索林碳酸氢盐心脏瓣膜假体的单中心经验：长期临床、血液学和血流动力学结果。

A single-center experience of the Sorin Bicarbon heart valve prosthesis: long-term clinical, hematological and hemodynamic results.

作者信息

Whitaker Donald C, James Stuart E, Walesby Robin K

机构信息

Department of Cardiothoracic Surgery, University College London Hospitals, London, UK.

出版信息

J Heart Valve Dis. 2004 Jan;13(1):97-102.

PMID:14765847

Abstract

BACKGROUND AND AIM OF THE STUDY

The Sorin Bicarbon (SB) bileaflet valve, available since 1990, has a good clinical safety profile. The study aim was to assess the long-term clinical results following implantation, plus hemodynamic and hematological aspects of the valve.

METHODS

A total of 195 SB prostheses (100 aortic, 67 mitral, 14 double valve replacements) was implanted in 181 patients (108 males, 73 females) since 1991.

RESULTS

Mean age at implantation was 60.5 +/- 10.8 years. Actuarial analysis at 9.0 years showed an overall survival of 63.9 +/- 5.5%; 28.2% of deaths were early (n = 11), and 71.8% late (n = 28). Freedom from thrombosis was 99.4 +/- 0.6% (one early event, successfully reoperated on), and from embolic events was 86.3 +/- 4.7%. Freedom from endocarditis and hemorrhagic complications were respectively 98.1 +/- 1.1% and 98.6 +/- 0.9%. No occurrence of hemolysis was reported. Freedom from non-structural valve dysfunction was 98.7 +/- 0.9%, and from reoperation was 96.1 +/- 1.6%. Hemodynamic evaluation by echocardiography and hematological testing was performed at 7.0 +/- 1.3 years (range 5-9 years) in a subset of 31 patients (20 males, 11 females). Mean valve size was 23.9 mm for aortic mitral. Echocardiography showed that aortic valves had a mean effective orifice area (EOA) of 2.26 +/- 1.28 cm2, with peak and mean pressure gradients of 23.6 +/- 14.6 and 12.9 +/- 8.1 mmHg, respectively. The mean EOA of mitral valve prostheses was 2.67 +/- 0.66 cm2, with peak and mean pressure gradients of 12.2 +/- 4.5 and 3.8 +/- 1.6 mmHg, respectively. Overall mean hemoglobin was 13.4 +/- 1.35 g/dl, and serum lactate dehydrogenase 630 +/- 13 IU/l. Serum haptoglobin was detectable in one patient only, and the mean reticulocyte count was 1.24 +/- 0.51%.

CONCLUSION

In the present authors' experience, the Sorin Bicarbon prosthesis has low complication rates and maintains an excellent hemodynamic function over time. Hemolytic potential is insignificant with this valve.

摘要

研究背景与目的

索林双叶瓣（SB）自1990年开始应用，具有良好的临床安全性。本研究旨在评估该瓣膜植入后的长期临床结果，以及其血流动力学和血液学方面的情况。

方法

自1991年起，共181例患者（108例男性，73例女性）植入了195个SB人工瓣膜（100个主动脉瓣，67个二尖瓣，14个双瓣膜置换）。

结果

植入时的平均年龄为60.5±10.8岁。9.0年的精算分析显示总体生存率为63.9±5.5%；28.2%的死亡为早期死亡（n = 11），71.8%为晚期死亡（n = 28）。血栓形成的发生率为99.4±0.6%（1例早期事件，成功再次手术），栓塞事件的发生率为86.3±4.7%。心内膜炎和出血并发症的发生率分别为98.1±1.1%和98.6±0.9%。未报告有溶血发生。非结构性瓣膜功能障碍的发生率为98.7±0.9%，再次手术的发生率为96.1±1.6%。对31例患者（20例男性，11例女性）进行了超声心动图血流动力学评估和血液学检测，时间为7.0±1.3年（范围5 - 9年）。主动脉二尖瓣的平均瓣膜尺寸为23.9 mm。超声心动图显示主动脉瓣的平均有效瓣口面积（EOA）为2.26±1.28 cm²，峰值和平均压力阶差分别为23.6±14.6和12.9±8.1 mmHg。二尖瓣人工瓣膜的平均EOA为2.67±0.66 cm²，峰值和平均压力阶差分别为12.2±4.5和3.8±1.6 mmHg。总体平均血红蛋白为13.4±1.35 g/dl，血清乳酸脱氢酶为630±13 IU/l。仅1例患者可检测到血清触珠蛋白，平均网织红细胞计数为1.24±0.51%。