Fiore A C, Barner H B, Swartz M T, McBride L R, Labovitz A J, Vaca K J, St Vrain J, Grunkemeier G L, Kaiser G C
Division of Cardiothoracic Surgery and Cardiology, Saint Louis University Health Sciences Center, Missouri 63110-0250, USA.
Ann Thorac Surg. 1998 Sep;66(3):707-12; discussion 712-3. doi: 10.1016/s0003-4975(98)00670-5.
This study was designed to better define the merits of the bileaflet and tilting-disc valves.
We prospectively randomized 156 patients (mean age, 59 years) to receive either the St. Jude (n = 80) or the Medtronic Hall (n = 76) mitral valve prosthesis between September 1986 and December 1997. The two groups were not significantly different with respect to preoperative New York Heart Association class, left ventricular ejection fraction, incidence of mitral stenosis or insufficiency, extent of coronary artery disease, completeness of revascularization, or cross-clamp or bypass time.
The operative mortality (11.2% versus 13.1%, St. Jude versus Medtronic Hall, respectively) and late mortality (27% versus 22%, St. Jude versus Medtronic Hall, respectively) were not significantly different. Follow-up was complete in all hospital survivors with a mean of 60.7 months (range, 1 to 133 months). The analysis of 10-year actuarial survival and freedom from valve-related events demonstrated no significant differences between the cohorts. Freedom from reoperation was higher in the St. Jude group (p < 0.01). Comparisons of patient functional status and echocardiographic hemodynamic parameters obtained at the time of follow-up demonstrated no significant differences between the two prostheses.
This study suggests that there is no difference between the St. Jude and Medtronic Hall prostheses with respect to late clinical performance or hemodynamic results and therefore does not support the preferential selection of either prosthesis.
本研究旨在更好地明确双叶瓣和倾斜碟瓣的优点。
在1986年9月至1997年12月期间，我们前瞻性地将156例患者（平均年龄59岁）随机分为两组，分别接受圣犹达瓣（n = 80）或美敦力Hall瓣（n = 76）二尖瓣置换术。两组在术前纽约心脏协会分级、左心室射血分数、二尖瓣狭窄或关闭不全的发生率、冠状动脉疾病的程度、血运重建的完整性、或阻断钳夹或体外循环时间方面无显著差异。
手术死亡率（圣犹达瓣组与美敦力Hall瓣组分别为11.2%和13.1%）和晚期死亡率（圣犹达瓣组与美敦力Hall瓣组分别为27%和22%）无显著差异。所有住院幸存者均完成随访，平均随访时间为60.7个月（范围1至133个月）。对10年精算生存率和无瓣膜相关事件的分析显示两组之间无显著差异。圣犹达瓣组再次手术的自由度更高（p < 0.01）。随访时获得的患者功能状态和超声心动图血流动力学参数的比较显示两种人工瓣膜之间无显著差异。
本研究表明，圣犹达瓣和美敦力Hall瓣在晚期临床表现或血流动力学结果方面无差异，因此不支持优先选择任何一种人工瓣膜。
