Kizuku Yamashita1,2, Satsuki Fukushima1, Yusuke Shimahara1, Atsushi Okada3, Makoto Amaki3, Hideaki Kanzaki3, Chisato Izumi3, Satoshi Yasuda3, Junjiro Kobayashi1, Tomoyuki Fujita4. 1. Departments 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. Departments of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan. 4. Departments of Cardiac Surgery, National Cerebral and Cardiovascular Center, 5-7-1 Fujishirodai, Suita, Osaka, 565-8565, Japan. tomofujita@nifty.com.
Abstract
OBJECTIVE: The mitral valve-in-valve procedure has been performed in the world. However, the early clinical outcomes in Japan remain unclear. Hence, we investigated the feasibility, safety, and efficacy in high-risk Japanese patients. METHODS: In May 2017, we launched the present clinical study of the mitral valve-in-valve procedure (MITRAL VIV study). The study enrolled four patients (three women; age range 69-85 years) with severe mitral regurgitation due to a degenerated mitral bioprosthesis. The median Society of Thoracic Surgeons score was 8.8 (range 8.4-9.8)%. RESULTS: In all patients, the mitral valve-in-valve procedure was successfully performed via a transapical approach at the initial attempt. The median grade of mitral insufficiency improved from grade 4 (range 3-4) to grade 1 (range 0-1) at days 7 and 30. The mean mitral pressure gradient of the median value changed from 7.0 (range 5.0-8.0) mmHg to 5.0 (range 5.0-9.5) mmHg at 7 days and 6.2 (range 4.0-11.0) mmHg at 30 days. The median New York Heart Association functional class improved from 2 (range 2-3) to 1 (range 1-3) at day 7 and to 1 (range 1-2) at day 30. We performed a bit deep implantation intentionally to avoid left ventricular outflow tract obstruction in one patient with a small aorto-mitral-annular angle. Neither mortality nor severe complications were observed at the last follow-up (range 207-513 days). CONCLUSIONS: In our experience, the safe mitral valve-in-valve procedure was feasible with cautious procedures.
OBJECTIVE: The mitral valve-in-valve procedure has been performed in the world. However, the early clinical outcomes in Japan remain unclear. Hence, we investigated the feasibility, safety, and efficacy in high-risk Japanese patients. METHODS: In May 2017, we launched the present clinical study of the mitral valve-in-valve procedure (MITRAL VIV study). The study enrolled four patients (three women; age range 69-85 years) with severe mitral regurgitation due to a degenerated mitral bioprosthesis. The median Society of Thoracic Surgeons score was 8.8 (range 8.4-9.8)%. RESULTS: In all patients, the mitral valve-in-valve procedure was successfully performed via a transapical approach at the initial attempt. The median grade of mitral insufficiency improved from grade 4 (range 3-4) to grade 1 (range 0-1) at days 7 and 30. The mean mitral pressure gradient of the median value changed from 7.0 (range 5.0-8.0) mmHg to 5.0 (range 5.0-9.5) mmHg at 7 days and 6.2 (range 4.0-11.0) mmHg at 30 days. The median New York Heart Association functional class improved from 2 (range 2-3) to 1 (range 1-3) at day 7 and to 1 (range 1-2) at day 30. We performed a bit deep implantation intentionally to avoid left ventricular outflow tract obstruction in one patient with a small aorto-mitral-annular angle. Neither mortality nor severe complications were observed at the last follow-up (range 207-513 days). CONCLUSIONS: In our experience, the safe mitral valve-in-valve procedure was feasible with cautious procedures.
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