Optim和硅橡胶涂层电极的临床应用比较研究

A comparative study of the clinical application of Optim-coated and silicone-coated electrodes

目的：观察Optim和硅橡胶涂层电极在临床实际工作中的电学稳定性表现（包括电极起搏阈值、感知和阻抗），并且分析电极断裂、绝缘层破损、穿孔、脱位、感染等相关不良反应发生情况。方法选择双腔起搏器植入患者300例，随机分为Optim组和硅橡胶组各150例，随访时间为1年，植入后0、3、6、9、12个月进行常规起搏器程控随访，主要不良反应包括各种存在记录的电极位置重新调整、电极拔除、电极更换。结果 Optim组电极断裂、绝缘层破损的发生率低于硅橡胶组（P＜0．05），电极脱位的发生率高于硅橡胶组（P＜0．05）；2组之间电极穿孔、感染的发生率未见明显差别（P＞0．05）。结论起搏器植入后Optim涂层电极感知灵敏度、阈值和阻抗表现稳定，电极断裂和绝缘层破裂的发生率较硅橡胶涂层电极减少，但电极脱位的发生率较高，建议由临床经验丰富的手术医师植入使用。

Objective To observe the electrical stability of Optim -coated and silicone-coated electrodes in clini-cal application , and potential adverse events , like lead fracture , electrode dislodgement or movement , insulation damage , cardiac perforation and infection .Methods Three hundred of patients implanted with a dual -chamber pacemaker in our hospital were selected and randomly divided into an Optim group （ n=150 ） and a silicone group （ n=150 ） .The performance of the pacemakers was assessed before and 3, 6, 9 and 12 months after implantation , with a median follow-up time of 1 year.Meanwhile, adverse events were recorded including electrode relocation , removal and replacement .Results The Optim group reported lower incidences of lead fracture and insulation damage , but higher rates of electrode dislodgement than the silicon group （P〈0.05）.No significant differences were detected as to the rates of cardiac perfo-ration and infection （P〉0.05）.Conclusion After implantation, the Optim-coated electrodes present good sensitivity, threshold values and resistance , with less frequent lead fracture and insulation damage but higher rates of electrode dislodgement compared with the silicone -coated ones .Its implantation by experienced surgeons is recommended .