圣犹达Silzone瓣膜植入术后栓塞及瓣周漏的发生率：来自加的夫栓塞风险因素研究的经验

Incidence of embolism and paravalvar leak after St Jude Silzone valve implantation: experience from the Cardiff Embolic Risk Factor Study.

作者信息

Ionescu A, Payne N, Fraser A G, Giddings J, Grunkemeier G L, Butchart E G

机构信息

Department of Cardiothoracic Surgery, University Hospital of Wales, Cardiff, UK.

出版信息

Heart. 2003 Sep;89(9):1055-61. doi: 10.1136/heart.89.9.1055.

DOI:10.1136/heart.89.9.1055

PMID:12923026

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1767860/

Abstract

BACKGROUND

Silver coating of the sewing ring (Silzone) was introduced as a modification of the St Jude Medical standard valve to provide antibacterial protection, but the valve has recently been withdrawn.

OBJECTIVE

To study patients with these prostheses to assess possible adverse effects, and to guide their follow up.

DESIGN

Prospective observational study of risk factors for stroke after valve replacement.

SETTING

Cardiology and cardiac surgery departments in a tertiary centre.

PATIENTS

There were 51 patients with Silzone and 116 with St Jude Medical standard valves. Patients undergoing aortic valve replacement were well matched for stroke risk factors. Silzone patients with mitral valve replacement were younger (mean (SD) age 61 (10) v 66 (7) years), more likely to be female (95% v 65%), and had more pulmonary arterial hypertension (100% v 78%), but fewer coronary artery bypass grafts (5% v 33%) than patients with standard mitral valve replacements (all p < 0.05).

RESULTS

Follow up was 100% in the Silzone group (mean duration 3.0 (0.9) years) and 97.4% in the standard group (4.7 (1.4) years). Survival, morbidity, and anticoagulant control were documented over 682 follow up years (153 for Silzone and 529 for standard). There were six embolic strokes and one peripheral embolism in the Silzone group, all within three months after operation, and five embolic strokes and one peripheral embolism in the standard group. Freedom from major thromboembolism at three months was 65% in the Silzone mitral valve replacement group and 100% in the standard mitral valve replacement group (difference 35%, 95% confidence interval 8% to 62%). There was one reoperation for paravalvar leak in the standard group, but none in the Silzone group (NS). Anticoagulant control in the two groups was similar.

CONCLUSIONS

Patients with Silzone mitral valves had a high rate of early postoperative embolism but no excess paravalvar leak.

摘要

背景

缝环银涂层（Silzone）是对圣犹达医疗标准瓣膜的一种改良，旨在提供抗菌保护，但该瓣膜最近已被撤出市场。

目的

研究使用这些人工瓣膜的患者，评估可能的不良反应，并指导对他们的随访。

设计

瓣膜置换术后中风危险因素的前瞻性观察研究。

地点

一家三级中心的心脏病学和心脏外科科室。

患者

有51例使用Silzone瓣膜的患者和116例使用圣犹达医疗标准瓣膜的患者。接受主动脉瓣置换的患者在中风危险因素方面匹配良好。接受二尖瓣置换的Silzone瓣膜患者更年轻（平均（标准差）年龄61（10）岁对66（7）岁），女性比例更高（95%对65%），肺动脉高压更多（100%对78%），但冠状动脉搭桥术比接受标准二尖瓣置换的患者少（5%对33%）（所有p<0.05）。

结果

Silzone组的随访率为100%（平均持续时间3.0（0.9）年），标准组为97.4%（4.7（1.4）年）。在682个随访年（Silzone组153个，标准组529个）中记录了生存率、发病率和抗凝控制情况。Silzone组有6例栓塞性中风和1例周围栓塞，均发生在术后三个月内，标准组有5例栓塞性中风和1例周围栓塞。Silzone二尖瓣置换组术后三个月无重大血栓栓塞的比例为65%，标准二尖瓣置换组为100%（差异35%，95%置信区间8%至62%）。标准组有1例因瓣周漏进行再次手术，Silzone组无（无显著性差异）。两组的抗凝控制情况相似。