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一项前瞻性随机试验:比较6Fr和8Fr引导导管在择期冠状动脉血管成形术中的益处和局限性——临床、操作、血管造影及经济终点

A prospective randomized trial comparing the benefits and limitations of 6Fr and 8Fr guiding catheters in elective coronary angioplasty: clinical, procedural, angiographic, and economic end points.

作者信息

Talley J D, Mauldin P D, Becker E R

机构信息

Section of Invasive and Interventional Cardiology, University of Louisville School of Medicine, Kentucky, USA.

出版信息

J Interv Cardiol. 1995 Aug;8(4):345-53. doi: 10.1111/j.1540-8183.1995.tb00556.x.

Abstract

OBJECTIVES

To determine the relation between guiding catheter size, procedural and angiographic details, and cost of coronary angioplasty.

BACKGROUND

Miniaturized angiographic equipment used during coronary angioplasty is proposed as a method to decrease the duration of supine bed rest, length of hospital stay, and cost of expensive inpatient hospitalization.

METHODS

One hundred and sixty patients were randomized to undergo elective coronary angioplasty with a 6Fr (external diameter, 0.079-in; internal diameter 0.062-in) or 8Fr (external diameter, 0.105-in internal diameter, 0.078-0.079-in) guiding catheter. Standard balloon dilatation catheters were used.

END POINTS

1 degree peripheral vascular complications, 2 degree technical and procedural outcomes; quantitative and qualitative quality of the coronary angiograms; and the in-hospital ("bottom up" cost accounting of equipment, supplies, support personnel, postcoronary angioplasty room), and physician cost (using Resource Based Relative Value Scale).

RESULTS

There was no difference in peripheral vascular complications between the two groups (6Fr, 21%; 8Fr, 30%; P = NS). Less contrast medium was used with the 6Fr guiding catheters (6Fr, 178 +/- 102 mL; 8Fr, 257 +/- 147 mL; P = 0.0001). The qualitative quality of the angiograms was better with 8Fr than with 6Fr guiding catheters. For the entire population, the total cost of coronary angioplasty was less with 6Fr guiding catheters ($3,956 +/- $2,415) than with 8F guiding catheters ($5,073 +/- $3,985, P = 0.03). Excluding patients with either a coronary or peripheral vascular complication, there was less cost savings (6F, $3,720 +/- $1,338; 8F, $4,376 +/- 2,699, P = 0.05). Independent variables associated with increased cost included: large body mass index; hypercholesterolemia; nonionic contrast media; 8F guiding catheter; complex lesions; and duration of procedure.

CONCLUSIONS

The use of smaller guiding catheters led to use of less contrast medium with a modest decrease in angiographic visualization. The cost savings seen with 6F guiding catheters is multifactorial due to smaller arteriotomy accompanying sheath insertion and reduced rate of clinically significant coronary and peripheral vascular complications.

摘要

目的

确定引导导管尺寸、手术及血管造影细节与冠状动脉成形术费用之间的关系。

背景

有人提出在冠状动脉成形术中使用小型化血管造影设备,作为一种减少仰卧卧床休息时间、缩短住院时间以及降低昂贵的住院费用的方法。

方法

160例患者被随机分为两组,分别使用6F(外径0.079英寸;内径0.062英寸)或8F(外径0.105英寸;内径0.078 - 0.079英寸)引导导管进行择期冠状动脉成形术。使用标准球囊扩张导管。

终点指标

1级外周血管并发症、2级技术及手术结果;冠状动脉造影的定量和定性质量;以及住院费用(设备、耗材、辅助人员、冠状动脉成形术后病房的“自下而上”成本核算)和医生费用(使用基于资源的相对价值尺度)。

结果

两组在外周血管并发症方面无差异(6F组为21%;8F组为30%;P = 无显著性差异)。6F引导导管使用的造影剂较少(6F组为178±102 mL;8F组为257±147 mL;P = 0.0001)。8F引导导管造影的定性质量优于6F引导导管。对于总体人群,6F引导导管的冠状动脉成形术总成本低于8F引导导管(3956±2415美元对5073±3985美元,P = 0.03)。排除有冠状动脉或外周血管并发症的患者后,成本节约较少(6F组为3720±1338美元;8F组为4376±2699美元,P = 0.05)。与成本增加相关的独立变量包括:高体重指数;高胆固醇血症;非离子型造影剂;8F引导导管;复杂病变;以及手术持续时间。

结论

使用较小的引导导管可减少造影剂用量,血管造影显影略有下降。6F引导导管节省成本是多因素的,这是由于鞘管插入时动脉切开较小以及临床上显著的冠状动脉和外周血管并发症发生率降低。

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