Department of Cardiac Surgery, University Hospital Basel, Spitalstrasse 21, CH-4031, Basel, Switzerland.
Department of Cardiology, University Hospital Basel, Basel, Switzerland.
World J Surg. 2020 Sep;44(9):3175-3181. doi: 10.1007/s00268-020-05588-x.
Mid-term data from a single centre showed the safety and durability of aortic valve neocuspidization using autologous pericardium (OZAKI procedure). Since validation data from other centres are missing, aim of this study was to analyze echocardiographic and clinical results of our first patients that were operated with the OZAKI technique.
Thirty-five patients (24 males, median (IQR) age 72.0 (59.0, 76.0) years) with aortic stenosis (AS; n = 10), aortic insufficiency (AR; n = 13) or a combination of both (AS/AR; n = 12), underwent aortic valve neocuspidization in our institution between September 2015 and May 2017. Echocardiographic follow-up was performed using a standardized examination protocol.
Clinical follow-up was completed in 97% of the patients. Median (IQR) follow-up time was 645 (430, 813) days. Mortality rate was 9% (n = 1: aspiration pneumonia; n = 1: unknown; n = 1: anaphylactic shock), and the reoperation rate was 3% (n = 1: endocarditis). No pacemaker implantation was necessary after isolated OZAKI procedures. Echocardiographic follow-up was performed in 83% of the patients (n = 29; median (IQR) time 664 (497, 815) days). Median (IQR) mean and peak gradients were 6 (5,9) mmHg and 12 (8, 17) mmHg. Moderate aortic regurgitation was seen in 2 patients (7%). No severe aortic regurgitation or moderate or severe aortic stenosis occurred within the follow-up period.
The OZAKI procedure is reliable and reoperation due to structural valve deterioration nil within a median 645 days follow-up period. The low rate of moderate aortic regurgitation will be surveilled very closely. Further studies are required to evaluate the significance of this procedure in aortic valve surgery.
ClinicalTrials.gov (ID NCT03677804).
来自单一中心的中期数据表明，使用自体心包（OZAKI 手术）进行主动脉瓣新生物成形术的安全性和耐久性。由于其他中心缺乏验证数据，本研究旨在分析我们第一批接受 OZAKI 技术治疗的患者的超声心动图和临床结果。
2015 年 9 月至 2017 年 5 月，我院对 35 例主动脉瓣狭窄（AS；n=10）、主动脉瓣关闭不全（AR；n=13）或两者并存（AS/AR；n=12）的患者进行了主动脉瓣新生物成形术。采用标准化的超声心动图检查方案进行随访。
97%的患者完成了临床随访。中位（IQR）随访时间为 645（430，813）天。死亡率为 9%（n=1：吸入性肺炎；n=1：原因不明；n=1：过敏性休克），再次手术率为 3%（n=1：心内膜炎）。孤立的 OZAKI 手术后不需要植入起搏器。83%的患者（n=29；中位（IQR）时间 664（497，815）天）进行了超声心动图随访。中位（IQR）平均和峰值梯度分别为 6（5，9）mmHg 和 12（8，17）mmHg。2 例（7%）患者出现中度主动脉瓣反流。在随访期间，未发生严重主动脉瓣反流或中重度主动脉瓣狭窄。
在中位 645 天的随访期间，OZAKI 手术可靠，且无结构性瓣膜恶化导致再次手术。中度主动脉瓣反流的发生率较低，将密切监测。需要进一步的研究来评估该手术在主动脉瓣手术中的意义。
ClinicalTrials.gov（ID NCT03677804）。
