国产心脏起搏器电极导线参数短期稳定性与安全性研究
|
摘要
目的探讨国产心脏起搏器电极导线参数短期稳定性与安全性。方法回顾性分析北部战区总医院自2017年8月至2018年6月行国产心脏起搏器植入的23例患者的临床资料。23例患者共植入国产主动电极导线40根,其中,QM7211-53电极导线17根,QM7211-60电极导线23根。分析并比较术中及术后1、3、6个月起搏导线的P/R波振幅、阈值、阻抗变化,同时,记录并发症发生情况。结果心房、心室术后1、3、6个月阈值均低于差异有统计学意义(P <0. 05);术后3个月时,阈值显著下降,低于术后1个月时,差异有统计学意义(P <0. 05);术后6个月时,阈值趋于稳定,与术后3个月时的阈值比较,差异无统计学意义(P> 0. 05)。心房、心室术中及术后1、3、6个月的P/R波振幅两两比较,差异均无统计学意义(P> 0. 05)。心房、心室术中及术后1、3、6个月的阻抗两两比较,差异均无统计学意义(P> 0. 05)。所有患者均于术后3～4 d出院,出院后随访时间> 6个月。随访期间,患者无起搏器囊袋感染、电极脱位、电极穿孔、起搏器综合征等并发症,且无病死与再住院。结论国产起搏电极导线性能良好,在植入术后的短期随访中,参数稳定,无并发症,安全性高,可作为临床应用选择之一。
Objective To investigate the stability and safety of domestic pacemaker leads during short term follow-up. Methods A retrospective study was performed on 23 cases of patients who were admitted and underwent domestic pacemaker implantation from August 2017 to June 2018. There were 23 cases of patients who were implanted 40 domestic active pacing leads,including 17 QM7211-53 pacing leads and 23 QM7211-60 pacing leads. The changes of pacemaker lead parameters( P/R wave amplitude,pacing threshold and pacing impedance) were compared during implantation,1,3 and 6 months after operation,and complications were analyzed.Results The thresholds of 1,3 and 6 months after the operation of atrium and ventricle were all lower than those during the operation,and the difference was statistically significant( P < 0. 05). The thresholds of 1,3 and 6 months after the operation of atrium and ventricle were all lower than those during the operation( P < 0. 05). At 3 months after surgery,the threshold value reduced significantly( P <0. 05). At 6 months after surgery,the threshold value tends to be stable,and the difference is not statistically significant compared with the threshold value at 3 months after surgery( P > 0. 05). Pairwise comparison of P/R wave amplitudes in atrium and ventricle during and 1,3 and 6 months after surgery showed no significant difference( P > 0. 05). There was no significant difference in impedance pairwise comparison between atrium and ventricle during and 1,3 and 6 months after surgery( P > 0. 05). All patients were discharged 3 to4 days after surgery,and the follow-up time after discharge was 6 months. During the follow-up,the patients had no complications such as pacemaker bag infection,electrode dislocation,electrode perforation,pacemaker syndrome,and no death or re-hospitalization occurred. Conclusion The performance of domestic pacemaker electrode leads is good. In the short-term follow-up after implantation,the parameters are stable,there are no complications,and the safety is high,which can be used as one of the options for clinical application.
