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植入式除颤器起搏/感知导线适配器的性能

Performance of implantable defibrillator pacing/sensing lead adapters.

作者信息

Sgarbossa E B, Shewchik J, Pinski S L

机构信息

Department of Cardiology, Cleveland Clinic Foundation, Ohio 44195, USA.

出版信息

Pacing Clin Electrophysiol. 1996 May;19(5):811-4. doi: 10.1111/j.1540-8159.1996.tb03363.x.

DOI:10.1111/j.1540-8159.1996.tb03363.x
PMID:8734748
Abstract

The wide variety of implantable defibrillators (ICDs) available from different manufactures and the lack of universal industry standards has resulted in the frequent need for lead adapters at time of ICD implant or change. We analyzed the performance of 81 consecutive ICD sensing/pacing lead adapters used between 1988 and 1993. A total of 66 adapters was used for new epicardial systems, and 15 adapters served as lead connectors during ICD generator replacement. Pacing/sensing lead adapters used were: model LA-201 (n = 28; 34.5%); model 030-308 (n = 26; 32%); model 5866-24 (n = 15; 18.5%); and miscellaneous (n = 12; 15%). After a mean follow-up of 21 +/- 16 months, nine pacing/sensing lead adapters had documented or strongly suspected failure. Most often pacing/sensing lead adapters presented clinically as frequent aborted shocks. Actuarial probability of freedom from failure for model LA-201 was 83% at 1 year, and 72% at 2 and 3 years; this was poorer than for the other sensing leads combined (P = 0.01; hazard ratio = 4.92; 95% confidence intervals = 1.2-20; log-rank test). In conclusion, pacing/sensing lead adapters are a potential source of ICD system complications. Performance is dissimilar among different models; specifically, model LA-201 may not be safe in the long-term, and patients with this lead adapter need to be closely monitored.

摘要

不同制造商提供的可植入式除颤器(ICD)种类繁多,且缺乏通用的行业标准,这导致在植入或更换ICD时经常需要使用导联适配器。我们分析了1988年至1993年间连续使用的81个ICD感知/起搏导联适配器的性能。共有66个适配器用于新的心外膜系统,15个适配器在更换ICD发生器时用作导联连接器。使用的起搏/感知导联适配器有:LA-201型(n = 28;34.5%);030-308型(n = 26;32%);5866-24型(n = 15;18.5%);以及其他类型(n = 12;15%)。平均随访21±16个月后,有9个起搏/感知导联适配器记录到或强烈怀疑出现故障。起搏/感知导联适配器临床上最常表现为频繁的电击中止。LA-201型在1年时无故障的精算概率为83%,在2年和3年时为72%;这比其他感知导联组合的情况要差(P = 0.01;风险比 = 4.92;95%置信区间 = 1.2 - 20;对数秩检验)。总之,起搏/感知导联适配器是ICD系统并发症的一个潜在来源。不同型号之间的性能存在差异;具体而言,LA-201型从长期来看可能不安全,使用这种导联适配器的患者需要密切监测。

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