Prospectively Randomized Comparison of Different Mechanical Aortic Valves
Prospectively Randomized Comparison of Different Mechanical Aortic Valves
复制标题
不同机械主动脉瓣的前瞻性随机比较
作者：
R. Autschbach;T. Walther;V. Falk;M. Kostelka;Annegret Rösler;G. Langebartels;Martin Krüger;A. Diegeler;F. Mohr
背景：本前瞻性随机研究的目的是评价3种不同双叶机械瓣膜置换主动脉瓣后的血流动力学和功能结局。方法和结果-300名连续患者被随机分配接受ATS（n=100）、Carbomedics（n=100）或St Jude Medical Hemodynamic Plus（n=100）机械主动脉瓣置换术。患者年龄（平均61±8岁）、体表面积（1.9±0.2 m2）、左心室功能（射血分数0.59±0.17）和主动脉瓣狭窄（90%、89%和91%）方面无显著差异。所有患者均接受术后以及6个月和1年随访，包括经胸超声心动图。进行多变量统计分析。植入的瓣膜尺寸相当，分别为24±2（ATS）、23.7±1.6（CM）和23.6±1.9（SJM HP）mm（NS）。在1年随访时，观察到以下事件发生率：死亡3/1/1，均与瓣膜无关;卒中0/1/1;轻微跨瓣关闭不全3/3/2;瓣周漏2/3/2;再次手术0/1/1（NS）。术后和6个月随访时的跨瓣流速分别为2.5/2.6/2.4 m/s（P =0.03）和2.4/2.4/2.3 m/s（NS）。所有患者的左心室质量均显著降低，但各组间无显著差异。结论-试验的双叶主动脉瓣之间没有临床相关差异。无论瓣膜类型如何，并发症发生率均较低。基于这些发现，所有3种双叶人工瓣膜均非常适合主动脉瓣置换术。
Background—The aim of this prospectively randomized study was to evaluate the hemodynamic and functional outcomes after aortic valve replacement with 3 different bileaflet mechanical valves. Methods and Results—Three hundred consecutive patients were randomly assigned to receive ATS (n=100), Carbomedics (n=100), or St Jude Medical Hemodynamic Plus (n=100) mechanical aortic valve replacement. There were no significant differences regarding patient age (average 61±8 years), body surface area (1.9±0.2 m2), left ventricular function (ejection fraction 0.59±0.17), and presence of aortic stenosis (90%, 89%, and 91%), respectively. All patients had postoperative as well as 6-month and 1-year follow-ups that included transthoracic echocardiography. Multivariate statistical analysis was performed. Implanted valve sizes were comparable at 24±2 (ATS), 23.7±1.6 (CM), and 23.6±1.9 (SJM HP) mm (NS). At 1-year follow-up, the following incidence of events was noted: death 3/1/1, all non–valve related; stroke 0/1/1; trivial transvalvular incompetence 3/3/2; paravalvular leak 2/3/2; and reoperation 0/1/1, respectively (NS). Transvalvular flow velocities were 2.5/2.6/2.4 m/s postoperatively (P =0.03) and 2.4/2.4/2.3 m/s at 6-month follow-up, respectively (NS). There was a significant decrease in left ventricular mass for all patients but no significant differences among the groups. Conclusions—There are no clinically relevant differences among the tested bileaflet aortic valves. Regardless of valve type, there was a low complication rate. On the basis of these findings, all 3 bileaflet prostheses are well suited for aortic valve replacement.