卡朋蒂埃-爱德华兹超环周型主动脉猪生物瓣膜：20年临床性能表现

Carpentier-Edwards supra-annular aortic porcine bioprosthesis: clinical performance over 20 years.

作者信息

Jamieson W R Eric, Burr Lawrence H, Miyagishima Robert T, Germann Eva, Macnab Joan S, Stanford Elizabeth, Chan Florence, Janusz Michael T, Ling Hilton

机构信息

Division of Cardiovascular Surgery, Department of Surgery, University of British Columbia, Vancouver, British Columbia, Canada.

出版信息

J Thorac Cardiovasc Surg. 2005 Oct;130(4):994-1000. doi: 10.1016/j.jtcvs.2005.03.040.

DOI:10.1016/j.jtcvs.2005.03.040

PMID:16214510

Abstract

OBJECTIVE

Experience with the Carpentier-Edwards supra-annular porcine bioprosthesis (Edwards Lifesciences, Irvine, Calif) has been evaluated longitudinally over 20 years. Clinical performance was evaluated by actuarial and actual analysis. Hemodynamic performance was evaluated by echocardiographic/Doppler assessment. Morphology of structural failure was evaluated from pathologic examinations.

METHODS

From 1981 through 1999, 1823 patients (mean age, 68.9 +/- 10.9 years; range, 19-89 years) underwent 1847 procedures. Concomitant coronary artery bypass was performed in 788 (42.7%) patients. Previous valve procedures were performed in 107 (5.8%) patients, and other cardiac procedures were performed in 87 (4.7%) patients.

RESULTS

The overall valve-related complication rate was 4.36% per patient-year (630 patients), with a fatality rate of 0.96% per patient-year (139 patients). Patient survival at 18 years was 15.8% +/- 1.6%. Overall late mortality rate was 6.3% per patient-year. Overall actual cumulative freedom at 18 years from reoperation was 85.0% +/- 1.2%, valve-related mortality was 88.7% +/- 1.1%, and valve-related residual morbidity was 96.3% +/- 5.0%. Actual freedom from structural valve deterioration at 18 years was 86.4% +/- 1.2% overall, 90.5% +/- 1.8% for age 61 to 70 years, and 98.2% +/- 0.6% for age greater than 70 years. Structural valve deterioration presented with pathologic evidence consistent with stenosis in 27.6% and insufficiency in 72.4%. Hemodynamic performance at 1 year revealed normal effective orifice area indexes for sizes 23 to 27 mm and mild-to-moderate reduction for size 21 mm.

CONCLUSIONS

The Carpentier-Edwards supra-annular aortic porcine bioprosthesis continues to provide excellent freedom from structural valve deterioration and overall freedom from valve-related residual morbidity, mortality, and reoperation up to 18 years. Hemodynamic performance is satisfactory. The prosthesis remains recommended for patients older than 70 years and for patients 61 to 70 years of age, especially when comorbid risk factors are not anticipated to provide extended survival.

摘要

目的

对Carpentier-Edwards超环周猪生物瓣膜（爱德华生命科学公司，加利福尼亚州欧文市）20多年来的使用经验进行了纵向评估。通过精算和实际分析评估临床性能。通过超声心动图/多普勒评估评估血流动力学性能。从病理检查评估结构失效的形态学。

方法

1981年至1999年，1823例患者（平均年龄68.9±10.9岁；范围19-89岁）接受了1847例手术。788例（42.7%）患者同期进行了冠状动脉搭桥术。107例（5.8%）患者曾接受过瓣膜手术，87例（4.7%）患者接受过其他心脏手术。

结果

总体瓣膜相关并发症发生率为每年4.36%（630例患者），死亡率为每年0.96%（139例患者）。18年时患者生存率为15.8%±1.6%。总体晚期死亡率为每年6.3%。18年时再次手术的总体实际累积自由度为85.0%±1.2%，瓣膜相关死亡率为88.7%±1.1%，瓣膜相关残余发病率为96.3%±5.0%。18年时瓣膜结构退化的实际自由度总体为86.4%±1.2%，61至70岁患者为90.5%±1.8%，70岁以上患者为98.2%±0.6%。瓣膜结构退化的病理证据显示，27.6%为狭窄，72.4%为关闭不全。1年时的血流动力学性能显示，23至27毫米尺寸的有效瓣口面积指数正常，21毫米尺寸的有效瓣口面积指数轻度至中度降低。