Yamashita Kizuku, Fukushima Satsuki, Shimahara Yusuke, Okada Atsushi, Amaki Makoto, Kanzaki Hideaki, Izumi Chisato, Yasuda Satoshi, Kobayashi Junjiro, Fujita Tomoyuki
Departments of Cardiac Surgery, National Cerebral and Cardiovascular Center, 5-7-1 Fujishirodai, Suita, Osaka, 565-8565, Japan.
William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.
Gen Thorac Cardiovasc Surg. 2020 Jan;68(1):1-8. doi: 10.1007/s11748-019-01147-x. Epub 2019 May 25.
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.
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)%.
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).
In our experience, the safe mitral valve-in-valve procedure was feasible with cautious procedures.
二尖瓣瓣中瓣手术已在全球开展。然而,其在日本的早期临床结果仍不明确。因此,我们研究了该手术在高危日本患者中的可行性、安全性和有效性。
2017年5月,我们启动了二尖瓣瓣中瓣手术的临床研究(二尖瓣瓣中瓣研究)。该研究纳入了4例(3例女性;年龄69 - 85岁)因二尖瓣生物瓣退变导致严重二尖瓣反流的患者。胸外科医师协会评分中位数为8.8%(范围8.4 - 9.8%)。
所有患者均在首次尝试时通过经心尖途径成功完成二尖瓣瓣中瓣手术。二尖瓣反流的中位数等级在术后7天和30天从4级(范围3 - 4级)改善至1级(范围0 - 1级)。中位数二尖瓣压力阶差在7天时从7.0(范围5.0 - 8.0)mmHg变为5.0(范围5.0 - 9.5)mmHg,在30天时变为6.2(范围4.0 - 11.0)mmHg。纽约心脏协会心功能分级中位数在术后7天从2级(范围2 - 3级)改善至1级(范围1 - 3级),在30天时改善至1级(范围1 - 2级)。对于1例主动脉 - 二尖瓣环夹角较小的患者,我们有意进行了稍深的植入以避免左心室流出道梗阻。在末次随访(范围207 - 513天)时未观察到死亡或严重并发症。
根据我们的经验,谨慎操作下安全的二尖瓣瓣中瓣手术是可行的。