Ellinor Patrick T, Guy Mary L, Ruskin Jeremy N, McGovern Brian A
Cardiac Arrhythmia Service, Cardiology Division, Massachusetts General Hospital, Boston, Massachusetts, USA.
Pacing Clin Electrophysiol. 2003 Jan;26(1 Pt 1):71-5. doi: 10.1046/j.1460-9592.2003.00153.x.
ICDs are used frequently to treat malignant ventricular arrhythmias. Despite the expanding role of these devices, little is known about the manufacturer variability in the performance of ICD generators. The purpose of this study is to explore the indications for ICD pulse generator replacement and to examine performance differences between the three major manufacturers of ICDs in the United States. The authors performed a retrospective review of ICD pulse generators that were implanted and replaced at Massachusetts General Hospital between February 1998 and March 2002. During the study period, 50 (7%) of the 707 devices in the study cohort were replaced. The most common indication for pulse generator replacement was related to battery performance followed by device recall, upgrade to a dual chamber device, and pulse generator malfunction. After exclusion of the recalled devices, a significantly higher number of pulse generators manufactured by St. Jude Medical (14/229) required replacement for battery depletion or prolonged change times during the study period compared with devices from Guidant (2/220) or Medtronic (0/273), P = 0.003 and P < 0.0001, respectively. This difference was attributable to reduced longevity in the Angstrom series of defibrillators.
植入式心脏除颤器(ICD)常用于治疗恶性室性心律失常。尽管这些设备的作用不断扩大,但对于ICD发生器性能方面的制造商差异却知之甚少。本研究的目的是探讨ICD脉冲发生器更换的指征,并考察美国三大ICD制造商产品之间的性能差异。作者对1998年2月至2002年3月期间在麻省总医院植入并更换的ICD脉冲发生器进行了回顾性研究。在研究期间,研究队列中的707台设备中有50台(7%)被更换。脉冲发生器更换最常见的指征与电池性能有关,其次是设备召回、升级为双腔设备以及脉冲发生器故障。排除召回的设备后,与Guidant公司(2/220)或美敦力公司(0/273)的设备相比,圣犹达医疗公司生产的脉冲发生器在研究期间因电池耗尽或更换时间延长而需要更换的数量显著更多,P值分别为0.003和<0.0001。这种差异归因于埃格斯特朗系列除颤器寿命的缩短。