Multicenter experience with failed and recalled implantable cardioverter-defibrillator pulse generators
Multicenter experience with failed and recalled implantable cardioverter-defibrillator pulse generators
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DOI：
10.1016/j.hrthm.2006.02.011
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发表时间：
2006-06-01
期刊：
影响因子：
5.5
通讯作者：
Tyers, G. Frank O.
中科院分区：
文献类型：
--
作者：
Hauser, Robert G.;Hayes, David L.;Tyers, G. Frank O.
背景尽管植入式心律转复除颤器（ICD）的广泛和日益增长的使用，很少有信息是关于他们的性能或先进的起搏功能对ICD的可靠性和Longevity. AcceptivesThe的影响，本研究的目的是检查当代ICD脉冲发生器的性能，失败或被替换，因为制造商recalles.METHODS ICD数据被前瞻性地输入了9个参与中心。ICD脉冲发生器故障被定义为因器械未按照制造商规范运行而停止使用。被召回的ICD是一个功能正常的脉冲发生器，被更换为召回或advisory.RESULTS的结果，从1998年至2005年，1,220 ICD失败，135被召回和更换。失败ICD的平均植入时间为4.4 ± 1.5年，召回ICD的平均植入时间为1.7 ± 0.8年。具有频率响应或心脏起搏（CRT-D）功能的单腔和双腔ICD的平均植入时间显著短于不具有这些功能的单腔或双腔器械的平均植入时间（P < .001）。提供频率响应或CRT-D起搏的ICD由于电池耗尽而更早失效（P < .001），并且更容易发生意外的电子或外壳故障（9% vs 5%，P = .008）和召回（25% vs 1%，P < .0001）。主要不良事件包括死亡（n = 2），未能转换室性快速性心律失常（n = 6），和不适当的电击（n = 11）。结论根据我们的分析失败和召回的设备，当代ICD的性能已受到不利影响的电池过早耗尽，电子故障，和制造商的召回。需要更多的研究来精确估计ICD的寿命，并确定意外ICD故障的发生率。
BACKGROUND Despite the widespread and growing use of implantable cardioverter-defibrillators (ICDs), little information is available regarding their performance or the impact of advanced pacing functions on ICD reliability and Longevity.OBJECTIVES The purpose of this study was to examine the performance of contemporary ICD pulse generators that failed or were replaced because of manufacturers recalls.METHODS ICD data were entered prospectively by nine participating centers. ICD pulse generator failure was defined as removal from service because the device was not functioning according to the manufacturer's specifications. A recalled ICD was a normally functioning pulse generator that was replaced as the result of a recall or advisory.RESULTS From 1998 to 2005, 1,220 ICDs failed and 135 were recalled and replaced. The average implant time of failed ICDs was 4.4 +/- 1.5 years and of recalled-ICDs was 1.7 +/- 0.8 years. The average implant time of single- and dual-chamber ICDs with rate responsive or cardiac resynchronization (CRT-D) pacing capabilities was significantly shorter than the average implant time of single- or dual-chamber devices without these features (P < .001). ICDs that provided rate responsive or CRT-D pacing failed earlier because of battery depletion (P < .001) and were significantly more prone to unexpected electronic or housing failure (9% vs 5%, P = .008) and recalls (25% vs 1%, P < .0001). Major adverse events included death (n = 2), failure to convert ventricular tachyarrhythmias (n = 6), and inappropriate shocks (n = 11).CONCLUSION Based on our analysis of failed and recalled devices, the performance of contemporary ICDs has been adversely affected by premature battery depletion, electronic failure, and manufacturers' recalls. Additional studies are needed to precisely estimate ICD longevity and to determine the incidence of unexpected ICD failure.