Objective To investigate the stability and safety of domestic pacemaker leads during short term follow-up. Methods A retrospective study was performed on 23 cases of patients who were admitted and underwent domestic pacemaker implantation from August 2017 to June 2018. There were 23 cases of patients who were implanted 40 domestic active pacing leads,including 17 QM7211-53 pacing leads and 23 QM7211-60 pacing leads. The changes of pacemaker lead parameters( P/R wave amplitude,pacing threshold and pacing impedance) were compared during implantation,1,3 and 6 months after operation,and complications were analyzed.Results The thresholds of 1,3 and 6 months after the operation of atrium and ventricle were all lower than those during the operation,and the difference was statistically significant( P < 0. 05). The thresholds of 1,3 and 6 months after the operation of atrium and ventricle were all lower than those during the operation( P < 0. 05). At 3 months after surgery,the threshold value reduced significantly( P <0. 05). At 6 months after surgery,the threshold value tends to be stable,and the difference is not statistically significant compared with the threshold value at 3 months after surgery( P > 0. 05). Pairwise comparison of P/R wave amplitudes in atrium and ventricle during and 1,3 and 6 months after surgery showed no significant difference( P > 0. 05). There was no significant difference in impedance pairwise comparison between atrium and ventricle during and 1,3 and 6 months after surgery( P > 0. 05). All patients were discharged 3 to4 days after surgery,and the follow-up time after discharge was 6 months. During the follow-up,the patients had no complications such as pacemaker bag infection,electrode dislocation,electrode perforation,pacemaker syndrome,and no death or re-hospitalization occurred. Conclusion The performance of domestic pacemaker electrode leads is good. In the short-term follow-up after implantation,the parameters are stable,there are no complications,and the safety is high,which can be used as one of the options for clinical application.
引文
[1]王立军.中国有了自己的心脏起搏器—具有自主知识产权的中国心脏起搏器注册上市[J].中国心脏起搏与心电生理杂志,2010,24(5):423.
[2]彭勇,王军贤,孟天宇,等.国产心脏起搏器Qin Ming2312S/M匹配进口主动心室起搏电极的观察[J].中国心脏起搏与心电生理杂志,2013,27(6):562.
[3]李晓燕,谈红,刘科卫,等.国产心脏起搏器Qin Ming2312S/M临床应用的研究[J].中国心脏起搏与心电生理杂志,2013,27(1):11.
[4] Kusumoto FM,Schoenfeld MH,Wilkoff BL,et al. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction[J]. Heart Rhythm,2017,14(12):e503-e551.
[5]赵亚樵.高龄患者植入永久性心脏起搏器的安全性评价[J].中国老年学杂志,2013,33(19):5675-5676.
[6]吴辉,杨俊,丁家望,等.国产与进口心脏单腔起搏器临床应用比较[J].中国心脏起搏与心电生理杂志,2016,30(2):146-148.
[7] Semelka M,Gera J,Usman S. Sick sinus syndrome:a review[J].Am Fam Physician,2013,87(10):691-696.
[8]戴研,杨杰孚,周玉杰,等.家庭监测系统在双腔起搏器植入患者中的多中心注册研究[J].中国循环杂志,2013,28(1):29-32.
[9]卢冬雨,蔡鑫,张恒,等.国产心脏起搏器单中心103例回顾[J].中国心脏起搏与心电生理杂志,2015,29(6):571-573.
[2]彭勇,王军贤,孟天宇,等.国产心脏起搏器Qin Ming2312S/M匹配进口主动心室起搏电极的观察[J].中国心脏起搏与心电生理杂志,2013,27(6):562.
[3]李晓燕,谈红,刘科卫,等.国产心脏起搏器Qin Ming2312S/M临床应用的研究[J].中国心脏起搏与心电生理杂志,2013,27(1):11.
[4] Kusumoto FM,Schoenfeld MH,Wilkoff BL,et al. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction[J]. Heart Rhythm,2017,14(12):e503-e551.
[5]赵亚樵.高龄患者植入永久性心脏起搏器的安全性评价[J].中国老年学杂志,2013,33(19):5675-5676.
[6]吴辉,杨俊,丁家望,等.国产与进口心脏单腔起搏器临床应用比较[J].中国心脏起搏与心电生理杂志,2016,30(2):146-148.
[7] Semelka M,Gera J,Usman S. Sick sinus syndrome:a review[J].Am Fam Physician,2013,87(10):691-696.
[8]戴研,杨杰孚,周玉杰,等.家庭监测系统在双腔起搏器植入患者中的多中心注册研究[J].中国循环杂志,2013,28(1):29-32.
[9]卢冬雨,蔡鑫,张恒,等.国产心脏起搏器单中心103例回顾[J].中国心脏起搏与心电生理杂志,2015,29(6):571-573.