Klampfleitner Stefanie, Mundel Markus, Schinke Karin, Neuberger Hans-Ruprecht
Sektion Kardiologie-Rhythmologie, Klinikum Traunstein, Traunstein, Germany.
Klinik für Innere Medizin III, Universitätsklinikum Homburg, Universität des Saarlandes, Saarbrücken, Saarland, Germany.
J Cardiovasc Electrophysiol. 2023 Mar;34(3):700-709. doi: 10.1111/jce.15804. Epub 2023 Jan 22.
Lead failure is the major limitation in implantable cardioverter-defibrillator (ICD) therapy. Long-term follow-up data for Biotronik Linox ICD leads are limited. Therefore, we analyzed the performance of all these leads implanted at our institution.
All Linox and Linox Smart ICD leads implanted between 2006 and 2015 were identified. Lead failure was defined as electrical dysfunction (oversensing, abnormal impedance, exit block). Lead survival was described, according to Kaplan-Meier. Associations between lead failure and specific variables were examined. p < .05 was considered significant.
We included 417 ICD leads. The median follow-up time for Linox (n = 205) was 81 months and for Linox Smart (n = 212) 75 months. During that follow-up time, 30 Linox (14.6%) and 16 Linox Smart leads (7.6%) showed a malfunction. The 5-year lead survival probability was 97.4% for Linox and 95.2% for Linox Smart (log-rank test, p = .19). The 6- and 8-year lead survival probability for Linox was 93.6% and 84.6%, and for Linox Smart 93% and 91.9%. The only factor significantly associated with lead failure was younger patient age at implantation (hazard ratio/year: 0.97, 95% CI: 0.94-0.99, p = .002).
This relatively large study with a long follow-up period highlights a relevant failure rate of Biotronik Linox leads. The performance of Linox versus Linox Smart ICD leads was comparable. Although we show an acceptable 5-year lead survival probability, we observed a marked drop after just 1 more year of follow-up. In an era of improving heart failure survival probability, a prolonged follow-up of ICD leads is increasingly clinically relevant.
导线故障是植入式心脏转复除颤器（ICD）治疗的主要限制因素。百多力Linox ICD导线的长期随访数据有限。因此，我们分析了在我们机构植入的所有这些导线的性能。
确定2006年至2015年间植入的所有Linox和Linox Smart ICD导线。导线故障定义为电功能障碍（感知过度、阻抗异常、出口阻滞）。根据Kaplan-Meier法描述导线生存率。检查导线故障与特定变量之间的关联。p < 0.05被认为具有统计学意义。
我们纳入了417根ICD导线。Linox导线（n = 205）的中位随访时间为81个月，Linox Smart导线（n = 212）为75个月。在该随访期间，30根Linox导线（14.6%）和16根Linox Smart导线（7.6%）出现故障。Linox导线的5年导线生存概率为97.4%，Linox Smart导线为95.2%（对数秩检验，p = 0.19）。Linox导线的6年和8年导线生存概率分别为93.6%和84.6%，Linox Smart导线分别为93%和91.9%。与导线故障显著相关的唯一因素是植入时患者年龄较小（每年风险比：0.97，95%可信区间：0.94 - 0.99，p = 0.002）。
这项随访期长的相对大型研究突出了百多力Linox导线的相关故障率。Linox与Linox Smart ICD导线的性能相当。尽管我们显示出可接受的5年导线生存概率，但在再随访1年后就观察到明显下降。在心力衰竭生存概率不断提高的时代，对ICD导线进行延长随访在临床上越来越重要。
