (ChiCTR-OPC-15006354). Procedural results and clinical outcomes up to 1-year were analyzed using Valve Academic Research Consortium 2 criteria. RESULTS: All patients (mean age, 73.9 ± 5.7 years) were considered at prohibitive or high risk for surgical valve replacement (logistic European System for Cardiac Operative Risk Evaluation, 20.0% to 44.4%; mean, 25.5% ± 5.3%) after evaluation by an interdisciplinary heart team. Transapical implantation was successful in 42 patients (97.7%). The 1-year outcomes included all-cause mortality (4.7%), disabling stroke (2.3%), new permanent pacemaker (4.7%), and valve-related reintervention (7.0%). At the 1-year follow-up, postprocedural paravalvular regurgitation was none/trace in 30 of 39 patients and mild in 8 of 39 patients, and the mean transvalvular gradient after valve implantation was favorable at 10.4 ± 4.5 mm Hg. CONCLUSIONS: After an initial demonstration of feasibility, this multicenter study shows that the J-Valve transcatheter heart valve system is a reasonable option for patients with predominant aortic regurgitation.
OBJECTIVE: To report on the Chinese multicenter study of the J-Valve transcatheter heart valve for treatment of predominant aortic regurgitation. METHODS: Transapical transcatheter aortic valve replacement with the J-Valve for treating high-risk severe aortic regurgitation was performed in 43 patients in 3 Chinese centers. The study was registered with the Chinese Clinical Trial Registry (ChiCTR-OPC-15006354). Procedural results and clinical outcomes up to 1-year were analyzed using Valve Academic Research Consortium 2 criteria. RESULTS: All patients (mean age, 73.9 ± 5.7 years) were considered at prohibitive or high risk for surgical valve replacement (logistic European System for Cardiac Operative Risk Evaluation, 20.0% to 44.4%; mean, 25.5% ± 5.3%) after evaluation by an interdisciplinary heart team. Transapical implantation was successful in 42 patients (97.7%). The 1-year outcomes included all-cause mortality (4.7%), disabling stroke (2.3%), new permanent pacemaker (4.7%), and valve-related reintervention (7.0%). At the 1-year follow-up, postprocedural paravalvular regurgitation was none/trace in 30 of 39 patients and mild in 8 of 39 patients, and the mean transvalvular gradient after valve implantation was favorable at 10.4 ± 4.5 mm Hg. CONCLUSIONS: After an initial demonstration of feasibility, this multicenter study shows that the J-Valve transcatheter heart valve system is a reasonable option for patients with predominant aortic regurgitation.
Authors: Erica L Soong; Yi Jing Ong; Jamie S Y Ho; Nichola W S Chew; William K F Kong; Tiong-Cheng Yeo; Ping Chai; Edgar L W Tay; Kent Tan; Yinghao Lim; Ivandito Kuntjoro; Ching-Hui Sia Journal: AsiaIntervention Date: 2021-12