固定螺旋主动固定导线植入早期及后期参数变化与安全性评价

目的 评价固定螺旋主动固定导线（Fineline Ⅱ EZ,美国波科公司）植入术中及术后3个月参数变化情况,评价其安全性.方法 2012年1月至2013年9月在青岛大学附属医院156例缓慢性心律失常患者行单腔或双腔起搏治疗,心室起搏导线均选用固定螺旋主动固定导线,经左或右侧锁骨下静脉置于右心室流出道间隔部,分别于导线旋入心肌即刻、旋入后5 min、术后即刻、术后3个月测试起搏参数：起搏阈值、导线阻抗和R波幅度,并观察术后有无导线脱位、导线穿孔、与经静脉有关的血栓形成及囊袋感染等严重并发症发生.结果 导线旋入即刻起搏阈值较高,5 min后明显下降[（0.76±0.22）V对（0.39±0.13）V,P＜0.001];术后即刻阈值较旋入5 min后进一步下降[（0.35±0.10）V对（0.39±0.13）V,P＜0.001].R波幅度在导线旋入后5 min测试较术后即刻降低[（12.70±4.94）mV对（8.94±4.07） mV,P＜0.001].术后仅1例患者出现导线脱位,无导线穿孔、囊袋感染等并发症发生.结论 固定螺旋主动固定导线旋入心肌5 min后起搏阈值明显降低,故可常规于旋入5min后进行测试,确定是否需要调整导线位置.固定螺旋主动固定导线在应用过程中是安全有效的.

Evaluation of pacing parameters in the implantation of fixed screw active-fixation pacing lead in the early and late stage

Objective To investigate the pacing parameter changes in different stages during and after the implantation,and evaluate the safety and efficiency of the active-fixation pacing lead （Fineline Ⅱ EZ）.Methods One hundred and forty-six patients with bradyarrhythmias and accepted single or dual chamber pacing therapy were included in the Affiliated Hospital of Qingdao University from January 2012 to septermber 2013.Fineline Ⅱ EZ was implanted in all patients through the left or right subclavicular vein and fixed in the right ventricular outflow tract.The pacing parameters,including pacing threshold,R wave amplitude and the electrode impedance,were tested at the moment after screwing the leads and 5 minutes later,immediately after the procedure and 3 months later.Complications such as electrode dislocation,electrodes perforation,intravenous associated thrombosis and pocket infection were also observed in all patients.Results Pacing threshold was tested at the moment after screwing the leads was a bit high （0.76±0.22） V,and decreased 5 minutes later （0.39±0.13） V,（P＜0.001）.Further decreasing was observed immediately after procedure （0.35±0.10） V,（P＜0.001）,and maintained stable after 3 months （0.34±0.10） V,（P=0.252）.The electrode impedance was tested at the moment after screwing leads and 5 minutes later,immediately after the procedure and 3 months later.No significant difference was found in R wave amplitude at immediately after the procedure and 3 months later.Only 1 patient had electrode dislocation,no electrode perforation,infection and other complications were observed during the follow-up period.Conclusion For the Fineline Ⅱ EZ,the pacing threshold reduced significantly 5 minutes later compared to the moment after screwed.So it is appropriate to test the pacing threshold 5 minutes after screwing the lead and to determine whether to adjust the electrode position or not.Fineline Ⅱ EZ,the active-fixation pacing lead,is safe and efficient in the clinical application.