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临床环境下植入式除颤器使用寿命分析:对设备选择的影响

Analysis of implantable defibrillator longevity under clinical circumstances: implications for device selection.

作者信息

Knops Paul, Theuns Dominic A M J, Res Jan C J, Jordaens Luc

机构信息

Erasmus Medical Center, Rotterdam, The Netherlands.

出版信息

Pacing Clin Electrophysiol. 2009 Oct;32(10):1276-85. doi: 10.1111/j.1540-8159.2009.02482.x.

DOI:10.1111/j.1540-8159.2009.02482.x
PMID:19796344
Abstract

INTRODUCTION

Information about implantable cardioverter-defibrillator (ICD) longevity is mostly calculated from measurements under ideal laboratory conditions. However, little information about longevity under clinical circumstances is available. This survey gives an overview on ICD service times and generator replacements in a cohort of consecutive ICD patients.

METHODS

Indications for replacement were classified as a normal end-of-service (EOS), premature EOS, system malfunction, infection and device advisory, or recall actions. From the premature and normal EOS group, longevity from single-chamber (SC), dual-chamber (DC), and cardiac resynchronization therapy defibrillator (CRT-D), rate-responsive (RR) settings, high output (HO) stimulation, and indication for ICD therapy was compared. Differences between brands were compared as well.

RESULTS

In a total of 854 patients, 203 ICD replacements (165 patients) were recorded. Premature and normal EOS replacements consisted of 32 SC, 98 DC and 24 CRT-D systems. Longevity was significantly longer in SC systems compared to DC and CRT-D systems (54 +/- 19 vs. 40 +/- 17 and 42 +/- 15 months; P = 0.008). Longevity between non-RR (n = 143) and RR (n = 11) settings was not significantly different (43 +/- 18 vs. 45 +/- 13 months) as it also was not for HO versus non-HO stimulation (43 +/- 19 vs. 46 +/- 17 months). Longevity of ICDs was not significantly different between primary and secondary prevention (42 +/- 19 vs. 44 +/- 18 months). The average longevity on account of a device-based EOS message was 43 +/- 18 months. Average longevity for Biotronik (BIO, n = 72) was 33 +/- 10 months, for ELA Medical (ELA, n = 12) 44 +/- 17 months, for Guidant (GDT, n = 36) 49 +/- 12 months, for Medtronic (MDT, n = 29) 62 +/- 22 months, and for St. Jude Medical (SJM, n = 5) 31 +/- 9 months (P < 0.001).

CONCLUSION

SC ICD generators had a longer service time compared to DC and CRT-D systems. No influence of indication for ICD therapy and HO stimulation on generator longevity was observed in this study. MDT ICDs had the longest service time.

摘要

引言

关于植入式心脏复律除颤器(ICD)使用寿命的信息大多是根据理想实验室条件下的测量得出的。然而,关于临床情况下使用寿命的信息却很少。本调查概述了一组连续ICD患者的ICD使用时间和发生器更换情况。

方法

更换指征分为正常服务结束(EOS)、过早EOS、系统故障、感染及设备咨询或召回行动。比较过早EOS组和正常EOS组中单腔(SC)、双腔(DC)和心脏再同步治疗除颤器(CRT-D)、频率应答(RR)设置、高输出(HO)刺激以及ICD治疗指征的使用寿命。同时也比较了不同品牌之间的差异。

结果

总共854例患者中,记录到203次ICD更换(165例患者)。过早和正常EOS更换包括32个SC系统、98个DC系统和24个CRT-D系统。SC系统的使用寿命明显长于DC和CRT-D系统(54±19个月对40±17个月和42±15个月;P = 0.008)。非RR(n = 143)和RR(n = 11)设置之间的使用寿命无显著差异(43±18个月对45±13个月),HO刺激与非HO刺激之间也无显著差异(43±19个月对46±17个月)。ICD在一级预防和二级预防之间的使用寿命无显著差异(42±19个月对44±18个月)。基于设备的EOS信息的平均使用寿命为43±18个月。百多力(BIO,n = 72)的平均使用寿命为33±10个月,伊拉医疗(ELA,n = 12)为44±17个月,Guidant(GDT,n = 36)为49±12个月,美敦力(MDT,n = 29)为62±22个月,圣犹达医疗(SJM,n = 5)为31±9个月(P < 0.001)。

结论

与DC和CRT-D系统相比,SC ICD发生器的使用时间更长。本研究未观察到ICD治疗指征和HO刺激对发生器使用寿命的影响。美敦力ICD的使用时间最长。

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