Kizuku Yamashita1,2, Satsuki Fukushima1, Yusuke Shimahara1, Yasuhiro Hamatani3, Hideaki Kanzaki3, Tetsuya Fukuda4, Chisato Izumi3, Satoshi Yasuda3, Junjiro Kobayashi1, Tomoyuki Fujita5. 1. Department of Cardiac Surgery, National Cerebral and Cardiovascular Center, 5-7-1 Fujishirodai, Suita, Osaka, 565-8565, Japan. 2. William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK. 3. Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan. 4. Department of Radiology, National Cerebral and Cardiovascular Center, Osaka, Japan. 5. Department of Cardiac Surgery, National Cerebral and Cardiovascular Center, 5-7-1 Fujishirodai, Suita, Osaka, 565-8565, Japan. tomofujita@nifty.com.
Abstract
OBJECTIVE: The valve-in-valve procedure, in which a transcatheter heart valve (THV) is implanted into a degenerated bioprosthetic valve, is standardized for high-risk patients. However, this procedure is challenging in Japanese patients who have a small aortic annulus. We investigated the feasibility, safety, and therapeutic efficacy of the valve-in-valve procedure involving a degenerated stented bioprosthesis, stentless bioprosthesis, or THV. METHODS: We performed a single-center, non-comparative study of the aortic valve-in-valve procedure (AORTIC VIV study). Beginning in October 2016, the aortic valve-in-valve procedure was performed in seven patients with a stented bioprosthesis, in three patients with a stentless bioprosthesis, and in one patient with a THV. RESULTS: No 30-day post-procedure mortality or severe morbidities occurred. The mean echocardiographic gradient in the aortic position improved from 41 (38-48) to 17 (11-22) mmHg at 30 days (p = 0.01). No paravalvular or mild and more transvalvular leaks were detected. The New York Heart Association functional class improved from 2 (2-2.5) to 1 (1-1) at 30 days postoperatively (p = 0.01). Although the procedure failed in two patients with an implanted stentless bioprosthesis, the third patient with a stentless bioprosthesis and the one patient with a degenerated THV successfully underwent the valve-in-valve procedure. CONCLUSIONS: Feasibility, safety, and potential efficacy of the aortic valve-in-valve procedure were confirmed in selected Japanese patients with a degenerated aortic bioprosthesis. The valve-in-valve procedure for stentless bioprostheses was technically challenging.
OBJECTIVE: The valve-in-valve procedure, in which a transcatheter heart valve (THV) is implanted into a degenerated bioprosthetic valve, is standardized for high-risk patients. However, this procedure is challenging in Japanese patients who have a small aortic annulus. We investigated the feasibility, safety, and therapeutic efficacy of the valve-in-valve procedure involving a degenerated stented bioprosthesis, stentless bioprosthesis, or THV. METHODS: We performed a single-center, non-comparative study of the aortic valve-in-valve procedure (AORTIC VIV study). Beginning in October 2016, the aortic valve-in-valve procedure was performed in seven patients with a stented bioprosthesis, in three patients with a stentless bioprosthesis, and in one patient with a THV. RESULTS: No 30-day post-procedure mortality or severe morbidities occurred. The mean echocardiographic gradient in the aortic position improved from 41 (38-48) to 17 (11-22) mmHg at 30 days (p = 0.01). No paravalvular or mild and more transvalvular leaks were detected. The New York Heart Association functional class improved from 2 (2-2.5) to 1 (1-1) at 30 days postoperatively (p = 0.01). Although the procedure failed in two patients with an implanted stentless bioprosthesis, the third patient with a stentless bioprosthesis and the one patient with a degenerated THV successfully underwent the valve-in-valve procedure. CONCLUSIONS: Feasibility, safety, and potential efficacy of the aortic valve-in-valve procedure were confirmed in selected Japanese patients with a degenerated aortic bioprosthesis. The valve-in-valve procedure for stentless bioprostheses was technically challenging.
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