Study Protocol for Transcatheter Aortic Valve Replacement for a Degenerated Aortic Bioprosthesis in a Japanese Cohort

Kizuku Yamashita; Satsuki Fukushima; Yusuke Shimahara; Takuma Yamasaki; Yorihiko Matsumoto; Naonori Kawamoto; Naoki Tadokoro; Takashi Kakuta; Yasuhiro Hamatani; Atsushi Okada; Hiroyuki Takahama; Makoto Amaki; Takuya Hasegawa; Hideaki Kanzaki; Chisato Izumi; Satoshi Yasuda; Junjiro Kobayashi; Tomoyuki Fujita

doi:10.1253/circrep.CR-18-0023

Protocol Paper

Study Protocol for Transcatheter Aortic Valve Replacement for a Degenerated Aortic Bioprosthesis in a Japanese Cohort

Kizuku Yamashita, Satsuki Fukushima, Yusuke Shimahara, Takuma Yamasaki, Yorihiko Matsumoto, Naonori Kawamoto, Naoki Tadokoro, Takashi Kakuta, Yasuhiro Hamatani, Atsushi Okada, Hiroyuki Takahama, Makoto Amaki, Takuya Hasegawa, Hideaki Kanzaki, Chisato Izumi, Satoshi Yasuda, Junjiro Kobayashi, Tomoyuki Fujita

Author information

Kizuku Yamashita
Department of Cardiac Surgery, National Cerebral and Cardiovascular Center
William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London
Satsuki Fukushima
Department of Cardiac Surgery, National Cerebral and Cardiovascular Center
Yusuke Shimahara
Department of Cardiac Surgery, National Cerebral and Cardiovascular Center
Takuma Yamasaki
Department of Cardiac Surgery, National Cerebral and Cardiovascular Center
Yorihiko Matsumoto
Department of Cardiac Surgery, National Cerebral and Cardiovascular Center
Naonori Kawamoto
Department of Cardiac Surgery, National Cerebral and Cardiovascular Center
Naoki Tadokoro
Department of Cardiac Surgery, National Cerebral and Cardiovascular Center
Takashi Kakuta
Department of Cardiac Surgery, National Cerebral and Cardiovascular Center
Yasuhiro Hamatani
Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
Atsushi Okada
Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
Hiroyuki Takahama
Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
Makoto Amaki
Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
Takuya Hasegawa
Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
Hideaki Kanzaki
Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
Chisato Izumi
Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
Satoshi Yasuda
Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center
Junjiro Kobayashi
Department of Cardiac Surgery, National Cerebral and Cardiovascular Center
Tomoyuki Fujita
Department of Cardiac Surgery, National Cerebral and Cardiovascular Center

Keywords: Transcatheter aortic valve replacement, TAV-in-SAV, TAV-in-TAV, Valve-in-valve

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Supplementary material

2019 Volume 1 Issue 2 Pages 102-106

DOI https://doi.org/10.1253/circrep.CR-18-0023

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Abstract

Background: The valve-in-valve (VIV) procedure is being increasingly performed in high-risk patients with a degenerated bioprosthesis in an aortic position in Western countries. The early safety and efficacy of the VIV procedure, however, remain unclear in Japanese patients with a small aortic annulus. We present the protocol for a study designed to evaluate the early safety and efficacy of the VIV procedure in the aortic position in Japanese patients.

Methods and Results: The prospective, single-center, non-comparative, clinical study of the VIV procedure for the aortic position (AORTIC VIV study) commenced in August 2016 and will end in March 2020. Patients will be monitored for ≥1 month after the VIV procedure. The targeted number of patients is 11. Eligible patients are those who have undergone transcatheter aortic valve replacement for a surgical valve (including stented or stentless bioprosthetic valves), or for a transcatheter heart valve. The VIV procedure is performed in high-operative-risk patients with substantial prosthetic valve stenosis, and regurgitation and heart failure resistant to medical treatment (unless the patient meets an exclusion criterion). The safety and efficacy of the VIV procedure will be evaluated in accordance with the Valve Academic Research Consortium-2 initiative.

Conclusions: The AORTIC VIV study will clarify the early safety and efficacy of the VIV procedure in Japanese patients.

Corresponding author

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