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基于制造商和心室起搏量的植入式心脏复律除颤器寿命的真实世界数据。

Real-world data on the lifespan of implantable cardioverter-defibrillators depending on manufacturers and the amount of ventricular pacing.

机构信息

Department of Medicine-Cardiology, University of Bonn, Bonn, Germany.

出版信息

J Cardiovasc Electrophysiol. 2012 Dec;23(12):1336-42. doi: 10.1111/j.1540-8167.2012.02408.x. Epub 2012 Aug 21.

DOI:10.1111/j.1540-8167.2012.02408.x
PMID:22909190
Abstract

INTRODUCTION

Implantable cardioverter-defibrillator (ICD) longevity is crucial for both patients and public health systems because it determines the number of surgical ICD replacements, which can generally be considered an additional risk factor for complications, and the cost-effectiveness of ICD therapy. Our objective was to obtain insight into the "real-world" longevities of implantable cardioverter-defibrillators, which quite often differ from those stated in the manufacturers' declarations.

METHODS AND RESULTS

On the basis of a prospective database, we analyzed all ICD implantations performed in our hospital from June 1988 to June 2009. We studied 980 patients (follow-up 58 ± 51 months) with 1,502 ICDs and all respective data until August 2010. We compared the percentage of still operating ICDs at different points in time in relation to manufacturers, types of device (single chamber 623, dual chamber 588, cardiac resynchronization therapy ICDs [CRT-D] 291), and amount of right ventricular pacing (VP). We found distinct differences between the mean lifespans of ICDs of different manufacturers (Biotronik 4.3 years, Sorin 4.5 years, Guidant/Boston Scientific 4.7 years, St. Jude Medical 5 years, Medtronic 5.8 years). CRT-D devices (hazard ratio [HR] 1.778, P = 0.0005) were associated with an elevated annual relative risk for device replacement while a decrease in the proportion of VP (HR 0.934 for each 10% decrease in VP, P < 0.0001) and Medtronic ICDs were associated with a reduced risk of device replacement (HR 0.544, P < 0.0001).

CONCLUSION

CRT-Ds and an elevated percentage of VP are associated with a significantly elevated risk for device replacement, while Medtronic ICDs showed the longest lifespans.

摘要

简介

植入式心脏复律除颤器(ICD)的使用寿命对患者和公共卫生系统都至关重要,因为它决定了需要进行 ICD 更换的手术数量,而更换手术通常被视为并发症的另一个风险因素,同时也决定了 ICD 治疗的成本效益。我们的目的是深入了解植入式心脏复律除颤器的“实际”使用寿命,因为它与制造商声明中的数据往往不同。

方法和结果

我们基于前瞻性数据库,分析了 1988 年 6 月至 2009 年 6 月在我院进行的所有 ICD 植入术。共纳入 980 例患者(随访 58±51 个月)和 1502 个 ICD,直至 2010 年 8 月,研究所有相关数据。我们比较了不同时间制造商、设备类型(单腔 623 个,双腔 588 个,心脏再同步治疗除颤器[CRT-D] 291 个)和右心室起搏(VP)量的仍在运行的 ICD 的百分比。我们发现不同制造商的 ICD 平均寿命存在明显差异(Biotronik 为 4.3 年,Sorin 为 4.5 年,Guidant/Boston Scientific 为 4.7 年,St. Jude Medical 为 5 年,Medtronic 为 5.8 年)。CRT-D 设备(风险比[HR]为 1.778,P=0.0005)与设备更换的年相对风险增加相关,而 VP 比例降低(VP 每降低 10%,HR 为 0.934,P<0.0001)和 Medtronic ICD 与设备更换风险降低相关(HR 为 0.544,P<0.0001)。

结论

CRT-D 和较高的 VP 比例与设备更换的风险显著增加相关,而 Medtronic ICD 显示出最长的使用寿命。

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