Medizinische Klinik II, Klinikum Kassel, Mönchebergstrasse 41-43, 34125, Kassel, Germany,
Clin Res Cardiol. 2015 Jun;104(6):456-60. doi: 10.1007/s00392-014-0807-y. Epub 2015 Feb 19.
In 2005, Bob Hauser published a paper in the Journal of the American College of Cardiology entitled "The growing mismatch between patient longevity and the service life of Implantable Cardioverter-Defibrillators". Now, nearly a decade later, I would like to perform a second look on the problem of a mismatching between ICD device service life and the survival of ICD recipients. Since 2005, the demographics of the ICD population has changed significantly. Primary prevention has become the dominant indication in defibrillator therapy and device implantation is indicated more and more in earlier stages of cardiac diseases. In former larger scale ICD trials, the patient average 5-year survival probability was in a range of 68-71%; in newer CRT-D trials in a range of 72-88%. Due to a progressively widened ICD indication and implantation preferentially performed in patients with better life expectancy, the problem of inadequate device service life is of growing importance. The early days of defibrillator therapy started with a generator volume of 145 ccm and a device service life <18 months. In this early period, the device miniaturization and extension of service life were similar challenges for the technicians. Today, we have reached a formerly unexpected extent of device miniaturization. However, technologic improvements were often preferentially translated in further device miniaturization and not in prolonging device service life. In his analysis, Bob Hauser reported a prolonged device service life of 2.3 years in ICD models with a larger battery capacity of 0.54 up to 0.69 Ah. Between 2008 and 2014, several studies had been published on the problem of ICD longevity in clinical scenarios. These analyses included "older" and currently used single chamber, dual chamber and CRT devices. The reported average 5-year device service life ranged from 0 to 75%. Assuming today technology, larger battery capacities will only result in minimal increase in device volume. Selected ICD patients may further benefit from device miniaturization-but the vast majority may much more benefit from a significant prolongation in device service life. All published cost-effectiveness analyses in ICD therapy show that device costs and device service life are the dominant determinants of the results. The performed "second look-nearly a decade later" revealed that there are still relevant limitations regarding the device service life in current defibrillator therapy. Technical improvements were preferentially transformed into device miniaturization but not into prolonging device service life. But this optimization is strongly enforced. The most feasible solution might be the use of device batteries with larger capacities. The economic burden, mainly caused by non-adequate device service life, may limit the future realization of ICD therapy in a progressively growing patient population. In the former years, physicians and device manufacturers have ignored the patient perspective in defibrillator therapy. However, it is the patient viewpoint that prolonged device service life is much more important than smaller generator size.
2005 年，Bob Hauser 在《美国心脏病学会杂志》上发表了一篇题为“患者寿命的延长与植入式心脏复律除颤器寿命之间日益不匹配”的论文。现在，将近十年后，我想对 ICD 设备寿命与 ICD 接受者生存之间不匹配的问题进行第二次研究。自 2005 年以来，ICD 人群的人口统计学特征发生了显著变化。一级预防已成为电复律治疗的主要适应证，并且越来越多地在心脏病的早期阶段进行设备植入。在前几次较大规模的 ICD 试验中，患者 5 年生存率在 68-71%的范围内；在最近的 CRT-D 试验中，这一比例在 72-88%之间。由于 ICD 适应证的不断扩大，以及在预期寿命更长的患者中优先进行植入，设备寿命不足的问题变得越来越重要。电复律治疗的早期，发生器体积为 145 ccm，设备寿命<18 个月。在这个早期阶段，设备的小型化和寿命的延长对技术人员来说是类似的挑战。如今，我们已经达到了一个以前未曾预料到的设备小型化程度。然而，技术进步往往更优先转化为进一步的设备小型化，而不是延长设备寿命。在他的分析中，Bob Hauser 报告说，在电池容量为 0.54 至 0.69 Ah 的更大电池容量的 ICD 模型中，设备寿命延长了 2.3 年。2008 年至 2014 年，已有几篇关于临床情况下 ICD 寿命问题的研究发表。这些分析包括“较旧”和目前使用的单腔、双腔和 CRT 设备。报告的平均 5 年设备寿命从 0 到 75%不等。假设采用当今的技术，更大的电池容量只会使设备体积略有增加。一些选定的 ICD 患者可能会进一步受益于设备小型化，但绝大多数患者可能会从设备寿命的显著延长中获益更多。在 ICD 治疗中进行的所有已发表的成本效益分析都表明，设备成本和设备寿命是结果的主要决定因素。进行的“第二次观察——近十年后”显示，目前的电复律治疗中仍然存在与设备寿命相关的限制。技术进步优先转化为设备小型化，而不是延长设备寿命。但这种优化是强制性的。最可行的解决方案可能是使用具有更大容量的设备电池。主要由设备寿命不足引起的经济负担可能会限制 ICD 治疗在不断增长的患者群体中的未来实现。在过去的几年里，医生和设备制造商忽视了电复律治疗中的患者观点。然而，对于患者来说，设备寿命的延长比发电机尺寸的缩小更为重要。
