Seifert Martin, Neuss Michael, Schöpp Maren, Koban Cornel, Butter Christian
Abteilung für Kardiologie, Immanuel Klinikum Bernau und Herzzentrum Brandenburg, Ladeburger Straße 17, 16321, Bernau bei Berlin, Germany.
Herzschrittmacherther Elektrophysiol. 2013 Sep;24(3):141-7. doi: 10.1007/s00399-013-0278-2. Epub 2013 Aug 6.
In the last decade manufacturers of cardiac rhythm management devices focused mainly on the reduction of both device and lead size. Furthermore the implementation of additional functions like cardiac monitoring and new algorithms as well as increasing defibrillation safety through higher energy delivery became of greater interest. The FDA recall (class I) of some of the commonly used ICD leads led to a change in thinking in ICD therapy, more attention to device and lead function control in addition to the increased awareness of lead complications. These issues changed our daily behaviour in ICD implantation and follow up effectively. The following article gives an overview of ICD lead performance, suitable recalls, complications as well as available control functions. The need for improved market supervision of lead function in the medical community and proven alternative device therapies for selected patients is being discussed.
在过去十年中，心律管理设备制造商主要专注于减小设备和导线的尺寸。此外，诸如心脏监测和新算法等附加功能的实现，以及通过更高能量输送提高除颤安全性，变得更受关注。美国食品药品监督管理局（FDA）对一些常用植入式心律转复除颤器（ICD）导线的召回（I类）导致了ICD治疗思路的转变，除了对导线并发症的认识提高外，更加关注设备和导线功能的控制。这些问题有效地改变了我们在ICD植入和随访中的日常行为。以下文章概述了ICD导线的性能、合适的召回情况、并发症以及可用的控制功能。还讨论了在医学界改善导线功能市场监管的必要性，以及为特定患者提供经过验证的替代设备疗法。
