Lai Wei1, Huan Liu1, Liming Zhu1, Ye Yang1, Jiayu Zheng1, Kefang Guo2, Hong Luo2, Weipeng Zhao3, Xue Yang4, Aikebaier Maimaiti1, Chunsheng Wang5. 1. Department of Cardiovascular Surgery, Shanghai Cardiovascular Institution and Zhongshan Hospital, Fudan University, Shanghai, China. 2. Department of Anesthesiology, Zhongshan Hospital, Fudan University, Shanghai, China. 3. Department of Echocardiography, Shanghai Cardiovascular Institution and Zhongshan Hospital, Fudan University, Shanghai, China. 4. Department of Medical Imaging, Zhongshan Hospital, Fudan University, Shanghai, China. 5. Department of Cardiovascular Surgery, Shanghai Cardiovascular Institution and Zhongshan Hospital, Fudan University, Shanghai, China. Electronic address: wcs_heartsurgeon@126.com.
Abstract
OBJECTIVES: This study introduces a newly designed transcatheter aortic valve system, the J-Valve system, and evaluates its application in patients with predominant aortic regurgitation without significant valve calcification. We also report the early results of one of the first series of transapical implantations of this device and aim to offer guidance on the technical aspects of the procedure. BACKGROUND: Transcatheter aortic valve replacement (TAVR) has been widely used in high-risk patients for surgical aortic valve replacement. However, the majority of the TAVR devices were designed for aortic valve stenosis with significant valve calcification. METHODS: Six patients with native aortic regurgitation without significant valve calcification (age, 61 to 83 years; mean age, 75.50 ± 8.14 years) underwent transapical implantation of the J-Valve prosthesis (JieCheng Medical Technology Co., Ltd., Suzhou, China), a self-expandable porcine valve, in the aortic position at our institution. All patients were considered to be prohibitive or high risk for surgical valve replacement (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation], 22.15% to 44.44%; mean, 29.32 ± 7.70%) after evaluation by an interdisciplinary heart team. Procedural and clinical outcomes were analyzed. RESULTS: Implantations were successful in all patients. During the follow-up period (from 31 days to 186 days, mean follow-up was 110.00 ± 77.944 days), only 1 patient had trivial prosthetic valve regurgitation, and none of these patients had paravalvular leak of more than mild grade. There were no major post-operative complications or mortality during the follow-up. CONCLUSIONS: Our study demonstrated the feasibility of transapical implantation of the J-Valve system in high-risk patients with predominant aortic regurgitation.
OBJECTIVES: This study introduces a newly designed transcatheter aortic valve system, the J-Valve system, and evaluates its application in patients with predominant aortic regurgitation without significant valve calcification. We also report the early results of one of the first series of transapical implantations of this device and aim to offer guidance on the technical aspects of the procedure. BACKGROUND: Transcatheter aortic valve replacement (TAVR) has been widely used in high-risk patients for surgical aortic valve replacement. However, the majority of the TAVR devices were designed for aortic valve stenosis with significant valve calcification. METHODS: Six patients with native aortic regurgitation without significant valve calcification (age, 61 to 83 years; mean age, 75.50 ± 8.14 years) underwent transapical implantation of the J-Valve prosthesis (JieCheng Medical Technology Co., Ltd., Suzhou, China), a self-expandable porcine valve, in the aortic position at our institution. All patients were considered to be prohibitive or high risk for surgical valve replacement (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation], 22.15% to 44.44%; mean, 29.32 ± 7.70%) after evaluation by an interdisciplinary heart team. Procedural and clinical outcomes were analyzed. RESULTS: Implantations were successful in all patients. During the follow-up period (from 31 days to 186 days, mean follow-up was 110.00 ± 77.944 days), only 1 patient had trivial prosthetic valve regurgitation, and none of these patients had paravalvular leak of more than mild grade. There were no major post-operative complications or mortality during the follow-up. CONCLUSIONS: Our study demonstrated the feasibility of transapical implantation of the J-Valve system in high-risk patients with predominant aortic regurgitation.