植入式心脏除颤复律器的寿命、影响因素及与行业预期寿命的比较。
Longevity of implantable cardioverter-defibrillators, influencing factors, and comparison to industry-projected longevity.
机构信息
Department of Cardiology, University of Basel Hospital, Basel, Switzerland.
出版信息
Heart Rhythm. 2009 Dec;6(12):1737-43. doi: 10.1016/j.hrthm.2009.09.013. Epub 2009 Sep 11.
BACKGROUND
Because the best possible device longevity is crucial (i.e., risk of infection with premature device exchange, current cost-effectiveness calculations depending on reasonable longevity, patient comfort), industry-independent real-life data are fundamental. However, only limited independent data on the longevity of implantable cardioverter-defibrillators (ICDs) are available.
OBJECTIVE
The purpose of this study was to determine ICD device longevity and influencing factors.
METHODS
From a prospective database, we studied overall device longevity and identified those devices with replacement for battery depletion or prolonged charge time. For every device, we determined factors that included averaged shocks, pacing percentage, pacing mode, device size, and time of implant. Survival probabilities at different time intervals were calculated, and Kaplan-Meier and Cox regression analyses were used. Observed longevity was compared to industry-projected longevity obtained from product performance reports.
RESULTS
A total of 644 ICDs (Medtronic 317, Guidant 189, St. Jude 118, Intermedics 20) were implanted in 499 patients. During follow-up, 163 (25.3%) ICDs were replaced. Manufacturer, time of implant, pacing mode, pacing percentage, and capacitor reformation interval influenced longevity, whereas device size and number of shocks did not. Median longevity was 7.6 years for Medtronic devices, 5.0 years for Guidant devices, and 3.8 years for St. Jude devices. After 5 years, only 70% of ICDs were still in service compared to the 80% projected by industry.
CONCLUSION
Marked differences in device longevity among manufacturers cannot be explained by pacing mode, number of shocks, or pacing percentage only. Overall, device performance requires further improvement for the sake of patient health and cost.
背景
由于尽可能延长设备寿命至关重要（例如，因过早更换设备而导致感染的风险、当前基于合理寿命的成本效益计算、患者舒适度），因此需要基于独立的现实数据。然而，目前只有有限的关于植入式心脏复律除颤器（ICD）寿命的独立数据。
目的
本研究旨在确定 ICD 设备的寿命及其影响因素。
方法
我们从前瞻性数据库中研究了总体设备寿命，并确定了因电池耗尽或充电时间延长而更换的设备。对于每台设备，我们确定了包括平均电击次数、起搏百分比、起搏模式、设备尺寸和植入时间等因素。计算了不同时间间隔的生存概率，并使用 Kaplan-Meier 和 Cox 回归分析。观察到的寿命与从产品性能报告中获得的行业预测寿命进行了比较。
结果
共植入 644 台 ICD（美敦力 317 台、Guidant 189 台、圣犹达 118 台、百多力 20 台）于 499 例患者。在随访期间，有 163 台（25.3%）ICD 被更换。制造商、植入时间、起搏模式、起搏百分比和电容器重建间隔影响了寿命，而设备尺寸和电击次数则没有影响。美敦力设备的中位寿命为 7.6 年，Guidant 设备为 5.0 年，圣犹达设备为 3.8 年。5 年后，只有 70%的 ICD 仍在使用，而行业预计为 80%。
结论
制造商之间设备寿命的显著差异不能仅用起搏模式、电击次数或起搏百分比来解释。总体而言，为了患者的健康和成本，设备性能需要进一步改进。
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