Avitall B, Khan M, Krum D, Jazayeri M, Hare J
Electrophysiology Laboratory, University of Wisconsin-Milwaukee Clinical Campus, Sinai Samaritan Medical Center 53201.
J Am Coll Cardiol. 1993 Nov 1;22(5):1367-72. doi: 10.1016/0735-1097(93)90544-b.
The objective of this study was to provide insight into the time course of electrical, physical and mechanical changes in ablation catheters after each use that may affect the safety and efficacy of the ablation procedure.
An increasing number of institutions are reusing deflectable ablation catheters. At present, there are no data concerning the safety of reusing ablation catheters.
Over a period of 1 year, 69 Webster/Mansfield deflectable catheters used in 336 ablation procedures were prospectively studied. An additional 18 new catheters were tested after multiple sterilizations only. The catheters were evaluated for electrical and physical integrity and mechanical capabilities. These include deflection at room temperature and 37 degrees C, shaft compression and buckling during deflection, tip craters, torquing ability, glue separation and tip attachment using a stereoscope at x30 magnification and electrical resistance for each electrode. After each use, the catheters were gas-sterilized with ethylene oxide.
The most common reasons for catheter rejection were tip electrode glue separation after 4.3 +/- 4.3 uses and loss of deflection after 5.0 +/- 3.3 uses. Electrical discontinuity between the catheter handle and electrodes was observed after 10.0 +/- 3.7 uses. There was no significant decrease in catheter torquing ability with repeated use. In this study the total estimated savings was $128,133, which includes the cost of catheter reprocessing. The reuse of Webster/Mansfield ablation catheters has not resulted in any major catheter failure or any major adverse clinical complications.
On the basis of these observations, we believe that the Webster/Mansfield catheter can be reused an average of five times. It is strongly recommended that after each use catheters be carefully examined under appropriate magnification (x30) and that special attention be given to the ablation tip electrode. The catheters should also be tested for deflection and electrical integrity.
本研究的目的是深入了解每次使用后消融导管的电学、物理和机械变化的时间进程，这些变化可能会影响消融手术的安全性和有效性。
越来越多的机构在重复使用可弯曲消融导管。目前，尚无关于重复使用消融导管安全性的数据。
在1年的时间里，对336例消融手术中使用的69根韦伯斯特/曼斯菲尔德可弯曲导管进行了前瞻性研究。另外，仅对18根新导管进行多次灭菌后进行测试。对导管的电学和物理完整性以及机械性能进行评估。这些评估包括在室温及37摄氏度下的弯曲度、弯曲过程中的轴压缩和弯曲、尖端凹陷、扭转能力、胶水分离以及使用30倍放大率的立体显微镜观察尖端连接情况，以及每个电极的电阻。每次使用后，导管用环氧乙烷进行气体灭菌。
导管被拒收的最常见原因是尖端电极胶水分离，平均使用4.3±4.3次后出现，以及弯曲度丧失，平均使用5.0±3.3次后出现。导管手柄与电极之间的电学连续性在平均使用10.0±3.7次后被观察到。随着重复使用，导管的扭转能力没有显著下降。在本研究中，估计总共节省了128,133美元，其中包括导管再处理的成本。韦伯斯特/曼斯菲尔德消融导管的重复使用未导致任何重大导管故障或任何重大不良临床并发症。
基于这些观察结果，我们认为韦伯斯特/曼斯菲尔德导管平均可重复使用五次。强烈建议每次使用后在适当放大倍数（30倍）下仔细检查导管，并特别关注消融尖端电极。还应测试导管的弯曲度和电学完整性。
