圣犹达医疗机械瓣膜假体的二十年经验

Twenty-year experience with the St Jude Medical mechanical valve prosthesis.

作者信息

Ikonomidis John S, Kratz John M, Crumbley Arthur J, Stroud Martha R, Bradley Scott M, Sade Robert M, Crawford Fred A

机构信息

Division of Cardiothoracic Surgery, Medical University of South Carolina, Charleston 29464, USA.

出版信息

J Thorac Cardiovasc Surg. 2003 Dec;126(6):2022-31. doi: 10.1016/j.jtcvs.2003.07.005.

DOI:10.1016/j.jtcvs.2003.07.005

PMID:14688722

Abstract

BACKGROUND

We have prospectively followed all adult St Jude Medical mechanical valve recipients at the Medical University of South Carolina since the initial implant in January 1979 and now present our 20-year experience.

METHODS

We prospectively followed 837 valve recipients (aortic valve replacement; n = 478; mitral valve replacement; n = 359) from January 1979 to December 2000 at 12-month intervals.

RESULTS

Ages ranged from 19 to 84 years. Follow-up averaged (mean +/- standard deviation) 7 +/- 5 years (98% complete). Patients were in New York Heart Association class III or IV in 77% (aortic valve replacement) and 89% (mitral valve replacement) preoperatively. A 19-mm valve was implanted in 15.5% of aortic valve replacement patients. Coronary bypass was required in 31% of aortic valve replacements and 20% of mitral valve replacements. Operative mortality was 17/478 (3.6%) in aortic valve replacement and 19/359 (5.3%) in mitral valve replacement, and multivariable predictors were 19-mm valve size, 3 or more coronary bypass grafts, and New York Heart Association class IV for aortic valve replacement and New York Heart Association class IV and age for mitral valve replacement. Actuarial survivorship at 10 and 20 years was 57% +/- 3% and 26% +/- 5% for aortic valve replacement and 61% +/- 3% and 39% +/- 4% for mitral valve replacement. Multivariable predictors of late death were African-American ethnicity, New York Heart Association class III or IV, coronary bypass, and age for aortic valve replacement and New York Heart Association class III or IV, coronary bypass, and age for mitral valve replacement. For aortic valve replacement, effective orifice area was univariately (P =.002) but not multivariately (P =.378) predictive of late death. Structural valve deterioration was not observed. For aortic valve replacement, actuarial freedom (at 10 and 20 years) from reoperation was 93% +/- 1% and 90% +/- 2%; thromboembolism, 82% +/- 3% and 68% +/- 8%; bleeding events, 77% +/- 3% and 66% +/- 6%; prosthetic valve endocarditis, 94% +/- 1% and 94% +/- 1%; valve-related mortality, 94% +/- 2% and 86% +/- 4%; and valve-related mortality or morbidity, 58% +/- 3% and 32% +/- 8%. For mitral valve replacement, actuarial freedom (at 10 and 20 years) from reoperation was 96% +/- 1% and 90% +/- 3%; thromboembolism, 77% +/- 3% and 59% +/- 7%; bleeding events, 86% +/- 2% and 65% +/- 8%; prosthetic valve endocarditis, 98% +/- 1% and 96% +/- 2%; valve-related mortality, 89% +/- 0.2% and 74% +/- 8%; and valve-related mortality or morbidity, 63% +/- 3% and 29% +/- 7%.

CONCLUSIONS

After 2 decades of observation with close follow-up, the St Jude Medical mechanical valve continues to be a reliable prosthesis.

摘要

背景

自1979年1月首次植入以来，我们对南卡罗来纳医科大学所有接受圣犹达医疗机械瓣膜置换术的成年患者进行了前瞻性随访，现展示我们20年的经验。

方法

1979年1月至2000年12月，我们对837例瓣膜置换患者（主动脉瓣置换术；n = 478；二尖瓣置换术；n = 359）进行前瞻性随访，随访间隔为12个月。

结果

年龄范围为19至84岁。随访平均（均值±标准差）7±5年（98%完整）。术前，77%（主动脉瓣置换术）和89%（二尖瓣置换术）的患者处于纽约心脏协会心功能Ⅲ或Ⅳ级。15.5%的主动脉瓣置换患者植入了19毫米的瓣膜。31%的主动脉瓣置换患者和20%的二尖瓣置换患者需要进行冠状动脉搭桥术。主动脉瓣置换术的手术死亡率为17/478（3.6%），二尖瓣置换术为19/359（5.3%），多变量预测因素包括主动脉瓣置换术的19毫米瓣膜尺寸、3条或更多冠状动脉搭桥血管以及纽约心脏协会心功能Ⅳ级，二尖瓣置换术的纽约心脏协会心功能Ⅳ级和年龄。主动脉瓣置换术10年和20年的精算生存率分别为57%±3%和26%±5%，二尖瓣置换术分别为61%±3%和39%±4%。晚期死亡的多变量预测因素包括非裔美国人种族、纽约心脏协会心功能Ⅲ或Ⅳ级、冠状动脉搭桥术以及主动脉瓣置换术的年龄和二尖瓣置换术的纽约心脏协会心功能Ⅲ或Ⅳ级、冠状动脉搭桥术和年龄。对于主动脉瓣置换术，有效瓣口面积单变量分析（P = 0.002）可预测晚期死亡，但多变量分析（P = 0.378）不能。未观察到结构性瓣膜退变。对于主动脉瓣置换术，再次手术的精算自由度（10年和20年）分别为93%±1%和90%±2%；血栓栓塞分别为82%±3%和68%±8%；出血事件分别为77%±3%和66%±6%；人工瓣膜心内膜炎分别为94%±1%和94%±1%；瓣膜相关死亡率分别为94%±2%和86%±4%；瓣膜相关死亡率或发病率分别为58%±3%和32%±8%。对于二尖瓣置换术，再次手术的精算自由度（10年和20年）分别为96%±1%和90%±3%；血栓栓塞分别为77%±3%和59%±7%；出血事件分别为86%±2%和65%±8%；人工瓣膜心内膜炎分别为98%±1%和96%±2%；瓣膜相关死亡率分别为89%±0.2%和74%±8%；瓣膜相关死亡率或发病率分别为63%±3%和29%±7%。