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圣犹达医疗公司植入式心律转复除颤器的预计寿命与实际寿命之间存在显著差异。

Significant Discrepancy Between Estimated and Actual Longevity in St. Jude Medical Implantable Cardioverter-Defibrillators.

作者信息

Doppalapudi Harish, Barrios James, Cuellar Jose, Gannon Melanie, Yamada Takumi, Kumar Vineet, Maddox William R, Plumb Vance J, Brown Todd M, McElderry H Tom

机构信息

Division of Cardiovascular Disease, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.

University of Texas, Houston, Texas, USA.

出版信息

J Cardiovasc Electrophysiol. 2017 May;28(5):552-558. doi: 10.1111/jce.13178. Epub 2017 Mar 7.

Abstract

BACKGROUND

Real-time estimated longevity has been reported in pacemakers for several years, and was recently introduced in implantable cardioverter-defibrillators (ICDs).

OBJECTIVE

We sought to evaluate the accuracy of this longevity estimate in St. Jude Medical (SJM) ICDs, especially as the device battery approaches depletion.

METHODS

Among patients with SJM ICDs who underwent generator replacements due to reaching elective replacement indicator (ERI) at our institution, we identified those with devices that provided longevity estimates and reviewed their device interrogations in the 18 months prior to ERI. Significant discrepancy was defined as a difference of more than 12 months between estimated and actual longevity at any point during this period.

RESULTS

Forty-six patients with Current/Promote devices formed the study group (40 cardiac resynchronization therapy [CRT] and 6 single/dual chamber). Of these, 34 (74%) had significant discrepancy between estimated and actual longevity (28 CRT and all single/dual). Longevity was significantly overestimated by the device algorithm (mean maximum discrepancy of 18.8 months), more in single/dual than CRT devices (30.5 vs. 17.1 months). Marked discrepancy was seen at voltages ≥2.57 volts, with maximum discrepancy at 2.57 volts (23 months). The overall longevity was higher in the discrepant group of CRT devices than in the nondiscrepant group (67 vs. 61 months, log-rank P = 0.03).

CONCLUSIONS

There was significant overestimation of longevity in nearly three-fourths of Current/Promote SJM ICDs in the last 18 months prior to ERI. Longevity estimates of SJM ICDs may not be reliable for making clinical decisions on frequency of follow-up, as the battery approaches depletion.

摘要

背景

起搏器的实时估计寿命已报道数年,最近在植入式心脏复律除颤器(ICD)中也开始应用。

目的

我们试图评估圣犹达医疗(SJM)公司ICD中这种寿命估计的准确性,尤其是在设备电池接近耗尽时。

方法

在我院因达到择期更换指征(ERI)而接受发生器更换的SJM ICD患者中,我们确定那些设备提供寿命估计的患者,并回顾他们在ERI前18个月的设备问询情况。显著差异定义为在此期间任何时间点估计寿命与实际寿命相差超过12个月。

结果

46例使用Current/Promote设备的患者组成研究组(40例心脏再同步治疗[CRT]和6例单腔/双腔)。其中,34例(74%)估计寿命与实际寿命存在显著差异(28例CRT以及所有单腔/双腔患者)。设备算法显著高估了寿命(平均最大差异为18.8个月),单腔/双腔设备比CRT设备更明显(30.5个月对17.1个月)。在电压≥2.57伏时出现明显差异,在2.57伏时差异最大(23个月)。CRT设备差异组的总体寿命高于无差异组(67个月对61个月,对数秩检验P = 0.03)。

结论

在ERI前的最后18个月,近四分之三的Current/Promote SJM ICD的寿命被显著高估。随着电池接近耗尽,SJM ICD的寿命估计可能无法可靠地用于做出关于随访频率的临床决策。

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