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.
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Authors | Huan Liu, Ye Yang, Wenshuo Wang, Da Zhu, Lai Wei, Kefang Guo, Weipeng Zhao, Xue Yang, Liming Zhu, Yingqiang Guo, Wei Wang, Chunsheng Wang |
Journal | The Journal of thoracic and cardiovascular surgery
(J Thorac Cardiovasc Surg)
Vol. 156
Issue 1
Pg. 106-116
(07 2018)
ISSN: 1097-685X [Electronic] United States |
PMID | 29525255
(Publication Type: Journal Article, Multicenter Study, Observational Study, Video-Audio Media)
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Copyright | Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved. |
Topics |
- Aged
- Aortic Valve
(diagnostic imaging, physiopathology, surgery)
- Aortic Valve Insufficiency
(diagnostic imaging, physiopathology, surgery)
- China
- Echocardiography, Doppler, Color
- Echocardiography, Transesophageal
- Feasibility Studies
- Female
- Heart Valve Prosthesis
- Hemodynamics
- Humans
- Male
- Multidetector Computed Tomography
- Postoperative Complications
(therapy)
- Prospective Studies
- Prosthesis Design
- Recovery of Function
- Risk Factors
- Time Factors
- Transcatheter Aortic Valve Replacement
(adverse effects, instrumentation)
- Treatment Outcome
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