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心脏导管插入术后按性别划分的局部不良事件风险。

Risk of local adverse events by gender following cardiac catheterization.

作者信息

Tavris Dale R, Gallauresi Beverly Albrecht, Dey Syamal, Brindis Ralph, Mitchel Kristi

机构信息

Food and Drug Administration, Center for Devices and Radiological Health Epidemiology Branch Gallauresi Beverly, MA, USA.

出版信息

Pharmacoepidemiol Drug Saf. 2007 Feb;16(2):125-31. doi: 10.1002/pds.1307.

Abstract

PURPOSE

To assess the reason for the relative high risk of local complications for women following cardiac catheterization by evaluating the associations between gender, sheath size, and local adverse outcomes following cardiac catheterization.

METHODS

The data used in this study were obtained from a portion of the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR), which included 13 878 patients who underwent cardiac catheterization at one of 59 participating cardiac catheterization institutions throughout the United States during late 2003. Rates of serious local vascular adverse events were calculated by gender following cardiac catheterization, by type of vascular hemostasis used, stratified by arterial sheath size.

RESULTS

Serious local vascular events were reported in 3.54% of patients, most commonly hematoma (2.00%). The relative risk for women of any vascular complication was 1.40 [95%CI = 1.17, 1.67, p = 0.0002]. A statistically significant relative risk for woman was evident when collagen plug devices or manual compression alone were used as the first method for hemostasis. The rate of vascular complications increased progressively with increasing sheath size, more so in women than in men.

CONCLUSIONS

High relative risk for women of local vascular complications following cardiac catheterization was demonstrated with use of manual compression, as well as with collagen plug devices to control femoral artery bleeding. Large sheath size is associated with both a relatively high absolute risk and a high relative risk for women. Knowledge of this information should be considered by interventional cardiologists in making decisions on how to achieve hemostasis following cardiac catheterization.

摘要

目的

通过评估性别、鞘管尺寸与心脏导管插入术后局部不良结局之间的关联,来探究女性心脏导管插入术后局部并发症相对风险较高的原因。

方法

本研究使用的数据取自美国心脏病学会-国家心血管数据注册库(ACC-NCDR)的一部分,其中包括2003年末在美国59家参与研究的心脏导管插入机构之一接受心脏导管插入术的13878例患者。根据心脏导管插入术后的性别、所使用的血管止血类型,并按动脉鞘管尺寸分层,计算严重局部血管不良事件的发生率。

结果

3.54%的患者报告发生了严重局部血管事件,最常见的是血肿(2.00%)。女性发生任何血管并发症的相对风险为1.40[95%置信区间=1.17, 1.67,p = 0.0002]。当单独使用胶原塞装置或手动压迫作为第一种止血方法时,女性的相对风险具有统计学意义。血管并发症的发生率随着鞘管尺寸的增加而逐渐升高,女性比男性升高得更明显。

结论

使用手动压迫以及胶原塞装置控制股动脉出血时,女性心脏导管插入术后发生局部血管并发症的相对风险较高。大鞘管尺寸与女性相对较高的绝对风险和相对风险均相关。介入心脏病学家在决定如何在心脏导管插入术后实现止血时,应考虑这一信息。

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